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full study rank 61293 study protocol section identification module n c t id NCT04838353 org study id info org study id CIP-0002 organization org full name Alleviant Medical, Inc. org class INDUSTRY brief title Alleviate-HF-2 Study official title Evaluation of the Safety and Effectiveness of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction status module status verified date July 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 3, 2021 start date type Actual primary completion date struct primary completion date September 1, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 26, 2022 last update post date struct last update post date July 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Alleviant Medical, Inc. lead sponsor class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% < EF < 50%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data conditions module condition list condition Heart Failure design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 13 enrollment type Actual arms interventions module intervention list intervention intervention type Device intervention name ALV1 System intervention description The ALV1 system is designed to create a controlled size interatrial shunt via a proprietary intra-cardiac catheter. There is no temporary or permanent implant used to create or maintain the interatrial shunt. The therapy is intended to be delivered in a single procedure administered under general anesthesia in a cardiac catheterization laboratory. outcomes module primary outcome list primary outcome primary outcome measure The composite incidence of one or more major adverse cardiac, cerebrovascular and thromboembolic events and change in supine exercise PCWP at peak exercise. primary outcome description Defined as cardiovascular death, embolic stroke, embolic myocardial infarction, pulmonary or arterial embolism, device-and/or procedure-related serious adverse cardiac events. primary outcome time frame At 1 month and through 12 months eligibility module eligibility criteria Inclusion Criteria: NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit. Medical history within the past 12 months of at least one hospitalization with heart failure as the primary or secondary diagnosis OR treatment with IV diuretics for heart failure.. LVEF (by Echo) > 40% as measured by the study-specific transthoracic echocardiography. Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol: LA diameter > 4cm LA volume index >28 mL Lateral e' <10 cm/s Septal e' <8 cm/s Lateral E/e' >10 Septal E/e' >15 As measured by the study-specific exercise hemodynamic right heart catheterization protocol performed during screening: Elevated left atrial pressure WITH a gradient compared to right atrial pressure (RAP) documented by: (1) end-expiratory PCWP at peak supine cycle ergometer exercise ≥ 25mmHg AND (2) PCWP greater than RAP by ≥ 5 mmHg, OR (1) ≥ 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND (2) PCWP greater than RAP by ≥ 5 mmHg. Patients must also have PCWP greater than RAP by ≥ 5 mmHg at rest. Exclusion Criteria: Presence of advanced heart failure defined as one or more of the following: ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF. Cardiac index less than 2.0 L/min/m2. Patient is on the cardiac transplant waiting list. Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months. Presence of moderate or worse valve disease, defined as one or more of the following: Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis. Moderate or worse tricuspid valve regurgitation. Moderate or worse aortic valve disease defined as moderate or worse AS or AI. . Presence of chronic pulmonary disease defined by one or more of the following: Requirement for continuous home oxygen use. Hospitalization within the past 12 months for treatment of pulmonary disease. Significant chronic pulmonary disease defined as FEV1 less than 50%. Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2 6-minute walk distance less than 50 m or greater than 450 m performed during screening. Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening. Presence of moderate or worse right heart dysfunction OR RV dysfunction defined as TAPSE less than 14 mm or RVFAC less than or equal to 30% Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units. Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm) SBP greater than 170 mmHg at screening. Documented left ventricular end diastolic diameter greater than 6 cm. healthy volunteers No gender All minimum age 40 Years std age list std age Adult Older Adult contacts locations module location list location location facility Flinders Medical Centre location city Adelaide location country Australia location facility Monash Medical Centre location city Clayton location country Australia location facility Centre Hospitalier de l'Université de Montréal (CHUM) location city Montréal location country Canada location facility Southern District Health Board location city Dunedin location country New Zealand location facility Karolinska University Hospital location city Stockholm location country Sweden derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006333 condition mesh term Heart Failure condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M8573 condition browse leaf name Heart Failure condition browse leaf as found Heart Failure condition browse leaf relevance high condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M4006 intervention browse leaf name Benzocaine intervention browse leaf relevance low intervention browse leaf id T433 intervention browse leaf name Tannic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements
NCT04838353
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full study rank 61691 study protocol section identification module n c t id NCT04833179 org study id info org study id 001320 organization org full name Tel-Aviv Sourasky Medical Center org class OTHER_GOV brief title Fecal Transplant for Alopecia Areata official title Fecal Transplant for Alopecia Areata status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 2021 start date type Anticipated primary completion date struct primary completion date April 2024 primary completion date type Anticipated completion date struct completion date April 2025 completion date type Anticipated study first submit date March 1, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Eli Sprecher, MD responsible party investigator title Liat Samuelov MD. Vice Chair, Division of Dermatology, Tel Aviv Sourasky Medical Center responsible party investigator affiliation Tel-Aviv Sourasky Medical Center lead sponsor lead sponsor name Tel-Aviv Sourasky Medical Center lead sponsor class OTHER_GOV oversight module is f d a regulated drug No is f d a regulated device No description module brief summary the investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. This may help dermatologists in the future and expand the treatment options for AA. detailed description Alopecia areata (AA) is a common autoimmune disease that triggers non scarring hair loss in different severities. Usually the hair loss will be contained to the scalp and / or beard, but in some cases, there will be total hair loss from the entire scalp (alopecia totalis), or complete loss of all body, facial and scalp hair (alopecia universalis). AA is an autoimmune disease that produces an inflammation surrounding the hair follicles, this leads to temporary hair loss. In cases the disease become chronic, the immune system attack may lead to a permanent hair loss. This common hair disease has a significant impact on the patient's quality of life, it can cause impairment on the patient's confidence, self-esteem, lead to depression and more. Lately two patients with AA and clostridium difficile infection were treated with fecal transplantation for their infection (Rebello et al. 2017). After the transplant a significant improvement was notice in hair growth. These 2 cases raised the option that a fecal transplant may have an additional effect on the autoimmune reaction against the hair follicle in AA. the investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. This may help dermatologists in the future and expand the treatment options for AA. conditions module condition list condition Alopecia Areata keyword list keyword Alopecia Areata Fecal transplant Microbiome design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description 110 patients with alopecia areata. Prior the beginning of the study all subjects will undergo: Complete physical examination Clinical image of involved locations will be taken Estimating the severity of the disease Microbiome samples Blood sample The patients with AA will undergo randomization into two groups. Group 1 - the subjects will receive a complete fecal transplant course. Group 2 - the subjects will receive placebo. design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 110 enrollment type Anticipated arms interventions module arm group list arm group arm group label fecal transplant arm group type Experimental arm group description Healthy donors will be selected by the fecal transplant unit, in Tel-Aviv medical center. The treatment will be given in the form of fecal capsule. Each capsule will contain a double capsule with 2 layers to ensure that the fecal material will be contained. The treatments will include 30 capsules for the first treatment, that will be taken in two consecutive days, each day 15 capsules. The second, third and fourth treatments will all include 15 fecal capsules. There will be 2 weeks intervals between each treatment. arm group intervention list arm group intervention name Biological: fecal transplant arm group label placebo arm group type Placebo Comparator arm group description Placebo capsule that can not be differentiate from the focal transplant capsule will be given in the same interval as the fecal transplant procedure written above. arm group intervention list arm group intervention name Other: placebo intervention list intervention intervention type Biological intervention name fecal transplant intervention description Healthy donors will be selected by the fecal transplant unit, in Tel-Aviv medical center. All donors will undergo a screening process that will include a detailed medical history, blood work and fecal tests. Only after passing the screening, the donor will be added to the groups of donors that will participant in this study. The treatment will be givenin the form of fecal capsule. Each capsule will contain a double capsule with 2 layers to ensure that the fecal material will be contained. The treatments will include 30 capsules for the first treatment, that will be taken in two consecutive days, each day 15 capsules. The second, third and fourth treatments will all include 15 fecal capsules. There will be 2 weeks intervals between each treatment. intervention arm group label list intervention arm group label fecal transplant intervention type Other intervention name placebo intervention description placebo intervention arm group label list intervention arm group label placebo outcomes module primary outcome list primary outcome primary outcome measure Severity alopecia tool score - SALT score I primary outcome description The SALT score I (Olsen, 2004) is a global severity score that captures percentage hair loss. The scalp area is divided into 4 quadrants - Left (L) Right (R) Back (B) Top (T). Photographs taken of the four views of the scalp. The percentage of hair loss in any one of the four views (areas) of the scalp = the percentage hair loss X percent surface area of the scalp in that area. left side view = ALOPECIA% x 18% right side view = ALOPECIA% x 18% top of scalp = ALOPECIA% x 40% back of scalp = ALOPECIA% x 24% The SUM of all equals the score. (possible score range: 0-100) primary outcome time frame up to1 year after fecal transplantation primary outcome measure Alopecia Areata Progression Index, AAPI primary outcome description formula for the total AAPI score (possible score range: 0-600). The scalp area is divided into 4 quadrants - Left (L) Right (R) Back (B) Top (T) using the Olsen/Canfield tool. The percent alopecic area (%AA) and score of hair loss activity (SL) is determined in each quadrant. The %AA is defined as the percentage of alopecic area in each compartment. SL is calculated as the sum of the results of hair pull tests (2 = positive, excessive, i.e. >20% of grasped hairs; 1 = positive, not excessive, 10-20%; 0 = negative, <10%) and the magnification findings associated with hair loss activity such as exclamation mark hairs, broken hairs and black dots (4 = ≥50%, 2 = <50%, 0 = 0%) in each quadrant. The total AAPI score is calculated by the following formula: [%AA(L) × SL(L) × 0.18] + [%AA(R) × SL(R) × 0.18] + [%AA(T) × SL(T) × 0.4] + [%AA(B) × SL(B) × 0.24]. (possible score range: 0-600) primary outcome time frame up to1 year after fecal transplantation primary outcome measure patient assessment. primary outcome description <25% regrowth. 25%<x<50% regrowth. 50%<x<70%regrowth. >75% regrowth. 100% regrowth. primary outcome time frame up to1 year after fecal transplantation eligibility module eligibility criteria Inclusion Criteria: AA patients with: Acute disease that appeared in the last 3 months. Recurrence of AA in the last 3 months, in a patient who had remission for at least one year. At least one patch of hair loss on the scalp and / or the beard, or with a widespread disease such as total loss of the hair over the entire scalp (alopecia totalis). In case of a single alopetic patch, the patch must be equal or bigger than 2 cm in diameter. All patients will be diagnosed by two separate dermatologist, or one dermatologist with the support of classical finding on skin biopsy. Exclusion Criteria: Patients who were treated with systemic corticosteroids / corticosteroids injection one year prior the study. Patients who were treated with topical corticosteroids two weeks prior the study. Patients who were treated with immunosuppressing medications or biological treatments one year prior the study. Patients who were treated with systemic antibiotics of any kind 3 months prior the study. Patient who were treated with topical antibiotics one months prior the study. Patients who were treated with probiotics one months prior the study. Patients with alopecia universalis (total loss of all body, scalp and facial hair). Patients with bowel disease or an active infection including clostridium difficile. Pregnant and breastfeeding women. Childrenbelow the age of 18. Malignant disease in the past 5 years. Patient with any infectious disease that require antibiotics during the study period. In any case a patient would like to withdraw from the study, for any reason, all samples will be destroyed immediately, and the patient will stop his participant in the study. healthy volunteers No gender All minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Efrat Bar-Ilan, MD central contact role Contact central contact phone +972-54-8186226 central contact e mail efratbarilan@gmail.com overall official list overall official overall official name Liat Samueluv, MD overall official affiliation Vice chair, Department of Dermatology Tel Aviv Sourasky Medical center, Israel overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000505 condition mesh term Alopecia condition mesh id D000000506 condition mesh term Alopecia Areata condition ancestor list condition ancestor condition ancestor id D000007039 condition ancestor term Hypotrichosis condition ancestor id D000006201 condition ancestor term Hair Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition browse leaf list condition browse leaf condition browse leaf id M2998 condition browse leaf name Alopecia condition browse leaf as found Alopecia condition browse leaf relevance high condition browse leaf id M2999 condition browse leaf name Alopecia Areata condition browse leaf as found Alopecia Areata condition browse leaf relevance high condition browse leaf id M9241 condition browse leaf name Hypotrichosis condition browse leaf relevance low condition browse leaf id M8445 condition browse leaf name Hair Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04833179
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full study rank 61852 study protocol section identification module n c t id NCT04831086 org study id info org study id OPTIM-PTL organization org full name Fundacion Clinic per a la Recerca Biomédica org class OTHER brief title To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis official title To Optimize Antenatal Management of Women Admitted With Pre Term Labor and Intact Membranes Using Multivariable Prediction Models: Multicenter Randomised Control Trial (OPTIM-PTL) acronym OPTIM-PTL status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 5, 2021 start date type Actual primary completion date struct primary completion date September 30, 2023 primary completion date type Anticipated completion date struct completion date December 30, 2023 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 11, 2022 last update post date struct last update post date May 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Teresa Cobo Cobo responsible party investigator title Senior Specialist responsible party investigator affiliation Fundacion Clinic per a la Recerca Biomédica lead sponsor lead sponsor name Fundacion Clinic per a la Recerca Biomédica lead sponsor class OTHER collaborator list collaborator collaborator name Hospital Vall d'Hebron collaborator class OTHER collaborator name Hospital Universitario La Fe collaborator class OTHER collaborator name Hospital Universitario La Paz collaborator class OTHER collaborator name Hospital Universitario 12 de Octubre collaborator class OTHER collaborator name Consorci Sanitari de Terrassa collaborator class OTHER collaborator name Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau collaborator class OTHER collaborator name Hospital Universitario Puerta del Mar collaborator class OTHER collaborator name Hospital Sant Joan de Deu collaborator class OTHER collaborator name Germans Trias i Pujol Hospital collaborator class OTHER collaborator name University Hospital Virgen de las Nieves collaborator class OTHER collaborator name Hospital Clínico Universitario Lozano Blesa collaborator class OTHER collaborator name Hospital Parc Taulí, Sabadell collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes detailed description To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection: Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes. It is a cost-effective strategy. It improves neonatal outcome (in premature newborns <30 weeks), and reduces infectious maternal morbility. It improves neurodevelopmental outcome at 1.2 and 5 years. conditions module condition list condition Preterm Birth Preterm Labor Intra-amniotic Infection Amniocentesis Affecting Fetus or Newborn design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor and intact membranes between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria. design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 340 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm group type Experimental arm group description In the intervention arm, the management will be optimized according to the risk of the predictive model. The predictive model of intra-amniotic infection includes maternal C-reactive protein (CRP) (in mg/L) and amniotic fluid glucose (in mg/dL), and the predictive model of spontaneous preterm delivery within 7 days includes gestational age (in weeks), cervical length (in mm), amniotic fluid glucose (in mg/dL) and Interleukin (IL)-6 (in a log10 scale). High risk will be defined when the risk is > 10% in the predictive model of spontaneous delivery in 7 days and > 20% in the predictive model of intra-amniotic infection: If low-risk: we will optimize the standard management reducing the dose of steroids (e.g not administering second doses), tocolysis duration and facilitating discharge home. If high-risk: we will follow the standard management of each center and we will treat with antibiotics arm group intervention list arm group intervention name Drug: Steroid Drug Drug: Tocolytic Agents arm group label Control arm group type No Intervention arm group description In the control arm the standard management of each center will be followed regarding doses of steroids, duration of tocolysis or maternal stay length duration. intervention list intervention intervention type Drug intervention name Steroid Drug intervention description Steroids doses will be optimized in the intervention group according the risk based on predictive models intervention arm group label list intervention arm group label Intervention intervention type Drug intervention name Tocolytic Agents intervention description Tocolysis duration will be optimized in the intervention group according the risk based on predictive models intervention arm group label list intervention arm group label Intervention outcomes module primary outcome list primary outcome primary outcome measure Antenatal steroid doses primary outcome description Number of antenatal steroid doses administered primary outcome time frame through study completion, an average of 1 year secondary outcome list secondary outcome secondary outcome measure maternal stay length secondary outcome description Maternal length of hospital stay (in days). secondary outcome time frame through study completion, an average of 1 year secondary outcome measure Clinical chorioamnionitis secondary outcome description Clinical chorioamnionitis occurrence defined by the presence of maternal fever >=38ºC, fetal tachycardia > 160 bpm, leukocytes > 14000/m2 without steroids effect and cervical purulent fluid secondary outcome time frame through study completion, an average of 1 year other outcome list other outcome other outcome measure Tocolysis duration other outcome description Tocolysis duration (in days) other outcome time frame through study completion, an average of 1 year other outcome measure Gestational age at delivery other outcome description Gestational age at delivery other outcome time frame through study completion, an average of 1 year other outcome measure Spontaneous delivery within 7 days after admission other outcome description Spontaneous delivery within 7 days after admission (yes/no), other outcome time frame through study completion, an average of 1 year other outcome measure Microbial invasion of amniotic cavity other outcome description Microbial invasion of amniotic cavity (yes/no) defined by the presence of a positive amniotic fluid culture, detection of 16S rRNA gene or visualization of microorganisms at the Gram stain other outcome time frame through study completion, an average of 1 year other outcome measure Cost analyses other outcome description Cost analyses: The following resource items will be collected: maternal and neonatal admissions, method of delivery, type of induction, outpatient visits, emergency visits, medication, surgical procedures, maternal stay length. other outcome time frame through study completion, an average of 1 year other outcome measure Maternal morbidity other outcome description Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need for transfusion, maternal death. other outcome time frame through study completion, an average of 1 year other outcome measure Neonatal length of hospital stay other outcome description Neonatal length of hospital stay (days) other outcome time frame through study completion, an average of 1 year other outcome measure Neonatal birthweight (in grams) other outcome description Neonatal anthropometric measurements other outcome time frame through study completion, an average of 1 year other outcome measure height (in centimeters) other outcome description Neonatal anthropometric measurements other outcome time frame through study completion, an average of 1 year other outcome measure cephalic, thoracic and abdominal perimeters (in millimeters) other outcome description Neonatal anthropometric measurements other outcome time frame through study completion, an average of 1 year other outcome measure arm circumference (in centimeters) other outcome description Neonatal anthropometric measurements other outcome time frame through study completion, an average of 1 year other outcome measure Adverse neonatal outcome other outcome description A composite adverse neonatal outcome (yes/no) defined as the presence or one or more of the following outcomes: fetal or neonatal death, early onset sepsis, moderate/severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, periventricular leukomalacia, surgical necrotizing enterocolitis, retinopathy requiring laser treatment. other outcome time frame through study completion, an average of 1 year eligibility module eligibility criteria Inclusion Criteria: Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria. Exclusion Criteria: Women who do no accept to be part of the study Maternal age < 18 years Multiple gestations Clinical chorioamnionitis at randomization (defined by the presence of fever above 38 celsius degrees (ºC), fetal tachycardia (>160 heart beat per minute >10 minutes), maternal White blood cells > 15000/mm3 (not justified by the administration of antenatal steroids). Cervical dilatation > 3 cm Major structural malformations of fetal complications that are related to neurodevelopmental impairment. Technical problems to perform an amniocentesis (prediction models include information from amniotic fluid: glucose and IL-6 concentration). healthy volunteers Accepts Healthy Volunteers gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Teresa Cobo, MD,PhD central contact role Contact central contact phone +34 93 227 54 00 central contact phone ext 7281 central contact e mail tcobo@clinic.cat central contact name Ana B Sánchez García, Bsc central contact role Contact central contact phone +34 93 227 54 00 central contact phone ext 7281 central contact e mail absanchez@clinic.cat overall official list overall official overall official name Teresa Cobo, MD, PhD overall official affiliation Fundació Recerca Biomèdica Clínica overall official role Principal Investigator location list location location facility Fundació Recerca Biomèdica Clínica location status Recruiting location city Barcelona location zip 08828 location country Spain location contact list location contact location contact name Teresa Cobo, MD, PhD location contact role Contact location contact phone 34932275600 location contact e mail tcobo@clinic.cat references module reference list reference reference p m i d 32147290 reference type result reference citation Cobo T, Aldecoa V, Figueras F, Herranz A, Ferrero S, Izquierdo M, Murillo C, Amoedo R, Rueda C, Bosch J, Martínez-Portilla RJ, Gratacós E, Palacio M. Development and validation of a multivariable prediction model of spontaneous preterm delivery and microbial invasion of the amniotic cavity in women with preterm labor. Am J Obstet Gynecol. 2020 Sep;223(3):421.e1-421.e14. doi: 10.1016/j.ajog.2020.02.049. Epub 2020 Mar 5. reference p m i d 34588268 reference type derived reference citation Cobo T, Aldecoa V, Bartha JL, Bugatto F, Paz Carrillo-Badillo M, Comas C, Diago-Almeda V, Ferrero S, Goya M, Herraiz I, Marti-Malgosa L, Olivella A, Paules C, Vives A, Figueras F, Palacio M, Gratacos E; OPTIM-PTL group. Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study). BMJ Open. 2021 Sep 28;11(9):e054711. doi: 10.1136/bmjopen-2021-054711. see also link list see also link see also link label Predictive models of spontaneous delivery within 7 days and of intra-amniotic infections description see also link u r l https://doi.org/10.1016/j.ajog.2020.02.049 i p d sharing statement module i p d sharing Yes i p d sharing description all collected IPD i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing time frame Data will be available after the end of the study i p d sharing access criteria https://apps.sjdhospitalbarcelona.org/redcap/ document section large document module large doc list large doc large doc type abbrev Prot_SAP large doc has protocol Yes large doc has s a p Yes large doc has i c f No large doc label Study Protocol and Statistical Analysis Plan large doc date February 17, 2021 large doc upload date 03/31/2021 10:27 large doc filename Prot_SAP_000.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000047928 condition mesh term Premature Birth condition mesh id D000007752 condition mesh term Obstetric Labor, Premature condition ancestor list condition ancestor condition ancestor id D000007744 condition ancestor term Obstetric Labor Complications condition ancestor id D000011248 condition ancestor term Pregnancy Complications condition browse leaf list condition browse leaf condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M25022 condition browse leaf name Premature Birth condition browse leaf as found Preterm condition browse leaf relevance high condition browse leaf id M9924 condition browse leaf name Obstetric Labor, Premature condition browse leaf as found Pre Term Labor condition browse leaf relevance high condition browse leaf id M9916 condition browse leaf name Obstetric Labor Complications condition browse leaf relevance low condition browse leaf id M13279 condition browse leaf name Pregnancy Complications condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000015149 intervention mesh term Tocolytic Agents intervention ancestor list intervention ancestor intervention ancestor id D000012102 intervention ancestor term Reproductive Control Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M3374 intervention browse leaf name Anti-Bacterial Agents intervention browse leaf relevance low intervention browse leaf id M3376 intervention browse leaf name Antibiotics, Antitubercular intervention browse leaf relevance low intervention browse leaf id M17021 intervention browse leaf name Tocolytic Agents intervention browse leaf as found Million CFU intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Repr intervention browse branch name Reproductive Control Agents
NCT04831086
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full study rank 61707 study protocol section identification module n c t id NCT04832971 org study id info org study id AROANG3-2001 organization org full name Arrowhead Pharmaceuticals org class INDUSTRY brief title Study of ARO-ANG3 in Adults With Mixed Dyslipidemia official title A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia acronym ARCHES-2 status module status verified date June 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date June 28, 2021 start date type Actual primary completion date struct primary completion date August 30, 2022 primary completion date type Actual completion date struct completion date December 2024 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date October 21, 2022 last update post date struct last update post date October 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Arrowhead Pharmaceuticals lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3. conditions module condition list condition Mixed Dyslipidemia design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 204 enrollment type Actual arms interventions module arm group list arm group arm group label ARO-ANG3 arm group type Experimental arm group description Two doses of ARO-ANG3 by subcutaneous (sc) injection during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period. arm group intervention list arm group intervention name Drug: ARO-ANG3 arm group label Placebo arm group type Placebo Comparator arm group description Calculated volume to match active treatment by sc injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period. arm group intervention list arm group intervention name Drug: ARO-ANG3 Drug: Placebo intervention list intervention intervention type Drug intervention name ARO-ANG3 intervention description ARO-ANG3 Injection intervention arm group label list intervention arm group label ARO-ANG3 Placebo intervention type Drug intervention name Placebo intervention description Sterile Normal Saline (0.9% NaCl) intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24 primary outcome time frame Baseline, Week 24 secondary outcome list secondary outcome secondary outcome measure Percent Change from Baseline in Fasting TG Over Time secondary outcome time frame Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) secondary outcome measure Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 secondary outcome time frame Baseline, Week 24 secondary outcome measure Percent Change from Baseline in Fasting Non-HDL-C Over Time secondary outcome time frame Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) secondary outcome measure Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24 secondary outcome time frame Baseline, Week 24 secondary outcome measure Percent Change from Baseline in Fasting Total ApoB Over Time secondary outcome time frame Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) secondary outcome measure Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24 secondary outcome time frame Baseline, Week 24 secondary outcome measure Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time secondary outcome time frame Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) secondary outcome measure Percent Change from Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24 secondary outcome time frame Baseline, Week 24 secondary outcome measure Percent Change from Baseline in ANGPTL3 Over Time secondary outcome time frame Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) secondary outcome measure Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24 secondary outcome time frame Baseline, Week 24 secondary outcome measure Percent Change from Baseline in Fasting HDL-C Over Time secondary outcome time frame Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) secondary outcome measure Plasma Concentrations of ARO-ANG3 Over Time secondary outcome time frame Baseline, up to Week 12 (double-blind treatment period), up to Month 24 (open-label extension) secondary outcome measure Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Week 24 secondary outcome time frame Week 24 secondary outcome measure Number of Participants with AEs and/or SAEs Over Time in the Double-Blind Treatment Period secondary outcome time frame up to Week 36 (double-blind treatment period) secondary outcome measure Number of Participants with AEs and/or SAEs Over Time in the Open-Label Extension secondary outcome time frame up to Month 24 (open-label extension) eligibility module eligibility criteria Inclusion Criteria: Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1 Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication Able and willing to provide written informed consent and to comply with study requirements Exclusion Criteria: Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule Active pancreatitis within 12 weeks prior to Day 1 Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study Acute coronary syndrome event within 24 weeks of Day 1 Major surgery within 12 weeks of Day 1 or planned surgery during the study Planned coronary intervention (e.g., stent placement or heart bypass) during the study Uncontrolled hypertension Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV) Uncontrolled hypothyroidism or hyperthyroidism Hemorrhagic stroke within 24 weeks of Day 1 History of bleeding diathesis or coagulopathy Current diagnosis of nephrotic syndrome Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply) Note: additional inclusion/exclusion criteria may apply per protocol healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Velocity Clinical Research location city Huntington Park location state California location zip 90255 location country United States location facility AGA Clinical Trials location city Hialeah location state Florida location zip 33012 location country United States location facility Global Research Solutions location city Miami location state Florida location zip 33144 location country United States location facility Progressive Medical Research location city Port Orange location state Florida location zip 32127 location country United States location facility University of Minnesota location city Minneapolis location state Minnesota location zip 55455 location country United States location facility Methodist Physicians Clinic Heart Consultants location city Omaha location state Nebraska location zip 68114 location country United States location facility Clinical Research of South Nevada location city Las Vegas location state Nevada location zip 89121 location country United States location facility Icahn School of Medicine at Mount Sinai (ISMMS) location city New York location state New York location zip 10029 location country United States location facility Medication Management LLC location city Greensboro location state North Carolina location zip 27408 location country United States location facility Lucas Research, Inc. location city Morehead City location state North Carolina location zip 28557 location country United States location facility Marion Area Health Center location city Marion location state Ohio location zip 43302 location country United States location facility Capital Area Research, LLC location city Camp Hill location state Pennsylvania location zip 17011 location country United States location facility Baylor College of Medicine location city Houston location state Texas location zip 77030 location country United States location facility Paratus Clinical Research location city Blacktown location state New South Wales location zip 2148 location country Australia location facility University of the Sunshine Coast Clinical Trials Centre location city Sippy Downs location state Queensland location zip 4556 location country Australia location facility Linear Clinical Research location city Nedlands location zip 6009 location country Australia location facility Lawson Health Research Institute location city London location state Ontario location zip N6A 5A5 location country Canada location facility Centre d'Etudes Cliniques location city Chicoutimi location state Quebec location zip G7H 7K9 location country Canada location facility Recherche Clinique Sigma Inc location city Québec location zip G1G 3Z4 location country Canada location facility Ctr de Recherche Clin de Laval location city Québec location zip H7T2P5 location country Canada location facility Lakeland Clinical Trials - Waitemata location city Birkenhead location zip 0626 location country New Zealand location facility NZCR OpCo Ltd. location city Christchurch location zip 8011 location country New Zealand location facility Lakeland Clinical Trials - Waikato location city Hamilton location zip 3200 location country New Zealand location facility Lakeland Clinical Trials - Rotorua location city Rotorua location zip 3010 location country New Zealand i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000050171 condition mesh term Dyslipidemias condition ancestor list condition ancestor condition ancestor id D000052439 condition ancestor term Lipid Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition browse leaf list condition browse leaf condition browse leaf id M25334 condition browse leaf name Dyslipidemias condition browse leaf as found Dyslipidemia condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M26182 condition browse leaf name Lipid Metabolism Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04832971
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full study rank 61179 study protocol section identification module n c t id NCT04839835 org study id info org study id waitingroom organization org full name Namik Kemal University org class OTHER brief title Anxiety on the First Day of Chemotherapy official title The Effect of Art Design in the Chemotherapy Waiting Room on the Anxiety of Patients Who Will Receive Chemotherapy for the First Time status module status verified date April 2021 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date November 1, 2020 start date type Actual primary completion date struct primary completion date August 31, 2021 primary completion date type Anticipated completion date struct completion date March 3, 2022 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Asoc. Prof. Erdoğan Selçuk Şeber responsible party investigator title Asoc. Prof. responsible party investigator affiliation Namik Kemal University lead sponsor lead sponsor name Namik Kemal University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary investigating chemotherapy anxieties detailed description Breast cancer is the most common type of cancer in women in the world, and it is the first in cancer-related deaths in women all over the world. In the treatment of breast cancer, in addition to surgery, patients with advanced stage or high risk of recurrence receive neoadjuvant and adjuvant chemotherapy treatments. This period starts with 3 months and extends according to the treatment protocols it will receive. Since the first diagnosis of breast cancer, it has psychological effects such as intense stress, decrease in quality of life and anxiety as well as physical effects on patients. The time spent in the "waiting room" while patients are examined and receiving treatment before chemotherapy inevitably has an effect on their anxiety. In this study; It was aimed to investigate the effects of environmental factors in waiting rooms on patients' anxiety. conditions module condition list condition Breast Cancer Anxiety design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 106 enrollment type Anticipated arms interventions module arm group list arm group arm group label standard waiting room arm group type No Intervention arm group description standard chemoterapy waiting room arm group label waiting room enriched with art objects arm group type Experimental arm group description waiting room enriched with music, paintings and artificial plants arm group intervention list arm group intervention name Other: waiting room enriched with music, paintings and artificial plants intervention list intervention intervention type Other intervention name waiting room enriched with music, paintings and artificial plants intervention description waiting room enriched with music, paintings and artificial plants intervention arm group label list intervention arm group label waiting room enriched with art objects outcomes module primary outcome list primary outcome primary outcome measure anxiety and stress measurements primary outcome description The State-Trait Anxiety Inventory (STAI) - Measuring anxiety with the Hospital Anxiety and Depression Scale (HADS) primary outcome time frame 60-120 minutes eligibility module eligibility criteria Inclusion Criteria: to receive chemotherapy for breast cancer for the first time give consent for the study Exclusion Criteria: not approving to participate in the study healthy volunteers No gender Female minimum age 18 Years maximum age 99 Years std age list std age Adult Older Adult contacts locations module location list location location facility Tekirdağ Namık Kemal ÜNiversitesi location city Tekirdağ location zip 59100 location country Turkey derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001008 condition mesh term Anxiety Disorders condition ancestor list condition ancestor condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf relevance low condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf as found Anxiety condition browse leaf relevance high condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders
NCT04839835
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full study rank 61375 study protocol section identification module n c t id NCT04837287 org study id info org study id 09.2020.47 organization org full name Marmara University org class OTHER brief title Investigation of the Effect of Different Term Stretching Exercise on Muscle Elasticity in Two Different Muscle Groups official title Investigation of the Effect of Short and Long Term Stretching Exercise on Muscle Elasticity in Two Different Muscle Groups status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 10, 2020 start date type Actual primary completion date struct primary completion date July 1, 2021 primary completion date type Anticipated completion date struct completion date July 1, 2021 completion date type Anticipated study first submit date February 21, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Eda Tonga responsible party investigator title Assoc. Prof. responsible party investigator affiliation Marmara University lead sponsor lead sponsor name Marmara University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary In the literature, the evidence regarding the effects of different static stretching times on elasticity is very limited, and the evidence on the effects on flexibility varies. Although 10 to 30 seconds of static stretching is said to be effective, studies on which duration is effective for which muscle group are quite limited. Based on these, the aim of this study is to examine the effects of stretching exercises of different periods on muscle elasticity to be applied to thin and thick muscle groups. In order to evaluate its effectiveness, assessment of evaluation of muscle flexibility, active-passive range of motion were being applied. detailed description Flexibility, the most important component of physical fitness, is defined as the maximal range of motion occurring in the joint or joint group. Elasticity is the ability of the structure to change its shape and size with the effect of force and to return to its previous position when the force is removed. These two components are also very effective on strength, agility, balance, speed, coordination and proprioception, which are other components of physical fitness. It is very important in reducing stress and tension, relieving muscle cramps, muscle relaxation, body fitness, reducing risks of injury and pain, regular sleep and daily life activities. Good levels of this increase the efficiency of the movement. Different stretching protocols are applied in traditional rehabilitation to increase these levels. Static stretching, which is one of these stretching protocols, is known to prevent injuries and benefit performance as a result of increasing the range of motion. It is a type of stretching that minimizes the risk of injury as well as easy application. However, stretching times that will change the elasticity and flexibility of a large-thick muscle and a thin-long muscle are different. In the literature, the evidence regarding the effects of different static stretching times on elasticity is very limited, and the evidence on the effects on flexibility varies. Although 10 to 30 seconds of static stretching is said to be effective, studies on which duration is effective for which muscle group are quite limited. Based on these, the aim of our study is to examine the effects of stretching exercises of different periods on muscle elasticity to be applied to thin and thick muscle groups. The study will be carried out on healthy, sedentary people aged 20-45 years. People who agree to participate in the study will be randomly divided into two groups. Static stretching will be applied to the hamstring and gracilis muscles of one group for 10 seconds while static stretching will be applied to the other group for 30 seconds. Static stretching exercises will be applied 8 weeks, 3 days a week, 3 times a day in 10 repetitions. On the dominant legs of the participants will be evaluated muscle elasticities with Myoton, muscle flexibility with flexibility tests, joint range of motion with goniometer. As a result of our thesis study, the investigators aim to find out how many seconds of static stretching will be more effective in different muscle groups, how different stretching times will change the muscle elasticity in different muscle groups, and thanks to this information, the investigators will be more successful in rehabilitation. conditions module condition list condition Rehabilitation Muscle Tightness keyword list keyword Static Stretching Exercises Stretching Time Muscle Elasticity Muscle Flexibility design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design masking description The participants of the study will be included in the stretching exercise program, but the participants will not have information about which group the participants belong to. design who masked list design who masked Participant enrollment info enrollment count 22 enrollment type Anticipated arms interventions module arm group list arm group arm group label Static Stretching Exercise for 10 Seconds arm group type Active Comparator arm group description After the participants are given one session of training, the participants do the exercises themselves at home. arm group intervention list arm group intervention name Other: Static Stretching Exercise for 10 Seconds arm group label Static Stretching Exercise for 30 Seconds arm group type Active Comparator arm group description After the participants are given one session of training, the participants do the exercises themselves at home. arm group intervention list arm group intervention name Other: Static Stretching Exercise for 30 Seconds intervention list intervention intervention type Other intervention name Static Stretching Exercise for 10 Seconds intervention description The participants were asked to do a static stretching exercise for the Hamstring and Gracilis muscles for 10 seconds. The participants were asked to continue for 8 weeks, 3 days a week, 3 times a day - 10 repetitions. intervention arm group label list intervention arm group label Static Stretching Exercise for 10 Seconds intervention type Other intervention name Static Stretching Exercise for 30 Seconds intervention description The participants were asked to do a static stretching exercise for the Hamstring and Gracilis muscles for 30 seconds. The participants were asked to continue for 8 weeks, 3 days a week, 3 times a day - 10 repetitions. intervention arm group label list intervention arm group label Static Stretching Exercise for 30 Seconds outcomes module primary outcome list primary outcome primary outcome measure Elasticity of the Muscle primary outcome description The method of measurement consists of recording damped natural oscillation of soft biological tissue in the form of an acceleration signal and the subsequent simultaneous computation of the parameters of State of Tension, Biomechanical and Viscoelastic properties. Damped natural oscillation is induced by an exterior, low force quick-release mechanical impulse under constant pre-load. At the end of this measurement, information about the muscle elasticity in logarithmic decrement on muscle is obtained. In our study, this measurement will be evaluated with Myoton. primary outcome time frame Pre exercise and Week 8 secondary outcome list secondary outcome secondary outcome measure Tone of the Muscle secondary outcome description The method of measurement consists of recording damped natural oscillation of soft biological tissue in the form of an acceleration signal and the subsequent simultaneous computation of the parameters of State of Tension, Biomechanical and Viscoelastic properties. Damped natural oscillation is induced by an exterior, low force quick-release mechanical impulse under constant pre-load. At the end of this measurement, information about the muscle tone in Hz is obtained. In our study, this measurement will be evaluated with Myoton. secondary outcome time frame Pre exercise and Week 8 secondary outcome measure Stiffness of the Muscle secondary outcome description The method of measurement consists of recording damped natural oscillation of soft biological tissue in the form of an acceleration signal and the subsequent simultaneous computation of the parameters of State of Tension, Biomechanical and Viscoelastic properties. Damped natural oscillation is induced by an exterior, low force quick-release mechanical impulse under constant pre-load. At the end of this measurement, information about the muscle stiffness in N/m is obtained. In our study, this measurement will be evaluated with Myoton. secondary outcome time frame Pre exercise and Week 8 secondary outcome measure Demographic Data Form secondary outcome description The participants are asked to fill in an information form that evaluates age, gender, educational background, occupation, presence of permanent disease, disability or surgeries, and when it happened, whether there are hip-knee-waist problems. secondary outcome time frame Pre exercise secondary outcome measure Hamstring Muscle Flexibility secondary outcome description The Hamstring muscle is evaluated by the Sit - Lie test. The participants are asked to take off their shoes and sit on the floor and place the soles flat on the measuring board. The participants are asked to lie forward as far as the participants can reach their fingertips by moving their bodies forward without bending the participants's knees and waiting at least 2 seconds at the last point. The point where the participants can reach is marked and the distance between the level of the feet and the marked point is measured by tape measure. The measurement is repeated twice and the highest value is recorded in cm. secondary outcome time frame Pre exercise, Measurement for 7 weeks, Week 8 secondary outcome measure Gracilis Muscle Flexibility secondary outcome description The Gracilis muscle is evaluated by Hip Abduction Flexibility Test. For testing, the participants sits with hip abduction, flexion and external rotation, knees flexed, and feet soles adjacent. The participants is asked to push their knees down, holding their knees. The distance between the lateral condyle of both knees and the ground is measured by tape measure. The measurement is recorded in cm. secondary outcome time frame Pre exercise, Measurement for 7 weeks, Week 8 secondary outcome measure Active - Passive Joint Range of Motion secondary outcome description The measured joint is placed according to the anatomical position, and this position is considered the starting position, and the measurement starts here. The participants is asked to do the movement as much as the participants can, and an angle measurement is made. In our study, this measurement will be done with the universal goniometer. secondary outcome time frame Pre exercise, Measurement for 7 weeks, Week 8 secondary outcome measure Exercise Diary secondary outcome description The participants will note the number of exercises the participants did at home in the exercise diary next to the image showing the exercise example day by day. All exercises will be evaluated as 100% when done with the number of repetitions required. secondary outcome time frame Pre exercise, Measurement for 7 weeks, Week 8 eligibility module eligibility criteria Inclusion Criteria: Being between the ages of 20-45 Have not had any disability or surgery in the past 6 months Not exercising regularly in the last 6 months No neural signs To participate regularly in the study Exclusion Criteria: Exercising regularly in the last 6 months, Having any disability or surgery not allowing stretching exercise, Having hip-knee-waist problem Having comorbidities not allowing stretching exercise such as inflammatory rheumatic disease, orthopedic and neurological disease healthy volunteers Accepts Healthy Volunteers gender All minimum age 20 Years maximum age 45 Years std age list std age Adult contacts locations module central contact list central contact central contact name Fatma Dilge AŞIK, PT central contact role Contact central contact phone 0506 371 44 44 central contact e mail asikfatmadilge@gmail.com central contact name Eda TONGA, Assoc. Prof. central contact role Contact central contact e mail eda.tonga@marmara.edu.tr overall official list overall official overall official name Fatma Dilge AŞIK, PT overall official affiliation Marmara University Faculty of Health Sciences overall official role Principal Investigator overall official name Eda TONGA, Assoc. Prof. overall official affiliation Marmara University Faculty of Health Sciences overall official role Study Director overall official name Yavuz YAKUT, Prof. Dr. overall official affiliation Hasan Kalyoncu University Faculty of Health Sciences overall official role Study Director location list location location facility Marmara University location status Recruiting location city İstanbul location country Turkey location contact list location contact location contact name Eda TONGA, Assoc. Prof. location contact role Contact location contact e mail eda.tonga@marmara.edu.tr derived section misc info module version holder December 02, 2022
NCT04837287
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full study rank 61698 study protocol section identification module n c t id NCT04833088 org study id info org study id SAIRE FOCUSGR organization org full name Vrije Universiteit Brussel org class OTHER brief title Exploratory Study About the Implementation of Technology in the Rehabilitation official title Exploratory Study About the Implementation of Technology in the Rehabilitation status module status verified date July 2022 overall status Completed expanded access info has expanded access No start date struct start date June 10, 2021 start date type Actual primary completion date struct primary completion date April 1, 2022 primary completion date type Actual completion date struct completion date April 1, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date July 6, 2022 last update post date struct last update post date July 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ruben Debeuf responsible party investigator title The Principal Investigator responsible party investigator affiliation Vrije Universiteit Brussel lead sponsor lead sponsor name Vrije Universiteit Brussel lead sponsor class OTHER collaborator list collaborator collaborator name Universitair Ziekenhuis Brussel collaborator class OTHER collaborator name AZ Sint Maria Halle collaborator class UNKNOWN collaborator name Odisee University college for applied sciences collaborator class OTHER collaborator name Erasmus University Rotterdam collaborator class OTHER collaborator name Jessa Hospital collaborator class OTHER collaborator name Rehabilitation hospital Inkendaal collaborator class UNKNOWN collaborator name Rehabilitation hopsital Revarte collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This qualitative study aims to identify the needs and recommendations of both patients and healthcare professionals in terms of rehabilitation technology, more specific three pre-defined user scenarios. These scenario were developed based on brainstorm sessions with healthcare professionals from the rehabilitation ward of UZ Brussel and AZ Sint-Maria Halle. The purpose of this study is to create an overview of recommendations that will be used to develop the smart devices in a later stage of the SAIRE project. detailed description STUDY DESIGN Based on the aforementioned user scenarios, an explorative qualitive study will be conducted investigating the recommendations and requirements of both patients and healthcare professionals in the development of the smart devices. Focus groups will be organized at UZ Brussel and AZ Sint Maria Halle to collect data from the participants. These discussions will be organized until data saturation is reached. Based on expectations, the investigators estimate on average 3 focus groups for every user scenario will be needed. The recommendations proposed in these focus group discussions will be analyzed and tested in the lab to determine what smart devices are eligible for rehabilitation. The data will also be used to develop AI algorithms that will be implemented in the smart devices. USER SCENARIOS The first scenario focuses on the registration and triggering of movement of the upper limb in patients with spatial neglect. The aim is to develop a low-budget smart device that stimulates and analyzes movement of the affected side and gives feedback when needed. The second user scenario aims to combine different smart devices and AI algorithms to create a mobile device that can be placed on a walking aid. This smart device will give feedback in terms of stride length and cadence through visual and auditive cues. A combination of sensor analysis and computer vision will monitor the gait pattern of the patient and correct where needed. These sensors will also incorporate a fall detection system that sends out a signal when a fall is detected. The third and final scenario describes a smart intravenous (IV) pole that monitors the location of the patient relative to the IV pole and automatically follows the patient during walking. This device consists of a tracker and an accelerometer placed on the patient, and a motorized IV pole that follows the patient and avoid obstacles through computer vision. Additionally, a fall detection system will be integrated to monitor falls. PROCEDURE Firstly, with regard to the Sars-COV-2 pandemic, all obligated prevention measure will be followed when conducting the focus group discussion. All participants and researchers will wear face masks, maintain distance (1.5 meters) and frequently disinfect hands using alcohol-based hand sanitizer. Additionally, an adequate ventilation of the room will be maintained. If necessary, the focus group discussions will be organized online, using Microsoft Teams (Microsoft, USA). Before the start of the focus groups, all participants will be asked to complete a form focusing on sociodemographic characteristics (age, gender, occupation, …). After this form is collected, the focus group starts. Each focus group discussion will be led by one moderator and one assistant.The moderator directs the discussion and ensures that all participants are involved. The observer on the other hand takes notes of the conversation with a focus on verbal and non-verbal signs, seating of the participants and unexpected interruptions. Additionally, the observer also watches the time limit of approximately one hour (with regard to limited concentration duration) and ensures no key issues are overlooked. All focus groups will be recorded, after obtaining ethical approval of the participants. As mentioned before, data-collection will be completed after data saturation is reached, and no new data is gathered from the participants. The focus group discussions start with an introduction in which the moderator presents him or herself and the observer, and explains the purpose of the study. Secondly, the participants are asked to shortly introduce themselves and describe any previous experience with smart devices or technology in their rehabilitation plan (what was good, what could have been better, …). Thirdly, a short presentation is given that creates a global picture of the user scenarios. Finally, the discussion between the participants and the moderator is started following a question guide. If necessary, side questions are used to refocus the conversation and avoid off-topic discussions. ANALYSIS Firstly, a descriptive analysis will be done for the sociodemographic characteristics of the participants based on the completed forms, using SPSS 27 (IBM, USA). Secondly, the data from the focus group discussion will be analyzed. The recorded focus groups will be transcribed verbatim using Word (Microsoft, USA). A thematic content analysis will be performed by the researchers using NVivo (QRS International, USA). For this analysis the six steps of Braun and Clarke (2006) will be followed. Firstly, the researchers will familiarize themselves with the data through repeated reading of the data. Secondly, the initial codes will be generated as the researchers begin to take notes on relevant data items. Once the entire data set is coded, the researcher will start collating the data in preparation of the third step. For this next step, the researchers will scan the collated data and take note of all themes that are potentially of relevance to form a thematic map. The forth step in the thematic analysis involves reviewing the themes. This review will be done both within each theme, as between different themes. All codes within a theme will be checked to ensure a proper fit within the theme, and all individual themes will be assessed in relation to the entire data set, to see whether the thematic map accurately represents the data. In the fifth step, the researchers will define each theme. Additionally, for each theme, the importance to the broader study topic will be described. Lastly, the final analysis will be written based on all previous steps. The researchers will first analyze the data separately. Afterwards, both researchers will compare their analysis and adjust until agreement is reached. Data will be stored on a secure and locked server of the Erasmushogeschool Brussel and will be kept five years after final publication of the study results. conditions module condition list condition Stroke Parkinson Disease Covid19 Neglect, Hemispatial design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 27 enrollment type Actual arms interventions module arm group list arm group arm group label Healthcare professionals arm group type Other arm group intervention list arm group intervention name Other: Focus group discussions arm group label Patients who suffer from spatial neglect arm group type Other arm group intervention list arm group intervention name Other: Focus group discussions arm group label Patients who have walking difficulties arm group type Other arm group intervention list arm group intervention name Other: Focus group discussions arm group label Patients who require long term use of an IV-stand arm group type Other arm group intervention list arm group intervention name Other: Focus group discussions intervention list intervention intervention type Other intervention name Focus group discussions intervention description Focus group discussions will be organized to investigate the needs and requirements of the participants in terms of three pre-defined user scenarios. intervention arm group label list intervention arm group label Healthcare professionals Patients who have walking difficulties Patients who require long term use of an IV-stand Patients who suffer from spatial neglect outcomes module primary outcome list primary outcome primary outcome measure Overview of needs and requirements for the development of the three predefined user scenarios primary outcome description Recurring themes in the transcribed data of the focus groups will be identified and checked for relevance in terms of the research question (e.g. key functionalities of the device, aesthetic requirements, ...). These relevant themes will then be combined to create an overview for every user scenario individually. primary outcome time frame through study completion, an average of 1 year eligibility module eligibility criteria Inclusion Criteria user scenario 1: adult (≥ 18 years) diagnosed with stroke (as defined by the World Health Organization) and suffering from spatial neglect able to verbally answer questions ability to give informed consent Exclusion Criteria user scenario 1: severe cognitive disability (based on assessment of the healthcare professionals) Inclusion criteria scenario 2: adult (≥ 18 years) suffering from gait problems (e.g. frail elderly, Parkinson Disease, recovering from COVID-19) able to verbally answer questions ability to give informed consent Exclusion Criteria user scenario 2: severe cognitive disability (based on assessment of the healthcare professionals) Inclusion criteria scenario 3: adult (≥ 18 years) requires intensive use of an IV-stand during hospitalisation able to verbally answer questions ability to give informed consent Exclusion Criteria user scenario 3: severe cognitive disability (based on assessment of the healthcare professionals) healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Eva Swinnen, Prof. Ph.D overall official affiliation Vrije Universiteit Brussel overall official role Principal Investigator location list location location facility Vrije Universiteit Brussel location city Jette location state Brussels Hoofdstedelijk Gewest location zip 1090 location country Belgium derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010300 condition mesh term Parkinson Disease condition mesh id D000010468 condition mesh term Perceptual Disorders condition ancestor list condition ancestor condition ancestor id D000020734 condition ancestor term Parkinsonian Disorders condition ancestor id D000001480 condition ancestor term Basal Ganglia Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000009069 condition ancestor term Movement Disorders condition ancestor id D000080874 condition ancestor term Synucleinopathies condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse leaf id M12365 condition browse leaf name Parkinson Disease condition browse leaf as found Parkinson's Disease condition browse leaf relevance high condition browse leaf id M12531 condition browse leaf name Perceptual Disorders condition browse leaf as found Neglect, Hemispatial condition browse leaf relevance high condition browse leaf id M21647 condition browse leaf name Parkinsonian Disorders condition browse leaf relevance low condition browse leaf id M24756 condition browse leaf name Ganglion Cysts condition browse leaf relevance low condition browse leaf id M15510 condition browse leaf name Synovial Cyst condition browse leaf relevance low condition browse leaf id M3926 condition browse leaf name Basal Ganglia Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11181 condition browse leaf name Movement Disorders condition browse leaf relevance low condition browse leaf id M2217 condition browse leaf name Synucleinopathies condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse leaf id M20979 condition browse leaf name Neurobehavioral Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases
NCT04833088
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full study rank 61258 study protocol section identification module n c t id NCT04838808 org study id info org study id Pro00105055 organization org full name University of Alberta org class OTHER brief title Rivaroxaban in Type 2 Myocardial Infarctions official title Rivaroxaban in Type 2 Myocardial Infarctions: A Feasibility, Placebo-controlled, Double-blinded, Randomized Controlled Trial acronym R2MI status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 5, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date March 11, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 19, 2022 last update post date struct last update post date May 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Alberta lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary This trial is the pilot phase of a randomized controlled trial to test the feasibility of recruiting patients with a type 2 myocardial infarction and randomizing them to low-dose rivaroxaban to reduce the risk of major cardiovascular events. detailed description This trial is an investigator-initiated prospective, single-center, placebo-controlled, double blinded, pilot randomized controlled trial of low-dose rivaroxaban (2.5mg oral twice daily) for 90-days following a type 2 myocardial infarction. The primary feasibility outcome is time to recruitment of 100 participants, stratified by sex. conditions module condition list condition Type II Myocardial Infarction keyword list keyword myocardial injury Type II myocardial infarction Anticoagulation design module study type Interventional phase list phase Phase 2 Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Rivaroxaban arm group type Active Comparator arm group description Rivaroxaban 2.5mg oral twice daily for 90-days arm group intervention list arm group intervention name Drug: Rivaroxaban 2.5 MG [Xarelto] arm group label Placebo arm group type Placebo Comparator arm group description Oral placebo tablet twice daily for 90-days arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Rivaroxaban 2.5 MG [Xarelto] intervention description Rivaroxaban 2.5mg twice daily for 90-days intervention arm group label list intervention arm group label Rivaroxaban intervention type Drug intervention name Placebo intervention description Placebo tablet twice daily for 90-days intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Feasibility outcome primary outcome description Time to recruitment of 100 participants, stratified by sex. primary outcome time frame Through study completion, estimated at 1-year secondary outcome list secondary outcome secondary outcome measure Number of participants who experience a composite of death, stroke or myocardial infarction secondary outcome description Composite of death, stroke or myocardial infarction secondary outcome time frame 90-days secondary outcome measure Number of participants who experience major bleeding secondary outcome description Major bleeding as per the International Society on Thrombosis and Haemostasis (ISTH) Fatal bleeding, symptomatic bleeding requiring presentation to an acute care facility or bleeding resulting in transfusion. secondary outcome time frame 90-days eligibility module eligibility criteria Inclusion Criteria: Participant age ≥ 65years or >45 years and an additional risk factor (smoking, diabetes mellitus, hypertension, dyslipidemia or known atherosclerotic disease) Rise in troponin level, with one troponin value above the 99th percentile of the upper limit of normal deemed to be due to a type 2 myocardial infarction by the attending team within the past 30 days Alive at the time of hospital discharge Exclusion Criteria: Current use of anticoagulation Current use of dual antiplatelet therapy Advanced kidney disease (eGFR <15ml/min) Previous hemorrhagic stroke at any time or embolic stroke within the past year Previous life-threatening bleeding event Life expectancy less than one year Anticoagulation recommended conditions - atrial fibrillation, pulmonary embolism, deep vein thrombosis, mechanical heart valves, rheumatic mitral valve disease, left ventricular thrombosis Surgery in the previous 30 days Inability to provide informed consent in English Pregnancy, breastfeeding or child bearing potential healthy volunteers No gender All minimum age 45 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Michelle Graham, MD central contact role Contact central contact phone 780-407-1590 central contact e mail mmg2@ualberta.ca central contact name Pishoy Gouda, MD central contact role Contact central contact phone 780-660-4791 central contact e mail gouda@ualebrta.ca overall official list overall official overall official name Michelle Graham, MD overall official affiliation University of Alberta overall official role Principal Investigator location list location location facility University of Alberta location status Recruiting location city Edmonton location state Alberta location zip T6W 1T7 location country Canada location contact list location contact location contact name Pishoy Gouda, MD location contact role Contact location contact phone 7806604791 location contact e mail gouda@ualberta.ca i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009203 condition mesh term Myocardial Infarction condition mesh id D000007238 condition mesh term Infarction condition ancestor list condition ancestor condition ancestor id D000007511 condition ancestor term Ischemia condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000009336 condition ancestor term Necrosis condition ancestor id D000017202 condition ancestor term Myocardial Ischemia condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M11307 condition browse leaf name Myocardial Infarction condition browse leaf as found Myocardial Infarction condition browse leaf relevance high condition browse leaf id M9434 condition browse leaf name Infarction condition browse leaf as found Infarction condition browse leaf relevance high condition browse leaf id M9695 condition browse leaf name Ischemia condition browse leaf relevance low condition browse leaf id M11436 condition browse leaf name Necrosis condition browse leaf relevance low condition browse leaf id M5698 condition browse leaf name Coronary Artery Disease condition browse leaf relevance low condition browse leaf id M18658 condition browse leaf name Myocardial Ischemia condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000069552 intervention mesh term Rivaroxaban intervention ancestor list intervention ancestor intervention ancestor id D000065427 intervention ancestor term Factor Xa Inhibitors intervention ancestor id D000000991 intervention ancestor term Antithrombins intervention ancestor id D000015842 intervention ancestor term Serine Proteinase Inhibitors intervention ancestor id D000011480 intervention ancestor term Protease Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000925 intervention ancestor term Anticoagulants intervention browse leaf list intervention browse leaf intervention browse leaf id M463 intervention browse leaf name Rivaroxaban intervention browse leaf as found Compare intervention browse leaf relevance high intervention browse leaf id M29666 intervention browse leaf name Factor Xa Inhibitors intervention browse leaf relevance low intervention browse leaf id M3458 intervention browse leaf name Antithrombin III intervention browse leaf relevance low intervention browse leaf id M3459 intervention browse leaf name Antithrombins intervention browse leaf relevance low intervention browse leaf id M13495 intervention browse leaf name Protease Inhibitors intervention browse leaf relevance low intervention browse leaf id M17543 intervention browse leaf name Serine Proteinase Inhibitors intervention browse leaf relevance low intervention browse leaf id M18761 intervention browse leaf name HIV Protease Inhibitors intervention browse leaf relevance low intervention browse leaf id M3396 intervention browse leaf name Anticoagulants intervention browse leaf relevance low intervention browse leaf id T18 intervention browse leaf name Serine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AnCoag intervention browse branch name Anticoagulants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev AA intervention browse branch name Amino Acids
NCT04838808
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full study rank 61437 study protocol section identification module n c t id NCT04836481 org study id info org study id 2020-0744 organization org full name University of Cincinnati org class OTHER brief title A Pharmacokinetic Analysis of Levetiracetam Prophylaxis in Critically Ill Patients With Severe Traumatic Brain Injury official title A Pharmacokinetic Analysis of Levetiracetam Prophylaxis in Critically Ill Patients With Severe Traumatic Brain Injury status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 1, 2021 start date type Actual primary completion date struct primary completion date June 2022 primary completion date type Anticipated completion date struct completion date June 2022 completion date type Anticipated study first submit date December 10, 2020 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Sarah Schuman Harlan responsible party investigator title Pharmacy Resident, Primary Investigator responsible party investigator affiliation University of Cincinnati lead sponsor lead sponsor name University of Cincinnati lead sponsor class OTHER collaborator list collaborator collaborator name American College of Clinical Pharmacy collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary This study aims is to describe the pharmacokinetic properties of levetiracetam through measurement of serum concentrations in critically ill, severe traumatic brain injury patients. detailed description Levetiracetam (LEV) is widely used for the prevention and treatment of seizures given its favorable pharmacokinetic profile. A strong correlation between serum concentrations and clinical efficacy has yet to be established; however, a target of 6-20 g/mL is recommended. Limited evidence exists supporting an optimal dosing strategy to achieve these target concentrations in neurocritically ill patients. Previous pharmacokinetic models suggest LEV 1000 mg every 8 hours achieves the highest proportion of therapeutic serum concentrations, but this dosing strategy has not been clinically studied in neurocritically ill patients. Additionally, only one phase two study has evaluated LEV pharmacokinetics in severe traumatic brain injury (TBI). The aim of this study is to describe the pharmacokinetic properties of LEV through measurement of serum concentrations in critically ill, severe TBI patients. Secondarily, this study aims to develop a population pharmacokinetic model aimed at characterizing LEV dose optimization in severe TBI. An exploratory aim is to evaluate LEV pharmacodynamics in severe TBI patients through evaluation of physiologic, electrophysiologic and biochemical changes using multimodal monitoring or surface electroencephalogram (EEG), as available. A subgroup analysis will evaluate LEV pharmacokinetics in severe TBI patients with augmented renal clearance (ARC). This prospective, single-center pharmacokinetic and pharmacodynamic study will include critically ill patients receiving intravenous LEV for seizure prophylaxis following severe TBI. Patients with severe TBI qualifying for multimodal monitoring will receive LEV 1000 mg every 8 hours (LEV8) per institutional practice. All other severe TBI patients will receive LEV 1000 mg every 12 hours (LEV12) according to institution practice. Patients with renal dysfunction (creatinine clearance < 50 mL/min) will be excluded. All patients will have five serum samples collected following the sixth or greater consecutive dose. Patients receiving LEV8 will have samples collected at 0.5, 1, 4, 6, and 8 hours. Patients receiving LEV12 will have samples collected at 0.5, 1, 4, 8, and 12 hours. Serum concentrations will be analyzed with pharmacokinetic modeling and Monte Carlo simulations. LEV pharmacodynamics will be evaluated in patients receiving multimodal monitoring or surface EEG, as available. Analysis of ARC will include patients with Augmented Renal Clearance in Trauma Intensive Care (ARTIC) score >6 during sampling. conditions module condition list condition Traumatic Brain Injury keyword list keyword Levetiracetam Seizure Prophylaxis Pharmacokinetic design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Prospective bio spec bio spec retention Samples Without DNA bio spec description Serum samples enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label LEV8 arm group description Levetiracetam 1000 mg every 8 hours arm group intervention list arm group intervention name Other: Serum Sample Collection arm group label LEV12 arm group description Levetiracetam 1000 mg every 12 hours arm group intervention list arm group intervention name Other: Serum Sample Collection intervention list intervention intervention type Other intervention name Serum Sample Collection intervention description Each patient will have 5 serum samples collected for analysis after a minimum six consecutive doses. Patients receiving LEV8 will have sampled collected at hours 0.5, 1, 4, 6, and 8. Patients receiving LEV12 will have sampled collected at hours 0.5, 1, 4, 8, and 12. intervention arm group label list intervention arm group label LEV12 LEV8 outcomes module primary outcome list primary outcome primary outcome measure Serum Levetiracetam Concentration 1 primary outcome description Serum levetiracetam concentration collected at 0.5 hours after target dose for sampling primary outcome time frame Hour 0.5 primary outcome measure Serum Levetiracetam Concentration 2 primary outcome description Serum levetiracetam concentration collected at hour 1 after target dose for sampling primary outcome time frame Hour 1 primary outcome measure Serum Levetiracetam Concentration 3 primary outcome description Serum levetiracetam concentration collected at hour 4 after target dose for sampling primary outcome time frame Hour 4 primary outcome measure Serum Levetiracetam Concentration 4 primary outcome description Serum levetiracetam concentration collected at hour 6 (patients receiving every 8 hour levetiracetam) or hour 8 (patients receiving every 12 hour levetiracetam) primary outcome time frame Hour 6-8 primary outcome measure Serum Levetiracetam Concentration 5 primary outcome description Serum levetiracetam concentration collected at hour 8 (patients receiving every 8 hour levetiracetam) or hour 12 (patients receiving every 12 hour levetiracetam) primary outcome time frame Hour 8-12 secondary outcome list secondary outcome secondary outcome measure Intracranial Pressure secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure Cerebral Perfusion Pressure secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure Pressure Reactivity Index secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure Cerebral Blood Flow secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure Cerebral Microdialysis Glucose Concentration secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure Cerebral Microdialysis Pyruvate Concentration secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure Cerebral Microdialysis Lactate Concentration secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure Cerebral Microdialysis Glutamate Concentration secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure Cerebral Microdialysis Glycerol Concentration secondary outcome description Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis secondary outcome time frame Baseline to Day 7 secondary outcome measure ARTIC Score secondary outcome description Calculated ARTIC score secondary outcome time frame Hour 0.5 (Collected at time of first serum sample collection) eligibility module eligibility criteria Inclusion Criteria: Admitted to the neurosurgical intensive care unit or surgical intensive care unit following severe traumatic brain injury (post-resuscitation GCS 3-8 with or without CT abnormalities) Receiving intravenous levetiracetam for seizure prophylaxis at a dose of 1000 mg every 12 hours or 1000 mg every 8 hours at time of enrollment Exclusion Criteria: Known history of epilepsy or seizure disorder Taking antiseizure medication prior to admission Taking medication with known effect on levetiracetam pharmacokinetics including carbamazepine, phenytoin, oxcarbazepine, mefloquine, methotrexate, mianserin, or orlistat Weight < 50 kg Anticipated survival <72 hours from injury, as deemed by the primary neurosurgical provider Acute Kidney Injury (Scr rise > 0.3 mg/dL from baseline) or creatinine clearance <50 mL/min at time of enrollment Prisoners Pregnant healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult study population The target population for this study will be patients with severe traumatic brain injury, defined as a post-resuscitation GCS 3-8 with or without CT abnormalities who are receiving intravenous levetiracetam 1000 mg every 8 or every 12 hours for seizure prophylaxis. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Sarah Schuman Harlan, PharmD central contact role Contact central contact phone 513-584-1070 central contact e mail sarah.schuman@uchealth.com central contact name Shaun Keegan, PharmD central contact role Contact central contact phone 513-584-7675 central contact e mail shaun.keegan@uchealth.com overall official list overall official overall official name Sarah Schuman Harlan, PharmD overall official affiliation University of Cincinnati overall official role Principal Investigator overall official name Shaun Keegan, PharmD overall official affiliation University of Cincinnati overall official role Principal Investigator overall official name Carolyn Philpott, PharmD overall official affiliation University of Cincinnati overall official role Principal Investigator location list location location facility University of Cincinnati Medical Center location status Recruiting location city Cincinnati location state Ohio location zip 45219 location country United States location contact list location contact location contact name Shaun Keegan, PharmD location contact role Contact location contact phone 513-584-7675 location contact e mail shaun.keegan@uchealth.com location contact name Carolyn Philpott, PharmD location contact role Contact location contact phone 513-584-8371 location contact e mail carolyn.philpott@uchealth.com location contact name Carolyn Philpott, PharmD location contact role Principal Investigator location contact name Sarah Schuman-Harlan, PharmD location contact role Principal Investigator location contact name Shaun Keegan, PharmD location contact role Principal Investigator location contact name Christopher Droege, PharmD location contact role Sub-Investigator location contact name Molly Droege, PharmD location contact role Sub-Investigator location contact name Eric Mueller, PharmD location contact role Sub-Investigator location contact name Kiranpal Sangha, PharmD location contact role Sub-Investigator location contact name Brandon Foreman, MD location contact role Sub-Investigator location contact name Laura Ngwenya, MD location contact role Sub-Investigator references module reference list reference reference p m i d 30723936 reference type background reference citation Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11. Review. reference p m i d 24277723 reference type background reference citation Rowe AS, Goodwin H, Brophy GM, Bushwitz J, Castle A, Deen D, Johnson D, Lesch C, Liang N, Potter E, Roels C, Samaan K, Rhoney DH; Neurocritical Care Society Pharmacy Section. Seizure prophylaxis in neurocritical care: a review of evidence-based support. Pharmacotherapy. 2014;34(4):396-409. doi: 10.1002/phar.1374. Epub 2013 Nov 26. Review. reference p m i d 28129261 reference type background reference citation Barletta JF, Mangram AJ, Byrne M, Sucher JF, Hollingworth AK, Ali-Osman FR, Shirah GR, Haley M, Dzandu JK. Identifying augmented renal clearance in trauma patients: Validation of the Augmented Renal Clearance in Trauma Intensive Care scoring system. J Trauma Acute Care Surg. 2017 Apr;82(4):665-671. doi: 10.1097/TA.0000000000001387. reference p m i d 27307089 reference type result reference citation Zangbar B, Khalil M, Gruessner A, Joseph B, Friese R, Kulvatunyou N, Wynne J, Latifi R, Rhee P, O'Keeffe T. Levetiracetam Prophylaxis for Post-traumatic Brain Injury Seizures is Ineffective: A Propensity Score Analysis. World J Surg. 2016 Nov;40(11):2667-2672. reference p m i d 25169249 reference type result reference citation Gabriel WM, Rowe AS. Long-term comparison of GOS-E scores in patients treated with phenytoin or levetiracetam for posttraumatic seizure prophylaxis after traumatic brain injury. Ann Pharmacother. 2014 Nov;48(11):1440-4. doi: 10.1177/1060028014549013. Epub 2014 Aug 28. reference p m i d 23425733 reference type result reference citation Inaba K, Menaker J, Branco BC, Gooch J, Okoye OT, Herrold J, Scalea TM, Dubose J, Demetriades D. A prospective multicenter comparison of levetiracetam versus phenytoin for early posttraumatic seizure prophylaxis. J Trauma Acute Care Surg. 2013 Mar;74(3):766-71; discussion 771-3. doi: 10.1097/TA.0b013e3182826e84. reference p m i d 18828701 reference type result reference citation Jones KE, Puccio AM, Harshman KJ, Falcione B, Benedict N, Jankowitz BT, Stippler M, Fischer M, Sauber-Schatz EK, Fabio A, Darby JM, Okonkwo DO. Levetiracetam versus phenytoin for seizure prophylaxis in severe traumatic brain injury. Neurosurg Focus. 2008 Oct;25(4):E3. doi: 10.3171/FOC.2008.25.10.E3. reference p m i d 19898966 reference type result reference citation Szaflarski JP, Sangha KS, Lindsell CJ, Shutter LA. Prospective, randomized, single-blinded comparative trial of intravenous levetiracetam versus phenytoin for seizure prophylaxis. Neurocrit Care. 2010 Apr;12(2):165-72. doi: 10.1007/s12028-009-9304-y. reference p m i d 16886975 reference type result reference citation Ramael S, Daoust A, Otoul C, Toublanc N, Troenaru M, Lu ZS, Stockis A. Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study. Epilepsia. 2006 Jul;47(7):1128-35. reference p m i d 31523280 reference type result reference citation Steinhoff BJ, Staack AM. Levetiracetam and brivaracetam: a review of evidence from clinical trials and clinical experience. Ther Adv Neurol Disord. 2019 Sep 9;12:1756286419873518. doi: 10.1177/1756286419873518. eCollection 2019. Review. reference p m i d 21950640 reference type result reference citation Spencer DD, Jacobi J, Juenke JM, Fleck JD, Kays MB. Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients. Pharmacotherapy. 2011 Oct;31(10):934-41. doi: 10.1592/phco.31.10.934. reference p m i d 31977751 reference type result reference citation Cotta MO, Abdul-Aziz MH, Frey OR, Sime FB, Roberts JA, Roehr AC. What Are the Predictors for Achieving Therapeutic Levetiracetam Serum Concentrations in Adult Neurological Patients? Ther Drug Monit. 2020 Aug;42(4):626-630. doi: 10.1097/FTD.0000000000000731. reference p m i d 22771222 reference type result reference citation Klein P, Herr D, Pearl PL, Natale J, Levine Z, Nogay C, Sandoval F, Trzcinsky S, Atabaki SM, Tsuchida T, van den Anker J, Soldin SJ, He J, McCarter R. Results of phase II pharmacokinetic study of levetiracetam for prevention of post-traumatic epilepsy. Epilepsy Behav. 2012 Aug;24(4):457-61. doi: 10.1016/j.yebeh.2012.05.011. Epub 2012 Jul 7. reference p m i d 19054418 reference type result reference citation Uges JW, van Huizen MD, Engelsman J, Wilms EB, Touw DJ, Peeters E, Vecht CJ. Safety and pharmacokinetics of intravenous levetiracetam infusion as add-on in status epilepticus. Epilepsia. 2009 Mar;50(3):415-21. doi: 10.1111/j.1528-1167.2008.01889.x. Epub 2008 Nov 17. reference p m i d 21048095 reference type result reference citation Udy A, Boots R, Senthuran S, Stuart J, Deans R, Lassig-Smith M, Lipman J. Augmented creatinine clearance in traumatic brain injury. Anesth Analg. 2010 Dec;111(6):1505-10. doi: 10.1213/ANE.0b013e3181f7107d. Epub 2010 Nov 3. reference p m i d 25761425 reference type result reference citation May CC, Arora S, Parli SE, Fraser JF, Bastin MT, Cook AM. Augmented Renal Clearance in Patients with Subarachnoid Hemorrhage. Neurocrit Care. 2015 Dec;23(3):374-9. doi: 10.1007/s12028-015-0127-8. reference p m i d 11454660 reference type result reference citation Tong X, Patsalos PN. A microdialysis study of the novel antiepileptic drug levetiracetam: extracellular pharmacokinetics and effect on taurine in rat brain. Br J Pharmacol. 2001 Jul;133(6):867-74. reference p m i d 1244564 reference type result reference citation Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001930 condition mesh term Brain Injuries condition mesh id D000070642 condition mesh term Brain Injuries, Traumatic condition mesh id D000014947 condition mesh term Wounds and Injuries condition ancestor list condition ancestor condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000006259 condition ancestor term Craniocerebral Trauma condition ancestor id D000020196 condition ancestor term Trauma, Nervous System condition browse leaf list condition browse leaf condition browse leaf id M18162 condition browse leaf name Critical Illness condition browse leaf relevance low condition browse leaf id M14604 condition browse leaf name Seizures condition browse leaf relevance low condition browse leaf id M4359 condition browse leaf name Brain Injuries condition browse leaf as found Brain Injury condition browse leaf relevance high condition browse leaf id M628 condition browse leaf name Brain Injuries, Traumatic condition browse leaf as found Traumatic Brain Injury condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Injury condition browse leaf relevance high condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M8501 condition browse leaf name Craniocerebral Trauma condition browse leaf relevance low condition browse leaf id M21176 condition browse leaf name Trauma, Nervous System condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M1741 intervention browse leaf name Levetiracetam intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AntiConv intervention browse branch name Anticonvulsants intervention browse branch abbrev NootAg intervention browse branch name Nootropic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04836481
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full study rank 61657 study protocol section identification module n c t id NCT04833621 org study id info org study id 01.02.2018 V:01 organization org full name Ondokuz Mayıs University org class OTHER brief title Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW? official title Is Neuromuscular Electrical Stimulator Treatment in Sepsis/ Septic Shock Patients Protective in the Development of Intensive Care Unit Acquired Muscle Weakness (ICU-AW)? status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date October 23, 2018 start date type Actual primary completion date struct primary completion date October 1, 2020 primary completion date type Actual completion date struct completion date October 1, 2020 completion date type Actual study first submit date February 19, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name GUNES COMBA CEBECI responsible party investigator title RESIDENT responsible party investigator affiliation Ondokuz Mayıs University lead sponsor lead sponsor name Ondokuz Mayıs University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Background: Sarcopenia (muscle weakness) characterized by a decrease in muscle mass, strength and performance is a condition that increases with old age. Sarcopenia can be seen in 5-13% of patients hospitalized in ICU where various treatment methods are used to prevent this weakness, the rate increases in patients with sepsis/ septic shock. Muscle treatment methods are used to prevent sarcopenia in similar patients hospitalized in ICU. It is predicted that "neuromuscular electrical stimulator-NMES" treatment may increase muscle mass and strength in patients who's can not be exercised actively. In this study, the contribution of NMES treatment to prevent the development of muscle weakness in patients with a diagnosis of sepsis/ septic shock followed in intensive care units (ICU) was evaluated. detailed description Background: Sarcopenia (muscle weakness) characterized by a decrease in muscle mass, strength and performance is a condition that increases with old age. Sarcopenia can be seen in 5-13% of patients hospitalized in ICU where various treatment methods are used to prevent this weakness, the rate increases in patients with sepsis/ septic shock. Muscle treatment methods are used to prevent sarcopenia in similar patients hospitalized in ICU. It is predicted that "neuromuscular electrical stimulator-NMES" treatment may increase muscle mass and strength in patients who's can not be exercised actively. In this study, the contribution of NMES treatment to prevent the development of muscle weakness in patients with a diagnosis of sepsis/ septic shock followed in intensive care units (ICU) was evaluated. Patients and methods: In our single-center, prospective clinical study, 80 patients with a diagnosis of sepsis/ septic shock who were hospitalized in ICU were included. The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed. The day when our patients were diagnosed with sepsis was recorded as the first day of the study. Anthropometric and ultrasonographic measurements of bilateral biceps brachii and bilateral rectus femoris muscles were recorded on the following days i.e. 3, 7, 14, 21, and 28. Sarcopenia was defined by anthropometric and ultrasonographic measurement, and all patient outcome data were recorded. conditions module condition list condition Intensive Care Unit Acquired Weakness Sepsis, Severe keyword list keyword ICU-AW NMES sarcopenia sepsis. design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design intervention model description SINGLE CENTER, PROSPECTIVE, DOUBLE BLINDED design primary purpose Supportive Care design masking info design masking Single design who masked list design who masked Investigator enrollment info enrollment count 148 enrollment type Actual arms interventions module arm group list arm group arm group label NMES GROUP arm group type Active Comparator arm group description NMES TREATMENT AND PHYSICAL TREATMENT arm group intervention list arm group intervention name Device: NMES GROUP arm group label CONTROL GROUP arm group type Active Comparator arm group description JUST PHYSICAL TREATMENT arm group intervention list arm group intervention name Device: NMES GROUP intervention list intervention intervention type Device intervention name NMES GROUP intervention description The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed intervention arm group label list intervention arm group label CONTROL GROUP NMES GROUP outcomes module primary outcome list primary outcome primary outcome measure Effects of NMES treatment on ICU-AW development, anthropometric measurement, primary outcome description The measurements of the patients were recorded as anthropometric (arm circumference and thigh circumference) on the 1st, 3rd, 7th, 14th, 21st and 28th days. Arm circumference(centimeter) measurement was measured from the thickest part of the biceps muscle(centimeter) when the elbow was flexed and thigh circumference (centimeter) was measured anthropometrically with a tape measure (centimeter), 15 centimeter above the patella with the leg in extension. primary outcome time frame 28 DAYS primary outcome measure Effects of NMES treatment on ICU-AW development, ultrasonographic measurement primary outcome description Using an ultrasound imaging device, the thickness of biceps brachii (cm^2) and rectus femoris muscles (cm^2) were measured ultrasonographically (at the same points of anthropometric measurements) with the linear probe. primary outcome time frame on the 1st, 3rd, 7th, 14th, 21st and 28th days primary outcome measure Effects of NMES treatment on ICU-AW development, scoring systems. primary outcome description The muscle strength of the patients were evaluated according to the Medical Research Council (MRC) scoring. primary outcome time frame on the 1st, 3rd, 7th, 14th, 21st and 28th days primary outcome measure Effects of NMES treatment on ICU-AW development, scoring systems. primary outcome description On the first day of the study, SOFA (Sequential Organ Failure Assessment) score,scoring systems were calculated for each patients. primary outcome time frame on the 1st, 3rd, 7th, 14th, 21st and 28th days primary outcome measure Effects of NMES treatment on ICU-AW development, scoring systems. primary outcome description On the first day of the study, qSOFA (quick Sequential Organ Failure Assessment) score scoring systems were calculated for each patients. primary outcome time frame first day primary outcome measure Effects of NMES treatment on ICU-AW development, scoring systems. primary outcome description On the first day of the study, APACHE-II (Acute Physiology And Chronic Health Evaluation II) scoring systems were calculated for each patients. primary outcome time frame first day primary outcome measure Effects of NMES treatment on ICU-AW development, scoring systems. primary outcome description When the follow-up was completed, duration of the ICU stay, intubated and/ or extubated days. primary outcome time frame 28 days primary outcome measure Effects of NMES treatment on ICU-AW development, scoring systems. primary outcome description When the follow-up was completed, duration of the ICU stay, , last BMI (body mass index)(kg/m^2) were recorded. primary outcome time frame 28 days primary outcome measure Effects of NMES treatment on ICU-AW development, nutrition. primary outcome description The diet of the patients were standardized by the dietitian. primary outcome time frame 28 days primary outcome measure height primary outcome description The height of the patients was calculated by measuring the knee height from many alternative height measurement methods. The measurement includes the length from the base of the foot to the anterior surface of the thigh while the lower extremity is flexed and is easily taken Chumlea et al. The equation created by the Chumlea method, known as the Chumlea method, is the most accurate equation used to estimate standing height from knee height. This method has been cross-validated for use in ICU patients. The original estimated equations are given. White Male Estimated height (cm) = (knee height (cm) × 1.88) + 71.85 White Female Estimated height (cm) = (knee height (cm) × 1.87) - (0.06 × age (y)) + 70.25 primary outcome time frame first day and last day ( end of the 28th day) primary outcome measure weight primary outcome description We calculated the body weight of our patients by indirectly using the method of calculating body weight in bedridden patients. Age (Year) 6-18 Male : (Knee length (cm) x 0.68) + (Arm circumference (cm)x 2.64) -50.08 Female : (Knee (cm) x 0.77) + (Arm (cm) x 2.47) - 50.16 19-59 Male : (Knee (cm) x 1.19) + (Arm (cm) x 3.21) -86.82 Female : (Knee (cm) x 1.01) + (Arm (cm) x 2.81) - 66.04 60-80 Male : (Knee (cm) x 1.10) + (Arm (cm) x 3.07) -75.81 Female : (Knee (cm) x 1.09) + (Arm circumference(cm) x 2.68) - 65.51 primary outcome time frame first day and last day (end of the 28th day) eligibility module eligibility criteria Inclusion Criteria: Being in the Intensive Care Unit Over the age of 18 Diagnosed with sepsis/ septic shock Exclusion Criteria: Under the age of 18 Pregnancy Having a cardiac pacemaker Amputated lower limbs Having severe venous insufficiency or major injuries to their lower extremities Having neuromuscular disease Malignancy healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Ondokuz Mayis University Faculty of Medicine location city Samsun location state Atakum location zip 55200 location country Turkey i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000018805 condition mesh term Sepsis condition mesh id D000014115 condition mesh term Toxemia condition mesh id D000001247 condition mesh term Asthenia condition ancestor list condition ancestor condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000018746 condition ancestor term Systemic Inflammatory Response Syndrome condition ancestor id D000007249 condition ancestor term Inflammation condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M20017 condition browse leaf name Sepsis condition browse leaf as found Sepsis condition browse leaf relevance high condition browse leaf id M16021 condition browse leaf name Toxemia condition browse leaf as found Sepsis condition browse leaf relevance high condition browse leaf id M14732 condition browse leaf name Shock, Septic condition browse leaf relevance low condition browse leaf id M14729 condition browse leaf name Shock condition browse leaf relevance low condition browse leaf id M27549 condition browse leaf name Sarcopenia condition browse leaf relevance low condition browse leaf id M12356 condition browse leaf name Paresis condition browse leaf relevance low condition browse leaf id M20097 condition browse leaf name Muscle Weakness condition browse leaf relevance low condition browse leaf id M3706 condition browse leaf name Asthenia condition browse leaf as found Weakness condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M19971 condition browse leaf name Systemic Inflammatory Response Syndrome condition browse leaf relevance low condition browse leaf id M9445 condition browse leaf name Inflammation condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases
NCT04833621
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full study rank 61817 study protocol section identification module n c t id NCT04831541 org study id info org study id FirstAHFujian6 organization org full name First Affiliated Hospital of Fujian Medical University org class OTHER brief title 68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer official title 68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date October 10, 2020 start date type Actual primary completion date struct primary completion date December 30, 2023 primary completion date type Anticipated completion date struct completion date December 30, 2023 completion date type Anticipated study first submit date September 5, 2020 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Weibing Miao, PhD responsible party investigator title Director, Department of Nuclear Medicine responsible party investigator affiliation First Affiliated Hospital of Fujian Medical University lead sponsor lead sponsor name First Affiliated Hospital of Fujian Medical University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To evaluate the potential usefulness of 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions, efficacy assessment and recurrence monitoring in various types of cancer. detailed description Subjects with various types of cancer underwent 68Ga-PSMA-11 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA-11 PET/CT were calculated. conditions module condition list condition Prostate Cancer Positron-Emission Tomography design module study type Interventional phase list phase Early Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 600 enrollment type Anticipated arms interventions module arm group list arm group arm group label 68Ga-PSMA-11 arm group type Experimental arm group description Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time. arm group intervention list arm group intervention name Drug: 68Ga-PSMA-11 intervention list intervention intervention type Drug intervention name 68Ga-PSMA-11 intervention description Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time. intervention arm group label list intervention arm group label 68Ga-PSMA-11 intervention other name list intervention other name Diagnostic Test: PET/CT scan outcomes module primary outcome list primary outcome primary outcome measure Standardized uptake value (SUV) primary outcome description Standardized uptake value (SUV) of 68Ga-PSMA-11 for each target lesion of subject or suspected primary tumor or/and metastasis. primary outcome time frame 30 days secondary outcome list secondary outcome secondary outcome measure Diagnostic efficacy secondary outcome description The sensitivity, specificity and accuracy of 68Ga-PSMA-11 PET/CT were calculated. secondary outcome time frame 30 days eligibility module eligibility criteria Inclusion Criteria: (i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-PSMA-11 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent. healthy volunteers No gender All minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Weibing Miao, MD central contact role Contact central contact phone 86-0591-87981618 central contact e mail miaoweibing@126.com central contact name Shaoming Chen, MD central contact role Contact central contact phone 86-0591-87981619 central contact e mail shaoming81@163.com location list location location facility Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University location status Recruiting location city Fuzhou location state Fujian location zip 350005 location country China location contact list location contact location contact name Weibing Miao, MD location contact role Contact location contact phone +86 591 87981618 location contact e mail miaoweibing@126.com location contact name Kaixian Lin, MD location contact role Contact location contact phone +86 591 87981619 location contact e mail kaysonlin@163.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition ancestor list condition ancestor condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostate Cancer condition browse leaf relevance high condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id C000718244 intervention mesh term Gallium 68 PSMA-11 intervention ancestor list intervention ancestor intervention ancestor id D000019275 intervention ancestor term Radiopharmaceuticals intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M346678 intervention browse leaf name Gallium 68 PSMA-11 intervention browse leaf as found Five days intervention browse leaf relevance high intervention browse leaf id M20411 intervention browse leaf name Radiopharmaceuticals intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04831541
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full study rank 61676 study protocol section identification module n c t id NCT04833374 org study id info org study id 1010PY (2020) -51 organization org full name Sixth Affiliated Hospital, Sun Yat-sen University org class OTHER brief title Steroids Therapy in IgA Nephropathy With Crescents official title Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. status module status verified date June 2021 overall status Recruiting expanded access info has expanded access No start date struct start date May 24, 2021 start date type Actual primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 2, 2021 last update post date struct last update post date June 4, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Sixth Affiliated Hospital, Sun Yat-sen University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with crescents. detailed description It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days, with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. However, according to Oxford classification, crescents in IgAN would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral prednisone 0.5mg/kg/d on alternate days. Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral prednisone 0.5mg/kg/d on alternate days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated. conditions module condition list condition IgA Nephropathy keyword list keyword IgA nephropathy crescent steroid proteinuria eGFR design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label 1-2-3 Group arm group type Experimental arm group description Patients in 1-2-3Group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month, then oral prednisone 0.5mg/kg/d on alternate days for 6 months. arm group intervention list arm group intervention name Drug: Methylprednisolone arm group label 1-3-5 Group arm group type Active Comparator arm group description Patients in 1-3-5 Group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral prednisone 0.5mg/kg/d on alternate days for 6 months. arm group intervention list arm group intervention name Drug: Methylprednisolone intervention list intervention intervention type Drug intervention name Methylprednisolone intervention description Patients will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd or 1st-3rd-5th month, then oral prednisone 0.5mg/kg/d on alternate days for 6 months. intervention arm group label list intervention arm group label 1-2-3 Group 1-3-5 Group intervention other name list intervention other name Prednisone outcomes module primary outcome list primary outcome primary outcome measure Complete remission of proteinuria primary outcome description Proteinuria<0.3g/24h and stable renal function primary outcome time frame 6 months secondary outcome list secondary outcome secondary outcome measure Partial remission of proteinuria secondary outcome description Proteinuria decline>50%, serum albumin>30g/L and stable renal function secondary outcome time frame 6 months secondary outcome measure Deterioration of renal function secondary outcome description The longitudinal decline of eGFR, serum creatinine arise>50%, or eGFR decline>25%, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation secondary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Age 14~65 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with crescents. Average urinary protein excretion of 0.3~3.5g/24h on two successive examinations. eGFR≥30 ml/min/1.73m2. Willingness to sign an informed consent. Exclusion Criteria: Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B-associated nephritis, etc. Rapidly progressive nephritic syndrome (crescent formation≥50%). Acute renal failure, including rapidly progressive IgAN. Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506). Date of renal biopsy exceeds more than 30 days. Cirrhosis, chronic active liver disease, and serious liver function damage. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease). Any Active systemic infection or history of serious infection within one month. Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases). Active tuberculosis Malignant hypertension that is difficult to be controlled by oral drugs. Known allergy, contraindication or intolerance to the steroids. Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception. Malignant tumors. Excessive drinking or drug abuse. Mental aberrations. Current or recent (within 30 days) exposure to any other investigational drugs. Current use of RAS inhibitors needs to be eluted for at least 1 week before participating in the study. healthy volunteers No gender All minimum age 14 Years maximum age 65 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Mengjun Liang, MM central contact role Contact central contact phone 86-020-38379727 central contact e mail liangmj7@mail.sysu.edu.cn central contact name Zongpei Jiang, MD,PhD central contact role Contact central contact phone 86-020-38379727 central contact e mail jiangzp@mail.sysu.edu.cn location list location location facility Sixth Affiliated Hospital, Sun Yat-sen University location status Recruiting location city Guangzhou location state Guangdong location zip 510655 location country China location contact list location contact location contact name Jun Hu location contact role Contact references module reference list reference reference p m i d 10093981 reference type result reference citation Pozzi C, Bolasco PG, Fogazzi GB, Andrulli S, Altieri P, Ponticelli C, Locatelli F. Corticosteroids in IgA nephropathy: a randomised controlled trial. Lancet. 1999 Mar 13;353(9156):883-7. reference p m i d 14694168 reference type result reference citation Pozzi C, Andrulli S, Del Vecchio L, Melis P, Fogazzi GB, Altieri P, Ponticelli C, Locatelli F. Corticosteroid effectiveness in IgA nephropathy: long-term results of a randomized, controlled trial. J Am Soc Nephrol. 2004 Jan;15(1):157-63. doi: 10.1097/01.asn.0000103869.08096.4f. reference p m i d 23782179 reference type result reference citation Wyatt RJ, Julian BA. IgA nephropathy. N Engl J Med. 2013 Jun 20;368(25):2402-14. doi: 10.1056/NEJMra1206793. No abstract available. reference p m i d 28341274 reference type result reference citation Trimarchi H, Barratt J, Cattran DC, Cook HT, Coppo R, Haas M, Liu ZH, Roberts IS, Yuzawa Y, Zhang H, Feehally J; IgAN Classification Working Group of the International IgA Nephropathy Network and the Renal Pathology Society; Conference Participants. Oxford Classification of IgA nephropathy 2016: an update from the IgA Nephropathy Classification Working Group. Kidney Int. 2017 May;91(5):1014-1021. doi: 10.1016/j.kint.2017.02.003. Epub 2017 Mar 22. reference p m i d 11877568 reference type result reference citation Hotta O, Furuta T, Chiba S, Tomioka S, Taguma Y. Regression of IgA nephropathy: a repeat biopsy study. Am J Kidney Dis. 2002 Mar;39(3):493-502. doi: 10.1053/ajkd.2002.31399. reference p m i d 10676716 reference type result reference citation Shoji T, Nakanishi I, Suzuki A, Hayashi T, Togawa M, Okada N, Imai E, Hori M, Tsubakihara Y. Early treatment with corticosteroids ameliorates proteinuria, proliferative lesions, and mesangial phenotypic modulation in adult diffuse proliferative IgA nephropathy. Am J Kidney Dis. 2000 Feb;35(2):194-201. doi: 10.1016/s0272-6386(00)70326-x. reference p m i d 26630142 reference type result reference citation Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B, Panzer U, Peters H, Benck U, Mertens PR, Kuhlmann U, Witzke O, Gross O, Vielhauer V, Mann JF, Hilgers RD, Floege J; STOP-IgAN Investigators. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. N Engl J Med. 2015 Dec 3;373(23):2225-36. doi: 10.1056/NEJMoa1415463. reference p m i d 28763548 reference type result reference citation Lv J, Zhang H, Wong MG, Jardine MJ, Hladunewich M, Jha V, Monaghan H, Zhao M, Barbour S, Reich H, Cattran D, Glassock R, Levin A, Wheeler D, Woodward M, Billot L, Chan TM, Liu ZH, Johnson DW, Cass A, Feehally J, Floege J, Remuzzi G, Wu Y, Agarwal R, Wang HY, Perkovic V; TESTING Study Group. Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial. JAMA. 2017 Aug 1;318(5):432-442. doi: 10.1001/jama.2017.9362. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007674 condition mesh term Kidney Diseases condition mesh id D000005922 condition mesh term Glomerulonephritis, IGA condition ancestor list condition ancestor condition ancestor id D000014570 condition ancestor term Urologic Diseases condition ancestor id D000005921 condition ancestor term Glomerulonephritis condition ancestor id D000009393 condition ancestor term Nephritis condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M9850 condition browse leaf name Kidney Diseases condition browse leaf as found Nephropathy condition browse leaf relevance high 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full study rank 61326 study protocol section identification module n c t id NCT04837924 org study id info org study id 0121812 organization org full name General Hospital Sveti Duh org class OTHER brief title Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients official title The Effects of Fascia Iliaca Compartment Block on Hip Fracture Patients acronym BLOCKPAIN status module status verified date August 2022 overall status Completed expanded access info has expanded access No start date struct start date April 21, 2021 start date type Actual primary completion date struct primary completion date May 26, 2022 primary completion date type Actual completion date struct completion date May 27, 2022 completion date type Actual study first submit date March 24, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 2, 2022 last update post date struct last update post date August 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Andela Simic responsible party investigator title Principal Investigator responsible party investigator affiliation General Hospital Sveti Duh lead sponsor lead sponsor name General Hospital Sveti Duh lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary BLOCKPAIN is a randomized controlled study, 80 participants. The participants will be hip fracture patients in Emergency Medicine Department in Clinical Hospital "Sveti Duh", Zagreb, Croatia. Upon patient arrival inclusion and exclusion criteria will be established. After signing the informed consent form participant will be randomized in one of two study groups. One study group is fascia iliaca compartment block (FICB), the other is placebo. All participants will be given paracetamol 1 gram IV as standard care. If needed, rescue analgesic will be tramadol 100 mg in 100 ml saline IV. The time frame is 24 hours after the FICB or placebo procedure. detailed description Hip fractures in older patients are a major public health problem. For acute pain management, nonopioid analgesics are often not sufficient enough, and opioids have many adverse events. For this reasons fascia iliaca compartment block could be the treatment of choice. The objective of this study is to evaluate the efficacy of the fascia iliaca compartment block for pain management in the emergency department, especially the effect on stress response and the effect on the acute confusional state. The investigators intend to conduct a randomized clinical trial in hip fracture patients years 65 and older presenting in the emergency department. In addition to standard analgesia with parenteral paracetamol, the first group of patients will receive fascia iliaca compartment block and the second group placebo. The investigators will monitor the effect of treatment protocol on laboratory parameters of stress response copeptin and cortisol, frequency and severity of acute confusional state, pain intensity and the need for additional opioid analgesics. Data obtained from this research could significantly improve the standard and quality of analgesia in the older patients with hip fracture. Regional anesthesia can diminish or prevent the development of stress response and cognitive impairment and these are the factors that complicate recovery of this fragile group of patients. conditions module condition list condition Hip Fractures keyword list keyword Hip Fractures Pain Management design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description 80 participants, stratified randomization will be used, men/women, age 65-75 years/older then 75 years, The American Society of Anesthesiologists physical status classification, (ASA status) I-II/ ASA III and IV, and type of hip fracture intra/extracapsular design primary purpose Treatment design masking info design masking Triple design masking description Participants will be blinded by sham procedure (disinfection, sting with blunt needle, (without piercing the skin), in the groin area, same place where actual FICB is given and covered with same gauze/patch). It will not be revealed to care providers and outcome measurement associate in which group participant is. After the data collection statistical analyst will not know is A group experimental or control. design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 80 enrollment type Actual arms interventions module arm group list arm group arm group label B (FICB) arm group type Experimental arm group description Participants receiving fascia iliaca compartment block (FICB) arm group intervention list arm group intervention name Procedure: fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml) Drug: paracetamol 1 gram IV Drug: Rescue analgesic tramadol 100 mg IV if needed arm group label A (PLACEBO) arm group type Sham Comparator arm group description Participants receiving sham injection matching fascia iliaca compartment block (FICB) arm group intervention list arm group intervention name Drug: paracetamol 1 gram IV Drug: Rescue analgesic tramadol 100 mg IV if needed Procedure: Sham injection intervention list intervention intervention type Procedure intervention name fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml) intervention description Land mark technique will be used to perform FICB on the side of the hip fracture. The injection site is one centimetre caudal from the junction between medial 2/3 and lateral 1/3 in the imaginary line between anterior superior iliac spine and ipsilateral pubic tubercle. The goal is to administer local anesthetic in the fascia iliaca compartment. intervention arm group label list intervention arm group label B (FICB) intervention type Drug intervention name paracetamol 1 gram IV intervention description paracetamol 1 gram IV every six hours, 4 times in 24 hours intervention arm group label list intervention arm group label A (PLACEBO) B (FICB) intervention type Drug intervention name Rescue analgesic tramadol 100 mg IV if needed intervention description Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours intervention arm group label list intervention arm group label A (PLACEBO) B (FICB) intervention type Procedure intervention name Sham injection intervention description Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block intervention arm group label list intervention arm group label A (PLACEBO) outcomes module primary outcome list primary outcome primary outcome measure Stress Response 1 primary outcome description cortisol plasma level primary outcome time frame Change from baseline cortisol plasma level at 24 hours primary outcome measure Stress Response 2 primary outcome description copeptin plasma level primary outcome time frame Change from baseline copeptin plasma level at 24 hours primary outcome measure Acute confusional state/Delirium primary outcome description Abbreviated Mental Test Score (AMTS) - 10 point scale, from 0 to 10, 10 is the best possible result, 2 and more point drop from baseline indicating delirium primary outcome time frame Change from baseline Abbreviated Mental Test Score at 24 hours secondary outcome list secondary outcome secondary outcome measure Pain Intensity secondary outcome description Pain intensity at rest and pain intensity at movement, Numerical Rating Scale (NRS), from 0 to 10, 0 meaning "no pain" and 10 "the worst pain ever possible" secondary outcome time frame Immediately prior and 30, 120, 240 minutes and 24 hours eligibility module eligibility criteria Inclusion Criteria: hip fracture after minor trauma/simple falls, confirmed by imaging technique (X-ray or CT scan or MRI) signed informed consent form (after a verbal explanation and written information sheet) Exclusion Criteria: pathological fracture head injury body mass bellow 50 kg cognitive impairment (Abbreviated Mental Test Score less then 6 points) oral anticoagulant drugs prior drug allergy (paracetamol, tramadol, local anesthetics) prior peripheral artery bypass surgery (on the same side as hip fracture) skin or soft tissue infection in the groin area (on the same side as hip fracture) simultaneously bilateral hip fracture opioid analgesics prior to hospital arrival healthy volunteers No gender All minimum age 65 Years std age list std age Older Adult contacts locations module overall official list overall official overall official name Anđela Simić overall official affiliation Clinical Hospital "Sveti Duh" overall official role Principal Investigator location list location location facility Clinical Hospital "Sveti Duh" location city Zagreb location zip 10 000 location country Croatia i p d sharing statement module i p d sharing Yes i p d sharing description All IPD will be shared on demand, via Principal Investigator e-mail. There is a prior signed consent of all participants. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code i p d sharing time frame 6 months after the study publication, unlimited i p d sharing access criteria The de-identified IPD will be available for research purposes by contacting the first author via e-mail. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000050723 condition mesh term Fractures, Bone condition mesh id D000006620 condition mesh term Hip Fractures condition ancestor list condition ancestor condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000005264 condition ancestor term Femoral Fractures condition ancestor id D000025981 condition ancestor term Hip Injuries condition ancestor id D000007869 condition ancestor term Leg Injuries condition browse leaf list condition browse leaf condition browse leaf id M25523 condition browse leaf name Fractures, Bone condition browse leaf as found Fracture condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M8848 condition browse leaf name Hip Fractures condition browse leaf as found Hip Fracture condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M7554 condition browse leaf name Femoral Fractures condition browse leaf relevance low condition browse leaf id M22258 condition browse leaf name Hip Injuries condition browse leaf relevance low condition browse leaf id M10033 condition browse leaf name Leg Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000000082 intervention mesh term Acetaminophen intervention mesh id D000014147 intervention mesh term Tramadol intervention mesh id D000000700 intervention mesh term Analgesics intervention mesh id D000077554 intervention mesh term Levobupivacaine intervention ancestor list intervention ancestor intervention ancestor id D000018712 intervention ancestor term Analgesics, Non-Narcotic intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000058633 intervention ancestor term Antipyretics intervention ancestor id D000000701 intervention ancestor term Analgesics, Opioid intervention ancestor id D000009294 intervention ancestor term Narcotics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000000779 intervention ancestor term Anesthetics, Local intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M16053 intervention browse leaf name Tramadol intervention browse leaf as found Personalized intervention browse leaf relevance high intervention browse leaf id M3261 intervention browse leaf name Anesthetics, Local intervention browse leaf relevance low intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf as found Resuscitation intervention browse leaf relevance high intervention browse leaf id M1832 intervention browse leaf name Levobupivacaine intervention browse leaf as found Fluorine-18 intervention browse leaf relevance high intervention browse leaf id M2341 intervention browse leaf name Acetaminophen intervention browse leaf as found Anterior intervention browse leaf relevance high intervention browse leaf id M19939 intervention browse leaf name Analgesics, Non-Narcotic intervention browse leaf relevance low intervention browse leaf id M28329 intervention browse leaf name Antipyretics intervention browse leaf relevance low intervention browse leaf id M3185 intervention browse leaf name Analgesics, Opioid intervention browse leaf relevance low intervention browse leaf id M11397 intervention browse leaf name Narcotics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev Antipy intervention browse branch name Antipyretics
NCT04837924
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full study rank 61898 study protocol section identification module n c t id NCT04830475 org study id info org study id NIV in obese organization org full name University of Campania "Luigi Vanvitelli" org class OTHER brief title NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery official title Non-invasive Ventilation Prevents Post-operative Respiratory Failure in Patient Undergoing Bariatric Surgery status module status verified date June 2022 overall status Completed expanded access info has expanded access No start date struct start date January 1, 2019 start date type Actual primary completion date struct primary completion date December 31, 2020 primary completion date type Actual completion date struct completion date February 20, 2021 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date June 16, 2022 last update post date struct last update post date June 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Claudio Gambardella responsible party investigator title Clinical Professor responsible party investigator affiliation University of Campania "Luigi Vanvitelli" lead sponsor lead sponsor name University of Campania "Luigi Vanvitelli" lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Postoperative non-invasive ventilation (NIV) has been proposed as an attractive strategy to reduce morbidity and improve postoperative outcomes in obese subjects undergoing general anesthesia. Bariatric patients present a peculiar negative feature; the increased body mass index (BMI) correlates with loss of perioperative functional residual capacity (FRC), expiratory reserve volume (ERV) and total lung capacity (TLC), decreased up to 50% of preoperative values. The aim of the current randomized trial is to evaluate the efficacy of NIV in post-anaesthesia care unit (PACU) in reducing post-extubation acute respiratory failure and the consequent admission in intensive care units (ICU) after BIBP in obese adult patients. conditions module condition list condition Obesity Postoperative Respiratory Distress design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description Retrospective Analysis design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 107 enrollment type Actual arms interventions module arm group list arm group arm group label NIV Group arm group type Experimental arm group description In poostoperative period, patients allocated in NIV Group fulfilled a 120-minute cycle of PSV + PEEP with full-face mask. Ventilation was performed with a Draeger Ventilator with the following basic settings: DeltaPInsp 10 mmHg + PEEP 5 mmHg + Fio2 60%. arm group intervention list arm group intervention name Device: Non invasive ventilation (NIV) arm group label Control Group arm group type Active Comparator arm group description In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m. arm group intervention list arm group intervention name Device: Conventional Venturi Mask intervention list intervention intervention type Device intervention name Non invasive ventilation (NIV) intervention description Patients allocated in NIV Group fulfilled a 120-minute cycle of PSV + PEEP with full-face mask. Ventilation was performed with a Draeger Ventilator with the following basic settings: DeltaPInsp 10 mmHg + PEEP 5 mmHg + Fio2 60%. intervention arm group label list intervention arm group label NIV Group intervention type Device intervention name Conventional Venturi Mask intervention description Patients were offered VenturiMask with Fio2 60% at 15 l / m. intervention arm group label list intervention arm group label Control Group outcomes module primary outcome list primary outcome primary outcome measure Intensive care unit admission rate primary outcome description The primary outcome was the evaluation of the ICU admission rate after NIV in postoperative management of obese patients primary outcome time frame 72 hours primary outcome measure Blood oxygen saturation (SaPo2) primary outcome description the evaluation of the oximetry values of obese patients after postoperative NIV adoption primary outcome time frame 12 hours eligibility module eligibility criteria Inclusion Criteria: Morbid Obesity Patients undergoing Biliointestinal Bypass (BIBP) Exclusion Criteria: Patients requiring emergency operation with rapid sequence induction Patients with suspected presence of difficult airway or pre-existing lung impairment Pregnancy Asthma Severe renal dysfunction, cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class >II healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility University of Campania Luigi Vanvitelli location city Napoli location zip 80131 location country Italy i p d sharing statement module i p d sharing Undecided i p d sharing description Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012131 condition mesh term Respiratory Insufficiency condition ancestor list condition ancestor condition ancestor id D000012120 condition ancestor term Respiration Disorders condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M14120 condition browse leaf name Respiratory Insufficiency condition browse leaf as found Respiratory Failure condition browse leaf relevance high condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf relevance low condition browse leaf id M14109 condition browse leaf name Respiration Disorders condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04830475
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full study rank 61833 study protocol section identification module n c t id NCT04831333 org study id info org study id 20210331001 organization org full name Beijing YouAn Hospital org class OTHER brief title Deep Learning-based System and AIDS-related Cytomegalovirus Retinitis official title Deep Learning-based System for Detection of AIDS-related Cytomegalovirus Retinitis in Ultra-Widefield Fundus Images status module status verified date July 2021 overall status Completed expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date May 1, 2021 primary completion date type Actual completion date struct completion date May 1, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 20, 2021 last update post date struct last update post date July 21, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Kuifang Du responsible party investigator title Principal investigator responsible party investigator affiliation Beijing YouAn Hospital lead sponsor lead sponsor name Kuifang Du lead sponsor class OTHER collaborator list collaborator collaborator name Beijing Tongren Hospital collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Ophthalmological screening for cytomegalovirus retinitis (CMVR) for HIV/AIDS patients is important. However, the manual screening with fundus imaging is laborious and subjective. Deep learning (DL) system has been developed for the automated detection of various eye diseases with high accuracy and efficiency, including diabetic retinopathy, glaucoma, age-related macular degeneration (AMD), papilledema, lattice degeneration and retinal breaks, from ocular fundus photographs. UWF imaging is a relatively new imaging modality for DL system but has also shown extraordinary talents in automatic retinal analysis With the press for routine CMVR screening in AIDS patients and the great capacity of DL system, the use of deep learning (DL) system to AIDS-related CMVR with Ultra-Widefield (UWF) fundus images is promising. The investigators previously developed a DL system to detect AIDS-related CMVR. For further evaluating the applicability of the DL system, a prospective dataset is needed. conditions module condition list condition Cytomegalovirus Retinitis keyword list keyword AIDS HIV Cytomegalovirus Retinitis Deep learning Ultra-wide-field imaging design module study type Observational patient registry Yes target duration 1 Day design info design observational model list design observational model Other design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 50 enrollment type Actual arms interventions module arm group list arm group arm group label Active CMVR arm group description The UWF images of cytomegalovirus retinitis (CMVR) included various patterns: hemorrhagic necrotizing lesion, granular lesion, frosted branch angiitis, and optic neuropathy lesion. Active CMVR lesion was defined as obvious opacity (mild, moderate, severe, very severe) arm group label Inactive CMVR arm group description Inactive CMVR lesion was defined as a lack of opacity or questionable/equivocal activity. arm group label Non-CMVR arm group description The non-CMVR images included normal retina and other retinopathies such as HIV-related microvascular retinopathy, diabetic retinopathy, retinal detachment, vitreous hemorrhage. intervention list intervention intervention type Other intervention arm group label list intervention arm group label Active CMVR Inactive CMVR Non-CMVR outcomes module primary outcome list primary outcome primary outcome measure Evaluating the applicability of the DL system to identify AIDS-related CMVR primary outcome description The investigators compared the performance between two trained (senior and junior) retinal ophthalmologists with the DL system. A senior retinal ophthalmologist and a junior retinal ophthalmologist were asked to independently screen the UWF images in the prospective dataset. Accuracy, sensitivity and specificity were used to evaluate the performance. primary outcome time frame April 2021 eligibility module eligibility criteria Inclusion Criteria: The UWF images from HIV/AIDS patients. Exclusion Criteria: The UWF images would be excluded if all three human graders gave different diagnosis. The UWF images with poor quality would be excluded. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population AIDS patients undergoing OPTOS camera (OPTOS® Daytona) from Department of Ophthalmology, Beijing Youan Hospital, were prospectively collected as a prospective dataset. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Kui-Fang Du overall official affiliation Beijing YouAn Hospital overall official role Study Director overall official name Li Dong overall official affiliation Beijing Tongren Hospital overall official role Study Director overall official name Kai Zhang overall official affiliation Beijing Tongren Hospital overall official role Principal Investigator overall official name Chao Chen overall official affiliation Beijing YouAn Hospital overall official role Principal Investigator overall official name Lian-Yong Xie overall official affiliation Beijing YouAn Hospital overall official role Principal Investigator overall official name Wen-Jun Kong overall official affiliation Beijing YouAn Hospital overall official role Principal Investigator overall official name Hong-Wei Dong overall official affiliation Beijing YouAn Hospital overall official role Principal Investigator overall official name He-Yan Li overall official affiliation Beijing Tongren Hospital overall official role Principal Investigator overall official name Rui-Heng Zhang overall official affiliation Beijing Tongren Hospital overall official role Principal Investigator overall official name Wen-Da Zhou overall official affiliation Beijing Tongren Hospital overall official role Principal Investigator overall official name Hao-Tian Wu overall official affiliation Beijing Tongren Hospital overall official role Principal Investigator overall official name Wen-Bin Wei overall official affiliation Beijing Tongren Hospital overall official role Study Chair location list location location facility Beijing Youan Hospital, Capital Medical University location city Beijing location state Beijing location zip 100069 location country China derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000017726 condition mesh term Cytomegalovirus Retinitis condition mesh id D000012173 condition mesh term Retinitis condition ancestor list condition ancestor condition ancestor id D000012164 condition ancestor term Retinal Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition ancestor id D000015828 condition ancestor term Eye Infections, Viral condition ancestor id D000015817 condition ancestor term Eye Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000003586 condition ancestor term Cytomegalovirus Infections condition ancestor id D000006566 condition ancestor term Herpesviridae Infections condition ancestor id D000004266 condition ancestor term DNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition browse leaf list condition browse leaf condition browse leaf id M17402 condition browse leaf name HIV Infections condition browse leaf relevance low condition browse leaf id M2674 condition browse leaf name Acquired Immunodeficiency Syndrome condition browse leaf relevance low condition browse leaf id M14160 condition browse leaf name Retinitis condition browse leaf as found Retinitis condition browse leaf relevance high condition browse leaf id M19091 condition browse leaf name Cytomegalovirus Retinitis condition browse leaf as found Cytomegalovirus Retinitis condition browse leaf relevance high condition browse leaf id M14151 condition browse leaf name Retinal Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M17523 condition browse leaf name Eye Infections condition browse leaf relevance low condition browse leaf id M17534 condition browse leaf name Eye Infections, Viral condition browse leaf relevance low condition browse leaf id M5943 condition browse leaf name Cytomegalovirus Infections condition browse leaf relevance low condition browse leaf id M8795 condition browse leaf name Herpesviridae Infections condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M6594 condition browse leaf name DNA Virus Infections condition browse leaf relevance low condition browse leaf id T1721 condition browse leaf name Cytomegalovirus Retinitis condition browse leaf as found Cytomegalovirus Retinitis condition browse leaf relevance high condition browse leaf id T1720 condition browse leaf name Cytomegalic Inclusion Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04831333
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full study rank 61613 study protocol section identification module n c t id NCT04834193 org study id info org study id 18/22.09.2020 organization org full name Azienda Ospedaliera Universitaria Integrata Verona org class OTHER brief title Wet-suction Versus Slow-pull for EUS-FNB of Solid Lesions official title Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial acronym WEST-FNB status module status verified date March 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date October 30, 2021 primary completion date type Actual completion date struct completion date April 30, 2022 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 19, 2022 last update post date struct last update post date March 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Stefano Francesco Crinò, MD responsible party investigator title Principal Investigator responsible party investigator affiliation Azienda Ospedaliera Universitaria Integrata Verona lead sponsor lead sponsor name Azienda Ospedaliera Universitaria Integrata Verona lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary A randomized cross-over study investigating the impact of two different suction techniques on histological yield and sample quality of specimens collected by endoscopic ultrasound biopsy from solid lesions using histology needles. conditions module condition list condition Endoscopic Ultrasound Fine-needle Aspiration design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Diagnostic design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 200 enrollment type Actual arms interventions module arm group list arm group arm group label WET-SUCTION arm group type Experimental arm group description The stylet will be removed and the needle will be pre-flushed with 1-2mL of saline. The lesion will then be punctured, and suction will be applied using a 10-mL pre-vacuum syringe. The sample collected will be pushed into a formalin vial with saline. arm group intervention list arm group intervention name Procedure: Endoscopic ultrasound-guided fine-needle biopsy arm group label SLOW-PULL arm group type Active Comparator arm group description After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm. The sample will be pushed into formalin using the stylet. arm group intervention list arm group intervention name Procedure: Endoscopic ultrasound-guided fine-needle biopsy intervention list intervention intervention type Procedure intervention name Endoscopic ultrasound-guided fine-needle biopsy intervention description Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull) intervention arm group label list intervention arm group label SLOW-PULL WET-SUCTION outcomes module primary outcome list primary outcome primary outcome measure Histologic yield primary outcome description The rate of samples containing a tissue "core" (yes/no) for histological evaluation, defined as an intact piece of tissue of at least 550 μ primary outcome time frame 6 months secondary outcome list secondary outcome secondary outcome measure Tissue integrity secondary outcome description Tissue integrity will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system: 0: No cells/tissue Cytological specimen (disaggregated cells representative of the target lesion not allowing for tissue architectural assessment) Histologic microfragments (sample adequate for histological evaluation, namely an architecturally intact piece of tissue but without a "core") Histologic "core" (defined as an architecturally intact piece of tissue measuring at least 550 μ) secondary outcome time frame 6 months secondary outcome measure Blood contamination secondary outcome description Blood contamination will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system: 0: Only blood High blood contamination (>50% of the surface) Moderate blood contamination (25-50% of the surface) Low blood contamination (<25% of the surface) secondary outcome time frame 6 months secondary outcome measure Tumor fraction secondary outcome description The rate of samples containing an adequate tumor fraction ≥20 percent (i.e., ≥ 20 percent tumor cells in a background of benign nucleated cells). secondary outcome time frame 6 months secondary outcome measure Diagnostic accuracy secondary outcome description Diagnostic accuracy (defined as the ratio between the sum of true positive and true negative values divided by the number of lesions) will be calculated for each study arm secondary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Solid pancreatic lesions 3 1cm Peri-GI tract lymph nodes 3 1cm Peri-GI tract masses Lesions of the GI wall Signed informed consent Exclusion Criteria: Pancreatic cystic lesions (more than 50% of the volume) Diameter of lesion ≤ 1 cm Lesion not seen at EUS Pregnancy Coagulopathy (platelet count <50.000/mm3 and/or international normalized ratio >1.5); Severe cardiorespiratory dysfunction precluding endoscopy; Failure to provide informed consent healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Azienda Ospedaliera Integrata Verona location city Verona location zip 37134 location country Italy references module reference list reference reference p m i d 35915956 reference type derived reference citation Crinò SF, Conti Bellocchi MC, Di Mitri R, Inzani F, Rimbaș M, Lisotti A, Manfredi G, Teoh AYB, Mangiavillano B, Sendino O, Bernardoni L, Manfrin E, Scimeca D, Unti E, Carlino A, Voiosu T, Mateescu RB, Fusaroli P, Lega S, Buscarini E, Pergola L, Chan SM, Lamonaca L, Ginès À, Fernández-Esparrach G, Facciorusso A, Larghi A. Wet-suction versus slow-pull technique for endoscopic ultrasound-guided fine-needle biopsy: a multicenter, randomized, crossover trial. Endoscopy. 2022 Sep 27. doi: 10.1055/a-1915-1812. [Epub ahead of print] document section large document module large doc list large doc large doc type abbrev Prot_SAP large doc has protocol Yes large doc has s a p Yes large doc has i c f No large doc label Study Protocol and Statistical Analysis Plan large doc date March 18, 2021 large doc upload date 04/05/2021 02:06 large doc filename Prot_SAP_000.pdf derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M7833 intervention browse leaf name Formaldehyde intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834193
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full study rank 61562 study protocol section identification module n c t id NCT04834856 org study id info org study id MP0420-CP204 secondary id info list secondary id info secondary id 2021-000365-33 secondary id type EudraCT Number organization org full name Molecular Partners AG org class INDUSTRY brief title Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients official title A Phase 2a Open Label, Non-comparative, Single Dose Escalation Study to Evaluate the Dynamics of Viral Clearance, Pharmacokinetics and Tolerability of Ensovibep in Patients With Symptomatic COVID-19 Disease status module status verified date September 2021 overall status Completed expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date August 20, 2021 primary completion date type Actual completion date struct completion date August 20, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 7, 2021 last update post date struct last update post date September 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Molecular Partners AG lead sponsor class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease conditions module condition list condition Covid19 keyword list keyword SARS-CoV-2 Corona DARPin design module study type Interventional phase list phase Phase 2 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 12 enrollment type Actual arms interventions module arm group list arm group arm group label ensovibep dose 1 arm group type Experimental arm group intervention list arm group intervention name Drug: ensovibep arm group label ensovibep dose 2 arm group type Experimental arm group intervention list arm group intervention name Drug: ensovibep intervention list intervention intervention type Drug intervention name ensovibep intervention description The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. One administration at day 1 by infusion. intervention arm group label list intervention arm group label ensovibep dose 1 ensovibep dose 2 intervention other name list intervention other name MP0420 outcomes module primary outcome list primary outcome primary outcome measure SARS-CoV-2 viral load primary outcome description Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs primary outcome time frame up to day 29 primary outcome measure SARS-CoV-2 viral cultures primary outcome description Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs primary outcome time frame up to day 29 primary outcome measure SARS-CoV-2 PCR days to negativity primary outcome description Duration in days to SARS-CoV-2 PCR negativity primary outcome time frame up to day 29 primary outcome measure Observed maximum concentration (Cmax) primary outcome description The maximum observed concentration (Cmax) is estimated based on the serum concentrations. primary outcome time frame up to day 91 primary outcome measure Terminal Elimination Half-Life (T½) primary outcome time frame up to day 91 primary outcome measure Time to Cmax (Tmax) primary outcome time frame up to day 91 primary outcome measure The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf) primary outcome time frame up to day 91 primary outcome measure The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) primary outcome time frame up to day 91 primary outcome measure Apparent total body clearance of the drug from plasma (CL) primary outcome time frame up to day 91 primary outcome measure Apparent volume of distribution at steady state (Vss) primary outcome time frame up to day 91 secondary outcome list secondary outcome secondary outcome measure 14 Common Covid-19 Related Symptoms score secondary outcome description Changes in the assessment of 14 Common Covid-19 Related Symptoms score secondary outcome time frame up to day 29 secondary outcome measure Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs) secondary outcome description Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study secondary outcome time frame up to day 91 secondary outcome measure Concomitant medication secondary outcome description Intake of concomitant medication will be assessed throughout the study secondary outcome time frame up to day 91 secondary outcome measure Vital Signs: Heart Rate (bpm) secondary outcome time frame up to day 91 secondary outcome measure Vital Signs: Blood Pressure Systolic and Diastolic (mmHg) secondary outcome time frame up to day 91 secondary outcome measure Vital Signs: Respiratory Rate (breaths per minute) secondary outcome time frame up to day 91 secondary outcome measure Vital Signs: Body Temperature (°C) secondary outcome time frame up to day 91 secondary outcome measure Vital Signs: Oxygen Saturation (SpO2) secondary outcome time frame up to day 91 secondary outcome measure Clinical laboratory tests (hematology and blood chemistry) secondary outcome time frame up to day 91 secondary outcome measure Physical examinations (symptom directed) secondary outcome time frame up to day 91 secondary outcome measure Local tolerability at injection site secondary outcome description Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score secondary outcome time frame up to 90 min post dose eligibility module eligibility criteria Inclusion Criteria: Men or non-pregnant women, between 18 and 70 years on the day of inclusion. Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test). Exclusion Criteria: Requiring hospitalization at time of screening, or at time of study drug administration. Oxygen saturation (SpO2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. Any co-morbidity requiring hospitalization or surgery within <7 days, or that is considered life-threatening within 29 days. A patient reported history (prior to the current episode) of a positive SARS-CoV-2 serology test or a history of PCR confirmed SARS-CoV-2 infection. Prior or concurrent use of SARS-CoV-2 antiviral medication, including convalescent serum or anti-viral antibodies. Concurrent enrollment in any other type of medical research for improving COVID-19 outcomes or that is judged by the investigator not to be scientifically or medically compatible with this study. Women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial. Severe immunocompromised status (primary immunodeficiency, supraphysiological dose of systemic corticosteroids, transplant patients, known untreated HIV and CD4 T-cells <200/microliter) or use of any immunosuppressants that, in the opinion of the investigator, should preclude participation in this study. Subjects at high risk for of COVID-19 related complications or mortality healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module location list location location facility Centre for Human Drug Research location city Leiden location zip 2333 location country Netherlands derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04834856
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full study rank 61183 study protocol section identification module n c t id NCT04839783 org study id info org study id 20201713 organization org full name Spine and Scoliosis Research Associates org class OTHER brief title Single Position Spine Surgery Registry official title Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry acronym SPSG Registry status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 7, 2020 start date type Actual primary completion date struct primary completion date July 7, 2030 primary completion date type Anticipated completion date struct completion date July 7, 2032 completion date type Anticipated study first submit date March 10, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date October 24, 2022 last update post date struct last update post date October 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Spine and Scoliosis Research Associates lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to systematically, prospectively compare surgical fusion techniques for thoracolumbar spinal fusion patients and assess long-term patient outcomes and revision rates following surgery. detailed description The goal of this study is to understand how the difference in positioning of a patient intraoperatively, as part of performing an anterior posterior spine fusion surgery, can affect short term and long term outcomes. This will be accomplished through observational techniques that will not affect the care patients will receive for their spinal conditions. Patients will be asked to complete health and wellness surveys before and after survey to determine how they are doing before surgery and then what if any changes their respective surgeries have had on their lives. Further spine x-rays that they have taken to plan their surgeries and assess their recovery will be measured, when available. X-rays will not be taken only for research purposes. Additionally aspects of their surgeries will be noted such as where hardware is placed and how long different parts of the surgery took. Follow-up is planned to be out to 10 years post-operatively with the goal of collecting information about any revision spine surgeries that would happen during those 10 years as well. conditions module condition list condition Spine Fusion Spinal Stenosis Degenerative Disc Disease design module study type Observational patient registry Yes target duration 10 Years design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 1000 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference primary outcome description Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Interference. primary outcome time frame 10 years primary outcome measure Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity primary outcome description Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Intensity. primary outcome time frame 10 years primary outcome measure Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Depression primary outcome description Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Depression. primary outcome time frame 10 years primary outcome measure Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Anxiety primary outcome description Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Anxiety. primary outcome time frame 10 years primary outcome measure Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Physical Function Scores primary outcome description Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates less Physical Function. primary outcome time frame 10 years primary outcome measure Difference in Radiographic Measurements-Cobb Angles primary outcome description Assess the difference between pre-op and post-op measurements of Cobb Angles using available spinal x-rays for patients whose Cobb Angle was to be changed as part of their surgical plan. primary outcome time frame 10 years primary outcome measure Difference in Radiographic Measurements-Fractional Curve Cobb Angles primary outcome description Assess the difference between pre-op and post-op measurements of Fractional Curve Cobb Angles using available spinal x-rays for patients whose Fractional Curve Cobb Angle was to be changed as part of their surgical plan. primary outcome time frame 10 years primary outcome measure Difference in Radiographic Measurements-C7 Sagittal Vertical Alignment (SVA) primary outcome description Assess the difference between pre-op and post-op measurements of C7 SVA using available spinal x-rays for patients whose C7 SVA was to be changed as part of their surgical plan. primary outcome time frame 10 years primary outcome measure Difference in Radiographic Measurements-Coronal Sagittal Vertical Alignment (SVA) primary outcome description Assess the difference between pre-op and post-op measurements of Coronal SVA using available spinal x-rays for patients whose Coronal SVA was to be changed as part of their surgical plan. primary outcome time frame 10 years primary outcome measure Difference in Radiographic Measurements-Pelvic Incidence (PI) primary outcome description Assess the difference between pre-op and post-op measurements of PI using available spinal x-rays for patients whose PI was to be changed as part of their surgical plan. primary outcome time frame 10 years primary outcome measure Difference in Radiographic Measurements-Pelvic Tilt (PT) primary outcome description Assess the difference between pre-op and post-op measurements of spinal x-rays for patients whose PT was to be changed as part of their surgical plan. primary outcome time frame 10 years primary outcome measure Difference in Radiographic Measurements-Lumbar Lordosis (LL) primary outcome description Assess the difference between pre-op and post-op measurements of spinal x-rays for patients whose LL was to be changed as part of their surgical plan. primary outcome time frame 10 years primary outcome measure Difference in Radiographic Measurements-T1 Pelvic Angle (TPA) primary outcome description Assess the difference between pre-op and post-op measurements of spinal x-rays, for patients whose TPA was to be changed as part of their surgical plan. primary outcome time frame 10 years primary outcome measure Revision Incidence primary outcome description Determine the incidence of spine surgery revisions after the initial surgery. primary outcome time frame 10 years eligibility module eligibility criteria Inclusion Criteria: Age greater than or equal to 18 years Ability to speak and read comfortably in English Affliction by a spinal condition warranting evaluation for operative treatment Exclusion Criteria: Current incarceration Individuals incapable of consenting and/or objectively responding to surveys, irrespective of reasonable assistance Women currently pregnant or expecting to become pregnant in the near future Subjects participating in another research study, whose protocol would conflict with comprehensive participation in this study Subjects with psychiatric pathology which may impair judgement or the ability to give informed consent. healthy volunteers No gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult study population Patients suffering from spinal conditions for which a spine surgeon has recommended an anterior posterior fusion, who meet all inclusion and no exclusion criteria. sampling method Non-Probability Sample contacts locations module location list location location facility New England Baptist Hospital location status Not yet recruiting location city Boston location state Massachusetts location zip 02120 location country United States location contact list location contact location contact name Brian Kwon, MD location contact role Contact location contact phone 617-754-6586 location contact e mail bkwon@nebh.org location contact name Brian Kwon, MD location contact role Principal Investigator location facility NYU Langone Health location status Recruiting location city New York location state New York location zip 10016 location country United States location contact list location contact location contact name Brooke O'Connell, MS location contact role Contact location contact phone 646-794-8643 location contact e mail brooke.oconnell@nyulangone.org location contact name Themistocles Protopsaltis, MD location contact role Sub-Investigator location contact name Aaron Buckland, MD location contact role Principal Investigator location facility Atlantic Neurosurgical and Spine Specialists location status Recruiting location city Wilmington location state North Carolina location zip 28401 location country United States location contact list location contact location contact name Bridgette Smith CCRC location contact role Contact location contact phone 919-259-3449 location contact e mail bridgette@atlanticneurosurgery.com location contact name Alex Thomas, MD location contact role Principal Investigator location facility The Spine Clinic of Oklahoma City location status Recruiting location city Oklahoma City location state Oklahoma location zip 73114 location country United States location contact list location contact location contact name Ashley Mason location contact role Contact location contact phone 405-419-5614 location contact e mail amason@okss.com location contact name Brett Braly, MD location contact role Principal Investigator location facility Austin Spine location status Not yet recruiting location city Austin location state Texas location zip 78626 location country United States location contact list location contact location contact name Ivan Cheng, MD location contact role Contact location contact phone 650-387-3528 location contact e mail ivanchengmd@gmail.com location contact name Ivan Cheng, MD location contact role Principal Investigator location facility Melbourne Orthopedic Group location status Recruiting location city Windsor location state Victoria location zip 3181 location country Australia location contact list location contact location contact name Aaron Buckland, MD location contact role Contact location contact phone 03 9529 3333 location contact e mail aaron.buckland@spineandscoliosis.org location contact name Aaron Buckland, MD location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013130 condition mesh term Spinal Stenosis condition mesh id D000055959 condition mesh term Intervertebral Disc Degeneration condition ancestor list condition ancestor condition ancestor id D000013122 condition ancestor term Spinal Diseases condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M15079 condition browse leaf name Spinal Stenosis condition browse leaf as found Spinal Stenosis condition browse leaf relevance high condition browse leaf id M27558 condition browse leaf name Intervertebral Disc Degeneration condition browse leaf as found Degenerative Disc Disease condition browse leaf relevance high condition browse leaf id M5627 condition browse leaf name Constriction, Pathologic condition browse leaf relevance low condition browse leaf id M15071 condition browse leaf name Spinal Diseases condition browse leaf relevance low condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04839783
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full study rank 61659 study protocol section identification module n c t id NCT04833595 org study id info org study id 27779 organization org full name Monash University Malaysia org class OTHER brief title Can Mindful Eating Improve Cholesterol and Glucose Level official title Can Mindful Eating Improve Cholesterol and Glucose Level: A Tele-Health Pilot-Randomised Controlled Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date August 31, 2021 primary completion date type Anticipated completion date struct completion date December 31, 2021 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Teoh Siew Li responsible party investigator title Lecturer responsible party investigator affiliation Monash University Malaysia lead sponsor lead sponsor name Monash University Malaysia lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study aims to explore the effectiveness of mindful eating and its effect on cholesterol and glucose level. The participants will be required to get tested for their fasting total cholesterol and blood glucose level for two times. At the first visit, they will be required to complete the survey given and be tested for their fasting total cholesterol and blood glucose level. A recommendation on healthy food intake will be sent to participants. At the end of each week, participants will be required 1) to submit THREE photos of the meals that they are most satisfied with in terms of healthiness and 2) using the photos to answer a questionnaire about their diet. The photos and completed questionnaire must be submitted to the research investigator each week for a total of 8 weeks. After 8 weeks, participants will be required to get tested for their fasting total cholesterol and blood glucose level in the appointed pharmacy for the second time. It is estimated to require 15-30 minutes of their time weekly. detailed description Consistently high cholesterol or/and glucose level pose harmful threat to the body that may cause lethal health conditions (e.g. stroke, cardiovascular diseases). In addition, 3.6 million Malaysians are suffering from diabetes, the highest rate of incidence in Asia and one of the highest in the world. There is crucial need to find ways to improve the situation. Tele-health interventions and mindful eating behaviours are proposed to be effective in improving the levels of cholesterol and glucose. To investigate and explore the intervention, a small-scale randomised controlled trial will be conducted by comparing the effectiveness of mindful eating and the effect on cholesterol and glucose level. Students will collect and analyse both quantitative and qualitative data. A small-scale randomised controlled trial will be conducted to compare the effectiveness of mindful eating and the effect on lipid level. Subjects will be randomly assigned to intervention or control group. For intervention group, subjects will be required to snap picture of every meal that they consume. At the end of the day, they are required to actively recall and reflect on how healthy they consider their meals to be. The reflection will be submitted to the research team daily together with the taken pictures of meal. As for the control group, subjects will only snap and submit the picture of their meals but without active recall and reflection. Subjects are required to return to the community pharmacy after two months to follow-up on their glucose and lipid levels post intervention. conditions module condition list condition Cholesterol; Lipidosis design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Mindfulness Arm arm group type Experimental arm group description A recommendation on healthy food intake will be sent to participants. At the end of each week, participants will be required 1) to submit THREE photos of the meals that they are most satisfied with in terms of healthiness and 2) using the photos to answer a questionnaire about their diet. The photos and completed questionnaire must be submitted to the research investigator each week for a total of 8 weeks. After 8 weeks, participants will be required to get tested for your fasting total cholesterol and blood glucose level in the appointed pharmacy for the second time. It is estimated to require 15-30 minutes of their time weekly. The questionnaire used for experimental group contains reflective questions as part of the mindfulness intervention. arm group intervention list arm group intervention name Behavioral: Mindfulness practice arm group label Non-mindfulness Arm arm group type Active Comparator arm group description Everything is similar to the experimental arm. However, the questionnaire used for control group does not contain reflective questions to serve as control group. arm group intervention list arm group intervention name Behavioral: Mindfulness practice intervention list intervention intervention type Behavioral intervention name Mindfulness practice intervention description Mindfulness is hypothesised to include reflective practice. Therefore, reflective questions are asked in the questionnaire for intervention group but not for control group. intervention arm group label list intervention arm group label Mindfulness Arm Non-mindfulness Arm outcomes module primary outcome list primary outcome primary outcome measure Fasting total cholesterol primary outcome description Total cholesterol taken after at least 8 hours fasting primary outcome time frame 8 weeks secondary outcome list secondary outcome secondary outcome measure Fasting glucose secondary outcome description Blood glucose taken after at least 8 hours fasting secondary outcome time frame 8 weeks eligibility module eligibility criteria Inclusion Criteria: Total fasting cholesterol of at least 5.2mmol/L Exclusion Criteria: Familial hypercholesterolaemia or Pregnant women. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Phaik Eong Poh, PhD central contact role Contact central contact phone +603 5514 6272 central contact e mail poh.phaik.eong@monash.edu overall official list overall official overall official name Phaik Eong Poh, PhD overall official affiliation Monash University Malaysia overall official role Study Director location list location location facility Monash University Malaysia location status Recruiting location city Subang Jaya location state Selangor location zip 47500 location country Malaysia location contact list location contact location contact name Siew Li Teoh, MPharm, PhD location contact role Contact location contact phone (+603) 5515-9646 location contact e mail teoh.siew.li@monash.edu i p d sharing statement module i p d sharing No i p d sharing description Only aggregated data will be shared upon request to investigator. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008064 condition mesh term Lipidoses condition ancestor list condition ancestor condition ancestor id D000008052 condition ancestor term Lipid Metabolism, Inborn Errors condition ancestor id D000008661 condition ancestor term Metabolism, Inborn Errors condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition ancestor id D000052439 condition ancestor term Lipid Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition browse leaf list condition browse leaf condition browse leaf id M10216 condition browse leaf name Lipidoses condition browse leaf as found Lipidosis condition browse leaf relevance high condition browse leaf id M10793 condition browse leaf name Metabolism, Inborn Errors condition browse leaf relevance low condition browse leaf id M10206 condition browse leaf name Lipid Metabolism, Inborn Errors condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M26182 condition browse leaf name Lipid Metabolism Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04833595
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full study rank 61306 study protocol section identification module n c t id NCT04838184 org study id info org study id PV_4805 organization org full name Universitätsklinikum Hamburg-Eppendorf org class OTHER brief title Short Implants in Edentulous Mandible official title Prospective Clinical Study of Straumann Roxolid®/SLactive® Short Implants in Edentulous Mandible status module status verified date March 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 19, 2015 start date type Actual primary completion date struct primary completion date March 31, 2024 primary completion date type Anticipated completion date struct completion date March 31, 2024 completion date type Anticipated study first submit date March 18, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Universitätsklinikum Hamburg-Eppendorf lead sponsor class OTHER collaborator list collaborator collaborator name Straumann AG collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years. detailed description It is hypothesized that survival rates after 1, 3, and 5 years of Straumann Roxolid® / SLActive® 4 mm short implants do not differ from values of Straumann SLActive implants with more than 4 mm length in the same clinical situation. conditions module condition list condition Tooth Loss Edentulous Jaw design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 20 enrollment type Actual arms interventions module arm group list arm group arm group label Dental patients arm group description Patients with an edentulous mandible who are demanding and receiving an implant-supported fixed dental prosthesis in the mandible arm group intervention list arm group intervention name Device: Dental Implants (Straumann Roxolid® / SLActive®) intervention list intervention intervention type Device intervention name Dental Implants (Straumann Roxolid® / SLActive®) intervention description In this study the 4 mm implants will be inserted in the area surrounding 36/46. The implant diameters will be defined based on the patient's situation. In the interforaminal region, two implants of conventional length with a minimum of 10 mm will be inserted. The implant diameter and the length will be defined based on the patient's situation. intervention arm group label list intervention arm group label Dental patients outcomes module primary outcome list primary outcome primary outcome measure Survival primary outcome description Survival of implants and suprastructure. Measure: survival rates primary outcome time frame 5 years secondary outcome list secondary outcome secondary outcome measure Implant stability secondary outcome description Within-subject comparison of primary (at implant placement) and secondary (at implant exposure) stability of short versus regular length implants. Measure / device: Resonance Frequency Analysis (RFA) secondary outcome time frame 3 months secondary outcome measure Success secondary outcome description Success of implants and suprastructure. Measure: success rates Biological success: No detectable clinical mobility (hand testing) No radiolucency surrounding the total surface of the implant No persistent pain refractory to medical therapy No recurrent peri-implant infection Peri-implant infection: peri-implant Probing Depth (PD), Plaque Index (Pl), and Bleeding on Probing (BoP) Bone loss: standardized intra-oral radiography with long-cone parallel technique Technical success: No screw loosening No fracture of metal base No fracture of veneering material secondary outcome time frame 5 years secondary outcome measure Oral health-related quality of life secondary outcome description Oral health-related quality of life (OHRQoL). Measure: questionnaire - 49-item Oral Health Impact Profile (OHIP) with a 5-point ordinal rating scale (possible range of summary scores: 0-196 with higher scores indicating more impairment) secondary outcome time frame 5 years secondary outcome measure Patient satisfaction secondary outcome description Patient satisfaction. Measure: questionnaire - Visual analogue scales (VAS) on ease of cleaning, speech, comfort, esthetic, stability, chewing ability, masticatory function, and oral health (possible range of scores: 0-10 for each item with higher scores indicating more satisfaction) secondary outcome time frame 5 years eligibility module eligibility criteria Inclusion Criteria: General criteria: Age: 18 to 70 Edentulous mandible with reduced bone level in the posterior region (> 5 mm and < 8 mm above nerve conduit) Physical and mental condition that allow surgery and a 5-year follow-up period to be carried out without foreseeable problems Obtained informed consent from the patient Specific criteria: Limited vertical space for implant placement, where conventional implants with lengths of more than 4 mm cannot be used Tooth loss or extraction at least 8 weeks before implant surgery Healthy implantation site Favorable and stable occlusal relationship Complete denture in the mandible. If no denture available, an interims prosthesis will be fitted Natural full dentition or sufficient complete or partial dentures in the maxilla Exclusion Criteria: General criteria: Any conditions or circumstances which would interfere with the requirements for oral surgery Allergy to any metallic implant component Acute, untreated periodontitis Previous oro-maxillo-facial radiotherapy Any disorders in the planned implant area such as previous tumors or chronic bone disease (e.g., rheumatoid disease) Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.) Alcohol or drug abuse Heavy smoking (>10 cigarettes/day) Uncontrolled diabetes Severe bruxism or other destructive oral habits Pregnant or lactating women Specific criteria: Need for a major bone regeneration technique Infections in adjacent tissue of the planned implantation site. Bleeding on probing (BOP) and plaque index (PI) higher 25% Insufficient bone volume in the posterior region for placing a Straumann Roxolid® / SLActive® 4mm short implant and in the interforaminal region for placing a Straumann Roxolid® / SLActive® implant with a minimum length of 10 mm determined by radiographic analysis (OPG) healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult study population Dental patients of university-based prosthodontic department (primary, secondary, and tertiary care clinic) sampling method Non-Probability Sample i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007575 condition mesh term Jaw, Edentulous condition mesh id D000009066 condition mesh term Mouth, Edentulous condition mesh id D000016388 condition mesh term Tooth Loss condition ancestor list condition ancestor condition ancestor id D000009059 condition ancestor term Mouth Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition ancestor id D000014076 condition ancestor term Tooth Diseases condition ancestor id D000010510 condition ancestor term Periodontal Diseases condition ancestor id D000007571 condition ancestor term Jaw Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M11178 condition browse leaf name Mouth, Edentulous condition browse leaf as found Edentulous condition browse leaf relevance high condition browse leaf id M17975 condition browse leaf name Tooth Loss condition browse leaf as found Tooth Loss condition browse leaf relevance high condition browse leaf id M9757 condition browse leaf name Jaw, Edentulous condition browse leaf as found Edentulous Jaw condition browse leaf relevance high condition browse leaf id M11171 condition browse leaf name Mouth Diseases condition browse leaf relevance low condition browse leaf id M11169 condition browse leaf name Stomatognathic Diseases condition browse leaf relevance low condition browse leaf id M15983 condition browse leaf name Tooth Diseases condition browse leaf relevance low condition browse leaf id M12571 condition browse leaf name Periodontal Diseases condition browse leaf relevance low condition browse leaf id M9753 condition browse leaf name Jaw Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases
NCT04838184
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full study rank 61408 study protocol section identification module n c t id NCT04836858 org study id info org study id CCMK389B12201 secondary id info list secondary id info secondary id 2020-003406-31 secondary id type EudraCT Number organization org full name Novartis org class INDUSTRY brief title A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. official title A Randomized, Subject and Investigator Blinded, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis status module status verified date November 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 20, 2021 start date type Actual primary completion date struct primary completion date December 8, 2022 primary completion date type Anticipated completion date struct completion date December 17, 2022 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 4, 2022 last update post date struct last update post date November 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Novartis Pharmaceuticals lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The main purpose of this phase 2 study is to assess the efficacy and safety of CMK389 in patients with atopic dermatitis. conditions module condition list condition Atopic Dermatitis keyword list keyword Atopic Dermatitis Safety Efficacy Atopic Eczema Eczema CMK389 design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 69 enrollment type Actual arms interventions module arm group list arm group arm group label CMK389 high dose arm group type Experimental arm group description Active arm group intervention list arm group intervention name Biological: CMK389 arm group label Placebo high dose arm group type Placebo Comparator arm group description Placebo arm group intervention list arm group intervention name Biological: Placebo arm group label CMK389 low dose arm group type Experimental arm group description Active arm group intervention list arm group intervention name Biological: CMK389 arm group label Placebo low dose arm group type Placebo Comparator arm group description Placebo arm group intervention list arm group intervention name Biological: Placebo intervention list intervention intervention type Biological intervention name CMK389 intervention description Active intervention arm group label list intervention arm group label CMK389 high dose CMK389 low dose intervention type Biological intervention name Placebo intervention description Placebo Comparator intervention arm group label list intervention arm group label Placebo high dose Placebo low dose outcomes module primary outcome list primary outcome primary outcome measure Change from baseline in Investigator Global assessment (IGA) response at Week 16 primary outcome description To assess the efficacy of CMK389 in participants with moderate to severe AD primary outcome time frame Week 16 secondary outcome list secondary outcome secondary outcome measure Number of adverse events and serious adverse events secondary outcome description To assess the safety and tolerability of CMK389 in participants with AD secondary outcome time frame Up to Week 32 (end of study) eligibility module eligibility criteria Inclusion Criteria: Adult male or female participants with chronic atopic dermatitis, aged 18 to 65 years, present for at least 1 year before screening. Participants with Moderate to severe AD defined by IGA score of ≥ 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at Baseline, EASI score of ≥ 12 at Baseline and Pruritus (NRS) of at least ≥ 3 at Baseline Participants who are candidates for a systemic therapy, defined as e.g. inadequate response to treatment with topical medications, or for whom topical treatments are otherwise medically inadvisable (e.g. because of important side effects or safety risks, patients with large affected body surface areas) as assessed by the investigator. Participants must have a body mass index (BMI) at screening within the range of 18 to ≤35 kg/m2. Exclusion Criteria: Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity. Participants taking prohibited medication not completing the wash out period Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations. Any active, recent or recurrent systemic or localized infection at screening or prior to first treatment which in the opinion of the investigator immunocompromises the participant and/or places the participant at unacceptable risk for immunomodulatory therapy, that has not resolved within 2 weeks prior to first treatment or within 12 months in case of ezcema herpeticum, Clinically infected AD within 4 weeks prior to first treatment, TB, HIV, Hepatitis B and C. Any other current or past clinically significant medical condition, including psychiatric condition, which in the Investigator's opinion may interfere with safety of the participant, study objectives or adherence to the protocol. Participants with confirmed abnormal absolute neutrophil count (ANC) of <1.5 x 109/L or with thrombocytopenia of < 75.0 x 109/L at screening and baseline History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. History of hypersensitivity to any component of the study drug product, or to drugs of similar chemical classes. History of severe or serious allergy or hypersensitivity reactions, such as anaphylactic shock, asthma, or uncontrolled urticaria. Pregnant or nursing (lactating) women. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module location list location location facility Novartis Investigative Site location city Pardubice location state Czech Republic location zip 530 02 location country Czechia location facility Novartis Investigative Site location city Praha 10 location zip 100 34 location country Czechia location facility Novartis Investigative Site location city Marseille location zip 13008 location country France location facility Novartis Investigative Site location city Nice Cedex location zip 06202 location country France location facility Novartis Investigative Site location city Rouen location zip 76031 location country France location facility Novartis Investigative Site location city Bad Bentheim location zip 48455 location country Germany location facility Novartis Investigative Site location city Berlin location zip 10117 location country Germany location facility Novartis Investigative Site location city Frankfurt location zip 60596 location country Germany location facility Novartis Investigative Site location city Heidelberg location zip 69120 location country Germany location facility Novartis Investigative Site location city Muenchen location zip 81377 location country Germany location facility Novartis Investigative Site location city Muenster location zip 48149 location country Germany location facility Novartis Investigative Site location city Osnabrueck location zip 49074 location country Germany location facility Novartis Investigative Site location city Budapest location zip 1085 location country Hungary location facility Novartis Investigative Site location city Szeged location zip 6720 location country Hungary location facility Novartis Investigative Site location city Gdansk location zip 80-546 location country Poland location facility Novartis Investigative Site location city Lodz location zip 90-265 location country Poland location facility Novartis Investigative Site location city Rzeszow location zip 35 055 location country Poland location facility Novartis Investigative Site location city Cordoba location state Andalucia location zip 14004 location country Spain i p d sharing statement module i p d sharing Yes i p d sharing description Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003876 condition mesh term Dermatitis, Atopic condition mesh id D000003872 condition mesh term Dermatitis condition mesh id D000004485 condition mesh term Eczema condition ancestor list condition ancestor condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000012873 condition ancestor term Skin Diseases, Genetic condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition ancestor id D000017443 condition ancestor term Skin Diseases, Eczematous condition ancestor id D000006969 condition ancestor term Hypersensitivity, Immediate condition ancestor id D000006967 condition ancestor term Hypersensitivity condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6219 condition browse leaf name Dermatitis condition browse leaf as found Dermatitis condition browse leaf relevance high condition browse leaf id M6223 condition browse leaf name Dermatitis, Atopic condition browse leaf as found Atopic Dermatitis condition browse leaf relevance high condition browse leaf id M6807 condition browse leaf name Eczema condition browse leaf as found Atopic Dermatitis condition browse leaf relevance high condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M14828 condition browse leaf name Skin Diseases, Genetic condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id M18864 condition browse leaf name Skin Diseases, Eczematous condition browse leaf relevance low condition browse leaf id M9170 condition browse leaf name Hypersensitivity condition browse leaf relevance low condition browse leaf id M9172 condition browse leaf name Hypersensitivity, Immediate condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev BC20 condition browse branch name Immune System Diseases
NCT04836858
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full study rank 61454 study protocol section identification module n c t id NCT04836260 org study id info org study id 2020-02989 organization org full name University Hospital, Geneva org class OTHER brief title Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19 official title Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 8, 2021 start date type Anticipated primary completion date struct primary completion date December 31, 2021 primary completion date type Anticipated completion date struct completion date December 31, 2021 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Diem-Lan Vu responsible party investigator title MD, PhD responsible party investigator affiliation University Hospital, Geneva lead sponsor lead sponsor name University Hospital, Geneva lead sponsor class OTHER collaborator list collaborator collaborator name University Hospital, Basel, Switzerland collaborator class OTHER collaborator name Ospedale Regionale di Lugano collaborator class OTHER collaborator name Hôpital Fribourgeois collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population. The aim of the present study is to offer convalescent plasma therapy to immunocompromised patients and older adults in the early phase of a SARS-Cov-2 infection in order to accelerate viral clearance and prevent complication detailed description This is an open-label non-controlled, non-randomised interventional study. Study population consist in immunocompromised patients and older adults with or without co-morbidities. Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 or equivalent at maximum 3-7 days after diagnosis by RT-PCR or symptom onset or if having mild-moderate disease (WHO scale <4). Patients will be followed-up up to 28 days to assess progression to WHO scale 4 disease, and 28-days mortality and viral load kinetics. conditions module condition list condition Covid19 Immuno-Deficiency Old Age; Debility keyword list keyword SARS-CoV-2 Convalescent plasma design module study type Interventional phase list phase Phase 3 design info design allocation Non-Randomized design intervention model Single Group Assignment design intervention model description open-label non-controlled, non-randomised interventional study design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module intervention list intervention intervention type Drug intervention name SARS-CoV-2 convalescent plasma intervention description Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 at maximum 3-7 days after diagnosis by RT-PCR or symptom onset. A second unit of plasma from a different donor can be proposed 24h after the first unit if immunocompromised and/or the patient received less than 3-5ml/kg of plasma volume. Additional units can be exceptionnally infused, at the investigator discretion. outcomes module primary outcome list primary outcome primary outcome measure Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement) primary outcome time frame 7 days after plasma infusion primary outcome measure Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement) primary outcome time frame 14 days after plasma infusion primary outcome measure Proportion of death primary outcome time frame 28 days after plasma infusion secondary outcome list secondary outcome secondary outcome measure Proportion of patients with cleared nasopharyngeal viral load secondary outcome description Cleared viral load is defined as CT value ≥30 secondary outcome time frame 7 days after plasma infusion secondary outcome measure Proportion of patients with cleared nasopharyngeal viral load secondary outcome description Cleared viral load is defined as CT value ≥30 secondary outcome time frame 14 days after plasma infusion other outcome list other outcome other outcome measure Proportion of patients that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement) other outcome time frame 21 days after plasma infusion other outcome measure Proportion of patients with cleared nasopharyngeal viral load other outcome description Will be evaluated if CT< 30 at 14 days other outcome time frame 21 days after plasma infusion eligibility module eligibility criteria Inclusion Criteria: Immunocompromised patients defined as Solid organ transplant ≤1 year before inclusion or treated for acute or chronic rejection episode or Allogeneic stem cell transplant recipients ≤2 years before inclusion or treated for acute GvHD ≥grade 2 or chronic moderate-severe GvHD or Active solid or haematological oncological disease with curative perspectives or HIV infection with CD4<350 or Hypogammaglobulinemia and other severe genetic immunological defect or Auto-immune disease with biological immunosuppressive treatment* or Other significant immunosuppressive condition such as IgG <6, treamtent with Rituximab or other biological lymphopenic treatment AND Age ≥ 18 years old and 2 distinct ABO group determination and Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 7 days and days post symptom onset (DPOS) ≤ 7 days at inclusion and/or No oxygen requirement (WHO 8 ordinal scale < 4): asymptomatic, mild or moderate disease, or O2 saturation ≥ 90% at room temperature and Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures) RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of infusion (highly suggested but not necessary) Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least one co-existing condition Arterial hypertension under pharmacological treatment Diabetes in treatment Obesity (BMI ≥ 30 kg/m2) Chronic obstructive pulmonary disease stade GOLD ≥2 Respiratory insufficiency due to any pneumopathy or neurologic disease. Cardiovascular disease as defined by either known coronary heart disease, history of ischemic or hemorrhagic stroke or cardiac insufficiency (ejection fraction <40%) Chronic kidney disease (GFR<60 ml/min) AND 2 distinct ABO group determination and Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 3 days and days post symptom onset (DPOS) ≤ 3 days at inclusion or RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of perfusion and No additional oxygen requirement compared to baseline (WHO 8 ordinal scale < 4): asymptomatic, mild or moderate disease and Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures) Exclusion criteria: Seroconversion at the time of inclusion Palliative care No signed informed consent History of previous transfusion-related Grade 3 adverse event according to Swissmedic definitions Disseminated intravascular coagulopathy (depending on specialist evaluation) Uncontrolled acute hypervolemia healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Diem-Lan Vu Cantero, MD, PhD central contact role Contact central contact phone +41795535512 central contact e mail diem-lan.vu@hcuge.ch central contact name Nina Khanna, MD central contact role Contact central contact phone +41613287325 central contact e mail nina.khanna@usb.ch overall official list overall official overall official name Laurent Kaiser, MD overall official affiliation University Hospital, Geneva overall official role Principal Investigator overall official name Enos Bernasconi, MD overall official affiliation Ospedale Regionale di Lugano overall official role Principal Investigator overall official name Véronique Erard, MD overall official affiliation HFR-Fribourg Hôpital Cantonal overall official role Principal Investigator overall official name Maja Weisser, MD overall official affiliation Klinik Infektiologie & Spitalhygiene overall official role Principal Investigator location list location location facility Universitätsspital Basel location status Recruiting location city Basel location zip 4031 location country Switzerland location contact list location contact location contact name Nina Khanna, MD location contact role Contact location contact phone +41613287325 location contact e mail nina.khanna@usb.ch location contact name Maja Weisser, MD location contact role Contact location contact phone +413286742 location contact e mail maja.weisser@usb.ch location contact name Andreas Buser, MD location contact role Sub-Investigator location facility HFR-Fribourg Hôpital Cantonal location status Recruiting location city Fribourg location zip 1708 location country Switzerland location contact list location contact location contact name Véronique Erard, MD location contact role Contact location contact phone +41 26 3060836 location contact e mail Veronique.erard@h-fr.ch location contact name Emmanuel Levrat, MD location contact role Sub-Investigator location facility Geneva University Hospitals location status Recruiting location city Geneva location zip 1205 location country Switzerland location contact list location contact location contact name Diem-Lan Vu Cantero, MD, PhD location contact role Contact location contact phone +41795535512 location contact e mail diem-lan.vu@hcuge.ch location contact name Laurent Kaiser, MD location contact role Contact location contact phone +41795533420 location contact e mail laurent.kaiser@hcuge.ch location contact name Sophie Waldvogel-Abramowski, MD location contact role Sub-Investigator location facility Ospedale Regionale di Lugano location status Recruiting location city Lugano location zip 6900 location country Switzerland location contact list location contact location contact name Enos Bernasconi, MD location contact role Contact location contact phone +41918116022 location contact e mail Enos.Bernasconi@eoc.ch location contact name Stefano Fontana, MD location contact role Sub-Investigator i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000007153 condition mesh term Immunologic Deficiency Syndromes condition mesh id D000073496 condition mesh term Frailty condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition 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NCT04836260
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full study rank 61506 study protocol section identification module n c t id NCT04835584 org study id info org study id KRT-232-117 organization org full name Kartos Therapeutics, Inc. org class INDUSTRY brief title KRT-232 and TKI Study in Chronic Myeloid Leukemia official title An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML) status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 7, 2021 start date type Actual primary completion date struct primary completion date December 31, 2024 primary completion date type Anticipated completion date struct completion date June 30, 2026 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 4, 2022 last update post date struct last update post date March 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Kartos Therapeutics, Inc. lead sponsor class INDUSTRY oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments. conditions module condition list condition Chronic Myeloid Leukemia keyword list keyword navtemadlin design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 109 enrollment type Anticipated arms interventions module arm group list arm group arm group label Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP arm group type Experimental arm group description KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. TKI (dasatinib or nilotinib) will be administered orally, per locally prescribed dose and schedule. arm group intervention list arm group intervention name Drug: KRT-232 Drug: Dasatinib Drug: Nilotinib arm group label Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP) arm group type Experimental arm group description KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasastinib will be administered orally, per locally prescribed dose and schedule. arm group intervention list arm group intervention name Drug: KRT-232 Drug: Dasatinib arm group label Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP) arm group type Experimental arm group description KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Nilotinib will be administered orally, per locally prescribed dose and schedule. arm group intervention list arm group intervention name Drug: KRT-232 Drug: Nilotinib arm group label Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP) arm group type Experimental arm group description KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasatinib or Nilotinib will be administered orally, per locally prescribed dose and schedule. arm group intervention list arm group intervention name Drug: KRT-232 Drug: Dasatinib Drug: Nilotinib intervention list intervention intervention type Drug intervention name KRT-232 intervention description KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth. intervention arm group label list intervention arm group label Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP) Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP) Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP) intervention type Drug intervention name Dasatinib intervention description Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth. intervention arm group label list intervention arm group label Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP) Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP) intervention other name list intervention other name Dasatinib Zentiva intervention type Drug intervention name Nilotinib intervention description Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth. intervention arm group label list intervention arm group label Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP Part 2, Arm B (KRT-232 combined with Nilotinib in patients with CML-CP) Part 2, Arm C (KRT-232 combined with Dasatinib or Nilotinib in patients with CML-AP) intervention other name list intervention other name Tasigna outcomes module primary outcome list primary outcome primary outcome measure Part 1: Maximum tolerated dose (MTD)/maximum administered dose (MAD) of KRT-232 primary outcome description DLTs will be used to establish the MTD/MAD of KRT-232 in combination with dasatinib or nilotinib primary outcome time frame 28 Days primary outcome measure Part 2, Arm A and B: Major molecular response (MMR) rate primary outcome description The proportion of subjects who achieved complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) according to modified ELN criteria primary outcome time frame 6 months primary outcome measure Part 2, Arm C: Major hematological response (MaHR) rate primary outcome description The proportion of subjects who achieved MaHR according to modified ELN criteria primary outcome time frame 6 months secondary outcome list secondary outcome secondary outcome measure CCyR rate secondary outcome description The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arms A and B secondary outcome time frame 12 months secondary outcome measure MCyR rate secondary outcome description The proportion of subjects who achieved CCyR or PCyR according to modified ELN criteria in Arm C secondary outcome time frame 47 months secondary outcome measure Duration of response secondary outcome description DOR (Kaplan-Meier estimate) defined as the time from first observation of response to progression/relapse or death, whichever comes first secondary outcome time frame 47 months secondary outcome measure Rate of complete hematologic response (CHR) secondary outcome description The proportion of subjects who achieve a CHR according to modified ELN criteria in Arms A and B secondary outcome time frame 47 months secondary outcome measure Progression-free survival (PFS) in each Arm secondary outcome description PFS is defined as the time from the first treatment dose date to progression/relapse or death, whichever comes first secondary outcome time frame 47 months secondary outcome measure Overall survival (OS) in each Arm secondary outcome description OS is defined as the time from the first treatment dose date to death from any cause secondary outcome time frame 47 months eligibility module eligibility criteria Inclusion Criteria: Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI. Adults ≥ 18 years of age. ECOG performance status of 0 to 2 Adequate hematologic, hepatic, and renal functions Exclusion Criteria: Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP Documented Ph+, BCR-ABL+ CML-BC Known T315I mutation. Prior treatment with MDM2 antagonist therapies. Intolerance to current TKI therapy. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name John Mei central contact role Contact central contact phone 650-542-0136 central contact e mail jmei@kartosthera.com location list location location facility University of Alabama Birmingham location status Recruiting location city Birmingham location state Alabama location zip 35294 location country United States location facility Georgia Cancer Center at Augusta University location status Recruiting location city Augusta location state Georgia location zip 30912 location country United States location facility University of Pittsburgh Medical Center location status Recruiting location city Pittsburgh location state Pennsylvania location zip 15232 location country United States location facility Texas Oncology- Sammons CC at Baylor location status Recruiting location city Dallas location state Texas location zip 75246 location country United States location facility Medical College of Wisconsin location status Recruiting location city Milwaukee location state Wisconsin location zip 53226 location country United States location facility Princess Margaret Cancer Center location status Recruiting location city Toronto location state Ontario location zip M5G 2C1 location country Canada location facility Centre Leon Berard location status Recruiting location city Lyon location zip 69008 location country France location facility APHM Hopital de la Timone location status Recruiting location city Marseille location zip 13005 location country France location facility Institut Paoli-Calmettes location status Recruiting location city Marseille location zip 13009 location country France location facility Centre Hospitalier Lyon Sud location status Recruiting location city Saint-Genis-Laval location zip 69310 location country France location facility Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda location status Recruiting location city Milano location state MI location zip 20122 location country Italy location facility Azienda Ospedaliero - Universitaria Mater Domini location status Recruiting location city Catanzaro location zip 88100 location country Italy location facility Istituto Romagnolo per lo Studio dei Tumori Dino Amadori location status Recruiting location city Meldola FC location zip 47014 location country Italy location facility Fondazione IRCCS Policlinico San Matteo location status Recruiting location city Pavia location zip 27100 location country Italy location facility Kyungpook National University Hospital location status Recruiting location city Daegu location country Korea, Republic of location facility Samsung Medical Center location status Recruiting location city Seoul location zip 135-710 location country Korea, Republic of location facility Seoul National University Hospital location status Recruiting location city Seoul location country Korea, Republic of location facility Severance Hospital location status Recruiting location city Seoul location country Korea, Republic of location facility Pratia Onkologia Katowice location status Recruiting location city Katowice location zip 40-519 location country Poland location facility National Medical Research Center of Hematology location status Recruiting location city Moscow location zip 125167 location country Russian Federation location facility Almazov National Medical Research Center location status Recruiting location city Saint Petersburg location zip 197341 location country Russian Federation location facility Samara State Medical University location status Recruiting location city Samara location zip 443001 location country Russian Federation location facility Clínica Universidad de Navarra location status Recruiting location city Madrid location state Navarra location zip 28027 location country Spain location facility Clinica Universidad de Navarra location status Recruiting location city Pamplona location state Navarra location zip 31008 location country Spain location facility Hospital Universitari Vall d'Hebron location status Recruiting location city Barcelona location zip 08035 location country Spain location facility Hospital Universitario La Paz location status Recruiting location city Madrid location zip 28046 location country Spain derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007938 condition mesh term Leukemia condition mesh id D000007951 condition mesh term Leukemia, Myeloid condition mesh id D000015464 condition mesh term Leukemia, Myelogenous, Chronic, BCR-ABL Positive condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000009196 condition ancestor term Myeloproliferative Disorders condition ancestor id D000001855 condition ancestor term Bone Marrow Diseases condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M10097 condition browse leaf name Leukemia condition browse leaf as found Leukemia condition browse leaf relevance high condition browse leaf id M10107 condition browse leaf name Leukemia, Myeloid condition browse leaf as found Myeloid Leukemia condition browse leaf relevance high condition browse leaf id M17275 condition browse leaf name Leukemia, Myelogenous, Chronic, BCR-ABL Positive condition browse leaf as found Chronic Myeloid Leukemia condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M11301 condition browse leaf name Myeloproliferative Disorders condition browse leaf relevance low condition browse leaf id M4286 condition browse leaf name Bone Marrow Diseases condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id T3995 condition browse leaf name Myeloid Leukemia condition browse leaf as found Myeloid Leukemia condition browse leaf relevance high condition browse leaf id T1309 condition browse leaf name Chronic Myeloid Leukemia condition browse leaf as found Chronic Myeloid Leukemia condition browse leaf relevance high condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse leaf id T1311 condition browse leaf name Chronic Myeloproliferative Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000069439 intervention mesh term Dasatinib intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000047428 intervention ancestor term Protein Kinase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M410 intervention browse leaf name Dasatinib intervention browse leaf as found Observation intervention browse leaf relevance high intervention browse leaf id M24973 intervention browse leaf name Protein Kinase Inhibitors intervention browse leaf relevance low intervention browse leaf id T22 intervention browse leaf name Tyrosine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AA intervention browse branch name Amino Acids
NCT04835584
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full study rank 61270 study protocol section identification module n c t id NCT04838652 org study id info org study id Uni-Koeln-3942 organization org full name University of Cologne org class OTHER brief title Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma official title Phase II Trial of Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma acronym Pembro-CORE status module status verified date August 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date December 2022 start date type Anticipated primary completion date struct primary completion date December 2024 primary completion date type Anticipated completion date struct completion date December 2026 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date August 5, 2022 last update post date struct last update post date August 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Prof. Dr. Andreas Engert responsible party investigator title Prof. responsible party investigator affiliation University of Cologne lead sponsor lead sponsor name University of Cologne lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). Synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (HDCT). conditions module condition list condition Classical Hodgkin Lymphoma design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 29 enrollment type Anticipated arms interventions module arm group list arm group arm group label Pembrolizumab plus Chemotherapy arm group type Experimental arm group description All patients will receive 1 dose of 200 mg pembrolizumab IV as single agent upfront, followed by 2 cycles of IV P-ICE (pembrolizumab, ifosfamide, carboplatin, etoposide) and a PET/CT-based restaging. Following a PET-guided treatment strategy, patients will then receive either another 2 cycles of IV P-ICE in case of a negative PET (i.e., Deauville score 1-3), or 2 to 4 cycles of IV P-DHAP (pembrolizumab, dexamethasone, cytarabine, cisplatin) in case of a positive PET (i.e., Deauville score > 3). After completion of treatment with P-ICE or P-DHAP, respectively, patients will receive a consolidation therapy with pembrolizumab for another 6 cycles. In case of non-CR after at least 4 cycles of combination therapy (4x P-ICE or 2x P-ICE + 2x P-DHAP), physicians may decide to go for HDCT or an alternative standard of care treatment option. arm group intervention list arm group intervention name Drug: Pembrolizumab plus Chemotherapy (ICE or DHAP) intervention list intervention intervention type Drug intervention name Pembrolizumab plus Chemotherapy (ICE or DHAP) intervention description Pembrolizumab (200mg) alone or in combination with ICE (or DHAP in case of PET positive findings after P-ICE) will be admistered. 6 additional courses of pembrolizumab will be administered after the completion P-ICE or P-DHAP intervention arm group label list intervention arm group label Pembrolizumab plus Chemotherapy outcomes module primary outcome list primary outcome primary outcome measure Complete Metabolic Response Rate (CMR) primary outcome description The proportion of patients with a Deauville score of 1-3 in the centrally reviewed restaging after treatment with 1 x pembrolizumab + 4 cycles of pembrolizumab and chemotherapy combined (4x P-ICE or 2x P-ICE + 2x P-DHAP) primary outcome time frame after completion of P+chemotherapy, an average of 3 months eligibility module eligibility criteria Inclusion Criteria: Histologically confirmed first relapse of cHL or primary refractory cHL Exclusion Criteria: Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Michael Fuchs central contact role Contact central contact e mail ghsg@uk-koeln.de overall official list overall official overall official name Andreas Engert, Prof. overall official affiliation 1st Department of Medicine, Cologne Universit Hospital overall official role Principal Investigator location list location location facility 1st Department of Medicine, Cologne University Hospital location city Cologne location country Germany derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008223 condition mesh term Lymphoma condition mesh id D000006689 condition mesh term Hodgkin Disease condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id M8903 condition browse leaf name Hodgkin Disease condition browse leaf as found Hodgkin Lymphoma condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id T2817 condition browse leaf name Hodgkin Lymphoma condition browse leaf as found Hodgkin Lymphoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000582435 intervention mesh term Pembrolizumab intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M5334 intervention browse leaf name Cisplatin intervention browse leaf relevance low intervention browse leaf id M17802 intervention browse leaf name Carboplatin intervention browse leaf relevance low intervention browse leaf id M289070 intervention browse leaf name Pembrolizumab intervention browse leaf as found Cognitive intervention browse leaf relevance high intervention browse leaf id M6254 intervention browse leaf name Dexamethasone intervention browse leaf relevance low intervention browse leaf id M5918 intervention browse leaf name Cytarabine intervention browse leaf relevance low intervention browse leaf id M7343 intervention browse leaf name Etoposide intervention browse leaf relevance low intervention browse leaf id M341694 intervention browse leaf name Etoposide phosphate intervention browse leaf relevance low intervention browse leaf id M9269 intervention browse leaf name Ifosfamide intervention browse leaf relevance low intervention browse leaf id M235540 intervention browse leaf name Dexamethasone acetate intervention browse leaf relevance low intervention browse leaf id M230809 intervention browse leaf name Isophosphamide mustard intervention browse leaf relevance low intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev AnEm intervention browse branch name Antiemetics intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents
NCT04838652
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full study rank 61360 study protocol section identification module n c t id NCT04837482 org study id info org study id 1883-306-013 organization org full name Allergan org class INDUSTRY brief title A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age official title Evaluating the Impact of AGN-190584 on Night-driving Performance acronym TAURUS status module status verified date November 2022 overall status Completed expanded access info has expanded access No start date struct start date May 14, 2021 start date type Actual primary completion date struct primary completion date December 7, 2021 primary completion date type Actual completion date struct completion date December 7, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual disp first submit date November 7, 2022 disp first submit q c date November 7, 2022 disp first post date struct disp first post date November 9, 2022 disp first post date type Actual last update submit date November 7, 2022 last update post date struct last update post date November 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Allergan lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary The purpose of this study is to evaluate night-driving performance in real-world driving conditions in participants with presbyopia treated with AGN-190584 versus vehicle. Adverse events and change in disease symptoms will be assessed. AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle. This study consists of two parts. Part 1 consists of Visit 2 and Visit 3, and Part 2 consists of Visit 4 and Visit 5. Approximately half of the participants will receive AGN-190584 at Visit 2 through Visit 3 (Sequence 1 participants) and the remaining participants (Sequence 2 participants) will receive AGN-190584 at Visit 4 through Visit 5. All participants will receive AGN-190584 at home as instructed. Approximately 54 adult participants with presbyopia will be enrolled AT 1 site in Australia. Treatment duration is expected to be no more than 71 days. In Part 1, at Visit 2 (Day 1) and at home as instructed for 7 to 14 days Sequence 1 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 3 (Day 8 to 15). In Part 2, at Visit 4 (Day 15 to 57) and at home as instructed for 7 to 14 days Sequence 2 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 5 (Day 22 to 71). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, asking about side effects, and completing questionnaires. conditions module condition list condition Presbyopia keyword list keyword Presbyopia AGN-190584 design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 43 enrollment type Actual arms interventions module arm group list arm group arm group label AGN-190584 Sequence 1 arm group type Experimental arm group description AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5). arm group intervention list arm group intervention name Drug: AGN-190584 arm group label AGN-190584 Sequence 2 arm group type Experimental arm group description AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5). arm group intervention list arm group intervention name Drug: AGN-190584 intervention list intervention intervention type Drug intervention name AGN-190584 intervention description Topical eyedrop intervention arm group label list intervention arm group label AGN-190584 Sequence 1 AGN-190584 Sequence 2 outcomes module primary outcome list primary outcome primary outcome measure Overall Composite Driving Z score approximately 1 hour after study intervention instillation primary outcome description An overall composite driving Z score approximately 1 hour after study intervention instillation will be derived to capture the overall driving performance of each participant compared with the whole group from the following parameters: percent hazards hit, percent sign recognition and recognition distance, pedestrian recognition distances, and percent of time outside of the lane. primary outcome time frame Day 8 to Day 71 primary outcome measure Number of Participants with Adverse Events primary outcome description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The investigator assesses the relationship of each event to the use of the study intervention. A serious adverse event (SAE) is an event that results in death, is life threatening, requires inpatient hospitalization or prolongs an existing hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug. primary outcome time frame Day -30 to Day 71 eligibility module eligibility criteria Inclusion Criteria: In good general health at the screening visit, as determined by the investigator from medical history. Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score > = 3) on at least 1 question on NEI VFQ-25 Questions 5 to 7 in the main questionnaire or near vision subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions, at the screening visit. Note: Please advise the participant that for this questionnaire they are to interpret the instructions as referring to glasses or contacts they need for seeing objects at a distance (if required), not their reading glasses or bifocals. Photopic, high-contrast, best distance correction in the range of spherical -4.00 D to +1.00 D inclusively and cylinder < = + -2.00 D with photopic at the screening visit and photopic, high-contrast BCDVA of 20/25 or better OD and OS at the screening visit. Photopic, high-contrast HDVA of 20/32 or better OU at screening as well as before and 1 hour after dosing at both driving tests. Only monofocal correction (either spectacles or contact lenses) is allowed for the driving tests. If the participant does not have monofocal correction of 20/32 or better OU, the study site will provide monofocal spectacles. Mesopic, high-contrast DCNVA of 20/40 to 20/100 OD and OS at screening Photopic, high-contrast near visual acuity correctable to 20/40 or better in each eye at the screening visit. Mesopic pupil diameter < 8.0 mm in both eyes at the screening visit. Exclusion Criteria: History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study. Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes. Corneal abnormalities in either eye that are likely to interfere with visual acuity. Narrow iridocomeal angles, history of angle-closure glaucoma, or previous iridotomy. Diagnosis of any type of glaucoma or ocular hypertension. Females who are pregnant, nursing, or planning a pregnancy during the study. Uncontrolled systemic disease. Severe dry eye disease. History of iris trauma. Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy. healthy volunteers No gender All minimum age 40 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name ALLERGAN INC. overall official affiliation Allergan overall official role Study Director location list location location facility School of Optometry and Vision Science, Queensland University of Technology /ID# 226378 location city Brisbane location state Queensland location zip 4059 location country Australia i p d sharing statement module i p d sharing Yes i p d sharing description AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) i p d sharing time frame For details on when studies are available for sharing, please refer to the link below i p d sharing access criteria Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link. i p d sharing u r l https://vivli.org/ourmember/abbvie/ results section more info module derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011305 condition mesh term Presbyopia condition ancestor list condition ancestor condition ancestor id D000012030 condition ancestor term Refractive Errors condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M13331 condition browse leaf name Presbyopia condition browse leaf as found Presbyopia condition browse leaf relevance high condition browse leaf id M14024 condition browse leaf name Refractive Errors condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11966 intervention browse leaf name Ophthalmic Solutions intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04837482
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full study rank 61239 study protocol section identification module n c t id NCT04839055 org study id info org study id JiangnanU RWang-1 organization org full name Jiangnan University org class OTHER brief title The Effects of Coenzyme A Combined With Abiraterone on Patients With CRPC official title The Purpose of This Study is to Compare the Therapy Effects and Clinical Safety of a Regulatory Metabolic Compound, Coenzyme A (CoA) With a Marketed Drug, Abiraterone, in Chinese Patients With Castration-resistant Prostate Cancer (CRPC) . acronym CoA-CRPC status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 18, 2021 start date type Actual primary completion date struct primary completion date April 1, 2021 primary completion date type Actual completion date struct completion date May 2021 completion date type Anticipated study first submit date April 8, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Jiangnan University lead sponsor class OTHER collaborator list collaborator collaborator name Affiliated Hospital of Jiangnan University collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to compare the therapy effects and clinical safety of a regulatory metabolic compound, coenzyme A (CoA) with a marketed drug, abiraterone, in Chinese patients with castration-resistant prostate cancer (CRPC) . detailed description Prostate Cancer (PCa) has developed into the second most common cancer in men. In The United States, PCa has the highest morbidity in man. In China, the incidence rate is lower than in Europe and the US, but it is growing faster and faster. Androgen deprivation therapy (ADT) has been the most commonly used treatment for men with advanced prostate cancer for hundreds of years, effective in more than 85 percent of cases, but usually after 20 months or so, half of patients will inevitably develop castration-resistant prostate cancer (CRPC), which will become resistant to ADT, and patients will relapse. There are several treatments that are trying to address this problem. Such as the chemotherapy docetaxel, cabataxel, and the radioactive drug radium 223 dichloride; PARP inhibitor olaparib, but the efficacy is limited. For finding some new pathways and targets to treat CRPC, a model of PCa persister cell was first been established at a cellular level in this study. In light of the new target, we first find a being used clinically drug, Coenzyme A (CoA), through prescription sieve to treat enzalutamide or abiraterone drug-fast CRPC patients. CoA functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. There is an efficient drug action at a cellular level and in animals, and we look forward to it at clinical utility. conditions module condition list condition Castration-resistant Prostate Cancer design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 50 enrollment type Anticipated arms interventions module arm group list arm group arm group label Experimental: Coenzyme A 200U arm group type Experimental arm group description Coenzyme A 200U per day arm group intervention list arm group intervention name Drug: Coenzyme A Combined With Abiraterone arm group label Placebo Comparator: Placebo arm group type Placebo Comparator arm group description Abiraterone without coenzyme A arm group intervention list arm group intervention name Drug: Abiraterone intervention list intervention intervention type Drug intervention name Coenzyme A Combined With Abiraterone intervention description Abiraterone 4 pieces per day. Coenzyme A 200U intervention arm group label list intervention arm group label Experimental: Coenzyme A 200U intervention type Drug intervention name Abiraterone intervention description Abiraterone intervention arm group label list intervention arm group label Placebo Comparator: Placebo outcomes module primary outcome list primary outcome primary outcome measure Total prostate specific antigen (TPSA) level primary outcome description The primary efficacy variable from 12.82 ng/mL to 13.01 ng/mL in serum TPSA level and 2 weeks of treatment. primary outcome time frame 2 weeks eligibility module eligibility criteria Inclusion Criteria: - 18-100 years of age combined use with abiraterone or enzalutamide CRPC Exclusion Criteria: - pregnancy acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit and creatine phosphokinase (CK) more than 3-fold the upper normal limit primary hypothyroidism psychiatric patients poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >110 mmHg using contraceptive agent using immunosuppressive drugs, prohibited medication or other non-PCa drugs long-term using CoA drug healthy volunteers No gender Male minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name YongQuan Chen, MD central contact role Contact central contact phone 051013812517168 central contact e mail yqchen@jiangnan.edu.cn central contact name Rong Wang, EM central contact role Contact central contact phone 051018652457101 central contact e mail 840174458@qq.com overall official list overall official overall official name YongQuan Chen, MD overall official affiliation Jiangnan University overall official role Study Chair location list location location facility Jiangnan University location status Recruiting location city Wuxi location state Jiangsu location zip 214000 location country China location contact list location contact location contact name YongQuan Chen, MD location contact role Contact location contact phone 051013812517168 location contact e mail yqchen@jiangnan.edu.cn location contact name rong wang, EM location contact role Contact location contact phone 051018652457101 location contact e mail W0826R@outlook.com location contact name YongQuan Chen, MD location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition ancestor list condition ancestor condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostate Cancer condition browse leaf relevance high condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions
NCT04839055
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full study rank 61321 study protocol section identification module n c t id NCT04837989 org study id info org study id 6860 organization org full name Oslo University Hospital org class OTHER brief title Effectiveness of the Diabetes Body Project Among Females With Type 1 Diabetes official title Diabetes Body Project: Effectiveness of a Virtually Delivered Eating Disorder Prevention Program Among Young Females With Type 1 Diabetes acronym DBP status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date February 1, 2021 start date type Actual primary completion date struct primary completion date December 31, 2025 primary completion date type Anticipated completion date struct completion date July 30, 2026 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 10, 2022 last update post date struct last update post date July 12, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Line Wisting responsible party investigator title Researcher, PhD responsible party investigator affiliation Oslo University Hospital lead sponsor lead sponsor name Oslo University Hospital lead sponsor class OTHER collaborator list collaborator collaborator name The Dam Foundation collaborator class OTHER collaborator name Norwegian Diabetes Association collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Young females with type 1 diabetes (T1D) is at high risk of eating disorders (ED), with prevalence rates of ED more than double those of non-diabetes peers. T1D and ED are both associated with serious somatic complications, and when occurring together the prognosis is even worse. Despite the frequency and severity of this comorbidity, there is a lack of intervention studies and no consensus on how to best prevent and treat this comorbidity. To remedy this, we have developed a virtual diabetes-adapted version of the ED prevention program Body Project, i.e. the Diabetes Body Project. This study examines the effectiveness of the Diabetes Body Project to reduce ED risk factors and symptoms among young females with T1D. detailed description Type 1 Diabetes (T1D) T1D is caused by an autoimmune destruction of the insulin-producing beta cells in the pancreas, leading to complete lack of insulin. Insulin is necessary to regulate blood glucose levels. T1D is a national and international health challenge and priority, and Norway has among the highest incidence of T1D in the world. This is a growing problem (incidence in Norway has increased by 30% in the last 15 years) with profound long-term complications due to sub optimal metabolic control, including atherosclerosis, with subsequent cerebrovascular and cardiovascular disease, retinopathy, neuropathy and nephropathy. Significant rates of psychological problems are associated with T1D. One study investigated young patients with T1D and found that 11% screened positive for depression, 21% for anxiety, and 21% for disordered eating. Patients with a positive screen had twice the odds of having poor metabolic control (high HbA1c) as those without. Other psychological correlates reported to influence T1D self-care and metabolic control include illness perceptions, attitudes to insulin, and quality of life. Eating disorders and Disturbed Eating Behaviors (DEB) ED affect approximately 5% of the female Norwegian population between the ages of 15-44 years, and onset is most common during adolescence. ED are characterized by disordered eating such as restricted intake or bingeing and purging, a morbid preoccupation with food, weight and shape and major disturbances in cognition with distortion of body image. The main eating disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) are Anorexia Nervosa (AN), Bulimia Nervosa (BN), Binge Eating Disorder (BED), and Otherwise Specified Feeding and Eating Disorders (OSFED). A large amount of disturbed eating behaviors do not meet full criteria for the diagnoses described above and is often referred to as sub-clinical eating problems or disturbed eating behaviors. The term "disturbed eating behavior" (DEB) is used here to refer to sub-clinical eating problems. Comorbid T1D and DEB Numerous studies indicate that T1D is a risk factor for the development of DEB. Possible mediating factors include weight loss accompanying disease onset, weight gain with the initiation of insulin treatment, dietary restraint as part of diabetes management, and the deliberate insulin under dosing or omission as an effective weight loss strategy. However, few longitudinal studies of comorbid T1D and DEB exist, and there is a lack of knowledge about the specific risk factors for the development of DEB in T1D. One recent longitudinal study states that DEB was common and persistent in their sample of adolescent females with T1D. At the 14-year follow-up, a total of 32% met criteria for a current eating disorder, and DEB was reported in 59% of the participant, confirming the severity of this comorbidity. The cumulative probability of onset was 60% by the age of 25 years. DEB is common and persistent in young women with T1D, with prevalence rates double those of non-diabetic populations. Our prior study found that the prevalence of DEB was 27% among young Norwegian girls with T1D, indicating that these comorbidities are common in Norway. Comorbid T1D and DEB are associated with poor metabolic control and increased rates of morbidity and mortality. For example in Nielsen's study of comorbid T1D and anorexia nervosa, the mortality rate at 10 years follow-up was 2.5 % for T1D and 6.5% for anorexia nervosa; though when comorbid it rose to 35%. DEB also poses a risk of serious physical complications, thereby contributing to much poorer prognosis. The nature of T1D-specific DEB It has been suggested that the nature of DEB in T1D is specific and qualitatively different from DEB in non-diabetes populations. It is hypothesized that a diabetes-specific DEB has its origins in the nature and course of T1D and T1D treatment. T1D constitutes a considerable burden on the young patients and their families. The continuous self-regulation task of adjusting insulin dose to diet, physical activity and emotional state to maintain blood glucose levels according to recommendations is accompanied by the threat of developing serious diabetes late complications. Such factors may contribute to increased weight- and shape concerns among patients with T1D (particularly females). Reducing or omitting insulin is an efficient weight loss strategy uniquely available to individuals with diabetes, but is associated with increased morbidity and mortality. In addition to insulin restriction, bulimic features such as binge eating and self-induced vomiting or misuse of laxatives are common symptoms of DEB in T1D. Despite the frequency and severity of comorbid T1D and DEB/ED, there is a lack of studies on how to prevent this condition. The Body Project is reported to be the most effective ED prevention program in the general population, but this has not been tested in a T1D population. The overall aim of this study is therefore to evaluate a diabetes-adapted version of the ED prevention program the Body Project (i.e. the Diabetes Body Project) among young females with T1D. Specifically, we hypothesize that the Diabetes Body Project can improve i) ED risk factors (i.e. thin beauty ideal internalization, body dissatisfaction, and dietary restraint) and symptoms (ED measure composite score); ii) blood glucose control (i.e. Hemoglobin A1c and time in range); and iii) diabetes-specific psychological aspects (i.e. diabetes distress and illness perceptions) relative to an educational condition. conditions module condition list condition Feeding and Eating Disorders Diabetes Mellitus, Type 1 Body Image design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Diabetes Body Project arm group type Experimental arm group description Participants randomized to the experimental condition will receive virtual Diabetes Body Project groups immediately. arm group intervention list arm group intervention name Behavioral: Diabetes Body Project arm group label Educational arm group type Active Comparator arm group description Participants randomized to the control condition will receive an education brochure and will be offered the Diabetes Body Project after 6 months. arm group intervention list arm group intervention name Behavioral: Psychoeducation intervention list intervention intervention type Behavioral intervention name Diabetes Body Project intervention description Six virtually delivered Diabetes Body Project groups over six weeks (one hour a week); 5-6 participants and 2 group facilitators intervention arm group label list intervention arm group label Diabetes Body Project intervention type Behavioral intervention name Psychoeducation intervention description Individuals assigned to the psychoeducational control condition will receive an educational brochure, and complete similar assessments and assessment time points as the experimental condition. Individuals in the control group will be offered Diabetes Body Project group participation after six months. intervention arm group label list intervention arm group label Educational outcomes module primary outcome list primary outcome primary outcome measure The Ideal-Body Stereotype Scale-Revised (IBSS-R) primary outcome description Thin beauty ideal internalization, scores range from 1-5, higher scores indicate higher levels of internalization primary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months primary outcome measure The Body Parts Scale primary outcome description Nine items on body dissatisfaction, scores range from 1-5, higher scores indicate more body dissatisfaction primary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months primary outcome measure Dietary restraint primary outcome description Eating restriction, scores range from 1-5, higher scores indicate more eating restriction primary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months primary outcome measure The Diabetes Eating Problem Survey - Revised primary outcome description Total score to indicate level of eating disorder psychopathology, scored 0-5, higher scores indicate higher levels of eating disorder psychopathology primary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months primary outcome measure Social attitudes towards appearance questionnaire (SATAQ) 4R primary outcome description Appearance pressures and internalization, answers range from 1-5, higher scores indicate more pressures/internalization primary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months primary outcome measure Social Comparison Scale primary outcome description The degree to which individuals compare themselves to others, score 1-10, higher scores indicate more favorable social compariso primary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months secondary outcome list secondary outcome secondary outcome measure Blood glucose control secondary outcome description Hemoglobin A1c (HbA1c) and time in range. Higher HbA1c indicate poorer blood glucose control. Higher time in range indicate better blood glucose control secondary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months secondary outcome measure Problem Areas in Diabetes (PAID) secondary outcome description Diabetes distress, scored 0-4, higher scores indicate higher degree of diabetes distress secondary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months secondary outcome measure Brief Illness Perception Questionnaire secondary outcome description Diabetes illness perceptions, scores range from 0-10, higher scores indicate more threatening/negative of their diabetes secondary outcome time frame Baseline, change from baseline to 6 weeks, change from baseline to 6-months eligibility module eligibility criteria Inclusion Criteria: Female, 16-35 years, type 1 diabetes, acknowledges at least some level of body image concerns Exclusion Criteria: Other forms of diabetes, males healthy volunteers No gender Female minimum age 16 Years maximum age 35 Years std age list std age Child Adult contacts locations module central contact list central contact central contact name Anne Louise Wennersberg central contact role Contact central contact phone 97076244 central contact e mail uxweac@ous-hf.no overall official list overall official overall official name Line Wisting, PhD overall official affiliation Oslo University Hospital, Division of Mental Health and Addiction overall official role Principal Investigator location list location location facility Oslo Unviersity Hospital location status Recruiting location city Oslo location zip 0424 location country Norway location contact list location contact location contact name Line Wisting, PhD location contact role Contact location contact phone 93495268 location contact e mail line.wisting@ous-hf.no derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003922 condition mesh term Diabetes Mellitus, Type 1 condition mesh id D000001068 condition mesh term Feeding and Eating Disorders condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M6269 condition browse leaf name Diabetes Mellitus, Type 1 condition browse leaf as found Diabetes Mellitus, Type 1 condition browse leaf relevance high condition browse leaf id M3532 condition browse leaf name Feeding and Eating Disorders condition browse leaf as found Feeding and Eating Disorders condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders
NCT04837989
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full study rank 61822 study protocol section identification module n c t id NCT04831476 org study id info org study id 2020-DTM-EL-126/133 organization org full name Elpen Pharmaceutical Co. Inc. org class INDUSTRY brief title Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin as Well as Their qualitY of Life official title A Non Interventional Post Authorisation Multicenter Study to Evaluate the Disease Control (Benign Prostate Hyperplasia Control) and Quality of Life (QoL) Following the 6-months Combination Treatment With Dutasteride and Tamsulosin as Well as Their qualitY of Life. acronym PROSPERITY status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date September 1, 2021 start date type Actual primary completion date struct primary completion date October 31, 2022 primary completion date type Anticipated completion date struct completion date October 31, 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date July 12, 2022 last update post date struct last update post date July 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Elpen Pharmaceutical Co. Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Investigation of the efficacy and safety of the stable combination of dutasteride and tamsulosin (Dinaplex®) in the Greek population as well as the evaluation of the quality of life of patients with benign prostatic hyperplasia (BPH) in treatment with a stable combination of dutasteride and tamsulosin (Dinaplex®) detailed description Combination therapy with the 5-α reductase inhibitor, dutasteride, and the α-blocker, tamsulosin, in men with moderate to severe benign prostatic hyperplasia and prostate enlargement, was studied in the Combination of Avodart ™ and Tamsulosin (CombAT) which was a four-year, global, multicenter, randomized, double-blind, parallel design (3 arms) study. The aim of the study was to investigate the benefits of combination therapy (dutasteride-tamsulosin) compared to monotherapy in terms of improvement of symptoms and long-term results (AUR and surgery), in men with moderate to severe BPH. The primary endpoint in the two years since the start of the study was the change in the IPSS score, while the primary endpoint, after four years of treatment, was the time until the long-term results manifested (i.e. AUR or CF surgery) as well as the percentage of participants who were led to them. Patients were at least 50 years old with a prostate tumor ≥30 cm3 and a PSA level ≥ 1.5 ng / mL. 4838 men (39) participated in this study. conditions module condition list condition Benign Prostatic Hyperplasia keyword list keyword Benign Prostate Hyperplasia IPSS (International Prostate Symptom Score) LUTS (Lower Urinary Tract Symptoms) design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Prospective enrollment info enrollment count 990 enrollment type Anticipated arms interventions module intervention list intervention intervention type Other intervention name Patients with Benign Prostate Hyperplasia intervention description patients with benign prostatic hyperplasia under fixed dose combΙnation treatment with dutasteride and tamsulosin outcomes module primary outcome list primary outcome primary outcome measure Evaluation of disease control (BPH) primary outcome description The change in the overall score (questions 1-7) of the IPSS (International Prostate Symptom Score) questionnaire. primary outcome time frame 3-6 months secondary outcome list secondary outcome secondary outcome measure IPSS question 7 score secondary outcome description The change in the score of the question related to quality of life, of the IPSS questionnaire. secondary outcome time frame 3-6 months secondary outcome measure U/S measurement secondary outcome description The change in the volume of the prostate and the change in the volume of the remaining urine (measurement by ultrasound). secondary outcome time frame 3-6 months secondary outcome measure Number of AEs secondary outcome description The recording of Adverse Events (Adverse Events, SA) if they occur during the study. secondary outcome time frame 3-6 months eligibility module eligibility criteria Inclusion Criteria: Adult male patient with moderate to severe BPH symptoms receiving either monotherapy, dual medication as monoproducts or other stable combination and not responding adequately to treatment. Adult male patient with BPH who has fully understood the study procedures and has signed a consent form after information. Exclusion Criteria: Patient who does not meet the criteria for taking the study drug (s), according to the Summary of Product Characteristics of each drug in the study. gender Male minimum age 18 Years maximum age 85 Years std age list std age Adult Older Adult study population Adult males who based on physician's recommedations will receive DINAPLEX®- Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367 mg tamsulosin) Tamsulosin hydrochloride Tamsulosin binds selectively and competitively to postsynaptic α1A adrenergic receptors and to a lesser extent to α1D adrenergic receptors. It relaxes the smooth muscles of the prostate and urethra. By relaxing the smooth muscle fibers of the bladder sphincter, it relieves obstructive effects and increases urine flow. It has little antihypertensive effect. Doutasteride Dutasteride lowers circulating dihydrotestosterone (DHT) levels by inhibiting the 5a-reductase isoenzymes type I and II, which are responsible for converting testosterone to DHT. The effect of dutasteride on DHT levels is dose-dependent and is observed within 1-2 weeks (85% and 90% reduction respectively). sampling method Non-Probability Sample contacts locations module location list location location facility Laikon Hospital of Athens location status Recruiting location city Athens location country Greece location contact list location contact location contact name K Konstantinidis, MD location contact role Contact location contact phone 2132061140 - 2132061470 location contact e mail ourologiki@laiko.gr references module reference list reference reference type background reference citation World Medical Association Declaration of Helsinki. 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Pharmacoepidemiol Drug Saf. 2005 Aug;14(8):589-95. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011470 condition mesh term Prostatic Hyperplasia condition mesh id D000006965 condition mesh term Hyperplasia condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M9168 condition browse leaf name Hyperplasia condition browse leaf as found Hyperplasia condition browse leaf relevance high condition browse leaf id M28617 condition browse leaf name Lower Urinary Tract Symptoms condition browse leaf relevance low condition browse leaf id M13486 condition browse leaf name Prostatic Hyperplasia condition browse leaf as found Prostatic Hyperplasia condition browse leaf relevance high condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf as found Quality of Life condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M270 intervention browse leaf name Dutasteride intervention browse leaf relevance low intervention browse leaf id M1790 intervention browse leaf name Tamsulosin intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Urol intervention browse branch name Urological Agents
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full study rank 61167 study protocol section identification module n c t id NCT04839991 org study id info org study id CBT307-1 secondary id info list secondary id info secondary id 2019-004584-46 secondary id type EudraCT Number organization org full name Crescendo Biologics Ltd. org class INDUSTRY brief title Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours. official title A Phase 1 Open-Label, Dose Escalation and Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of CB307, a Trispecific Humabody® T-cell Enhancer, in Patients With PSMA+ Advanced and/or Metastatic Solid Tumours acronym POTENTIA status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 8, 2021 start date type Actual primary completion date struct primary completion date July 25, 2023 primary completion date type Anticipated completion date struct completion date September 25, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 23, 2022 last update post date struct last update post date November 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Crescendo Biologics Ltd. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety and tolerability to determine MTD and RP2D. detailed description FIH, Phase 1, open-label, multi centre, non randomised study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours. The study will consist of a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) which will consist of 2 arms. Approximately 70 patients will participate in total. Patients will receive CB307 IV, until loss of clinical benefit, unacceptable toxicity, withdrawal of consent or end of study. The dose escalation may be adapted by the SRC based on clinical experience and safety review. conditions module condition list condition Advanced and/or Metastatic Solid Tumours keyword list keyword Prostate Specific Membrane Antigen (PSMA) Solid Tumours Castration-resistant prostate cancer (CRPC) First in Human (FIH) Phase 1 Study CD137 4-1BB Crescendo Biologics CB307 Humabody design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Single Group Assignment design intervention model description Initial dose escalation cohorts followed by a single dose expansion cohort. The cohort expansion phase will consist of 2 arms. design primary purpose Treatment design masking info design masking None (Open Label) design masking description Open Label multi center non randomised study. enrollment info enrollment count 70 enrollment type Anticipated arms interventions module arm group list arm group arm group label Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A arm group type Experimental arm group description Patients will receive CB307 IV infused every 7 days. Duration of treatment cycle is 21 days. Once the Dose Escalation phase (Part 1) is completed Cohort Expansion phase (Part 2) will begin. Part 2A arm will enrol patients with PSMA+ solid tumours. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months. arm group intervention list arm group intervention name Drug: CB307 arm group label Multi center open label Dose Escalation followed by Cohort Expansion: Part 2B arm group type Experimental arm group description Patients will receive CB307 IV infused every 7 days. Duration of treatment cycle is 21 days. Once the Dose Escalation phase (Part 1) is completed Cohort Expansion phase (Part 2) will begin. Part 2B arm will enrol patients with PSMA+ metastatic, castration resistant prostate cancer patients with mutations of sponsor interest. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months. arm group intervention list arm group intervention name Drug: CB307 intervention list intervention intervention type Drug intervention name CB307 intervention description Tri-specific Humabody targeting CD137, prostate specific membrane antigen and human serum albumin intervention arm group label list intervention arm group label Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A Multi center open label Dose Escalation followed by Cohort Expansion: Part 2B outcomes module primary outcome list primary outcome primary outcome measure Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 primary outcome description The objective of the study is to assess the safety and tolerability of the study drug CB307 and to determine the MTD (maximum tolerated dose) primary outcome time frame The nature and frequency of any DLTs during the DLT-monitoring period assessed based on NCI CTCAE v5.0. up to 20 months duration. secondary outcome list secondary outcome secondary outcome measure To evaluate clinical efficacy measured as progression-free survival according to RECIST v.1.1 or PCWG3 secondary outcome description To measure how well the treatment succeeds in producing the desired effect. secondary outcome time frame Progression-free survival according to RECIST v1.1 or PCWG3 up to 20 months duration; and change from baseline in anti-drug (CB307) antibodies (ADA up to 20 months duration secondary outcome measure To measure how the body processes CB307 in the body over time secondary outcome description To evaluate the pharmacokinetic trough levels before administration of CB307 secondary outcome time frame PK parameters of CB307: data collected at time point 0 at each dosing period up to 20 months duration. secondary outcome measure Pharmacokinetic of CB307 T1/2 secondary outcome description To evaluate the pharmacokinetic T1/2 after 3rd dose via IV for multiple dose levels of CB307 secondary outcome time frame Data collected up to 20 months duration. secondary outcome measure Pharmacokinetic of CB307 Tmax secondary outcome description To evaluate the pharmacokinetic Tmax after 3rd dose via IV for multiple dose levels of CB307 secondary outcome time frame Data collected up to 20 months duration. secondary outcome measure To measure Tumour Immune response secondary outcome description To determine the potential of CB307 to produce an immune response and assess the relationship with other outcome measures secondary outcome time frame Tumor response per RECIST ver 1.1 up to 20 months duration secondary outcome measure Relationship of CB307 to anti tumour response secondary outcome description To evaluate the preliminary CB307 dose in relationship to activity of changes in tumour secondary outcome time frame PSA response defined as a >50% decrease in PSA up to 20 months duration eligibility module eligibility criteria Inclusion Criteria: Capable of understanding the written informed consent Aged at least 18 years Not amenable to standard of care ECOG PS 0-1 Has documented histologically confirmed diagnosis of PSMA+ advanced or metastatic solid tumours Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for castration resistant prostate cancer patients with only bone metastasis Adequate organ function Cohort Expansion phase - Part 2B arm patients only: Has known mutations of sponsor interest Exclusion Criteria: Subjects with autoimmune disease or regular immunosuppressants Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD-L1 antibody because of intolerable toxicity Has brain metastasis including leptomeningeal metastasis or primary brain tumour Has current or history of CNS disease Has known active infection healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name MD central contact role Contact central contact phone 01223497140 central contact e mail Clinicaltrials@crescendobiologics.com central contact name J Tilson central contact role Contact central contact phone 07725 844778 central contact e mail jtilson@crescendobiologics.com overall official list overall official overall official name J Tilson overall official affiliation Crescendo Biologics overall official role Study Director location list location location facility Antoni van Leeuwenhoek location status Recruiting location city Amsterdam location state Noord-Holland location zip 1066 CX location country Netherlands location contact list location contact location contact name MD location contact role Contact location contact e mail f.opdam@nki.nl location facility VUMC Research B.V location status Recruiting location city Amsterdam location state Noord-Holland location zip 1081 HV location country Netherlands location contact list location contact location contact name MD location contact role Contact location contact e mail c.menke@amsterdamumc.nl location facility University Medical Center Groningen, location status Recruiting location city Groningen location zip P.O. Box 30 001 location country Netherlands location contact list location contact location contact name MD location contact role Contact location contact e mail e.g.e.de.vries@umcg.nl location contact name Elisabeth De Vries location contact role Principal Investigator location facility Erasmus University Medical Center Rotterdam location status Recruiting location city Rotterdam location country Netherlands location contact list location contact location contact name MD location contact role Contact location contact e mail m.lolkema@erasmusmc.nl location facility UMC Utrecht Cancer Center location status Recruiting location city Utrecht location zip 3584 CX location country Netherlands location contact list location contact location contact name MD location contact role Contact location contact e mail E.H.Gort-2@umcutrecht.nl location facility Hospital Universitario 12 de Octubre location status Recruiting location city Madrid location zip 28041 location country Spain location contact list location contact location contact name Daniel Castellano location contact role Contact location contact e mail cdanicas@hotmail.com location contact name Daniel Castellano location contact role Principal Investigator location facility Hospital Universitario HM Sanchinarro location status Recruiting location city Madrid location zip 28050 location country Spain location contact list location contact location contact name Irene Moreno location contact role Contact location contact e mail irene.moreno@startmadrid.com location contact name Irene Moreno location contact role Principal Investigator location facility The Christie NHS Foundation Trust location status Recruiting location city Manchester location state Greater Manchester location zip M20 4BX location country United Kingdom location contact list location contact location contact name MD location contact role Contact location contact e mail fiona.thistlethwaite@christie.nhs.uk location contact name Fiona Thistlethwaite location contact role Principal Investigator location facility The Clatterbridge Cancer Centre NHS Foundation Trust location status Withdrawn location city Bebington location state Merseyside location zip CH63 4JY location country United Kingdom location facility Royal Marsden Hospital location status Recruiting location city London location state Surrey location zip SM2 5PT location country United Kingdom location contact list location contact location contact name MD location contact role Contact location contact e mail Johann.DeBono@icr.ac.uk location contact name Johann De Bono location contact role Principal Investigator location facility University College London Hospitals NHS Foundation Trust location status Recruiting location city London location zip NW1 2BU location country United Kingdom location contact list location contact location contact name Anya Williams location contact role Contact location contact e mail Anja.Williams@hcahealthcare.co.uk location contact name Anya Williams location contact role Principal Investigator location facility Sarah Cannon Research Institute, UK location status Recruiting location city London location zip W1G 6AD location country United Kingdom location contact list location contact location contact name Anuradha Jayaram location contact role Contact location contact e mail a.jayaram@ucl.ac.uk location contact name Anuradha Jayaram location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009369 condition mesh term Neoplasms condition browse leaf list condition browse leaf condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions
NCT04839991
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full study rank 61611 study protocol section identification module n c t id NCT04834219 org study id info org study id 189_2020.01.18_15 organization org full name Bozok University org class OTHER brief title Off-Pump and On-Pump Techniques and Oxidative Stress in CABG Surgery official title Effect of Off-Pump and On-Pump Techniques on Oxidative Stress Biomarkers in CABG acronym CABG status module status verified date September 2021 overall status Completed expanded access info has expanded access No start date struct start date January 15, 2021 start date type Actual primary completion date struct primary completion date September 15, 2021 primary completion date type Actual completion date struct completion date September 24, 2021 completion date type Actual study first submit date April 2, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 24, 2021 last update post date struct last update post date September 28, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ökkeş Hakan Miniksar responsible party investigator title Assistant Professor responsible party investigator affiliation Bozok University lead sponsor lead sponsor name Bozok University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary CABG (coronary artery bypass graft) surgery is among the most common heart surgeries performed in the heart pump. In CABG surgery, operations performed on the beating heart without the use of CPB (off-pump) are frequently performed (30-60%) (1). To the best of our knowledge, there has been no study examining cerebral oxygenation values, oxidative stress levels and postoperative results in CABG operations. detailed description CABG (coronary artery bypass graft) surgery is among the most common heart surgeries performed in the heart pump. In CABG surgery, operations performed on the beating heart without the use of CPB (off-pump) are frequently performed (30-60%) (1). Off-pump coronary artery bypass surgery is also called beating-heart surgery, and its purpose is to avoid cardiopulmonary bypass completely without the support of a heart lung machine, thereby avoiding its adverse effects (3-5). It has been reported that the off-pump CPB surgical method is associated with a decrease in the incidence of early stage and major complications compared to the traditional CPB method (2). Exposure to surgical stress leads to autonomic, visceral, and immunological responses, leading to oxidative stress, neurochemical and hormonal abnormalities (3).In addition to the non-physiological hemodynamic conditions that occur during CABG surgery, a significant increase is observed in inflammatory response and oxidative stress biomarkers due to surgical trauma, cardiopulmonary bypass (CPB) and organ reperfusion injury (4).For this reason, it is important to detect the presence and severity of postoperative adverse outcomes after CABG early. To the best of our knowledge, there has been no study examining cerebral oxygenation values, oxidative stress levels and postoperative results in CABG operations. This prospective observational study is planned to include 64 adult patients aged 30-80 years who will undergo CABG surgery. Patients will be grouped according to the surgical technique (on-pump and off-pump) determined (indicated) according to the cardiovascular risk status of the patient by the Cardiovascular Surgery department. Patients' perioperative cerebral hemoglobin oxygen saturations will be recorded with the Regional Oximeter (non-invasive cerebral oxygenation measurement device). In patients undergoing On-Pump bypass, at the beginning of the CABG surgery (basal), during the aortic clamp, 15 minutes after the clamp is lifted, the remaining 3 ml of blood will be centrifuged at 3000 rpm for 5 minutes and the serum part will be separated. In off-pump bypass surgery patients, 3 ml of blood will be centrifuged at the beginning of the operation, at the beating phase and 15 minutes after the beating process is completed. Total antioxidant status, Total oxidant status, Superoxide dismutase, Malondialdehyde will be measured in the Enzyme-Linked ImmunoSorbent Assay device from blood samples taken from all patients in the study, and their concentrations will be determined. conditions module condition list condition Cerebral Oxygenation Oxidative Stress Myocardial Infarction keyword list keyword Coronary artery bypass surgery Oxidative stress Cerebral oxygenation design module study type Observational patient registry Yes target duration 6 Months design info design observational model list design observational model Other design time perspective list design time perspective Prospective enrollment info enrollment count 64 enrollment type Actual arms interventions module arm group list arm group arm group label On-pump CABG arm group description Patients with an on-pump indication by the cardiovascular surgery department will be included in the study. arm group intervention list arm group intervention name Procedure: On-Pump CABG Procedure: Off-Pump CABG arm group label Off-pump CABG arm group description Patients with an off-pump indication by the cardiovascular surgery department will be included in the study. arm group intervention list arm group intervention name Procedure: On-Pump CABG Procedure: Off-Pump CABG intervention list intervention intervention type Procedure intervention name On-Pump CABG intervention description Patients who have undergone on-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery. intervention arm group label list intervention arm group label Off-pump CABG On-pump CABG intervention type Procedure intervention name Off-Pump CABG intervention description Patients who have undergone off-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery. intervention arm group label list intervention arm group label Off-pump CABG On-pump CABG outcomes module primary outcome list primary outcome primary outcome measure Oxidative stress level primary outcome description Oxidative stress biomarker levels between on-pump and off-pump coronary artery bypass groups primary outcome time frame Intraoperative period primary outcome measure TAS primary outcome description Total antioxidant status primary outcome time frame Intraoperative period primary outcome measure TOS primary outcome description Total oxidant status primary outcome time frame Intraoperative period primary outcome measure SOD primary outcome description Superoxide dismutase primary outcome time frame Intraoperative period secondary outcome list secondary outcome secondary outcome measure Cerebral oximetry secondary outcome description Cerebral haemoglobin oxygen saturations (%) secondary outcome time frame Intraoperative period eligibility module eligibility criteria Inclusion Criteria: Undergo CABG surgery with on-pump and off-pump technique, Volunteer to participate in the study, 30-80 years old Exclusion Criteria: Those with chronic kidney failure Those with liver failure Under 30 and over 80 healthy volunteers No gender All minimum age 30 Years maximum age 80 Years std age list std age Adult Older Adult study population It is planned to participate in this prospective observational study of 64 volunteer patients undergoing Coronary artery bypass grafting (CABG) surgery by the Department of Cardiovascular Surgery. sampling method Probability Sample contacts locations module overall official list overall official overall official name Ökkeş Hakan Miniksar, Asist.Prof overall official affiliation YOZGAT BOZOK UNIVERSITY overall official role Study Chair location list location location facility Bozok University Medical Center location city Yozgat location country Turkey references module reference list reference reference p m i d 27648039 reference type result reference citation Hussain G, Azam H, Baig MA, Ahmad N. Early outcomes of on-pump versus off-pump coronary artery bypass grafting. Pak J Med Sci. 2016 Jul-Aug;32(4):917-21. doi: 10.12669/pjms.324.9680. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009203 condition mesh term Myocardial Infarction condition mesh id D000007238 condition mesh term Infarction condition ancestor list condition ancestor condition ancestor id D000007511 condition ancestor term Ischemia condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000009336 condition ancestor term Necrosis condition ancestor id D000017202 condition ancestor term Myocardial Ischemia condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M11307 condition browse leaf name Myocardial Infarction condition browse leaf as found Myocardial Infarction condition browse leaf relevance high condition browse leaf id M9434 condition browse leaf name Infarction condition browse leaf as found Infarction condition browse leaf relevance high condition browse leaf id M9695 condition browse leaf name Ischemia condition browse leaf relevance low condition browse leaf id M11436 condition browse leaf name Necrosis condition browse leaf relevance low condition browse leaf id M5698 condition browse leaf name Coronary Artery Disease condition browse leaf relevance low condition browse leaf id M18658 condition browse leaf name Myocardial Ischemia condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04834219
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full study rank 61630 study protocol section identification module n c t id NCT04833972 org study id info org study id 2013P000395_3 organization org full name Massachusetts General Hospital org class OTHER brief title Eliciting Perceived Norms About Substance Use official title Eliciting Perceived Norms About Substance Use status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 10, 2021 start date type Actual primary completion date struct primary completion date December 31, 2021 primary completion date type Anticipated completion date struct completion date December 31, 2021 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Alexander Tsai responsible party investigator title Associate Professor of Psychiatry responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Mbarara University of Science and Technology collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Survey experiment to elicit perceived norms about substance use detailed description Health behaviors and health risk behaviors are known to be associated with the extent to which one perceives these behaviors as normative. The canonical example of this phenomenon is taken from the U.S. literature, which has robustly shown that undergraduate students on college campuses tend to drink more heavily and frequently if they believe their classmates drink heavily and frequently, irrespective of their classmates' actual levels and frequency of use. However, there remains little systematic understanding about the best ways to elicit these perceived norms through survey-based research studies. This randomized survey experiment compares different ways of eliciting perceived norms. conditions module condition list condition Tobacco Use Alcohol Drinking design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking Double design masking description Study participants are randomly assigned to be read survey questions with slight changes in the wording of the response options. Neither study participants nor outcomes assessors are provided with information about "treatment" assignment. design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 1553 enrollment type Anticipated arms interventions module arm group list arm group arm group label Experimental: V1: Binary Response Options arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire has binary (yes/no) response options. arm group intervention list arm group intervention name Other: Survey questionnaire arm group label Experimental: V2: Categorical Response Options arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire has categorical response options: all or almost all; more than half, but fewer than 90%; fewer than half, but more than 10%; very few, or no one arm group intervention list arm group intervention name Other: Survey questionnaire arm group label Experimental: V3: Open-Ended Numerical Estimate arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. Each question in this version of the survey questionnaire permits the study participant to provide an open-ended numerical estimate. arm group intervention list arm group intervention name Other: Survey questionnaire intervention list intervention intervention type Other intervention name Survey questionnaire intervention description Each version of the questionnaire has the same questions about perceived norms about substance use in the community but differs in how the response options are offered. intervention arm group label list intervention arm group label Experimental: V1: Binary Response Options Experimental: V2: Categorical Response Options Experimental: V3: Open-Ended Numerical Estimate outcomes module primary outcome list primary outcome primary outcome measure Perception of Tobacco Use Frequency Among Men primary outcome description "According to your perception, have most men in your cell in this parish smoked cigarettes four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Tobacco Use Frequency Among Women primary outcome description "According to your perception, have most women in your cell in this parish smoked cigarettes four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Alcohol Use Frequency Among Men primary outcome description "According to your perception, have most men in your cell in this parish taken alcohol four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Alcohol Use Frequency Among Women primary outcome description "According to your perception, have most women in your cell in this parish taken alcohol four or more times per week in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Alcohol-Related Blackouts Among Men primary outcome description "According to your perception, have most men in your cell in this parish been unable to remember what happened the night before at least once as a result of them taking alcohol in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 30 days) primary outcome measure Perception of Alcohol-Related Blackouts Among Women primary outcome description "According to your perception, have most women in your cell in this parish been unable to remember what happened the night before at least once as a result of them taking alcohol in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 30 days) primary outcome measure Perception of Alcohol-Related Spousal Problems Among Men primary outcome description "According to your perception, have most men in your cell in this parish quarreled after taking alcohol with their spouse or main partner if they have one in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 30 days) primary outcome measure Perception of Alcohol-Related Spousal Problems Among Women primary outcome description "According to your perception, have most women in your cell in this parish quarreled after taking alcohol with their spouse or main partner if they have one in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 30 days) primary outcome measure Perception of Alcohol Intoxication Among Men primary outcome description "According to your perception, have most men in your cell in this parish experienced drunkenness or intoxication on 3 or more days in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 30 days) primary outcome measure Perception of Alcohol Intoxication Among Women primary outcome description "According to your perception, have most women in your cell in this parish experienced drunkenness or intoxication on 3 or more days in the past 30 days?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 30 days) primary outcome measure Perception of Alcohol Use Financial Harms Among Men primary outcome description "According to your perception, have most men in your cell in this parish had a harmful effect on their household's finances due to them taking alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Alcohol Use Financial Harms Among Women primary outcome description "According to your perception, have most women in your cell in this parish had a harmful effect on their household's finances due to them taking alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Alcohol Spending Among Men primary outcome description "According to your perception, have most men in your cell in this parish spent more than 35,000 USh on any kind of alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Alcohol Spending Among Women primary outcome description "According to your perception, have most women in your cell in this parish spent more than 35,000 USh on any kind of alcohol in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Alcohol Binge Use Frequency Among Men primary outcome description "According to your perception, have most men in your cell in this parish taken 6 or more drinks in a single morning, afternoon, or night in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) primary outcome measure Perception of Alcohol Binge Use Frequency Among Women primary outcome description "According to your perception, have most women in your cell in this parish taken 6 or more drinks in a single morning, afternoon, or night in the past 12 months?" (single item, culturally adapted and developed for this study; categorical response options) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate, and participants are asked about the past 12 months) eligibility module eligibility criteria Inclusion Criteria: All adults who consider Nyakabare their primary place of residence and who are capable of providing consent Exclusion Criteria: Minors younger than 18 years of age, with the exception of emancipated minors Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor) healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Alexander C Tsai, MD central contact role Contact central contact phone 617-724-1120 central contact e mail actsai@partners.org central contact name Emily Satinsky, MSc central contact role Contact central contact phone 617-724-1120 central contact e mail esatinsky@partners.org overall official list overall official overall official name Alexander C Tsai, MD overall official affiliation Massachusetts General Hospital overall official role Principal Investigator location list location location facility Mbarara University of Science and Technology location status Recruiting location city Mbarara location country Uganda location contact list location contact location contact name Bernard Kakuhikire, MBA location contact role Contact location contact phone 256-075-250-4030 location contact e mail baitwakaku@gmail.com location contact name Charles Baguma, MPH location contact role Contact location contact phone 256-077-564-1558 location contact e mail cbaguma@mustresearch.org i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000019966 condition mesh term Substance-Related Disorders condition mesh id D000000428 condition mesh term Alcohol Drinking condition ancestor list condition ancestor condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000004327 condition ancestor term Drinking Behavior condition browse leaf list condition browse leaf condition browse leaf id M2926 condition browse leaf name Alcohol Drinking condition browse leaf as found Alcohol Drinking condition browse leaf relevance high condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf as found Substance Use condition browse leaf relevance high condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M6654 condition browse leaf name Drinking Behavior condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders
NCT04833972
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full study rank 61928 study protocol section identification module n c t id NCT04830085 org study id info org study id 2017/22 organization org full name Mersin University org class OTHER brief title Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis official title Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 10, 2017 start date type Actual primary completion date struct primary completion date August 10, 2017 primary completion date type Actual completion date struct completion date August 10, 2017 completion date type Actual study first submit date March 27, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hakan Aytan responsible party investigator title Professor Dr. responsible party investigator affiliation Mersin University lead sponsor lead sponsor name Mersin University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Adenomyosis is a relatively common benign disorder in which endometrial gland and stroma are located within the myometrium resulting angiogenesis of the spiral vessel, hypertrophy of the surrounding smooth muscles and enlargement of the uterus. So far the definitive diagnosis still requires histologic analysis of the hysterectomy specimens or hysteroscopic or laparoscopic biopsy. There is no specific laboratory tests and reliable clinical standards for the diagnosis. The preoperative diagnosis of adenomyosis, would prevent unnecessary therapies, loss of time and use of resources in vain. Therefore precise prediction of this disease without surgery gains importance. Developing a scoring system with clinical evaluation for this purpose will be very helpful in solving this problem. From this point, the investigators aimed to develop a scoring system that will predict presence of adenomyosis wİth high sensitivity using clinical evaluation methods such as history, physical examination, ultrasonography and laboratory tests. A prospective cohort study was conducted with 221 patients. In the study, the investigators have created a clinical scoring system for this purpose for the first time in the literature. In this scoring system, there are simple parameters that can be easily used by the clinician, have a low cost and are repeatable. The effect of each parameter on predicting adenomyosis is different, and the total effect can be calculated according to the answer to be given to all questions. In this simple scoring system, parity, menarche, VAS scores of dysmenorrhea and dyspareunia, myometrial heterogeneity in ultrasonography and presence of tenderness during pelvic examination were found to be useful parameters in predicting the diagnosis of adenomyosis. detailed description A prospective cohort study was conducted in Mersin University Faculty of Medicine Department of Obstetrics and Gynecology between 10.02.2017 and 10.08.2017 with 221 patients who had undergone hysterectomy for benign disorders. The patients who were admitted to the hospital with the hysterectomy indications for benign pathologies were visited before the operation and a detailed anamnesis was obtained. Physical and pelvic examinations with transvaginal ultrasound examinations were performed by the same investigator. Demographic characteristics, obstetric and gynecologic histories were noted. The amount of percieved pain was measured with Visual Analog Scale (VAS). Observing myometrial cysts, enlarged uterus, heterogeneous myometrium and or focal nodular areas during transvaginal sonography was considered to suggest adenomyosis. The hysterectomy specimes were evaluated by department of pathology. The diagnosis of adenomyosis was based on the presence of glandular extension ≥2.5 mm below the endometrial myometrial interface. In order to develop a scoring system a regression analysis was carried out to find the parameters that were associated with the presence of adenomyosis. Number of parities, dyspareunia and dysmenorrhea VAS scores, age of menarche, presence of uterine tenderness and detection of heterogenous myometrium and myometrial cysts during ultrasonography were found to be the significant parameters. conditions module condition list condition Adenomyosis design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 221 enrollment type Actual arms interventions module arm group list arm group arm group label Patients with adenomyosis arm group type Experimental arm group description Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was diagnosed with histopathological assessment. arm group intervention list arm group intervention name Procedure: Hysterectomy arm group label Patients without adenomyosis arm group type Active Comparator arm group description Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was excluded with histopathological assessment. arm group intervention list arm group intervention name Procedure: Hysterectomy intervention list intervention intervention type Procedure intervention name Hysterectomy intervention description Hysterectomy (abdominal, vaginal or laparoscopic) intervention arm group label list intervention arm group label Patients with adenomyosis Patients without adenomyosis intervention other name list intervention other name Histopathological evaluation outcomes module primary outcome list primary outcome primary outcome measure Severity of dysmenorrhea measured with Visual Analog Scale primary outcome time frame 6 months primary outcome measure Severity of dyspareunia measured with Visual Analog Scale primary outcome time frame 6 months primary outcome measure Detection of myometrial heterogeneity during transvaginal ultrasonographic examination primary outcome time frame 6 months primary outcome measure Detection of myometrial cysts during transvaginal ultrasonographic examination primary outcome time frame 6 months primary outcome measure Presence of uterine tenderness during pelvic examination primary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: The patients who were admitted to the hospital with the hysterectomy indications for benign pathologies Exclusion Criteria: Patients with postoperative diagnosis of gynecologic malignancies and who were pregnants healthy volunteers No gender Female minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name HAKAN AYTAN, Prof. MD overall official affiliation Mersin University overall official role Study Director location list location location facility Mersin University location city Mersin location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000062788 condition mesh term Adenomyosis condition ancestor list condition ancestor condition ancestor id D000014591 condition ancestor term Uterine Diseases condition browse leaf list condition browse leaf condition browse leaf id M29165 condition browse leaf name Adenomyosis condition browse leaf as found Adenomyosis condition browse leaf relevance high condition browse leaf id M16491 condition browse leaf name Uterine Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions
NCT04830085
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full study rank 61386 study protocol section identification module n c t id NCT04837144 org study id info org study id MAKStrokeUSII organization org full name MarsiBionics org class INDUSTRY brief title Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke official title Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke status module status verified date June 2021 overall status Completed expanded access info has expanded access No start date struct start date October 6, 2020 start date type Actual primary completion date struct primary completion date April 30, 2021 primary completion date type Actual completion date struct completion date June 23, 2021 completion date type Actual study first submit date November 3, 2020 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 23, 2021 last update post date struct last update post date June 24, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name MarsiBionics lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study aims to evaluate the safety and usability of a motorized mobility assistance exoskeleton (MAK). The procedure explores the use of the MAK exoskeleton during the static and dynamic rehabilitation sessions with the intention to evaluate the safety and usability of the device in the studied population. The protocol has been focused on defining how the device can be used appropriately in this population in a safe manner by rehabilitation specialists.The study also aims to assess the safety of clinicians implementing the intervention, as well as possible benefits derived from the use of the device. As a secondary outcome, efficacy measurements will be collected. conditions module condition list condition Stroke Gait, Hemiplegic keyword list keyword exoskeleton robotic device gait assistance design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 6 enrollment type Actual arms interventions module arm group list arm group arm group label Intervention Group arm group type Experimental arm group description The Intervention Group will receive 9 physical rehabilitation sessions using the MAK device. Each session will consist of approximately 90 minutes. arm group intervention list arm group intervention name Device: Physical Rehabilitation with MAK exoskeleton intervention list intervention intervention type Device intervention name Physical Rehabilitation with MAK exoskeleton intervention description The participants will assist to 9 physical rehabilitation sessions with the MAK exoskeleton. During these sessions, different movements and therapies will be conducted using the studied device. intervention arm group label list intervention arm group label Intervention Group outcomes module primary outcome list primary outcome primary outcome measure Safety as number of serious device adverse events primary outcome description Presence of a serious device adverse events where the participant or therapist is involved primary outcome time frame after each use of exoskeleton, for 5 weeks secondary outcome list secondary outcome secondary outcome measure Safety as presence of adverse events or adverse device events secondary outcome description Presence of a device adverse events where the participant or therapist is involved secondary outcome time frame after each use of exoskeleton, for 5 weeks secondary outcome measure Exercises [measured as time per exercise in seconds] secondary outcome description Measured as time per event at each therapy session secondary outcome time frame after each use of exoskeleton, for 5 weeks secondary outcome measure Transfers [measured as time to carry out the transfers in seconds] secondary outcome description Measured as time and level of assistance to carry out the transfers secondary outcome time frame At each use of exoskeleton, for 5 weeks secondary outcome measure Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants] secondary outcome description Measured as abandon ratio secondary outcome time frame at the end of the 5th week secondary outcome measure Accessibility [number of potential participants in relation with the included participants] secondary outcome description Measured as relation between number of participants and number of potential participants which weren't recruited secondary outcome time frame at the end of the 5th week secondary outcome measure Fall Prevalence [number of falls during the using of the device] secondary outcome description Number of falling events ocurred from the participant or therapist secondary outcome time frame During the use of the device, for 5 weeks secondary outcome measure Skin integrity [number of skin injuries related to the device] secondary outcome description skin integrity measured as the number of skin injuries secondary outcome time frame before and after each use of exoskeleton, for 5 weeks secondary outcome measure Pain [VAS scale] secondary outcome description Pain registered before and after the use of the device, by the participant and therapist secondary outcome time frame Before and after the use of the device, during 5 weeks secondary outcome measure Fatigue [Borg Scale] secondary outcome description Fatigue registered before and after the use of the device, by the participant and therapist secondary outcome time frame Before and after the use of the device, during 5 weeks secondary outcome measure Spasticity [Modified Ashworth Scale] secondary outcome description Spasticity registered before and after the use of the device secondary outcome time frame Before and after the use of the device, during 5 weeks secondary outcome measure Heart rate [measured with sphygmomanometer] secondary outcome description Number of heart beats per minute secondary outcome time frame Before and after the use of the device, during 5 weeks secondary outcome measure Physical evaluation [number of physical injuries detected] secondary outcome description Physical Evaluation as presence of tissue damage secondary outcome time frame Before and after the use of the device, during 5 weeks secondary outcome measure Muscle Strength [measured with Hand Held Dynamometer in N] secondary outcome description Muscle Strength measured at hip, knee and ankle muscles secondary outcome time frame At the first day, 3rd week and 5th week secondary outcome measure ROM [measured with goniometer] secondary outcome description Range of Movement secondary outcome time frame At the first day, 3rd week and 5th week secondary outcome measure Functional Mobility [Functional Ambulation Category scale] secondary outcome description Functional Mobility with and without the device secondary outcome time frame At the first day, 3rd week and 5th week secondary outcome measure System Usability [System Usability Scale] secondary outcome description Measurement of System's Usability measured by the therapist secondary outcome time frame At the 5th week secondary outcome measure User perception of the device [QUEST 2.0] secondary outcome description QUEST 2.0 will be assessed by the therapist and participant secondary outcome time frame At the 5th week secondary outcome measure Distance covered walking [6MWT] secondary outcome description 6MWT recorded using the device secondary outcome time frame At the first day, 3rd week and 5th week secondary outcome measure Device malfunction [as number and type of device malfunction] secondary outcome description Any device malfunction will be recorded secondary outcome time frame During the use of the device, for 5 weeks secondary outcome measure Particpant's stability [TUG] secondary outcome description Timed Up and Go Scale secondary outcome time frame At the first day, 3rd week and 5th week secondary outcome measure Breath Rate [Breathings per minute] secondary outcome description Number of breaths per 1 minute secondary outcome time frame Before and after the use of the device, during 5 weeks secondary outcome measure SP/DP [sphygmomanometer] secondary outcome description Systolic and Diastolic Pressure measured in mmHg secondary outcome time frame Before and after the use of the device, during 5 weeks secondary outcome measure SpO2 [pulse oximeter] secondary outcome description SpO2 measured in % secondary outcome time frame Before and after the use of the device, during 5 weeks eligibility module eligibility criteria Inclusion Criteria: Age between 18 and 85 years Weight < 100 kg Height between 1.5 and 1.9 meters Anthropometric measurements to fit in the exoskeleton: Distance from the center of the knee joint to the ground: 42 - 55 cm Distance from the center of the knee to the groin fold: more than 28 cm. Perimeter in thigh (midpoint trochanter - epicondyle): 40 - 63 cm. Perimeter in calf (point of greater volume): 30 - 44 cm. Ability to follow simple commands and communicate basic needs Presence of unilateral hemiparesis Diagnosis of stroke confirmed with imaging tests. Sub-acute or chronic patients (time since diagnosis 1 month or more) Score on FAC scale from 1 to 4 Sufficient postural control to maintain standing posture and to take a step with the weight on the affected lower limb, manual assistance or technical aids being allowed Exclusion Criteria: Spasticity > 3 in lower limbs according to the MAS scale Skin alterations in the contact areas with the exoskeleton Planned surgical intervention during the duration of the study Two or more osteoporotic fractures in the lower limbs in the last 2 years Presence of other pathologies that cause exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, Parkinson's, severe lung disease) Surgical operation in the 3 months prior to the start of the study on the lower limbs healthy volunteers No gender All minimum age 18 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module location list location location facility MarsiCare location city Madrid location state Arganda Del Rey location zip 28500 location country Spain i p d sharing statement module i p d sharing No i p d sharing description There's no intention to share the individual participant data with researchers outside the scope of the present study. The participant data will be collected anonymized using a code for each participant. The data will be collected and stored according to the EU regulations and local laws and guidelines. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000020521 condition mesh term Stroke condition mesh id D000020233 condition mesh term Gait Disorders, Neurologic condition ancestor list condition ancestor condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf as found Stroke condition browse leaf relevance high condition browse leaf id M21211 condition browse leaf name Gait Disorders, Neurologic condition browse leaf as found Gait, Hemiplegic condition browse leaf relevance high condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04837144
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full study rank 61345 study protocol section identification module n c t id NCT04837677 org study id info org study id PRT1419-02 organization org full name Prelude Therapeutics org class INDUSTRY brief title A Study of PRT1419 in Patients With Advanced Solid Tumors official title A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 in Patients With Advanced Solid Tumors status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 11, 2021 start date type Actual primary completion date struct primary completion date August 31, 2023 primary completion date type Anticipated completion date struct completion date August 31, 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 26, 2022 last update post date struct last update post date May 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Prelude Therapeutics lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419. detailed description This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients with relapsed or refractory solid tumors, including breast, lung, sarcoma and melanoma as part of a 28-day treatment cycle. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified. conditions module condition list condition Sarcoma Melanoma Lung Cancer Breast Cancer Esophageal Cancer Cervical Cancer Head and Neck Cancer keyword list keyword MCL1 design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label PRT1419 arm group type Experimental arm group description PRT1419 will be administered by intravenous infusion arm group intervention list arm group intervention name Drug: PRT1419 intervention list intervention intervention type Drug intervention name PRT1419 intervention description PRT1419 will be administered by intravenous infusion intervention arm group label list intervention arm group label PRT1419 outcomes module primary outcome list primary outcome primary outcome measure Dose limiting toxicities (DLT) of PRT1419 primary outcome description Dose limiting toxicities will be evaluated through the first cycle primary outcome time frame Baseline through Day 28 primary outcome measure Maximally tolerated dose (MTD) and/or optimal biological dose (OBD) primary outcome description The MTD and/or OBD will be established for further investigation in participants with advanced solid tumors. primary outcome time frame Baseline through approximately 2 years primary outcome measure Recommended phase 2 dose (RP2D) and schedule of PRT1419 primary outcome description The RP2D will be established for further investigation in participants with advanced solid tumors. primary outcome time frame Baseline through approximately 2 years secondary outcome list secondary outcome secondary outcome measure Safety and tolerability of PRT1419: AEs, SAEs, CTCAE assessments secondary outcome description Safety and tolerability will be assessed by recording adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) secondary outcome time frame Baseline through approximately 2 years secondary outcome measure Pharmacokinetic profile of PRT1419: maximum observed plasma concentration secondary outcome description PRT1419 pharmacokinetics will be calculated including the maximum observed plasma concentration secondary outcome time frame Baseline through approximately 2 years secondary outcome measure Anti-tumor activity of PRT1419: measurement of objective responses secondary outcome description Anti-tumor activity of PRT1419 will be based on the measurement of objective responses secondary outcome time frame Baseline through approximately 2 years secondary outcome measure Progression-free survival secondary outcome description Progression-free survival will be calculated from the first administration of PRT1419 until death or until the criteria for disease progression are met secondary outcome time frame Baseline through approximately 2 years eligibility module eligibility criteria Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Adequate organ function (bone marrow, hepatic, renal, cardiovascular) Left ventricular ejection fraction of ≥ 50% Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use a highly effective method of contraception during the trial Patients must have recovered from the effects of any prior cancer related therapy, radiotherapy or surgery (toxicity ≤ Grade 1) All patients on prior investigational agents must wait at least 5 half-lives of the agent in question, or 28 days, whichever is longer before study entry Most recent lab values meet the following criteria: Absolute neutrophil count > 1.0 x 10^3/μL; Platelet count > 75,000/μL; Hemoglobin > 9.0 g/dL Histologically confirmed advanced or metastatic solid tumor indicated below that is relapsed, refractory, or intolerant to available therapies with known benefit: Sarcoma not amendable to curative treatment with surgery or radiotherapy; Melanoma (non-resectable or metastatic); Small cell lung cancer (extensive-stage); Non-small cell lung cancer; Triple negative breast cancer (histopathologically or cytologically confirmed). Esophageal cancer Cervical cancer Head and neck cancer Exclusion Criteria: Known hypersensitivity to any of the components of PRT1419 Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression Female patients who are pregnant or lactating Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption Mean QTcF interval of >480 msec History of heart failure, additional risk factors for arrhythmias or requiring concomitant medications that prolong the QT/QTc interval HIV positive; known active hepatitis B or C Uncontrolled intercurrent illnesses Treatment with strong inhibitors of CYP2C8 Prior exposure to an MCL1 inhibitor History of another malignancy except: Malignancy treated with curative intent with no known active disease for >2 years at study entry; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated carcinoma in situ without evidence of disease; Other concurrent low-grade malignancies (i.e chronic lymphocytic leukemia (Rai 0)) may be considered after consultation with Sponsor. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Study Contact central contact role Contact central contact phone See Email central contact e mail PRT1419-02IVStudy@preludetx.com location list location location facility Sarah Cannon Research Institute at HealthONE location status Recruiting location city Denver location state Colorado location zip 80218 location country United States location facility Florida Cancer Specialists location status Recruiting location city Lake Mary location state Florida location zip 32746 location country United States location facility Florida Cancer Specialists location status Recruiting location city Sarasota location state Florida location zip 34232 location country United States location facility University of Iowa Hospitals and Clinics location status Recruiting location city Iowa City location state Iowa location zip 52242 location country United States location facility Thomas Jefferson University, Sidney Kimmel Cancer Center location status Recruiting location city Philadelphia location state Pennsylvania location zip 19107 location country United States location facility UPMC Hillman Cancer Center location status Recruiting location city Pittsburgh location state Pennsylvania location zip 15232 location country United States location facility Tennessee Oncology location status Recruiting location city Nashville location state Tennessee location zip 37203 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M10324 condition browse leaf name Lung Neoplasms condition browse leaf relevance low condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf relevance low condition browse leaf id M4982 condition browse leaf name Uterine Cervical Neoplasms condition browse leaf relevance low condition browse leaf id M14479 condition browse leaf name Sarcoma condition browse leaf relevance low condition browse leaf id M10680 condition browse leaf name Melanoma condition browse leaf relevance low condition browse leaf id M7240 condition browse leaf name Esophageal Neoplasms condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse leaf id T5284 condition browse leaf name Soft Tissue Sarcoma condition browse leaf relevance low condition browse leaf id T2141 condition browse leaf name Esophageal Cancer condition browse leaf as found Esophageal Cancer condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04837677
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full study rank 61475 study protocol section identification module n c t id NCT04835987 org study id info org study id 20CH250 secondary id info list secondary id info secondary id 2020-A03326-33 secondary id type Other Identifier secondary id domain ANSM organization org full name Centre Hospitalier Universitaire de Saint Etienne org class OTHER brief title Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer official title Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer acronym PROSNACO status module status verified date December 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date December 2021 start date type Anticipated primary completion date struct primary completion date March 2023 primary completion date type Anticipated completion date struct completion date September 2023 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date December 1, 2021 last update post date struct last update post date December 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Centre Hospitalier Universitaire de Saint Etienne lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Esophageal surgery is a complex surgery, with high post-operative morbidity and mortality. The incidence of complications associated with esophagectomy varies from 17% to 74%, in the literature. A section of vagus nerves is conventionally performed during esophagectomy for cancer, because of oncological margins. The vagus nerve is responsible for the parasympathetic innervation at the gastrointestinal level, but also at the cardiac and pulmonary level. The post-operative morbidity of these procedures could be linked in part to the bilateral section of the vagus nerves, because of their impact on the autonomous regulation of this vital functions. The main objective of the study is to find a modification of the sympathomimetic balance pre and post operatively, in patients undergoing esophagectomy. detailed description The sympathomimetic balance was measured using a Holter-ECG heart rate monitor. The parameters collected were used to calculate the variability of the heart rate, the high frequencies (HF, reflection of the parasympathetic system), the low frequencies (LF, reflection of the sympathetic system and the parasympathetic system) and the ratio // LF / HF (reflection of the sympathetic activity) thanks to Fourier analysis and the use of HRVanalysis software. The measurements were taken at night, to overcome the great sympathomimetic variabilities due to external stimulations during the day: one night 3 month before surgery/before the first chemotherapy, one night between 2 and 4 weeks before hospitalization (remotely of possible chemotherapy), the night before the intervention (context of hospitalization and preoperative stress), one night between D7 and D10 (context of hospitalization, and distance from anesthetic drugs), one night at home between 4 and 8 weeks post-operative, and one night at home at 3 months post-operative. The measurements were therefore not carried out the first nights following the intervention to overcome the anesthetic drugs that affect the balance of the autonomic nervous system. A baroreflex measurement was carried out at the patient's entrance, the day before the intervention, during hospitalization, and the day of discharge. This measure was renewed at 3 months. A measurement of patient activity was carried out preoperatively by wearing an actimeter watch for 1 week then renewed at 3 months. A Respiratory Functional Exploration associated with a stress test with calculation of the VO2max is systematically carried out before the esophageal surgery. A Respiratory Functional Exploration was renewed 4 to 8 weeks after the intervention, and then at 3 months. the 6-minute walk test was performed at the same time. conditions module condition list condition Esophageal Cancer keyword list keyword Esophagectomy surgery Holter-ECG design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Prospective enrollment info enrollment count 15 enrollment type Anticipated arms interventions module intervention list intervention intervention type Diagnostic Test intervention name Holter ECG intervention description Measurement of the modification of the sympathomimetic balance intervention type Behavioral intervention name Questionary intervention description Lifestyle questionary (time spent in front of television, physical activity) intervention type Diagnostic Test intervention name Pupillometry intervention description Monitoring of nociception and autonomic nervous system by pupillometry in intraoperative. outcomes module primary outcome list primary outcome primary outcome measure Analysis of Standard deviation of all NN (SDNN) (ms) primary outcome description Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery primary outcome time frame before surgery primary outcome measure Analysis of Standard deviation of all NN (SDNN) (ms) primary outcome description Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery primary outcome time frame day 7 to day 90 secondary outcome list secondary outcome secondary outcome measure HF activity secondary outcome description Day 0 = surgery measured with the Holter Electrocardiogram secondary outcome time frame before surgery : Day -82, Day -30, Day -1 secondary outcome measure LF activity secondary outcome description Day 0 = surgery measured with the Holter Electrocardiogram secondary outcome time frame before surgery : Day -82, Day -30, Day -1 secondary outcome measure LF/HF ratio secondary outcome description Day 0 = surgery measured with the Holter Electrocardiogram secondary outcome time frame before surgery : Day -82, Day -30, Day -1 secondary outcome measure HF activity secondary outcome description Day 0 = surgery measured with the Holter Electrocardiogram secondary outcome time frame after surgery : day 7, day 60, day 90 secondary outcome measure LF activity secondary outcome description Day 0 = surgery measured with the Holter Electrocardiogram secondary outcome time frame after surgery : day 7, day 60, day 90 secondary outcome measure LF/HF ratio secondary outcome description Day 0 = surgery measured with the Holter Electrocardiogram secondary outcome time frame after surgery : day 7, day 60, day 90 secondary outcome measure change in baroreflex secondary outcome description baroreflex sensitivity : ms/mmHg Day 0 = surgery secondary outcome time frame Day -1, Day 7, day discharge, day 90 secondary outcome measure modify the respiratory functional exploration secondary outcome description Peak expiratory volume per second : L Day 0 = surgery secondary outcome time frame Day -30, Day 30, Day 60 secondary outcome measure intraoperative pupillometry secondary outcome description pupillary diameter : mm secondary outcome time frame during surgery secondary outcome measure physical capacity secondary outcome description walking distance in 6 minutes Day 0 = surgery secondary outcome time frame Day-30, Day 30, Day 90 eligibility module eligibility criteria Inclusion Criteria: Esophagectomy for cancer written and oral agreement Exclusion Criteria: pregnant women, patients with permanent atrial fibrillation, patients with pace-maker Patients under guardianship/curatorship healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population population aged over 18 years with esophagectomy for cancer sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name EVE HUART, MD central contact role Contact central contact phone 0)4 77 82 83 37 central contact phone ext 33 central contact e mail eve.huart@chu-st-etienne.fr central contact name DAVID HUPIN, MC central contact role Contact central contact phone 0)477127985 central contact phone ext 33 central contact e mail david.hupin@chu-st-etienne.fr overall official list overall official overall official name EVE HUART, MD overall official affiliation CHU ST ETIENNE overall official role Principal Investigator location list location location facility Centre Hospitalier Universitaire de Saint-Etienne location city Saint-Étienne location zip 42055 location country France location contact list location contact location contact name MARIE PEURIERE location contact role Contact location contact phone (0)4 77 12 08 26 location contact phone ext +33 location contact e mail marie.peuriere@chu-st-etienne.fr location contact name EVE HUART, MD location contact role Principal Investigator location contact name David HUPIN, MD location contact role Sub-Investigator location contact name Olivier TIFFET, MD PhD location contact role Sub-Investigator location contact name David CHARIER, MD location contact role Sub-Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M7240 condition browse leaf name Esophageal Neoplasms condition browse leaf relevance low condition browse leaf id T2141 condition browse leaf name Esophageal Cancer condition browse leaf as found Esophageal Cancer condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M15497 intervention browse leaf name Sympathomimetics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04835987
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full study rank 61668 study protocol section identification module n c t id NCT04833478 org study id info org study id Paeds Anxiety organization org full name Altamash Institute of Dental Medicine org class OTHER brief title Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients official title Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients -A Single Blind Randomized Controlled Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date August 1, 2020 start date type Actual primary completion date struct primary completion date December 31, 2020 primary completion date type Actual completion date struct completion date December 31, 2020 completion date type Actual study first submit date March 16, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hira Abbasi responsible party investigator title Principal Investigator responsible party investigator affiliation Altamash Institute of Dental Medicine lead sponsor lead sponsor name Altamash Institute of Dental Medicine lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To evaluate the efficacy of different techniques for the reduction of dental anxiety in pediatric patients. Generally, anxiety amongst paediatric patients is higher as compared to adult patients. So different modalities are used by the dentists in order to reduce the anxiety of such patient to help to make treatment procedures easier and optimal. detailed description Children who suffer from dental anxiety avoid any sort of dental treatment provided to them, which leads to poor oral hygiene, and if unaddressed, problems like missing teeth and decayed teeth further in life develop, and ultimately leading to problems making treatment planning intricate. Children normally follow the footsteps of their parents so it is of importance to consider how to avoid creating dental anxiety among them. If dental anxiety is left untreated, it might persist during adulthood, which eventually will deteriorate the oral health of such patients. Due to the substantial effect of dental anxiety in paediatric patients, many methods have been devised to alleviate or eliminate such anxieties of the patients. This study aimed to employ different strategies and measure heart rate and Facial Image Scale scores to determine their efficacy in reducing paediatric patient's dental anxiety by using these techniques before and after the procedure to compare the effectiveness of each of these techniques. conditions module condition list condition Anxiety Paediatric Dental Anxiety Behaviour keyword list keyword Anxiety Dental Application Dental Song Tell-Show-Do Behaviour design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Factorial Assignment design primary purpose Supportive Care design masking info design masking Double design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 120 enrollment type Actual arms interventions module arm group list arm group arm group label Application arm group type Experimental arm group description Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter arm group intervention list arm group intervention name Behavioral: Anxiety arm group label Dental Song arm group type Experimental arm group description Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter arm group intervention list arm group intervention name Behavioral: Anxiety arm group label Tell Show Do arm group type Experimental arm group description Measuring anxiety level of the patients using Facial Image Scale and Pulse Oximeter arm group intervention list arm group intervention name Behavioral: Anxiety intervention list intervention intervention type Behavioral intervention name Anxiety intervention description Techniques used to reduce anxiety in paediatric patients. intervention arm group label list intervention arm group label Application Dental Song Tell Show Do outcomes module primary outcome list primary outcome primary outcome measure Group 1: Little Lovely Dentist App measuring anxiety using pulse oximeter primary outcome description Measuring Anxiety Levels primary outcome time frame 5 months primary outcome measure Group 1: Little Lovely Dentist App measuring anxiety using facial image scale. primary outcome description Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value primary outcome time frame 5 months primary outcome measure Group 2: Dental Song measuring anxiety using pulse oximeter primary outcome description Measuring Anxiety Levels primary outcome time frame 5 months primary outcome measure Group 2: Dental Song measuring anxiety using facial image scale. primary outcome description Measuring Anxiety Levels, 1 Minimum value and 5 Maximum value primary outcome time frame 5 months primary outcome measure Group 3: Tell-Show-Do measuring anxiety using pulse oximeter primary outcome description Measuring Anxiety Levels primary outcome time frame 5 months primary outcome measure Group 3: Tell-Show-Do measuring anxiety using facial image scale. primary outcome description Measuring Anxiety Levels 1 Minimum value and 5 Maximum value primary outcome time frame 5 months eligibility module eligibility criteria Inclusion Criteria: Only the children age ranged from 4 to 11 years with no positive medical history. Exclusion Criteria: Rest were excluded. healthy volunteers Accepts Healthy Volunteers gender All gender based Yes minimum age 4 Years maximum age 11 Years std age list std age Child contacts locations module overall official list overall official overall official name Hira Abbasi, BDS, Post Graduate Trainee overall official affiliation Altamash Institute of Dental Medicine overall official role Principal Investigator location list location location facility Altamash Institute of Dental Medicine location city Karachi location state Sindh location zip 75500 location country Pakistan derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001008 condition mesh term Anxiety Disorders condition ancestor list condition ancestor condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf as found Anxiety condition browse leaf relevance high condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04833478
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full study rank 61604 study protocol section identification module n c t id NCT04834310 org study id info org study id UCLA PRS organization org full name University of California, Los Angeles org class OTHER brief title Postoperative Antibiotics Following Primary and Secondary Breast Augmentation official title Postoperative Antibiotics Following Primary and Secondary Breast Augmentation: A Double-Blinded, Randomized Trial status module status verified date September 2022 overall status Withdrawn why stopped Do not have adequate funding to proceed with project. expanded access info has expanded access No start date struct start date April 1, 2021 start date type Anticipated primary completion date struct primary completion date May 30, 2024 primary completion date type Anticipated completion date struct completion date July 30, 2024 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 9, 2022 last update post date struct last update post date September 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Karie Villanueva, MD responsible party investigator title Principal Investigator responsible party investigator affiliation University of California, Los Angeles lead sponsor lead sponsor name University of California, Los Angeles lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary Postoperative antibiotics are routinely used for implant-based breast augmentation at the investigators' institution. From 2017-2019, the investigators' institution has conducted approximately 270 primary and secondary breast augmentation procedures. Current plastic surgery literature does not provide recommendations for antibiotic prophylaxis following implant-based breast procedures. Despite controversy surrounding their utility during the postoperative course, postoperative antibiotics have become commonplace for many plastic surgeons. To date, strong scientific evidence supporting this practice is minimal and based largely on anecdotal evidence and limited studies, including poorly controlled retrospective and non-blinded prospective series. The goal of this study is to conduct a prospective randomized trial to assess whether extended antibiotic prophylaxis is necessary to prevent infection and long-term complications (e.g. capsular contracture) in patients undergoing augmentation mammoplasty with implants. The investigators' anticipate that extended antibiotic prophylaxis is not required. The rationale for discontinuing postoperative antibiotics is based on the following: (1) a single dose of preoperative intravenous antibiotics has been demonstrated to be sufficient prophylaxis for most breast surgeries and (2) there are patient safety concerns associated with prolonged antimicrobial use such as the development of resistant bacterial strains and clostridium-related infections. Concrete evidence that extended antibiotic prophylaxis is not required would encourage plastic surgeons to practice better antibiotic stewardship and help stymie the rise of drug-resistant organisms. detailed description The investigators will perform a randomized, double-blinded, placebo-controlled trial at University of California Los Angeles Ronald Reagan Medical Center for patients undergoing primary and secondary breast augmentation between 2021-2025. The study will be added to a research registry before patient enrollment begins (i.e. www.clinicaltrials.gov) with study methods and results presented in the manner recommended by the CONSORT statement (available at www.consort-statement.org). The study will be designed as a non-inferiority trial with two parallel groups: the experimental group will receive an intraoperative dose of antibiotics followed by oral antibiotics for 5 days postoperatively (Cephalexin 500 mg four times per day or Clindamycin 300 mg four times per day, if Penicillin allergic) while the control group will receive an intraoperative dose of antibiotics (Cefazolin 1 g or 2 g, or Clindamycin 600 mg or 900 mg, if Penicillin allergic, higher doses provided if BMI > 30 kg/m2) followed by a placebo for 5 days postoperatively. Inclusion criteria will include: females and transgender females 18 years or older, patients undergoing primary breast augmentation, breast augmentation-mastopexy, and secondary breast augmentation with subglandular or submuscular implants. Secondary breast augmentation will include patients undergoing implant exchange secondary to capsular contracture and implant rupture. Exclusion criteria will include refusal or inability to consent, patients with biopsy-proven breast cancer, patients undergoing expander-based and autologous flap breast reconstruction following mastectomies, history of chest radiation, and the presence of active infection at the time of surgery. Patients who fail to take the placebos or antibiotics provided in the study for any reason, miss postoperative visits, and/or withdraw consent at any stage of the study will also be excluded. For the analysis, the investigators plan to obtain hospital records with intraoperative procedural and postoperative clinic notes. Demographic information including gender, body mass index, comorbidities, smoking use, and prior breast surgeries will be collected and used for analysis. Power analysis for statistical equivalency using 8% infection rate yields a required sample size of 164 total patients, with planned 82 patients per group (i.e. experimental and control). This would provide 80 percent power at a significance level of 5 percent. The experimental group will consist of patients who receive an intraoperative dose of antibiotics followed by oral antibiotics for 5 days postoperatively. The control group includes patients who receive an intraoperative dose of antibiotics followed by a placebo for 5 days postoperatively. All medications and placebos will be formulated, compounded and dispensed by the University of California Los Angeles Investigational Research Pharmacy. An appointed Data and Safety Monitoring Board (DSMB) will monitor data and safety as recommended by the Investigational Review Board (IRB). Antibiotics of choice include intravenous Cefazolin and oral Cephalexin. Intravenous and oral Clindamycin will be made available for subjects who are allergic to Penicillin. Subject allocation will be based on a 1:1 ratio for each group. Surgeons, nursing, and administrative staff will be responsible for recruitment. Prior to surgery, patients will be given a consent form to explain their involvement in the randomized trial. The consent process will inform the participant about details of the study and indicate participation is voluntary. They will also be given the risks, benefits, alternatives, and confidentiality of their information with proceeding with the study. Risks discussed with participants will include those associated with antibiotic use, including gastrointestinal symptoms, yeast infections, allergic reactions, development of resistant bacterial strains, and clostridium-related infections. Potential risks associated with no antibiotic use (i.e. placebo group), include infection. The interventions to protect those affected by these risks include hospital admission as detailed in the informed consent under the section "Office of the Human Research Protection Program (OHRPP)," and the option to opt out of the study. There are no medical benefits with participating in the study. However, participants will be informed that the results may contribute to the body of knowledge around postoperative antibiotics, and improve surgical protocols and postoperative care. Randomization will be performed prior to surgery, and an assigned study coordinator will generate group assignments. Patients and surgeons will be blinded to the study before randomization takes place. However, surgeons will have access to information following medication dispensation in case any complications arise so that the provider can carry out appropriate interventions. Review of the rate of subject accrual and compliance will occur monthly during the recruitment phase. An interim analysis will be performed on the primary endpoint when 50% of patients have been randomized and have complete their 6-month follow up period. An independent statistician blinded to treatment allocation will perform the analyses. The statistician will report to DSMB who will have unmasked access to all data. Interim analysis will be used to inform stopping guidelines and trial adaptations (e.g. sample size re-estimation, alteration to the proportion of participants allocated to each study group, and changes to eligibility criteria). The Principal Investigator (PI) will be responsible for ensuring participants' safety on a daily basis. The DSMB will act in an advisory capacity to monitor participant safety, evaluate the progress of the study, and review procedures for maintaining the confidentiality, quality, management, and analysis of the data. An adverse event will be any untoward medical occurrence in a subject without regard to the possibility of a causal relationship. Adverse events will be collected after the subject has provided consent and enrolled in the study. All adverse events occurring after entry into the study and up to their first postoperative visit will be recorded. A serious adverse event for this study is any untoward medical occurrence that is believed by the investigators to be causally related to study-drug and results in any of the following: life-threatening condition (i.e. immediate risk of death); severe or permanent disability, prolonged hospitalization, or a significant hazard as determined by the DSMB. Investigators will determine relatedness of an event to study based on a temporal relationship, as well as whether the event is unexpected or unexplained given the subject's clinical course, previous medical conditions, and concomitant medications. All adverse and severe events related to antibiotic use, including anaphylaxis requiring hospital admission and/or resulting in death, will be monitored through patient examination and chart review. Furthermore, events that meet criteria for an adverse and serious adverse will be reported to the IRB. Six plastic surgeons will be involved in the study and will utilize a standardized surgical protocol. Initial follow up visits will be arranged within 1-2 weeks following surgery. Data on adherence to the treatment protocol will be collected monthly by research staff and reviewed quarterly by the Principal Investigator and the study statistician. Adherence of participants will be evaluated by inquiring about completion of antibiotics or placebos at each postoperative visit. During follow-up visits, inquiry will be made to assure patients receive their antibiotics or placebos. This information along with any post-operative complications will be transferred onto the patient's electronic medical record accordingly. Primary outcomes including surgical site infection, secondary outcomes (e.g. hematoma, seroma, wound dehiscence, implant loss, and capsular contracture), and antibiotic-related complications (e.g. antibiotic resistance, diarrhea, clostridium infection, yeast infections, rash, urinary tract infections, and gastrointestinal upset) will be documented. Surgical site infections will be determined by the surgeon however will be defined by the presence of the following signs and symptoms: fevers, purulent drainage, pain, tenderness, localized edema, heat, erythema, positive wound cultures, and leukocytosis. Study endpoints will include diagnosis of surgical site infection, development of secondary outcomes, and subject death or loss to follow-up. Follow-up will be continued until all patients have reached one of the study endpoints. Statistical tests will be performed by a statistician using statistical software and determined after enough data has been generated to perform preliminary analysis. Threats to study validity include under recruitment of subjects, subjects lost to follow-up, subject non-compliance, and subject crossovers. This study will be stopped prior to its completion if: the intervention is associated with adverse effects that call into question the safety of the intervention; difficulty in study recruitment or retention will significantly impact the ability to evaluate the study endpoints; any new information becomes available during the trial that necessitates stopping the trial; or other situations occur that might warrant stopping the trial. conditions module condition list condition Surgical Site Infection Capsular Contracture Associated With Breast Implant Antibiotic Resistant Infection Antibiotic Side Effect design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description The study will be designed as a non-inferiority trial with two parallel groups: the experimental group will receive an intraoperative dose of antibiotics followed by oral antibiotics for 5 days postoperatively (Cephalexin 500 mg QID or Clindamycin 300 mg QID, if Penicillin allergic) while the control group will receive an intraoperative dose of antibiotics (Cefazolin 1 g or 2 g, or Clindamycin 600 mg or 900 mg, if Penicillin allergic, higher doses provided if BMI > 30 kg/m2) followed by a placebo for 5 days postoperatively. design primary purpose Treatment design masking info design masking Triple design masking description Randomization will be performed prior to surgery, and an assigned coordinator will generate group assignments. Patients and surgeons will be blinded to the study before randomization takes place. However, surgeons will have access to information following medication dispensation in case any complications arise so that the provider can carry out appropriate interventions. design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label Intraoperative and Postoperative Antibiotics arm group type Experimental arm group description The experimental group will receive an intraoperative dose of antibiotics, which is standard protocol at our institution, followed by oral antibiotics for 5 days postoperatively. arm group intervention list arm group intervention name Drug: Cefazolin Drug: Cephalexin arm group label Intraoperative Antibiotics and Placebo arm group type Placebo Comparator arm group description The control group will receive an intraoperative dose of antibiotics, which is standard protocol at our institution, followed by a placebo for 5 days postoperatively arm group intervention list arm group intervention name Drug: Cefazolin Other: Placebo intervention list intervention intervention type Drug intervention name Cefazolin intervention description All patients will receive an intraoperative dose of IV Cefazolin 2 g (re-dose after 4 hours) or IV Clindamycin 600mg (re-dose after 6 hours) for penicillin allergic patients. intervention arm group label list intervention arm group label Intraoperative Antibiotics and Placebo Intraoperative and Postoperative Antibiotics intervention other name list intervention other name Ancef Clindamycin Cleocin intervention type Drug intervention name Cephalexin intervention description The experimental group will receive a postoperative 5-day course of Cephalexin 500 mg QID or Clindamycin 300 mg QID for penicillin allergic patients. All capsules will be encapsulated with size 00 dark-colored capsules compounded by the UCLA Investigational Pharmacy. intervention arm group label list intervention arm group label Intraoperative and Postoperative Antibiotics intervention other name list intervention other name Keflex Clindamycin Cleocin intervention type Other intervention name Placebo intervention description The placebo group will receive a postoperative 5-day course of placebos (sugar capsules). All capsules will be encapsulated with size 00 dark-colored capsules compounded by the UCLA Investigational Pharmacy. intervention arm group label list intervention arm group label Intraoperative Antibiotics and Placebo outcomes module primary outcome list primary outcome primary outcome measure Number of participants with surgical site infection primary outcome description Surgical site infections will be determined by the surgeon however will be defined by the presence of the following signs and symptoms: fevers, purulent drainage, pain, tenderness, localized edema, heat, erythema, positive wound cultures, and leukocytosis. primary outcome time frame 365 days following surgery secondary outcome list secondary outcome secondary outcome measure Number of participants with hematoma secondary outcome description Fluid collection consisting of blood secondary to procedure identified by clinical exam and/or ultrasound. secondary outcome time frame 365 days following surgery secondary outcome measure Number of participants with seroma secondary outcome description Fluid collection consisting of serous fluid secondary to procedure identified by clinical exam and/or ultrasound. secondary outcome time frame 365 days following surgery secondary outcome measure Number of participants with wound dehiscence secondary outcome description Any re-opening of surgical incision following procedure which was closed primarily. secondary outcome time frame 365 days following surgery secondary outcome measure Number of participants with implant loss secondary outcome description Extrusion of implant or condition resulting in implant removal secondary to procedure. secondary outcome time frame 365 days following surgery secondary outcome measure Number of participants with antibiotic-related complications secondary outcome description Diarrhea, clostridium infection, yeast infections, rash, urinary tract infections, and gastrointestinal upset secondary outcome time frame 365 days following surgery secondary outcome measure Number of participants with antibiotic resistance secondary outcome description Local wound infections and fluid collections will be cultured and sent for identification and susceptibility. Resistant strains will be documented and treated with alternative antibiotics. secondary outcome time frame 365 days following surgery other outcome list other outcome other outcome measure Patient compliance other outcome description Patients will be asked during the first postoperative visit if they had taken their placebos or antibiotics. other outcome time frame 365 days following surgery eligibility module eligibility criteria Inclusion Criteria: Age 18 year or older Participants undergoing primary breast augmentation with subglandular or submuscular implants Participants undergoing breast augmentation-mastopexy with subglandular or submuscular implants Participants undergoing secondary breast augmentation with subglandular or submuscular implants (i.e. patients undergoing implant exchange secondary to capsular contracture and implant rupture) Exclusion Criteria: Refusal or inability to obtain consent from participants Participants with biopsy-proven breast cancer Participants undergoing expander-based breast reconstruction Participants undergoing autologous flap breast reconstruction Participants with history of chest radiation Participants with active infection at the time of surgery Participants who fail to take the placebos or antibiotics provided in the study for any reason Participants who miss postoperative visits Participants who withdraw consent at any stage of the study healthy volunteers Accepts Healthy Volunteers gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Karie Villanueva, MD overall official affiliation University of California, Los Angeles overall official role Principal Investigator overall official name Jaco Festekjian, MD overall official affiliation University of California, Los Angeles overall official role Study Chair references module reference list reference reference p m i d 27922894 reference type background reference citation Chopra K, Gowda AU, McNichols CHL, Brown EN, Slezak S, Rasko Y. Antimicrobial Prophylaxis Practice Patterns in Breast Augmentation: A National Survey of Current Practice. Ann Plast Surg. 2017 Jun;78(6):629-632. doi: 10.1097/SAP.0000000000000942. reference p m i d 23416440 reference type background reference citation Hardwicke JT, Bechar J, Skillman JM. Are systemic antibiotics indicated in aesthetic breast surgery? A systematic review of the literature. Plast Reconstr Surg. 2013 Jun;131(6):1395-1403. doi: 10.1097/PRS.0b013e31828bd752. Review. reference p m i d 28439510 reference type background reference citation Keramidas E, Lymperopoulos NS, Rodopoulou S. Is antibiotic prophylaxis in breast augmentation necessary? A prospective study. Plast Surg (Oakv). 2016 Fall;24(3):195-198. Epub 2016 Aug 19. reference p m i d 1950803 reference type background reference citation LeRoy J, Given KS. Wound infection in breast augmentation: the role of prophylactic perioperative antibiotics. Aesthetic Plast Surg. 1991 Fall;15(4):303-5. reference p m i d 22231414 reference type background reference citation Mirzabeigi MN, Mericli AF, Ortlip T, Tuma GA, Copit SE, Fox JW 4th, Moore JH Jr. Evaluating the role of postoperative prophylactic antibiotics in primary and secondary breast augmentation: a retrospective review. Aesthet Surg J. 2012 Jan;32(1):61-8. doi: 10.1177/1090820X11430830. reference p m i d 2195567 reference type background reference citation Gylbert L, Asplund O, Berggren A, Jurell G, Ransjö U, Ostrup L. Preoperative antibiotics and capsular contracture in augmentation mammaplasty. Plast Reconstr Surg. 1990 Aug;86(2):260-7; discussion 268-9. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007239 condition mesh term Infections condition mesh id D000003141 condition mesh term Communicable Diseases condition mesh id D000013530 condition mesh term Surgical Wound Infection condition mesh id D000003286 condition mesh term Contracture condition ancestor list condition ancestor condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000014946 condition ancestor term Wound Infection condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal 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Chemicals
NCT04834310
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full study rank 61625 study protocol section identification module n c t id NCT04834037 org study id info org study id B.30.2.ODM.0.20.08/390 organization org full name Ondokuz Mayıs University org class OTHER brief title Effect of Provision of Information and Supportive Nursing Care: A Randomised Controlled Trial official title The Effect of Provision of Information and Supportive Nursing Care on Blood Gas, Vital Signs, Anxiety, Stress and Agitation Levels in COPD Patients Treated With NIV: A Randomised Controlled Trial status module status verified date June 2021 overall status Completed expanded access info has expanded access No start date struct start date September 1, 2019 start date type Actual primary completion date struct primary completion date December 30, 2019 primary completion date type Actual completion date struct completion date December 30, 2020 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 1, 2021 last update post date struct last update post date June 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ilknur Aydin Avci responsible party investigator title Head of Nursing Department responsible party investigator affiliation Ondokuz Mayıs University lead sponsor lead sponsor name Ondokuz Mayıs University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Background: Informative and supportive nursing care is essential to reduce complications and improve outcomes in Chronic Obstructive Pulmonary Disease (COPD) patients treated with Non-Invasive Ventilation (NIV). Objective: Aim of the study is to determine the effect of provision of information and supportive nursing care on blood gas, vital signs, anxiety, stress and agitation levels in COPD patients treated with NIV. Research Methodology: A randomised controlled design was used between September-December 2019. The universe of the study consisted of COPD patients treated with NIV in intensive care unit in a state hospital. A total of 60 patients, composed of 30 interventions and 30 controls, were randomly included in the sample. Provision of information and supportive nursing care was applied to the patients in the intervention group. The data were evaluated with SPSS program. Results: Following the intervention, the findings showed that the provision of information and supportive nursing care has a positive effect on the blood gas, vital signs, anxiety, stress and agitation levels of patients. Conclusions: The provision of information and supportive nursing care is recommended to alleviate anxiety, stress and agitation in COPD patients treated with NIV detailed description Trial design and the participants A randomised controlled design was used between September-December 2019. This study has been approved (B.30.2.ODM.0.20.08/390) by an ethics committee. In order to carry out the study, an application permit (17186359-604.02) was obtained from the Provincial Health Directorate and the relevant hospital. In addition, written consent forms were obtained from all the patients. The sample size was determined using G * Power 3.1 software since there was no pilot data. According to the power analysis, the number of the participants was calculated as at least 54 when a type 1 error was taken as 0.05, power as 0.95, and the effect size as moderate (0.25) for two groups design with two repeated measures. In order to prevent possible data loss, the volume of the sample was increased by 10% and the total number of the participants was determined as 60. A total of 60 COPD patients treated with NIV in intensive care unit, composed of 30 interventions and 30 controls, were randomly included in the sample. Provision of information and supportive nursing care was applied to the patients in the intervention group while the control group received routine nursing care. The inclusion criteria for participants were: (a) a diagnosis of COPD (b) treated with NIV (c) be conscious of (d) agreement to participate in the study and (e) COPD patients starting NIV therapy for the first time. Patients who were intubated and therefore unable to speak, received sedation and had a Glaskow Coma Scale score below 14 were excluded. There was no drop-out during the study. Data collection tools Personal Information Form: The form, developed by the researchers, included questions about age, gender, educational level, marital status, smoking, information on COPD, nausea and vomiting, information on NIV use. Depression Anxiety Stress Scale (DASS-21): The scale was first developed by Lovibond and Lovibond (1995) with 42 items and three sub-dimensions. It was later revised to 21 items in 1997. The scale is 4-point Likert type, consists of 21 items and 3 sub-dimensions (depression, anxiety, stress). The adaptation of the scale to Turkish and its validity and reliability studies were conducted. Evaluation is obtained by summing the scores given to the items it contains for each sub-dimension. Minimum 0 and maximum 21 points can be obtained in all dimensions. The subscales of the scale are Cronbach's alpha values; depression 0.81, anxiety 0.80, stress 0.75. Richmond Agitation-Sedation Scale (RASS): RASS scale was developed by a multidisciplinary team at Virginia Common Wealth University. RASS is a 10-point scale that is evaluated using verbal stimulation followed by eye contact, which is not available in other scales. It is proven that RASS has excellent validation compared to a wide range of visual analog scales and selected sedation measurements for adult medical and surgical intensive care patients. While zero (0) points on the scale indicate the ideal level, it reflects the increasing agitation towards the (+4) level and the decreasing sedation level to the (-5) level. Since patients receiving sedation were not included in this study, only the agitation dimension of the RASS scale was used. Glaskow Coma Scale (GCS): It was developed in Scotland / Glasgow in 1974 to describe the consciousness level of patients. The scale is widely used to assess patients' level of consciousness. There are 3 separate sections in the scale: eye opening, verbal and motor response. GCS is obtained by summing the points the patient gets from each section. This score ranges from three (3) to fifteen (15). If the GCS total score is 13-15, the patient is considered awake, between 8-12 as precoma, and below 8 as coma. Intervention Patients in the experimental group were provided with information in addition to routine nursing care and supportive care interventions were made. The information leaflet was explained to the patients in the experimental group face to face by the researchers and the information was repeated according to the patient's needs. Supportive nursing care was also practiced to the patients in the experimental group by the researchers. Routine nursing care was practiced to the control group in the intensive care clinic where the patients were located. As a pre-test measure, blood gases were taken from the patients in the experimental and control groups, their vital signs were measured, their state of consciousness was evaluated, and DASS-21 (anxiety and stress sub-dimension) and RASS (agitation dimension) were practiced by face-to-face interviews with the patients. As the last test, the same measurements were made 5 days after the first measurement and before the patients were transferred to the normal service. An information pamphlet consisting of textual material about NIV treatment was developed. The content of the information leaflet consisted of topics that will facilitate patient compliance to treatment, such as the introduction of equipment used in NIV treatment, the intended use of NIV and its effects on the patient, what patients generally experience during treatment, compliance problems in NIV, how the procedure will be performed, each procedure the nurse will do and for what purpose, the duration of the treatment, what the patient can and cannot do during the treatment, what kind of process will proceed if everything goes well. As supportive care, patients were allowed to express their feelings and thoughts about NIV treatment, an accepting and empathetic approach was shown to the patients, care was taken to make eye contact while communicating, therapeutic touch technique was used, it was explained how the patients could reach the nurse when needed, the environment was arranged, each procedure performed was explained with its objectives, they were placed in a position where they could see the clock, strategies that will make it easier for the patients to cope during the treatment were determined and they were encouraged to do so (for example, some patients wanted to read a book and some patients wanted to sleep), the patients were encouraged to ask questions comfortably, it was stated that the treatment could be interrupted for a while when they felt bad due to the mask, and it was ensured that the patients met with their relatives during the visiting hours. Data analysis The Statistical Package for Social Sciences (SPSS) 20.0 package program was used in the analysis of the data. Descriptive statistics were used as mean ± standard deviation for variables with normal distribution, and median (min - max) for variables with non-normal distribution. Nominal variables were shown as the number of patients (n) and (%). The compliance of the data to normal distribution was examined with the Shapiro-Wilk test and the homogeneity of the variances with the Levene test. For the comparison of the experimental and control groups, Student's T test was used for data with normal distribution, Mann Whitney U test was used for data with non-normal distribution. Chi-Square and Fisher's Exact tests were used for group comparisons of nominal variables. "Analysis of Variance in Repeated Measures" was used to analyze the values of the experimental and control groups before and after the training in order to evaluate the effectiveness of the provision of information and supportive nursing care intervention practised to the experimental group. In the analysis of all tests, p value <0.05 was considered statistically significant. conditions module condition list condition Chronic Obstructive Pulmonary Disease keyword list keyword Anxiety, Agitation, Noninvasive Ventilation, Intensive care design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Single Group Assignment design intervention model description Randomized controlled experimental design design primary purpose Prevention design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Experimental arm group type Experimental arm group description Patients in the experimental group were provided with information in addition to routine nursing care and supportive care interventions were made. The information leaflet was explained to the patients in the experimental group face to face by the researchers and the information was repeated according to the patient's needs. As a pre-test measure, blood gases were taken from the patients in the experimental and control groups, their vital signs were measured, their state of consciousness was evaluated, and DASS-21 (anxiety and stress sub-dimension) and RASS (agitation dimension) were practiced by face-to-face interviews with the patients. As the last test, the same measurements were made 5 days after the first measurement and before the patients were transferred to the normal service. An information pamphlet consisting of textual material about NIV treatment was developed. arm group intervention list arm group intervention name Behavioral: Behavioral arm group label No intervention arm group type No Intervention arm group description Routine nursing care was practiced to the control group in the intensive care clinic where the patients were located. intervention list intervention intervention type Behavioral intervention name Behavioral intervention description The provision of information and supportive nursing care is recommended to alleviate anxiety, stress and agitation in COPD patients treated with NIV. intervention arm group label list intervention arm group label Experimental outcomes module primary outcome list primary outcome primary outcome measure Depression Anxiety Stress Scale (DASS-21) primary outcome description The scale was first developed by Lovibond and Lovibond (1995) with 42 items and three sub-dimensions. It was later revised to 21 items by Brown et al. (1997) in 1997. The scale is 4-point Likert type, consists of 21 items and 3 sub-dimensions (depression, anxiety, stress). The adaptation of the scale to Turkish and its validity and reliability studies were conducted by Yılmaz et al. (2017). Evaluation is obtained by summing the scores given to the items it contains for each sub-dimension. Minimum 0 and maximum 21 points can be obtained in all dimensions. The subscales of the scale are Cronbach's alpha values; depression 0.81, anxiety 0.80, stress 0.75 (Yılmaz et al., 2017). primary outcome time frame 3 months primary outcome measure Richmond Agitation-Sedation Scale (RASS) primary outcome description RASS scale was developed by a multidisciplinary team at Virginia Common Wealth University (Sessler et al. , 2002). RASS is a 10-point scale that is evaluated using verbal stimulation followed by eye contact, which is not available in other scales. It is proven that RASS has excellent validation compared to a wide range of visual analog scales and selected sedation measurements for adult medical and surgical intensive care patients. While zero (0) points on the scale indicate the ideal level, it reflects the increasing agitation towards the (+4) level and the decreasing sedation level to the (-5) level. Since patients receiving sedation were not included in this study, only the agitation dimension of the RASS scale was used. primary outcome time frame 3 months primary outcome measure Glaskow Coma Scale (GCS) primary outcome description It was developed in Scotland / Glasgow in 1974 to describe the consciousness level of patients. The scale is widely used to assess patients' level of consciousness. There are 3 separate sections in the scale: eye opening, verbal and motor response. GCS is obtained by summing the points the patient gets from each section. This score ranges from three (3) to fifteen (15). If the GCS total score is 13-15, the patient is considered awake, between 8-12 as precoma, and below 8 as coma (Sepit, 2005). primary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria: a diagnosis of COPD treated with NIV be conscious of agreement to participate in the study COPD patients starting NIV therapy for the first time Exclusion Criteria: intubated therefore unable to speak received sedation had a Glaskow Coma Scale score below 14 were excluded healthy volunteers No gender All minimum age 48 Years maximum age 88 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name İlknur AYDIN AVCİ, Prof. overall official affiliation Ondokuz Mayıs University overall official role Study Director overall official name Yasemin ÇEKİÇ, Dr. overall official affiliation Ankara University overall official role Principal Investigator overall official name Tuba YILMAZ BULUT, Msc overall official affiliation Ondokuz Mayıs University overall official role Principal Investigator location list location location facility Bafra State Hospital location city Samsun location country Turkey derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008173 condition mesh term Lung Diseases, Obstructive condition mesh id D000029424 condition mesh term Pulmonary Disease, Chronic Obstructive condition ancestor list condition ancestor condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M22602 condition browse leaf name Pulmonary Disease, Chronic Obstructive condition browse leaf as found Chronic Obstructive Pulmonary Disease condition browse leaf relevance high condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M10322 condition browse leaf name Lung Diseases, Obstructive condition browse leaf as found Obstructive Pulmonary Disease condition browse leaf relevance high condition browse leaf id M13604 condition browse leaf name Psychomotor Agitation condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04834037
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full study rank 61464 study protocol section identification module n c t id NCT04836130 org study id info org study id Omfs 3.3.10 organization org full name Cairo University org class OTHER brief title Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique official title Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 2021 start date type Anticipated primary completion date struct primary completion date May 2022 primary completion date type Anticipated completion date struct completion date June 2022 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Ahmed Morad responsible party investigator title lecturer assistant responsible party investigator affiliation Cairo University lead sponsor lead sponsor name Ahmed Morad lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique conditions module condition list condition Zygomatic Fractures design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 26 enrollment type Anticipated arms interventions module arm group list arm group arm group label (ZMC) Fractures reduction Using Patient Specific Guide (PSG) arm group type Active Comparator arm group intervention list arm group intervention name Procedure: patient specific guide arm group label (ZMC) Fractures reduction Using Conventional Technique arm group type Active Comparator arm group intervention list arm group intervention name Procedure: conventional technique intervention list intervention intervention type Procedure intervention name patient specific guide intervention description patient specific guide reduction intervention arm group label list intervention arm group label (ZMC) Fractures reduction Using Patient Specific Guide (PSG) intervention type Procedure intervention name conventional technique intervention description conventional anatomical reduction intervention arm group label list intervention arm group label (ZMC) Fractures reduction Using Conventional Technique outcomes module primary outcome list primary outcome primary outcome measure accuracy of reduction of the fractured zygoma ( facial asymetry ) primary outcome description assessed by ct primary outcome time frame up to 6 months secondary outcome list secondary outcome secondary outcome measure operation time secondary outcome description in hours secondary outcome time frame up to 6 months eligibility module eligibility criteria Inclusion Criteria: • Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13) Age (18-60 years) Recent fracture (less than 2 weeks) Exclusion Criteria: • Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13) Medical compromised patient Patient on radiotherapy Bone disease healthy volunteers No gender All minimum age 18 Years maximum age 60 Years std age list std age Adult i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015051 condition mesh term Zygomatic Fractures condition mesh id D000050723 condition mesh term Fractures, Bone condition ancestor list condition ancestor condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000008446 condition ancestor term Maxillofacial Injuries condition ancestor id D000005151 condition ancestor term Facial Injuries condition ancestor id D000006259 condition ancestor term Craniocerebral Trauma condition ancestor id D000020196 condition ancestor term Trauma, Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000012887 condition ancestor term Skull Fractures condition browse leaf list condition browse leaf condition browse leaf id M25523 condition browse leaf name Fractures, Bone condition browse leaf as found Fracture condition browse leaf relevance high condition browse leaf id M16938 condition browse leaf name Zygomatic Fractures condition browse leaf as found Zygomatic Fractures condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M10581 condition browse leaf name Maxillofacial Injuries condition browse leaf relevance low condition browse leaf id M20242 condition browse leaf name Facies condition browse leaf relevance low condition browse leaf id M7446 condition browse leaf name Facial Injuries condition browse leaf relevance low condition browse leaf id M8501 condition browse leaf name Craniocerebral Trauma condition browse leaf relevance low condition browse leaf id M21176 condition browse leaf name Trauma, Nervous System condition browse leaf relevance low condition browse leaf id M14842 condition browse leaf name Skull Fractures condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04836130
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full study rank 61561 study protocol section identification module n c t id NCT04834869 org study id info org study id CoVaST organization org full name Masaryk University org class OTHER brief title COVID-19 Vaccines Safety Tracking (CoVaST) official title COVID-19 Vaccines Safety Tracking: Global Consortium Study status module status verified date October 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date December 31, 2025 primary completion date type Anticipated completion date struct completion date December 31, 2026 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2022 last update post date struct last update post date April 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Masaryk University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution. detailed description Introduction: COVID-19 vaccines are the foremost asset to overcome the ongoing pandemic; therefore, mass vaccination has become a high priority for the world's governments. While vaccination strategies need to be accelerated to minimise daily fatalities and relieve the pandemic's economic burdens, vaccine hesitancy (VH) remains a serious challenge for these efforts. VH refers to "delay in acceptance or refusal of vaccines despite availability of vaccine services",; and it is an emerging public health challenge nourished by misinformation related to vaccines effectiveness and safety. Aversion to vaccines' potential side effects is the most frequent cause of VH among population groups. Therefore, a recent systematic review revealed that raising public awareness of vaccines' effectiveness and side effects is vital for improving vaccine uptake. Public health systems globally experience a novel and unique challenge due to the variety of vaccines manufacturers and the high levels of public awareness about those manufacturers and their marketing strategies. This unprecedented situation is predicted to create what we can refer to as "vaccine selectivity, " increasing the pressure on our weakened health systems and economies and increasing vaccine hesitancy levels. Independent (non-sponsored) studies with rigorous methods can perfectly lead the pharmacovigilance efforts of COVID-19 vaccines globally. Given their independent nature and transparent design, these studies can play a key role in suppressing vaccine hesitancy levels by enhancing public confidence in vaccines. Design This project comprises two phases; a) a cross-sectional survey for the short-term side effects of COVID-19 vaccines; b) a prospective cohort study for the long-term safety of COVID-19 vaccines. Phase A: A validated self-administered questionnaire will be developed and delivered online to the target population groups (HCW, OA & ST). The questionnaire will be inquiring about the short-term side effects that emerged within 30 days following the vaccine shot (either the first or the second dose). The side effects will be classified as local or systemic, and their onset, duration, and intensity will be self-assessed and self-reported by the respondents. This phase is proposed to take place until December 31st, 2021. Phase B: A validated self-administered questionnaire will be developed and delivered online to the volunteers who participated in Phase A and expressed their interest to report their long-term side effects. In this phase, the vaccine effectiveness and side effects will be evaluated after booster doses. Phase B will take place for five consecutive years starting from 2022. conditions module condition list condition Adverse Reaction to Vaccine COVID19 Vaccine keyword list keyword COVID-19 Vaccines Safety Side Effects design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Prospective enrollment info enrollment count 30000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Pfizer-BioNTech COVID-19 Vaccine arm group description Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) arm group intervention list arm group intervention name Biological: BNT162b2 arm group label Moderna COVID-19 Vaccine arm group description Recently vaccinated individuals by Moderna COVID-19 Vaccine arm group intervention list arm group intervention name Biological: mRNA-1273 arm group label AstraZeneca-Oxford University COVID-19 Vaccine arm group description Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria) arm group intervention list arm group intervention name Biological: AZD1222 arm group label CoronaVac arm group description Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine) arm group intervention list arm group intervention name Biological: CoronaVac arm group label Sinopharm arm group description Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine) arm group intervention list arm group intervention name Biological: Sinopharm arm group label Sputnik V arm group description Recently vaccinated individuals by Sputnik V COVID-19 Vaccine arm group intervention list arm group intervention name Biological: Gam-COVID-Vac arm group label Janssen arm group description Recently vaccinated individuals by Janssen COVID-19 Vaccine arm group intervention list arm group intervention name Biological: JNJ-78436735 arm group label CureVac arm group description Recently vaccinated individuals by CureVac COVID-19 Vaccine arm group intervention list arm group intervention name Biological: CVnCoV arm group label Novavax arm group description Recently vaccinated individuals by Novavax COVID-19 Vaccine arm group intervention list arm group intervention name Biological: NVX-CoV2373 arm group label Covaxin arm group description Recently vaccinated individuals by Covaxin COVID-19 Vaccine arm group intervention list arm group intervention name Biological: BBV152 arm group label CanSino arm group description Recently vaccinated individuals by CanSino COVID-19 Vaccine intervention list intervention intervention type Biological intervention name BNT162b2 intervention description Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine) intervention arm group label list intervention arm group label Pfizer-BioNTech COVID-19 Vaccine intervention type Biological intervention name mRNA-1273 intervention description Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine) intervention arm group label list intervention arm group label Moderna COVID-19 Vaccine intervention type Biological intervention name AZD1222 intervention description Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine) intervention arm group label list intervention arm group label AstraZeneca-Oxford University COVID-19 Vaccine intervention type Biological intervention name CoronaVac intervention description Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine) intervention arm group label list intervention arm group label CoronaVac intervention type Biological intervention name Sinopharm intervention description Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine intervention arm group label list intervention arm group label Sinopharm intervention type Biological intervention name Gam-COVID-Vac intervention description Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V) intervention arm group label list intervention arm group label Sputnik V intervention type Biological intervention name JNJ-78436735 intervention description Receiving JNJ-78436735 (Janssen COVID-19 Vaccine) intervention arm group label list intervention arm group label Janssen intervention type Biological intervention name CVnCoV intervention description Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine) intervention arm group label list intervention arm group label CureVac intervention type Biological intervention name NVX-CoV2373 intervention description Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine) intervention arm group label list intervention arm group label Novavax intervention type Biological intervention name BBV152 intervention description Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine) intervention arm group label list intervention arm group label Covaxin outcomes module primary outcome list primary outcome primary outcome measure Local Side Effects primary outcome description Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness) primary outcome time frame 0-30 days after the COVID-19 vaccine shot primary outcome measure Systemic Side Effects primary outcome description Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc) primary outcome time frame 0-30 days after the COVID-19 vaccine shot secondary outcome list secondary outcome secondary outcome measure Unrecognized Side Effects secondary outcome description Dichotomous outcome for the emergence of oral and dermatologic side effects (e.g. oral paresthesia, oral ulcers, dysgeusia, skin rash, acne, urticaria, etc) secondary outcome time frame 0-30 days after the COVID-19 vaccine shot eligibility module eligibility criteria Inclusion Criteria: HCW, OA and ST who received COVID-19 vaccine. Participating subjects should be at least 18-year-old and able to give their informed consent independently. Exclusion Criteria: Non HCW, OA and ST who received the COVID-19. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population In Phase A, a pragmatic approach will track each target group according to the governmental plan; in most countries, it went from HCW to OA to ST. The sample of Phase B will be pre-identified based on the outcome of Phase A. If ≥ 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest to join Phase B, no additional recruitment will be required. If < 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest in Phase B, additional recruitment will be carried out targeting healthcare workers who will receive booster doses. In case of the emergence of special side effects after booster doses, additional recruitment of healthcare workers will be required. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Miloslav Klugar, PhD central contact role Contact central contact phone +420549495676 central contact e mail klugar@med.muni.cz central contact name Abanoub Riad, DDS central contact role Contact central contact phone +420549496572 central contact e mail abanoub.riad@med.muni.cz location list location location facility American College of Physicians location status Not yet recruiting location city Philadelphia location state Pennsylvania location zip 19106 location country United States location contact list location contact location contact name Amir Qassem, MD, PhD location contact role Contact location contact e mail aqaseem@acponline.org location facility McMaster University location status Not yet recruiting location city Hamilton location state Ontario location country Canada location contact list location contact location contact name Holger Schünemann, MD, PhD location contact role Contact location contact e mail schuneh@mcmaster.ca location facility University of Split location status Not yet recruiting location city Split location country Croatia location contact list location contact location contact name Tina Poklepović Peričić, DDS, PhD location contact role Contact location contact e mail tinapoklepovic@gmail.com location contact name Marija Franka Žuljević, MD location contact role Contact location contact e mail marija.franka@gmail.com location facility Masaryk University location status Recruiting location city Brno location country Czechia location contact list location contact location contact name Miloslav Klugar, PhD location contact role Contact location contact e mail klugar@med.muni.cz location contact name Abanoub Riad, DDS location contact role Contact location contact e mail abanoub.riad@med.muni.cz location facility University of Tartu location status Not yet recruiting location city Tartu location country Estonia location contact list location contact location contact name Mikk Jürisson, MD, PhD location contact role Contact location contact e mail mikk.jurisson@ut.ee location contact name Ruth Klada, MD, PhD location contact role Contact location contact e mail ruth.kalda@ut.ee location contact name Katrin Lang, MD, PhD location contact role Sub-Investigator location facility Jimma University location status Recruiting location city Jimma location country Ethiopia location contact list location contact location contact name Morankar Sudhakar, PhD location contact role Contact location contact e mail morankarsn@yahoo.com location contact name Elias Yesuf, MD, PhD location contact role Contact location contact e mail elias.yesuf@gmail.com location facility Justus-Liebig University Giessen location status Recruiting location city Giessen location country Germany location contact list location contact location contact name Sameh Attia, DDS location contact role Contact location contact e mail Sameh.Attia@dentist.med.uni-giessen.de location facility University of Ghana location status Not yet recruiting location city Accra location country Ghana location contact list location contact location contact name Anthony Danso-Appiah, PhD location contact role Contact location contact e mail adanso-appiah@ug.edu.gh location facility Sinaloa's Pediatric Hospital location status Not yet recruiting location city Culiacán location country Mexico location contact list location contact location contact name Giordano Pérez-Gaxiola, MD, MSc location contact role Contact location contact e mail giordano@cochrane.mx location facility Medical University of Silesia location status Recruiting location city Katowice location country Poland location contact list location contact location contact name Arkadiusz Dziedzic, DDS, PhD location contact role Contact location contact e mail adziedzic@sum.edu.pl location facility Nursing School of Coimbra location status Not yet recruiting location city Coimbra location country Portugal location contact list location contact location contact name João Apóstolo, PhD location contact role Contact location contact e mail apostolo@esenfc.pt location facility Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences location status Recruiting location city Irkutsk location zip 664033 location country Russian Federation location contact list location contact location contact name Konstantin Apartsin, MD, PhD location contact role Contact location contact e mail director@isc.irk.ru location facility University of Belgrade location status Recruiting location city Belgrade location zip 11221 location country Serbia location contact list location contact location contact name Ivana Tadić, PhD location contact role Contact location contact e mail ivana.tadic@pharmacy.bg.ac.rs location contact name Marina Odalović, PhD location contact role Contact location contact e mail marina.odalovic@pharmacy.bg.ac.rs location facility University of Ljubljana location status Not yet recruiting location city Ljubljana location country Slovenia location contact list location contact location contact name Janja Marc, PharmD location contact role Contact location contact e mail janja.marc@ffa.uni-lj.si references module reference list reference reference p m i d 33916020 reference type background reference citation Riad A, Pokorná A, Attia S, Klugarová J, Koščík M, Klugar M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. J Clin Med. 2021 Apr 1;10(7). pii: 1428. doi: 10.3390/jcm10071428. reference p m i d 34360156 reference type derived reference citation Riad A, Schunemann H, Attia S, Pericic TP, Zuljevic MF, Jurisson M, Kalda R, Lang K, Morankar S, Yesuf EA, Mekhemar M, Danso-Appiah A, Sofi-Mahmudi A, Perez-Gaxiola G, Dziedzic A, Apostolo J, Cardoso D, Marc J, Moreno-Casbas M, Wiysonge CS, Qaseem A, Gryschek A, Tadic I, Hussain S, Khan MA, Klugarova J, Pokorna A, Koscik M, Klugar M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects. Int J Environ Res Public Health. 2021 Jul 25;18(15):7859. doi: 10.3390/ijerph18157859. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 removed country list removed country Iran, Islamic Republic of Romania Spain condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834869
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full study rank 61245 study protocol section identification module n c t id NCT04838977 org study id info org study id HD096350 secondary id info list secondary id info secondary id R24HD096350 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R24HD096350 organization org full name University of Utah org class OTHER brief title Recovery After Stress Toolkit (RESET) Study official title Pediatric Injury: Modules to Manage Medical Stress acronym ReSeT status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 23, 2021 start date type Actual primary completion date struct primary completion date October 15, 2023 primary completion date type Anticipated completion date struct completion date April 15, 2024 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 24, 2022 last update post date struct last update post date March 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Utah lead sponsor class OTHER collaborator list collaborator collaborator name Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) collaborator class NIH oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care. detailed description As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS. conditions module condition list condition Post-Traumatic Stress Disorder in Children Post-Traumatic Stress Disorder in Adolescence design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Study comparing treatment to usual care. design primary purpose Treatment design masking info design masking Single design masking description Investigators will not be aware of study assignment. design who masked list design who masked Investigator enrollment info enrollment count 106 enrollment type Anticipated arms interventions module arm group list arm group arm group label RESET arm group type Experimental arm group description Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth. arm group intervention list arm group intervention name Behavioral: RESET arm group label Control arm group type No Intervention arm group description Children will receive usual post-trauma care. intervention list intervention intervention type Behavioral intervention name RESET intervention description Therapy intervention arm group label list intervention arm group label RESET outcomes module primary outcome list primary outcome primary outcome measure Child PTSD Symptom Scale (CPSS) primary outcome description 17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80. primary outcome time frame 12 weeks poat-randomization secondary outcome list secondary outcome secondary outcome measure Screen for Anxiety Related Emotional Disorders (SCARED) secondary outcome description 41-item survey with three point Likert scale responses (not sure, somewhat true, very true) that asks about common difficulties for children with anxiety. Higher scores indicate worse outcomes. The range are: Anxiety is 0-18; Panic Disorder 0-26; Separation Anxiety Disorder 0 - 16; Social Anxiety Disorder 0 to 8., secondary outcome time frame 12 weeks post-randomization secondary outcome measure Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms secondary outcome description PROMIS pediatric item bank : 8 questions with a 5-point Likert response from Never to Almost Always. Higher scores means more depressive symptoms. T-score with mean = 50; Standard Deviation (SD)=10. secondary outcome time frame 12-weeks post-randomization secondary outcome measure Pediatric Quality of Life Inventory (PedsQL) secondary outcome description 15 question scale based on physical, emotional, social and school functioning answered on a 5-point Likert scale (never to almost always). Score is 0 - 100 with higher scores indicating better HRQoL. Parent proxy scale. secondary outcome time frame 12-weeks other outcome list other outcome other outcome measure Connor David Resilience Scale other outcome description 10-item scale with LIkert response from 0 - not true to 4=true nearly all of the time. Range is 0 to 40 with higher scores indicating more resilience (better). other outcome time frame 12-weeks other outcome measure PROMIS Pediatric Anger other outcome description 5 question PROMIS measure answered with a 5-point Likert scale. A higher score indicates more anger (worse). T-score with mean = 50; SD = 10. other outcome time frame 12-weeks post-randomization other outcome measure PROMIS Pediatric Psychological Stress Experience other outcome description 8-question PROMIS measure answered with a 5-point Likert scale. A higher score is more stress (worse). T-score with mean 50; SD 10. other outcome time frame 12-weeks post-randomization other outcome measure PROMIS Pediatric Physical Stress Experience other outcome description 8-question PROMIS measure answered on a 5-point Likert scale. A higher score is more physical stress (worse). T-score with mean 50; SD 10. other outcome time frame 12-weeks other outcome measure PROMIS Pediatric Anxiety other outcome description 8-question PROMIS measure answered on a 5-point LIkert scale. A higher score is more anxiety (worse). T-score with mean 50; SD 10. other outcome time frame 12-weeks other outcome measure PROMIS Pediatric Global Health other outcome description Seven questions about global health with 5-point Likert response from excellent to poor. A higher score is more poor health (worse). T-score with mean 50; SD 10. other outcome time frame 12-weeks eligibility module eligibility criteria Inclusion Criteria: 8 years to 17 years at enrollment Treated for an injury in the ED or hospitalized Abbreviated Injury Scale (AIS) score 2 or greater Parent and child English speaking Broad band internet availability at home Residing with parent or legal guardian Exclusion Criteria: Moderate or severe traumatic brain injury (GCS less than 13) Diagnosed with moderate or severe intellectual disability Pre-existing psychiatric disorder that required hospitalization Abuse or interpersonal injury as mechanism of injury Currently receiving psychotherapy Hospitalized for injury over 30 ays Death of a family member or friend at time of injury healthy volunteers No gender All minimum age 8 Years maximum age 17 Years std age list std age Child contacts locations module central contact list central contact central contact name Heather T Keenan, MDCM central contact role Contact central contact phone 801.587.7611 central contact e mail heather.keenan@hsc.utah.edu overall official list overall official overall official name Heather T Keenan, MDCM overall official affiliation University of Utah overall official role Principal Investigator location list location location facility Cincinnati CHildren's Hospital location status Recruiting location city Cincinnati location state Ohio location zip 45056 location country United States location contact list location contact location contact name Shari Wade, PHD location contact role Contact location contact e mail shari.wade@cchmc.org location facility University of Texas Health Sciences Center location status Recruiting location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Linda Ewing-Cobbs, PHD location contact role Contact location contact phone 713-500-3878 location contact e mail Linda.Ewing-Cobbs@uth.tmc.edu location facility University of Utah location status Recruiting location city Salt Lake City location state Utah location zip 84101 location country United States location contact list location contact location contact name Heather T Keenan, MDCM location contact role Contact location contact phone 801-587-7611 location contact e mail heather.keenan@hsc.utah.edu i p d sharing statement module i p d sharing Yes i p d sharing description Individual de-identified participant data underlying the trial will be made available 3 years after the last enrolled subject has completed all procedures to investigators who provide a methodologically sound proposal. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) i p d sharing time frame 36 months after last subject has completed all procedures. Data will be available for 36 months. i p d sharing access criteria Investigators who provide a methodologically sound proposal derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004194 condition mesh term Disease condition mesh id D000040921 condition mesh term Stress Disorders, Traumatic condition mesh id D000013313 condition mesh term Stress Disorders, Post-Traumatic condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000068099 condition ancestor term Trauma and Stressor Related Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M15255 condition browse leaf name Stress Disorders, Post-Traumatic condition browse leaf as found Post Traumatic Stress Disorder condition browse leaf relevance high condition browse leaf id M24069 condition browse leaf name Stress Disorders, Traumatic condition browse leaf as found Traumatic Stress Disorder condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M222 condition browse leaf name Trauma and Stressor Related Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries
NCT04838977
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full study rank 61201 study protocol section identification module n c t id NCT04839549 org study id info org study id The ROSE Study organization org full name Eye Associates of Central Texas org class OTHER brief title Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea official title Randomized, Open Label, Prospective Study on the Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea (ROSE Study) status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 2021 start date type Anticipated primary completion date struct primary completion date April 2022 primary completion date type Anticipated completion date struct completion date July 2022 completion date type Anticipated study first submit date October 19, 2020 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Lena Dixit, MD responsible party investigator title Principal Investigator responsible party investigator affiliation Eye Associates of Central Texas lead sponsor lead sponsor name Eye Associates of Central Texas lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to a standard steroid drop regimen in the contralateral eye for the treatment of ocular rosacea. detailed description Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye receives Dextenza (Group A) intracanalicular insert and the contralateral eye receives topical fluorometholone 0.1% BID (Group B) for 2 weeks then once daily for 2 weeks for the treatment of ocular rosacea. All patients will be placed on oral doxycycline 100mg BID for one month and tapered to a maintenance dose of 100mg once daily for the remainder of the study. Patient evaluations will be performed at Screening/Baseline, Insertion Day, Month 1 and Month 2. conditions module condition list condition Ocular Rosacea design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 50 enrollment type Anticipated arms interventions module arm group list arm group arm group label Dextenza (Intracanalicular ) 0.4mg arm group type Experimental arm group description Dextenza for the treatment of Ocular Rosacea arm group intervention list arm group intervention name Drug: Dextenza 0.4Mg Ophthalmic Insert arm group label Fluoromethalone .01% arm group type Active Comparator arm group description Fluoromethalone .1% BID for 2 weeks then once daily for 2 weeks for the treatment of Ocular Rosacea arm group intervention list arm group intervention name Drug: Fluoromethalone .01% intervention list intervention intervention type Drug intervention name Dextenza 0.4Mg Ophthalmic Insert intervention description Dextenza 0.4Mg Ophthalmic Insert intervention arm group label list intervention arm group label Dextenza (Intracanalicular ) 0.4mg intervention type Drug intervention name Fluoromethalone .01% intervention description Fluoromethalone .01% intervention arm group label list intervention arm group label Fluoromethalone .01% outcomes module primary outcome list primary outcome primary outcome measure Change in OSDI primary outcome description As measured by OSDI questionnaire primary outcome time frame Accessed at all time points (Day -30 - day -1, week 4, week 8) primary outcome measure Patient preference in treatment therapy primary outcome description As measured by Adapted COMTOL questionnaire primary outcome time frame Accessed at Week 4 secondary outcome list secondary outcome secondary outcome measure Change in tear breakup time secondary outcome description As measured by Fluoroscein (Bioglo strip moistened with saline) placed in the inferior fornix of each eye. A cobalt blue light beam will be used to count the number of seconds between the last blink and the appearance of a dry spot or break in tear film. secondary outcome time frame Accessed at all time points (Day -30 - day -1, week 4, week 8) secondary outcome measure Change in Expression of Gland Scale secondary outcome description As measured by digitally compressing the lower and upper lids and quantified on a 4-point scale: (0- all five glands, 1 - three to four glands, 2 - one to two glands, 3 - zero glands). The values will be averaged for each eye. secondary outcome time frame Accessed at all time points (Day -30 - day -1, week 4, week 8) secondary outcome measure Change in corneal staining secondary outcome description As measured by the NEI/Industry Grading system secondary outcome time frame Accessed at all time points (Day -30 - day -1, week 4, week 8) eligibility module eligibility criteria Inclusion Criteria: Be at least 18 years of age, any gender or race Provide written informed consent Sign the HIPAA form Attend all study visits Take all study medications as directed Be willing to avoid all disallowed medications Be willing to avoid all contact lens wear between Dextenza insertion (Visit 2) and Post-op 1 month visit (Visit 3) Have a best-corrected visual acuity (BCVA) or greater than or equal to 50 ETDRS letters (20/100 Snellen equivalent) or better in each eye at the screening visit. For women of childbearing age (menarche to less than 12 months of menopause who have not undergone surgical sterilization), be willing to have a urine pregnancy test and agree to use a medically acceptable form of birth control throughout the study duration. Have a documented diagnosis of Ocular Rosacea and exhibit typical signs or symptoms associated with the diagnosis (irritation, burning, foreign body sensation, redness, itching, inflammation, dry eye, discharge) Exclusion Criteria: Have any allergy or other historical contraindication to the medications in the protocol Is unable to use the study medications regularly as directed Have any other ocular disease that could affect the subject's ability to participate in the study safely (narrow angle glaucoma, iritis, current infection, elevated intraocular pressure, history of significant steroid response with and IOP >22mmHg, punctal size less than 0.4mm or lid malformation that would preclude insertion of the Dextenza insert) Have known history of herpetic eye disease (either active or historical) Have a history of refractive surgery within the past 2 years Have a history of retinal detachment, diabetic retinopathy, or active retinal disease Is currently (within the past 7 days) using an ophthalmic steroid preparation (drop, ointment or insert form) Is currently using ocular, topical, or systemic non-steroidal anti-inflammatory drugs (NSAIDs) - Baby aspirin (81mg) is allowed as long as a stable dose has been maintained for at least 30 days prior to Dextenza insertion and will continue to be maintained for the duration of the study Have an active infectious disease or is currently taking (or has taken within 7 days of initiation into the study) oral antibiotics Is actively being treated with local or systemic immunosuppression, including systemic steroids Have a planned ocular or systemic surgery within 30 days of the placement of the Dextenza insert. Have used a study drug or participated in a clinical study within 30 days of the beginning of this study Is currently pregnant, planning to become pregnant, or breastfeeding Is an employee or direct family member of an employee at the clinic site Have a diagnosis of any significant uncontrolled illness Have a history of alcohol or drug abuse in the past year Is a current smoker Have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial Have an intraocular pressure that is less than 5mmHg or greater than 22mmHg or any type of glaucoma Is deemed unsafe for the study by the investigator healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jamie Johnson central contact role Contact central contact phone 512-244-1991 central contact e mail jjohnson@eyeassociatestexas.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012393 condition mesh term Rosacea condition ancestor list condition ancestor condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M14366 condition browse leaf name Rosacea condition browse leaf as found Ocular Rosacea condition browse leaf relevance high condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000005469 intervention mesh term Fluorometholone intervention ancestor list intervention ancestor intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000005938 intervention ancestor term Glucocorticoids intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000018926 intervention ancestor term Anti-Allergic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M6254 intervention browse leaf name Dexamethasone intervention browse leaf relevance low intervention browse leaf id M235540 intervention browse leaf name Dexamethasone acetate intervention browse leaf relevance low intervention browse leaf id M199079 intervention browse leaf name BB 1101 intervention browse leaf relevance low intervention browse leaf id M7749 intervention browse leaf name Fluorometholone intervention browse leaf as found Sinus infection intervention browse leaf relevance high intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id M20115 intervention browse leaf name Anti-Allergic Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev AnEm intervention browse branch name Antiemetics intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AAll intervention browse branch name Anti-Allergic Agents
NCT04839549
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full study rank 61712 study protocol section identification module n c t id NCT04832906 org study id info org study id FMASU M D 71/2019 organization org full name Ain Shams Maternity Hospital org class OTHER brief title UA Versus UAE in Treatment of Fibroids official title Ulipristal Acetate Therapy Versus Uterine Artery Embolization in Management of Uterine Fibroids status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 13, 2019 start date type Actual primary completion date struct primary completion date March 13, 2021 primary completion date type Actual completion date struct completion date March 13, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Paula Naseef responsible party investigator title Principal Investigator responsible party investigator affiliation Ain Shams Maternity Hospital lead sponsor lead sponsor name Ain Shams Maternity Hospital lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibroid-related symptoms, and to compare its results with those of uterine artery embolization. Design: A randomized control trial. Setting: Maternity Hospital, Ain Shams University. Patients: Women with symptomatic uterine fibroids. Interventions: 70 women were randomly assigned to either Ulipristal Acetate (UA) group or uterine artery embolization (UAE) group (35 in each group). Both groups were followed up to detect the decline in fibroid size as well as the improvement of symptoms. detailed description Inclusion Criteria: Women with symptomatic uterine fibroids were recruited into the study after fulfilling the following criteria: Their age should range from 35 to 50 years. Their body mass index (BMI) should range from 18 to 35 Kg/m2. The presence of multiple symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification. The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound. They should not be seeking future fertility. They should be refusing any surgical intervention whether myomectomy or hysterectomy. Exclusion Criteria: Post-menopausal status or premature ovarian failure. Type 0, 1 and 7 uterine fibroids according to FIGO classification. Previous myomectomy or any uterine surgery. Previous or ongoing hormonal treatment. Sampling Method: The study sample will be a "convenient sample" where women fulfilling the inclusion criteria and consenting to participate in the study will be recruited. Sample Size justification: The study will include 70 women with symptomatic uterine fibroids who will be randomized into two groups with 35 women in each group. The required sample size has been calculated using the PASS 15 Power Anal-ysis and Sample Size Software (PASS©) version 15 (2017); NCSS, LLC. Kaysville, Utah, USA. The main outcome measure is the reduction in fibroid volume. The secondary outcome measures are symptoms relief and improvement in quality of life. A previous study reported that Ulipristal Acetate (UA) was comparable to uterine artery embolization (UAE) as regards the percentage of reduction in fibroid volume with median (interquartile range) percentage reduction of 48.1 (24.8 - 66) % versus 47.3 (29.5 - 69.5) % for UPA and UAE respectively (Czuczwar et al., 2015). Using the methods described by Wan et al (2014) and Luo et al (2018), we calculated that the mean ± SD percentage of reduction in fibroid volume was 44.0 ± 28.5 % versus 48.9 ±32.3 % for UPA and UAE respectively, with mean difference of 4.9 % and common within group SD of 30.5%. Taking into consideration a "drop-out rate" of about 10%, due to loss of follow up or withdrawal from the study, it is estimated that a sample size of 35 patients per group achieves 80% power using a one-sided equivalence test with a significance level of 5% (alpha-error = 0.05), when the difference between the two means is 4.9 %, common within group SD is 30.5 %, and equivalence limits are -25% and 25%. On the other hand, this sample size achieves a power of 82% to detect a statistically significant difference between the two groups as regards the symptoms scores and measures of ovarian reserve (AFC and AMH) for an effect size equivalent to a Cohen's d of 0.75 (i.e., 0.75 common SD) using a two-sided unpaired t-test with the same significance level of alpha = 0.05. These equivalence limits and effect size have been targeted, as they may be considered clinically important. Informed consent: The nature and scope of the clinical study will be explained in an understand-able way to the patients and an informed consent form, in Arabic language, including all the study procedures, advantages and possible risks and specifying who informed the patient, will be provided and the patient must sign on it before participation. The study protocol and patient informed consent will be reviewed and approved by the Ethics Committee of the Obstetrics and Gynecology Department, Ain Shams University. Funding: This study will be funded by the researcher himself and Ain Shams University Randomization and Allocation concealment: The participants will be randomly assigned into one of the two study groups using a computer random sequence generator. The randomization will be made using sequentially numbered, opaque sealed envelopes; each envelope contains the method of intervention according to the random sequence and will be opened just before the intervention. Study Procedures: All participants will undergo full assessment before starting either treatment options. This assessment will include: Detailed History: Personal history: including patient's full name, age, marital status, parity, occupation and residence will be recorded. Menstrual history: including age of menarche, D/C, amount of menstrual flow and associated dysmenorrhea. Contraceptive history: to exclude other causes for uterine bleeding. Past medical history of Diabetes Mellitus, hypertension, bronchial asthma, cardiac diseases, anemia, etc. Past surgical history of uterine surgeries. History of present illness with detailed analysis of each patient's complaint whether abnormal uterine bleeding, dysmenorrhea and pelvic pressure symptoms such as urinary urgency or constipation. Physical Examination: General examination including: Pulse, blood pressure, temperature, body mass index (BMI), auscultation of lungs and heart, and complex-ion as pallor due to anemia caused by heavy bleeding. Abdominal examination: inspection for any scar, palpation of the abdomen for any tenderness and for pelviabdominal masses. Pelvic examination: complete bimanual examination for uterine size, mobility and palpable uterine fibroids. Investigations: Baseline hemoglobin, hematocrit, and blood grouping. Blood chemistry: AST, ALT, serum creatinine and RBS. Trans-vaginal ultrasound for uterine volume and fibroid location, volume and maximum diameter. Uterine volume (expressed in cubic centimeters) will be calculated by measuring the maximum length, antero-posterior and transverse diameters of the uterine corpus, using the US device software formula for calculation of the uterine volume. Myoma volumes will be measured by using the existing 2-dimensional US methods. The FIGO classification system (figure 1) will be used for defining the myoma location. Study groups: Patients recruited in this study will be randomized into one of the following study groups: Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35): Patients within this group will receive oral Ulipristal Acetate (Fibristal ©) 5 mg / day starting from the first day of menstrual bleeding, and for 3 months (period of the study). Group B "Uterine artery embolization (UAE) group" (n=35): Patients within this group will undergo bilateral selective uterine artery embolization, during which polyvinyl alcohol (PVA) particles will be administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected. The gelatin sponge cap was thought to both complete the occlusion of the uterine artery and to prevent PVA particles from being drawn out of the uterine artery by the Venturi effect, which would result in non-target embolization. Follow up: Each patient within both groups will be subjected to follow-up trans-vaginal ultrasound (US) 3 months after Ulipristal acetate (UA) therapy or after uterine artery embolization (UAE) session to detect the decline in uterine fibroid volumes in comparison to their baseline. To reduce inter-observer variability associated with ultrasound imaging, measurements will be always taken by the same sonographer. Each patient within both groups will be evaluated clinically for the symptoms reported at least 1 month before starting the treatment (baseline) and 3 months after Ulipristal acetate (UA) therapy or after uterine artery embolization (UAE) session. Durability of the used treatment line will be tested by follow up after one year from initiating therapy. Fibroid-related heavy menstrual bleeding (HMB) will be evaluated by the pictorial blood assessment chart score (figure 2). This instrument is a self-administered pictorial chart that takes account of the number of sanitary pads and tampons used, presence of blood clots, and episodes of bleeding. The 1-month pictorial blood assessment chart score was calculated from the addition of daily scores for 28 days. A score of higher than 100 during the first 8 days of menstruation will be defined as heavy menstrual bleeding (HMB). Subjective feelings of pelvic pressure, urinary urgency, and constipation will be recorded on a simplified questionnaire containing 2 categories defined as "absent "and "present." The visual analog scale (VAS) pain score (figure 3) will be used to determine the presence or absence of pelvic pain. Statistical Methods: Data will be analyzed using Intention to treat (ITT) analysis. According to Fisher et al (1990), the ITT analysis includes all randomized patients in the groups to which they were randomly assigned, regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol. In other words, ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores non-compliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis is usually described as "once randomized, always analyzed". ITT analysis avoids overoptimistic estimates of the efficacy of one of the two interventions resulting from the removal of non-compliers by accepting that noncompliance and protocol deviations are likely to occur in actual clinical practice. Efficacy of the two study interventions will be compared using Odds ratio (OR), Relative risk (RR), Number needed to treat (NNT) and Number needed to harm (NNH). Data will be analyzed using IBM© SPSS© Statistics version 23 (IBM© Corp., Armonk, NY). Normally distributed numerical data will be presented as mean and SD, and skewed data as median and interquartile range. Qualitative data will be presented as number and percentage. Normally distributed numerical data will be compared using the unpaired t test and skewed data using the Mann-Whitney test. Categorical data will be compared using the Pearson chi-squared test or Fisher's exact test, if appropriate. A two-sided p-value <0.05 will be considered statistically significant. conditions module condition list condition Uterine Fibroid keyword list keyword Abnormal uterine bleeding (AUB) Benign gynecologic conditions Ulipristal acetate Uterine artery embolization design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 70 enrollment type Actual arms interventions module arm group list arm group arm group label Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35) arm group type Active Comparator arm group description Patients within this group received oral Ulipristal Acetate (Fibristal ©) 5 mg / day starting from the first day of menstrual bleeding, and for 3 months (period of the study). arm group intervention list arm group intervention name Drug: Ulipristal Oral Tablet arm group label Group B "Uterine artery embolization (UAE) group" (n=35) arm group type Active Comparator arm group description Patients within this group underwent bilateral selective uterine artery embolization, during which polyvinyl alcohol (PVA) particles was administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected. The gelatin sponge cap was thought to both complete the occlusion of the uterine artery and to prevent PVA particles from being drawn out of the uterine artery by the Venturi effect, which would result in non-target embolization. arm group intervention list arm group intervention name Procedure: Uterine artery embolization intervention list intervention intervention type Drug intervention name Ulipristal Oral Tablet intervention description A selective progesterone receptor modulator (SPRM), as a medical line of treatment for uterine fibroids. Due to its selective anti-proliferative and pro-apoptotic action, Ulipristal Acetate (UA) is assumed to be effective in reducing abnormal uterine bleeding (AUB) and fibroid size. intervention arm group label list intervention arm group label Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35) intervention type Procedure intervention name Uterine artery embolization intervention description Selective embolization of uterine arteries bilaterally, using polyvinyl alcohol (PVA) particles administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected. intervention arm group label list intervention arm group label Group B "Uterine artery embolization (UAE) group" (n=35) outcomes module primary outcome list primary outcome primary outcome measure Decline in dominant fibroid volume (in cubic centimeters). primary outcome description measured by transvaginal ultrasound. primary outcome time frame 3 months secondary outcome list secondary outcome secondary outcome measure Relief of abnormal uterine bleeding. secondary outcome description measured by reduction in Pictorial Blood Loss Assessment Chart Score. secondary outcome time frame 3 months secondary outcome measure Relief of pelvic pain. secondary outcome description measured by reduction in Visual Analogue Scale Score. secondary outcome time frame 3 months secondary outcome measure Relief of pelvic pressure symptoms. secondary outcome description Subjective feelings of pelvic pressure symptoms including urinary urgency, and constipation was recorded using a simplified questionnaire containing 2 categories defined as "absent "and "present." secondary outcome time frame 3 months secondary outcome measure Adverse effects. secondary outcome description resulting from either treatment options within the 2 arms of the study. secondary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Their age should range from 35 to 50 years. Their body mass index (BMI) should range from 18 to 35 Kg/m2. The presence of one or more symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification. The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound. They should not be seeking future fertility. They should be refusing any surgical intervention whether myomectomy or hysterectomy. Exclusion Criteria: Post-menopausal status or premature ovarian failure. Type 0, 1 and 7 uterine fibroids according to FIGO classification. Previous myomectomy or any uterine surgery. Previous or ongoing hormonal treatment. healthy volunteers No gender All minimum age 35 Years maximum age 50 Years std age list std age Adult contacts locations module location list location location facility Ain Shams Maternity Hospital location city Cairo location state Abbassia location zip 11517 location country Egypt i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007889 condition mesh term Leiomyoma condition mesh id D000047708 condition mesh term Myofibroma condition ancestor list condition ancestor condition ancestor id D000009379 condition ancestor term Neoplasms, Muscle Tissue condition ancestor id D000018204 condition ancestor term Neoplasms, Connective and Soft Tissue condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000009372 condition ancestor term Neoplasms, Connective Tissue condition ancestor id D000003240 condition ancestor term Connective Tissue Diseases condition browse leaf list condition browse leaf condition browse leaf id M8708 condition browse leaf name Hemorrhage condition browse leaf relevance low condition browse leaf id M10053 condition browse leaf name Leiomyoma condition browse leaf as found Uterine Fibroids condition browse leaf relevance high condition browse leaf id M24999 condition browse leaf name Myofibroma condition browse leaf as found Uterine Fibroids condition browse leaf relevance high condition browse leaf id M16492 condition browse leaf name Uterine Hemorrhage condition browse leaf relevance low condition browse leaf id M19502 condition browse leaf name Neoplasms, Connective and Soft Tissue condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M11469 condition browse leaf name Neoplasms, Connective Tissue condition browse leaf relevance low condition browse leaf id M5616 condition browse leaf name Connective Tissue Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id C000555622 intervention mesh term Ulipristal acetate intervention ancestor list intervention ancestor intervention ancestor id D000080066 intervention ancestor term Contraceptive Agents, Hormonal intervention ancestor id D000003270 intervention ancestor term Contraceptive Agents intervention ancestor id D000012102 intervention ancestor term Reproductive Control Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000003271 intervention ancestor term Contraceptive Agents, Female intervention browse leaf list intervention browse leaf intervention browse leaf id M2929 intervention browse leaf name Ethanol intervention browse leaf relevance low intervention browse leaf id M13397 intervention browse leaf name Progesterone intervention browse leaf relevance low intervention browse leaf id M266225 intervention browse leaf name Ulipristal acetate intervention browse leaf as found Immersion intervention browse leaf relevance high intervention browse leaf id M5646 intervention browse leaf name Contraceptive Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Repr intervention browse branch name Reproductive Control Agents
NCT04832906
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full study rank 61808 study protocol section identification module n c t id NCT04831658 org study id info org study id hnslblzlzx20210303 organization org full name Zhengzhou University org class OTHER brief title A Prospective Clinical Study of BTK Inhibitor, PD-1 and Formustine in the First-line Treatment of Primary Central Nervous System Lymphoma official title A Prospective Clinical Study of a New Generation of BTK Inhibitors Combined With PD-1 and Formustine in the First-line Treatment of Primary Central Nervous System Lymphoma status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date September 15, 2023 primary completion date type Anticipated completion date struct completion date September 15, 2024 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 30, 2022 last update post date struct last update post date June 2, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Mingzhi Zhang responsible party investigator title the director of oncology department of the first affiliated hospital responsible party investigator affiliation Zhengzhou University lead sponsor lead sponsor name Mingzhi Zhang lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary To observe the efficacy and safety of a new generation of BTK inhibitor Orelabrutinib combined with PD-1 and fotemustine in the treatment of patients with primary central nervous system lymphoma (PCNSL). detailed description This study includes a dose escalation phase and an extended treatment phase . The dose-escalation phase： Primary study endpoint: Safety endpoint: including dose-limiting toxicity (DLT), adverse events, ECOG performance score, laboratory tests, vital signs, physical examination . Secondary research endpoints: effectiveness endpoints: including complete response rate (CRR), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). The study adopts the "3+3" design, that is, 3-6 subjects in each group complete the administration, and the dose group determined as the maximum tolerated dose (MTD) is included in the group of 6 subjects, totaling 9-18 example. The dose planned to be explored is the daily oral dose of the BTK inhibitor abutinib, which is 100 mg, 150 mg and 200 mg, respectively. The doses of other drugs in the plan will not be escalated. After the last subject in each dose group completes the 28-day restricted toxicity (DLT) assessment window after the administration, the investigator can start the entry into the next dose group after evaluating and agreeing to enter the next dose group based on clinical safety data.DLT was defined as any grade 3 or higher nonhematologic toxicity, any grade 4 hematologic toxicity, grade 3 febrile neutropenia, and grade 3 thrombocytopenia with significant bleeding. When 1 case of DLT occurs among 3 subjects in a certain dose group, 3 subjects need to be added to the same dose group (6 subjects in this dose group complete the DLT assessment): If the additional 3 subjects are tested If there is no DLT, continue the dose escalation; if 1 of the 3 increased subjects has DLT, stop the dose escalation; if the increased 3 subjects have >1 of the subjects DLT, the dose escalation is stopped, and the dose needs to be lowered to continue to enroll 3 subjects for DLT evaluation. If DLT occurs in 2 of the 3 or 6 subjects in the dose group, then the previous low dose is defined as the maximum tolerated dose (MTD). The extended treatment phase : Primary study endpoints: objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) . Secondary endpoints: time to disease progression (TTP), median survival (MST), adverse reactions (ADR), quality of life (QOL) . The study adopts an open, one-arm, prospective clinical collaborative study . The initial treatment is BTK inhibitor (Obutinib), PD-1 monoclonal antibody combined with formustine ：Orelabrutinib continues to be taken orally until the tumor is relieved for 3 months; PD-1 monoclonal antibody is used by intravenous drip, 21 days as a treatment cycle, and a total of 1 year of observation; formustine is used by intravenous drip for 21 days It is a treatment cycle, a total of 6 cycles of observation; after 2 cycles, the efficacy is evaluated, and adverse reactions are recorded. At the same time, MTX 12mg+Ara-C 50mg+Dex 5mg was injected into the CSF cytology-positive sheath, and intrathecal injection once per treatment cycle, a total of 6 times. Second stage treatment ：The efficacy was evaluated after 6 cycles of treatment in the initial stage. The CR patients continued to take orally abutinib (150mg, qd) for three months, and the PD-1 monoclonal antibody was used for maintenance treatment for up to 1 year; the PR patients received whole brain radiotherapy (WBRT), and at the same time Continue oral obritinib (150mg, qd) for three months and PD-1 monoclonal antibody maintenance treatment for up to one year; SD and PD patients choose methotrexate + pemetrexed combined chemotherapy for 4 cycles followed by whole brain radiotherapy (WBRT). WBRT: Regardless of age, supplementary WBRT 30-36Gy + partial reduction field irradiation up to 45Gy. conditions module condition list condition Primary Central Nervous System Lymphoma keyword list keyword BTK inhibitor PD-1 fotemustine CRR ORR DCR PFS OS ADR Adverse events ECOG score laboratory examination vital signs physical examination Time to disease progression (TTP) median survival (MST) quality of life (QOL) adverse reactions (ADR) design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Orelabrutinib combined with PD-1 and fotemustine arm group type Experimental arm group description To observe the efficacy and safety of a new generation of BTK inhibitor abutinib combined with PD-1 and formustine in the treatment of newly-treated patients with primary central nervous system lymphoma (PCNSL) arm group intervention list arm group intervention name Drug: the dose-escalation phase intervention list intervention intervention type Drug intervention name the dose-escalation phase intervention description The study adopts the "3+3" design,The dose planned to be explored is the daily oral dose of the BTK inhibitor abutinib, which is 100 mg, 150 mg and 200 mg, respectively.Orelabrutinib continues to be taken orally until the tumor is relieved for 3 months; PD-1 monoclonal antibody is used by intravenous drip, 21 days as a treatment cycle, and a total of 1 year of observation; formustine is used by intravenous drip for 21 days It is a treatment cycle, a total of 6 cycles of observation; after 2 cycles, the efficacy is evaluated, and adverse reactions are recorded. At the same time, MTX 12mg+Ara-C 50mg+Dex 5mg was injected into the CSF cytology-positive sheath, and intrathecal injection once per treatment cycle, a total of 6 times. intervention arm group label list intervention arm group label Orelabrutinib combined with PD-1 and fotemustine intervention other name list intervention other name The extended treatment phase outcomes module primary outcome list primary outcome primary outcome measure DLT primary outcome description Dose-limiting toxicity primary outcome time frame up to 24 months primary outcome measure AE primary outcome description adverse events primary outcome time frame up to 24 months primary outcome measure ECOG performance score primary outcome description ECOG performance score primary outcome time frame up to 24 months primary outcome measure laboratory tests primary outcome description laboratory tests primary outcome time frame up to 24 months primary outcome measure vital signs primary outcome description vital signs primary outcome time frame up to 24 months primary outcome measure physical examination primary outcome description physical examination primary outcome time frame up to 24 months primary outcome measure ORR primary outcome description Objective Responder Rate primary outcome time frame up to 24 months primary outcome measure DCR primary outcome description Disease Control Rate primary outcome time frame up to 24 months primary outcome measure PFS primary outcome description Progression Free Survival primary outcome time frame up to 24 months primary outcome measure OS primary outcome description Overall Survival primary outcome time frame up to 24 months secondary outcome list secondary outcome secondary outcome measure ORR secondary outcome description Objective Responder Rate secondary outcome time frame up to 24 months secondary outcome measure DCR secondary outcome description Disease Control Rate secondary outcome time frame up to 24 months secondary outcome measure PFS secondary outcome description Progression Free Survival secondary outcome time frame up to 24 months secondary outcome measure OS secondary outcome description Overall Survival secondary outcome time frame up to 24 months secondary outcome measure ADR secondary outcome description Adverse Reaction Rate secondary outcome time frame up to 24 months secondary outcome measure CRR secondary outcome description complete response rate secondary outcome time frame up to 24 months secondary outcome measure TTP secondary outcome description Time to disease progression secondary outcome time frame up to 24 months secondary outcome measure MST secondary outcome description median survival secondary outcome time frame up to 24 months secondary outcome measure ADR secondary outcome description adverse reactions secondary outcome time frame up to 24 months secondary outcome measure QOL secondary outcome description quality of life secondary outcome time frame up to 24 months eligibility module eligibility criteria Inclusion Criteria: Age 18-69 years; KPS score ≥ 60 points or ECOG score ≤ 2 points; expected survival time of more than 3 months; PCNSL confirmed pathologically by tissue biopsy (limited to the brain, not accompanied by lymphoma in other parts of the body) , And histopathological type is diffuse large B-cell lymphoma; no chemotherapy contraindications (blood picture and physiological examination result time <7 days); at least one measurable lesion according to RECIST standards; no other serious diseases that conflict with this plan ; Follow-up is possible; other anti-tumor drugs are not used during this treatment period, and bisphosphonate anti-bone metastasis therapy and other symptomatic treatments can be applied; understand the situation of this study and sign the informed consent. Exclusion Criteria: Those who are currently receiving other chemical, radiotherapy and targeted therapies (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or have not recovered from the acute toxicity of any previous treatment); pregnant or lactating women; yes Any uncontrollable medical disease (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction, and interstitial pneumonia, etc.); those who are contraindicated with chemotherapy such as cachexia; have had other malignant tumors in the past Those who have uncontrolled infections; those who have a history of uncontrollable mental illness; those who are considered unsuitable to participate in this trial by the investigator. healthy volunteers No gender All minimum age 18 Years maximum age 69 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Mingzhi zhang, Pro.Dr. central contact role Contact central contact phone 13838565629 central contact e mail Mingzhi_zhang@126.com overall official list overall official overall official name Mingzhi zhang overall official affiliation The First Affiliated Hospital of Zhengzhou University overall official role Principal Investigator location list location location facility Oncology Department of The First Affiliated Hospital of Zhengzhou University location status Recruiting location city Zhengzhou location state Henan location zip 450052 location country China location contact list location contact location contact name Mingzhi Zhang, Doctor location contact role Contact location contact phone 13838565629 location contact e mail mingzhi_zhang@126.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008223 condition mesh term Lymphoma condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id M19712 condition browse leaf name Disease Progression condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id T4686 condition browse leaf name Primary Central Nervous System Lymphoma condition browse leaf as found Primary Central Nervous System Lymphoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse leaf id M3382 intervention browse leaf name Antibodies, Monoclonal intervention browse leaf relevance low intervention browse leaf id M11134 intervention browse leaf name Morphine intervention browse leaf relevance low intervention browse leaf id M5918 intervention browse leaf name Cytarabine intervention browse leaf relevance low intervention browse leaf id M231513 intervention browse leaf name Fotemustine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents
NCT04831658
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full study rank 61874 study protocol section identification module n c t id NCT04830800 org study id info org study id COVIVAC-0102 organization org full name Institute of Vaccines and Medical Biologicals, Vietnam org class INDUSTRY brief title A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC official title A Phase 1/2 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults Aged 18-75 Years in Vietnam status module status verified date November 2022 overall status Completed expanded access info has expanded access No start date struct start date March 10, 2021 start date type Actual primary completion date struct primary completion date August 23, 2021 primary completion date type Actual completion date struct completion date March 11, 2022 completion date type Actual study first submit date March 12, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 9, 2022 last update post date struct last update post date November 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Institute of Vaccines and Medical Biologicals, Vietnam lead sponsor class INDUSTRY collaborator list collaborator collaborator name National Institute of Hygiene and Epidemiology, Vietnam collaborator class OTHER collaborator name Hanoi Medical University collaborator class OTHER collaborator name Center for Disease Control of Thai Binh Province collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts. Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years. In Part 2 of this combined Phase 1/2 study, 300 adults aged 18-75 years will be randomized (2:5:5) to placebo, or one of two selected formulations of COVIVAC being evaluated in Phase 1 detailed description This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts. Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years. An interim analysis of Phase 1 data conducted after the last subject last visit for V6 (D57) will serve as the basis for decisions about down selection and advancing to Part 2 of the study (Phase 2). Down selection and advancement to Part 2 (Phase 2) will be based on the following parameters: Post-dose 2 immunogenicity results at the aggregate treatment level o A threshold immune response at Visit 5 (D43) will be required: the observed seroresponse rate in a treatment group (defined as the percentage of subjects with at least a 4-fold rise from baseline in 80% neutralizing antibody titers) will need to be ≥52% at the LL of the 95% CI for that treatment (vaccine formulation) to be considered for advancement to Phase 2. Post-dose 1 and post dose 2 safety results including all solicited and unsolicited adverse events, serious adverse events, and clinical laboratory results. The following process will be followed for the decision about down selection and advancing to Part 2 (Phase 2): The DSMB will review the unblinded safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing a formulation to Phase 2. The Sponsor will review the DSMB recommendation in conjunction with the immunogenicity data and select two formulations to advance to Phase 2. o If multiple formulations achieve the threshold immune response (as well as have an adequate safety and tolerability profile per the DSMB), the Sponsor will select two formulations to advance to Phase 2 based on consideration of such factors as the relative functional immunogenicity of these formulations, opportunity for dose sparing, and opportunity to limit cost and possible supply constraints associated with use of the CpG adjuvant. The selection and recommendation to advance to Phase 2 along with the interim report will be jointly reviewed by NIHE's IRB and MoH prior to Phase 2 enrollment. In Part 2 of this combined Phase 1/2 study, 300 adults aged 18-75 years will be randomized (2:5:5) to placebo, or one of two selected formulations of COVIVAC being evaluated in Phase 1. At least one-third of the subjects in Phase 2 will be aged ≥60 years to ensure that adequate safety and immune data will be available from older and elderly adults to inform the selection of the COVIVAC formulation to advance to Phase 3 studies. The Phase 2 cohort will follow the same visit schedule, and undergo the same procedures and assessments, as in Phase 1. In addition, as exploratory objectives, the anti-NDV HN IgG response will be assessed at V1, V3, V5, and V8 in all subjects, and 36 subjects (equally distributed between the two age strata) will be randomly selected in a 1:1:1 ratio to provide additional blood at V1, V5 and V7 to be used to isolate peripheral blood mononuclear cells (PBMCs) for assessment of T-cell-mediated immunity (CMI). An interim analysis of Phase 2 data (combined with immunogenicity and safety data generated for the placebo group and two selected COVIVAC formulations from Phase 1) will be conducted after the last subject of the Phase 2 cohort completes V6 (D57) as the basis for selecting the optimal formulation of COVIVAC to advance to Phase 3 studies. As was the case for the Phase 1 interim analysis at the same timepoint, the data generated will include unblinded post-dose 1 and dose 2 safety results for review by the DSMB, and immunogenicity results aggregated by treatment group for review by the Sponsor. The DSMB will consider all accumulated safety data from both phases of the study prior to making any recommendation to the Sponsor that it not advance a formulation based on safety concerns. The Sponsor will ultimately select the formulation to advance to Phase 3 that, in addition to having been judged by the DSMB to have an adequate safety and tolerability profile, is optimal based on relative functional immunogenicity and other programmatic considerations such as those noted above. conditions module condition list condition COVID-19 Disease SARS Pneumonia Pneumonia, Viral COVID-19 Vaccine keyword list keyword COVID-19 COVIVAC COVID-19 disease SARS-CoV-2 COVID-19 vaccine design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description In Phase 1 is dose escalation design, eligible participants will be randomized to received study vaccine or placebo from low dose to higher dose and later to the formulation with CpG adjuvant. In phase 2, eligible participants will received 2 selected doses (from phase 1) or placebo. design primary purpose Prevention design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 420 enrollment type Actual arms interventions module arm group list arm group arm group label COVIVAC 1mcg arm group type Experimental arm group description 1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. arm group intervention list arm group intervention name Biological: COVIVAC arm group label COVIVAC 3mcg arm group type Experimental arm group description 3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. arm group intervention list arm group intervention name Biological: COVIVAC arm group label COVIVAC 10mcg arm group type Experimental arm group description 10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. arm group intervention list arm group intervention name Biological: COVIVAC arm group label COVIVAC 1mcg + CpG1018 1.5mg arm group type Experimental arm group description 1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. arm group intervention list arm group intervention name Biological: COVIVAC arm group label Placebo arm group type Placebo Comparator arm group description Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart. arm group intervention list arm group intervention name Biological: Phosphate-buffered saline intervention list intervention intervention type Biological intervention name COVIVAC intervention description COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 intervention arm group label list intervention arm group label COVIVAC 10mcg COVIVAC 1mcg COVIVAC 1mcg + CpG1018 1.5mg COVIVAC 3mcg intervention type Biological intervention name Phosphate-buffered saline intervention description Phosphate buffer solution (pH 7.2), manufactured by IVAC intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Number and severity of solicited local and systemic adverse events (AEs) primary outcome description Safety outcome measurement primary outcome time frame During the first 7 days after each vaccination primary outcome measure Number, severity, and relatedness of clinically significant hematological and biochemical measurements primary outcome description Safety outcome measurement primary outcome time frame At 7 days post each vaccination primary outcome measure Number, severity and relatedness of all unsolicited AEs primary outcome description Safety outcome measurement primary outcome time frame During the first 28 days after each vaccination primary outcome measure Number, severity and relatedness of serious adverse events (SAEs) primary outcome description Safety outcome measurement primary outcome time frame Through study completion, up to Day 365 primary outcome measure Number, severity and relatedness of medically-attended AEs (MAAEs) primary outcome description Safety outcome measurement primary outcome time frame Through study completion, up to Day 365 primary outcome measure Number, severity and relatedness of adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC) primary outcome description Safety outcome measurement primary outcome time frame Through study completion, up to Day 365 secondary outcome list secondary outcome secondary outcome measure 50% and 80% neutralizing antibody (NT50 and NT80) geometric mean titer (GMT) against SARS-CoV-2 pseudovirus secondary outcome description Immunogenicity outcome measurement secondary outcome time frame At 28 days after the first vaccination, and 14 days, 6 months and 12 months after the second vaccination in subjects who are anti-S IgG seronegative at baseline secondary outcome measure Geometric mean fold rise (GMFR) (from baseline) in NT50 and NT80 against SARS-CoV-2 pseudovirus secondary outcome description Immunogenicity outcome measurement secondary outcome time frame At 28 days after the first vaccination, and 14 days, 6 months and 12 months after the second vaccination in subjects who are anti-S IgG seronegative at baseline secondary outcome measure Percentage of subjects with NT50 and NT80 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline secondary outcome description Immunogenicity outcome measurement secondary outcome time frame At 28 days after the first vaccination, and 14 days, 6 months and 12 months after the second vaccination in subjects who are anti-S IgG seronegative at baseline eligibility module eligibility criteria Inclusion Criteria: Phase 1 Only: Adult 18 through 59 years of age inclusive at the time of randomization. Healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. Phase 2 Only: Adult 18 through 75 years of age inclusive at the time of randomization. Having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. Both Phase 1 and Phase 2: Has provided written informed consent prior to performance of any study-specific procedure. Has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening. Resides in study site area and is able and willing to adhere to all protocol visits and procedures. If a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and during the 24 hours prior to receipt of the first dose of IP), must plan to avoid pregnancy for at least 28 days after the last dose of IP, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of IP. Exclusion Criteria: Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation. History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination within 3 months after enrolment. Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Vietnam during the course of study participation is not exclusionary if administered after Visit 5. Previous receipt of investigational vaccine for SARS or MERS, or any investigational or licensed vaccine that may have an impact on interpretation of the trial results History of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine History of egg or chicken allergy History of angioedema History of anaphylaxis Acute illness (moderate or severe) and/or fever (body temperature measured orally ≥38°C) Any abnormal vital sign deemed clinically relevant by the PI Abnormality in screening laboratory test deemed exclusionary by the PI in consultation with the Sponsor A positive serologic test for hepatitis B (HBsAg) or hepatitis C (HCV Ab) History of confirmed HIV History of laboratory-confirmed COVID-19 History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ Any confirmed or suspected immunosuppressive or immunodeficient state Administration of immunoglobulin or any blood product within 90 days prior to first study injection or planned administration during the study period. Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within six months prior to first study injection, or planned administration during the study period (includes systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone; the use of topical steroids including inhaled and intranasal steroids is permitted). History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. (e.g, thalassemia, coagulation factor deficiencies). Recent history (within the past year) or signs of alcohol or substance abuse. Any medical, psychiatric or behavior condition that in the opinion of the PI may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up. Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module location list location location facility Hanoi Medical University location city Hanoi location zip 10000 location country Vietnam location facility Thai Binh Center of Disease Control location city Thai Binh location country Vietnam references module reference list reference reference p m i d 35577631 reference type derived reference citation Duc Dang A, Dinh Vu T, Hai Vu H, Thanh Ta V, Thi Van Pham A, Thi Ngoc Dang M, Van Le B, Huu Duong T, Van Nguyen D, Lawpoolsri S, Chinwangso P, McLellan JS, Hsieh CL, Garcia-Sastre A, Palese P, Sun W, Martinez JL, Gonzalez-Dominguez I, Slamanig S, Manuel Carreño J, Tcheou J, Krammer F, Raskin A, Minh Vu H, Cong Tran T, Mai Nguyen H, Mercer LD, Raghunandan R, Lal M, White JA, Hjorth R, Innis BL, Scharf R. Safety and immunogenicity of an egg-based inactivated Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomized, placebo-controlled, phase 1/2 trial in Vietnam. Vaccine. 2022 Jun 9;40(26):3621-3632. doi: 10.1016/j.vaccine.2022.04.078. Epub 2022 May 14. i p d sharing statement module i p d sharing No i p d sharing description There should be an agreement and approval by IRB before sharing IDP derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000011014 condition mesh term Pneumonia condition mesh id D000011024 condition mesh term Pneumonia, Viral condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf as found Pneumonia condition browse leaf relevance high condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf as found Pneumonia, Viral condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse leaf id M256611 intervention browse leaf name 1018 oligonucleotide intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions
NCT04830800
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full study rank 61543 study protocol section identification module n c t id NCT04835103 org study id info org study id 201812052RIND organization org full name National Taiwan University Hospital org class OTHER brief title Build a Research Clinic for Somatoform Patients official title Build a Psychosomatic Research Clinic for Providing Comprehensive Managements to Somatoform Patients status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 9, 2021 start date type Actual primary completion date struct primary completion date June 30, 2024 primary completion date type Anticipated completion date struct completion date June 30, 2024 completion date type Anticipated study first submit date January 29, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 25, 2022 last update post date struct last update post date November 28, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name National Taiwan University Hospital lead sponsor class OTHER collaborator list collaborator collaborator name National Taiwan University Hospital, Yun-Lin Branch collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To investigate the effects of the two following interventions on somatoform patients:1. case management model2. psychotherapy, based on cognitive-behavioral therapy and biofeedback therapy detailed description Patients with presentations of somatic symptoms and associated psychological features are named as "somatoform disorders" in psychiatric field. Because the patients' concerns are somatic distress, they often seek help in non-psychiatric clinics. However, the symptoms are usually medically unexplained. This group of diagnoses can be managed from the psychiatric perspective, including medications and psychotherapies. However, many patients do not receive psychiatric management in current medical practice. The goal of this project is to establish an association named "psychosomatic center" for providing comprehensive evaluations and treatments to the somatoform patients. Besides the psychiatrist, a case manager, a clinical psychologist, and a research assistant will be included in this association for the purposes of connection, performing psychotherapy and examinations. After entering the psychosomatic clinic, the investigators will routinely perform diagnostic interview, measure psychological and physiological features, and arrange individualized treatment program. The investigators will follow the important psychological and biological indexes every 3-6 months for building a cohort. At the same time, the case manager will connect with non-psychiatric clinics for ensuring the patients physical problems to be managed. The investigators expect this project to enhance the quality of treatment on the patients, to reduce the excessive examinations for the frequent attenders, and to improve the emotional burden of medical staffs. conditions module condition list condition Somatoform Disorders Somatic Symptom Disorder keyword list keyword somatoform disorders somatic symptom disorder psychosomatic medicine medically unexplained symptoms design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation; psychotherapy for patients with somatoform disorders (combined cognitive-behavioral treatment and biofeedback therapy) design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Set a case management model for somatoform patients arm group type Other arm group description Somatoform patients receiving case management, single group assignment, open label arm group intervention list arm group intervention name Behavioral: CM arm group label Time-limited psychotherapy for somatoform patients arm group type Other arm group description Somatoform patients receiving psychotherapy (based on cognitive-behavioral therapy and biofeedback therapy) vs treatment as usual, open label, non-randomized arm group intervention list arm group intervention name Behavioral: P/T intervention list intervention intervention type Behavioral intervention name CM intervention description Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation intervention arm group label list intervention arm group label Set a case management model for somatoform patients intervention type Behavioral intervention name P/T intervention description Psychotherapy, based on both cognitive-behavioral therapy and biofeedback therapy, structuralized, 6-10 sessions, performed by a psychiatrist or psychologist intervention arm group label list intervention arm group label Time-limited psychotherapy for somatoform patients outcomes module primary outcome list primary outcome primary outcome measure Changes from baseline Patient Health Questionnaire-15 (PHQ-15) score at 3 months and 6 months (for psychotherapy); changes from baseline PHQ-15 score at 3, 6, 12, 24 months (for case management) primary outcome description PHQ-15 is a scale rating the severity of somatic distress. It is a 3-point Likert scale with 15 items. The scores range from 0 (lowest level of somatic distress) to 30 (highest level of somatic distress). primary outcome time frame 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management) primary outcome measure Changes from baseline Health Anxiety Questionnaire (HAQ) score at 3 months and 6 months (for psychotherapy); changes from baseline HAQ score at 3, 6, 12, 24 months (for case management) primary outcome description HAQ is a scale rating the severity of health anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of health anxiety) to 63 (highest level of health anxiety). primary outcome time frame 3, 6 months after initiating psychotherapy (for psychotherapy); 3, 6, 12, 24 months after initiating case management (for case management) secondary outcome list secondary outcome secondary outcome measure Scores of Scale for the Assessment of Illness Behavior (SAIB) secondary outcome description SAIB is a scale rating the illness behavior. It is a 4-point Likert scale with 25 items. The scores range from 0 to 75. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Scores of Cognition About Body and Health Questionnaire (CABAH) secondary outcome description CABAH is a scale rating the cognition about health anxiety. It is a 4-point Likert scale with 39 items. The scores range from 0 to 117. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Scores of Beck Depression Inventory-II (BDI- II) secondary outcome description BDI- II is a scale rating the severity of depression. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of depression) to 63 (highest level of depression). secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Scores of Beck Anxiety Inventory (BAI) secondary outcome description BAI- II is a scale rating the severity of anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of anxiety) to 63 (highest level of anxiety). secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Penn State Worry Questionnaire (PSWQ) secondary outcome description PSWQ-16 is a scale rating the severity of worry. It is 5-point Likert scale with 16 items. The scores range from 1 (lowest level of worry) to 80 (highest level of worry). secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Scores of WHOQOL-BREF secondary outcome description It is a self-report questionnaire measuring health-related quality of life. It is a 4-point Likert scale with 28 items, which belong to 5 domains (the overall, physical, psychological, social and environmental domains). The scores of each domain are usually normalized with 0-20 or 0-100. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Changes from baseline standard deviation of normal to normal RR intervals (SDNN) secondary outcome description SDNN reflects all the cyclic components responsible for variability in the period of recording, therefore it represents total variability. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Changes from baseline high-frequency power (HF) secondary outcome description HF component of HRV represents parasympathetic activity. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Changes from baseline ratio of low-frequency power to high-frequency power (LF/HF) secondary outcome description LF/HF was considered to reflect sympathovagal balance by some scholars. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Changes from baseline value of skin conductance. secondary outcome description In skin conductance, an electrodermograph imposes an imperceptible current across the skin and measures how easily it travels through the skin. Skin conductance is usually considered as a biomarker of sympathetic activity. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Changes from baseline value of Respiratory sinus arrhythmia secondary outcome description Respiratory sinus arrhythmia is an index combining the heart rate and respiratory signal, it represents parasympathetic activity. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Changes from baseline value of Finger temperature. secondary outcome description Finger temperature is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy. secondary outcome time frame 3, 6, 12, 24 months secondary outcome measure Changes from baseline value of electromyogram secondary outcome description Electromyogram is found to be related to emotional disturbance (such as depression and anxiety), and it is often used in biofeedback therapy. secondary outcome time frame 3, 6, 12, 24 months eligibility module eligibility criteria Inclusion Criteria: 1. Between 15 and 80 years old 2. Meet the diagnosis of DSM-5 somatic symptom disorder Exclusion Criteria: 1. With psychotic symptoms (such as schizophrenia, bipolar disorder with psychotic symptoms) or cognitive impairment 2. Having potentially lethal physical diseases (such as cancer, coronary artery diseases, cerebrovascular diseases; because under this condition, high health anxiety is quite rational. Patients with common physical diseases can still enter this trial) 3. Unable to read or understand the questionnaires healthy volunteers No gender All minimum age 15 Years maximum age 80 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Wei-Lieh Huang central contact role Contact central contact phone +886 5 532 3911 central contact phone ext 7101 central contact e mail weiliehhuang@gmail.com location list location location facility Department of Psychiatry, National Taiwan University Hospital Yunlin Branch location status Recruiting location city Douliu location country Taiwan location contact list location contact location contact name Wei-Lieh Huang, MD location contact role Contact location contact phone +886 5 532 3911 location contact phone ext 7101 location contact e mail weiliehhuang@gmail.com location contact name Wei-Lieh Huang location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004194 condition mesh term Disease condition mesh id D000071896 condition mesh term Medically Unexplained Symptoms condition mesh id D000013001 condition mesh term Somatoform Disorders condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M885 condition browse leaf name Medically Unexplained Symptoms condition browse leaf as found Somatic Symptom condition browse leaf relevance high condition browse leaf id M14955 condition browse leaf name Somatoform Disorders condition browse leaf as found Somatoform Disorders condition browse leaf relevance high condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders
NCT04835103
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full study rank 61471 study protocol section identification module n c t id NCT04836039 org study id info org study id E-10840098-772.02-2682 organization org full name Medipol University org class OTHER brief title Rehabilitation Experiences of Physiotherapists in Covid-19 Outbreak official title Evaluation of Rehabilitation Experiences of Physiotherapists in Covid-19 Outbreak status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date January 27, 2021 start date type Actual primary completion date struct primary completion date February 27, 2021 primary completion date type Actual completion date struct completion date February 27, 2021 completion date type Actual study first submit date April 2, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Pınar Ciddi responsible party investigator title Assistant Professor responsible party investigator affiliation Medipol University lead sponsor lead sponsor name Medipol University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to evaluate the process experienced by physiotherapists while providing rehabilitation services during the epidemic and to investigate the procedures adopted by physiotherapists who are currently working. In addition, by analyzing the effects of both the pandemic and the clinical and educational organizations in the Physiotherapy and Rehabilitation Clinics where physiotherapists were working during the COVID-19 epidemic, the needs arising after the pandemic can be reported. Assessments will be carried out by researcher physiotherapists through a questionnaire based on research and examples in the literature, and scales measuring anxiety, depression and stress levels. The measurement tool will be the online survey application. detailed description The aim of this study is to evaluate the process experienced by physiotherapists while providing rehabilitation services during the epidemic and to investigate the procedures adopted by physiotherapists who are currently working. In addition, by analyzing the effects of both the pandemic and the clinical and educational organizations in the Physiotherapy and Rehabilitation Clinics where physiotherapists were working during the COVID-19 epidemic, the needs arising after the pandemic can be reported. Assessments will be carried out by researcher physiotherapists through a questionnaire based on research and examples in the literature, and scales measuring anxiety, depression and stress levels. The measurement tool will be the online survey application. Data collection is planned to take place in February-March 2021. Surveys will be distributed via WhatsApp, e-mail, social media links. This questionnaire was sent to 3 physiotherapists and subjected to a pre-test. This questionnaire is about the following situations and contains 37 questions: Information on employment status: In this section, physiotherapists' name-surname, gender, age, professional practice experience (years), generally applied physiotherapy subgroup (more than one can be selected), whether they are self-employed or employees, and the status of performing face-to-face clinical practices will be questioned. If so, it will be questioned which protection measures have been applied. Information about tele-rehabilitation practices: In this section, it will be questioned whether physiotherapists start to follow their patients remotely, if they are, in what way they do it, whether the number of weekly sessions continues, and whether the amount collected is the same as the face-to-face amount. General information about COVID 19 rehabilitation: In this section, did the departments where physiotherapists work returned to COVID 19 services, did they work in COVID 19 units, rehabilitation approaches in COVID 19 patients, protocol and / or guidelines on exercises for rehabilitation management and treatment of COVID 19 patients. material development / implementation status will be questioned. The impact of the pandemic on the health and teaching activities of physiotherapists and the sustainability of clinical / thesis studies during this period will be questioned. Finally, the CES Depression Scale (Center for Epidemiologic Studies Depression Scale, CES-D) will be used to determine depression level, the Generalized Anxiety Disorder 7 (GAD-7) Test will be used to evaluate generalized anxiety level, Perceived Stress Scale (PSS) will be used to determine stress level. conditions module condition list condition Physical Therapy design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 400 enrollment type Actual arms interventions module arm group list arm group arm group label Physiotherapists arm group description Individuals between the ages of 22-65 who continue to work as a self-employed or employee physiotherapist. arm group intervention list arm group intervention name Other: A questionnaire and scales. intervention list intervention intervention type Other intervention name A questionnaire and scales. intervention description Participants will be evaluated by applying a questionnaire and scales created by the researcher physiotherapists based on the researches and examples in the literature. intervention arm group label list intervention arm group label Physiotherapists outcomes module primary outcome list primary outcome primary outcome measure A questionnaire created by research physiotherapists based on researches and examples in the literature. primary outcome description Participants will be evaluated by applying a questionnaire and scales created by the researcher physiotherapists based on the researches and examples in the literature. primary outcome time frame The evaluation will take place in one interview (the interview will take 30 minutes) secondary outcome list secondary outcome secondary outcome measure Assessment of depression level with Center for Epidemiologic Studies Depression Scale secondary outcome description The Center for Epidemiologic Studies Depression Scale will be used to determine depression level. The scale consists of 20 questions in the form of a self-report that measure the emotional state of the person in depression, perceptions and behaviors towards depression. 4-point Likert type questionnaire with 0-60 points range is encoded in 0-3 points range. secondary outcome time frame The evaluation will take place in one interview (the interview will take 30 minutes) secondary outcome measure Assessment of anxiety level with Generalized Anxiety Disorder 7 Test secondary outcome description The Generalized Anxiety Disorder 7 test will be used to determine anxiety level. It is a 7-item four-point Likert (0 = none, 1 = many days, 2 = more than half of the days, 3 = almost every day), which evaluates the experiences asked in the scale items in the last 2 weeks. The total scores obtained from the scale are 5, 10, and 15 cut-off points for mild, moderate, and severe anxiety, respectively. secondary outcome time frame The evaluation will take place in one interview (the interview will take 30 minutes) secondary outcome measure Assessment of stress level with Perceived Stress Scale secondary outcome description Perceived Stress Scale will be used to determine stress level. Participants rate how often their lives were seen as unpredictable, uncontrollable, and overly intense during the previous month on the 5-point Likert scale (0 = Never, 4 = Very often). Total scores range from 0 to 40, with higher scores indicating a higher perceived stress level. secondary outcome time frame The evaluation will take place in one interview (the interview will take 30 minutes) eligibility module eligibility criteria Inclusion Criteria: Individuals between the ages of 22-65 who continue to work as a self-employed or employee physiotherapist. Exclusion Criteria: Not meeting the inclusion criteria healthy volunteers Accepts Healthy Volunteers gender All minimum age 22 Years maximum age 65 Years std age list std age Adult Older Adult study population Individuals between the ages of 22-65 who continue to work as a self-employed or employee physiotherapist. sampling method Probability Sample contacts locations module overall official list overall official overall official name Gülay Aras Bayram, asAss. Prof. overall official affiliation Medipol University overall official role Study Chair location list location location facility Medipol University location city Istanbul location state Beykoz location zip 34815 location country Turkey derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04836039
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full study rank 61195 study protocol section identification module n c t id NCT04839627 org study id info org study id PROGESTE organization org full name Hospital St. Joseph, Marseille, France org class OTHER brief title Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates. official title Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates status module status verified date June 2021 overall status Recruiting expanded access info has expanded access No start date struct start date June 16, 2021 start date type Actual primary completion date struct primary completion date June 2023 primary completion date type Anticipated completion date struct completion date June 2023 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date June 17, 2021 last update post date struct last update post date June 23, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Hospital St. Joseph, Marseille, France lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions (fresh and frozen). The investigators propose to perform a prospective cross-sectional single-center cohort study to measure progesterone levels on the day of the ET on all AMP cycles and to compare these levels between active pregnancies and ET unsuccessful cycles. They will determine progesterone threshold levels corresponding to successful attempts in all ET strategies (fresh and frozen) as well as clinical and biological risk factors leading to luteal phase deficiency during ET. They could therefore individualize progesterone supplementation according to patient's needs. conditions module condition list condition Infertility keyword list keyword serum progesterone embryo transfer pregnancy rate design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 750 enrollment type Anticipated arms interventions module arm group list arm group arm group label serum progesterone measurement arm group intervention list arm group intervention name Other: serum progesterone measurement intervention list intervention intervention type Other intervention name serum progesterone measurement intervention description progesterone levels measurement on the day of the embryo transfer on all AMP cycles intervention arm group label list intervention arm group label serum progesterone measurement outcomes module primary outcome list primary outcome primary outcome measure Serum progesterone levels on the day of embryo transfer primary outcome description µg/L primary outcome time frame During the procedure secondary outcome list secondary outcome secondary outcome measure pregnancy rate secondary outcome description Post-embryo transfer βHCG levels (UI/l). secondary outcome time frame 1 month after procedure eligibility module eligibility criteria Inclusion Criteria: Age ≥ 18 years planned embryo transfer signed informed consent Exclusion Criteria: patients falsely included, major inclusion criteria not respected lack of social insurance refusal to participate in the research healthy volunteers No gender Female minimum age 18 Years std age list std age Adult Older Adult study population all patients who need an embryo transfer in the center. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Xavier Donato central contact role Contact central contact phone 04 91 80 14 31 central contact e mail xdonato@hopital-saint-joseph.fr location list location location facility Hopital Saint Joseph Marseille location status Recruiting location city Marseille location zip 13008 location country France location contact list location contact location contact name Xavier DONATO location contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007246 condition mesh term Infertility condition browse leaf list condition browse leaf condition browse leaf id M9442 condition browse leaf name Infertility condition browse leaf as found Infertility condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000011374 intervention mesh term Progesterone intervention ancestor list intervention ancestor intervention ancestor id D000011372 intervention ancestor term Progestins intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M13397 intervention browse leaf name Progesterone intervention browse leaf as found Selected intervention browse leaf relevance high intervention browse leaf id M13396 intervention browse leaf name Progestins intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04839627
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full study rank 61554 study protocol section identification module n c t id NCT04834960 org study id info org study id I1429 organization org full name Johns Hopkins Bloomberg School of Public Health org class OTHER brief title Missed Opportunities for Vaccine Equity official title Missed Opportunities for Vaccine Equity acronym MOVE status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date September 24, 2020 start date type Actual primary completion date struct primary completion date September 16, 2021 primary completion date type Actual completion date struct completion date September 16, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 5, 2022 last update post date struct last update post date October 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Johns Hopkins Bloomberg School of Public Health lead sponsor class OTHER collaborator list collaborator collaborator name Postgraduate Institute of Medical Education and Research, Chandigarh collaborator class OTHER collaborator name Aminu Kano Teaching Hospital collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Despite the overwhelming impact of vaccines on child health and the tremendous progress in vaccine coverage globally, challenges of vaccine inequities persist. Missed opportunities for vaccination (MOV) is defined as any contact with health services by an individual who is eligible for vaccination which does not result in the recommended vaccines being given. This is common in several countries, and it presents a window of opportunity to provide vaccine services to those vulnerable children accessing healthcare facilities. The overall purpose of this project is to reduce missed opportunities for vaccinations by targeting hospitalized children who are vulnerable to poor health outcomes, but who are also within easy access of the healthcare system. The research team proposes implementing the Missed Opportunities for Vaccination Equity (MOVE), an intervention to improve timeliness and coverage of vaccination, and increase demand for vaccination services, through a combination of sensitization of children's caregivers and health workers, manual vaccination data capture in the ward, and re-purposed vaccination resources. The strategy engages key stakeholders in the design of the intervention through a co-creation workshop; their involvement in the design and execution of the intervention will improve sustainability in the long-term. This intervention builds on existing healthcare systems, and, when scaled up, can target inequities in vaccination coverage in the general population, without placing additional strain on the healthcare system in terms of workforce or financial resources. detailed description This pilot project is structured as a pre-post analysis of an implementation strategy to address missed opportunities for vaccination (MOV) among hospitalized children in India and Nigeria. India and Nigeria have similar rates of missed opportunities for vaccinations, and similar discrepancies with monitoring vaccination records when a child is in the hospital. The research team intends to collect the same pre-data in both India and Nigeria, implement the same intervention in both countries, and collect the same post-data in both study sites. The pre-intervention, intervention, and post-intervention, are all described below. Pre-Intervention period: The first three months of the project constitute the pre-intervention period, and they will consist of a situational analysis which will assess the burden of MOV as well as the barriers and facilitators for reducing MOV. Eligible participants will be enrolled after providing informed consent. Procedures would include verifying vaccination cards and medical records at admission and at discharge, conducting in-depth interviews with parents or caregivers during the hospital course, and administering structured questionnaires to hospital healthcare personnel crucial to hospitalized child care and provision of vaccinations. Intervention: This will begin with a co-creation workshop where the results of the pre-intervention period will be discussed, and the MOV intervention will be implemented. In summary, the intervention will include four components which are: (1) Disseminate (vaccination awareness among healthcare providers and child caregivers); (2) Document (vaccination status); (3) Deploy (vaccines); and (4) Discharge (provide advice/referrals for catch-up and routine vaccinations). Using a human-centered design approach, the research team will design an intervention, endorsed by local healthcare providers and stakeholders, which will be implemented primarily by the existing hospital healthcare staff. Research staff will play a role in data collection for monitoring purposes, but will not play a role in implementing the intervention. Post-Intervention period: Ongoing data collection after the MOV intervention is initiated and continued, will constitute the 'post-intervention' period. During this period, data collectors will collect the same data that is being collected in the pre-intervention. The research team intends to compare the results of our pre and post intervention data, to determine if this intervention has reduced the amount of children who are missed for vaccinations. conditions module condition list condition Under-vaccinated keyword list keyword vaccination under-vaccination missed opportunities for vaccination design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description This is a 'pre-post' study design, where the intervention is designed and implemented by the regular non-research clinical staff. This intervention has four components that are described in the 'intervention' section. design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 900 enrollment type Actual arms interventions module arm group list arm group arm group label MOV Intervention arm group type Other arm group description Pre-intervention and post-intervention design arm group intervention list arm group intervention name Other: Minimizing Missed Opportunities for Vaccination (MOV) intervention list intervention intervention type Other intervention name Minimizing Missed Opportunities for Vaccination (MOV) intervention description This bundle of interventions has four components that include: (1) Disseminate (vaccination awareness among healthcare providers and child caregivers); (2) Document (vaccination status); (3) Deploy (vaccines); and (4) Discharge (provide advice/referrals for catch-up and routine vaccinations). intervention arm group label list intervention arm group label MOV Intervention outcomes module primary outcome list primary outcome primary outcome measure Proportion of Children Fully Vaccinated Hospital Discharge primary outcome description The number fully vaccinated at admission + number given catch-up vaccination while in hospital, and up to the date at discharge / the number of all enrolled children. This outcome measures the desired outcome of full vaccination coverage among children who pass through in-patient health facilities. This is the main outcome of interest and will be compared in the pre-intervention and post-intervention phases. primary outcome time frame time of admission to discharge (about 1-2 weeks) primary outcome measure Partially Vaccinated or Un-vaccinated Children at Admission primary outcome description This is the proportion of those children who are under-vaccinated at hospital admission. primary outcome time frame time of admission to discharge (about 1-2 weeks) primary outcome measure Proportion of Under-Vaccinated children Deemed "Missed Opportunities of Vaccination" primary outcome description The number of eligible children who do not receive their due catch-up vaccines prior to hospital discharge / the number of children identified as under-vaccinated at hospital admission. primary outcome time frame time of admission to discharge (about 1-2 weeks) primary outcome measure Proportion of all Enrolled Children at Admission Given Vaccination Advice primary outcome description The number of all enrolled children at admission who get vaccination-related advice and/or referrals during the hospital stay / the number of all enrolled children participating in the study. primary outcome time frame time of admission to discharge (about 1-2 weeks) primary outcome measure Proportion of Incompletely Vaccinated Children Caught up After Discharge primary outcome description The number of incompletely vaccinated children at hospital discharge who get caught up on vaccinations within 1-4 weeks of hospital discharge / the number of children identified as under-vaccinated at hospital discharge. primary outcome time frame time of admission (about 1-2 weeks) to 1 month post discharge eligibility module eligibility criteria Inclusion Criteria: Children between the ages 0-23 months who are admitted into the emergency or inpatient unit of the hospital Caregiver has access to the child's vaccination card or has direct knowledge of the child's vaccination history Caregiver willing to provide informed consent for the study Exclusion Criteria: Health condition that precludes the use of vaccines such as a primary or secondary immune deficiency, such as HIV, malignancy requiring chemotherapy, or ongoing steroid therapy Allergies or contraindications to any vaccine (or component thereof) in the national schedule healthy volunteers No gender All minimum age 0 Months maximum age 23 Months std age list std age Child contacts locations module overall official list overall official overall official name Anita Shet, MD, PhD overall official affiliation Johns Hopkins Bloomberg School of Public Health overall official role Principal Investigator location list location location facility Post Graduate Institute of Medical Education and Research, India (PGIMER) location city Chandigarh location country India location facility Aminu Kano Teaching Hospital location city Kano location state Kano State location country Nigeria i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834960
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full study rank 61276 study protocol section identification module n c t id NCT04838574 org study id info org study id 2021/CHU/03 organization org full name Centre Hospitalier Universitaire de la Réunion org class OTHER brief title Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years official title Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years acronym ChikRhuma15 status module status verified date March 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date June 2021 start date type Anticipated primary completion date struct primary completion date June 2024 primary completion date type Anticipated completion date struct completion date June 2024 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Centre Hospitalier Universitaire de la Réunion lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Reunion Island was struck by a severe Chikungunya outbreak in 2005-2006. Three hundred and seven Chikungunya patients were evaluated by 4 rheumatologists 2 months after the initial infection (RHUMATOCHIK study). Eighty-three percents still reported joint pain and 43% joint swelling in telephone interviews after 32 months (Bouquillard et al., 2018). The primary objective of the present study is to assess and classify precisely persistent Chi-related joint diseases after 15 years, in a second rheumatology examination. detailed description Reunion Island was struck in 2005-2006 by the most severe Chikungunya outbreak (seroprevalence 38% (Gérardin et al., 2013)) in a developed but previously non-immunized country, providing an unique opportunity for studying Chikungunya-related joint symptoms and their long-term evolution. In a previous study, the investigators demonstrated that at least 17/73 patients initially classified as Chikungunya-related inflammatory joint diseases after 40 months still suffered from inflammatory joint symptoms fullfilling validated classification criteria after 13 years (Guillot et al., 2020). However, in this monocentric study, the investigators did not consider the full spectrum of Chikungunya-related rheumatic diseases, the population was not fully representative and the sample size was not sufficient to perform statistical analyses nor identify poor prognosis markers. In the RHUMATOCHIK cohort study, 307 patients were evaluated by 4 rheumatologists 2 months after the infection, 83% and 43% reported persistent joint pain and joint swelling respectively after 32 months in potentially biased telephone interviews (Bouquillard et al., 2018). In this context, the present study aims at performing a systematic clinical rheumatologic re-evaluation of the RHUMATOCHIK patients after 15 years, in order to precisely describe and classify the full spectrum of persistent Chikungunya-related joint diseases in a larger population. After a telephone interview and screening questionnaire, these patients will be clinically re-evaluated by a second rheumatologist in a multicenter transversal follow-up study. conditions module condition list condition Chikungunya design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 220 enrollment type Anticipated arms interventions module intervention list intervention intervention type Other intervention name 15 years Follow-up group intervention description Phone recruitment, screening interview and eligibility questionnaire. Patient inclusion during rheumatologic evaluation : questionnaire, examination and data collection in one of the 4 study hospital centers. outcomes module primary outcome list primary outcome primary outcome measure Describe the phenotype of chronic post-Chikungunya rheumatological pictures persisting 15 years after the initial infection primary outcome description The primary outcome is the distribution (%) of rheumatic disease types among the patients with persistent Chikungunya-related rheumatic symptoms after 15 years ie. the percentage of patients fullfilling validated classification criteria of inflammatory rheumatic diseases (Rheumatoid Arthritis (Aletaha et al., 2010), Spondyloarthritis (Dougados et al., 1991; Rudwaleit et al., 2011a), Psoriatic Arthritis (Taylor et al., 2006), RS3PE - or undifferentiated arthritis), or classified in other rheumatic diseases (osteoarthritis, tendinitis, capsulitis, carpal tunnel syndrome, radicular pain, crystal-induced arthritis (Neogi et al., 2015), fibromyalgia (Wolfe et al., 2011)) - at inclusion. primary outcome time frame Day 0 secondary outcome list secondary outcome secondary outcome measure To describe the phenotype of post-Chikungunya chronic rheumatological pictures that have resolved 15 years after the initial infection. secondary outcome description The distribution (%) of rheumatic disease types among the patients with no more Chikungunya-related rheumatic symptoms after 15 years. secondary outcome time frame Day 0 secondary outcome measure To specify the time of onset in relation to the initial infection of rheumatological pictures initially attributed to Chikungunya. secondary outcome description The mean duration (months) of Chikungunya-related rheumatic diseases. secondary outcome time frame Day 0 secondary outcome measure Timing of onset of rheumatologic symptomatology in relation to CHIKV infection secondary outcome description Date of infection, date of onset of rheumatologic symptoms, time between the two (months), average duration (months) of rheumatologic symptomatology attributed to CHIKV infection secondary outcome time frame Day 0 secondary outcome measure Rheumatological pictures pre-existing the infection secondary outcome description Comparison of patients with persistent versus resolving Chikungunya-related rheumatic diseases after 15 years, in order to identify prognostic factors secondary outcome time frame Day 0 eligibility module eligibility criteria Inclusion Criteria: Patients previously included in the RHUMATOCHIK study (N=307), or diagnosed as Chikungunya-related Rheumatoid Arthritis (N=21) after telephonic screening and given their oral consent Chikungunya infection (positive serology and/or evocative symptoms in the epidemic context) Exclusion Criteria: Impossible informed consent (cognitive impairment,…). Lost-to-follow-up patients, refusal to participate. -Pre-existing chronic inflammatory rheumatic disease (prior to CHIKV infection)- healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Adult patients previously included in the RHUMATOCHIK study, or diagnosed as Chikungunya-related Rheumatoid Arthritis in the Reunion Island. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Xavier GUILLOT central contact role Contact central contact phone 0262 90 59 20 central contact e mail xavier.guillot@chu-reunion.fr location list location location facility GH Est Réunion location city Saint-Benoît location country Réunion location contact list location contact location contact name Elsa DENOIX location contact role Contact location contact e mail elsa.denoix@chu-reunion.fr location contact name Elsa DENOIX location contact role Principal Investigator location facility CHU La Réunion location city Saint-Denis location zip 97400 location country Réunion location contact list location contact location contact name Xavier GUILLOT location contact role Contact location contact e mail xavier.guillot@chu-reunion.fr location contact name Xavier GUILLOT location contact role Principal Investigator location contact name Judith PAYET location contact role Sub-Investigator location facility CH Ouest Réunion location city Saint-Paul location country Réunion location contact list location contact location contact name Julia GOOSSENS location contact role Contact location contact e mail Ju.GOOSSENS@chor.re location contact name Julia GOOSSENS location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000065632 condition mesh term Chikungunya Fever condition mesh id D000012216 condition mesh term Rheumatic Diseases condition ancestor list condition ancestor condition ancestor id D000018354 condition ancestor term Alphavirus Infections condition ancestor id D000001102 condition ancestor term Arbovirus Infections condition ancestor id D000079426 condition ancestor term Vector Borne Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000014036 condition ancestor term Togaviridae Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000003240 condition ancestor term Connective Tissue Diseases condition browse leaf list condition browse leaf condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf as found Rheumatism condition browse leaf relevance high condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M29699 condition browse leaf name Chikungunya Fever condition browse leaf as found Chikungunya condition browse leaf relevance high condition browse leaf id M2455 condition browse leaf name Hyperthermia condition browse leaf relevance low condition browse leaf id M7616 condition browse leaf name Fever condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M19645 condition browse leaf name Alphavirus Infections condition browse leaf relevance low condition browse leaf id M3564 condition browse leaf name Arbovirus Infections condition browse leaf relevance low condition browse leaf id M2054 condition browse leaf name Vector Borne Diseases condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M15944 condition browse leaf name Togaviridae Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M5616 condition browse leaf name Connective Tissue Diseases condition browse leaf relevance low condition browse leaf id T1131 condition browse leaf name Chikungunya condition browse leaf as found Chikungunya condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04838574
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full study rank 61723 study protocol section identification module n c t id NCT04832763 org study id info org study id 3C-19-4 secondary id info list secondary id info secondary id NCI-2020-02581 secondary id type Registry Identifier secondary id domain CTRP (Clinical Trial Reporting Program) secondary id 3C-19-4 secondary id type Other Identifier secondary id domain USC / Norris Comprehensive Cancer Center secondary id P30CA014089 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/P30CA014089 organization org full name University of Southern California org class OTHER brief title Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer official title Colorectal Cancer in Adolescents and Young Adults: A Pilot Study of Medical and Psychosocial Issues status module status verified date August 2022 overall status Terminated why stopped Insufficient Accrual expanded access info has expanded access No start date struct start date September 27, 2019 start date type Actual primary completion date struct primary completion date August 25, 2021 primary completion date type Actual completion date struct completion date August 25, 2021 completion date type Actual study first submit date May 9, 2020 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date August 19, 2022 last update post date struct last update post date August 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Southern California lead sponsor class OTHER collaborator list collaborator collaborator name National Cancer Institute (NCI) collaborator class NIH oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary This study investigates the medical and psychosocial consequences of colorectal cancer on adolescents and young adults. Measuring physical function in adolescents and young adults with colorectal cancer may help doctors better understand the level of physical function during cancer treatment and how to improve the management of colorectal cancer in adolescents and young adults. This study may also help design a future exercise program to decrease risk factors including high blood pressure, high blood sugar, and high cholesterol. detailed description PRIMARY OBJECTIVES: I. To prospectively characterize the symptom burden and assess the health-related quality of life of adolescents and young adults (AYAs) in active treatment for colorectal cancer in comparison to older patients to identify differences that contribute to the development of appropriately timed, age appropriate interventions. II. To characterize the symptom burden and assess the health-related quality of life of AYAs who have completed curative therapy and are in surveillance for colorectal cancer compared to older patients to identify differences that contribute to the development of appropriately timed, age-appropriate interventions. SECONDARY OBJECTIVE: I. Using a prospective and cross-sectional design, characterize physical function, body composition, and biomarkers of comorbid conditions among AYAs with colorectal cancer (CRC) on active therapy and after completion of therapy in survivorship to identify targets for and timing of interventions. EXPLORATORY OBJECTIVE: I. To assess across Aims differences by cancer site (colon versus [vs.] rectal) by sex, and by race/ethnicity. OUTLINE: Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline. conditions module condition list condition Stage I Colorectal Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage IIA Colorectal Cancer AJCC v8 Stage IIB Colorectal Cancer AJCC v8 Stage IIC Colorectal Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 32 enrollment type Actual arms interventions module arm group list arm group arm group label Physical function testing, questionnaire arm group type Experimental arm group description Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline. arm group intervention list arm group intervention name Procedure: Biospecimen Collection Other: Medical Chart Review Other: Physical Performance Testing Other: Quality-of-Life Assessment Other: Questionnaire Administration intervention list intervention intervention type Procedure intervention name Biospecimen Collection intervention description Undergo collection of blood sample intervention arm group label list intervention arm group label Physical function testing, questionnaire intervention type Other intervention name Medical Chart Review intervention description Review of medical charts intervention arm group label list intervention arm group label Physical function testing, questionnaire intervention other name list intervention other name Chart Review intervention type Other intervention name Physical Performance Testing intervention description Undergo physical function testing intervention arm group label list intervention arm group label Physical function testing, questionnaire intervention other name list intervention other name Physical Fitness Testing Physical Function Testing intervention type Other intervention name Quality-of-Life Assessment intervention description Ancillary studies intervention arm group label list intervention arm group label Physical function testing, questionnaire intervention other name list intervention other name Quality of Life Assessment intervention type Other intervention name Questionnaire Administration intervention description Complete questionnaire intervention arm group label list intervention arm group label Physical function testing, questionnaire outcomes module primary outcome list primary outcome primary outcome measure Symptom Burden primary outcome description Symptom burden will be assessed with computer adaptive tests (CATs) from the PROMIS measurement system. PROMIS is an NIH-sponsored system for measuring patient-reported health status, including physical, mental, and social well-being. Participants will complete the PROMIS Anxiety, Depression, Fatigue, and Pain Interference computer adaptive tests (CATs), which administer the minimum number of items necessary to accurately measure patient-reported outcomes while minimizing participant burden. primary outcome time frame Up to 6 months primary outcome measure Change in health-related quality of life (HRQoL) primary outcome description HRQoL will be measured using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life Instrument, a disease-specific quality of life measure. The FACT-C includes 38 items assessing five domains of health-related quality of life: Physical, Social/Family, Emotional and Functional Well-Being, and a subscale that examines health symptoms specific to CRC patients. Participants evaluate how they have been feeling over the preceding week on a five-point Likert-type scale with a possible total score of 0 to 136, with higher scores reflecting better QoL. primary outcome time frame Baseline up to 6 months secondary outcome list secondary outcome secondary outcome measure Physical function - cardiorespiratory fitness secondary outcome description Physical function will be measured using the following in-lab test for cardiorespiratory fitness (6-minute walk test): 6-minute Walk Test (6MWT): Participants will be instructed to walk as quickly as possible without running on an indoor pre-measured walkway for 6 minutes. The investigator will follow behind the participant so as not to pace the participant, and record the distance covered. Approximate time: 10 minutes. secondary outcome time frame Up to 6 months secondary outcome measure Physical function - power (stair climb) secondary outcome description Functional power will be measured using a stair climb test (Margaria Stair Climb) that has been successfully performed and correlated with lower-extremity power and mobility performance in older adults with a reliability coefficient of 0.99. Participants will be instructed to ascend a flight of 10 stairs one step at a time as quickly as possible without using a handrail. Timing will begin when one foot steps on the 3rd stair, and ends when one foot reaches the 9th stair. Time is recorded to the nearest .01 second, and an average of 3 trials is calculated. One practice trial will be given before the 3 trials. Approximate time: 5 minutes. secondary outcome time frame Up to 6 months secondary outcome measure Physical function - Mobility secondary outcome description Mobility will be assessed using the Timed Up and Go (TUG) test, which has been shown to predict immediate fall risk better than static balance tests or isometric muscle strength. Participants begin seated in a chair with hands on the armrests, are asked to rise, walk to a line on the floor 3 meters from the chair, turn around, and return to the same seated position as quickly and safe as possible. Scores will be taken as the time to complete the task, with one practice trial given. An average of time for 3 trials is calculated. Approximate time: 5 minutes secondary outcome time frame Up to 6 months secondary outcome measure Body composition secondary outcome description Body composition will be assessed via bioelectrical impedance using a validated device (InBody 570, Cerritos, CA). Participants will be asked to remove their shoes and socks and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on their age, sex, height, and body weight. A tape measure will be used to obtain hip circumference defined as the distance around the widest girth of the buttocks using the greater trochanter as a landmark. A tape measure will be used to obtain waist circumference defined as the distance around the midpoint between the last palpable rib and top of the iliac crest. secondary outcome time frame Up to 6 months secondary outcome measure Biomarker analysis - insulin secondary outcome description Fasting insulin levels measured in blood secondary outcome time frame Up to 6 months secondary outcome measure Biomarker analysis - glucose secondary outcome description Fasting glucose levels measured in blood secondary outcome time frame Up to 6 months secondary outcome measure Biomarker analysis - C-Reactive Protein secondary outcome description C- reactive protein levels measured in blood secondary outcome time frame Up to 6 months eligibility module eligibility criteria Inclusion Criteria: Diagnosis of colorectal cancer (any stage) Any type of prior therapy Age >= 18-39 years for AYA/young adult sample, age 40+ for older comparison group For patients on active therapy: must have been diagnosed within the past three months. For survivors: must have completed curative therapy and are 6-24 months post-diagnosis Speak English or Spanish Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Patients who are more than 3 months from diagnosis, and survivors who are more than 24 months from initial diagnosis Patients who have a life expectancy of less than 6 months per their medical oncologist Patients who are deemed too ill or unable to participate by their medical oncologist (e.g., have cognitive impairment or brain metastases) Patients who do not speak English or Spanish healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Kimberly Miller, MD overall official affiliation University of Southern California overall official role Principal Investigator location list location location facility Los Angeles County-USC Medical Center location city Los Angeles location state California location zip 90033 location country United States location facility USC / Norris Comprehensive Cancer Center location city Los Angeles location state California location zip 90033 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015179 condition mesh term Colorectal Neoplasms condition ancestor list condition ancestor condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000012002 condition ancestor term Rectal Diseases condition browse leaf list condition browse leaf condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf as found Colorectal Cancer condition browse leaf relevance high condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M13996 condition browse leaf name Rectal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04832763
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full study rank 61636 study protocol section identification module n c t id NCT04833894 org study id info org study id ARGX-113-2006 organization org full name argenx org class INDUSTRY brief title Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis official title Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date October 26, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date March 30, 2023 completion date type Anticipated study first submit date March 16, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 2, 2022 last update post date struct last update post date November 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name argenx lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: The maximum trial duration for each individual participant will be approximately 28 weeks The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B) conditions module condition list condition Generalized Myasthenia Gravis design module study type Interventional phase list phase Phase 2 Phase 3 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 12 enrollment type Anticipated arms interventions module arm group list arm group arm group label Efgartigimod arm group type Experimental arm group description Patients receiving efgartigimod intravenous (IV) treatment arm group intervention list arm group intervention name Biological: Efgartigimod IV intervention list intervention intervention type Biological intervention name Efgartigimod IV intervention description Intravenous infusion of Efgartigimod intervention arm group label list intervention arm group label Efgartigimod outcomes module primary outcome list primary outcome primary outcome measure Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Clearance (CL) primary outcome description Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod primary outcome time frame up to 26 weeks primary outcome measure Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Volume of Distribution (Vd) primary outcome description Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod primary outcome time frame up to 26 weeks primary outcome measure Total Immunoglobulin G (IgG) levels as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis primary outcome description Total Immunoglobulin G levels will be measured from blood samples primary outcome time frame up to 26 weeks primary outcome measure Anti-acetylcholine receptors antibodies (AChR-Ab) as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis primary outcome description Total Immunoglobulin G (IgG) levels will be measured from blood samples primary outcome time frame up to 26 weeks secondary outcome list secondary outcome secondary outcome measure Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) secondary outcome time frame up to 28 weeks secondary outcome measure Efgartigimod serum concentrations from blood samples secondary outcome time frame up to 26 weeks secondary outcome measure Absolute values of levels of total Immunoglobulin G (IgG) from blood samples secondary outcome time frame up to 26 weeks secondary outcome measure Change from baseline of levels of total Immunoglobulin G (IgG) from blood samples secondary outcome time frame up to 26 weeks secondary outcome measure Percentage change from baseline of total Immunoglobulin G (IgG) from blood samples secondary outcome time frame up to 26 weeks secondary outcome measure Absolute values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples secondary outcome time frame up to 26 weeks secondary outcome measure Change from baseline of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples secondary outcome time frame up to 26 weeks secondary outcome measure Percentage change from baseline of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples secondary outcome time frame up to 26 weeks secondary outcome measure Incidence of anti-drug antibodies (ADAs) against efgartigimod in serum samples secondary outcome time frame up to 28 weeks secondary outcome measure Prevalence of anti-drug antibodies (ADAs) against efgartigimod in serum samples secondary outcome time frame up to 28 weeks secondary outcome measure Absolute values of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment. secondary outcome time frame up to 26 weeks secondary outcome measure Change from baseline of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment. secondary outcome time frame up to 26 weeks secondary outcome measure Absolute values of total Quantitative Myasthenia Gravis Score (QMG score). The total possible score is 39, where higher total scores indicate more severe impairments. secondary outcome time frame up to 26 weeks secondary outcome measure Change from baseline of total Myasthenia Gravis Score (QMG score). The total possible score is 39, where higher total scores indicate more severe impairments. secondary outcome time frame up to 26 weeks secondary outcome measure Absolute values of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y) secondary outcome description Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems in any of the 5 dimensions and 33333 would indicate worst problems in any of the 5 dimensions. secondary outcome time frame up to 26 weeks secondary outcome measure Change from baseline of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y) secondary outcome description Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems and 33333 would indicate worst problems in any of the 5 dimensions. secondary outcome time frame up to 26 weeks secondary outcome measure Values of Neurological Quality of Life (Neuro-QoL) pediatric fatigue questionnaire secondary outcome time frame up to 26 weeks secondary outcome measure Change from baseline of Neurological Quality of Life (Neuro-QoL) pediatric fatigue questionnaire secondary outcome time frame up to 26 weeks secondary outcome measure Change in protective antibody titers to vaccines received before or during the trial from blood samples secondary outcome time frame up to 28 weeks eligibility module eligibility criteria Inclusion Criteria: Ability of the participant and/or his/her legally authorized representative to understand the requirements of the trial and provide written informed consent/assent, if applicable (including consent/assent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including attending the required trial visits). Male or female participants between 2 to less than 18 years of age at the time of providing informed consent/assent. Age groups are enrolled in a staggered fashion respectively: 6 participants in the 12 to less than 18 years of age group followed by 6 participants in the 2 to less than 12 years of age group at the time of providing informed consent/assent. Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, and IVa. Eligible participants should have an unsatisfactory response (efficacy and/or safety) to immunosuppressants, steroids or acetylcholinesterase (AChE) inhibitors and should be on stable concomitant Generalized Myasthenia Gravis (gMG) therapy of adequate duration before screening. Positive serologic test for acetylcholine receptor (anti-AChR) antibodies at screening (for younger participants (<15kg) historical values can be used). Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Male participants: Male participants must agree to not donate sperm from the time the informed consent form was signed until the end of the trial. Female participants: Female adolescents of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before investigational medicinal product (IMP) can be administered. Exclusion Criteria: Participants with Myasthenia Gravis Foundation of America (MGFA) class I, IVb, and V. Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, or the participant intends to become pregnant during the trial or within 90 days after the last dose of investigational medicinal product (IMP). Has any of the following medical conditions: Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk. History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the investigational medicinal product (IMP). Participants with the following cancers can be included at any time: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histological findings of prostate cancer (TNM Classification of Malignant Tumors stage T1a or T1b) Clinical evidence of other significant serious diseases, or have had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the trial or put the participant at undue risk Worsening muscle weakness secondary to concurrent infections or medications (aminoglycosides, fluoro-quinolones, beta-blockers, etc). A documented lack of clinical response to plasma exchange (PLEX). Received a live or live-attenuated vaccine fewer than 28 days before screening. Receiving an inactivated, subunit, polysaccharide, or conjugate vaccine any time before screening is not exclusionary. Received a thymectomy <3 months before screening or 1 is planned to be performed during the trial period. The following results from these diagnostic assessments will be considered exclusionary: Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection Hepatitis C virus (HCV) based on HCV antibody assay Human immunodeficiency virus (HIV) associated with a CD4 count <200 cells/mm3 with an acquired immunodeficiency syndrome (AIDS)-defining condition, such as: Cytomegalovirus retinitis with loss of vision, Pneumocystis jiroveci pneumonia, chronic intestinal cryptosporidiosis, HIV-related encephalopathy, Mycobacterium tuberculosis (pulmonary or extrapulmonary), or invasive cervical cancer Positive nasopharyngeal swab polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening. Using the following prior or concomitant therapies: Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the investigational medicinal product (IMP). Use of any monoclonal antibody within the 6 months before the first dose of the investigational medicinal product (IMP). Use of intravenous immunoglobulin (IVIg), administered subcutaneously or intramuscularly, or Plasma exchange (PLEX) within 4 weeks before screening. Total immunoglobulin (IgG) levels <6 g/L below the lower limit of normal (LLN) according to the reference ranges of the central laboratory for participant by sex and age at screening. A known hypersensitivity reaction to efgartigimod or any of its excipients. healthy volunteers No gender All minimum age 2 Years maximum age 18 Years std age list std age Child Adult contacts locations module central contact list central contact central contact name Sabine Coppieters, MD central contact role Contact central contact phone 857-350-4834 central contact e mail ClinicalTrials@argenx.com location list location location facility Investigator Site 16 - US0010123 location status Not yet recruiting location city Chicago location state Illinois location zip 60611 location country United States location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 857-350-4834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 15 - US0010003 location status Not yet recruiting location city Chapel Hill location state North Carolina location zip 27514 location country United States location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 857-350-4834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 11 - AT0430010 location status Not yet recruiting location city Wien location zip 1090 location country Austria location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 5 - BE0320021 location status Not yet recruiting location city Antwerpen location zip 2650 location country Belgium location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 4 - FR0330032 location status Not yet recruiting location city Marseille location zip 13004 location country France location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 12 - FR0330041 location status Not yet recruiting location city Paris location zip 75015 location country France location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 1 - GEO9950017 location status Recruiting location city Tbilisi location zip 0177 location country Georgia location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 857-350-4834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 2 - GEO9950018 location status Not yet recruiting location city Tbilisi location zip 0186 location country Georgia location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 857-350-4834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 14 - DE0490032 location status Not yet recruiting location city Essen location zip 45147 location country Germany location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 13 - IT0390047 location status Not yet recruiting location city Florence location zip 50139 location country Italy location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 10 - NL0310001 location status Recruiting location city Leiden location zip 2333 location country Netherlands location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 9 - PL0480035 location status Not yet recruiting location city Gdańsk location state Woj. 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Slaskie location zip 40-123 location country Poland location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 6 - PL0480034 location status Recruiting location city Warszawa location zip 02-097 location country Poland location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 7 - ES0340040 location status Not yet recruiting location city Barcelona location state Cataluña location zip 08950 location country Spain location contact list location contact location contact name Sabine Coppieters, MD location contact role Contact location contact phone 8573504834 location contact e mail clinicaltrials@argenx.com location facility Investigator Site 3 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NCT04833894
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full study rank 61820 study protocol section identification module n c t id NCT04831502 org study id info org study id TAK-906-1005 organization org full name Takeda org class INDUSTRY brief title Bioavailability and Food Effect Study of Two Formulations of TAK-906 official title A Phase 1, Open Label, Randomized, Single-Dose, Replicate Crossover Study to Determine the Bioavailability of the Tablet Formulation Relative to the Capsule Formulation of TAK-906 and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Subjects status module status verified date March 2022 overall status Withdrawn why stopped Business decision expanded access info has expanded access No start date struct start date April 2, 2021 start date type Actual primary completion date struct primary completion date February 2, 2022 primary completion date type Actual completion date struct completion date February 2, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 22, 2022 last update post date struct last update post date March 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Takeda lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting. This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906. detailed description The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test [Treatment B]) relative to single oral dose of 50 mg capsule (reference [Treatment A]) under fasted conditions. The study will also explore the effect of food on 50 mg tablet formulation (Treatment C: high-fat/high-calorie meal) on TAK-906 PK following tablet administration relative to the fasted state (Treatment B). The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 2 treatment sequences. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 60 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment. conditions module condition list condition Healthy Volunteers keyword list keyword Drug Therapy design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C) arm group type Experimental arm group description Participants will receive TAK-906 50 milligram (mg) as Treatment A (TAK-906 capsule) and Treatment B (TAK-906 tablet) under fasted conditions and Treatment C (TAK-906 tablet) under fed conditions, orally, once on Day 1 of Periods 1 to 5. A washout interval of at least 3 days will be maintained between each Treatment Period. arm group intervention list arm group intervention name Drug: TAK-906 arm group label Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C) arm group type Experimental arm group description Participants will receive TAK-906 50 mg as Treatment B (TAK-906 tablet) and Treatment A (TAK-906 capsule) under fasted conditions and Treatment C (TAK-906 tablet) under fed conditions, orally, once on Day 1 of Periods 1 to 5. A washout interval of at least 3 days will be maintained between each Treatment Period. arm group intervention list arm group intervention name Drug: TAK-906 intervention list intervention intervention type Drug intervention name TAK-906 intervention description TAK-906 Tablets. intervention arm group label list intervention arm group label Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C) Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C) intervention type Drug intervention name TAK-906 intervention description TAK-906 Capsules. intervention arm group label list intervention arm group label Sequence 1: TAK 906 50 mg (Treatment A+Treatment B+Treatment A+Treatment B+Treatment C) Sequence 2: TAK-906 50 mg (Treatment B+Treatment A+Treatment B+Treatment A+Treatment C) outcomes module primary outcome list primary outcome primary outcome measure Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State primary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose primary outcome measure Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State primary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose primary outcome measure Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State primary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome list secondary outcome secondary outcome measure Number of Participants Reporting one or More Adverse Events (AEs) secondary outcome time frame Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31) secondary outcome measure Number of Participants Reporting one or More Serious Adverse Events (SAEs) secondary outcome time frame Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31) secondary outcome measure Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure AUC%extrap: Percent of AUCinf Extrapolated After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure Tmax: Time to Reach Maximum Plasma Concentration After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure Tlag: Lag Time to First Quantifiable Concentration After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure Kel: Apparent Terminal First Order Elimination Rate Constant After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure CL/F: Apparent Plasma Clearance After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose secondary outcome measure t½: Terminal Half-life After Single Dose of TAK-906 secondary outcome time frame Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose eligibility module eligibility criteria Inclusion Criteria: Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting and urine cotinine test. Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 30.0 kilogram per square meter (kg/m^2) at the screening. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs) performed at the screening visit and before administration of the initial dose of trial drug, as deemed by the investigator or designee. Exclusion Criteria: Presence of infectious diseases (example, Coronavirus disease-19 [COVID-19] and flu) at the time of screening or check-in. Any history of major surgery that may affect absorption, metabolism or excretion of study drug (example, intestinal resections, hepatectomy, nephrectomy, cholecystectomy), and/or digestive organ resection (except appendectomy). History of any illness that, in the opinion of the investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing. Positive urine drug or alcohol results at screening or check-in. Positive urine cotinine at screening. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). QT interval corrected for heart rate using Frederica's equation (QTcF) is greater than (>) 450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening. Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening. Unable to refrain from or anticipates the use of: o Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (up to 2 grams [g] per 24 hours) may be administered at the discretion of the investigator or designee; sponsor must be consulted prior to administering acetaminophen to a participants. Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within 30 days prior to the first dosing and throughout the study. Is lactose intolerant or unable/unwilling to eat the high-fat, high-calorie breakfast. Donation of blood or significant blood loss within 56 days prior to the first dosing. Plasma donation within 7 days prior to the first dosing. Participation in another clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dosing. The 30-day window or 5 half lives (whichever is longer) will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name Study Director overall official affiliation Takeda overall official role Study Director location list location location facility Celerion location city Tempe location state Arizona location zip 85283 location country United States references module see also link list see also link see also link label To obtain more information on the study, click here/on this link see also link u r l https://clinicaltrials.takeda.com/study-detail/606d6617620b3b001e9dbb59 i p d sharing statement module i p d sharing Yes i p d sharing description Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing access criteria IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. i p d sharing u r l https://vivli.org/ourmember/takeda/ derived section misc info module version holder December 02, 2022
NCT04831502
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full study rank 61319 study protocol section identification module n c t id NCT04838015 org study id info org study id 8037 organization org full name University Hospital, Strasbourg, France org class OTHER brief title Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS official title Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS acronym SEP-RR status module status verified date February 2021 overall status Recruiting expanded access info has expanded access No start date struct start date November 13, 2020 start date type Actual primary completion date struct primary completion date November 13, 2021 primary completion date type Anticipated completion date struct completion date November 13, 2021 completion date type Anticipated study first submit date February 26, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 13, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University Hospital, Strasbourg, France lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Multiple Sclerosis (MS) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system. The diagnosis resides in clinical and radiological criteria according to 2017 McDonald criteria. Once the diagnosis of MS has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy. Ocrelizumab is used as a first-line or second-line treatment in Relapsing Remitting MS (RRMS) It is an anti-CD20 monoclonal antibody that provides rapid depletion of circulating CD20+ B lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. The main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of MS. The secondary objective is the search of predictive factors of response to treatment. conditions module condition list condition Multiple Sclerosis keyword list keyword MS-RR Ocrelizumab Switch design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 250 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Retrospective study of the impact of ocrelizumab used in patients with multiple sclerosis primary outcome time frame Files analysed retrospectively from October 01, 2018 to November 31, 2020 will be examined] eligibility module eligibility criteria Inclusion criteria: Major subject (≥18 years old) Suffering from relapsing-remitting MS (RRMS) Supported in a neurology department at Strasbourg or Nancy University Hospital between 10/01/2018 and 11/31/2020. Treated with ocrelizumab 600mg every 6 months during the period from 01/10/2018 to 01/05/2020. Have had an M0, M3 / M6 and M12 MRI after initiation of treatment. Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research Exclusion criteria: Subject having expressed opposition to participating in the study Primary progressive multiple sclerosis (MS-PP), secondarily progressive (MS-SP) Subject not meeting all the inclusion criteria Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.) Subjects under safeguard of justice Subject under guardianship or guardianship gender All minimum age 18 Years std age list std age Adult Older Adult study population Major subject Suffering from relapsing-remitting MS sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Nicolas COLLONGUES, MD central contact role Contact central contact phone 33 3 88 12 87 33 central contact e mail nicolas.collongues@chru-strasbourg.fr central contact name Saïd CHAYER, PhD, HDR central contact role Contact central contact phone 33 3 88 11 66 90 central contact e mail said.chayer@chru-strasbourg.fr location list location location facility Hautepierre Clinical Investigation Center - Strasbourg University Hospitals location status Recruiting location city Strasbourg location zip 67091 location country France location contact list location contact location contact name Nicolas COLLONGUES, MD location contact role Contact location contact phone 33 3 88 12 87 33 location contact e mail nicolas.collongues@chru-strasbourg.fr location contact name Saïd CHAYER, PhD, HDR location contact role Contact location contact phone 33 3 88 11 66 90 location contact e mail said.chayer@chru-strasbourg.fr location contact name Nicolas COLLONGUES, MD location contact role Principal Investigator location contact name Margaux TIBERI, MD location contact role Sub-Investigator location contact name Kévin BIGAUT, MD location contact role Sub-Investigator location contact name Nicolas MEYER, MD, PhD location contact role Sub-Investigator location contact name Guillaume MATHEY, MD location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009103 condition mesh term Multiple Sclerosis condition ancestor list condition ancestor condition ancestor id D000020278 condition ancestor term Demyelinating Autoimmune Diseases, CNS condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000003711 condition ancestor term Demyelinating Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11212 condition browse leaf name Multiple Sclerosis condition browse leaf as found Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M14567 condition browse leaf name Sclerosis condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21251 condition browse leaf name Demyelinating Autoimmune Diseases, CNS condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M6061 condition browse leaf name Demyelinating Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M288912 intervention browse leaf name Ocrelizumab intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04838015
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full study rank 61922 study protocol section identification module n c t id NCT04830163 org study id info org study id STUDY00000896 organization org full name University of Texas at Austin org class OTHER brief title Brain State-dependent PCMS in Chronic Stroke official title Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation status module status verified date December 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 1, 2022 start date type Actual primary completion date struct primary completion date July 2024 primary completion date type Anticipated completion date struct completion date July 2025 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date December 1, 2022 last update post date struct last update post date December 2, 2022 last update post date type Estimate sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Texas at Austin lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary After stroke, people often have difficulty using their hands. Combined brain and nerve stimulation can strengthen the neural pathways that control hand function. In this study, we will deliver combined brain and nerve stimulation during specific time windows that increase activation of neural pathways underlying hand function. We will compare the effects of combined brain and nerve stimulation during these optimal time windows to the effects of combined brain and nerve stimulation applied during random time windows on post-stroke hand function. conditions module condition list condition Stroke keyword list keyword chronic, movement design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation Randomized design intervention model Single Group Assignment design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 45 enrollment type Anticipated arms interventions module arm group list arm group arm group label PCMS during brain states reflecting strong corticospinal transmission arm group type Experimental arm group intervention list arm group intervention name Combination Product: Brain state-dependent paired corticomotoneuronal stimulation (PCMS) arm group label PCMS during random brain states arm group type Active Comparator arm group intervention list arm group intervention name Combination Product: Brain state-dependent paired corticomotoneuronal stimulation (PCMS) intervention list intervention intervention type Combination Product intervention name Brain state-dependent paired corticomotoneuronal stimulation (PCMS) intervention description Paired corticomotoneuronal stimulation (PCMS) involves delivering precisely timed pairs of transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) so that the neuronal activity evoked by such stimulation arrives synchronously at corticospinal-motoneuronal synapses. This synchronous arrival is postulated to cause long-term potentiation via spike timing-dependent plasticity, which then improves corticospinal transmission and hand function. In this study, paired corticomotoneuronal stimulation (PCMS) will be applied during specific brain states that reflect increased recruitment of motoneurons via the corticospinal tract. This increased recruitment is expected to enhance the beneficial effects of PCMS on human hand function after stroke. intervention arm group label list intervention arm group label PCMS during brain states reflecting strong corticospinal transmission PCMS during random brain states outcomes module primary outcome list primary outcome primary outcome measure Maximum hand force output primary outcome description This will be measured using maximum voluntary contractions of the stroke-affected first dorsal interosseous hand muscle during pinching actions. primary outcome time frame up to 1 hour after intervention primary outcome measure Maximum hand muscle activation primary outcome description This will be measured using electromyography recordings of the stroke-affected first dorsal interosseous muscle during maximum voluntary contractions during pinching actions primary outcome time frame up to 1 hour after intervention secondary outcome list secondary outcome secondary outcome measure Amplitude of motor evoked potentials secondary outcome description This will be measured as the peak-to-peak amplitude of motor-evoked potentials recorded from the stroke-affected first dorsal interosseous muscle secondary outcome time frame up to 1 hour after intervention secondary outcome measure Time to complete the 9-hole peg test secondary outcome description This will be measured as the time needed to complete the task using the stroke-affected hand. secondary outcome time frame up to 1 hour after intervention eligibility module eligibility criteria Inclusion Criteria: History of stroke > 6 months ago Presence of residual upper extremity hemiparesis Willingness to participate Ability to provide informed consent Upper extremity Fugl-Meyer score < 66 Mini Mental State Exam score > 24 Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere Exclusion Criteria: History of neurological disease other than stroke Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants. Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale) Mini Mental State Exam score <= 24 No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility University of Texas at Austin location status Recruiting location city Austin location state Texas location zip 78712 location country United States location contact list location contact location contact name Sara Hussain location contact role Contact location contact phone 512-232-2686 location contact e mail sara.hussain@austin.utexas.edu i p d sharing statement module i p d sharing Undecided i p d sharing description Individual participant data may be shared using an open-access data repository. No personally-identifiable information will be shared. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000020521 condition mesh term Stroke condition ancestor list condition ancestor condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf as found Stroke condition browse leaf relevance high condition browse leaf id M13515 condition browse leaf name Protein-Energy Malnutrition condition browse leaf relevance low condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04830163
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full study rank 61431 study protocol section identification module n c t id NCT04836559 org study id info org study id CR108943 secondary id info list secondary id info secondary id 2020-003698-24 secondary id type EudraCT Number secondary id 40411813EPY2001 secondary id type Other Identifier secondary id domain Janssen Research & Development, LLC organization org full name Janssen Research & Development, LLC org class INDUSTRY brief title A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy official title A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-40411813 as Adjunctive Therapy in Subjects With Focal Onset Seizures With Suboptimal Response to Levetiracetam or Brivaracetam status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 18, 2021 start date type Actual primary completion date struct primary completion date April 1, 2024 primary completion date type Anticipated completion date struct completion date April 15, 2026 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 9, 2022 last update post date struct last update post date November 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Janssen Research & Development, LLC lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of this study is to evaluate the efficacy of up to 3 dose levels of adjunctive JNJ-40411813 compared to placebo based on the time to baseline monthly seizure count in participants with focal onset seizures who are receiving levetiracetam or brivaracetam and up to 3 other anti-epileptic drugs (AEDs) (double-blind treatment period) and to evaluate the long-term efficacy and safety of adjunctive therapy with JNJ-40411813 in participants with epilepsy (open-label extension [OLE] period). detailed description JNJ-40411813 is a positive allosteric modulator (PAM) of the metabotropic glutamate receptor-2 (mGlu2), which is abundantly expressed in the forebrain and cerebellum. The mGlu2 receptor functions as a presynaptic auto-receptor that, upon activation, decreases the release of the excitatory neurotransmitter glutamate. Positive allosteric modulation of a receptor will result in the direct enhancement of the agonist-induced signal while PAMs themselves have generally no or low intrinsic activity at the receptor. The net effect of JNJ-40411813 is hypothesized to be a normalization of hyper-glutamatergic transmission. JNJ-40411813 is being evaluated for the treatment of disorders of the central nervous systems (CNS), such as epilepsy, and has been evaluated in schizophrenia and anxious depression. This study will consist of 1 to a maximum of 3 cohorts. In each cohort, for each participant the study consists of a screening period (up to minus [-] 8 weeks), an 8-week prospective pretreatment baseline period, an up to 12-week double-blind treatment period and a 2-year OLE period or a follow-up telephone visit 2 weeks after the last dose of study intervention. Safety assessments including physical and neurological examination, vital signs, 12 lead electrocardiogram (ECG), clinical chemistry, hematology, and urinalysis will be performed. The total maximal duration of the study is up to 2 years and 5 months. conditions module condition list condition Focal Onset Seizures design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 160 enrollment type Anticipated arms interventions module arm group list arm group arm group label JNJ-40411813 arm group type Experimental arm group description Participants will receive JNJ-40411813 twice a day (bid) up to 12 weeks in double blind period. Up to 3 different doses (low, medium, high) of JNJ-40411813 will be administered in this study. Participants will also receive concomitant anti-epileptic drugs (AEDs) one of which must include levetiracetam or brivaracetam. Immediately after the last study drug intake by the participants in the double-blind period, participants will enter into a 2-year open label extension (OLE) period and continue receiving JNJ-40411813 as well as the AEDs during OLE period. arm group intervention list arm group intervention name Drug: JNJ-40411813 arm group label Placebo arm group type Placebo Comparator arm group description Participants will receive JNJ-40411813 matching placebo (bid) up to 12 weeks. Participants will also receive concomitant AEDs one of which must include levetiracetam or brivaracetam during double blind period. Participants who had been receiving placebo in double blind period will start with the JNJ-40411813 dose in the OLE period. arm group intervention list arm group intervention name Drug: JNJ-40411813 Drug: Placebo intervention list intervention intervention type Drug intervention name JNJ-40411813 intervention description JNJ-40411813 will be administered orally. intervention arm group label list intervention arm group label JNJ-40411813 Placebo intervention type Drug intervention name Placebo intervention description Placebo will be administered orally. intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Time to Baseline Monthly Seizure Count up to the end of the 12-week Double-blind Treatment Period primary outcome description Time to baseline monthly seizure count is defined, for each participant, as the number of days until the participants experienced the number of seizures equal to baseline monthly seizure count, up to the end of the 12-week double-blind treatment period. Baseline monthly seizure count will be defined as the number of observable focal onset seizures recorded during the baseline period, multiplied by 28/ XBL, where XBL is the number of days comprising the baseline. primary outcome time frame Baseline to 12 weeks primary outcome measure Open Label Extension (OLE) Period: Seizure Count primary outcome description Seizure count will be reported. Seizure count per 28 days will be calculated as (28/the number of days between visits)*(seizures counted between the visits). primary outcome time frame Up to 2 years in OLE period primary outcome measure OLE Period: Number of Participants with Adverse Events (AEs) primary outcome description An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. primary outcome time frame Up to 2 years in OLE period primary outcome measure OLE Period: Number of Participants with Clinically Significant Changes in Vital Signs primary outcome description Number of participants with clinically significant changes in vital signs including blood pressure and oral or tympanic temperature will be reported. primary outcome time frame Up to 2 years in OLE period primary outcome measure OLE Period: Number of Participants with Clinically Significant Changes in Laboratory Assessments primary outcome description Number of participants with clinically significant changes in laboratory assessments including hematology, serum chemistry, serology, and urinalysis will be reported. primary outcome time frame Up to 2 years in OLE period secondary outcome list secondary outcome secondary outcome measure Double Blind Treatment Period: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability secondary outcome description An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. secondary outcome time frame Up to 22 weeks secondary outcome measure Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Laboratory Results secondary outcome description Number of participants with clinically significant changes in laboratory results related to hematology, serum chemistry, serology, and urinalysis will be reported. secondary outcome time frame Up to 12 weeks secondary outcome measure Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Vital Signs secondary outcome description Number of participants with clinically significant changes in vital signs including blood pressure and oral or tympanic temperature will be reported. secondary outcome time frame Up to 12 weeks secondary outcome measure Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results secondary outcome description Number of participants with clinically significant changes in ECG results will be reported. secondary outcome time frame Up to 12 weeks secondary outcome measure Double Blind Treatment Period: Percent reduction in the Double-blind Monthly Seizure Count secondary outcome description Percent reduction in the double-blind monthly seizure count is defined as the double-blind monthly seizure count minus the baseline monthly seizure count, divided by the baseline monthly seizure count. The double-blind monthly seizure count is defined as the total number of observable focal onset seizures occurring during the 12-week double blind treatment period, multiplied by 28/XDB, where XDB is the number of days comprising the double-blind period. Observable seizures that will be counted during baseline and throughout the study include focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures will not be counted. secondary outcome time frame Baseline, up to 12 weeks secondary outcome measure Double Blind Treatment Period: Percentage of Participants with no Seizures During Double-blind Period and who Achieve a More than (>) 50 Percent (%) Reduction in Monthly Seizure Count Relative to Baseline Monthly Seizure Count secondary outcome description Percentage of participants with no seizures during double-blind period and who achieve a > 50% reduction in monthly seizure count relative to baseline monthly seizure count will be reported. secondary outcome time frame Baseline, up to 12 weeks secondary outcome measure Double Blind Treatment Period: Plasma Concentration of JNJ-40411813 secondary outcome description Plasma samples will be analyzed to determine concentration of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC -MS/MS) methods. secondary outcome time frame Baseline (Day 1), Weeks 4, 8, and 12 secondary outcome measure Double Blind Treatment Period: Plasma Concentration of Levetiracetam or Brivaracetam secondary outcome description Plasma samples will be analyzed to determine concentration of levetiracetam or brivaracetam using a validated, specific, and sensitive LC -MS/MS methods. secondary outcome time frame Baseline (Day 1), Weeks 4, 8, and 12 secondary outcome measure OLE Period: Plasma Concentration of JNJ-40411813 secondary outcome description Plasma samples will be analyzed to determine concentration of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC -MS/MS) methods. secondary outcome time frame Up to 1 year in OLE period secondary outcome measure OLE Period: Plasma Concentration of Anti-epileptic Drugs (AEDs) secondary outcome description Plasma samples will be analyzed to determine concentration of AEDs using a validated, specific, and sensitive LC-MS/MS methods. secondary outcome time frame Up to 1 year in OLE period secondary outcome measure OLE Period: Plasma Concentration of Levetiracetam or Brivaracetam secondary outcome description Plasma samples will be analyzed to determine concentration of levetiracetam or brivaracetam using a validated, specific, and sensitive LC MS/MS methods. secondary outcome time frame Up to 1 year in OLE period eligibility module eligibility criteria Inclusion Criteria: Body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2). Minimum body weight should be 40-kilogram (kg) Established diagnosis of focal epilepsy, for at least 1 year using the International League Against Epilepsy (ILAE) criteria. Participants should not be enrolled if they are known to have had fewer than 3 or more than 100 seizures in any monthly period in the past 6 months. It is preferred that participants have experience in maintaining a seizure e-diary Must have had a neuroimaging procedure within 10 years, including a computed tomography (CT) scan or magnetic resonance imaging (MRI), that excluded a progressive neurologic disorder; these procedures may be performed within the 8-week baseline period Cohort 1: Current treatment with at least 1 and up to 4 anti-epileptic drugs (AEDs) (including levetiracetam), administered at stable dosage(s) for at least 1 month before screening, and no new AEDs added for the previous 2 months; these AEDs must remain unchanged throughout the pretreatment and double-blind treatment periods (with the exception of dosage reductions of concomitant AEDs because of suspected elevated AED levels or side effects) Cohort 2 and beyond: Current treatment with at least 1 and up to 4 AEDs (including levetiracetam or brivaracetam), administered at the appropriate dosage(s) and for a sufficient treatment period before screening. These AEDs must remain unchanged throughout the pretreatment and double-blind treatment periods (with the exception of dosage reductions of concomitant AEDs because of suspected elevated AED levels or side effects). Important note: screening of participants receiving brivaracetam will start when enrolling for Cohort 2 Currently showing inadequate response to levetiracetam, administered at the appropriate dosage(s) and for a sufficient treatment period, based on the judgment of the investigator Healthy based on clinical laboratory tests, physical examination, medical history, vital signs, and 12-lead ECG Men or women between 18 and 69 years old Exclusion Criteria: Have a generalized epileptic syndrome Diagnosis of Lennox-Gastaut Syndrome Currently experiencing seizures that cannot be counted accurately History of any current or past nonepileptic seizures, including psychogenic seizures Known allergies, hypersensitivity, or intolerance to placebo, JNJ-40411813 or its excipients Current treatment with vagus nerve stimulation, deep brain and cortical stimulation for 1 year or less Planned epilepsy surgery within the next 6 months or completed epilepsy surgery less than (<) 6 months ago Current treatment with vigabatrin History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) Current or past (within the past year) major psychotic disorder, such as schizophrenia, bipolar disorder, or other psychotic conditions, recent (within the past 6 months) interictal psychosis, and major depressive disorder (MDD) with psychotic features Exacerbation of MDD within the past 6 months; antidepressant use is allowed Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 (active suicidal ideation with some intent to act, without specific plan) or 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past 1 year, as validated by the CSSRS at screening Has a history of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 1 year before Screening healthy volunteers No gender All minimum age 18 Years maximum age 69 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Study Contact central contact role Contact central contact phone 844-434-4210 central contact e mail Participate-In-This-Study@its.jnj.com overall official list overall official overall official name Janssen Research & Development, LLC Clinical Trial overall official affiliation Janssen Research & Development, LLC overall official role Study Director location list location location facility Tucson Neuroscience Research location status Completed location city Tucson location state Arizona location zip 85710 location country United States location facility Research Institution of Orlando, LLC location status Completed location city Orlando location state Florida location zip 32806 location country United States location facility Accel Research Sites location status Completed location city Port Orange location state Florida location zip 32127 location country United States location facility Emory University School of Medicine location status Not yet recruiting location city Atlanta location state Georgia location zip 30307 location country United States location facility Ascension Medical Group location status Withdrawn location city Wichita location state Kansas location zip 67214 location country United States location facility Maine Medical Center location status Recruiting location city Scarborough location state Maine location zip 04074 location country United States location facility Mid-Atlantic Epilepsy and Sleep Center location status Recruiting location city Bethesda location state Maryland location zip 20817 location country United States location facility Clinical Research Professionals location status Withdrawn location city Chesterfield location state Missouri location zip 63005 location country United States location facility Thomas Jefferson University Hospital location status Recruiting location city Philadelphia location state Pennsylvania location zip 19107 location country United States location facility Vanderbilt University Medical Center location status Not yet recruiting location city Nashville location state Tennessee location zip 37212 location country United States location facility University of Virginia location status Recruiting location city Charlottesville location state Virginia location zip 22903 location country United States location facility AZ Sint-Jan location status Not yet recruiting location city Brugge location zip 8000 location country Belgium location facility Cliniques Universitaires Saint-Luc location status Not yet recruiting location city Bruxelles location zip 1200 location country Belgium location facility UZ Antwerpen location status Not yet recruiting location city Edegem location zip 2650 location country Belgium location facility Az Groeninge location status Recruiting location city Kortrijk location zip 8500 location country Belgium location facility UZ Leuven location status Not yet recruiting location city Leuven location zip B-3000 location country Belgium location facility CHU UCL Namur - Site Godinne location status Not yet recruiting location city Yvoir location zip 5530 location country Belgium location facility Vivantes Humboldt Klinikum location status Recruiting location city Berlin location zip 13509 location country Germany location facility Krankenhaus Mara - Bethel location status Recruiting location city Bielefeld location zip 33617 location country Germany location facility Universitatsklinikum Bonn location status Recruiting location city Bonn location zip 53127 location country Germany location facility Universitaetsklinik Erlangen location status Recruiting location city Erlangen location zip 91054 location country Germany location facility Universitaetsklinikum Frankfurt location status Recruiting location city Frankfurt location zip 60590 location country Germany location facility Universitaetsmedizin Greifswald location status Withdrawn location city Greifswald location zip 17475 location country Germany location facility Evangelisches Krankenhaus Alsterdorf gGmbH location status Withdrawn location city Hamburg location zip 22337 location country Germany location facility Diakonie Kork - Epilepsiezentrum location status Recruiting location city Kehl-Kork location zip 77694 location country Germany location facility Universitaetsklinikum Giessen und Marburg GmbH location status Recruiting location city Marburg location zip 35043 location country Germany location facility Klinikum Großhadern der Ludwig-Maximilians-Universität location status Withdrawn location city München location zip 81377 location country Germany location facility Chungnam National University Hospital location status Recruiting location city Daejeon location zip 35015 location country Korea, Republic of location facility Seoul National University Hospital location status Recruiting location city Seoul location zip 03080 location country Korea, Republic of location facility Severance Hospital, Yonsei University Health System location status Recruiting location city Seoul location zip 03722 location country Korea, Republic of location facility Konkuk University Medical Center location status Recruiting location city Seoul location zip 05030 location country Korea, Republic of location facility Asan Medical Center location status Recruiting location city Seoul location zip 05505 location country Korea, Republic of location facility Samsung Medical Center location status Recruiting location city Seoul location zip 06351 location country Korea, Republic of location facility Centrum Medyczne Neuromedica location status Withdrawn location city Bydgoszcz location zip 85-163 location country Poland location facility Copernicus Podmiot Leczniczy Sp. z o.o location status Recruiting location city Gdansk location zip 80-803 location country Poland location facility NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis' location status Recruiting location city Katowice location zip 40-123 location country Poland location facility Centrum Terapii SM location status Recruiting location city Katowice location zip 40-571 location country Poland location facility NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna location status Recruiting location city Katowice location zip 40-686 location country Poland location facility Specjalistyczne Gabinety Lekarskie location status Recruiting location city Krakow location zip 31-156 location country Poland location facility Centrum Leczenia Padaczki i Migreny. NZOZ location status Recruiting location city Kraków location zip 31-209 location country Poland location facility Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj location status Recruiting location city Ksawerów location zip 95-054 location country Poland location facility Clinical Best Solutions Sp. z o.o., Sp. K. location status Recruiting location city Lublin location zip 20-078 location country Poland location facility Twoja Przychodnia - Centrum Medyczne Nowa Sol location status Recruiting location city Nowa Sol location zip 67-100 location country Poland location facility Clinical Research Center sp. z o.o MEDIC-R s.k. location status Recruiting location city Poznan location zip 61-731 location country Poland location facility NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy location status Recruiting location city Poznan location zip 61-853 location country Poland location facility MTZ Clinical Research Powered by Pratia location status Recruiting location city Warszawa location zip 02-172 location country Poland location facility Institute of Psychiatry and Neurology location status Not yet recruiting location city Warszawa location zip 02-957 location country Poland location facility Centrum Medyczne Oporow location status Recruiting location city Wrocław location zip 52-416 location country Poland location facility Republic Clinical Hospital location status Completed location city Kazan location zip 420064 location country Russian Federation location facility Research Medical Center Your Health location status Completed location city Kazan location zip 420097 location country Russian Federation location facility Specialized clinical psychiatric hospital #1 location status Completed location city Krasnodar location zip 350007 location country Russian Federation location facility Clinical City Hospital #1 location status Completed location city Moscow location zip 119049 location country Russian Federation location facility Nizny Novgorod clinical psychiatric hospital 1 location status Completed location city Nizny Novgorod location zip 603155 location country Russian Federation location facility SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky location status Completed location city Saratov location zip 410028 location country Russian Federation location facility Smolensk Regional Clinical Hospital location status Completed location city Smolensk location zip 214018 location country Russian Federation location facility Psychoneurological Dispensary of Frunzensky District location status Completed location city St-Petersburg location zip 190013 location country Russian Federation location facility Psychoneurological dispensary 10 location status Withdrawn location city St-Petersburg location zip 190121 location country Russian Federation location facility St-Petersburg Bekhterev Psychoneurological Research Institute location status Completed location city St-Petersburg location zip 192109 location country Russian Federation location facility Yaroslavl State Medical University location status Completed location city Yaroslavl location zip 150000 location country Russian Federation location facility Hosp. Del Mar location status Recruiting location city Barcelona location zip 08003 location country Spain location facility Hosp. Univ. Vall D Hebron location status Recruiting location city Barcelona location zip 08035 location country Spain location facility Hosp. Clinic I Provincial de Barcelona location status Recruiting location city Barcelona location zip 08036 location country Spain location facility Hosp. de La Santa Creu I Sant Pau location status Recruiting location city Barcelona location zip 08041 location country Spain location facility Hosp. Univ. de La Princesa location status Recruiting location city Madrid location zip 28006 location country Spain location facility Hosp. Regional Univ. de Malaga location status Recruiting location city Malaga location zip 29010 location country Spain location facility Centro Neurologia Avanzada Sevilla location status Recruiting location city Sevilla location zip 41013 location country Spain location facility Hosp. Mutua Terrassa location status Not yet recruiting location city Terrassa location zip 08222 location country Spain location facility Centro de Inv. Avanzada Neurociencias location status Recruiting location city Zaragoza location zip 50001 location country Spain location facility Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc location status Terminated location city Dnipro location zip 49005 location country Ukraine location facility Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3' location status Withdrawn location city Kharkiv location zip 61068 location country Ukraine location facility Medical Center of Private Enterprise Neuron location status Terminated location city Kharkiv location zip 61091 location country Ukraine location facility Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa) location status Withdrawn location city Kyiv location zip 02192 location country Ukraine location facility Mnpe of Lviv Regional Council 'Lviv Regional Clinical Psycho-Neurological Dispensary' location status Withdrawn location city Lviv location zip 79000 location country Ukraine location facility Cnce of Lviv Regional Council 'Lviv Regional Clinical Hospital' location status Terminated location city Lviv location zip 79010 location country Ukraine location facility Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council' location status Completed location city Nove Settlement, Kropyvnytskyi location zip 25491 location country Ukraine location facility Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb location status Terminated location city Ternopil location zip 46027 location country Ukraine location facility Llc Diamed Medical Center location status Completed location city Uzhhorod location zip 88000 location country Ukraine location facility Cnpe 'Vinnytsia Regional Clinical Psycho-Neurological Hospital N.A. Ac. O.I. Yushchenko' of Vrc location status Completed location city Vinnytsya location zip 21037 location country Ukraine i p d sharing statement module i p d sharing Yes i p d sharing description The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu i p d sharing u r l https://www.janssen.com/clinical-trials/transparency derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012640 condition mesh term Seizures condition ancestor list condition ancestor condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M7135 condition browse leaf name Epilepsy condition browse leaf relevance low condition browse leaf id M14604 condition browse leaf name Seizures condition browse leaf as found Seizures condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M249645 intervention browse leaf name Brivaracetam intervention browse leaf relevance low intervention browse leaf id M1741 intervention browse leaf name Levetiracetam intervention browse leaf relevance low intervention browse leaf id M3398 intervention browse leaf name Anticonvulsants intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AntiConv intervention browse branch name Anticonvulsants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev NootAg intervention browse branch name Nootropic Agents
NCT04836559
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full study rank 61901 study protocol section identification module n c t id NCT04830436 org study id info org study id Denutrition_AVC2 organization org full name Groupe Hospitalier Paris Saint Joseph org class OTHER brief title Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke official title Analysis of the Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke acronym Denut_AVC status module status verified date June 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 31, 2021 start date type Actual primary completion date struct primary completion date May 4, 2021 primary completion date type Actual completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date June 29, 2022 last update post date struct last update post date June 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Groupe Hospitalier Paris Saint Joseph lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Undernutrition is a frequent problem in hospitals (at least 30% of patients, SENECA-NHANES studies). Its impact on morbidity and mortality is well known in gerontology, oncology and intensive care. There are very few neurovascular studies dealing with the consequences of undernutrition present before the stroke. Indeed, most of the medical literature concerns only undernutrition acquired after a stroke. The investigator propose to analyze medical data from a cohort of patients over 70 years of age thrombolysed and/or thrombectomized in the neurovascular department between the years 2014 and 2019. conditions module condition list condition Stroke design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 248 enrollment type Actual outcomes module primary outcome list primary outcome primary outcome measure Clinical evolution of the patients: NIHSS primary outcome description This outcome correspond to the National Institute of Health Stroke Score (NIHSS) at day 5. The score is 0: No stroke symptoms; 1-4: Minor stroke; 5-15: Moderate stroke; 16-20: Moderate to severe stroke; 21-42 : Severe stroke. primary outcome time frame Day 5 primary outcome measure Modified Rankin Scale primary outcome description The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Rankin scale: 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. primary outcome time frame Month 3 eligibility module eligibility criteria Inclusion Criteria: Patients over 70 years of age with cerebral infarction, thrombolysed and/or thrombectomized between 2014 and 2019, managed in the Neurology and Neurovascular Department of the Paris Saint-Joseph Hospital French-speaking patient Exclusion Criteria: Patients with non-thrombolyzed stroke Patient with a TIA (Transient Ischemic Attack) Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Patients who object to the use of their data for this research healthy volunteers No gender All minimum age 70 Years std age list std age Older Adult study population Patients hospitalized for cerebral infarction who received thrombolysis and/or thrombectomy treatment between 2014 and 2019 sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Marie Bruandet, MD overall official affiliation Groupe Hospitalier Paris Saint Joseph overall official role Principal Investigator location list location location facility Groupe Hospitalier Paris Saint-Joseph location city Paris location zip 75014 location country France references module reference list reference reference p m i d 26420177 reference type background reference citation Zhang J, Zhao X, Wang A, Zhou Y, Yang B, Wei N, Yu D, Lu J, Chen S, Wang Y, Wang C, Xue R, Zhang Y, Li Y, Yu L, Wang S, Chen Z, Zheng T, Zhang Z, Xia M, He M, Li W, Zhang Z, Zeng F, Chen S, Fu Y, Liu G, Wang L, Huang Z, Ma J, Mu F, Xu Y, Huang R, Wang L, Wang Y. Emerging malnutrition during hospitalisation independently predicts poor 3-month outcomes after acute stroke: data from a Chinese cohort. Asia Pac J Clin Nutr. 2015;24(3):379-86. doi: 10.6133/apjcn.2015.24.3.13. reference p m i d 18195138 reference type background reference citation Yoo SH, Kim JS, Kwon SU, Yun SC, Koh JY, Kang DW. Undernutrition as a predictor of poor clinical outcomes in acute ischemic stroke patients. Arch Neurol. 2008 Jan;65(1):39-43. doi: 10.1001/archneurol.2007.12. reference p m i d 8303747 reference type background reference citation Unosson M, Ek AC, Bjurulf P, von Schenck H, Larsson J. Feeding dependence and nutritional status after acute stroke. Stroke. 1994 Feb;25(2):366-71. reference p m i d 1687315 reference type background reference citation Euronut - SENECA. Nutrition and the elderly in Europe. 1st European Congress on Nutrition and Health in the Elderly. The Netherlands, December 1991. Eur J Clin Nutr. 1991 Dec;45 Suppl 3:1-196. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000020521 condition mesh term Stroke condition mesh id D000044342 condition mesh term Malnutrition condition ancestor list condition ancestor condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf as found Stroke condition browse leaf relevance high condition browse leaf id M24459 condition browse leaf name Malnutrition condition browse leaf as found Undernutrition condition browse leaf relevance high condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases
NCT04830436
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full study rank 61531 study protocol section identification module n c t id NCT04835259 org study id info org study id Soh-Med-21-01-10 organization org full name Sohag University org class OTHER brief title Efficacy of Topical Antioxidants in Tretment of Photoaging official title Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 2021 start date type Anticipated primary completion date struct primary completion date April 2022 primary completion date type Anticipated completion date struct completion date June 2022 completion date type Anticipated study first submit date January 19, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 18, 2021 last update post date struct last update post date April 20, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name esraa ismail responsible party investigator title assistant lecturer responsible party investigator affiliation Sohag University lead sponsor lead sponsor name Sohag University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary This randomized controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin. detailed description •Sample size calculation: The sample size was assessed prospectively using Openepi version 3.01 to provide a 80% power to detect a 40-50% difference before and after treatment using either topical antioxidants or retinoids with a significance level of 0.05 (based on the results of a previous clinical trial). Assuming 10% dropout, 30 patients will be recruited in each treatment group. •Statistical analysis: Data will be collected and recorded on excel data sheet. Data will be tested for normality. Quantitative data will be represented as mean and standard deviation, or median and interquartile range. Qualitative data will be presented as number and percentage. The relevant statistical method will be used for comparison. P value will be considered statistically significant if it is less than 0.05 conditions module condition list condition Photoaging keyword list keyword topical antioxidants photoaged skin design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 90 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group 1(treatment group) arm group type Active Comparator arm group description Topical application of a cream of a combination of antioxidants once daily at night for 6 months Name: Selenium ACE cream (Interpharma UK company, Egypt) Ingredients: Selenium (Selenium amino acid chelate) 0.5% Vitamin C (Sodium ascorbyl phosphate - stay C) %1 Vitamin E (Tocopheryl acetate) % 0.5 Vitamin A (Retinyl palmitate) %1 Emulsifiers ( Ceteareth 20 , Glycerol monostearate , Cetyl alcohol) Emollient(Caprylic capric triglycerides) arm group intervention list arm group intervention name Drug: Selenium Amino Acid Chelate (Selenium ACE cream) arm group label Group 2 (positive control) arm group type Active Comparator arm group description Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt) arm group intervention list arm group intervention name Drug: Selenium Amino Acid Chelate (Selenium ACE cream) arm group label Group 3 (Negative control) arm group type Placebo Comparator arm group description Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt) arm group intervention list arm group intervention name Drug: Selenium Amino Acid Chelate (Selenium ACE cream) intervention list intervention intervention type Drug intervention name Selenium Amino Acid Chelate (Selenium ACE cream) intervention description application of a topical agent over the whole face for 6 months intervention arm group label list intervention arm group label Group 1(treatment group) Group 2 (positive control) Group 3 (Negative control) intervention other name list intervention other name topical retinoid (Acretin 0.05% cream) topical panthenol (Panthenol cream) outcomes module primary outcome list primary outcome primary outcome measure change in Dermoscopy photoaging scale primary outcome description Dermoscopy photoaging scale (DPAS) is a reliable and valid diagnostic tool that can evaluate photoaged skin quantitatively by the help of objective criteria. It can be used to evaluate the effect of preventive and therapeutic applications for skin aging. primary outcome time frame assesed every month for 6 months eligibility module eligibility criteria Inclusion Criteria: Adult volunteers < 50 years old Clinical and dermoscopic features of photoaging. Exclusion Criteria: Genodermatoses associated with photosensitivity. Treatment by medications affecting skin aging (eg, topical and systemic retinoids) in the last 6 months prior to enrollment. Any recent cosmetic procedures. healthy volunteers Accepts Healthy Volunteers gender All minimum age 30 Years maximum age 50 Years std age list std age Adult contacts locations module central contact list central contact central contact name esraa ismail central contact role Contact central contact phone 00201000509636 central contact e mail esraasalah123@yahoo.com overall official list overall official overall official name esraa ismail overall official affiliation Sohag University overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012871 condition mesh term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf as found Photoaging condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000012643 intervention mesh term Selenium intervention ancestor list intervention ancestor intervention ancestor id D000000975 intervention ancestor term Antioxidants intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000014131 intervention ancestor term Trace Elements intervention ancestor id D000018977 intervention ancestor term Micronutrients intervention browse leaf list intervention browse leaf intervention browse leaf id M2929 intervention browse leaf name Ethanol intervention browse leaf relevance low intervention browse leaf id M22125 intervention browse leaf name Tocopherols intervention browse leaf relevance low intervention browse leaf id M16705 intervention browse leaf name Vitamin E intervention browse leaf relevance low intervention browse leaf id M22122 intervention browse leaf name alpha-Tocopherol intervention browse leaf relevance low intervention browse leaf id M16710 intervention browse leaf name Vitamins intervention browse leaf relevance low intervention browse leaf id M3665 intervention browse leaf name Ascorbic Acid intervention browse leaf relevance low intervention browse leaf id M3444 intervention browse leaf name Antioxidants intervention browse leaf relevance low intervention browse leaf id M6961 intervention browse leaf name Emollients intervention browse leaf relevance low intervention browse leaf id M14607 intervention browse leaf name Selenium intervention browse leaf as found Prenatal intervention browse leaf relevance high intervention browse leaf id M16696 intervention browse leaf name Vitamin A intervention browse leaf relevance low intervention browse leaf id M8248 intervention browse leaf name Glycerol intervention browse leaf relevance low intervention browse leaf id M16117 intervention browse leaf name Tretinoin intervention browse leaf relevance low intervention browse leaf id M22128 intervention browse leaf name Tocotrienols intervention browse leaf relevance low intervention browse leaf id M5012 intervention browse leaf name Chelating Agents intervention browse leaf relevance low intervention browse leaf id M302471 intervention browse leaf name Retinol palmitate intervention browse leaf relevance low intervention browse leaf id M346883 intervention browse leaf name Ascorbate-2-phosphate intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse leaf id M20162 intervention browse leaf name Micronutrients intervention browse leaf relevance low intervention browse leaf id M16037 intervention browse leaf name Trace Elements intervention browse leaf relevance low intervention browse leaf id T466 intervention browse leaf name Tocopherol intervention browse leaf relevance low intervention browse leaf id T480 intervention browse leaf name Vitamin E intervention browse leaf relevance low intervention browse leaf id T462 intervention browse leaf name Retinol intervention browse leaf relevance low intervention browse leaf id T477 intervention browse leaf name Vitamin C intervention browse leaf relevance low intervention browse leaf id T437 intervention browse leaf name Ascorbic Acid intervention browse leaf relevance low intervention browse leaf id T468 intervention browse leaf name Vitamin A intervention browse leaf relevance low intervention browse leaf id T467 intervention browse leaf name Tocotrienol intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev Derm intervention browse branch name Dermatologic Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev Vi intervention browse branch name Vitamins
NCT04835259
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full study rank 61751 study protocol section identification module n c t id NCT04832399 org study id info org study id PRT-TYS-12-10409 organization org full name Biogen org class INDUSTRY brief title Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants official title Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT) acronym TYPIFI status module status verified date April 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date November 12, 2013 start date type Actual primary completion date struct primary completion date August 31, 2023 primary completion date type Anticipated completion date struct completion date August 31, 2023 completion date type Anticipated study first submit date March 16, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 12, 2022 last update post date struct last update post date April 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Biogen lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS). conditions module condition list condition Relapsing Remitting Multiple Sclerosis design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Natalizumab arm group description Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks. arm group intervention list arm group intervention name Drug: Natalizumab intervention list intervention intervention type Drug intervention name Natalizumab intervention description As described in the treatment arm. intervention arm group label list intervention arm group label Natalizumab intervention other name list intervention other name Tysabri BG00002 outcomes module primary outcome list primary outcome primary outcome measure Overall Disease-Free Status at Month 12 primary outcome time frame Month 12 primary outcome measure Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year primary outcome time frame Month 12 primary outcome measure Annualized Relapse Rate at Month 12 in Comparison to the Previous Year primary outcome time frame Month 12 secondary outcome list secondary outcome secondary outcome measure Overall Disease-Free Status at Months 24, 36 and 48 secondary outcome time frame Months 24, 36 and 48 secondary outcome measure Clinical Disease-free Status Every 6 Months secondary outcome time frame Every 6 months (Up to 48 months) secondary outcome measure Annualized Relapse Rate (ARR) secondary outcome time frame Months 12, 24, 36 and 48 secondary outcome measure Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained) secondary outcome description The EDSS is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). secondary outcome time frame Months 12, 24, 36 and 48 secondary outcome measure MRI measures: T2, T1, T1 with Gadolinium (Gd) secondary outcome time frame Months 12, 24, 36 and 48 secondary outcome measure Cognitive Impairment Using Symbol Digit Modalities Test (SDMT) secondary outcome time frame Months 12, 24, 36 and 48 secondary outcome measure Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire secondary outcome description The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages ranging from 0-100%, with higher numbers indicating greater impairment and less productivity. secondary outcome time frame Months 12, 24, 36 and 48 secondary outcome measure Quality of life (QoL) Assessed Using Fatigue Severity Scale secondary outcome description The FSS is a self-assessment questionnaire that provides a score as a measurement of the severity of fatigue. It consists of 9 questions scored from 1 to 7. A low value (e.g., 1); indicates strong disagreement with the statement, whereas a high value (e.g., 7); indicates strong agreement. A total score of 36 or more suggests presence of fatigue. secondary outcome time frame Months 12, 24, 36 and 48 secondary outcome measure QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test secondary outcome description MSFC has 2 component- timed 25-foot walk (T25FW) and 9-hole peg test (9HPT) [dominant and nondominant hands]. The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT-2)/2, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z >0) or lower (Z <0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes. secondary outcome time frame Months 12, 24, 36 and 48 secondary outcome measure QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II) secondary outcome description BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression. secondary outcome time frame Months 12, 24, 36 and 48 secondary outcome measure QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29) secondary outcome description MSIS-29 is a brief self-administered instrument measuring physical (20 items) and psychological (9 items) impact of Multiple Sclerosis (MS). Each of the 29 items on MSIS-29 tool is a question that ask for participants views about the impact of MS on their day to day lives. Each item is scored on 1 to 5 (1=Not at all; 5=Extremely). secondary outcome time frame Months 12, 24, 36 and 48 eligibility module eligibility criteria Key Inclusion Criteria: Documented diagnosis of Relapsing Remitting Multiple Sclerosis (McDonald 2010 Criteria). EDSS ≤ 3.0. Must fulfill Tysabri indication (relapse and MRI criteria). Decision to start treatment with Natalizumab must precede enrollment. Up to four natalizumab infusions. Key Exclusion Criteria: Any prior treatment with Natalizumab. Prior imunossupressive treatment (Mitoxantrone, Azathioprine, Methotrexate, Cyclophosphamide, Mycophenolate, Cladribine, Rituximab). Contraindications to treatment with Natalizumab. History of Progressive Multifocal Leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections. Immunocompromised at the time of enrollment. Known active malignancies. Inability to comply with study requirements. Note: Other protocol defined Inclusion/Exclusion criteria may apply. healthy volunteers No gender All minimum age 18 Years maximum age 55 Years std age list std age Adult study population Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Medical Director overall official affiliation Biogen overall official role Study Director location list location location facility Research Site location city Amadora location zip 2720-276 location country Portugal location facility Research Site location city Angra do Heroismo location zip 9700-049 location country Portugal location facility Research Site location city Aveiro location zip 3810-164 location country Portugal location facility Research Site location city Braga location zip 4710-243 location country Portugal location facility Research Site location city Coimbra location zip 3004-561 location country Portugal location facility Research Site location city Faro location zip 8000-386 location country Portugal location facility Research Site location city Funchal location zip 9000-177 location country Portugal location facility Research Site location city Guimaraes location zip 4835-044 location country Portugal location facility Research Site location city Leiria location zip 2410-197 location country Portugal location facility Research Site location city Lisboa location zip 1649-028 location country Portugal location facility Research Site location city Loures location zip 2674-514 location country Portugal location facility Research Site location city Matosinhos location zip 4450-021 location country Portugal location facility Research Site location city Penafiel location zip 4564-007 location country Portugal location facility Research Site location city Porto location zip 4200-319 location country Portugal location facility Research Site location city Santa Maria da Feira location zip 4520-220 location country Portugal location facility Research Site location city Setubal location zip 2910-446 location country Portugal location facility Research Site location city Viana do Castelo location zip 4904-858 location country Portugal location facility Research Site location city Vila Nova de Gaia location zip 4434-502 location country Portugal derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009103 condition mesh term Multiple Sclerosis condition mesh id D000020529 condition mesh term Multiple Sclerosis, Relapsing-Remitting condition mesh id D000012598 condition mesh term Sclerosis condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020278 condition ancestor term Demyelinating Autoimmune Diseases, CNS condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000003711 condition ancestor term Demyelinating Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11212 condition browse leaf name Multiple Sclerosis condition browse leaf as found Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M14567 condition browse leaf name Sclerosis condition browse leaf as found Sclerosis condition browse leaf relevance high condition browse leaf id M21467 condition browse leaf name Multiple Sclerosis, Relapsing-Remitting condition browse leaf as found Relapsing Remitting Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21251 condition browse leaf name Demyelinating Autoimmune Diseases, CNS condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M6061 condition browse leaf name Demyelinating Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000069442 intervention mesh term Natalizumab intervention ancestor list intervention ancestor intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M411 intervention browse leaf name Natalizumab intervention browse leaf as found Resveratrol intervention browse leaf relevance high intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832399
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full study rank 61234 study protocol section identification module n c t id NCT04839120 org study id info org study id MDPK67b-1001 organization org full name Med Discovery SA org class INDUSTRY brief title PK, PD, Tolerability and Safety of MDPK67b in Healthy Volunteers official title Phase I Clinical Trial of the KLK Inhibitor MDPK67b to Assess Its Pharmacokinetic, Pharmacodynamic, Tolerability and Safety Profile in Healthy Male Volunteers status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 21, 2017 start date type Actual primary completion date struct primary completion date June 7, 2017 primary completion date type Actual completion date struct completion date June 7, 2017 completion date type Actual study first submit date March 29, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Med Discovery SA lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a Phase I, single centre, prospective, randomized, alternating panels, ascending doses with interspersed placebo, double-blind, crossover trial. The trial will include 8 volunteers divided into 2 panels (A and B) investigated in alternance, each submitted to 4 investigation periods following a crossover design in double blind, with ascending intravenous doses of MDPK67b and an interspersed placebo. The ascending dose sequence ranges from 2 to 48 mg, with 2-fold increase steps (3 to 4- fold increase steps in each individual volunteer). Three single doses will be administered at a minimum of 2 weeks intervals during the first 3 periods, and finally during the last period 4 repeated doses will be administered at a three days intervals, using either the highest dose of the ascending sequence (i.e. 24 or 48 mg) or the maximal tolerated dose (if it has been exceeded in the ascending sequence of single doses). conditions module condition list condition Prostatic Neoplasms design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 8 enrollment type Actual arms interventions module arm group list arm group arm group label MDPK67b arm group type Active Comparator arm group intervention list arm group intervention name Drug: MDPK67b arm group label Placebo arm group type Placebo Comparator arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name MDPK67b intervention description Two subgroups (Panels A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals. intervention arm group label list intervention arm group label MDPK67b intervention type Drug intervention name Placebo intervention description Two subgroups (Panel A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals. intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Incidence of Adverse Events (AEs) primary outcome description Subjects were assessed for AEs at each visit. primary outcome time frame Week 8 primary outcome measure MDPK67b serum level primary outcome description Serum concentrations of MDPK67b were measured using an ELISA method. primary outcome time frame Up to 144 hours after drug administration eligibility module eligibility criteria Inclusion Criteria: Healthy male subjects aged between 18 and 45 years Body weight (BW) ranging between 55 and 95 kg, providing body mass index (BMI) is between 18 and 29 kg/m2 Absence of significant findings in the medical history and physical examination as judged by the investigator, especially for cardiovascular, pulmonary, haematological and nervous systems Absence of significant laboratory abnormalities as judged by the investigator. Gilbert's syndrome (increased total and unconjugated bilirubin when fasting) will be accepted if mild 12-lead ECG without significant abnormalities Negative urine drug screen (amphetamines, benzodiazepines, cannabis, cocaine, opiates) Negative alcohol breath test Ability to understand the procedures, agreement to participate and willingness to give written informed consent Co-operative attitude and availability for scheduled visits over the entire study period. The subjects will have to refrain from travels outside Europe over the whole study duration. Exclusion Criteria: History of major cardiovascular, pulmonary, hepatic, immunological, renal, haematological, gastrointestinal, genitourinary, neurological, or rheumatologic disorders Active diseases of any type, including inflammatory disorders and infections. Mild acne is permissible providing no systemic or local treatment is provided or planned (except for cleaning lotions) History of significant allergy or asthma. Allergic rhinitis or conjunctivitis is acceptable if non symptomatic when starting the study and if symptoms are not anticipated to occur during the study to a point that would require corticosteroid therapy (e.g. in case of annual use) History of cardiovascular dysfunction if considered as clinically relevant (conduction abnormality, arrhythmia, bradycardia, angina pectoris, cardiac hypertrophy unless elicited by training, pulmonary embolism) Hypertension defined as supine blood pressure >150/90 mmHg or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension Any clinically significant coagulation disorder, based on either clinical manifestations (abnormal bleeding etc.) or abnormal laboratory values (platelet count, TP, aPTT, Thrombin time and fibrinogen). Sick sinus syndrome, known long QT syndrome, reproducible observation of QTc >440 ms or of pronounced sinus bradycardia (<40 bpm) Intense sport activities. Moderate sport is acceptable and activities should remain fairly constant throughout the study Any clinically significant laboratory value on screening that are not within normal range on single repeat (Gilbert's syndrome acceptable if mild) Positive hepatitis B or C antigen screen Positive HIV antibody screen or screen not performed Any recent acute illness or sequelae thereof which could expose the subject to a higher risk or might confound the results of the study Treatment in the previous three months with any drug known to have well-defined potential for toxicity to a major organ History of hypersensitivity to any drug if considered as serious Use of any medication the week prior to study or as based on 5 serum half-life rule and throughout study, including aspirin or other over-the-counter (OTC) preparation. Paracetamol is permissible before and during study as a rescue medication but only with investigator's permission. Participation in a clinical investigation or blood donation of 500 ml within the past 3 months History of relevant alcohol or drug abuse Smoking. Consumption of ≤5 cigarettes/day or equivalent is acceptable providing the subject can refrain from smoking from one week before and during the whole study duration Consumption of a large quantity of coffee, tea, chocolate (more than 4 cups/day) or equivalent (Cola drinks) Present consumption of a large quantity of alcohol or wine (>0.5 L wine/day) or equivalent, (equivalent to more than 35 g ethanol per day). Psychological status which could impact on subject's ability to give informed consent Any feature of subject's medical history or present condition which, in the investigator's opinion, could confound the results of the study, complicate its interpretation, or represent a potential risk for the subject. healthy volunteers Accepts Healthy Volunteers gender Male minimum age 18 Years maximum age 45 Years std age list std age Adult contacts locations module location list location location facility Centre Hospitalier Universitaire Vaudois (CHUV) - Division of Clinical Pharmacology location city Lausanne location country Switzerland derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition ancestor list condition ancestor condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostatic Neoplasms condition browse leaf relevance high condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions
NCT04839120
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full study rank 61710 study protocol section identification module n c t id NCT04832932 org study id info org study id 20210103MEBO organization org full name Mebo Research, Inc. org class OTHER brief title The COVID-19 Back-to-Normal Study official title A Phenotypic Study of Safety, Tolerability, Reactogenicity, Immunogenicity, and Virus Shedding With Post-Vaccination Infections of Emergency-Use-Authorized Vaccines Against COVID-19 status module status verified date November 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date December 1, 2022 primary completion date type Anticipated completion date struct completion date April 15, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 8, 2022 last update post date struct last update post date November 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Mebo Research, Inc. lead sponsor class OTHER collaborator list collaborator collaborator name Aurametrix collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary During the study, members of different online and offline communities will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference. Hypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes. detailed description The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a Public Health Emergency of International Concern in January 2020 and upgraded to pandemic in March 2020. First vaccines to prevent COVID-19 were authorized for emergency use in the US in December 2020, but a number of unknowns still remains. One of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. Study groups will be based on age, metabolism, donated diagnostic test results and self-reported symptoms. Data will be collected continuously via surveys and investigator-participant interactions, as needed. Statistical methods used will be the ones with the greatest power. conditions module condition list condition COVID-19 Vaccines keyword list keyword Drug-Related Side Effects and Adverse Reactions Long-term adverse effects Immunogenicity, Vaccine COVID-19 design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Other enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label 80 years of age or older arm group description Individuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine arm group intervention list arm group intervention name Biological: COVID-19 vaccines arm group label 60-79 years of age arm group description Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine arm group intervention list arm group intervention name Biological: COVID-19 vaccines arm group label 40-59 years of age arm group description Individuals in 40-49, 50-59 age range who received COVID-19 vaccine arm group intervention list arm group intervention name Biological: COVID-19 vaccines arm group label 18-39 years of age arm group description Individuals in 18-29, 30-39 age range who received COVID-19 vaccine arm group intervention list arm group intervention name Biological: COVID-19 vaccines arm group label MEBO/PATM arm group description Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine arm group intervention list arm group intervention name Biological: COVID-19 vaccines arm group label Chronic Disease arm group description Individuals with self-reported chronic health conditions who received COVID-19 vaccine arm group intervention list arm group intervention name Biological: COVID-19 vaccines intervention list intervention intervention type Biological intervention name COVID-19 vaccines intervention description Emergency-use authorized COVID-19 vaccines intervention arm group label list intervention arm group label 18-39 years of age 40-59 years of age 60-79 years of age 80 years of age or older Chronic Disease MEBO/PATM intervention other name list intervention other name BNT162b2 mRNA-1273 JNJ-78436735 AZD1222 Gam-KOVID-Vak CoronaVac/Sinovac BBIBP-CorV BBV152 NVX-CoV2373 outcomes module primary outcome list primary outcome primary outcome measure Adverse reactions/events primary outcome description Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2 primary outcome time frame 10 days after any dose of study intervention. secondary outcome list secondary outcome secondary outcome measure Long-term adverse events secondary outcome description Percentage of occurrence, types, duration and severity of adverse events throughout study period secondary outcome time frame Throughout the study period, until 12 months post-final-dose secondary outcome measure Incidence of COVID-19 cases secondary outcome description The number of COVID-19 cases occurring <=14 or ≥ 15 days after any dose of study intervention. secondary outcome time frame From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose eligibility module eligibility criteria Inclusion Criteria: Individuals 18 or older at the time of consent Intention to vaccinate and of being available for entire study period Exclusion Criteria: Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Individuals 18 or older interested in vaccinating sampling method Probability Sample contacts locations module overall official list overall official overall official name Irene Gabashvili, PhD overall official affiliation Mebo Research, Inc. overall official role Principal Investigator location list location location facility MEBO Research, Inc location city Miami location state Florida location zip 33175 location country United States location facility Kahite location city Vonore location state Tennessee location zip 37885 location country United States location facility Gabashvili location city Tbilisi location country Georgia location facility MEBO Research Africa location city Kilifi location zip 8 010 location country Kenya location facility Mebo Research (Uk) location city London location state England location zip W10 5LE location country United Kingdom references module reference list reference reference p m i d 36309347 reference type result reference citation Gabashvili IS. The Incidence and Effect of Adverse Events Due to COVID-19 Vaccines on Breakthrough Infections: Decentralized Observational Study With Underrepresented Groups. JMIR Form Res. 2022 Nov 4;6(11):e41914. doi: 10.2196/41914. see also link list see also link see also link label Study updates see also link u r l https://www.aurametrix.com/nct04832932.html i p d sharing statement module i p d sharing No i p d sharing description individual participant data will remain confidential, unless specifically requested to be shared by the participant derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M6948 condition browse leaf name Emergencies condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M29456 condition browse leaf name Drug-Related Side Effects and Adverse Reactions condition browse leaf relevance low condition browse leaf id M420 condition browse leaf name Long Term Adverse Effects condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832932
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full study rank 61343 study protocol section identification module n c t id NCT04837703 org study id info org study id CETB115B2003I organization org full name Novartis org class INDUSTRY brief title MAP to Provide Access to Eltrombopag, for Treatment of Patients With Medically Significant Thrombocytopenia official title Managed Access Program (MAP) to Provide Access to Eltrombopag, for Treatment of Patients With Medically Significant Thrombocytopenia status module status verified date March 2022 overall status Available expanded access info has expanded access No study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 8, 2022 last update post date struct last update post date March 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Novartis Pharmaceuticals lead sponsor class INDUSTRY oversight module description module brief summary The purpose of this Cohort Treatment Plan is to allow access to eltrombopag for eligible patients diagnosed with medically significant thrombocytopenia. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. conditions module condition list condition Thrombocytopenia keyword list keyword Eltrombopag thrombocytopenia Idiopathic thrombocytopenic purpura ITP Severe aplastic anemia SAA HCV Hepatitis C virus design module study type Expanded Access arms interventions module intervention list intervention intervention type Drug intervention name Eltrombopag intervention description Eltrombopag should be taken at least two hours before or four hours after any products such as antacids, dairy products, or mineral supplements containing polyvalent cation (e.g. aluminum, calcium, iron, magnesium, selenium and zinc). Eltrombopag may be taken with food containing little (< 50 mg) or preferably no calcium. eligibility module eligibility criteria Inclusion Criteria: Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria: - Written informed consent must be obtained prior to any screening procedures or treatment assignment. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. An acceptable alternative (e.g., an assent form, or consent from a parent or guardian) should be signed for legally incompetent patients (e.g., children). - In addition to informed consent, patients eligible for inclusion in this Treatment Plan may not be enrolled into any other eltrombopag clinical trial and must meet all of the following criteria (only one of the diseases listed under criterion No 1 is enough): The patient must have any of the following diseases: A confirmed diagnosis of chronic idiopathic thrombocytopenic purpura (ITP) according to the American Society of Haematology/ICR International consensus report on the investigation and management of primary immune thrombocytopenia reported by Neunert (2011) and Provan (2009), and the patient must be refractory to OR has relapsed after at least one prior ITP treatment recommended by the ASH/BCSH guidelines (corticosteroids or intravenous immunoglobulin (IVIg) or anti-D). Alternatively, a patient who is medically not eligible to receive corticosteroids must have had at least one alternative ITP treatment as recommended by the guidelines. Previous therapies for ITP and dates of administration must be recorded on the application form. Severe aplastic anemia (SAA) patients who does not have an access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist). HCV patients requiring treatment with an interferon based therapy and who have no access to alternative treatments. The patient must have adequate medical condition and adequate organ function (e.g. renal, hepatic, cardiac function, etc.), as assessed by the treating physician. Patients in childbearing age must be practicing an acceptable method of contraception from two weeks prior to administration of eltrombopag, throughout administration of eltrombopag, and 1 month after the last dose of eltrombopag. Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of program treatment and agree to use effective contraception, during the program and for one week following the last dose of program treatment. The patient is able to understand and comply with all the requirements and instructions for receiving MAP Exclusion Criteria: Patients eligible for this Treatment Plan must not meet any of the following criteria: Presence of moderate to severe impaired renal function as indicated by any or all of the following criteria: Creatinine clearance < 45 mL/min as calculated using Cockcroft-Gault formula Serum creatinine > 1.5 mg/dL Total bilirubin > 1.5 × upper limit of normal (ULN) Aspartate transaminase (AST) > 3.0 × ULN Alanine transaminase (ALT) > 3.0 × ULN Patient with liver cirrhosis. Infection not adequately controlled with appropriate therapy. Patients who are human immune deficiency virus (HIV), hepatitis C virus or hepatitis B surface antigen (HBsAg) positive. HCV-RNA negative patients are allowed to be enrolled. Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to consent, be compliant with study procedures, tolerate protocol therapy, or patients with less than 3 months of life expectancy. History of hypersensitivity to eltrombopag or to any of the excipients in eltrombopag Patients with any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing oestrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis. Patients with concurrent malignant disease. Patients with SLE, antiphospholipid antibody syndrome or chronic hepatitis B infection, Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the treatment guidelines. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of program treatment. History of non-compliance with medical regimens or patients who are considered potentially unreliable and/or not cooperative, unwilling or unable to comply with the treatment guidelines. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, (or female partners of male patients) unless they are using highly effective methods of contraception while taking study treatment and for 3 months after stopping medication. Highly effective methods of contraception methods include: Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example, hormone vaginal ring or transdermal hormone contraception.. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks in advance. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. Sexually active males must be willing to use a condom during intercourse while taking study treatment and for 3 months after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF). No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients. healthy volunteers No gender All minimum age 18 Years maximum age 99 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Novartis Pharmaceuticals central contact role Contact central contact phone +41613241111 central contact e mail novartis.email@novartis.com central contact name Novartis Pharmaceuticals central contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013921 condition mesh term Thrombocytopenia condition ancestor list condition ancestor condition ancestor id D000001791 condition ancestor term Blood Platelet Disorders condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M8744 condition browse leaf name Hepatitis A condition browse leaf relevance low condition browse leaf id M8743 condition browse leaf name Hepatitis condition browse leaf relevance low condition browse leaf id M15832 condition browse leaf name Thrombocytopenia condition browse leaf as found Thrombocytopenia condition browse leaf relevance high condition browse leaf id M18097 condition browse leaf name Purpura, Thrombocytopenic, Idiopathic condition browse leaf relevance low condition browse leaf id M3222 condition browse leaf name Anemia condition browse leaf relevance low condition browse leaf id M8763 condition browse leaf name Hepatitis C condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M3223 condition browse leaf name Anemia, Aplastic condition browse leaf relevance low condition browse leaf id M13699 condition browse leaf name Purpura condition browse leaf relevance low condition browse leaf id M13702 condition browse leaf name Purpura, Thrombocytopenic condition browse leaf relevance low condition browse leaf id M4224 condition browse leaf name Blood Platelet Disorders condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id T3021 condition browse leaf name Immune Thrombocytopenia condition browse leaf relevance low condition browse leaf id T3007 condition browse leaf name Idiopathic Thrombocytopenic Purpura condition browse leaf relevance low condition browse leaf id T460 condition browse leaf name Aplastic Anemia condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M4533 intervention browse leaf name Calcium intervention browse leaf relevance low intervention browse leaf id M4550 intervention browse leaf name Calcium, Dietary intervention browse leaf relevance low intervention browse leaf id M9685 intervention browse leaf name Iron intervention browse leaf relevance low intervention browse leaf id M3340 intervention browse leaf name Antacids intervention browse leaf relevance low intervention browse leaf id M14607 intervention browse leaf name Selenium intervention browse leaf relevance low intervention browse leaf id M16920 intervention browse leaf name Zinc intervention browse leaf relevance low intervention browse leaf id M3371 intervention browse leaf name Anti-Ulcer Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev BDCA intervention browse branch name Bone Density Conservation Agents intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents
NCT04837703
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full study rank 61466 study protocol section identification module n c t id NCT04836104 org study id info org study id InCaveoDanielandDaniel2022 organization org full name [Redacted] brief title [Trial of device that is not approved or cleared by the U.S. FDA] official title [Trial of device that is not approved or cleared by the U.S. FDA] status module overall status Withheld delayed posting Yes expanded access info has expanded access No study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party old name title [Redacted] responsible party old organization [Redacted] lead sponsor lead sponsor name [Redacted] derived section misc info module version holder December 02, 2022
NCT04836104
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full study rank 61585 study protocol section identification module n c t id NCT04834557 org study id info org study id Treating Rheumatoid Arthritis organization org full name Tanta University org class OTHER brief title Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis official title Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 1, 2021 start date type Actual primary completion date struct primary completion date May 2022 primary completion date type Anticipated completion date struct completion date July 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2022 last update post date struct last update post date April 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mariam George Tadros Bolous responsible party investigator title Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University responsible party investigator affiliation Tanta University lead sponsor lead sponsor name Tanta University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to investigate the potential therapeutic effects of the cardiac glycoside digoxin and the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients with variant disease activity. detailed description This study is a randomized, open-labeled, controlled prospective study to evaluate the potential therapeutic effects of the cardiac glycoside digoxin and the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients with variant disease activity. The study population will be rheumatoid arthritis patients attending the Physical Medicine, Rheumatology and Rehabilitation Department at Menoufia University Hospital, Menoufia, Egypt. A total of 90 rheumatoid arthritis patients who will meet the inclusion criteria will be enrolled in this study. The 90 participants will be divided into 30 rheumatoid arthritis patients who will receive placebo + the current DMARDs treatments of rheumatoid arthritis for 24 weeks and serve as the control group, 30 rheumatoid arthritis patients who will receive DMARDs + digoxin 25 mg every other day for 24 weeks and the last 30 rheumatoid arthritis patients who will receive DMARDs + ursodeoxycholic acid (UDCA) 500 mg/day for 24 weeks. Clinical Examinations and laboratory parameters will be performed and measured at the beginning of the study, 12 weeks and 24 weeks after randomization to evaluate the efficacy of digoxin and UDCA in the treatment of rheumatoid arthritis. conditions module condition list condition Rheumatoid Arthritis keyword list keyword Rheumatoid arthritis Digoxin Ursodeoxycholic acid Synovial inflammation leukocyte infiltration Autoimmune diseases Th17 and Treg cells Synovial hypoxia design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description This study is a randomized controlled prospective study design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 90 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control arm group type Placebo Comparator arm group description Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 24 weeks. arm group intervention list arm group intervention name Drug: Placebo arm group label Digoxin arm group type Experimental arm group description Participants in this arm will receive digoxin 0.25 mg every other day + DMARDs for 24 weeks. arm group intervention list arm group intervention name Drug: Digoxin 0.25 mg arm group label Ursodeoxycholic acid (UDCA) arm group type Experimental arm group description Participants in this arm will receive ursodeoxycholic acid (UDCA) 500 mg/day + DMARDs for 24 weeks. arm group intervention list arm group intervention name Drug: Ursodeoxycholic acid (UDCA) 500 mg intervention list intervention intervention type Drug intervention name Placebo intervention description Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis. intervention arm group label list intervention arm group label Control intervention type Drug intervention name Digoxin 0.25 mg intervention description All subjects will receive digoxin administered at 0.25 mg every other day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis. intervention arm group label list intervention arm group label Digoxin intervention type Drug intervention name Ursodeoxycholic acid (UDCA) 500 mg intervention description All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis. intervention arm group label list intervention arm group label Ursodeoxycholic acid (UDCA) outcomes module primary outcome list primary outcome primary outcome measure Changes from Baseline in Clinical Disease Activity Index (CDAI) Score primary outcome description To evaluate the effect of the use of digoxin and UDCA as an add-on therapy in patients with rheumatoid arthritis by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores. A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity. Total range is from 0-100, with the high scores representing high disease activity. primary outcome time frame Baseline, after 12 weeks, after 24 weeks primary outcome measure Changes in C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR) primary outcome description C- reactive Protein (CRP) values and Erythrocyte Sedimentation Rate (ESR) will be made at baseline and after 12 as well as 24 weeks to determine the number of patients whose test result improved or worsened CRP value (normal range <1.0 mg/dl). ESR (normal range 0-28 mm/hr) . If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved. primary outcome time frame Baseline, after 12 weeks, after 24 weeks secondary outcome list secondary outcome secondary outcome measure Changes from baseline Measurement of IL-17A and HIF-1α at 12 and 24 weeks secondary outcome description Serum IL-17A and HIF-1α levels will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturer's protocol. secondary outcome time frame Baseline, after 12 weeks, after 24 weeks secondary outcome measure Numbers of participants with treatment-related adverse events secondary outcome description The adverse events in each group will be observed and documented during the whole procedure to show the safety of the treatment. secondary outcome time frame Baseline, after 12 weeks, after 24 weeks eligibility module eligibility criteria Inclusion Criteria: Diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria. Having active rheumatoid arthritis disease activity (the 28-joint disease activity score [DAS28] according to the CRP formula > 2.6). Aged between 18 and 80 years. With clear consciousness and able to cooperate with this study. Personal willingness and ability to comply with the study follow-up schedule and other requirements of the study protocol. Both male and female will be included All patients receiving non-biological drugs will be also included. Sign an informed consent for the clinical study. Exclusion Criteria: Pregnant or planning to be pregnant and breast-feeding women Patients suffering from any chronic diseases Patients with other autoimmune diseases, such as systemic lupus erythematosus, Sjogren's syndrome and mixed connective tissue disease. Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis). Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis). Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease. Patients treated with biological therapy such as TNF-α or IL-1β antagonists. Patients with infectious or inflammatory diseases, endocrine disorders, any past or current psychiatric or neurological diseases. Patients with cardiovascular diseases such as arrhythmias and acute myocardial infarction. Patients with electrolyte disturbances (such as hypokalemia, hypomagnesemia, and hypercalcemia) could potentially elevate the risk of digoxin toxicity. Patients with clinically significant hepatic and renal dysfunction or impairment. Alcohol abuse Patients with evidence of viral (HBV or HCV), autoimmune hepatitis, and decompensated liver disease. Patients with cancer currently diagnosed or in medical history, if no recovery was achieved. Patients who are allergic to digoxin or Ursodeoxycholic acid (UDCA) Patients who are unconscious and unable to complete the study. Patients with acute inflammation of the gall bladder or the biliary tract, frequent episodes of biliary colic, and impaired contractility of the gall bladder, will be excluded. Patients with cholestasis, primary biliary cirrhosis, or biliary obstruction will also be excluded. Patients who have received an organ transplant. healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Mariam George Tadros, Master central contact role Contact central contact phone +20 1285600693 central contact e mail mariam.tadros77@gmail.com central contact name Dalia Salah, PHD central contact role Contact central contact phone +20 1008312704 central contact e mail sdalia30@gmail.com overall official list overall official overall official name Nageh Ahmed El-Mahdy, Professor overall official affiliation Professor of Pharmacology and Toxicology Faculty of Pharmacy, Tanta University overall official role Study Chair overall official name Medhat Ismail Abdel Hamid, Professor overall official affiliation Professor of Pharmacology and Toxicology Faculty of Medicine, Al-Azhar University overall official role Study Director overall official name Dalia Salah Seif, PHD overall official affiliation Associate Professor of Physical Medicine, Rheumatology and Rehabilitation Faculty of Medicine, Menoufyia University overall official role Study Director overall official name Enass Yousef Osman, PHD overall official affiliation Lecturer of Pharmacology and toxicology, Faculty of Pharmacy, Tanta University overall official role Study Director overall official name Mariam George Tadros Bolous, Master overall official affiliation Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University overall official role Principal Investigator location list location location facility Menoufia University Hospital location status Recruiting location city Shibīn Al Kawm location country Egypt location contact list location contact location contact name Mariam George Tadros Bolous, Master Degree location contact role Contact location contact phone +20 1285600693 location contact e mail mariam.tadros77@gmail.com location contact name Dalia Salah Seif, Associate Professor location contact role Contact location contact phone +20 1008312704 location contact e mail sdalia30@gmail.com references module reference list reference reference p m i d 20872595 reference type background reference citation Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584. reference p m i d 20872596 reference type background reference citation Neogi T, Aletaha D, Silman AJ, Naden RL, Felson DT, Aggarwal R, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Khanna D, Kvien TK, Laing T, Liao K, Mease P, Ménard HA, Moreland LW, Nair R, Pincus T, Ringold S, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovský J, Wolfe F, Hawker G; American College of Rheumatology; European League Against Rheumatism. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis: Phase 2 methodological report. Arthritis Rheum. 2010 Sep;62(9):2582-91. doi: 10.1002/art.27580. reference p m i d 27445820 reference type background reference citation Hua S, Dias TH. Hypoxia-Inducible Factor (HIF) as a Target for Novel Therapies in Rheumatoid Arthritis. Front Pharmacol. 2016 Jun 27;7:184. doi: 10.3389/fphar.2016.00184. eCollection 2016. reference p m i d 28539269 reference type background reference citation Lee EJ, Kwon JE, Park MJ, Jung KA, Kim DS, Kim EK, Lee SH, Choi JY, Park SH, Cho ML. Ursodeoxycholic acid attenuates experimental autoimmune arthritis by targeting Th17 and inducing pAMPK and transcriptional corepressor SMILE. Immunol Lett. 2017 Aug;188:1-8. doi: 10.1016/j.imlet.2017.05.011. Epub 2017 May 21. reference p m i d 27340129 reference type background reference citation O'Dwyer AM, Lajczak NK, Keyes JA, Ward JB, Greene CM, Keely SJ. Ursodeoxycholic acid inhibits TNFalpha-induced IL-8 release from monocytes. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G334-41. doi: 10.1152/ajpgi.00406.2015. Epub 2016 Jun 23. reference p m i d 32106058 reference type background reference citation Saeed H, Mateen S, Moin S, Khan AQ, Owais M. Cardiac glycoside digoxin ameliorates pro-inflammatory cytokines in PBMCs of rheumatoid arthritis patients in vitro. Int Immunopharmacol. 2020 Feb 24;82:106331. doi: 10.1016/j.intimp.2020.106331. Online ahead of print. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001168 condition mesh term Arthritis condition mesh id D000001172 condition mesh term Arthritis, Rheumatoid condition ancestor list condition ancestor condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000003240 condition ancestor term Connective Tissue Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M3337 condition browse leaf name Hypoxia condition browse leaf relevance low condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf as found Arthritis condition browse leaf relevance high condition browse leaf id M9445 condition browse leaf name Inflammation condition browse leaf relevance low condition browse leaf id M3632 condition browse leaf name Arthritis, Rheumatoid condition browse leaf as found Rheumatoid Arthritis condition browse leaf relevance high condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M5616 condition browse leaf name Connective Tissue Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000004077 intervention mesh term Digoxin intervention mesh id D000014580 intervention mesh term Ursodeoxycholic Acid intervention ancestor list intervention ancestor intervention ancestor id D000000889 intervention ancestor term Anti-Arrhythmia Agents intervention ancestor id D000002316 intervention ancestor term Cardiotonic Agents intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000002756 intervention ancestor term Cholagogues and Choleretics intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M6417 intervention browse leaf name Digoxin intervention browse leaf as found Week 2 intervention browse leaf relevance high intervention browse leaf id M16481 intervention browse leaf name Ursodeoxycholic Acid intervention browse leaf as found Arm description intervention browse leaf relevance high intervention browse leaf id M3365 intervention browse leaf name Anti-Arrhythmia Agents intervention browse leaf relevance low intervention browse leaf id M4724 intervention browse leaf name Cardiotonic Agents intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AnArAg intervention browse branch name Anti-Arrhythmia Agents intervention browse branch abbrev CaAg intervention browse branch name Cardiotonic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents
NCT04834557
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full study rank 61748 study protocol section identification module n c t id NCT04832438 org study id info org study id 2102 organization org full name Actuate Therapeutics Inc. org class INDUSTRY brief title 9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma official title Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma status module status verified date September 2021 overall status Withdrawn why stopped Replaced by NCT05010629 expanded access info has expanded access No start date struct start date December 18, 2030 start date type Anticipated primary completion date struct primary completion date June 18, 2033 primary completion date type Anticipated completion date struct completion date June 18, 2034 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date February 5, 2022 last update post date struct last update post date February 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Actuate Therapeutics Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary 9-ING-41 is a small molecule potent selective GSK-3β inhibitor with antitumor activity. This study investigates 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC). Patients with advanced SGC (including all histologic subtypes and adenoid cystic carcinoma [ACC]) will receive 9-ING-41 intravenously (IV) along with carboplatin IV at standard dosing together on Day 1, and 9-ING-41 alone on Day 4 of a 21-day cycle. Participants will be enrolled to two histologic cohorts: Cohort 1 will be comprised of those with ACC, and Cohort 2 will include patients with non-ACC SGC (or all other salivary gland cancer histologies). Treatment will continue until progression of disease, death, or discontinuation of therapy for any reason. detailed description 9-ING-41 is a small molecule potent selective GSK-3β inhibitor with antitumor activity. It acts through downregulation of NF-κB and decreases the expression NF-κB target genes cyclin D1, Bcl-2, anti-apoptotic protein (XIAP) and B-cell lymphoma-extra large (Bcl-XL) leading to inhibition of tumor growth in multiple solid tumor cell and lymphoma lines and patient derived xenograft (PDX) models. 9-ING-41 may also function as an immune modulatory agent by decreasing checkpoint expression and enhancement of T-cell / NK-cell effector function. This is a phase 2, open-label, non-randomized, single institution study investigating the novel glycogen synthase kinase-3 beta (GSK-3β) inhibitor 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC). The safety of this combination has been established in the Actuate 1801 study. Thirty-one evaluable patients with advanced SGC (including all histologic subtypes and adenoid cystic carcinoma [ACC]) will receive 9-ING-41 intravenously (IV) along with carboplatin IV at standard dosing together on Day 1, and 9-ING-41 alone on Day 4 of a 21-day cycle. Participants will be enrolled to two histologic cohorts: Cohort 1 will be comprised of those with ACC, and Cohort 2 will include patients with non-ACC SGC (or all other salivary gland cancer histologies). Treatment will continue until progression of disease, death, or discontinuation of therapy for any reason. The primary aim of the study is to assess the overall response rate (ORR) as defined by RECIST v1.1 in the overall study population (including both Cohorts 1 and 2). Secondary aims include assessing progression-free survival (PFS), overall survival (OS), determining safety and tolerability, measuring patient-reported quality of life metrics, and correlating efficacy with molecular and immunologic predictors of response. We hypothesize that the novel combination of a GSK-3β inhibitor with carboplatin chemotherapy will result in an ORR of 25% or greater in this patient population where no approved therapies have been established. conditions module condition list condition Salivary Gland Carcinoma Adenoid Cystic Carcinoma Salivary Gland Cancer Salivary Gland Neoplasms keyword list keyword advanced metastatic 9-ING-41 carboplatin refractory design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label 9-ING-41 plus carboplatin arm group type Experimental arm group description Patients will receive 9-ING-41 (15 mg/kg IV on Day 1 and Day 4) in addition to carboplatin (AUC 5 IV on Day 1) each of a 21-day cycle arm group intervention list arm group intervention name Drug: 9-ING-41 Drug: Carboplatin intervention list intervention intervention type Drug intervention name 9-ING-41 intervention description 15 mg/kg as intravenous infusion on Days 1 and Day 4 of a 21-day cycle intervention arm group label list intervention arm group label 9-ING-41 plus carboplatin intervention type Drug intervention name Carboplatin intervention description Carboplatin AUC 5 intravenously on Day 1 of a 21-day cycle intervention arm group label list intervention arm group label 9-ING-41 plus carboplatin outcomes module primary outcome list primary outcome primary outcome measure Number of evaluable patients with objective response as measured by RECIST version 1.1 primary outcome description Response and progression will be evaluated in this study using the international Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. primary outcome time frame 3-24 months eligibility module eligibility criteria Inclusion Criteria: Participants must have histologically confirmed salivary gland carcinoma (any histologic subtype, including ACC) with evidence of recurrent, metastatic or advanced, unresectable disease. Willing to provide tumor tissue from a diagnostic biopsy or prior surgery. Age 18 years or older ECOG performance status 0-2 (see Appendix A) Participant must have organ and marrow function as defined below within 14 days prior to study registration: leukocytes ≥ 3,000/mcL absolute neutrophil count ≥ 500/mcL hemoglobin ≥ 8.5 g/dL platelets ≥ 75,000/mcL total bilirubin ≤ 2.0 g/dL AST(SGOT)/ALT(SGPT) ≤ 2.5× institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study registration (progression of disease over any interval is allowed) and/or new or worsening disease-related symptoms within 12 months prior to study registration. Participants must have at least one RECIST v1.1 measurable non-CNS based lesion. Prior systemic therapy: At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (3 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE Version 5.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy). Any number of prior therapies for recurrent/metastatic SGC are permitted (including prior carboplatin exposure). Ability to understand and the willingness to sign a written informed consent document. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study treatment. Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 90 days after the last dose of investigational product. Exclusion Criteria: Metastatic disease impinging on the spinal cord or threatening spinal cord compression. Patients that have had previous treatment of disease with impinging on the cord with either surgery or radiotherapy with clinical or radiographic evidence of response or stability are eligible. Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment), and have no evidence of new or enlarging brain metastases. Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Pregnant or lactating women. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Glenn J Hanna, MD overall official affiliation Dana-Farber Cancer Institute overall official role Principal Investigator location list location location facility Dana-Farber Cancer Institute location city Boston location state Massachusetts location zip 02215 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000012468 condition mesh term Salivary Gland Neoplasms condition mesh id D000003528 condition mesh term Carcinoma, Adenoid Cystic condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000009062 condition ancestor term Mouth Neoplasms condition ancestor id D000006258 condition ancestor term Head and Neck Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009059 condition ancestor term Mouth Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition ancestor id D000012466 condition ancestor term Salivary Gland Diseases condition ancestor id D000000230 condition ancestor term Adenocarcinoma condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M14439 condition browse leaf name Salivary Gland Neoplasms condition browse leaf as found Salivary Gland Neoplasms condition browse leaf relevance high condition browse leaf id M5885 condition browse leaf name Carcinoma, Adenoid Cystic condition browse leaf as found Adenoid Cystic Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M11174 condition browse leaf name Mouth Neoplasms condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse leaf id M11171 condition browse leaf name Mouth Diseases condition browse leaf relevance low condition browse leaf id M11169 condition browse leaf name Stomatognathic Diseases condition browse leaf relevance low condition browse leaf id M14437 condition browse leaf name Salivary Gland Diseases condition browse leaf relevance low condition browse leaf id M2737 condition browse leaf name Adenocarcinoma condition browse leaf relevance low condition browse leaf id T201 condition browse leaf name Adenoid Cystic Carcinoma condition browse leaf as found Adenoid Cystic Carcinoma condition browse leaf relevance high condition browse leaf id T4265 condition browse leaf name Oral Cancer condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000016190 intervention mesh term Carboplatin intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M17802 intervention browse leaf name Carboplatin intervention browse leaf as found Program intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832438
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full study rank 61425 study protocol section identification module n c t id NCT04836637 org study id info org study id M236 organization org full name University of Copenhagen org class OTHER brief title ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women official title ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial acronym RENEW status module status verified date September 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date May 17, 2021 start date type Actual primary completion date struct primary completion date June 2023 primary completion date type Anticipated completion date struct completion date June 2023 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 17, 2022 last update post date struct last update post date September 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Inge Tetens responsible party investigator title Professor responsible party investigator affiliation University of Copenhagen lead sponsor lead sponsor name University of Copenhagen lead sponsor class OTHER collaborator list collaborator collaborator name Zealand University Hospital collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The primary objective of this study is to investigate the effects of 12-months supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on changes in markers of bone formation and resorption and in bone mass density (BMD) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation. detailed description The study will include an information visit, a randomization visit, a month 3 visit and a final visit at month 12. Besides, two visits at month 6 and 9 for dispensing of trial products. Outcome parameters will be measured using blood samples obtained at the randomization visit, the month 3 visit and at the final visit at month 12. Outcome parameters will moreover be analyzed based on DXA scan obtained at the randomization visit and at the final visit at 12 months. conditions module condition list condition Osteoporosis, Postmenopausal design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 420 enrollment type Actual arms interventions module arm group list arm group arm group label Product with placebo (no calcium supplementation). arm group type Placebo Comparator arm group description Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year. arm group intervention list arm group intervention name Dietary Supplement: Maltodextrin arm group label Product with calcium-carbonate arm group type Active Comparator arm group description 800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year. arm group intervention list arm group intervention name Dietary Supplement: Calcium-carbonate arm group label Product with calcium-enriched permeate "Capolac" arm group type Experimental arm group description 800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year. arm group intervention list arm group intervention name Dietary Supplement: Calcium-enriched permeate arm group label Product with calcium-enriched permeate "Capolac" and Inulin arm group type Experimental arm group description 800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year. arm group intervention list arm group intervention name Dietary Supplement: Calcium-enriched permeate with Inulin intervention list intervention intervention type Dietary Supplement intervention name Maltodextrin intervention description Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily. intervention arm group label list intervention arm group label Product with placebo (no calcium supplementation). intervention type Dietary Supplement intervention name Calcium-carbonate intervention description Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily. intervention arm group label list intervention arm group label Product with calcium-carbonate intervention type Dietary Supplement intervention name Calcium-enriched permeate intervention description Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily. intervention arm group label list intervention arm group label Product with calcium-enriched permeate "Capolac" intervention other name list intervention other name Capolac intervention type Dietary Supplement intervention name Calcium-enriched permeate with Inulin intervention description Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily. intervention arm group label list intervention arm group label Product with calcium-enriched permeate "Capolac" and Inulin intervention other name list intervention other name Capolac Inulin outcomes module primary outcome list primary outcome primary outcome measure The change in bone turnover marker CTX. primary outcome description Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit) primary outcome time frame 1 year primary outcome measure The change in bone turnover marker P1NP. primary outcome description Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit) primary outcome time frame 1 year primary outcome measure The change in loss of bone mineral density. primary outcome description Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit) primary outcome time frame 1 year secondary outcome list secondary outcome secondary outcome measure Changes in blood parameters of iPTH secondary outcome description Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit) secondary outcome time frame 1 year secondary outcome measure Changes in blood parameters of Vitamin D secondary outcome description Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit) secondary outcome time frame 1 year secondary outcome measure Changes in blood parameters of total calcium secondary outcome description Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit) secondary outcome time frame 1 year secondary outcome measure Changes in blood parameters of phosphate secondary outcome description Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit) secondary outcome time frame 1 year other outcome list other outcome other outcome measure Changes in BMI other outcome description Changes in BMI from randomization to 12 months visit (final visit) other outcome time frame 1 year other outcome measure Changes in physical activity other outcome description Changes in physical activity level attained by IPAQ from randomization to 12 months visit (final visit) other outcome time frame 1 year other outcome measure Changes in habitual dietary intake other outcome description Changes in habitual dietary intake attained by Myfood24 7-day recording from randomization to 12 months visit (final visit) other outcome time frame 1 year other outcome measure Changes in fecal pH other outcome description Changes in fecal pH from randomization to 12 months visit (final visit) other outcome time frame 1 year other outcome measure Changes in gut microbiome other outcome description Changes in microbial taxonomy and microbial gene content measured via sequencing of DNA extracted from fecal samples from randomization to 12 months visit (final visit) other outcome time frame 1 year other outcome measure Changes in urinary metabolites other outcome description Changes in urine metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatinine, amines, amino acids, alcohols, carboxylic acids including short-chain fatty acids, keto acids, purine, pyridine and pyrimidine derivatives, sugars and derivatives. other outcome time frame 1 year other outcome measure Changes in fecal metabolites other outcome description Changes in fecal metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatine, creatinine, amines, amino acids, carboxylic acids including short-chain fatty acids, keto acids, nucleotides and derivatives. other outcome time frame 1 year eligibility module eligibility criteria Inclusion Criteria: Subject is between 45 years and 65 years of age by the time of inclusion. Subject has been menopausal for at least 1 year, defined as 12 months after last bleeding and up to 10 years. Subject is Caucasian. Has a BMI below 35.0. Holder of a computer. Has a sufficient vitamin D status (plasma 25OHD concentration > 50 nmol/L). Subject is willing and able to provide written informed consent prior to participation. Exclusion Criteria: Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy evaluated by the investigator. Intake of antibiotics in the last 3 months before enrollment. Subject with an osteoporosis diagnosis or history of osteoporotic fractures. Presence of renal, gastrointestinal, hepatic or endocrinological diseases. Subject with any serious illness or history of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer). Known or suspected abuse of alcohol or recreational drugs. Known milk allergy. Known or suspected hypersensitivity to trial products or related products. Blood donation except from the donation in this study. Subject where it is not possible to obtain sufficient data. healthy volunteers Accepts Healthy Volunteers gender Female minimum age 45 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Mette F Hitz, Doctor overall official affiliation Zealand University Hospital, Køge overall official role Principal Investigator location list location location facility Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition location city Copenhagen location state Frederiksberg location country Denmark location facility Zealand University Hospital location city Køge location zip 4600 location country Denmark i p d sharing statement module i p d sharing No i p d sharing description The results will be analyzed and attempted published in international journals regardsless of whether the study leads to positive, negative or inconclusive results. The study protocol will be registered and made publicly avalailable at www.clinicaltrials.gov. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010024 condition mesh term Osteoporosis condition mesh id D000015663 condition mesh term Osteoporosis, Postmenopausal condition ancestor list condition ancestor condition ancestor id D000001851 condition ancestor term Bone Diseases, Metabolic condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition browse leaf list condition browse leaf condition browse leaf id M12099 condition browse leaf name Osteoporosis condition browse leaf as found Osteoporosis condition browse leaf relevance high condition browse leaf id M17406 condition browse leaf name Osteoporosis, Postmenopausal condition browse leaf as found Osteoporosis, Postmenopausal condition browse leaf relevance high condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M4282 condition browse leaf name Bone Diseases, Metabolic condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000002136 intervention mesh term Calcium, Dietary intervention mesh id D000002119 intervention mesh term Calcium Carbonate intervention mesh id D000002118 intervention mesh term Calcium intervention ancestor list intervention ancestor intervention ancestor id D000077264 intervention ancestor term Calcium-Regulating Hormones and Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000050071 intervention ancestor term Bone Density Conservation Agents intervention ancestor id D000000863 intervention ancestor term Antacids intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M4533 intervention browse leaf name Calcium intervention browse leaf as found Diabetes intervention browse leaf relevance high intervention browse leaf id M4550 intervention browse leaf name Calcium, Dietary intervention browse leaf as found Diabetes intervention browse leaf relevance high intervention browse leaf id M4534 intervention browse leaf name Calcium Carbonate intervention browse leaf as found Overall intervention browse leaf relevance high intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M3340 intervention browse leaf name Antacids intervention browse leaf relevance low intervention browse leaf id M3371 intervention browse leaf name Anti-Ulcer Agents intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id T401 intervention browse leaf name Inulin intervention browse leaf as found Silicone intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev BDCA intervention browse branch name Bone Density Conservation Agents intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements
NCT04836637
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full study rank 61241 study protocol section identification module n c t id NCT04839029 org study id info org study id IDIRB2017122601-293 organization org full name Benha University org class OTHER brief title Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT official title Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 1, 2019 start date type Actual primary completion date struct primary completion date August 30, 2022 primary completion date type Anticipated completion date struct completion date September 1, 2022 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 17, 2022 last update post date struct last update post date July 19, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Waleed El-Shaer, MD responsible party investigator title Associate professor responsible party investigator affiliation Benha University lead sponsor lead sponsor name Benha University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT. en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes conditions module condition list condition Bladder Cancer Bladder Neoplasm keyword list keyword NMIBC TURBT En bloc resection design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Bipolar En bloc TURBT arm group type Experimental arm group description patient subjected to bipolar Needlescopic En bloc resection of NMIBC arm group intervention list arm group intervention name Procedure: Bipolar En bloc TURBT arm group label Monopolar En bloc TURBT arm group type Active Comparator arm group description patient subjected to Monopolar Needlescopic En bloc resection of NMIBC arm group intervention list arm group intervention name Procedure: Monopolar En bloc TURBT intervention list intervention intervention type Procedure intervention name Bipolar En bloc TURBT intervention description patients subjected to Bipolar resection of bladder tumor by Collins loop intervention arm group label list intervention arm group label Bipolar En bloc TURBT intervention type Procedure intervention name Monopolar En bloc TURBT intervention description patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife) intervention arm group label list intervention arm group label Monopolar En bloc TURBT outcomes module primary outcome list primary outcome primary outcome measure Quality of tumor Resection primary outcome description presence of detrusor muscle primary outcome time frame immediatly post operative primary outcome measure adequacy of tumor Resection primary outcome description Presence of residual tumor at the bed of previously resected NMIBC primary outcome time frame 2 to 6 weeks postoprative secondary outcome list secondary outcome secondary outcome measure Complications secondary outcome description Modified Clavien-Dindo classification scale secondary outcome time frame within 30 days post-operative eligibility module eligibility criteria Inclusion Criteria: confirmed primary NMIBC (Ta, Tis, T1) Age > 18 years Exclusion Criteria: MIBC anterior located mass ( difficult or non visualized) healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Waleed El-Shaer, M.D central contact role Contact central contact phone 01015767331 central contact phone ext 0020 central contact e mail waleed_elshaer@hotmail.com overall official list overall official overall official name Waleed El-Shaer, M.D overall official affiliation Faculty of medicine, Banha university overall official role Principal Investigator location list location location facility Banha university hospital location status Recruiting location city Banhā location state Qalubia location zip 13511 location country Egypt derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001749 condition mesh term Urinary Bladder Neoplasms condition ancestor list condition ancestor condition ancestor id D000014571 condition ancestor term Urologic Neoplasms condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001745 condition ancestor term Urinary Bladder Diseases condition ancestor id D000014570 condition ancestor term Urologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M4182 condition browse leaf name Urinary Bladder Neoplasms condition browse leaf as found Bladder Cancer condition browse leaf relevance high condition browse leaf id M16472 condition browse leaf name Urologic Neoplasms condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M4178 condition browse leaf name Urinary Bladder Diseases condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions
NCT04839029
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full study rank 61904 study protocol section identification module n c t id NCT04830397 org study id info org study id QC-201 organization org full name Qlaris Bio, Inc. org class INDUSTRY brief title Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension). official title A Randomized Active-controlled Multi-site Double-masked Study to Evaluate the Safety and Tolerability of 3 Concentrations of QLS-101 Versus Timolol Maleate Preservative Free (PF) 0.5% Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 31, 2021 start date type Actual primary completion date struct primary completion date February 17, 2022 primary completion date type Actual completion date struct completion date February 17, 2022 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 3, 2022 last update post date struct last update post date May 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Qlaris Bio, Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension. detailed description Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension conditions module condition list condition Primary Open Angle Glaucoma Ocular Hypertension keyword list keyword elevated intraocular pressure design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 84 enrollment type Actual arms interventions module arm group list arm group arm group label QLS-101 0.5% arm group type Experimental arm group intervention list arm group intervention name Drug: QLS-101 arm group label QLS-101 1% arm group type Experimental arm group intervention list arm group intervention name Drug: QLS-101 arm group label QLS-101 2% arm group type Experimental arm group intervention list arm group intervention name Drug: QLS-101 arm group label Timolol Maleate 0.5% preservative free ophthalmic solution arm group type Active Comparator arm group intervention list arm group intervention name Drug: Timolol Maleate intervention list intervention intervention type Drug intervention name QLS-101 intervention description Ophthalmic solution 1x daily intervention arm group label list intervention arm group label QLS-101 0.5% QLS-101 1% QLS-101 2% intervention type Drug intervention name Timolol Maleate intervention description Ophthalmic solution 1x daily intervention arm group label list intervention arm group label Timolol Maleate 0.5% preservative free ophthalmic solution outcomes module primary outcome list primary outcome primary outcome measure Ocular safety primary outcome description Number of participants with treatment-related adverse events will be monitored primary outcome time frame 100 days secondary outcome list secondary outcome secondary outcome measure Ocular hypotensive efficacy secondary outcome description Number of participants with intraocular pressure reduction from baseline will be calculated. secondary outcome time frame 28 days eligibility module eligibility criteria Inclusion Criteria: Visual acuity +1.0 logMAR or better Willing to give informed consent Ability to washout from current intraocular pressure lowering medications - Exclusion Criteria: Severe glaucomatous damage Previous glaucoma intraocular or laser surgery Refractive surgery Ocular infection or inflammation healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Dixon Eye Care location city Albany location state Georgia location zip 31701 location country United States references module see also link list see also link see also link label Company website, pipeline see also link u r l https://qlaris.bio/our-science/#our-pipeline derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005901 condition mesh term Glaucoma condition mesh id D000005902 condition mesh term Glaucoma, Open-Angle condition mesh id D000009798 condition mesh term Ocular Hypertension condition mesh id D000006973 condition mesh term Hypertension condition ancestor list condition ancestor condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf as found Hypertension condition browse leaf relevance high condition browse leaf id M8165 condition browse leaf name Glaucoma condition browse leaf as found Glaucoma condition browse leaf relevance high condition browse leaf id M8166 condition browse leaf name Glaucoma, Open-Angle condition browse leaf as found Primary Open Angle Glaucoma condition browse leaf relevance high condition browse leaf id M11883 condition browse leaf name Ocular Hypertension condition browse leaf as found Ocular Hypertension condition browse leaf relevance high condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC11 condition browse branch name Eye Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000013999 intervention mesh term Timolol intervention ancestor list intervention ancestor intervention ancestor id D000000319 intervention ancestor term Adrenergic beta-Antagonists intervention ancestor id D000018674 intervention ancestor term Adrenergic Antagonists intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000000889 intervention ancestor term Anti-Arrhythmia Agents intervention ancestor id D000000959 intervention ancestor term Antihypertensive Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M11966 intervention browse leaf name Ophthalmic Solutions intervention browse leaf relevance low intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse leaf id M245711 intervention browse leaf name Maleic acid intervention browse leaf relevance low intervention browse leaf id M15909 intervention browse leaf name Timolol intervention browse leaf as found Outreach intervention browse leaf relevance high intervention browse leaf id M2823 intervention browse leaf name Adrenergic beta-Antagonists intervention browse leaf relevance low intervention browse leaf id M19899 intervention browse leaf name Adrenergic Agents intervention browse leaf relevance low intervention browse leaf id M19908 intervention browse leaf name Adrenergic Antagonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M3365 intervention browse leaf name Anti-Arrhythmia Agents intervention browse leaf relevance low intervention browse leaf id M3429 intervention browse leaf name Antihypertensive Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AnArAg intervention browse branch name Anti-Arrhythmia Agents intervention browse branch abbrev AnAg intervention browse branch name Antihypertensive Agents
NCT04830397
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full study rank 61524 study protocol section identification module n c t id NCT04835350 org study id info org study id 01-CIP-27-11-20 organization org full name University Hospital, Motol org class OTHER brief title Feasibility and Safety Study of the Automated Insulin Delivery Closed Loop System Pancreas4ALL official title Feasibility Study of the Pancreas4ALL Closed-loop Automated Glycemic Control System in Patients With Type 1 Diabetes Mellitus: Pancreas4ALL Project - Good News Study - Phase I acronym ASAP status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 19, 2021 start date type Actual primary completion date struct primary completion date April 30, 2021 primary completion date type Anticipated completion date struct completion date May 2021 completion date type Anticipated study first submit date March 23, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Lenka Petruzelkova responsible party investigator title MD, PhD responsible party investigator affiliation University Hospital, Motol lead sponsor lead sponsor name Lenka Petruzelkova lead sponsor class OTHER collaborator list collaborator collaborator name CLOSED LOOP Systems s.r.o. collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system. detailed description Screening - day 0 Hospitalization (Day 1-10) Day 1 - Deployment of study equipment, patient education Day 2 - Start of study, activation of Pancreas4ALL closed loop in mode - hybrid closed loop (2.7.1) Day 4 - Randomization of patients to Group A and to Group B Group A - Activation of Pancreas4ALL closed loop in closed loop mode - "food announcement" (2.7.2) Group B - Activation of Pancreas4ALL closed loop in mode - full closed loop mode (2.7.3) Day 7 - Crossover - Group exchange Day 10 - Return to the initial treatment modality. Termination of the study Detailed description of the clinical trial - study control plan: Outpatient check: Signing of informed consents to the study and GDPR consent to the processing of personal data by the legal representative and the entity that will be included in the study Urine pregnancy test for women and girls after menarche Blood collection for the determination of HbA1c, TSH and creatinine Evaluation of entry criteria (inclusion criteria); if all criteria are met, the subject will be included in the study. Day 1: Hospitalization in the inpatient part of the University Hospital and the 2nd Medical Faculty of Charles University, Department of Endocrinology and Diabetology. Download data from an existing pump / sensor for the last 3 months to Carelink or Diasend Creating a DexCom Clarity and Diasend / Tidepool account (certified patient data store) Training of the patient in the use of the DANA RS Diabcare pump and the DexCom G6 CGM Training of Samsung S10e mobile phone with active version of Pancreas4ALL application connected to Dana RS Diabcare and Dexcom G6 IP - mode open loop Application of DANA RS Diabcare insulin pump and CGM Dexcom G6 to the patients Optimization of basal dose and bolus calculator settings using Pancreas4ALL advisor (calculation based on patient's age, weight and CDD) Education about the necessary inputs (data entered by the patient) into the Pancreas4ALL application. Activation of the Pancreas4ALL application - open loop. Preprandial bolus calculated by the patient using a bolus calculator, part of the Pancreas4ALL application. Completion of the Quality of Life (QoL) Questionnaire PedsQl Defined Pancreas4ALL settings for all subjects. Target glycemia 5.5 mmol / mol Active insulin time 6 hours Setting automatic functions: In case of hypoglycemia (glycemia below 3.9 mmol / l), a temporary blood glucose target of 8 mmol / l is automatically set for 30 minutes after the hypoglycemia has occurred. Another activities: In case of physical activity, it is recommended that the patient temporarily increase the target glycemia to 8 mmol / l, switch to a temporary profile of 70-80% depending on the intensity of physical activity (automatic recalculation of basal dose, insulin sensitivity, insulin carbohydrate ratio to 70-80%) In case of illness accompanied by an increase in glycaemia, the patient is recommended to switch to a temporary profile of 120-150% (automatic recalculation of the basal dose, insulin sensitivity, insulin carbohydrate ratio at the set 120-150%) Day 2: 1) Initiation - activation of the "closed loop" Pancreas4All in the hybrid closed loop mode (2.7.1) The patient will enter the number of carbohydrates eaten into the application, using the bolus calculator to calculate the preprandial bolus. Meal blood glucose will be corrected using the Pancreas4All automated system. In case of glycemia above 13 mmol / l 30 min after a meal, the correction bolus will be calculated using a bolus calculator. Hyperglycemia management see appendix. In case of hypoglycaemia (glycaemia <3.9 mmol /), the subject will be given dextrose in the form of tablets or a sweet drink (the amount of dextrose will be calculated according to the patient's weight, current level and glycemic trend) See Appendix. Day 4: Randomization to group A and group B Randomization will be performed using an IT application according to age, gender, weight and input glycated hemoglobin. Randomization: Group A: Activation of Pancreas4ALL in closed loop mode in "meal announcement" (version 2.7.2). The patient will only enter a notification in the application that he is going to eat. Group B: Activation of the Pancreas4ALL application in mode full closed loop mode (version 2.7.3). The subject will not enter any notification or notification into the application that it is going to eat. Other settings + glycemic control remain as in the previous phase. Day 7 - Cross-over - change of settings for groups A and B: The basic settings remain unchanged Change the setting mode in groups A and B Blood glucose control see above. Day 10 - Visit 2 - End of study: Download data from pump to DexCom clarity and Diasend / Tidepool, check data storage from IP and sensor Evaluation of glycemic control for the last week Completion of the PedsQl Quality of Life (QoL) Questionnaire + System Satisfaction Questionnaire. Termination of the study - return to the standard treatment modality of the patients conditions module condition list condition Type 1 Diabetes keyword list keyword closed loop system design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design intervention model description Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of Pancreas4All automated "closed loop" system. design primary purpose Device Feasibility design masking info design masking None (Open Label) enrollment info enrollment count 16 enrollment type Anticipated arms interventions module arm group list arm group arm group label Hybrid closed loop group arm group type No Intervention arm group description Patients using AID system Pancreas4ALL in mode hybrid closed loop. arm group label Closed loop meal announcment arm group type Experimental arm group description Patients using AID system Pancreas4ALL in mode meal announcment. They only announce what amout of carbs going to eat. They calculate no bolus arm group intervention list arm group intervention name Device: Pancreas4ALL - meal announcement or full closed loop arm group label Full closed loop arm group type Experimental arm group description Patients using AID system Pancreas4ALL in mode full closed loop. They eating with no permission and they do not calculate and sending bolus anymore. arm group intervention list arm group intervention name Device: Pancreas4ALL - meal announcement or full closed loop intervention list intervention intervention type Device intervention name Pancreas4ALL - meal announcement or full closed loop intervention description Patient using AID Pancreas4ALL in mode meal announcment or full closed loop. intervention arm group label list intervention arm group label Closed loop meal announcment Full closed loop outcomes module primary outcome list primary outcome primary outcome measure The feasibility of the prototype device Pancreas4ALL primary outcome description Percentage of time of automatic control of glucose by Pancreas4ALL would be > 90% primary outcome time frame ten days primary outcome measure The safety of the prototype device Pancreas4ALL primary outcome description Percentage of time spent in hypoglycemia 2.degrees (<3 mmol / L) would be < 1% during sutomatic glucose control by Pancreas4ALL primary outcome time frame ten days secondary outcome list secondary outcome secondary outcome measure GCM parametrs of glycemic control secondary outcome description Calculation of Time in range (3.9 - 10 mmol / l) which would be > 75% throughout the study Translation results "The secondary goal is excellent glycemic control in all tested versions of the Pancreas4ALL closed loop application (version 2.7.1, version 2.7.2, version 2.7.3), defined as the time spent in Time in range (3.9 - 10 mmol / l) > 70% throughout the study. " secondary outcome time frame ten days secondary outcome measure Quality of life of patient living on closed loop system Pancreas4ALL secondary outcome description PedsQL Diabetes Module 3.2 - questionnaire secondary outcome time frame seven days eligibility module eligibility criteria Inclusion Criteria: Subjects will be included in the study if they meet the following entry criteria: The subject was diagnosed with type 1 DM ≥ 1 year The subject is aged 15-25 The subject has an HbA1C value between 43 mmol / mol and 75 mmol / mol at the time of the screening visit The subject must have experience with insulin pump therapy and CGM ≥ 3 months The subject is willing to use the system Pancreas4ALL continuously throughout the study Exclusion Criteria: 1. The subject does not tolerate the adhesive patch at the sensor site for CGM 2. Women of productive age who have a positive pregnance test at the time of screening or are planning to become pregnant at the time of the study 4. The subject underwent the following diagnoses in the year preceding screening: myocardial infarction, unstable angina pectoris, coronary artery bypass passage, stent insertion into the coronary artery, transient ischemic attack, cerebrovascular accident, angina pectoris, congestive heart failure, ventricular arrhythmia or thromboembolism 5. The subject has an abnormal (> 1.5x times the upper reference limit, as assessed by the laboratory) creatinine at the time of screening 6. The subject has clinically significant abnormalities (outside the reference range as assessed by the laboratory) of thyroid stimulating hormone (TSH) at the time of screening 7. The subject has taken any oral or injectable corticosteroids in the last 8 weeks prior to the screening visit, or plans to take any oral or injectable corticosteroids during the study 8. The subject is actively involved in any research study (drug or instrumental) in which he or she has undergone treatment with a research drug or research facility in the previous 2 weeks prior to the screening visit. 9. The subject is currently using illicit drugs 10. The subject is currently abusing prescription drugs 11. The subject is currently addicted to alcohol 12. The subject is taking pramlintide (Symlin) or an SGLT2 inhibitor at the time of the screening visit 13. The subject suffers from a visual impairment that does not allow him to participate in the study and to safely perform all tasks within the study, as determined by the investigator 14. The subject has planned elective surgery requiring general anesthesia for the duration of the study 15. The subject has currently been diagnosed with an eating disorder such as anorexia or bulimia 16. The subject has been diagnosed with chronic renal failure leading to chronic anemia 17. The subject is dialyzed healthy volunteers No gender All minimum age 15 Years maximum age 25 Years std age list std age Child Adult contacts locations module central contact list central contact central contact name Lenka Petruzelkova, MD, PhD central contact role Contact central contact phone +420775983866 central contact e mail lenkapetruzelkova@gmail.com central contact name Milos Kozak central contact role Contact central contact phone +420775983866 central contact e mail M.Kozak@sysop.cz overall official list overall official overall official name Lenka Petruzelkova, MD, PhD overall official affiliation Department of Paediatrics, Motol University Hospital, Charles University overall official role Principal Investigator location list location location facility Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University location status Recruiting location city Prague location zip 15006 location country Czechia location contact list location contact location contact name Lenka Petruzelkova, MD, PhD location contact role Contact location contact phone +420775983866 location contact e mail lenkapetruzelkova@gmail.com i p d sharing statement module i p d sharing Yes i p d sharing description basic characteristic of participants and all results i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing time frame 3 months derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003922 condition mesh term Diabetes Mellitus, Type 1 condition ancestor list condition ancestor condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M6269 condition browse leaf name Diabetes Mellitus, Type 1 condition browse leaf as found Type 1 Diabetes condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000020799 intervention mesh term Pancrelipase intervention ancestor list intervention ancestor intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M9517 intervention browse leaf name Insulin intervention browse leaf relevance low intervention browse leaf id M172956 intervention browse leaf name Insulin, Globin Zinc intervention browse leaf relevance low intervention browse leaf id M21707 intervention browse leaf name Pancrelipase intervention browse leaf as found Anti-inflammatory intervention browse leaf relevance high intervention browse leaf id M12266 intervention browse leaf name Pancreatin intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Hypo intervention browse branch name Hypoglycemic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents
NCT04835350
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full study rank 61545 study protocol section identification module n c t id NCT04835077 org study id info org study id IstanbulC organization org full name Istanbul University-Cerrahpasa org class OTHER brief title Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome official title Comparison of the Effectiveness of Structured Aerobic Exercises and Postural Stabilization Exercises in Patients With Fibromyalgia Syndrome status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date April 1, 2022 primary completion date type Actual completion date struct completion date December 30, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 2, 2022 last update post date struct last update post date November 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mustafa Yilmaz responsible party investigator title MSc Physiotherapsit responsible party investigator affiliation Istanbul University-Cerrahpasa lead sponsor lead sponsor name Istanbul University-Cerrahpasa lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Fibromyalgia Syndrome (FMS) is a chronic rheumatic disease characterized by a wide range of symptoms such as widespread muscle pain, fatigue, sleep disturbances, anxiety-depression, impaired balance, falling risk, poor physical condition, cognitive dysfunction, and irritable bowel syndrome. The aim of the study; It is a comparison of the effectiveness of aerobic exercises and postural stabilization exercises that are structured to reduce the pain severity, fatigue, sleep problems and anxiety-depression levels of patients who are being followed up with a diagnosis of FMS, and to increase the duration of physical activity and quality of life. conditions module condition list condition Fibromyalgia Syndrome Physiotherapy Rehabilitation keyword list keyword Aerobic Exercise Postural Control Fibromyalgia design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized Control Study design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Structured Aerobic Exercises arm group type Experimental arm group description Following the training on aerobic exercise content and effectiveness; First Week; participants 5 minutes warm-up, 20 minutes of aerobic exercise with 60-70% of maximum heart rate, and 5 minutes of cool down. In the following weeks, the aerobic exercise duration of all participants will be increased by 5 minutes compared to the previous week. The duration of the sessions in the 7th and 8th weeks will progressively progress to 40 minutes and the intensity to 75-80% of the maximum heart rate. arm group intervention list arm group intervention name Other: aerobic exercise arm group label Postural Stabilization Exercises arm group type Experimental arm group description Exercises; It will consist of postural exercises to be done in prone, supine, side lying, crawling, sitting and standing positions. All exercises will be done in 2 sets per day, the number of repetitions will be determined individually and progressed. Breathing exercises Four-way stretching and strengthening of the neck muscles Shoulder girdle stretching and strengthening exercises Hip flexors, hamstring, itb, lumbar extensor stretching and strengthening Lying down exercises in the crawling position Shuttle movement Plank movement Toe taps Bridging Straight leg lift Straight leg raises in side-lying Prone knee flexion arm group intervention list arm group intervention name Other: postural stabilization exercises arm group label Control arm group type No Intervention arm group description The individuals without any treatment will continue their normal lives and will be included in the study as a control group. Exercise will be given after 8 weeks. intervention list intervention intervention type Other intervention name aerobic exercise intervention description Structured aerobic exercises (Each session will consist of 50 minutes and will be divided into three parts: 5 minutes of warm-up exercises, 40 minutes of aerobic exercises, 5 minutes of cool down exercises) will be taught in the first session. intervention arm group label list intervention arm group label Structured Aerobic Exercises intervention type Other intervention name postural stabilization exercises intervention description Structured postural stabilization exercises (strengthening exercises, balance-coordination exercises, flexibility exercises) will be taught in the first session. intervention arm group label list intervention arm group label Postural Stabilization Exercises outcomes module primary outcome list primary outcome primary outcome measure Fibromyalgia Impact Questionnaire (FIQ) primary outcome description This scale; It measures 10 different characteristics: physical function, feeling unwell, not going to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the sense of well-being, lower scores indicate improvement or less affected by the disease. FIQ is filled by the patient. The maximum possible score for each subtitle is 10. Thus, the total maximum score is 100. While the average FM patient gets 50 points, more severely affected FM patients usually score above 70. primary outcome time frame change from baseline at 8 weeks secondary outcome list secondary outcome secondary outcome measure Visual Analogue Scale (VAS) secondary outcome description VAS; It is a scale that provides a one-dimensional measurement of pain intensity in different adult populations. It usually consists of a 10 cm long horizontal (HVAS) or vertical (VVAS) line. In measuring the severity of pain; A score of 0 is defined as no pain, a score of 10 as worst pain possible or worst imaginable pain. Although the period of time when pain is questioned varies, the most common time for the patient's pain is the current pain or the pain experienced in the last 24 hours. secondary outcome time frame change from baseline at 8 weeks other outcome list other outcome other outcome measure Brief Pain Inventory (BPI) other outcome description The BPI questionnaire is a short, easy-to-apply assessment method that can be used to assess pain. It includes simple 0 to 10 numerical evaluation scales that are easy to understand and translate into different languages. In the short pain inventory, a score of 1-4 of the worst pain is defined as mild pain, 5-6 as moderate pain, and 7-10 as severe pain. Evaluates the severity of pain, localization of pain, medical treatments for pain, and the effect of pain on daily functions, and questions how much pain has been reduced in the last 24 hours or last week. It takes a short time, like 5-10 minutes, to answer all questions. other outcome time frame change from baseline at 8 weeks other outcome measure Pittsburgh Sleep Quality Index (PSQI) other outcome description PSQI is a 19-item self-report scale that evaluates sleep quality and disorder over the past month. Each item of the test is equally scored between 0 and 3. The scale consists of 7 subscales that evaluate subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping pills and daytime functionality loss. The total PSQI score ranging from 0 to 21 is obtained by summing the subscales. A total PSQI score greater than 5 indicates that the individual's sleep quality is insufficient with 89.6% sensitivity and 86.5% specificity, and indicates severe impairment in at least two areas, or moderate deterioration in three areas. other outcome time frame change from baseline at 8 weeks other outcome measure Fatigue Severity Scale (FSS) other outcome description The person indicates how much they agree with each item by choosing numbers from 1 to 7. 1 indicates that they disagree at all, 7 indicates that they agree completely. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue. The total score is calculated by taking the average of 9 items. The cut-off value for pathological fatigue was set at 4 and above. The lower the total score, the less fatigue. other outcome time frame change from baseline at 8 weeks other outcome measure 2 Minute Walking Test other outcome description Subjects begin to walk for 2 minutes at their own walking pace in the 21-meter corridor marked from the starting line, wearing their shoes and using their normal walking aids. The lines at both ends of the floor of the corridor indicate where the subjects will turn. The evaluator walks behind the subjects to ensure their safety and to minimize changes in pacing speed while walking. It also keeps time using a digital stopwatch. other outcome time frame change from baseline at 8 weeks other outcome measure Short Form Health Survey (SF-36) other outcome description It is one of the most common generic measures used to measure quality of life. This scale examines 8 dimensions of health such as physical function, role restrictions, social function, mental health, energy, pain and general perception of health with 36 items. The scale gives a separate total score for each subscale rather than just a single total score, and the scores range from 0 to 100. While 100 points indicate good health, 0 points indicate poor health. other outcome time frame change from baseline at 8 weeks other outcome measure International Physical Activity Questionnaire Short Form (IPAQ Short Form) other outcome description IPAQ Short Form; It consists of nine questions measuring the intensity of physical activity. The questions provide information about physical activities (climbing stairs, walking, shopping, sitting time) in the last 7 days. From these data, the total weekly physical activity level (MET / hour / week) is classified as low, medium and high. Individuals who indicate that they do not have physical activity must have a low physical activity level x ≤ 600 MET / minute / week, and in order to be at an intense or moderate level of physical activity, total physical activity must be attained to a minimum of x ≥ 600-3000 MET / minute / week. other outcome time frame change from baseline at 8 weeks other outcome measure PostureZone Mobile Application other outcome description PostureZone mobile application is a new application that makes posture assessment more effective in different environments. Free versions of this easy-to-use and fast application are available on mobile devices. For posture analysis, participants are photographed anteriorly and laterally in front of a flat surface using the device camera. Then, after manually marking the anatomical points on the photograph, the program performs the analysis. With this program, shift and tilt values occurring in the head, shoulder, rib and hip in the anterior and shift and tilt values occurring in the head, shoulder, hip and knee in the lateral can be calculated. If desired, the total shift and tilt values obtained from both angles can be saved. This program, which aims to obtain reliable information through the processing and interpretation of photographic images, can be used in postural assessments thanks to the quantification of linear and angular measurements. other outcome time frame change from baseline at 8 weeks other outcome measure Plank position time other outcome description Plank; It is called a type of exercise that develops the leg and chest muscles, especially the abdominal muscles, and is done 45 degrees with the ground. Plank movement improves bodily qualities such as strength, balance and endurance when properly applied. This movement works the entire abdominal muscle. Apart from that, it strengthens the neck, back, waist, chest and front / back leg muscles; Corrects posture disorders. It ensures that the shoulders are back and the breasts are high. The whole body is tightened with the help of the fingertip on the elbows and the head is facing forward. The evaluator keeps time using a digital stopwatch. other outcome time frame change from baseline at 8 weeks eligibility module eligibility criteria Inclusion Criteria: Being in the age range of 25-60 According to the 2013 American College of Rheumatology (ACR) diagnostic criteria, the Pain Placement Score (AES) is 17 and the Symptomatic Effect Score (SES) is ≥21. FMS symptoms persist for more than 3 months Ability to adapt to exercise Having the ability to use the necessary devices for web-based training Exclusion Criteria: Any disease that may hinder exercise Finding cardiological problems for aerobic exercises Presence of loss of sense and sense of position Presence of an unhealed fracture or surgical wound Patients with mental / psychotic disorders healthy volunteers No gender All minimum age 25 Years maximum age 60 Years std age list std age Adult contacts locations module central contact list central contact central contact name MUSTAFA YILMAZ central contact role Contact central contact phone +905445455424 central contact e mail fzt.mustafayilmaz@gmail.com overall official list overall official overall official name MUSTAFA YILMAZ overall official affiliation MSc Physiotherapist overall official role Principal Investigator location list location location facility Mustafa Yilmaz location status Recruiting location city Istanbul location state Büyükçekmece location zip 34500 location country Turkey location contact list location contact location contact name MUSTAFA YILMAZ, PhD (c) location contact role Contact location contact phone +905445455424 location contact e mail fzt.mustafayilmaz@gmail.com location contact name ELA TARAKCI, prof. location contact role Sub-Investigator location contact name SERDAL UGURLU, prof. location contact role Sub-Investigator references module reference list reference reference p m i d 20461783 reference type background reference citation Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140. reference p m i d 27682568 reference type background reference citation Walker J. Fibromyalgia: clinical features, diagnosis and management. Nurs Stand. 2016 Sep 28;31(5):51-63. doi: 10.7748/ns.2016.e10550. reference p m i d 23203795 reference type background reference citation Vincent A, Lahr BD, Wolfe F, Clauw DJ, Whipple MO, Oh TH, Barton DL, St Sauver J. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken). 2013 May;65(5):786-92. doi: 10.1002/acr.21896. reference p m i d 24737367 reference type background reference citation Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005356 condition mesh term Fibromyalgia condition mesh id D000009209 condition mesh term Myofascial Pain Syndromes condition mesh id D000013577 condition mesh term Syndrome condition ancestor list condition ancestor condition ancestor id D000004194 condition ancestor term Disease condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf as found Syndrome condition browse leaf relevance high condition browse leaf id M7638 condition browse leaf name Fibromyalgia condition browse leaf as found Fibromyalgia condition browse leaf relevance high condition browse leaf id M11313 condition browse leaf name Myofascial Pain Syndromes condition browse leaf as found Fibromyalgia Syndrome condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M12183 intervention browse leaf name Oxymetazoline intervention browse leaf relevance low intervention browse leaf id M12713 intervention browse leaf name Phenylephrine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev VaCoAg intervention browse branch name Vasoconstrictor Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev CaAg intervention browse branch name Cardiotonic Agents
NCT04835077
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full study rank 61384 study protocol section identification module n c t id NCT04837170 org study id info org study id SAFE-SK-A organization org full name Chinese PLA General Hospital org class OTHER brief title Safety and Efficacy Evaluation of S (+) - Ketamine in Adults official title Safety and Efficacy Evaluation of S（+）-Ketamine for Postoperative Acute Pain in Adults in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Anticipated primary completion date struct primary completion date June 1, 2022 primary completion date type Anticipated completion date struct completion date June 30, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Weidong Mi responsible party investigator title Director of the Department of Anesthesiology, Chinese PLA General Hospital responsible party investigator affiliation Chinese PLA General Hospital lead sponsor lead sponsor name Chinese PLA General Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Jiangsu Provincial People's Hospital collaborator class OTHER collaborator name Beijing Hospital collaborator class OTHER_GOV collaborator name The Affiliated Hospital of Qingdao University collaborator class OTHER collaborator name Renmin Hospital of Wuhan University collaborator class OTHER collaborator name First Affiliated Hospital Xi'an Jiaotong University collaborator class OTHER collaborator name First Affiliated Hospital, Sun Yat-Sen University collaborator class OTHER collaborator name Shengjing Hospital collaborator class OTHER collaborator name Southern Medical University, China collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in adults in perioperative settings. detailed description Patients often suffer acute pain after operation ，which may affect the recovery. Opioid such as morphine is the most commonly analgesic drugs, but opioid has many obviously adverse reactions ,for example respiratory depression,circulation inhibition,tolerance, addiction, nausea, vomiting, pruritus, etc. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese patients undergoing surgery. Objective:Evaluate the efficacy and safety of S (+) - ketamine on acute perioperative pain for chinese adult patients,and look for the best dosage, mode of administration, timing, and compatibility ,as well explore the effect of S (+) - ketamine on postoperative delirium,anxiety ,depression and cognitive dysfunction. conditions module condition list condition Postoperative Pain Adults Anesthesia keyword list keyword S-ketamine,Esketamine,S (+) - ketamine Acute Pain Depression, Anxiety Delirium Hyperalgesia design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Experimental group : Control group=2:1 design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 12000 enrollment type Anticipated arms interventions module arm group list arm group arm group label S (+)-Ketamine group arm group type Experimental arm group description Drug: Conventional therapy + S (+)-Ketamine In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection,but the recommended dosage is given, which is lower than the dosage specified in the instructions. Recommended use and dosage of S (+)-Ketamine: Bolus intravenous injection before skin incision, the dose is 0.1~0.5 mg/kg; Bolus intravenous injection (dose 0.1~0.5 mg/kg) before skin incision +continuous intravenous infusion (dose of 0.1~0.25 mg/kg/h) during operation; Continuous intravenous infusion after surgery with a dose of 0.02~0.1 mg/kg/h for 24~48 h. arm group intervention list arm group intervention name Drug: Conventional therapy + S (+)-Ketamine arm group label Control group arm group type Active Comparator arm group description Drug: Conventional therapy Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine. arm group intervention list arm group intervention name Drug: Conventional therapy intervention list intervention intervention type Drug intervention name Conventional therapy + S (+)-Ketamine intervention description Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction,maintenance or postoperative analgesia. intervention arm group label list intervention arm group label S (+)-Ketamine group intervention other name list intervention other name Conventional therapy + S-ketamine Conventional therapy + Esketamine intervention type Drug intervention name Conventional therapy intervention description Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine. intervention arm group label list intervention arm group label Control group intervention other name list intervention other name Routine treatment outcomes module primary outcome list primary outcome primary outcome measure The area under the broken line of NRS score primary outcome description The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain. primary outcome time frame Hour 0-48 after surgery primary outcome measure Opioid consumption primary outcome description Total opioid consumption(conversion to equivalent morphine) primary outcome time frame Hour 0-48 after surgery secondary outcome list secondary outcome secondary outcome measure NRS pain scores secondary outcome description The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain. secondary outcome time frame Hour 0-48 after surgery secondary outcome measure Time of first rescue analgesia secondary outcome description The time from the end of the operation to the first rescue analgesics after the operation. Rescue analgesia refers to the analgesia according to the patient's requirements in addition to routine postoperative analgesia. secondary outcome time frame Hour 0-48 after surgery secondary outcome measure The incidence of rescue analgesia secondary outcome description The incidence of rescue analgesia within 48h after surgery secondary outcome time frame Hour 0-48 after surgery secondary outcome measure Recovery time secondary outcome description The time from the end of the operation to recovery(can be awakened) secondary outcome time frame Day 0 secondary outcome measure The incidence of unexpected intraoperative events secondary outcome description Unexpected events during operation include intraoperative cough, laryngeal spasm, body movement, tachycardia,decreased oxygen saturation, respiratory depression, bradycardia, hypertension and hypotension. secondary outcome time frame Intraoperative secondary outcome measure The Patient Efficacy Questionnaire (IPOQ ) scores secondary outcome description Patient Efficacy Questionnaire (IPOQ ) scale include 13 questions , each question's score is 0-10 or 0-100%, it involves postoperative pain, mood and quality of life. The higher the score, the more severe the pain symptoms. secondary outcome time frame Hour 48 after surgery secondary outcome measure The incidence of adverse events after surgery secondary outcome description The incidence of adverse events from the end of the operation to 48h after surgery. Including nausea, vomiting, increased secretions, dizziness, oversedation, infection,anesthetic awareness, nightmares, restlessness, pruritus, disorientation, delirium, respiratory depression, diplopia, diarrhea, intestinal obstruction, urinary retention, gastroesophageal reflux, constipation, chills, hallucinations, etc. secondary outcome time frame Hour 0-48 after surgery secondary outcome measure Pharmacoeconomic indicators secondary outcome description Calculating incremental cost-effectiveness ratio （ICER）based on cost-effectiveness analysis. secondary outcome time frame Hour 48 after surgery secondary outcome measure Incidence of postoperative delirium secondary outcome description The Chinese version of the 3D-CAM scale is used for the diagnosis of delirium, and the assessment will be carried out at 24h, 48h and 72h after the operation. If the patient is discharged 72h after the patient is discharged, it may not be assessed. secondary outcome time frame Hour 0-48 after surgery secondary outcome measure Simple Mental State Examination (MMSE) Scale score secondary outcome description The total score of Simple Mental State Examination Scale (MMSE) is 30,the higher the score, the better the cognitive function. secondary outcome time frame Hour 48 after surgery secondary outcome measure Hospital Anxiety and Depression (HAD) Scale score secondary outcome description Hospital Anxiety and Depression Scale (HAD) includes anxiety measure(7questions,0-21pionts) and depression measure(7 questions,0-21pionts),the higher the score, the more severe thesymptoms. secondary outcome time frame Hour 48 after surgery eligibility module eligibility criteria Inclusion Criteria: 1. Age ≥18 years old; 2. Scheduled for elective digestive tract surgery, gynecological surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or body surface surgery (thyroid surgery or breast surgery), head and neck surgery; 3. ASA score Ⅰ～Ⅲ; 4. The informed consent form was signed by the patients. Exclusion Criteria: 1. The expected length of hospital stay of the patient is less than 48h; 2. Patients expected to be admitted to the ICU after surgery; 3. Patients expected to return to the ward with tracheal catheter after surgery; 4. Be allergic to S (+) - ketamine; 5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction; 6. Patients with a history of severe cardiovascular disease (congestive heart failure, severe angina attack, or unstable angina or myocardial infarction within 6 months); 7. Patients during pregnancy or lactation; 8. Patients with MMSE score <18 points; 9. Patients with any of the following contraindications of S (+) - ketamine: Patients with risk of serious rise of blood pressure or intracranial pressure; Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg); Patients with untreated or undertreated hyperthyroidism. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Weidong Mi, MD central contact role Contact central contact phone 8613381082966 central contact e mail wwdd1962@aliyun.com central contact name Hong Wang, MD central contact role Contact central contact phone 8613661363231 central contact e mail 301wh@163.com overall official list overall official overall official name Weidong Mi, MD overall official affiliation Chinese PLA General Hospital overall official role Study Chair references module reference list reference reference p m i d 34916327 reference type derived reference citation Wang H, Duan CY, Huang WQ, Zhao P, Zhou LZ, Liu YH, Liu CM, Chu HC, Wang Q, Diao YG, Hua Z, Meng QT, Li H, Zhang XY, Mi WD, Chen PY. Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial). BMJ Open. 2021 Dec 16;11(12):e054681. doi: 10.1136/bmjopen-2021-054681. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010149 condition mesh term Pain, Postoperative condition ancestor list condition ancestor condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Postoperative Pain condition browse leaf relevance high condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf relevance low condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf relevance low condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf relevance low condition browse leaf id M6046 condition browse leaf name Delirium condition browse leaf relevance low condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M28678 condition browse leaf name Acute Pain condition browse leaf relevance low condition browse leaf id M9133 condition browse leaf name Hyperalgesia condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000007649 intervention mesh term Ketamine intervention mesh id C000629870 intervention mesh term Esketamine intervention ancestor list intervention ancestor intervention ancestor id D000000700 intervention ancestor term Analgesics intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000000778 intervention ancestor term Anesthetics, Dissociative intervention ancestor id D000018686 intervention ancestor term Anesthetics, Intravenous intervention ancestor id D000018681 intervention ancestor term Anesthetics, General intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000018691 intervention ancestor term Excitatory Amino Acid Antagonists intervention ancestor id D000018683 intervention ancestor term Excitatory Amino Acid Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000928 intervention ancestor term Antidepressive Agents intervention ancestor id D000011619 intervention ancestor term Psychotropic Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M271913 intervention browse leaf name Esketamine intervention browse leaf as found Multidisciplinary intervention browse leaf relevance high intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M9826 intervention browse leaf name Ketamine intervention browse leaf as found Hospital intervention browse leaf relevance high intervention browse leaf id M6262 intervention browse leaf name Dextromethorphan intervention browse leaf relevance low intervention browse leaf id M3040 intervention browse leaf name Amantadine intervention browse leaf relevance low intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M3260 intervention browse leaf name Anesthetics, Dissociative intervention browse leaf relevance low intervention browse leaf id M19919 intervention browse leaf name Anesthetics, Intravenous intervention browse leaf relevance low intervention browse leaf id M19914 intervention browse leaf name Anesthetics, General intervention browse leaf relevance low intervention browse leaf id M19924 intervention browse leaf name Excitatory Amino Acid Antagonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M3399 intervention browse leaf name Antidepressive Agents intervention browse leaf relevance low intervention browse leaf id M13626 intervention browse leaf name Psychotropic Drugs intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PsychDr intervention browse branch name Psychotropic Drugs intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev AnTuAg intervention browse branch name Antitussive Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev AnDyAg intervention browse branch name Anti-Dyskinesia Agents
NCT04837170
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full study rank 61887 study protocol section identification module n c t id NCT04830618 org study id info org study id B-1204/152-004 organization org full name Seoul National University Hospital org class OTHER brief title Aberrant DNA Methylation to Predict Metachronous Gastric Neoplasms official title Aberrant DNA Methylation Maker for Predicting Metachronous Recurrence After Endoscopic Resection of Gastric Neoplasms status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date September 11, 2012 start date type Actual primary completion date struct primary completion date November 16, 2017 primary completion date type Actual completion date struct completion date December 31, 2020 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 31, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dong Ho Lee responsible party investigator title M.D., Ph.D. responsible party investigator affiliation Seoul National University Hospital lead sponsor lead sponsor name Seoul National University Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The study is a prospective cohort study to investigate whether aberrant DNA methylation can be useful for the prediction of metachronous recurrence after endoscopic resection of gastric neoplasms (dysplasia or cancer). From 2012 to 2017, 300 patients were prospectively enrolled after endoscopic resection (ER) of gastric dysplasia or early gastric cancer. All lesions were assessed by endoscopy and biopsy before ER. Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) was performed for gastric dysplasia and early gastric cancers which met the absolute indication (differentiated adenocarcinoma, intramucosal cancer, lesions < 20 mm, and no endoscopic evidence of ulceration). All lesions were curatively resected; if non-curatively resected, the patients were not enrolled from the study. All subjects, who provided informed consent, were asked to complete a questionnaire under the supervision of a well-trained interviewer. The questionnaire included questions regarding demographic data (age, sex), socioeconomic data (smoking, alcohol, and education), their family history of GC in first-degree relatives, and history of H. pylori eradication therapy. Also, MOS methylation level at baseline was measured from noncancerous gastric mucosae at corpus. When H. pylori was positive by CLOtest or histology at baseline or during the follow-up, eradication therapy was done. To evaluate whether H. pylori was eradicated, 13C-urea breath testing was performed at least 4 weeks after completion of the eradication therapy. All study subjects were closely followed up since recurrent tumors at previous endoscopic resection sites can be easily detected on endoscopy with biopsy and treated during follow-up. Patients with local recurrence underwent further treatments, including repeated ESD, APC, and gastrectomy based on pathology, and patients who refused treatment received supportive care. All patients underwent endoscopy with biopsy within 6 months, then at 12 months after ESD to check for metachronous lesions or local recurrences. After 12 months, endoscopy with biopsy was performed annually. In case of EGCs, abdominal CT scan was performed in the first year and biennially thereafter to detect lymph node or distant metastases. The definition of the completion of the study protocol was 1) endoscopic and/or radiologic follow-up for more than 3 years, or 2) development of metachronous gastric neoplasm (primary outcome: gastric dysplasia or cancer) during the follow-up. Metachronous recurrence was defined as secondary dysplasia or cancers detected > 1 year after initial diagnosis. conditions module condition list condition Metachronous Neoplasm Gastric Cancer Gastric Neoplasm Aberrant DNA Methylation design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 300 enrollment type Actual outcomes module primary outcome list primary outcome primary outcome measure Metachronous recurrence primary outcome description Metachronous recurrence was defined as secondary dysplasia or cancers detected > 1 year after initial diagnosis. primary outcome time frame at least > 1 year after enrollment (initial diagnosis), from enrollment to Dec 2020 eligibility module eligibility criteria Inclusion Criteria: Patients who underwent endoscopic resection of gastric neoplasms (dysplasia or early gastric cancer) All gastric neoplasms at diagnosis should be curatively resected before enrollment. Exclusion Criteria: Previous history of all cancers. Previous history of gastrectomy Non-curative resection of gastric neoplasms Refusal to consent healthy volunteers No gender All std age list std age Child Adult Older Adult study population Patients with gastric neoplasms (gastric dysplasia or early gastric cancer) which was curatively resected endoscopically. sampling method Non-Probability Sample references module reference list reference reference p m i d 35038821 reference type derived reference citation Shin CM, Kim N, Yoon H, Choi YJ, Park JH, Park YS, Lee DH. Aberrant DNA Methylation Maker for Predicting Metachronous Recurrence After Endoscopic Resection of Gastric Neoplasms. Cancer Res Treat. 2022 Oct;54(4):1157-1166. doi: 10.4143/crt.2021.997. Epub 2022 Jan 18. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009369 condition mesh term Neoplasms condition mesh id D000013274 condition mesh term Stomach Neoplasms condition mesh id D000016609 condition mesh term Neoplasms, Second Primary condition ancestor list condition ancestor condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000013272 condition ancestor term Stomach Diseases condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf relevance low condition browse leaf id M15216 condition browse leaf name Stomach Neoplasms condition browse leaf as found Gastric Neoplasm condition browse leaf relevance high condition browse leaf id M18141 condition browse leaf name Neoplasms, Second Primary condition browse leaf as found Metachronous Neoplasm condition browse leaf relevance high condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M15214 condition browse leaf name Stomach Diseases condition browse leaf relevance low condition browse leaf id T5486 condition browse leaf name Stomach Cancer condition browse leaf as found Gastric Neoplasm condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04830618
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full study rank 61794 study protocol section identification module n c t id NCT04831840 org study id info org study id 20201198 organization org full name University of Miami org class OTHER brief title Recurrent Urinary Tract Infections and the Microbiome official title Is PCR Amplification More Sensitive Than Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Recurrent Bladder Infections? status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 26, 2021 start date type Actual primary completion date struct primary completion date June 1, 2023 primary completion date type Anticipated completion date struct completion date June 1, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 23, 2022 last update post date struct last update post date May 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Laura Martin responsible party investigator title Assistant Professor responsible party investigator affiliation University of Miami lead sponsor lead sponsor name University of Miami lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The primary objective is to determine if polymerase chain reaction (PCR) (UTIP™) is more sensitive in identifying urinary tract infections (UTI's) than standard urine cultures. conditions module condition list condition Recurrent Urinary Tract Infection design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 180 enrollment type Anticipated arms interventions module arm group list arm group arm group label Female participants with recurrent urinary tract infections (RUTI). arm group description Patients with RUTIs (Group A) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. arm group label Female control patients without RUTIs arm group description Patients without RUTIs (Group B) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. outcomes module primary outcome list primary outcome primary outcome measure Proportion of uropathogens primary outcome description The proportion of uropathogens found on PCR versus urine culture from urine samples. primary outcome time frame Day 1 primary outcome measure Proportion of patients negative for repeat testing primary outcome description The proportion of negative patient on repeat testing of urine samples. primary outcome time frame Up to 4 weeks eligibility module eligibility criteria Inclusion Criteria: 18 y/o-90 y/o Able to consent Female Group A only: Recurrent UTI (2 UTIs in 6 months) Group B only: No history of recurrent UTIs Exclusion Criteria: Pregnant Pelvic radiation Urinary retention (>200 ml residual) Greater than Stage 2 prolapse Renal calculi Immunosuppressed Neurologic disorder with significant bladder impairment No current UTI via dip stick healthy volunteers Accepts Healthy Volunteers gender Female minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult study population Female patients with RUTIs and controls will be enrolled from University of Miami's or Holy Cross Hospital's female pelvic medicine and reconstructive surgery clinics. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Laura Martin, DO central contact role Contact central contact phone 3052436590 central contact e mail lem114@med.miami.edu overall official list overall official overall official name Laura Martin, DO overall official affiliation University of Miami overall official role Principal Investigator location list location location facility Holy Cross Hospital location status Not yet recruiting location city Fort Lauderdale location state Florida location zip 33301 location country United States location contact list location contact location contact name GW Davila, MD location contact role Contact location contact phone 954-229-8660 location contact e mail gwilly.davila@holy-cross.com location contact name GW Davila, MD location contact role Principal Investigator location facility University of Miami location status Recruiting location city Miami location state Florida location zip 33136 location country United States location contact list location contact location contact name Laura Martin, DO location contact role Contact location contact phone 305-243-6590 location contact e mail lem114@med.miami.edu location contact name Laura Martin, DO location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007239 condition mesh term Infections condition mesh id D000003141 condition mesh term Communicable Diseases condition mesh id D000014552 condition mesh term Urinary Tract Infections condition mesh id D000012008 condition mesh term Recurrence condition ancestor list condition ancestor condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000014570 condition ancestor term Urologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf as found Recurrent condition browse leaf relevance high condition browse leaf id M9170 condition browse leaf name Hypersensitivity condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf as found Infection condition browse leaf relevance high condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf as found Infection condition browse leaf relevance high condition browse leaf id M16454 condition browse leaf name Urinary Tract Infections condition browse leaf as found Urinary Tract Infections condition browse leaf relevance high condition browse leaf id M5913 condition browse leaf name Cystitis condition browse leaf relevance low condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions
NCT04831840
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full study rank 61281 study protocol section identification module n c t id NCT04838509 org study id info org study id 2021PI034 organization org full name Central Hospital, Nancy, France org class OTHER brief title Diagnoses Associated With Persistent Elevation of Creatine Kinase official title Diagnoses Associated With Persistent Elevation of Creatine Kinase status module status verified date June 2021 overall status Completed expanded access info has expanded access No start date struct start date May 1, 2021 start date type Actual primary completion date struct primary completion date June 24, 2021 primary completion date type Actual completion date struct completion date June 24, 2021 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date June 24, 2021 last update post date struct last update post date June 25, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Lev VOLKOV responsible party investigator title Dr responsible party investigator affiliation Central Hospital, Nancy, France lead sponsor lead sponsor name Central Hospital, Nancy, France lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Serum creatinine kinase (CK) level varies with age, gender, race and physical activity. For these reasons there is no normal serum CK level. Many pathological situations cause hyperCKemia, such as neuromuscular disorders (muscular dystrophy, inflammatory myositis, mitochondrial myopathy) and multiple systemic causes. The diagnostic approach to pauci or asymtomatic hyperCKemia can therefore be difficult and lead to multiple, and sometimes invasive tests, such as muscle biopsy. This study aims to describe the diagnoses associated with persistent elevation of serum creatine kinase and to precise the role of the muscule biopsy. conditions module condition list condition Creatine Kinase Muscular Diseases keyword list keyword Creatine Kinase design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 148 enrollment type Actual arms interventions module arm group list arm group arm group label Patients with elevated creatine kinase arm group intervention list arm group intervention name Other: no intervention intervention list intervention intervention type Other intervention name no intervention intervention description retrospective descriptive without intervention intervention arm group label list intervention arm group label Patients with elevated creatine kinase outcomes module primary outcome list primary outcome primary outcome measure Diagnosis primary outcome description The final diagnosis, as written in the medical record at the end of the investigations in the ward of internal medicin, responsible for the elevation of creatine kinase between: inflammatory myositis, mitochondrial myopathy, muscular dystrophy, non neuromuscular pathology primary outcome time frame at the end of all investigations, an average of 12 months secondary outcome list secondary outcome secondary outcome measure Muscle biopsy secondary outcome description Among the patients who underwent a muscle biopsy, number of anormal biopsies that contributed to make the final diagnosis responsible of the elevation of creatine kinase secondary outcome time frame at the end of all investigations, an average of 12 months secondary outcome measure Clinical presentation secondary outcome description association between the initial clinical presentation and the final diagnosis secondary outcome time frame at the end of all investigations, an average of 12 months secondary outcome measure Paraclinical presentation secondary outcome description association between the initial paraclinical presentation and the final diagnosis secondary outcome time frame at the end of all investigations, an average of 12 months eligibility module eligibility criteria Inclusion Criteria: patients hospitalised in a ward of internal medicin having a persistent elevation of serum creatine kinase >3 times the upper normal laboratory value, repeated for 2 times Exclusion Criteria: known neuro-muscular disease causing elevation of creatine kinase evident post-traumatic cause responsible for the elevation of creatine kinase incomplete medical records healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients hospitalised in the ward of internal medicin of Nancy University Hospital or UNEOS General Hospital of Metz between 2009 and 2018. sampling method Probability Sample contacts locations module location list location location facility CHRU Nancy location city Nancy location zip 54000 location country France derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009135 condition mesh term Muscular Diseases condition ancestor list condition ancestor condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf as found Muscular Diseases condition browse leaf relevance high condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id T385 intervention browse leaf name Creatine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04838509
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full study rank 61632 study protocol section identification module n c t id NCT04833946 org study id info org study id IN/201001/PARACTIN/OA organization org full name Vedic Lifesciences Pvt. Ltd. org class INDUSTRY brief title To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint. official title A Double-blind, Randomized, Placebo-controlled Study to Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint. status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 13, 2021 start date type Actual primary completion date struct primary completion date December 30, 2023 primary completion date type Anticipated completion date struct completion date December 30, 2023 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 29, 2022 last update post date struct last update post date November 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Vedic Lifesciences Pvt. Ltd. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Sponsor aimed to study hydroalcoholic extract of Andrographis paniculata (for its effect on OA disease progression in OA patients with moderate to severe knee OA. Hydroalcoholic extract of Andrographis paniculata (standardized for 50% bioactive andrographolides).Andrographis paniculata may have an effect on increasing the expression of collagen type II protein and also mitigate the migration of inflammatory cells or angiogenesis detailed description Sponsor aimed to study hydroalcoholic extract of Andrographis paniculata (for its effect on OA disease progression in OA patients with moderate to severe knee OA. Hydroalcoholic extract of Andrographis paniculata (standardized for 50% bioactive andrographolides). It has been evaluated in clinical studies for its anti-inflammatory and anti-oxidant activities. Although the potential cartilage regenerative mechanism of Andrographis paniculata is unknown, Sponsor believe that Andrographis paniculata may have an effect on increasing the expression of collagen type II protein and also mitigate the migration of inflammatory cells or angiogenesis. In the present study, knee morphometrics (joint space narrowing of tibiofemoral joint, and cartilage thickness at the femur, tibia and patella compartments), cartilage turnover (serum COMP levels), bone turnover (serum Bone specific alkaline phosphatase) along with symptomatic relief (Using mWOMAC) in patients with primary knee OA over a period of 336 days will be evaluated. conditions module condition list condition Knee Osteoarthritis (Knee OA) design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 111 enrollment type Anticipated arms interventions module arm group list arm group arm group label Andrographis paniculata [150 mg] arm group type Active Comparator arm group description One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime arm group intervention list arm group intervention name Other: Andrographis paniculata [150 mg] arm group label Microcrystalline Cellulose (MCC) arm group type Placebo Comparator arm group description One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime arm group intervention list arm group intervention name Other: Microcrystalline Cellulose (MCC) intervention list intervention intervention type Other intervention name Andrographis paniculata [150 mg] intervention description One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime intervention arm group label list intervention arm group label Andrographis paniculata [150 mg] intervention type Other intervention name Microcrystalline Cellulose (MCC) intervention description One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime intervention arm group label list intervention arm group label Microcrystalline Cellulose (MCC) outcomes module primary outcome list primary outcome primary outcome measure Joint Space Narrowing as assessed by magnetic resonance imaging primary outcome description to evaluate the effect of 336 days of IP consumption on change in joint space narrowing (JSN) in the tibiofemoral joint of knee as measured by magnetic resonance imaging (MRI) primary outcome time frame Day 0 and day 336 secondary outcome list secondary outcome secondary outcome measure Modified Western Ontario and McMaster Universities Pain and total scores secondary outcome description Patients rate their pain, stiffness, or physical function using five ordinal responses: none, mild, moderate, severe, and extreme..Change in knee joint pain as assessed by the Western Ontario and McMaster University Arthritis Index pain subscale (mWOMAC -P) secondary outcome time frame day 0, 28, 84, 140, 168, 252 and day 336 secondary outcome measure Cartilage thickness at femur, tibia and patella compartments secondary outcome description Change in cartilage thickness at the femur, tibia and patella compartments as assessed by MRI secondary outcome time frame Day 0 and day 336 secondary outcome measure Outcome Measures in Arthritis Clinical Trials OA Research Society International secondary outcome description Treatment responders as assessed by OMERACT-OARSI in comparison to placebo secondary outcome time frame day 336 secondary outcome measure Bone turnover (by measuring bone specific alkaline phosphatase levels) secondary outcome description Change in bone turnover as assessed by change in serum levels of bone specific alkaline phosphatase secondary outcome time frame Day 0 and day 336 secondary outcome measure Cartilage turnover as assessed by Cartilage Oligomeric matrix protein (COMP) secondary outcome description Change in cartilage turnover as assessed by change in serum levels of cartilage oligomeric matrix protein secondary outcome time frame Day 0 and day 336 secondary outcome measure Change in the Quality of Life secondary outcome description Change in Quality of life as assessed by using Short Form-36 secondary outcome time frame Day 0, 84, 168, and day 336 eligibility module eligibility criteria Inclusion Criteria: Male and female Patients aged ≥40 and ≤85 years. Patients with a history of clinically symptomatic OA of the knee for ≥ 6 months. Index knee joint pain rated ≥60 mm on a 100 point Pain Visual Analogue Scale (VAS). Patient must have a diagnosis of idiopathic OA according to the American College of Rheumatology clinical and radiographic criteria with knee pain, osteophytes, and fulfilment of at least 2 of the 3 criteria: Age of ≥50 years Stiffness lasting <30 minutes after getting up in the morning Crepitus Radiographic evidence of grade II- III knee OA based on the Kellgren and Lawrence (KL) radiographic entry criteria for OA. Grade II: - Definite osteophytes and possible joint space narrowing (JSN) on the anteroposterior weight-bearing radiograph. Grade III: Anteroposterior weight-bearing knee radiograph demonstrates definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends. Patients with normal liver & renal function defined as: Serum Alkaline phosphatase levels up to 1.5 of ULN (Upper Limit of Normal). Serum AST and ALT levels up to 2.5 of ULN. Serum creatinine levels up to 1.5 of ULN. Blood Urea Nitrogen levels up to 1.5 of ULN. Female Patients must not be of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) Patients must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting from the screening visit until completing participation in the study. Abstinence from any home-based remedies or any other form of topical products intended for knee joint pain relief for the entire study duration. Patient must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting routine) for the duration of the study starting from the screening visit. Ability to read and provide written, personally signed, and dated informed consent to participate in the study. An understanding, ability, and willingness to fully comply with study procedures and restrictions. Exclusion Criteria: Patients who have any contraindications to MRI, such as, but not limit to:A metal device affected by MRI (e.g. any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted cardiac defibrillator); - Have history of orbit trauma by a potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) for which they sought medical attention; - Have claustrophobia; - Have difficulty fitting into the MRI knee coil due to greater than normal thigh diameter. Any other lower limb dis-functionality of lower limb other than the knee that, in the opinion of the Investigator, could interfere with pain and functional assessments related to the knee. Patients who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee. Patients who has had significant injury, as judged by the Investigator, involving the target knee within the 6 months before screening. Patients who has used opiates or corticosteroids within 30 days before screening for the target knee or who requires treatment with chronic opiates or corticosteroids or had intra articular injections of corticosteroids, hyaluronic acid, or visco supplements to a knee to be treated within the 3 months before Screening. Patients who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen. Known sensitivity to the investigational product or any excipients of the drug product. Patients who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, or other conditions that may affect the target joint or the functional and pain assessments (eg, osteonecrosis, chondrocalcinosis). Patients has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease, or any other condition that, in the investigator's opinion, could compromise the Patient's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation. Patients has any other clinically significant laboratory finding at screening that in the investigator's opinion contraindicates study participation. Presence of uncontrolled hypertension (Defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg). Uncontrolled diabetes defined as fasting blood glucose (FBG) > 125 mg/dL. Patients with heavy alcohol consumption, defined as - For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day. - For women: More than 7 SAD/week or more than 3 SAD in a day. (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol). Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a 2-hour time frame. Individuals having a history (in past 2 years) of smoking or currently smoking or using any form of smokeless tobacco. Patients without access to telephone and/or ability to gain technology access. Patients who participated in another human trial within last 90 days prior to screening. Any condition that could, in the opinion of the investigator, preclude the Patient's ability to successfully and safely complete the study or that may confound study outcomes. healthy volunteers Accepts Healthy Volunteers gender All minimum age 40 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Dr. Shalini Srivastava, MD - Md central contact role Contact central contact phone 02242172325 central contact e mail shalini.s@vediclifesciences.com central contact name Dr Sonali Ghosh, BAMS central contact role Contact central contact phone 8097572024 central contact e mail sonali.g@vediclifesciences.com location list location location facility Ayush Nursing Home location status Active, not recruiting location city Mumbai- location state Maharashtra location zip 400067 location country India location facility New Healthcare Nursing Home location status Active, not recruiting location city Thāne location state Maharashtra location zip 401107 location country India location facility Jaipur National University Institute for Medical Sciences and Research Center location status Recruiting location city Jaipur location state Rajasthan location zip 302017 location country India location contact list location contact location contact name Dr. Shrinivas Yadkikar, MBBS, MS Ortho location contact role Contact location contact phone 9902097190 location contact e mail advisoroffice@jnujaipur.ac.in location contact name Dr. Shrinivas Yadkikar, MBBS, MS Ortho location contact role Principal Investigator location facility Asopa Hospital location status Not yet recruiting location city Jaipur location state Rajasthan location zip 30201 location country India location contact list location contact location contact name Dr. Arwind Asopa, MS Ortho location contact role Contact location contact phone 9829013481 location contact e mail dr.asopa@gmail.com location contact name Dr. Arwind Asopa, MS Ortho location contact role Principal Investigator location facility Shubham Sudbhawana Super Specialty Hospital location status Active, not recruiting location city Varanasi location state Uttar Pradesh location zip 221005 location country India derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010003 condition mesh term Osteoarthritis condition mesh id D000020370 condition mesh term Osteoarthritis, Knee condition mesh id D000018450 condition mesh term Disease Progression condition ancestor list condition ancestor condition ancestor id D000001168 condition ancestor term Arthritis condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf as found Osteoarthritis condition browse leaf relevance high condition browse leaf id M21321 condition browse leaf name Osteoarthritis, Knee condition browse leaf as found Osteoarthritis of Knee condition browse leaf relevance high condition browse leaf id M19712 condition browse leaf name Disease Progression condition browse leaf as found Disease Progression condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf relevance low condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000030419 intervention mesh term Andrographolide intervention ancestor list intervention ancestor intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000000894 intervention ancestor term Anti-Inflammatory Agents, Non-Steroidal intervention ancestor id D000018712 intervention ancestor term Analgesics, Non-Narcotic intervention ancestor id D000000700 intervention ancestor term Analgesics intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000000981 intervention ancestor term Antiprotozoal Agents intervention ancestor id D000000977 intervention ancestor term Antiparasitic Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention ancestor id D000000998 intervention ancestor term Antiviral Agents intervention ancestor id D000010975 intervention ancestor term Platelet Aggregation Inhibitors intervention browse leaf list intervention browse leaf intervention browse leaf id M219533 intervention browse leaf name Andrographolide intervention browse leaf as found Venturi mask intervention browse leaf relevance high intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M3370 intervention browse leaf name Anti-Inflammatory Agents, Non-Steroidal intervention browse leaf relevance low intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M19939 intervention browse leaf name Analgesics, Non-Narcotic intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M3450 intervention browse leaf name Antiprotozoal Agents intervention browse leaf relevance low intervention browse leaf id M3446 intervention browse leaf name Antiparasitic Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse leaf id M3466 intervention browse leaf name Antiviral Agents intervention browse leaf relevance low intervention browse leaf id M13017 intervention browse leaf name Platelet Aggregation Inhibitors intervention browse leaf relevance low intervention browse leaf id T53 intervention browse leaf name Andrographis intervention browse leaf as found Venturi mask intervention browse leaf relevance high intervention browse leaf id T112 intervention browse leaf name Chirata intervention browse leaf as found Every 2 minutes intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev PlAggInh intervention browse branch name Platelet Aggregation Inhibitors intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical
NCT04833946
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full study rank 61729 study protocol section identification module n c t id NCT04832685 org study id info org study id 2021P000704 organization org full name Massachusetts General Hospital org class OTHER brief title Neuromodulation of Mind-Wandering in Depression official title Neuromodulation of Mind-Wandering in Depression status module status verified date April 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date February 2023 start date type Anticipated primary completion date struct primary completion date April 2025 primary completion date type Anticipated completion date struct completion date April 2025 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 4, 2022 last update post date struct last update post date April 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Darin Dougherty, MD responsible party investigator title Director, Division of Neurotherapeutic, Department of Psychiatry responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes description module brief summary The specific aim of this proposed study is to investigate the feasibility and therapeutic potential of LIFUP in changing negative cognition in depression. Specifically, the investigators will study if modulating DMN activity can change maladaptive mind-wandering. The investigators hypothesize that DOWN-modulation of the posterior cingulate cortex (PCC), a key DMN node, will decrease DMN resting state functional connectivity, perfusion, and activation during a cognitive-affective task (description below). The investigators also hypothesize that DOWN-modulation of the PCC will be associated with decreased mind-wandering and increased mindfulness. Finally, the investigators hypothesize that the opposite will be true for UP-modulation of the PCC. detailed description The default mode network (DMN) is a network of structurally and functionally connected brain regions that was first identified during "passive" states. Since its initial discovery, the conceptualization of the DMN has evolved over time; the DMN has now been linked with a range of higher-order cognitive processes such as spontaneous, self-generated thoughts (i.e. mind-wandering) and thinking about oneself in the past, future, and in relation to others. Given the DMN's involvement in cognition, researchers have investigated its role in psychiatric disorders associated with cognitive issues, such as Major Depressive Disorder (MDD). MDD is a mood disorder in which people experience a persistent negative mood or loss of interest or pleasure, thoughts of worthlessness and guilt, and/or suicidal ideation. The majority of literature suggests that currently depressed individuals have increased DMN resting-state functional connectivity at rest and greater DMN activation when processing negative stimuli. Researchers have suggested that this DMN hyperactivity reflects the tendency for depressed individuals to engage in negative cognition, such as maladaptive mind-wandering (i.e. task-irrelevant thought when individuals are supposed to be focused on a task) and rumination (i.e. negative, repetitive, self-focused thinking). Mind-wandering, in general, has been linked to unhappiness. Rumination is associated with the maintenance of a current depressive episode and is a predictor of future depressive episodes. Therefore, changing these forms of negative cognition, via modulation of DMN activity, could be of benefit to individuals with MDD. One way of modulating DMN activity is to use brain stimulation. The investigators have previously used transcranial Direct Current Stimulation (tDCS) of a DMN brain region to effect a small yet significant reduction in mind-wandering behavior in a community sample. However, tDCS has low spatial specificity and neuroimaging was not used to determine if tDCS was actually changing mind-wandering via changes in DMN activity. Low Intensity Focused Ultrasound Pulsation (LIFUP) is a novel non-invasive brain stimulation method which has high spatial specificity, unlike other non-invasive brain stimulation methods such as Transcranial Magnetic Stimulation (TMS) and tDCS. Specifically, LIFUP can deliver acoustic energy to a brain region of a few millimeters in diameter. This method has been applied to the thalamus to restore consciousness to patients in minimally conscious states, and the investigators have been using this method in multiple IRB-approved studies as applied to the amygdala, ventral striatum, and entorhinal cortex. Specific Aims The specific aim of this proposed study is to investigate the feasibility and therapeutic potential of LIFUP in changing negative cognition in depression. Specifically, the investigators will study if modulating DMN activity can change maladaptive mind-wandering. The investigators hypothesize that DOWN-modulation of the posterior cingulate cortex (PCC), a key DMN node, will decrease DMN resting state functional connectivity, perfusion, and activation during a cognitive-affective task (description below). The investigators also hypothesize that DOWN-modulation of the PCC will be associated with decreased mind-wandering and increased mindfulness. Finally, the investigators hypothesize that the opposite will be true for UP-modulation of the PCC. Subject Selection Twenty participants (n = 10 healthy controls, n = 10 individuals with MDD) aged 18-64 years old will be recruited. The Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5-RV)10 will be used to determine eligibility. Subject Enrollment Participants will be recruited through email announcements at MGH, postings to college websites, and flyers (see attached flyer) posted at MGH and in the community (e.g., community centers, public libraries, coffee shops, restaurants, and laundromats). A phone screening will be performed to efficiently confirm likelihood that subjects will meet inclusion and exclusion criteria prior to committing time for further evaluation of eligibility. Informed consent will be obtained prior to the performance of any protocol procedures. The informed consent document will be used to explain in simple terms the risks and benefits of study participation to the subject. The nature of the study will be fully explained to the subject by the PI, co-investigators or specially-trained study staff. The subject will be encouraged to ask questions pertaining to their participation in the study and the subject may take as much time as they feel necessary to consider his/her participation in the study as well as consult with family members or their physicians. Participation in this study is voluntary and the subjects may withdraw from the study at any time. The IRB-approved informed consent documents will be signed and dated by the subject and the person obtaining consent. Study Procedures After providing study information and obtaining IRB approved informed consent, participants will complete up to three study visits on three different days. Visit 1 (up to 1 hour) For participants who are recruited as healthy controls, the SCID-5-RV will be administered to determine if the participant has no current or past history of any mood disorders. For participants who are recruited as individuals with MDD, the SCID-5-RV will be administered to determine if the participant meets criteria for a current MDD diagnosis. Participants will be excluded from further study procedures if they do not meet the above-described criteria. Visits 2 and 3 (up to 3.5 hours each; spaced 1 week apart) Questionnaires At Visits 2 and 3, participants will complete questionnaires assessing depressive symptoms (Beck Depression Inventory), anxiety (The State-Trait Anxiety Inventory), mindfulness (Five Facet Mindfulness Questionnaire), and rumination (Ruminative Responses Scale of the Response Styles Questionnaire). To assess the subjective experience of LIFUP and its effects on mood, participants will rate their negative and positive mood on Visual Analog Scales as well as complete the 11-factor Altered States of Consciousness questionnaire (ASC) after LIFUP. Computer Task After completing questionnaires, participants will practice the cognitive-affective task they will be performing in the MRI scanner before and after LIFUP. Participants will complete a modified version of the Multi-Source Interference Task (MSIT) overlaid on negative, neutral, and positive images from the International Affective Picture System (IAPS). Subjects must identify the number in a three digit number that is different. For example, if the participant sees "010" the correct answer would be "1" since it is the different number. This MSIT-IAPS task has been used to assess cognitive-affective deficits in bipolar disorder. During this task, participants will also be randomly interrupted. Instead of seeing a digit on the screen, participants will be asked if they were thinking about the task or something else. Participants respond by pressing one key if they were having Task-related thoughts (Task) and another key for task unrelated (Not Task) thoughts. Participants then see other screens asking if they were thinking about themselves, the past, present, or future, and if they were having positive, neutral, or negative thoughts. After answering these questions, participants resume seeing digits on the screen. The investigators have used these random thought probes during the MSIT in a previous tDCS study. MRI Scan After completing the practice computer task, participants will complete the MR Screening Safety form. After confirming the participant does not have MRI contraindications, they will be scanned using a 3 Tesla Siemens MRI scanner at the Athinoula A. Martinos Center for Biomedical Imaging. At baseline, a T1 MEMPRAGE structural scan, blood-oxygen-level-dependent (BOLD) resting state scan, Arterial Spin Labelled (ASL) scan, and a BOLD functional MRI scan paired with the MSIT-IAPS task (described above) will be collected. Participants will then exit the MRI scanner and will be asked to retrospectively report on their mind-wandering thoughts during the MSIT-IAPS task, using the Thought Sampling Questionnaire. LIFUP Sonication Participants will next be fitted with the LIFUP device, the BX Pulsar 1002 (BrainSonix Corporation). The transducer will be placed on the head using landmarks and will be positioned using their structural MRI scan to localize the PCC. Participants will then receive either DOWN-modulation (Pulse Repetition Frequency = 10 Hz, Pulse-Width = 0.5 ms, Duty Cycle = 5%, ISPPA = 14.4 mW/cm2, 720 mW/cm2) or UP-modulation (Pulse Repetition Frequency = 100 Hz, Pulse-Width = 0.5 ms, Duty Cycle = 5%, ISPPA = 14.4 mW/cm2, ISPTA = 720 mW/cm2). The order will be counterbalanced across subjects. The sonications will be delivered in a 30-seconds on, 30-seconds off block design, for a total duration of 10 minutes. The investigators are using the same LIFUP parameters in other IRB-approved LIFUP studies and these parameters have been safely used at other research collaborator sites at UCLA and MUSC. After receiving LIFUP, participants will then be scanned again using the same MRI protocol as described above. Biostatistical Analysis fMRI data during the MSIT-IAPS task will be analyzed using SPM12 software (Wellcome Department of Cognitive Neurology, London, UK). Individual subject-level data will be slice-time corrected, realigned and unwarped, coregistered to the individual's structural images, normalized, and smoothed. First-level contrast images will be created comparing BOLD activation during the MSIT-IAPS task before and after LIFUP. These contrast images will then be entered into a 2nd level random effects flexible factorial model. The investigators will investigate whether there is a group (MDD versus healthy control) by condition (UP vs. DOWN modulation) interaction on BOLD activation in DMN regions. Beta signal values will be extracted from DMN regions and the investigators will investigate if there are significant correlations between DMN activation and behavioral measures of depressive symptoms, anxiety, and mindfulness/mind-wandering. BOLD resting state scan data will be similarly preprocessed and entered into CONN toolbox. The PCC will be used as a seed region and Fischer-transformed functional connectivity beta values with other DMN regions will be extracted for each individual subject. Repeated-measures ANOVAs will be conducted to again investigate whether there is a group by condition interaction on DMN resting state functional connectivity. Correlational analyses will also be performed to explore correlations with behavioral measures. ASL data will be analyzed using Bayesian Inference for Arterial Spin Labeling MRI. Perfusion maps corresponding to pre and post LIFUP will be subtracted from each other to determine if there is decreased or increased perfusion in DMN regions associated with UP vs. DOWN modulation. Previous studies have demonstrated that 20 participants are sufficient to achieve statistical significance (p < 0.05) in a voxel-based analysis. conditions module condition list condition Depression keyword list keyword Ultrasound design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description Participants will be divided into 2 groups, healthy controls and participants with depression. Both groups will receive UP and DOWN modulation. design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label UP and DOWN-Modulation arm group type Experimental arm group description All participants will receive UP- and DOWN-modulation of the posterior cingulate cortex (PCC). arm group intervention list arm group intervention name Device: UP- and DOWN-Modulation intervention list intervention intervention type Device intervention name UP- and DOWN-Modulation intervention description All participants in both groups will receive UP- and DOWN-modulation of the PCC. intervention arm group label list intervention arm group label UP and DOWN-Modulation outcomes module primary outcome list primary outcome primary outcome measure Mind-wandering frequency during task primary outcome description Changes in reported frequency of negative mind-wandering thoughts during the MSIT-IAPS task before and after UP- and DOWN-modulation primary outcome time frame 3 hours primary outcome measure Default mode network activation during task primary outcome description Changes in Blood-Oxygen-Level Dependent activation in the default mode network during the MSIT-IAPS task before and after UP- and DOWN-modulation primary outcome time frame 3 hours secondary outcome list secondary outcome secondary outcome measure Depressive symptoms secondary outcome description Depressive symptoms as measured by the Beck Depression Inventory in the week after the UP- and DOWN-modulation sessions secondary outcome time frame 1 week secondary outcome measure Default mode network connectivity secondary outcome description Changes in default mode network resting state functional connectivity before and after UP- and DOWN-modulation secondary outcome time frame 3 hours eligibility module eligibility criteria Inclusion Criteria: Male or female Age 18-64 Right-handed Normal or corrected-to normal vision and hearing For group with depression, current diagnosis of depression Exclusion Criteria: Active significant medical illness or neurological disorder MRI scan contraindications (e.g., metal implant, claustrophobia, weigh over 250 pounds, etc.) For healthy control group, any current or past history of mood disorders healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 64 Years std age list std age Adult contacts locations module central contact list central contact central contact name Ben Borron central contact role Contact central contact phone 617-643-9357 central contact e mail bborron@mgh.harvard.edu location list location location facility Massachusetts General Hospital location city Boston location state Massachusetts location zip 02114 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition mesh id D000003866 condition mesh term Depressive Disorder condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04832685
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full study rank 61391 study protocol section identification module n c t id NCT04837079 org study id info org study id NSETP-China organization org full name Xiangya Hospital of Central South University org class OTHER brief title National Survey of Essential Tremor Plus in China official title National Survey of Essential Tremor Plus in China status module status verified date April 2021 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date May 1, 2021 start date type Anticipated primary completion date struct primary completion date April 30, 2022 primary completion date type Anticipated completion date struct completion date April 30, 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Xiangya Hospital of Central South University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary National Survey of Essential Tremor Plus in China（NSETP-China）is a multicenter cross-sectional study designed to investigate the clinical features of ET-plus in mainland China. detailed description Essential tremor (ET) is one of the most common adult-onset movement disorders, affecting 0.9% of the population across all ages worldwide. ET is a chronic, progressive neurologic disease whose the most recognizable clinical feature is a 4~12 Hz kinetic tremor of the upper limbs, usually occurring during a variety of voluntary movements. The etiology and pathogenesis of ET remain elusive. Essential tremor-plus (ET-plus) is a new term coined in 2018 MDS consensus statement on tremor. ET-plus is defined as tremor with the characteristics of essential tremor, with additional neurological signs of uncertain clinical significance, such as impaired tandem gait, questionable dystonic posturing, memory impairment, or other mild neurological signs of unknown clinical significance that do not suffice to make an additional syndrome classification or diagnosis. ET-plus is a controversial new concept. We will use scales or questionnaires to investigate the common soft neurological signs of ET-plus in mainland China. The details are as follows: (1) The tremor's impact on activities of daily living and clinical measurement of ET severity are evaluated by The Essential Tremor Rating Assessment Scale (TETRAS). (2) Cognitive condition is assessed by Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA). (3) The non-motor symptoms are evaluated by Non-motor Symptom Scale (NMSS). (4) Clinical assessment of balance and gait in ET-plus: we will use Tandem walk, Berg balance scale (BBS) and 10 meter walk timing test. (5) The Unified Dystonia Rating Scale (UDRS) for evaluation of dystonia in ET-plus. (6) The scale for the Assessment and Rating of Ataxia (SARA) is used to evaluate ataxia in ET-plus. conditions module condition list condition Essential Tremor-plus design module study type Observational patient registry Yes target duration 1 Year design info design observational model list design observational model Cohort design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module intervention list intervention intervention type Other intervention name Clinical observational study intervention description Clinical observational study outcomes module primary outcome list primary outcome primary outcome measure The tremor's impact on activities of daily living and clinical measurement of ET severity are evaluated by The Essential Tremor Rating Assessment Scale (TETRAS). primary outcome description TETRAS consists of two subscales. The first one, Activities of Daily Living (ADL) Subscale contains 12 selfscored items, rating tremor's impact on ADL in a 0-4 Likert-type scale. Total score varies from 0-48. Higher score indicates a bigger impact on activities of daily living. The second part is the Performance Subscale, and is rated by clinicians'examination. The subscale is formed by 9 items that rate action tremor in the head, face, voice, limbs, and trunk from 0 to 4. Total score varies from 0-64. Higher score indicates severer tremor. For most items, the scores are defined only by whole numbers, but 0.5 increments may be used if you believe the rating is between two whole number ratings and cannot be reconciled to a whole number. Each 0.5 increment in rating is specifically defined for the assessment of upper limb postural and kinetic tremor and the dot approximation task (items 4 and 8). primary outcome time frame May 1, 2021-April 30, 2022 secondary outcome list secondary outcome secondary outcome measure The non-motor symptoms are evaluated by Non-motor Symptom Scale. secondary outcome description This scale includes 30 items which is divided into 9 domains. Total score varies from 0-360. Higher score indicates severer symptoms. Domain 1 evaluates cardiovascular system symptoms. Score of domain 1 varies from 0-24. Domain 2 evaluates sleep condition. Score of domain 2 varies from 0-48. Domain 3 evaluates cognitive function. Score of domain 3 varies from 0-72. Domain 4 evaluates illusion. Score of domain 4 varies from 0-36. Domain 5 evaluates attention and memory. Score of domain 5 varies from 0-36. Domain 6 evaluates gastrointestinal symptoms. Score of domain 6 varies from 0-36. Domain 7 evaluates urinary symptoms. Score of domain 7 varies from 0-36. Domain 8 evaluate sensory symptoms. Score of domain 8 varies from 0-24. Domain 9 evaluates other non-motor symptoms. Score of domain 9 varies from 0-48. secondary outcome time frame May 1, 2021-April 30, 2022 secondary outcome measure Cognitive condition is assessed by Mini Mental State Examination (MMSE). secondary outcome description MMSE scale includes 30 items. Score of all the questions will be summed. All items were rated on a 2-point scale (0-1), with a minimal score of 0, and maximum total score of 30. A higher score demonstrates more better cognitive condition. The definition of cognitive disorder differs in education level. For those only receive elementary education, the cut-off value is 20. For other patients, presence of cognitive impairment was defined as MMSE scores less than 25. secondary outcome time frame May 1, 2021-April 30, 2022 secondary outcome measure Cognitive condition is assessed by Montreal Cognitive Assessment (MOCA). secondary outcome description MOCA scale is a one page 30 point test. 16 items and 11 categories to assess multiple cognitive domains, including short-term memory recall task, visuospatial abilities, executive functions, attention, concentration and working memory, language and orientation to time and place. A cutoff 26 is used to define cognitive impairment. 1 point is added to the test-taker's score if they have 12 years education or less. secondary outcome time frame May 1, 2021-April 30, 2022 secondary outcome measure Tandem walk, Berg balance scale (BBS) and 10 meter walk timing test are used to evaluate balance and gait in ET-plus. secondary outcome description Tandem walk：In this test, patients are asked to walk 10 steps on a straight path, with the heel of the leading foot touching the toe of the following foot. The number of missteps, defined as the number of steps away from the straight-line path, is the primary outcome reported. Balance is assessed by Berg Balance (BBS). The total score of the this scale is 56. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4. 0" indicates the lowest level of function and "4" the highest level of function. 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance. Walking condition is assessed by 10 metre Walk Test (10 MWT). Patients walk without assistance 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. secondary outcome time frame May 1, 2021-April 30, 2022 secondary outcome measure The Unified Dystonia Rating Scale (UDRS) for evaluation of dystonia in ET-plus. secondary outcome description Dystonia postural is assessed by revised Dystonia Rating Scales (UDRS). The total score of this scale is 112, includes ratings for 7 items. For each of the items assessed, the UDRS has a severity and a duration rating. The severity rating is specific for each body region assessed and ranges from 0 (no dystonia) to 4 (extreme dystonia). The Duration rating assesses whether dystonia occurs at rest or with action, and whether it is predominantly at maximal or sub maximal intensity. The total score for the UDRS is the sum of the severity and duration factors. secondary outcome time frame May 1, 2021-April 30, 2022 secondary outcome measure The scale for the Assessment and Rating of Ataxia (SARA) is used to evaluate ataxia in ET-plus. secondary outcome description SARA has eight items that yield a total score of 0 (no ataxia) to 40 (most severe ataxia); 1: gait (score 0 to 8), 2: stance (score 0 to 6), 3: sitting (score 0 to 4), 4: speech disturbance (score 0 to 6), 5: finger chase (score 0 to 4), 6: nose-finger test (score 0 to 4), 7: fast alternating hand movements (score 0 to 4), 8: heel-shin slide (score 0 to 4). Limb kinetic functions (items 5 to 8) are rated independently for both sides, and the arithmetic mean of both sides is included in the SARA total score. secondary outcome time frame May 1, 2021-April 30, 2022 eligibility module eligibility criteria Inclusion Criteria: Patients diagnosed with ET and/or ET-plus by the Consensus Statement on the Classification of Tremors, from the Task Force on Tremor of the International Parkinson and Movement Disorder Society. Exclusion Criteria: Lack of capacity to consent to participate in the project healthy volunteers No gender All std age list std age Child Adult Older Adult study population Patients are Han Chinese from mainland China. sampling method Probability Sample contacts locations module location list location location facility Xiangya Hospital of Central South University location city Changsha location state Hunan location zip 410008 location country China derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014202 condition mesh term Tremor condition mesh id D000020329 condition mesh term Essential Tremor condition ancestor list condition ancestor condition ancestor id D000020820 condition ancestor term Dyskinesias condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000009069 condition ancestor term Movement Disorders condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M16108 condition browse leaf name Tremor condition browse leaf as found Tremor condition browse leaf relevance high condition browse leaf id M21290 condition browse leaf name Essential Tremor condition browse leaf as found Essential Tremor condition browse leaf relevance high condition browse leaf id M21727 condition browse leaf name Dyskinesias condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M11181 condition browse leaf name Movement Disorders condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04837079
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full study rank 61704 study protocol section identification module n c t id NCT04833010 org study id info org study id 020-353 organization org full name Baylor Research Institute org class OTHER brief title Effects of Face Masks During Exercise official title Effects of Face Coverings During Physical Activity status module status verified date March 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date January 20, 2021 start date type Actual primary completion date struct primary completion date December 1, 2022 primary completion date type Anticipated completion date struct completion date December 1, 2022 completion date type Anticipated study first submit date February 9, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date March 21, 2022 last update post date struct last update post date March 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Simon Driver responsible party investigator title Research Center Director - The STAR at Frisco responsible party investigator affiliation Baylor Research Institute lead sponsor lead sponsor name Baylor Research Institute lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To describe the primary and secondary outcomes of athletes during a Cardiopulmonary Exercise Test (CPET) on a cycle ergometer with and without a face mask. conditions module condition list condition Cardiopulmonary Exercise Cognitive Performance Covid19 design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Actual arms interventions module arm group list arm group arm group label No cloth face mask arm group type Active Comparator arm group description Cross-over randomization. Participants randomized to this arm will not wear a cloth face mask for Test 1 which they do a progressive step-exercise cycling test to exhaustion arm group intervention list arm group intervention name Other: Cardiopulmonary Exercise Test Other: Cognitive Performance Test arm group label Cloth face mask arm group type Experimental arm group description Cross-over randomization. Participants randomized to this arm will wear a cloth face mask for Test 1 which they do a progressive step-exercise cycling test to exhaustion arm group intervention list arm group intervention name Other: Cardiopulmonary Exercise Test Other: Cognitive Performance Test intervention list intervention intervention type Other intervention name Cardiopulmonary Exercise Test intervention description Participants will complete a Cardiopulmonary Exercise test on cycle ergometer in which they will perform progressive step-exercise cycling to exhaustion intervention arm group label list intervention arm group label Cloth face mask No cloth face mask intervention type Other intervention name Cognitive Performance Test intervention description Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test. intervention arm group label list intervention arm group label Cloth face mask No cloth face mask outcomes module primary outcome list primary outcome primary outcome measure VO2 max during cardiopulmonary exercise testing on a cycle ergometer primary outcome description Exercise capacity measured by Cosmed K5 metabolic equipment primary outcome time frame Week 1 primary outcome measure VO2 max during cardiopulmonary exercise testing on a cycle ergometer primary outcome description Exercise capacity measured by Cosmed K5 metabolic equipment primary outcome time frame Week 2 primary outcome measure Test duration (time) of cardiopulmonary exercise test on a cycle ergometer primary outcome description Total time of test primary outcome time frame Week 1 primary outcome measure Test duration (time) of cardiopulmonary exercise test on a cycle ergometer primary outcome description Total time of test primary outcome time frame Week 2 primary outcome measure Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer primary outcome description Cognitive testing will take place at the end of each stage of the CPET. Cognitive testing using the SACL Cognition application on iPad will include a baseline SRT measurement and additional measurements at the end of each stage of the CPET. The baseline will include a 30s session of SRT for familiarization and then a 30s session will be scored. SRT will then be administered for 30s at the end of each stage of the CPET. The SRT task includes a visual stimulus presented on the touchscreen. Subjects will be instructed to press the stimulus on-screen as quickly as possible. Reaction time will be measured on the SRT task. Reaction time is calculated as the average amount of time in seconds between stimulus presentation and user response within a session. primary outcome time frame Week 1 primary outcome measure Reaction time of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer primary outcome description Cognitive testing will take place at the end of each stage of the CPET. Cognitive testing using the SACL Cognition application on iPad will include a baseline SRT measurement and additional measurements at the end of each stage of the CPET. The baseline will include a 30s session of SRT for familiarization and then a 30s session will be scored. SRT will then be administered for 30s at the end of each stage of the CPET. The SRT task includes a visual stimulus presented on the touchscreen. Subjects will be instructed to press the stimulus on-screen as quickly as possible. Reaction time will be measured on the SRT task. Reaction time is calculated as the average amount of time in seconds between stimulus presentation and user response within a session. primary outcome time frame Week 2 primary outcome measure Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer primary outcome description Cognitive testing will take place at the end of each stage of the CPET. Cognitive testing using the SACL Cognition application on iPad will include a baseline SRT measurement and additional measurements at the end of each stage of the CPET. The baseline will include a 30s session of SRT for familiarization and then a 30s session will be scored. SRT will then be administered for 30s at the end of each stage of the CPET. The SRT task includes a visual stimulus presented on the touchscreen. Subjects will be instructed to press the stimulus on-screen as quickly as possible. Accuracy will be measured on the SRT task. Accuracy is calculated as the total number of correct responses to stimuli divided by the total number of stimuli presented during a session (presented as a percentage). primary outcome time frame Week 1 primary outcome measure Accuracy of cognitive performance testing during cardiopulmonary exercise test on a cycle ergometer primary outcome description Cognitive testing will take place at the end of each stage of the CPET. Cognitive testing using the SACL Cognition application on iPad will include a baseline SRT measurement and additional measurements at the end of each stage of the CPET. The baseline will include a 30s session of SRT for familiarization and then a 30s session will be scored. SRT will then be administered for 30s at the end of each stage of the CPET. The SRT task includes a visual stimulus presented on the touchscreen. Subjects will be instructed to press the stimulus on-screen as quickly as possible. Accuracy will be measured on the SRT task. Accuracy is calculated as the total number of correct responses to stimuli divided by the total number of stimuli presented during a session (presented as a percentage). primary outcome time frame Week 2 secondary outcome list secondary outcome secondary outcome measure Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer secondary outcome description The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during cardiopulmonary exercise test on a cycle ergometer. secondary outcome time frame Week 1 secondary outcome measure Subjective dyspnea rating during cardiopulmonary exercise testing on a cycle ergometer secondary outcome description The Modified Borg Dyspnea Scale (0-10) will be used to assess subjective shortness of breath. Measured during each stage of the exercise protocol during cardiopulmonary exercise test on a cycle ergometer. secondary outcome time frame Week 2 secondary outcome measure Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer secondary outcome description The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during cardiopulmonary exercise test on a cycle ergometer secondary outcome time frame Week 1 secondary outcome measure Ratings of perceived exertion during cardiopulmonary exercise testing on a cycle ergometer secondary outcome description The Borg Rating of Perceived Exertion (6-20) scale will be used during the test to assess subjective exertion. Measured during each stage of the exercise protocol during cardiopulmonary exercise test on a cycle ergometer secondary outcome time frame Week 2 secondary outcome measure Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer secondary outcome description Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer secondary outcome time frame Week 1 secondary outcome measure Oxygen saturation during cardiopulmonary exercise testing on a cycle ergometer secondary outcome description Measured by a pulse oximeter during each stage of the exercise protocol of the cardiopulmonary exercise test on a cycle ergometer secondary outcome time frame Week 2 secondary outcome measure Blood lactate during cardiopulmonary exercise testing on a cycle ergometer secondary outcome description Blood lactate will be measured pre and post-CPET using a Nova Medical Lactate Plus: Blood Lactate Measuring Meter-Version 2 device. secondary outcome time frame Week 1 secondary outcome measure Blood lactate during cardiopulmonary exercise testing on a cycle ergometer secondary outcome description Blood lactate will be measured pre and post-CPET using a Nova Medical Lactate Plus: Blood Lactate Measuring Meter-Version 2 device. secondary outcome time frame Week 2 eligibility module eligibility criteria Inclusion Criteria: Be able to come to Baylor Scott & White Sports Therapy and Research at The Star in Frisco, Texas twice in three weeks. Be willing to wear a face mask during exercise capacity testing on a stationary bicycle. Exclusion Criteria: - healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 39 Years std age list std age Adult contacts locations module location list location location facility Baylor Scott & White Sports Therapy & Research at The Star location city Frisco location state Texas location zip 75034 location country United States references module see also link list see also link see also link label Baylor Scott & White Sports Therapy and Research at The Star see also link u r l https://www.bswhealth.com/Star i p d sharing statement module i p d sharing Undecided i p d sharing description Considered upon request. document section large document module large doc list large doc large doc type abbrev Prot_SAP large doc has protocol Yes large doc has s a p Yes large doc has i c f No large doc label Study Protocol and Statistical Analysis Plan large doc date February 23, 2021 large doc upload date 02/09/2022 12:27 large doc filename Prot_SAP_000.pdf derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse leaf id M20242 condition browse leaf name Facies condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04833010
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full study rank 61568 study protocol section identification module n c t id NCT04834778 org study id info org study id HC-404-FCP-2011 organization org full name HiberCell, Inc. org class INDUSTRY brief title A Study of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD) official title A Multicenter, Open-label, Phase 1a Study of HC-5404-FU in Subjects With Advanced Solid Tumors status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 8, 2021 start date type Actual primary completion date struct primary completion date January 29, 2023 primary completion date type Anticipated completion date struct completion date July 1, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 7, 2022 last update post date struct last update post date July 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name HiberCell, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name Covance collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary Study HC-404-FCP-2011 is a first in human, Phase 1a, multi-center, open-label study to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of oral dosing of HC-5404-FU in a dose-escalating fashion. Up to 36 qualified subjects at 3 to 5 US sites, who have specific tumor types of renal cell carcinoma (RCC), gastric cancer (GC), metastatic breast cancer (MBC), small cell lung cancer (SCLC), and other solid tumors (e.g., non-small cell lung cancer, colorectal cancer, carcinoma of unknown primary) with the exception of rapidly progressing neoplasms (e.g., pancreatic cancer, glioblastoma, hepatocellular carcinoma) will receive HC-5404-FU. Every effort will be made to ensure approximately 50% of all subjects enrolled will be subjects with RCC and GC. The starting dose level is 25 mg twice daily (BID), escalating to 50, 100, and 200 mg BID as safety allows, following the Bayesian Optimal Interval (BOIN) design. The safety monitoring committee (SMC) will evaluate the DLTs and cumulative safety and PK data at the end of each cohort. Based on the SMC recommendations after a comprehensive review of PK and safety data for 200 mg BID dose, higher dose levels will be evaluated, starting with 400 mg BID. The dose will escalate to 600 mg and then 900 mg following the BOIN design starting with 1 subject at each escalated dose, until the MTD is reached or the sponsor or SMC declares the dose most appropriate for clinical development. This Phase 1a will be expanded into a Phase 1b/2a study through a protocol amendment and will then assess the dose and tumor type(s) selected in Phase 1a as the most appropriate for further clinical development. Subjects will be dosed until unacceptable toxicity, disease progression per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), subject withdrawal, any other administrative reasons, or after 2 years of treatment, whichever occurs first. Efficacy will be assessed via Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, including occurrence of dose-limiting toxicities (DLTs), pharmacokinetics (PK), and biomarker parameters will also be assessed. detailed description HC 5404-FU will be orally administered BID with food or within 30 minutes of completing a meal, starting at 25 mg, with doses escalating to 50, 100, 200, 400, 600 and 900 mg BID as safety allows. Up to 24 subjects will be enrolled to ensure 12 subjects complete the study at the estimated MTD of HC 5404-FU. Dosing will occur in 3-week cycles. Subjects are to spend Cycle 1/Day 1 (C1D1) in the clinic followed by an overnight stay for safety monitoring and PK sampling. Subjects will be hospitalized for administration of first 3 doses: C1D1 am and pm doses, and Cycle 1/Day 2 (C1D2) am dose; on Days 8, 15, and 21 the am dose will be taken in the clinic after the planned PK samples. All other doses are to be self administered at home. After the initial hospital stay at the start of study, subjects will be seen in outpatient clinic on Days 8, 15, and 21 of Cycle 1 for PK assessment and thereafter, the first day of each cycle for physical and laboratory assessments, adverse event (AE), and dosing compliance monitoring; the end of treatment visit will also be in person in outpatient clinic. Following completion of the treatment period of the study, subjects will be monitored for survival up for up to 24 months after the last post treatment follow-up visit. Dose escalation will follow the Bayesian Optimal Interval (BOIN) design. The decision to escalate to the next dose level will be based on safety assessments after all subjects of a cohort have reached the end of Cycle 1/Day 21 (DLT evaluation period). The safety monitoring committee (SMC) will be responsible for dose escalation decisions, including whether to modify the dose escalation based on the DLT observations and review of available PK data. The target toxicity rate of 30%, with limits of 0.236 to 0.359 for escalation/de escalation, will be employed to determine the MTD. With these predefined parameters, when the observed toxicity rate in a dose level is less than 0.236, the dose for the next cohort can escalate. If the observed toxicity rate is higher than 0.359, the dose will de escalate. Otherwise, the dose remains the same. Individual subjects may be considered for treatment at a higher dose than the dose to which they were initially assigned after subject has completed 2 cycles of treatment and 1 postbaseline CT scan and maintained at least a stable disease (SD) response. In order to escalate a dose level, the subject must have tolerated his/her current dose level without experiencing a DLT, and the dose level to which the subject is planned to be escalated must have completed a DLT evaluation period, not exceeded the MTD, and been declared safe. Each subject can go through 2 dose escalations and do not need to go through a DLT evaluation period for either escalation. Intrasubject dose escalation will be considered on a case-by-case basis, each case to be assessed and approved by the sponsor. conditions module condition list condition Renal Cell Carcinoma Gastric Cancer Metastatic Breast Cancer Small-cell Lung Cancer Other Solid Tumors keyword list keyword RCC GC MCA SCLC Phase 1 First in human HC-5404-FU HC-5404 design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 36 enrollment type Anticipated arms interventions module arm group list arm group arm group label Cohort 1 - 25 mg arm group type Experimental arm group description 25 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle arm group intervention list arm group intervention name Drug: HC-5404-FU arm group label Cohort 2 - 50 mg arm group type Experimental arm group description 50 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle arm group intervention list arm group intervention name Drug: HC-5404-FU arm group label Cohort 3 - 100 mg arm group type Experimental arm group description 100 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle arm group intervention list arm group intervention name Drug: HC-5404-FU arm group label Cohort 4 - 200 mg arm group type Experimental arm group description 200 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle arm group intervention list arm group intervention name Drug: HC-5404-FU arm group label Cohort 5 - 400 mg arm group type Experimental arm group description 400 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle arm group intervention list arm group intervention name Drug: HC-5404-FU arm group label Cohort 6 - 600 mg arm group type Experimental arm group description 600 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle arm group intervention list arm group intervention name Drug: HC-5404-FU arm group label Cohort 7 - 900 mg arm group type Experimental arm group description 900 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle arm group intervention list arm group intervention name Drug: HC-5404-FU arm group label Cohort 8 - 300 mg arm group type Experimental arm group description 300 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle arm group intervention list arm group intervention name Drug: HC-5404-FU intervention list intervention intervention type Drug intervention name HC-5404-FU intervention description HC 5404-FU (hemi fumarate salt of HC 5404) is a novel, highly selective, and potent PERK inhibitor. Preclinical pharmacological studies demonstrated high specificity of HC 5404-FU to PERK and decreased viability of tumor cells. HC 5404-FU will be orally administered BID every day with food or within 30 minutes of completing a meal, starting at 25 mg, with doses escalating to 50, 100, 200, 400, 600, and 900 mg BID as safety allows for each 3-week treatment cycle. intervention arm group label list intervention arm group label Cohort 1 - 25 mg Cohort 2 - 50 mg Cohort 3 - 100 mg Cohort 4 - 200 mg Cohort 5 - 400 mg Cohort 6 - 600 mg Cohort 7 - 900 mg Cohort 8 - 300 mg intervention other name list intervention other name HC-5404 outcomes module primary outcome list primary outcome primary outcome measure Determination of MTD of HC-5404-FU primary outcome description When orally administered in a dose escalating fashion in subjects with selected, advanced solid tumors primary outcome time frame Within 18 months of last patient enrolled primary outcome measure Occurrence of dose-limiting toxicities (DLTs) primary outcome time frame Within 18 months of last patient enrolled primary outcome measure Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related TEAEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0 primary outcome time frame Within 18 months of last patient enrolled primary outcome measure Incidence of TEAEs leading to premature discontinuation primary outcome time frame Within 18 months of last patient enrolled primary outcome measure Incidence of significant laboratory abnormalities, based on hematology, serum chemistry, and urinalysis test results primary outcome time frame Within 18 months of last patient enrolled primary outcome measure Incidence of abnormalities observed in 12 lead ECG parameters primary outcome time frame Within 18 months of last patient enrolled primary outcome measure Incidence of abnormalities observed in vital signs measurements and physical examinations primary outcome time frame Within 18 months of last patient enrolled secondary outcome list secondary outcome secondary outcome measure Area under the plasma concentration versus time curve from time 0 until last measurable concentration (AUC0 last) secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Area under the plasma concentration versus time curve from time 0 to 12 hours postdose (AUC0 12) secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0 ∞) secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Area under the plasma concentration versus time curve over a dosing interval (AUC0 t) secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Peak plasma concentration (Cmax) secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Time of the maximum observed plasma concentration (tmax) secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Apparent total clearance (CL/F) of plasma concentration secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Apparent volume of distribution during the terminal phase (Vz/F) of plasma concentration secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Apparent terminal elimination half life (t1/2) of plasma concentration secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Accumulation ratio based on AUC0 t (ARAUC) of plasma concentration secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Linearity ratio (LR) of plasma concentration secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Overall response rate (ORR) to HC-5404-FU using iRECIST secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Duration of response (DOR) to HC-5404-FU using iRECIST secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Time to treatment failure (TTF) secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Progression-free survival (PFS) using iRECIST secondary outcome time frame Within 24 months of last patient enrolled secondary outcome measure Overall response (OS) using iRECIST secondary outcome time frame Within 24 months of last patient enrolled eligibility module eligibility criteria Inclusion Criteria: Have a signed informed consent form prior to any study specific procedures or treatment Be ≥18 years of age (male or female) at the time of consent Have 1 of the following histologically or cytologically confirmed tumor types with qualifying characteristics, and have received a minimum of 2 (and no more than 5) lines of prior therapy for metastatic (Stage IV) disease: RCC (renal cell carcinoma - clear cell or papillary) SCLC (small cell lung cancer) OR have received a minimum of 3 (and no more than 5) lines of prior therapy for metastatic (Stage IV) disease: GC (gastric adenocarcinoma) Human epidermal growth factor receptor positive (HER2+) MBC (metastatic breast cancer) Other solid tumors (e.g., non-small cell lung cancer, colorectal cancer, carcinoma of unknown primary) with the exception of rapidly progressing neoplasms (e.g., pancreatic cancer, glioblastoma, hepatocellular carcinoma) Note: Subjects with RCC and GC are a priority and should constitute approximately 50% (12 subjects) of the enrolled popululation. Enrollment of all others will be capped when reaching a combined 50%, in order to maintain 12 slots for subjects with RCC and GC. Have at least 1 radiologically measurable lesion as per RECIST v 1.1, defined as a lesion that is at least 10 mm in longest diameter or lymph node and that is at least 15 mm in short axis imaged by CT scan or magnetic resonance imaging (MRI) and obtained by imaging within 28 days prior to screening. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions Have resolution of all previous treatment related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (≤ Grade 2) and alopecia. If the subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention Provided there are suitable and accessible lesions, no biopsy contraindications, minimal risk of complications and a positive informed decision, subject as are willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality, for assessment of biomarker status. Two biopsies will be necessary: at baseline (within 30 days prior to first dose) and within 7 days after Cycle 3/Day 1. Newly obtained biopsy specimens are preferred to archived samples and formalin- fixed, paraffin-embedded block specimens are preferred to slides. In the event a fresh pre-treatment biopsy is not able to be provided, the most recent archival biopsy must be provided in its place Have Eastern Cooperative Oncology Group performance status of 0 or 1 and sustained between screening and initiation of dosing on Day 1 QT interval corrected for heart rate using Fridericia's (QTcF) method ≤450 msec Have an albumin level of ≥3 g/dL at screening Have life expectancy of 3 months or greater as determined by the treating physician Have adequate organ function within 15 days prior to first administration of study drug on Day 1, as defined by meeting all of the following criteria: Total bilirubin ≤1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5 x ULN Aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN or ≤5 × ULN for subjects with known hepatic metastases Fasting serum glucose within normal range and hemoglobin A1c ≤8% Thyroid function tests (thyroid stimulating hormone [TSH] within normal limits for subjects with normal thyroid function and free thyroxine [FT4]) within normal limits for subjects on thyroid treatment Have adequate renal function within 15 days prior to first administration of study drug on Day 1, as defined by creatinine ≤1.5 × ULN and creatinine clearance ≥30 mL/min, as per the below Cockcroft Gault formula Have adequate hematologic function within 15 days prior to first administration of study drug on Day 1, as defined by meeting all of the following criteria: Hemoglobin ≥9 g/dL (uncorrected by red blood cell transfusion or erythropoietin support) Absolute neutrophil count ≥1.5 × 109/L Platelet count ≥100 × 109/L Have adequate coagulation function within 15 days prior to first administration of study drug on Day 1, as defined by either of the following criteria: International normalized ratio (INR) <1.5 × ULN OR for subjects receiving warfarin or low molecular weight heparin, the subject must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy Activated partial thromboplastin time (aPTT) <1.5 × ULN unless subject is receiving anticoagulant therapy, provided prothrombin time or aPTT is within therapeutic range of intended use of anticoagulants Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Female subject of childbearing potential must be willing to use an adequate form of contraception from the first dose of study medication through 90 days after the last dose of study drug Female subject must agree not to breastfeed and not to donate ova starting at screening and throughout the study treatment, and for 90 days after the last dose of study drug Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time partner is breastfeeding throughout the study period and for 90 days after the last dose of study drug Male subject with female partner(s) of childbearing potential must not donate sperm during the treatment period and for at least 90 days after the last dose of study drug Male subject with female partner(s) of childbearing potential should agree to use a highly effective method of contraception during the treatment period and for at least 90 days after the last dose of the study drug Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of study treatment or who has not recovered from adverse reactions due to a previously administered agent or major surgery Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids (≤30 mg/day of hydrocortisone, ≤10 mg/day of prednisone, ≤2 mg/day of dexamethasone, or equivalent) may be approved after consultation with the sponsor Has taken a medication that is a strong CYP3A4 inhibitor or inducer within 4 weeks of the first dose of treatment (see Appendix 12) Has known history of active tuberculosis Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) Has known active Hepatitis B (anti hepatitis B surface antibody, anti hepatitis B core antibody, hepatitis B surface antigen [HBsAg]) or Hepatitis C (hepatitis C antibody) infection Has a current diagnosis of severe acute respiratory syndrome coronavirus (SARS CoV) 2 infection confirmed by reverse transcription polymerase chain reaction (PCR) test. Subject needs to have a negative PCR test at screening and a negative PCR test within 14 days prior to the first dose of study treatment Has a history of clinically severe autoimmune disease, or a history of organ transplant Has insulin dependent (Type I) diabetes or poorly controlled Type II diabetes (per clinical discretion) with hemoglobin A1c >8% Has known additional malignancy that is progressing or required active treatment within previous 5 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, superficial bladder cancer, or in situ cervical cancer. Subjects with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease free for at least 5 years Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using systemic steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability Has a history of interstitial lung disease, pneumonitis within 12 months prior to screening or current pneumonitis Has an active infection requiring systemic therapy Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator Has a history or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, congestive heart failure, baseline ECG abnormalities, including, but not limited to, QTc prolongation (prolonged QTcF defined as ≥450 msec) or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification Has overt or latent disorders of the exocrine pancreas (such as acute or chronic pancreatitis of any etiology) or chronic (including autoimmune) gastrointestinal disorders such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, lupus, scleroderma, Sjogren's syndrome, and polyarteritis nodosa Has a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trial Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial, starting with the prescreening or screening visit through 90 days after the last dose of study drug Is a first degree relative of the investigator, staff, or study sponsor. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Viviana Cecinato, MPharm central contact role Contact central contact phone 708-295-1226 central contact e mail Viviana.Cecinato@covance.com central contact name Matthew Barnes central contact role Contact central contact e mail Matthew.Barnes@covance.com overall official list overall official overall official name Jose Iglesias, MD overall official affiliation Consultant Chief Medical Officer for HiberCell, Inc. overall official role Study Director location list location location facility Karmanos Cancer Institute location status Recruiting location city Detroit location state Michigan location zip 48201 location country United States location contact list location contact location contact name Dipesh Uprety, MD location contact role Contact location contact phone 313-576-8722 location contact e mail upretyd@karmanos.org location contact name Kelsey Desrosier location contact role Contact location contact phone 313-576-9697 location contact e mail Desrosierk@karmanos.org location facility HealthPartners Cancer Care Center location status Recruiting location city Saint Paul location state Minnesota location zip 55101 location country United States location contact list location contact location contact name Jacquelyn Christenson location contact role Contact location contact phone 651-254-3602 location contact e mail Jacquelyn.christenson@parknicollet.com location contact name Octav Pacurar location contact role Contact location contact phone 651-254-3604 location contact e mail octav.pacurar@parknicollet.com location contact name Arkadiusz Dudek, MD, PhD location contact role Principal Investigator location facility Baylor University Medical Center location status Recruiting location city Dallas location state Texas location zip 75246 location country United States location contact list location contact location contact name Joyce Ghormley, CCRC location contact role Contact location contact phone 214-818-8961 location contact e mail Joyce.Ghormley@BSWHealth.org location contact name Mohamed Hwaili location contact role Contact location contact phone 214-818-8472 location contact e mail Mohamed.Hwaili@BSWHealth.org location facility The University of Texas M.D. Anderson Cancer Center location status Recruiting location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Katrien Van Roosbroeck location contact role Contact location contact phone 713-563-1055 location contact e mail kvan1@mdanderson.org location contact name Rabia Khan location contact role Contact location contact phone (713) 563-4667 location contact e mail rkhan@mdanderson.org location contact name Sarina Piha-Paul, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002292 condition mesh term Carcinoma, Renal Cell condition mesh id D000055752 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NCT04834778
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full study rank 61681 study protocol section identification module n c t id NCT04833309 org study id info org study id JS-CT-2021-02 organization org full name Jaseng Medical Foundation org class OTHER brief title Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial official title Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 26, 2021 start date type Actual primary completion date struct primary completion date August 31, 2022 primary completion date type Anticipated completion date struct completion date August 31, 2022 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date February 25, 2022 last update post date struct last update post date March 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name In-Hyuk Ha, KMD responsible party investigator title Director of Jaseng Spine and Joint Research Institute responsible party investigator affiliation Jaseng Medical Foundation lead sponsor lead sponsor name Jaseng Medical Foundation lead sponsor class OTHER collaborator list collaborator collaborator name Korea Institute of Oriental Medicine collaborator class OTHER_GOV oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. detailed description This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. Participants of each group will receive total 5 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific type and volume of pharmacopuncture and physical therapy. conditions module condition list condition Chronic Low-back Pain design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Pharmacopuncture therapy arm group type Experimental arm group description Pharmacopuncture will be administered to the subjects in the pharmacopuncture therapy group. The physicians will choose the specific type and volume of pharmacopuncture according to participants' conditions. arm group intervention list arm group intervention name Procedure: pharmacopuncture therapy arm group label Physical therapy arm group type Active Comparator arm group description Physical therapy will be applied to the subjects in the physical therapy group. The physicians will choose the specific type and volume of pharmacopuncture according to participants' conditions. arm group intervention list arm group intervention name Procedure: physical therapy intervention list intervention intervention type Procedure intervention name pharmacopuncture therapy intervention description The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and dosage will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively. intervention arm group label list intervention arm group label Pharmacopuncture therapy intervention type Procedure intervention name physical therapy intervention description The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and body part will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively. intervention arm group label list intervention arm group label Physical therapy outcomes module primary outcome list primary outcome primary outcome measure Numeric rating scale (NRS) of low-back pain primary outcome description NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. primary outcome time frame week 6 secondary outcome list secondary outcome secondary outcome measure Numeric rating scale (NRS) of low-back pain secondary outcome description NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. secondary outcome time frame week 1, 2, 3, 4, 5, 6, 13, 25 secondary outcome measure Numeric rating scale (NRS) of radiating pain in lower extremities secondary outcome description NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. secondary outcome time frame week 1, 2, 3, 4, 5, 6, 13, 25 secondary outcome measure Visual analogue scale (VAS) of leg radiating pain secondary outcome description Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome. secondary outcome time frame week 1, 2, 3, 4, 5, 6, 13, 25 secondary outcome measure Visual analogue scale (VAS) of low-back pain secondary outcome description Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome. secondary outcome time frame week 1, 2, 3, 4, 5, 6, 13, 25 secondary outcome measure Oswestry Disability Index (ODI) secondary outcome description ODI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome). secondary outcome time frame week 1, 6, 13, 25 secondary outcome measure Korean version of the Roland-Morris Disability Questionnaire (RMDQ) secondary outcome description The Roland Morris Disability Questionnaire consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). There is no weighting applied to the statements, therefore the score can range from 0 (no disability) to 24 (maximal disability). secondary outcome time frame week 1, 6, 13, 25 secondary outcome measure Patient Global Impression of Change (PGIC) secondary outcome description Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.) secondary outcome time frame week 6, 13, 25 secondary outcome measure Short Form-12 Health Survey version 2 (SF-12 v2) secondary outcome description The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life. secondary outcome time frame week 1, 6, 13, 25 secondary outcome measure EuroQol-5 Dimension (EQ-5D-5L) secondary outcome description The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) secondary outcome time frame week 1, 6, 13, 25 eligibility module eligibility criteria Inclusion Criteria: low back pain for more than 6 months Numeric rating scale (NRS) score for low back pain 5 or more 19-70 years old participants who agreed and signed informed consent form Exclusion Criteria: Spine metastasis of cancer, acute fracture of spine, or spine dislocation Progressive neurologic deficits or severe neurologic deficits Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc) Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc) Concurrent use of steroids, immunosuppressants, or psychotropic medications Hemorrhagic disease, severe diabetes or taking anticoagulant drug Participants who took NSAIDs or pharmacopuncture within 1 week Pregnant or lactating women Participants who had undergone lumbar surgery within 3 months Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial Participants who can not write informed consent Participants who is difficult to participate in the trial according to investigator's decision healthy volunteers No gender All minimum age 19 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name In-Hyuk Ha, KMD,Ph.D central contact role Contact central contact phone +82-2-2222-2740 central contact e mail hanihata@gmail.com overall official list overall official overall official name In-Hyuk Ha, KMD,Ph.D overall official affiliation Jaseng Medical Foundation overall official role Study Director location list location location facility Jaseng Hospital of Korean Medicine location status Recruiting location city Seoul location state Gangnam-Gu location zip 135-896 location country Korea, Republic of location contact list location contact location contact name Kyoung Sun Park, Dr location contact role Contact location contact phone +82-2-2222-2749 location contact e mail lovepks0116@gmail.com location facility Bucheon Jaseng Hospital of Korean Medicine location status Recruiting location city Bucheon location state Gyeonggi Province location zip 14598 location country Korea, Republic of location contact list location contact location contact name Ji Yeon Seo, KMD location contact role Contact location contact phone 82-2-2222-2745 location contact e mail wownpan21@gmail.com location facility Haeundae Jaseng Hospital of Korean Medicine location status Recruiting location city Busan location zip 48102 location country Korea, Republic of location contact list location contact location contact name HYUN WOO CHO, PhD location contact role Contact location contact phone +82-51-791-5091 location contact e mail kamui0328@hanmail.net location facility Daejeon Jaseng Hospital of Korean Medicine location status Recruiting location city Daejeon location zip 35262 location country Korea, Republic of location contact list location contact location contact name Sunah Kim, KMD location contact role Contact location contact phone +82-42-1577-0007 location contact e mail tnsdk2648@jaseng.org references module reference list reference reference p m i d 36072909 reference type derived reference citation Park KS, Kim S, Seo JY, Cho H, Lee JY, Lee YJ, Lee J, Kim MJ, Choi YE, Yang CS, Han CH, Ha IH. Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Low Back Pain: A Protocol for a Pragmatic Randomized Controlled Trial. J Pain Res. 2022 Sep 1;15:2629-2639. doi: 10.2147/JPR.S375231. eCollection 2022. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001416 condition mesh term Back Pain condition mesh id D000017116 condition mesh term Low Back Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M18585 condition browse leaf name Low Back Pain condition browse leaf as found Low Back Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M3866 condition browse leaf name Back Pain condition browse leaf as found Back Pain condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04833309
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full study rank 61889 study protocol section identification module n c t id NCT04830592 org study id info org study id NG-641-02 organization org full name PsiOxus Therapeutics Ltd org class INDUSTRY brief title A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck official title A Multicentre, Open-label, Dose-escalating, Phase Ib, Study of Intravenous Dosing of NG-641, as Monotherapy or in Combination With Pembrolizumab in Patients With Surgically Resectable Squamous Cell Carcinoma of the Head and Neck acronym MOAT status module status verified date June 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 4, 2021 start date type Actual primary completion date struct primary completion date August 2023 primary completion date type Anticipated completion date struct completion date December 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date June 23, 2022 last update post date struct last update post date June 29, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name PsiOxus Therapeutics Ltd lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN). detailed description Part A (NG-641 monotherapy): Approximately 16 evaluable patients will receive three doses of IV NG-641 in Part A. Patients will then proceed to planned surgical resection. Part B (NG-641 and pembrolizumab): Up to 20 evaluable patients will receive three doses of IV NG-641 and one dose of pembrolizumab. Patients will then proceed to planned surgical resection. conditions module condition list condition Squamous Cell Carcinoma of the Head and Neck keyword list keyword Squamous cell carcinoma of the head and neck SCCHN NG-641 Pembrolizumab design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 36 enrollment type Anticipated arms interventions module arm group list arm group arm group label Part A arm group type Experimental arm group description NG-641 monotherapy arm group intervention list arm group intervention name Biological: NG-641 arm group label Part B arm group type Experimental arm group description NG-641 and pembrolizumab arm group intervention list arm group intervention name Biological: NG-641 Biological: Pembrolizumab intervention list intervention intervention type Biological intervention name NG-641 intervention description Patients receive three doses of NG-641 by intravenous infusion. intervention arm group label list intervention arm group label Part A Part B intervention type Biological intervention name Pembrolizumab intervention description Patients receive three doses of NG-641 by intravenous infusion and a single dose of Pembrolizumab by intravenous infusion. intervention arm group label list intervention arm group label Part B outcomes module primary outcome list primary outcome primary outcome measure Incidence of adverse events (safety and tolerability) primary outcome description Assess the safety and tolerability of NG-641 by review of adverse events (AEs), serious adverse events, AEs resulting in delays to planned surgery, AEs leading to study treatment or study discontinuation and AEs resulting in death. primary outcome time frame End of Study Treatment Visit (Day 57) eligibility module eligibility criteria Inclusion Criteria: Newly diagnosed or recurrence of clinical stage III-IVb, histologically confirmed oral cavity, larynx, hypopharynx or oropharynx SCCHN (T1 with N2-3; T2 with N2-3; T3 with N0-3; T4a with N0-3) Disease is considered resectable, definitive surgery is planned in the next 8 weeks from screening, and the patient is willing to undergo surgery (potential for 2-3 cm of resected tumour specimen to be available for translational research purposes) Provide written informed consent to participate Aged 18 years or over Willing to consent to tumour biopsies at baseline ECOG performance status 0 or 1 Ability to comply with study procedures in the Investigator's opinion Adequate renal function Adequate hepatic function Adequate bone marrow function Meeting reproductive status requirements Exclusion Criteria: Prior allogeneic or autologous bone marrow or organ transplantation Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection. Active infection requiring systemic therapy within 1 week of the anticipated first dose of study drug Active viral disease or positive test for hepatitis B virus, hepatitis C virus (HCV) or HIV/AIDS Patients who have active autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving systemic immunosuppressive treatment (see protocol for full criteria) Treatment with any COVID-19 vaccine in the 28 days before the first dose of NG-641, unless the vaccine is known to not be based on an adenoviral vector (e.g., mRNA vaccines) Treatment with any vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before first dose of NG-641 History of clinically significant chronic liver disease History of clinically significant interstitial lung disease (including pneumonitis) History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment Use of antiviral agents Incomplete recovery from surgery, incomplete healing of an incision site or evidence of infection Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding or risk factors for gastrointestinal bleeding, infectious or inflammatory bowel disease, pulmonary embolism or other uncontrolled thromboembolic event, history or evidence of haemoptysis, or significant cardiovascular or cerebrovascular event Any known Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 coagulation abnormality/coagulopathy Prior history of bowel obstruction, or infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational drug/therapy in the 28 days before the first dose of study treatment: • All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment. Patients with toxicities (other than renal toxicities) attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enrol Other prior malignancy active within the previous 3 years Tumour location/extent considered by the Investigator to present a significant risk of airway obstruction if tumour flare or necrosis were to occur Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results Previous treatment with any other enadenotucirev-based therapy, or fibroblast activation protein (FAP) targeting agent Known allergy/immune-related adverse reactions to NG-641 transgene or immune checkpoint inhibitor products or formulation; severe hypersensitivity to another monoclonal antibody Any other medical or psychological condition that would affect the patient's ability to comply with all visits and assessments, or compromise ability to give informed consent Related to or a dependent of the site staff, or a member of the site staff. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name PsiOxus Therapeutics central contact role Contact central contact phone +44 (0)1235 835 328 central contact e mail enquiries@psioxus.com overall official list overall official overall official name Christian Ottensmeier, Prof. overall official affiliation The Clatterbridge Cancer Centre overall official role Principal Investigator location list location location facility Cardiff & Vale University LHB location status Not yet recruiting location city Cardiff location country United Kingdom location contact list location contact location contact name Mererid Evans, Dr location contact role Contact location facility The Clatterbridge Cancer Centre location status Recruiting location city Liverpool location country United Kingdom location contact list location contact location contact name Christian Ottensmeier, Prof. location contact role Contact location facility The Royal Marsden Hospital location status Recruiting location city London location country United Kingdom location contact list location contact location contact name Kevin Harrington, Prof. location contact role Contact location facility University Hospital Southampton NHS Foundation Trust location status Not yet recruiting location city Southampton location zip SO16 6YD location country United Kingdom location contact list location contact location contact name Ioannis Krydis, Dr location contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000002294 condition mesh term Carcinoma, Squamous Cell condition mesh id D000077195 condition mesh term Squamous Cell Carcinoma of Head and Neck condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000018307 condition ancestor term Neoplasms, Squamous Cell condition ancestor id D000006258 condition ancestor term Head and Neck Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition browse leaf list condition browse leaf condition browse leaf id M1689 condition browse leaf name Squamous Cell Carcinoma of Head and Neck condition browse leaf as found Squamous Cell Carcinoma of the Head and Neck condition browse leaf relevance high condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M4702 condition browse leaf name Carcinoma, Squamous Cell condition browse leaf as found Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M19604 condition browse leaf name Neoplasms, Squamous Cell condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id C000582435 intervention mesh term Pembrolizumab intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M289070 intervention browse leaf name Pembrolizumab intervention browse leaf as found Cognitive intervention browse leaf relevance high intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04830592
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full study rank 61835 study protocol section identification module n c t id NCT04831307 org study id info org study id H21-00749 organization org full name British Columbia Cancer Agency org class OTHER brief title 68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical official title Evaluation of the in Vivo Biodistribution and Radiation Dosimetry of 68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical status module status verified date March 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date August 30, 2021 start date type Actual primary completion date struct primary completion date December 1, 2021 primary completion date type Actual completion date struct completion date August 2022 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date December 1, 2021 last update post date struct last update post date December 3, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name British Columbia Cancer Agency lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a preliminary evaluation of a radiotracer's biodistribution in human subjects. It is a prospective, single-centre, open-label, single group assignment interventional study. Prostate cancer is very common, and PSMA imaging is currently the most accurate means of localizing these tumours. The goal is to evaluate the biodistribution and safety of [68Ga]HTK03149 PET/CT for prostate cancer imaging. detailed description Each subject will have a PET/CT scan using [68Ga]HTK03149 . The [68Ga]HTK03149 radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. After providing informed written consent subjects will complete a medical history questionnaire. Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of [68Ga]HTK03149 . Eighteen to seventy-two hours after [68Ga]HTK03149 administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire. Follow-up Assessments The following information will be collected up to 12 months following the PET/CT scans: Initiation of a new treatment, Laboratory results and pathology reports, Results of imaging studies, Final clinical diagnosis by physician and relevant clinical notes. The study is expected to take up to 1 year for accrual. conditions module condition list condition Prostate Cancer Prostatic Neoplasm Prostatic Disease Urogenital Neoplasms Disease Attributes Neoplasms design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 10 enrollment type Actual arms interventions module arm group list arm group arm group label [68Ga]Ga-HTK03149 PET/CT arm group type Experimental arm group description 200 MBq/m2 of body surface area, with a 200 MBq minimum adult administered activity will be injected intravenously prior to perform the PET/CT arm group intervention list arm group intervention name Other: [68Ga]Ga-HTK03149 PET/CT intervention list intervention intervention type Other intervention name [68Ga]Ga-HTK03149 PET/CT intervention description 200 MBq/m2 of body surface area, with a 200 MBq minimum adult administered activity will be injected intravenously prior to perform the PET/CT intervention arm group label list intervention arm group label [68Ga]Ga-HTK03149 PET/CT outcomes module primary outcome list primary outcome primary outcome measure Biodistribution of 68Ga-HTK03149 PET/CT in human subjects primary outcome description Evaluate the biodistribution of 68Ga-HTK03149 in human subjects, which will enable calculating the radiation dosimetry of this radiopharmaceutical. The efficacy parameters will be the following: Individual organ dose and effective dose measured in mSV/MBq. Descriptive statistics on normal organ and tumour uptake reported in standardized uptake values (SUV). Tumour/blood, tumour/liver, tumour/kidney and tumour/lung ratios will be reported. primary outcome time frame Up to 12 months secondary outcome list secondary outcome secondary outcome measure Number of participants with 68Ga-HTK03149 related adverse events as assessed by abnormal vital sign measurement secondary outcome description Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at four time points. All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event. secondary outcome time frame Before injection, 1 hours post injection, 2 hours post injection and 2.5 hours post injection secondary outcome measure Number of participants with self-reported 68Ga-HTK03149 related adverse event secondary outcome description Patients will return to the department 18-72 hours after the 68Ga-HTK03149 PET/CT scan to see if they experienced any adverse events. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report. secondary outcome time frame 18-72 hours secondary outcome measure Perform a preliminary assessment of 68Ga-HTK03149 uptake in prostate cancer lesions secondary outcome description Determination of tumour uptake will be performed by contouring the tumours using a threshold to match the size of the lesion on CT imaging. The standardized uptake value (SUV) will be calculated and normalized for both body weight and lean body mass (SUVlean). The maximal, mean and peak (activity in the highest 1 cc voxel cluster) will be determined and recorded. The tumour/blood, tumour/liver and tumour/lung ratios will be reported for descriptive analysis. secondary outcome time frame Up to 12 months eligibility module eligibility criteria Inclusion Criteria: Participants with newly diagnosed or documented prostate cancers (PCa), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-DCFPyL or 68Ga-PSMA-11 PET). ECOG performance status of 2 or less. Exclusion Criteria: Medically unstable (eg. acute illness, unstable vital signs) Unable to lie supine for the duration of imaging Unable to provide written consent Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm) Patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes. Patients with baseline ALT or AST higher than 5× ULN or 250 U/L. Patients with elevated baseline levels of total bilirubin (higher than 1.2× ULN, or 1.3 mg/dL, (with exception of Gilbert's syndrome), with INR >1.2, or platelet count below the lower limit of normal (typically <150 000/μL. Patients with elevated alkaline phosphatase (ALP), equal to or higher than 2× ULN or 250 U/L, unless the ALP elevation is not from a hepatic origin. healthy volunteers No gender Male gender based Yes minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult contacts locations module location list location location facility BC Cancer location city Vancouver location state British Columbia location zip V5Z 4E6 location country Canada derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition mesh id D000009369 condition mesh term Neoplasms condition mesh id D000014565 condition mesh term Urogenital Neoplasms condition mesh id D000011469 condition mesh term Prostatic Diseases condition mesh id D000020969 condition mesh term Disease Attributes condition ancestor list condition ancestor condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostatic Neoplasms condition browse leaf relevance high condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf as found Urogenital Neoplasms condition browse leaf relevance high condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf as found Disease Attributes condition browse leaf relevance high condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf as found Prostatic Diseases condition browse leaf relevance high condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M20411 intervention browse leaf name Radiopharmaceuticals intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04831307
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full study rank 61242 study protocol section identification module n c t id NCT04839016 org study id info org study id SHR-1314-301 organization org full name Jiangsu HengRui Medicine Co., Ltd. org class INDUSTRY brief title Efficacy 、Safety and PK of SHR-1314 in Patients With Moderate-to-Severe Plaque Psoriasis official title A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 25, 2021 start date type Anticipated primary completion date struct primary completion date August 30, 2023 primary completion date type Anticipated completion date struct completion date August 30, 2023 completion date type Anticipated study first submit date April 8, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Jiangsu HengRui Medicine Co., Ltd. lead sponsor class INDUSTRY oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis conditions module condition list condition Moderate-to-Severe Plaque Psoriasis design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 660 enrollment type Anticipated arms interventions module arm group list arm group arm group label Treatment group A arm group type Experimental arm group intervention list arm group intervention name Drug: SHR-1314 arm group label Treatment group B arm group type Placebo Comparator arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name SHR-1314 intervention description SHR-1314 intervention arm group label list intervention arm group label Treatment group A intervention type Drug intervention name Placebo intervention description Placebo intervention arm group label list intervention arm group label Treatment group B outcomes module primary outcome list primary outcome primary outcome measure Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90) at Week 12 primary outcome time frame Week 12 primary outcome measure sPGA of 0 or 1 response at Week 12 primary outcome time frame Week 12 secondary outcome list secondary outcome secondary outcome measure Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12； secondary outcome time frame Week 12； secondary outcome measure Percentage of subjects who achieve at least 100% improvement in PASI score (PASI 100) at Week 12 secondary outcome time frame Week 12 secondary outcome measure sPGA of 0 response at Week 12 secondary outcome time frame Week 12 eligibility module eligibility criteria Inclusion Criteria: Men or women at least 18 years of age at time of screening. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization. Moderate to severe psoriasis as defined at Baseline/ randomization by: PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater. Subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy. Body Mass Index (BMI) is 18 kg/m2 or above at screening Exclusion Criteria: Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization. Drug-induced psoriasis. Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0). Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis. History of inflammatory bowel disease or have other ongoing active autoimmune diseases. At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. History of congestive heart failure (New York Heart Association [NYHA] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study. Active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization. History of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline (Posner K et al, 2011), The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide. All subjects will be tested for tuberculosis status using IGRA and X-ray test. Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies. Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Yang Shen central contact role Contact central contact phone 0518-82342973 central contact e mail Shenyang@hrglobe.cn central contact name Xiaolan Lu central contact role Contact central contact phone 0518-82342973 central contact e mail luxiaolan@hrglobe.cn derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011565 condition mesh term Psoriasis condition ancestor list condition ancestor condition ancestor id D000017444 condition ancestor term Skin Diseases, Papulosquamous condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M13574 condition browse leaf name Psoriasis condition browse leaf as found Psoriasis condition browse leaf relevance high condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M18865 condition browse leaf name Skin Diseases, Papulosquamous condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04839016
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full study rank 61896 study protocol section identification module n c t id NCT04830501 org study id info org study id TT00434CN01 organization org full name TransThera Sciences (Nanjing), Inc. org class INDUSTRY brief title Study of the of the Safety and Tolerability of TT-00434 in Patients With Advanced Solid Tumors official title A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profile, and Preliminary Efficacy of TT-00434 in Patients With Advanced Solid Tumors status module status verified date October 2021 overall status Recruiting expanded access info has expanded access No start date struct start date July 12, 2021 start date type Actual primary completion date struct primary completion date August 30, 2022 primary completion date type Anticipated completion date struct completion date December 30, 2022 completion date type Anticipated study first submit date March 28, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 25, 2021 last update post date struct last update post date October 26, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name TransThera Sciences (Nanjing), Inc. lead sponsor class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This is a phase I study of the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of TT-00434 in patients with advanced solid tumors. detailed description This is a phase I, First-in-Human (FIH), open-label, dose escalation clinical study in patients who have a histological or cytologically confirmed diagnosis of advanced or recurrent tumors that all standard treatments have been used or are not feasible. It aims to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for study, evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics and the preliminary anti-tumor activity of TT-00434, and explore the relationship between the anti-tumor activity of TT-00434 and the tumor FGFR alterations. conditions module condition list condition Advanced Solid Tumors design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Dose Escalation arm group type Experimental arm group description This study adopts an accelerated titration design (ATD) and utilizes an accelerated dose escalation phase in order to minimize suboptimal drug exposures, followed by a conventional 3+3 dose escalation phase to achieve MTD. arm group intervention list arm group intervention name Drug: TT-00434 intervention list intervention intervention type Drug intervention name TT-00434 intervention description Once daily [QD], 28 days/cycle. intervention arm group label list intervention arm group label Dose Escalation outcomes module primary outcome list primary outcome primary outcome measure Dose Limiting Toxicity (DLT) primary outcome description Safety and tolerability primary outcome time frame At the end of Cycle 1 (each cycle is 28 days) primary outcome measure Incidence of AEs primary outcome description Safety and tolerability primary outcome time frame up to 30 days from study discontinuation secondary outcome list secondary outcome secondary outcome measure Peak Plasma Concentration (Cmax) secondary outcome description PK evaluation secondary outcome time frame At the end of Cycle 1 (each cycle is 28 days) secondary outcome measure Area under the plasma concentration versus time curve (AUC) secondary outcome description PK evaluation secondary outcome time frame At the end of Cycle 1 (each cycle is 28 days) secondary outcome measure Time of first Occurance of Cmax（tmax) secondary outcome description PK evaluation secondary outcome time frame At the end of Cycle 1 (each cycle is 28 days) secondary outcome measure Serum phosphate levels secondary outcome description PD biomarker secondary outcome time frame up to 30 days from study discontinuation secondary outcome measure Objective response rate (ORR) secondary outcome description Assess anti-tumor activity secondary outcome time frame through study completion, an average of 1 year secondary outcome measure Disease control rate (DCR) secondary outcome description Assess anti-tumor activity secondary outcome time frame through study completion, an average of 1 year secondary outcome measure Progression Free Survival (PFS) secondary outcome description Assess anti-tumor activity secondary outcome time frame through study completion, an average of 1 year secondary outcome measure Overall Survival (OS) secondary outcome description Assess anti-tumor activity secondary outcome time frame through study completion, an average of 1 year eligibility module eligibility criteria Inclusion Criteria: Age ≥ 20 years. Patients must have a histological or cytologically confirmed diagnosis of advanced or recurrent malignant solid tumors. Patients have received all currently available standard treatments (unless the therapy is contraindicated, intolerable or unavailable due to any reasons). Patients must have measurable or evaluable disease (according to RECIST 1.1) Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 Must agree to take sufficient contraceptive methods to avoid pregnancy during the study and until at least 6 months after ceasing study treatment Patients must have fully understood and voluntarily signed informed consent form (ICF) for this study. Exclusion Criteria: Patients who received other investigational products or devices in other clinical trials within 4 weeks before the first dose. Patients who received anti-tumor therapy within 4 weeks, or within 5-half-lives (which is longer) before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can enrol), targeted therapy or immunotherapy. Patients who have previous toxicity of anti-tumor therapy that has not recovered to Grade 1. (except for ≤ Grade 2 alopecia, chemotherapy-induced peripheral neurotoxicity, and ototoxicity). Patients who have gastrointestinal disorders that will affect oral administration or the Investigator judges that the absorption of TT-00434 will be interfered. Patients underwent major surgery (except biopsy) within 4 weeks, or the surgical incision has not completely healed prior to the first dose. Patients who have active bacterial or fungal infections (CTCAE, Grade ≥ 2) that required systemic treatment within 2 weeks prior to the first dose. Patients who have active HBV infection (HBV DNA copies ≥ ULN) and/or HCV infection (HCV RNA copies ≥ ULN) Patients who test positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. Has received a live-virus vaccination within 30 days of planned first dose NOTE: Seasonal flu vaccines are permitted. Known or suspected drug hypersensitivity to any ingredients of TT-00434 tablets. Female patients in pregnancy or lactation. Male patients or female patients at reproductive ages who are unwilling to receive effective contraceptive measures. Patients who are judged by the Investigator to be unsuitable for this study. healthy volunteers No gender All minimum age 20 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jia Wang central contact role Contact central contact phone 8602558216298 central contact e mail wangjia@transtherabio.com overall official list overall official overall official name Huey En Tzeng overall official affiliation Taipei Medical University Hospital overall official role Principal Investigator overall official name Chia Jui Yen overall official affiliation National Cheng-Kung University Hospital overall official role Principal Investigator overall official name Ching Liang Ho overall official affiliation Tri-Service General Hospital overall official role Principal Investigator location list location location facility National Cheng Kung University Hospital location status Recruiting location city Tainan location country Taiwan location facility Taipei Medical University Hospital location status Recruiting location city Taipei location country Taiwan location facility Tri-Service General Hospital location status Recruiting location city Taipei location country Taiwan i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009369 condition mesh term Neoplasms
NCT04830501
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full study rank 61178 study protocol section identification module n c t id NCT04839848 org study id info org study id Bengan V organization org full name Karolinska Institutet org class OTHER brief title Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty official title Mesh and Fixation Combinations in the Lichtenstein Groin Hernioplasty: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study. status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 1, 2012 start date type Actual primary completion date struct primary completion date November 6, 2019 primary completion date type Actual completion date struct completion date November 6, 2020 completion date type Actual study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Bengt Novik responsible party investigator title MD, SSOD responsible party investigator affiliation Karolinska Institutet lead sponsor lead sponsor name Karolinska Institutet lead sponsor class OTHER collaborator list collaborator collaborator name Uppsala University collaborator class OTHER collaborator name Swedish Hernia Registry collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export Yes description module brief summary The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) after Lichtenstein repair of groin hernia, depending on mesh type and fixation suture material. For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR). detailed description This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in SHR, which covers > 95% of all groin hernia repairs in Sweden. The large database enables assessment of the relative risks for CPIP depending on in particular mesh and mesh fixation, adjusted for other plausible risk factors. Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. One year postop, each patient was sent a questionnaire focusing on present pain. conditions module condition list condition Hernia, Inguinal Hernia, Femoral Postoperative Pain Chronic Pain PROM Suture Related Complication keyword list keyword Swedish Hernia Registry Lichtenstein Surgical mesh Surgical sutures design module study type Observational patient registry Yes target duration 1 Year design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 81628 enrollment type Actual arms interventions module arm group list arm group arm group label Permanent suture arm group description Mesh fixation with permanent suture arm group intervention list arm group intervention name Device: Lichtenstein mesh repair arm group label Long-term absorbable arm group description Mesh fixation with long-term absorbable suture arm group intervention list arm group intervention name Device: Lichtenstein mesh repair arm group label Short-term absorbable arm group description Mesh fixation with short-term absorbable suture arm group intervention list arm group intervention name Device: Lichtenstein mesh repair arm group label Fibrin glue arm group description Biologic glue/sealant produced from human donor blood arm group intervention list arm group intervention name Device: Lichtenstein mesh repair arm group label Progrip arm group description Pre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic arm group intervention list arm group intervention name Device: Lichtenstein mesh repair intervention list intervention intervention type Device intervention name Lichtenstein mesh repair intervention description A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures intervention arm group label list intervention arm group label Fibrin glue Long-term absorbable Permanent suture Progrip Short-term absorbable outcomes module primary outcome list primary outcome primary outcome measure CPIP primary outcome description Chronic postoperative inguinal pain primary outcome time frame 1 year eligibility module eligibility criteria Inclusion Criteria: All Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until November 11, 2019. Exclusion Criteria: Laparoscopic repairs. Preperitoneal open repairs. Pure suture repairs Patients not having a 10-digit state-assigned Patient Identification Number. healthy volunteers No gender All minimum age 15 Years std age list std age Child Adult Older Adult study population An unselected, consecutive nationwide cohort during 7 years, with a 1-year follow-up sampling method Non-Probability Sample references module reference list reference reference p m i d 21242440 reference type background reference citation Novik B, Nordin P, Skullman S, Dalenbäck J, Enochsson L. More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs. Arch Surg. 2011 Jan;146(1):12-7. doi: 10.1001/archsurg.2010.302. reference p m i d 16424986 reference type background reference citation Novik B, Hagedorn S, Mörk UB, Dahlin K, Skullman S, Dalenbäck J. Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study with a 40-month prospective follow-up period. Surg Endosc. 2006 Mar;20(3):462-7. Epub 2006 Jan 19. Erratum in: Surg Endosc. 2022 May;36(5):3675. reference p m i d 18161900 reference type background reference citation Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014. reference p m i d 30478683 reference type background reference citation Olsson A, Sandblom G, Franneby U, Sonden A, Gunnarsson U, Dahlstrand U. The Short-Form Inguinal Pain Questionnaire (sf-IPQ): An Instrument for Rating Groin Pain After Inguinal Hernia Surgery in Daily Clinical Practice. World J Surg. 2019 Mar;43(3):806-811. doi: 10.1007/s00268-018-4863-8. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000059350 condition mesh term Chronic Pain condition mesh id D000010149 condition mesh term Pain, Postoperative condition mesh id D000006547 condition mesh term Hernia condition mesh id D000006552 condition mesh term Hernia, Inguinal condition mesh id D000006550 condition mesh term Hernia, Femoral condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition ancestor id D000046449 condition ancestor term Hernia, Abdominal condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Postoperative Pain condition browse leaf relevance high condition browse leaf id M8777 condition browse leaf name Hernia condition browse leaf as found Hernia condition browse leaf relevance high condition browse leaf id M28595 condition browse leaf name Chronic Pain condition browse leaf as found Chronic Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M8782 condition browse leaf name Hernia, Inguinal condition browse leaf as found Hernia, Inguinal condition browse leaf relevance high condition browse leaf id M8780 condition browse leaf name Hernia, Femoral condition browse leaf as found Hernia, Femoral condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse leaf id M24828 condition browse leaf name Hernia, Abdominal condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M17443 intervention browse leaf name Fibrin Tissue Adhesive intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Coag intervention browse branch name Coagulants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04839848
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full study rank 61770 study protocol section identification module n c t id NCT04832152 org study id info org study id 412579-19406 organization org full name Thomas Jefferson University org class OTHER brief title Telehealth Intervention for Autism Spectrum Disorder official title Testing the Feasibility of a Teletherapy Plus Parent Coaching Intervention for Children With Autism status module status verified date April 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date June 15, 2022 start date type Anticipated primary completion date struct primary completion date September 30, 2022 primary completion date type Anticipated completion date struct completion date October 14, 2022 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 15, 2022 last update post date struct last update post date April 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Thomas Jefferson University lead sponsor class OTHER collaborator list collaborator collaborator name Montefiore Medical Center collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children. Most children with ASD experience challenges participating in daily activities (e.g.: eating, sleeping, bathing, grooming, playing, etc.) and receive occupational therapy intervention to address these. The COVID-19 pandemic has restricted in-person therapy for many of these children and there is an urgent need for evidence-based, validated telehealth intervention. This project will adapt an evidence-based occupational therapy intervention, termed OT4ASD to a telehealth delivery model. The aims of the project are to: 1) adapt the existing intervention protocol to a telehealth delivery model, 2) train therapists and evaluate the therapist's ability to conduct OT4ASD, 3) determine if OT4ASD delivered via the telehealth is acceptable and feasible to parents and interventionists; and 4) whether children improve in the daily living skills. OT4ASD follows a systematic protocol and uses active, individually-tailored sensory motor activities that are specifically designed to address the child's needs. The investigators believe this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the daily life activity and participation levels. detailed description Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children1. As a lifelong condition, individuals with ASD experience a range of intellectual, behavioral, sensory, motor, and functional challenges that impact successful participation in daily life activities and tasks. As a result, occupational therapy (OT) intervention is a frequently requested and utilized service in ASD, and clinically validated OT approaches are needed. In a series of studies funded by the NIH and autism foundations, our team manualized and studied an OT intervention that targets the sensory and motor factors impacting participation in daily life activities and tasks and showed significant improvements in those that received the intervention in comparison to controls 2-4. In this project, the investigators plan to adapt our existing protocol to a telehealth model of service delivery, and evaluate its feasibility and preliminary effectiveness. The COVID-19 global pandemic created a call to action for healthcare providers to design unique and innovative methods for therapeutic service delivery. This shift creates an urgent need for remote solutions so that therapeutic services can be delivered in safely and effectively. Since the onset of the COVID-19 pandemic, families have reported regression in adaptive functioning in addition to a negative impact on social skills and increased anxiety, and an impact to daily routines of children with ASD5. In a recent survey of families with children with ASD, 95% of the parents reported that disruptions in services/therapies negatively impacted their child's behaviors and only 35% of families were receiving telehealth services/therapies6. To address these increased needs for children with ASD and to meet the need of manualized telehealth intervention, the investigators propose to adapt the existing intervention to a telehealth delivery model. This intervention, termed occupational therapy for children with Autism Spectrum Disorder (OT4ASD) targets the sensory motor factors that impact behavior and participation in life activities and tasks. This project is significant in that it will address the need for evidence-based OT services for children with ASD using an innovative telehealth model. Given that many children with ASD require treatment for the sensory and motor symptoms that impact their optimal participation in a range of daily life activities and tasks, and that the current COVID 19 pandemic has compromised access to this therapy, this project is urgently needed. Innovation: Telehealth offers an emerging and innovative approach for OT intervention. Research shows that children with ASD require intensive intervention to assure best outcomes and telehealth offers an innovative solution for providing therapy during a pandemic. To the investigator's knowledge, this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the activity and participation levels of the ICF framework. Importantly, the investigators will adapt an evidence-based, manualized intervention with solid data on outcomes to a telehealth model. The protocol will operationalize the data-driven decision making (DDDM) approach into an on-line format. DDDM is innovative in that it explicitly guides the therapist to contextualize intervention within the child and family's real life participation challenges and use data from assessment to individualize the intervention. DDDM measures outcomes at the proximal (sensory and motor factors) and distal (functional/participation-based goals) levels facilitating an intervention that is context-specific and participation-oriented. Methods: The project will first adapt the existing protocol into a telehealth delivery model using a formative approach that includes a modified Delphi process to obtain input and consensus from experts in telehealth and autism interventions and key stakeholders (parents and clinical interventionists). Next, the investigators will conduct a feasibility trial to assess the acceptability, satisfaction and implementation fidelity as well as gather data on clinically meaningful outcomes. Outcomes will be measured at the proximal and distal levels using validated outcome measures to assure information gained is relevant and scientifically rigorous. Data from the feasibility trial will be used to support an R01 application to conduct a randomized trial of OT4ASD. To implement the project, the investigators utilize a highly skilled team of clinicians and scientists with experience in conducting randomized trials in autism who will work collaboratively to translate knowledge gained into useful information that will impact the lives of families and children with ASD. Our approach is consistent with contemporary models of evidence-based practice and rehabilitation science promoting promote high integrity, evidence-based information from research that targets relevant and meaningful areas for each child and family. The timeline is ambitious and the investigators feel well-equipped to meet it given past experiences and expertise. In summary, this project addresses an urgent need to provide rehabilitation services to children with ASD using remote technology. It will operationalize best practices in telehealth to adapt an existing evidence-based OT intervention and utilize a skilled and experienced team of investigators. As such, this project is consistent with the AACPDM mission to promote excellence in research and services for persons with childhood-onset disabilities. conditions module condition list condition Autism Spectrum Disorder design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description The purpose of this project is to adapt an existing, evidence-based occupational therapy intervention for children with ASD to a telehealth delivery model. The main objectives of the project are to 1) adapt the manual so that it operationalizes best-practices of occupational therapy telehealth50,51, 2) test its feasibility, and 3) evaluate preliminary outcomes. Design: In the formative research aspect of this project will use survey methodology and a modified Delphi process to adapt our current intervention to a telehealth delivery model (Aim 1). In Aim 2 we will conduct a feasibility trial (Figure 2) to assess therapists' fidelity, participant recruitment and retention, acceptability of the protocol by parents and therapists, and clinically meaningful differences. design primary purpose Other design masking info design masking None (Open Label) design masking description none. This is a feasiblity trial enrollment info enrollment count 10 enrollment type Anticipated arms interventions module arm group list arm group arm group label Feasibility trial group arm group type Other arm group description One group (arm) trial where all will receive treatment. arm group intervention list arm group intervention name Other: OT4ASD intervention list intervention intervention type Other intervention name OT4ASD intervention description Occupational therapy will focus on education and coaching of families/caregivers of children with autism spectrum disorder to help them adapt their daily routines to address their child's sensory needs. intervention arm group label list intervention arm group label Feasibility trial group outcomes module primary outcome list primary outcome primary outcome measure Daily Living Skills Change Score - Pediatric Evaluation of Disabilities Inventory primary outcome description Change in daily living skills (on a scale of 0 to 25) measured with the Pediatric Evaluation of Disabilities Inventory. Change score range 0-25; higher score means better outcome. primary outcome time frame up to 14 weeks primary outcome measure Pervasive Developmental Disorders Behavioral Inventory T Score Autism Behaviors primary outcome description Change is autism behaviors and sensory approach behaviors. Raw scores are converted to T Score. Minimum = 10 Maximum = 80 primary outcome time frame up to 14 weeks secondary outcome list secondary outcome secondary outcome measure Goal Attainment Scale T Score secondary outcome description Rating of individual goals. Rating Scale -2 to +2 is converted to T-Score; higher score means better outcome. secondary outcome time frame up to 14 weeks secondary outcome measure Sensory Processing Measure secondary outcome description Change in sensory hypo or hyper reactivity. T scores range from 40 to 80; Lower score means better outcome. secondary outcome time frame up to 14 weeks eligibility module eligibility criteria Inclusion Criteria: Diagnosis of Autism Spectrum Disorder Between the ages of 4 years 0 months and 12 years 0 months Evidence of sensory symptoms based on the Sensory Processing Measure Family is willing to participate Physically able to participate in active, sensorimotor activities Exclusion Criteria: Primary (visual or auditory) uncorrected sensory deficits Do not meet age or diagnostic criteria healthy volunteers Accepts Healthy Volunteers gender All minimum age 4 Years maximum age 12 Years std age list std age Child contacts locations module central contact list central contact central contact name Roseann C Schaaf, PhD central contact role Contact central contact phone 6102912179 central contact e mail roseann.schaaf@jefferson.edu central contact name Rachel L Dumont, M.S. central contact role Contact central contact phone 6107641035 central contact e mail rachel.dumont@jefferson.edu i p d sharing statement module i p d sharing Yes i p d sharing description Publication in high impact autism journal, and presentation at international autism research meetings. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) i p d sharing time frame Data will be available following completion of the study and publication of findings. i p d sharing access criteria Upon written request (reviewed by principal investigator) information will be shared. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001321 condition mesh term Autistic Disorder condition mesh id D000067877 condition mesh term Autism Spectrum Disorder condition ancestor list condition ancestor condition ancestor id D000002659 condition ancestor term Child Development Disorders, Pervasive condition ancestor id D000065886 condition ancestor term Neurodevelopmental Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M3775 condition browse leaf name Autistic Disorder condition browse leaf as found Autism condition browse leaf relevance high condition browse leaf id M206 condition browse leaf name Autism Spectrum Disorder condition browse leaf as found Autism Spectrum Disorder condition browse leaf relevance high condition browse leaf id M5055 condition browse leaf name Child Development Disorders, Pervasive condition browse leaf relevance low condition browse leaf id M5054 condition browse leaf name Developmental Disabilities condition browse leaf relevance low condition browse leaf id M29797 condition browse leaf name Neurodevelopmental Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04832152
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full study rank 61756 study protocol section identification module n c t id NCT04832334 org study id info org study id Medipol Hospital 21 organization org full name Medipol University org class OTHER brief title Investigation Of The Relationship Between Imagery Ability, Balance And Functionality After Stroke official title Is There a Relationship Between Imagination Ability, Balance and Functionality After Stroke? status module status verified date November 2021 overall status Completed expanded access info has expanded access No start date struct start date March 20, 2021 start date type Actual primary completion date struct primary completion date September 20, 2021 primary completion date type Actual completion date struct completion date September 20, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 27, 2021 last update post date struct last update post date December 10, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name İkbal Tunç responsible party investigator title Physiotherapist responsible party investigator affiliation Medipol University lead sponsor lead sponsor name Medipol University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary It was aimed to determine the relationship between post-stroke imagination ability, balance, and functionality, and to compare the motor imagery skills of those who had stroke with compatible healthy individuals. detailed description İn the study, 20 individuals with hemiplegic or chronic hemiparesis who agreed to participate by signing the voluntary consent form, who meet the inclusion criteria, and 20 healthy individuals who are similar in terms of age, gender and education level will be included. The individuals included in the study will be divided into two groups: Group 1: Stroke Patients Group 2: Control Group conditions module condition list condition Stroke Motor İmagery Ability Mental Chronometry Balance Functionality keyword list keyword stroke motor imagery mental chronometry balance functionality design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 40 enrollment type Actual arms interventions module arm group list arm group arm group label Stroke Participants arm group description Stroke patients with hemiplegia or chronic hemiparesis arm group intervention list arm group intervention name Other: Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test. Other: Berg Balance Scale, Functional Reach Test Other: Timed Up and Go Test, Functional Independence Scale arm group label Healthy Participants arm group description The healthy control group was matched with stroke participants in terms of age, gender, dominant side and education level. arm group intervention list arm group intervention name Other: Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test. Other: Berg Balance Scale, Functional Reach Test Other: Timed Up and Go Test, Functional Independence Scale intervention list intervention intervention type Other intervention name Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test. intervention description Imagery ability was determined. intervention arm group label list intervention arm group label Healthy Participants Stroke Participants intervention type Other intervention name Berg Balance Scale, Functional Reach Test intervention description Balance level was determined. intervention arm group label list intervention arm group label Healthy Participants Stroke Participants intervention type Other intervention name Timed Up and Go Test, Functional Independence Scale intervention description Functionality was evaluated. intervention arm group label list intervention arm group label Healthy Participants Stroke Participants outcomes module primary outcome list primary outcome primary outcome measure Fugl - Meyer Motor Recovery Assessment Form primary outcome description It will only be evaluated in the stroke group. It is a scale that evaluates sensorimotor recovery after stroke. Each parameter was scored as 0 points: unsuccessful, 1 point: partially successful, 2 points: completely successful performance on the scale, which includes 50 items specific to stroke and based on performance. The maximum score that can be taken for the upper extremity in the scale where voluntary movement, reflex activity, grip, coordination and speed are evaluated is 66 and 34 for the lower extremity. primary outcome time frame Day 0 primary outcome measure Mini-Mental State Test primary outcome description It was used to determine the cognitive state. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points. The ideal threshold value of the Mini-Mental State Test was found to be 24. primary outcome time frame Day 0 primary outcome measure Clock Drawing Test primary outcome description It will be used to assess the phenomenon of neglect of the stroke individual. The individual is asked to draw a clock circle and insert the numbers of the clock into it. After finishing the numbers, the hands of the clock are placed to show 11 to 10 past. primary outcome time frame Day 0 primary outcome measure Digit Span Test primary outcome description This test to evaluate the ability to sustain attention is a subtest of the Wechsler Adult Intelligence Scale--Revised battery. The test consists of two parts as forward and reverse range. In both parts, random numbers are read to the person at one second intervals, the numbers increase with each attempt and the person is asked to repeat in the same way. In both episodes, the number of digits of the previous sequence in which the person failed twice in a row constitutes the range. The maximum score that can be obtained for each section is 7, and a total of 14 points for the whole test. primary outcome time frame Day 0 primary outcome measure Kinesthetic and Visual Imaging Questionnaire primary outcome description The Kinesthetic and Visual Imaging Questionnaire has been developed to evaluate the imagination ability in individuals with physical disabilities. The purpose of the questionnaire is to determine to what extent individuals visualize and feel the movements they imagine. primary outcome time frame Day 0 primary outcome measure Box and Block Test primary outcome description It is a highly sensitive test for changes in upper extremity functional performance. However, this study will be used for evaluating mental chronometry ability rather than functional performance. primary outcome time frame Day 0 primary outcome measure Functional Independence Scale primary outcome description It is a scale used to evaluate the motor and cognitive competence of patients in daily life activities. Scale; It consists of 18 items that evaluate six functions: self-care, sphincter control, transfer, displacement, communication, and social perception. Each item is scored between 1 (activity fully dependent) and 7 (activity fully independent) in proportion to the amount of assistance received. A minimum of 18 and a maximum of 126 points can be obtained. A low score means that the level of addiction has increased. primary outcome time frame Day 0 primary outcome measure Berg Balance Scale primary outcome description It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully. The total score of the test is between 0-56.0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation. primary outcome time frame Day 0 primary outcome measure Time Up and Go Test primary outcome description The test measures the speed during many functional maneuvers such as standing up, walking, turning, and sitting. In the test, the person is asked to stand up from the chair, walk 3 meters (10 feet) at a safe and normal pace, turn, walk back and sit on the chair, and the time is recorded in seconds. A short performance period indicates a good balance performance. primary outcome time frame Day 0 primary outcome measure Functional Reach Test primary outcome description Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1). The placement of the end of the third metacarpal along the yardstick will recorded. Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded. No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated. primary outcome time frame Day 0 primary outcome measure Hand Lateralization Test primary outcome description It requires participants to question the laterality of the hand images presented and is commonly used to measure motor imagination ability in humans. It is used to evaluate implicit motor imagination ability. It is also a test that evaluates mental rotation, another dimension of imagination. primary outcome time frame Day 0 eligibility module eligibility criteria Inclusion Criteria: Post-stroke hemiplegia or chronic hemiparesis Not having any neurological disorder other than stroke Not having vision problems that will affect the materials to be used during the treatment. To be able to communicate enough to understand the orders given Standardized Mini Mental Test (SMMT) score of 24 and above Not having seen a visualization application before Inclusion Criteria for Healthy Participants: Being between the ages of 40-80 To be similar in terms of age, gender, education level of individuals with stroke Exclusion Criteria: Having an advanced degree of aphasia Unilateral neglect Standardized Mini Mental Test (SMMT) score below 24 points Multiple stroke history Having pain and limitation of joint motion that will interfere with functional activity Walking restriction Serious communication or understanding problems Presence of serious cardiovascular, respiratory, metabolic or orthopedic problems Presence of a secondary neurological disease healthy volunteers Accepts Healthy Volunteers gender All minimum age 40 Years maximum age 80 Years std age list std age Adult Older Adult study population In this study, we will enroll patients based on the statistics of the articles titled "Motor imagery in stroke patients or plegic patients with spinal cord or peripheral diseases" and "Effects of a single mental chronometry training session in subacute stroke patients - a randomized controlled trial". We calculated the power analysis from this article. According to this calculated; α=0.05, 1-β=0.90, effect size=0.96. Stroke patients treated at Istanbul Medipol University Pendik Hospital Physical Medicine and Rehabilitation Clinic Neurology Rehabilitation Unit and healthy individuals matching them will be included. sampling method Probability Sample contacts locations module overall official list overall official overall official name Fatma Mutluay, Professor overall official affiliation İstanbul Medipol University overall official role Study Director location list location location facility Istanbul Medipol University location city Istanbul location state Beykoz location country Turkey references module reference list reference reference p m i d 23129815 reference type background reference citation Cho HY, Kim JS, Lee GC. Effects of motor imagery training on balance and gait abilities in post-stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Aug;27(8):675-80. doi: 10.1177/0269215512464702. Epub 2012 Nov 5. reference p m i d 27294678 reference type background reference citation Amesz S, Tessari A, Ottoboni G, Marsden J. An observational study of implicit motor imagery using laterality recognition of the hand after stroke. Brain Inj. 2016;30(8):999-1004. doi: 10.3109/02699052.2016.1147600. Epub 2016 Jun 13. reference p m i d 22247502 reference type background reference citation Liepert J, Greiner J, Nedelko V, Dettmers C. Reduced upper limb sensation impairs mental chronometry for motor imagery after stroke: clinical and electrophysiological findings. Neurorehabil Neural Repair. 2012 Jun;26(5):470-8. doi: 10.1177/1545968311425924. Epub 2012 Jan 13. reference p m i d 30911582 reference type background reference citation Morioka S, Osumi M, Nishi Y, Ishigaki T, Ishibashi R, Sakauchi T, Takamura Y, Nobusako S. Motor-imagery ability and function of hemiplegic upper limb in stroke patients. Ann Clin Transl Neurol. 2019 Feb 17;6(3):596-604. doi: 10.1002/acn3.739. eCollection 2019 Mar. reference p m i d 16741183 reference type background reference citation Sharma N, Pomeroy VM, Baron JC. Motor imagery: a backdoor to the motor system after stroke? Stroke. 2006 Jul;37(7):1941-52. doi: 10.1161/01.STR.0000226902.43357.fc. Epub 2006 Jun 1. i p d sharing statement module i p d sharing No i p d sharing description We will not plan to share individual participant data. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000020521 condition mesh term Stroke condition ancestor list condition ancestor condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf as found Stroke condition browse leaf relevance high condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04832334
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full study rank 61413 study protocol section identification module n c t id NCT04836793 org study id info org study id 2021-A00166-35 organization org full name Centre Hospitalier Universitaire de Besancon org class OTHER brief title COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2 official title Study of Humoral and Cellular Immune Responses Following SARS-CoV-2 Vaccination to Predict Immune Responses in Cancer Patients acronym CACOV-VAC status module status verified date June 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date March 25, 2022 primary completion date type Anticipated completion date struct completion date March 25, 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 4, 2021 last update post date struct last update post date June 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Centre Hospitalier Universitaire de Besancon lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary T-cell adaptive immunity is known to be required to sustain a long term immunoglobulin production and a long term memory against several infections. Previous results suggest a lack in the generation of T-cell responses against CoV-N, M and S proteins among cancer patients exposed to SARS-CoV-2 virus highlighting that cancer patients failed to mount a protective T-cell immunity. Given this context, our hypothesis is that COVID-19 vaccine candidates are not immunogenic in some cancer patients. Thus, the monitoring of CD4 and CD8 T-cell responses before and after vaccination might provide information related to the correlation between induction of CD4 T-cells (including helper follicular T-cells) by the vaccine and long-term IgG production (serological index). Additionally, the failure of COVID-19 vaccines in some patients should be monitor carefully in order to provide specific recommendations to avoid COVID-19 infections. The main objective is to assess humoral immune responses following COVID-19 vaccination in a population of cancer patients. conditions module condition list condition Cancer Elderly Healthy Aging keyword list keyword vaccination T cell SARS-COV-2 COVID-19 cancer design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples Without DNA bio spec description PBMC PLASMA enrollment info enrollment count 300 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients with cancer arm group description Patients with active treatment in adjuvant/induction setting, Patients with active treatment in metastatic/relapse setting, Patients without active treatment (last treatment above 6 months). arm group intervention list arm group intervention name Other: Additional biological samples arm group label Patients without cancer but aged above 70 years arm group intervention list arm group intervention name Other: Additional biological samples arm group label Healthy person arm group intervention list arm group intervention name Other: Additional biological samples intervention list intervention intervention type Other intervention name Additional biological samples intervention description Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected intervention arm group label list intervention arm group label Healthy person Patients with cancer Patients without cancer but aged above 70 years outcomes module primary outcome list primary outcome primary outcome measure Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses primary outcome time frame 2 years secondary outcome list secondary outcome secondary outcome measure Rate of virus-specific IgG at 6 months following COVID-19 vaccination measured in plasma to assess humoral immune responses. secondary outcome time frame 2 years secondary outcome measure Frequency of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination secondary outcome time frame 2 years secondary outcome measure Magnitude of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination secondary outcome time frame 2 years eligibility module eligibility criteria *Inclusion Criteria: Male or female patients Age ≥ 18 years Not having developed a symptomatic form of COVID-19 within the last 3 months before inclusion Eligible to the vaccination against SARS-CoV-2 Affiliation to French social security or receiving such a regime, Signed informed consent Ability to comply with the study protocol, in the Investigator's judgment Cancer patients Patients under active anticancer treatment: in adjuvant or neoadjuvant setting or in first line of treatment in metastatic setting. Except for prostate cancer (until metastatic castration-resistant prostate cancer); and breast cancer hormonal receptor positive/HER2 negative (until apparition of hormonal resistance). Patients in follow-up (active treatment < 3 months). Elderly: Age ≥ 70 years old Healthy person: Age ≥ 18 years old and < 70 years old *Exclusion Criteria: Patient under guardianship, guardianship or under the protection of justice Receipt of a live, attenuated vaccine within 4 weeks prior to the initiation of treatment or anticipation that such a live, attenuated vaccine will be required during the study. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients vaccinated against COVID-19 sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name marie kroemer, PharmD, PhD central contact role Contact central contact phone 03 81 66 83 02 central contact e mail mkroemer@chu-besancon.fr central contact name laura mansi, MD, PhD central contact role Contact central contact e mail lmansi@chu-besancon.fr location list location location facility Marie KROEMER location status Recruiting location city Besançon location zip 25000 location country France location contact list location contact location contact name Marie KROEMER location contact role Contact location contact e mail mkroemer@chu-besancon.fr location contact name Laura Mansi, MD PhD location contact role Principal Investigator references module reference list reference reference p m i d 33318627 reference type background reference citation Gomez-Cadena A, Spehner L, Kroemer M, Khelil MB, Bouiller K, Verdeil G, Trabanelli S, Borg C, Loyon R, Jandus C. Severe COVID-19 patients exhibit an ILC2 NKG2D(+) population in their impaired ILC compartment. Cell Mol Immunol. 2021 Feb;18(2):484-486. doi: 10.1038/s41423-020-00596-2. Epub 2020 Dec 14. reference p m i d 32853599 reference type result reference citation Kroemer M, Spehner L, Vettoretti L, Bouard A, Eberst G, Pili Floury S, Capellier G, Lepiller Q, Orillard E, Mansi L, Clairet AL, Westeel V, Limat S, Dubois M, Malinowski L, Bohard L, Borg C, Chirouze C, Bouiller K. COVID-19 patients display distinct SARS-CoV-2 specific T-cell responses according to disease severity. J Infect. 2021 Feb;82(2):282-327. doi: 10.1016/j.jinf.2020.08.036. Epub 2020 Aug 25. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04836793
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full study rank 61327 study protocol section identification module n c t id NCT04837911 org study id info org study id CHRU de Nancy organization org full name Central Hospital, Nancy, France org class OTHER brief title Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study official title Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study acronym SPIROMUCO status module status verified date March 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Anticipated primary completion date struct primary completion date September 30, 2021 primary completion date type Anticipated completion date struct completion date April 1, 2022 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Central Hospital, Nancy, France lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Respiratory diseases (asthma, cystic fibrosis, COPD…) need for the diagnosis and the follow-up the use of pulmonary function tests. These technics which are used since the nineteenth century and their discovery by Hutchinson, are now currently performed in pediatrics hospitals but they require trained personnel. Spirometry can be a difficult technic, especially for children. The accuracy and repeatability depend on many factors: equipment, patient effort, supervision and encouragement of a technician. A longitudinal follow up of measures can be good especially in pediatric populations, where children have generally more difficulties recognising their symptoms. Cystic fibrosis is a severe genetic chronic disease, that affects 1/4500 birth in France. It's a multi system disease that affects the respiratory system, with a decline in lung function over the time and consecutive to pulmonary exacerbations, the digestive system (malabsorption of fat and vitamins) and the endocrine system (diabetes). Pulmonary function is an important clinical indicator of the health of individuals with cystic fibrosis. Close monitoring of patient health with daily recording of physical measurements and symptoms didn't have a negative impact, home spirometry function test could help detect earlier a decline of the lung function and pulmonary exacerbations. Frequent exacerbations are associated with morbidity, mortality, accelerated decline in lung function and a decreased quality of life. They are also a major driver of health costs.Their early detection is a goal. Children with cystic fibrosis have more difficulties recognizing symptoms of exacerbations. Few studies in pediatric showed a good observance in realizing home spirometry, especially in young patients and those living far from the hospital and with a good satisfaction. Daily monitoring of lung function is probably too tedious for children who already have lots of medication. Medical adhesion of adolescent's patients is often suboptimal, compared with younger patients. But it's during this period that the decline of the respiratory function is the most important, with its principal cause: pulmonary exacerbations. Frequent home pulmonary function test is possible and can improve medication adherence without adding too much time, but there was no change in the decline of the FEV1 and the number of pulmonary exacerbations. The association of home monitoring of lung function and a symptom questionary (cough, sputum and dyspnea) can predict exacerbation with a good specificity and sensibility. The Mir Spirobank Smart is a bluetooth connected device, permitting patients to realize spirometry at home with a smartphone. The accuracy of the Spirobank Smart compared with a spirometry in a hospital showed a good correlation (asthma and COPD population), if it's used by trained personnel. The aim of this study is to determine the feasibility of a home respiratory monitoring in a pediatric cohort of patients with cystic fibrosis and the satisfaction of the kids, the parents and the team of the CRCM. conditions module condition list condition Cystic Fibrosis in Children design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description The spirometers have been purchased with charitable donations, that's why we have 35 of them. design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 35 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients using the Spirobank Smart arm group type Other arm group description Use of a portable spirometry arm group intervention list arm group intervention name Device: Spirobank Smart intervention list intervention intervention type Device intervention name Spirobank Smart intervention description Patients using the Spirobank Smart intervention arm group label list intervention arm group label Patients using the Spirobank Smart outcomes module primary outcome list primary outcome primary outcome measure The observance of the realization of a follow up of pulmonary function in a cohort of cystic fibrosis's pediatric patients primary outcome description Observance = the percentage (%) of measures realised during the 3 months, (number of measures done/ number of measures expected to be done according to the protocol) primary outcome time frame 3 months secondary outcome list secondary outcome secondary outcome measure The workload of managing the alerts secondary outcome description The number of alerts received by each doctor and the number and therapeutic's changes following these alerts secondary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria: Patients with a cystic fibrosis diagnosis confirmed by a sweat chloride measurement ≥ 60 mmol/L Age between 10 and 20 years at enrolment Able to perform spirometry Having a smartphone Written consent adapted to the age Affiliated with a social insurance Exclusion Criteria: Antibiotic therapy for a pulmonary exacerbation in the 2 weeks before enrollment Lung transplantation (past or future) Colonization with Bulkholderia cepacia in the last 2 years Absence of contentment Inability to access technology required to transmit home spirometry data Inability to speak and read French well enough to understand the use of the home spirometry and to complete the questionaries healthy volunteers No gender All minimum age 10 Years maximum age 20 Years std age list std age Child Adult contacts locations module central contact list central contact central contact name Aurélie Mrs TATOPOULOS, Doctor central contact role Contact central contact phone 033383154556 central contact e mail au.tatopoulos@chru-nancy.fr overall official list overall official overall official name Aurélie Mrs TATOPOULOS, Doctor overall official affiliation CHRU Nancy, France overall official role Principal Investigator references module reference list reference reference p m i d 32592537 reference type background reference citation Kruizinga MD, Essers E, Stuurman FE, Zhuparris A, van Eik N, Janssens HM, Groothuis I, Sprij AJ, Nuijsink M, Cohen AF, Driessen GJA. Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis. Pediatr Pulmonol. 2020 Sep;55(9):2463-2470. doi: 10.1002/ppul.24932. Epub 2020 Jul 8. reference p m i d 28229102 reference type background reference citation Shakkottai A, Nasr SZ. The Use of Home Spirometry in Pediatric Cystic Fibrosis Patients: Results of a Feasibility Study. Glob Pediatr Health. 2017 Feb 2;4:2333794X17690315. doi: 10.1177/2333794X17690315. eCollection 2017. reference p m i d 1579374 reference type background reference citation Finkelstein SM, Wielinski CL, Kujawa SJ, Loewenson R, Warwick WJ. The impact of home monitoring and daily diary recording on patient status in cystic fibrosis. Pediatr Pulmonol. 1992 Jan;12(1):3-10. reference p m i d 20565480 reference type background reference citation Sarfaraz S, Sund Z, Jarad N. Real-time, once-daily monitoring of symptoms and FEV in cystic fibrosis patients--a feasibility study using a novel device. Clin Respir J. 2010 Apr;4(2):74-82. doi: 10.1111/j.1752-699X.2009.00147.x. reference p m i d 29457700 reference type background reference citation Shakkottai A, Kaciroti N, Kasmikha L, Nasr SZ. Impact of home spirometry on medication adherence among adolescents with cystic fibrosis. Pediatr Pulmonol. 2018 Apr;53(4):431-436. doi: 10.1002/ppul.23950. Epub 2018 Feb 19. reference p m i d 28955051 reference type background reference citation van Horck M, Winkens B, Wesseling G, van Vliet D, van de Kant K, Vaassen S, de Winter-de Groot K, de Vreede I, Jöbsis Q, Dompeling E. Early detection of pulmonary exacerbations in children with Cystic Fibrosis by electronic home monitoring of symptoms and lung function. Sci Rep. 2017 Sep 27;7(1):12350. doi: 10.1038/s41598-017-10945-3. Erratum in: Sci Rep. 2018 Dec 13;8(1):17946. reference p m i d 22269344 reference type background reference citation Degryse J, Buffels J, Van Dijck Y, Decramer M, Nemery B. Accuracy of office spirometry performed by trained primary-care physicians using the MIR Spirobank hand-held spirometer. Respiration. 2012;83(6):543-52. doi: 10.1159/000334907. Epub 2012 Jan 21. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003550 condition mesh term Cystic Fibrosis condition mesh id D000005355 condition mesh term Fibrosis condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010182 condition ancestor term Pancreatic Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition ancestor id D000007232 condition ancestor term Infant, Newborn, Diseases condition browse leaf list condition browse leaf condition browse leaf id M5907 condition browse leaf name Cystic Fibrosis condition browse leaf as found Cystic Fibrosis condition browse leaf relevance high condition browse leaf id M7637 condition browse leaf name Fibrosis condition browse leaf as found Fibrosis condition browse leaf relevance high condition browse leaf id M12254 condition browse leaf name Pancreatic Diseases condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id M9428 condition browse leaf name Infant, Newborn, Diseases condition browse leaf relevance low condition browse leaf id T1710 condition browse leaf name Cystic Fibrosis condition browse leaf as found Cystic Fibrosis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04837911
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full study rank 61695 study protocol section identification module n c t id NCT04833127 org study id info org study id 7682 organization org full name New York State Psychiatric Institute org class OTHER brief title A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women official title Developing a Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women acronym Masibambane status module status verified date June 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 30, 2021 start date type Actual primary completion date struct primary completion date June 24, 2022 primary completion date type Actual completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date March 21, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 28, 2022 last update post date struct last update post date July 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Susie Hoffman responsible party investigator title Associate Professor of Clinical Epidemiology (in Psychiatry) responsible party investigator affiliation New York State Psychiatric Institute lead sponsor lead sponsor name New York State Psychiatric Institute lead sponsor class OTHER collaborator list collaborator collaborator name Medical Research Council, South Africa collaborator class OTHER collaborator name Brown University collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This is a phase 1 pilot study to assess feasibility and acceptability and potential for impact of a gender-enhanced virtual group workshop focused on oral Pre-Exposure Prophylaxis (PrEP) as an HIV prevention method for young South African women. It was developed in collaboration with South African adolescent girls and young women (AGYW) aged 18-25. The investigators will compare AGYW (N=100) assigned to the virtual group-based (GE) workshop to those assigned to an Individually Accessed (IA) condition in which women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. Investigators also are evaluating the acceptability and feasibility of peer-driven recruitment (PDR). AGYW assigned to either intervention condition will be invited to become Peer Health Advocates (PHAs), who are incentivized to talk to social network members and refer up to three to the intervention type the PHA attended. The aim is to assess if PDR is self-sustaining and is effective at reaching women who might not be reached in clinics. detailed description South African adolescent girls and young women (AGYW) remain at extraordinarily high risk of HIV infection. Oral pre-exposure prophylaxis (PrEP) has the potential to alter the epidemic in this vulnerable population, given that it is has been shown that if it is adhered to, oral PrEP can protect women from HIV infection. Yet, a critical question is whether AGYW will adopt and adhere to oral PrEP. The investigators propose that two innovations can reach young, at-risk AGYW, inform them about PrEP and motivate them to use it: (1) introducing PrEP through a gender lens in a group workshop; and (2) peer-driven recruitment-recruiting women to attend the workshop by those who have already attended it. To inform intervention development, the investigators conducted six focus groups with at-risk AGYW (aged 18-25), 8 qualitative interviews with focus group participants, and 20 qualitative interviews with men (10 HIV-positive, 10 HIV-negative or of unknown status) partnered with women in this age range that explored knowledge of, beliefs about, motivators for, and concerns about using PrEP in the context of gendered relationship dynamics and PrEP-related stigma. Guided by gender theory and the Information Motivation Behavior (IMB) model, and in collaboration with a Working Group of AGYW, a virtual (online) group-based Gender-Enhanced (GE) Workshop (using the WhatsApp® platform) was developed. The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session and aims to provide PrEP information and address AGYW's barriers to using it. The goal of the intervention is to promote consideration of and uptake of PrEP. In this phase 1 pilot study to assess feasibility and acceptability and potential for impact of the workshop, investigators will compare AGYW (N=100) assigned to the virtual group-based (GE) workshop or to an Individually Accessed (IA) condition in which women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. To evaluate Peer-driven recruitment (PDR), AGYW randomized to either condition will be invited to become Peer Health Advocates (PHAs), who are incentivized to talk to social network members and refer up to three to the workshop type the PHA attended. Acceptability and feasibility of PDR will be evaluated by assessing whether the method can be self-sustaining (i.e., on average >50% attendees become PHAs and >2 recruitees/PHA attend a workshop); and whether it reaches high-risk women and women who would not be captured by other methods of recruitment (percent who score high on HIV risk; percent who never tested or attended family planning). If promising, these approaches will be further tested in a larger study. conditions module condition list condition HIV Infections keyword list keyword Pre-Exposure Prophylaxis, oral South African Adolescent girls and young women HIV prevention design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Actual arms interventions module arm group list arm group arm group label Masibambane - Gender-Enhanced arm group type Active Comparator arm group description A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a "real-time" "live" interactive session. arm group intervention list arm group intervention name Behavioral: Gender-Enhanced -- Masibambane arm group label Individually accessed arm group type Other arm group description In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. arm group intervention list arm group intervention name Behavioral: Individually accessed intervention list intervention intervention type Behavioral intervention name Gender-Enhanced -- Masibambane intervention description The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators. intervention arm group label list intervention arm group label Masibambane - Gender-Enhanced intervention type Behavioral intervention name Individually accessed intervention description The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options intervention arm group label list intervention arm group label Individually accessed outcomes module primary outcome list primary outcome primary outcome measure Percent of participants who have an individual counseling session about PrEP. primary outcome description Percent of all participants who request and undergo an individual counseling session with the study nurse about the possibility of taking up PrEP. This behavioral measure will be documented by the study nurse primary outcome time frame Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up) secondary outcome list secondary outcome secondary outcome measure Percent of participants who undergo HIV-testing and counseling (HCT). secondary outcome description Percent of all participants who undergo HIV testing and counseling, using self-administered OraQuick, either on her own or with study nurse support. This behavioral measure will be documented by the study nurse. secondary outcome time frame Immediate post-intervention up to 3 months after the intervention secondary outcome measure Percent taking up PrEP secondary outcome description If participant is PrEP-eligible (HIV-negative) she initiates PrEP. This outcome will be based on self-report. secondary outcome time frame Immediate post-intervention up to 3 months after the intervention other outcome list other outcome other outcome measure Number of correct reponses on PrEP information scale other outcome description 5-item scale developed for this study. Count of correct responses other outcome time frame baseline to immediate post-intervention and 3 month follow-up other outcome measure Mean value on Perceived risk for HIV scale other outcome description 8-item measure from Napper LE, Fisher DG, Reynolds GL. Development of the perceived risk of HIV scale. AIDS and Behavior. 2012;16(4):1075-83. other outcome time frame baseline to immediate post-intervention and 3 month follow-up other outcome measure Mean value on Perceived effectiveness of PrEP scale other outcome description 10-item measure from Golub et al., Predictors of PrEP Uptake AIDS and Behavior 2019 23:1917-1924. other outcome time frame baseline to immediate post-intervention and 3 month follow-up other outcome measure Mean value on Positive outcomes of taking PrEP scale other outcome description 5-item measure from Teitelman et al., 2020 Beliefs associated with intention to use PrEP among cis-gender US women at risk: Archives of Sexual Behavior (2020) 49:2213-2221. other outcome time frame baseline to immediate post-intervention and 3 month follow-up other outcome measure Mean value on PrEP anticipated stigma, PrEP-user stereotypes subscale other outcome description The PrEP Anticipated Stigma Scale- PrEP-User Stereotypes subscale. from Calabrese et al. HIV Pre-Exposure Prophylaxis Stigma as a Multidimensional Barrier to Uptake Among Women Who Attend Planned Parenthood J Acquir Immune Defic Syndr 2018;79:46-53. other outcome time frame baseline to immediate post-intervention and 3 month follow-up other outcome measure Mean value on PrEP Anticipated stigma, Disapproval by others subscale other outcome description The PrEP Anticipated Stigma Scale- Disapproval by others subscale. from Calabrese et al.J Acquir Immune Defic Syndr 2018;79:46-53 other outcome time frame baseline to immediate post-intervention and 3 month follow-up other outcome measure Mean value on Medication beliefs other outcome description 4-item scale adapted from adapted from Kalichman et al. Medication Beliefs and Structural barriers to Treatment Adherence Among People Living with HIV Infection. Psychol Health. 2016 April ; 31(4): 383-395. other outcome time frame baseline to immediate post-intervention and 3 month follow-up other outcome measure Mean value on gendered partner disclosure beliefs other outcome description 5-item measure developed by the team for this study other outcome time frame baseline to immediate post-intervention and 3 month follow-up other outcome measure Increase in value on Stage of change scale other outcome description Stages of Change based on Prochaska, J. O., & Norcross, J. C. (2002). Stages of Change. In J. C. Norcross (Ed.), Psychotherapy relationships that work: Therapist contributions and responsiveness to patients (p. 303-313). Oxford University Press. other outcome time frame baseline to immediate post-intervention and 3 month follow-up eligibility module eligibility criteria Inclusion Criteria: self-reported HIV-negative or unknown status heterosexual vaginal or anal intercourse reported in the past 6 months Is not currently taking PrEP or planning to begin PrEP presently residing in eThekweni-metropolitan Durban has private smart-phone access Conversant in isiZulu or English Willing to recruit other women (if in first group of participants); (If recruited subsequent to first group): Recruited by a peer health advocate (someone the participant knew knew prior to being recruited) Exclusion Criteria: Overt signs of cognitive impairment Was a participant in the previously conducted focus groups If assigned to the online group intervention, unwilling to be audio-recorded healthy volunteers Accepts Healthy Volunteers gender Female gender based Yes gender description Based on self-representation of gender identity minimum age 18 Years maximum age 25 Years std age list std age Adult contacts locations module location list location location facility South African Medical Research Council location city Durban location state KwaZulu-Natal location country South Africa references module reference list reference reference p m i d 35306944 reference type background reference citation Harrison A, Bhengu N, Miller L, Exner T, Tesfay N, Magutshwa S, Khumalo S, Bergam S, Hoffman S, Hanass-Hancock J. "You tell him that 'baby, I am protecting myself'": Women's agency and constraint around willingness to use pre-exposure prophylaxis in the Masibambane Study. Womens Health (Lond). 2022 Jan-Dec;18:17455057221087117. doi: 10.1177/17455057221087117. reference p m i d 35218452 reference type background reference citation Bergam S, Harrison AD, Benghu N, Khumalo S, Tesfay N, Exner T, Miller L, Dolezal C, Hanass-Hancock J, Hoffman S. Women's Perceptions of HIV- and Sexuality-Related Stigma in Relation to PrEP: Qualitative Findings from the Masibambane Study, Durban, South Africa. AIDS Behav. 2022 Sep;26(9):2881-2890. doi: 10.1007/s10461-022-03632-6. Epub 2022 Feb 26. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015658 condition mesh term HIV Infections condition ancestor list condition ancestor condition ancestor id D000086982 condition ancestor term Blood-Borne Infections condition ancestor id D000003141 condition ancestor term Communicable Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000015229 condition ancestor term Sexually Transmitted Diseases, Viral condition ancestor id D000012749 condition ancestor term Sexually Transmitted Diseases condition ancestor id D000016180 condition ancestor term Lentivirus Infections condition ancestor id D000012192 condition ancestor term Retroviridae Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007153 condition ancestor term Immunologic Deficiency Syndromes condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M17402 condition browse leaf name HIV Infections condition browse leaf as found HIV Infections condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M2674 condition browse leaf name Acquired Immunodeficiency Syndrome condition browse leaf relevance low condition browse leaf id M2595 condition browse leaf name Blood-Borne Infections condition browse leaf relevance low condition browse leaf id M14710 condition browse leaf name Sexually Transmitted Diseases condition browse leaf relevance low condition browse leaf id M17085 condition browse leaf name Sexually Transmitted Diseases, Viral condition browse leaf relevance low condition browse leaf id M17792 condition browse leaf name Lentivirus Infections condition browse leaf relevance low condition browse leaf id M14178 condition browse leaf name Retroviridae Infections condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M9351 condition browse leaf name Immunologic Deficiency Syndromes condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M5646 intervention browse leaf name Contraceptive Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Repr intervention browse branch name Reproductive Control Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04833127
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full study rank 61857 study protocol section identification module n c t id NCT04831021 org study id info org study id RECHMPL20_0462 organization org full name University Hospital, Montpellier org class OTHER brief title Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role? official title Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role? acronym EXP DIAL status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date September 24, 2021 start date type Actual primary completion date struct primary completion date October 2022 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date December 31, 2021 last update post date struct last update post date January 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University Hospital, Montpellier lead sponsor class OTHER collaborator list collaborator collaborator name AIDER- Santé collaborator class UNKNOWN collaborator name Avignon University (EA4278 - LaPEC) collaborator class UNKNOWN collaborator name Pr Philippe OBERT collaborator class UNKNOWN collaborator name Dr Claire MAUFRAIS collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study aims at evaluating, in chronic kidney disease patients on dialysis, the effect of acute per- or pre-dialytic physical exercise on regional myocardial function and myocardial stunning, blood viscosity, arterial stiffness, variability of sinus rhythm, dialysis efficacy, inflammation, mineral and bone disorders, myokines and cardiac remodeling markers. conditions module condition list condition Chronic Kidney Diseases keyword list keyword Chronic kidney disease on dialysis Physical exercise Regional myocardial function Myocardial stunning design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description All patients will be assigned to one dialysis session without physical exercise, one dialysis session with pre-dialytic physical exercise and one dialysis session with per-dialytic physical exercise in random order. design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 32 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients issued from dialysis units (clinic) arm group type Experimental arm group intervention list arm group intervention name Procedure: Dialysis without physical exercise Procedure: Dialysis with pre-dialytic physical exercise Procedure: Dialysis with per-dialytic physical exercise intervention list intervention intervention type Procedure intervention name Dialysis without physical exercise intervention description Hemodialysis control condition intervention arm group label list intervention arm group label Patients issued from dialysis units (clinic) intervention type Procedure intervention name Dialysis with pre-dialytic physical exercise intervention description Patients will pedal for 30 minutes using a ergometer directly attached to the dialysis bed. The exercise will be performed 60 minutes before connection to hemodialysis. intervention arm group label list intervention arm group label Patients issued from dialysis units (clinic) intervention type Procedure intervention name Dialysis with per-dialytic physical exercise intervention description Patients will pedal for 30 minutes using a ergometer directly attached to the dialysis bed. The exercise will start 30 minutes after the start of dialysis. intervention arm group label list intervention arm group label Patients issued from dialysis units (clinic) outcomes module primary outcome list primary outcome primary outcome measure Change in regional myocardial function and myocardial stunning primary outcome time frame Weekly over a period of 3 weeks secondary outcome list secondary outcome secondary outcome measure Change in blood viscosity secondary outcome time frame Weekly over a period of 3 weeks secondary outcome measure Change in arterial stiffness secondary outcome time frame Weekly over a period of 3 weeks secondary outcome measure Change in sinus rhythm secondary outcome time frame Weekly over a period of 3 weeks secondary outcome measure Change in dialysis efficacy secondary outcome time frame Weekly over a period of 3 weeks secondary outcome measure Change in inflammatory markers secondary outcome time frame Weekly over a period of 3 weeks secondary outcome measure Change in mineral and bone metabolism markers secondary outcome time frame Weekly over a period of 3 weeks secondary outcome measure Change in myokines secondary outcome time frame Weekly over a period of 3 weeks secondary outcome measure Change in cardiac remodeling markers secondary outcome time frame Weekly over a period of 3 weeks eligibility module eligibility criteria Inclusion Criteria: Patient aged ≥ 20 to ≤ 79 years Undernourished patient according to the ARNOS score : ≥ 2 No medical contraindication to physical activity Life expectancy greater than 6 months Patient on hemodialysis for more than 3 months Patients with relatively good echogenicity Exclusion Criteria: Patient is participating in another Category I interventional study, or has participated in another interventional study within the past 3 months The patient is in an exclusion period determined by a previous study The patient is under legal protection or under guardianship or curatorship It turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent Pregnant, parturient or breastfeeding patient Patient with a contraindication to retraining Patient with valvular heart disease, arteriopathy of the lower limbs stage III and IV, amputation or knee or hip prosthesis Patient with musculoskeletal problems Patient with severe respiratory failure Paired sleep apnea syndrome BMI> 35 Patient with automatic implantable defibrillator Heart transplant Uncontrolled high blood pressure Ejection fraction <45% Unstabilized coronaries Non-contributory stress ultrasound healthy volunteers No gender All minimum age 20 Years maximum age 79 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jean Paul CRISTOL, MD, PhD central contact role Contact central contact phone 04 67 33 83 14 central contact e mail jp-cristol@chu-montpellier.fr overall official list overall official overall official name Jean Paul CRISTOL, MD, PhD overall official affiliation CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE overall official role Principal Investigator overall official name François ROUBILLE, MD, PhD overall official affiliation CHU ADV, Department of Cardiology, Montpellier, FRANCE overall official role Study Chair overall official name Cécile TURC-BARON, MD overall official affiliation AIDER Santé, Montpellier, FRANCE overall official role Study Chair overall official name Jérôme ADDA, MD overall official affiliation CHU ADV, Department of Cardiology, Montpellier, FRANCE overall official role Study Chair location list location location facility Lapeyronie Hospital clinical trials Department location status Not yet recruiting location city Montpellier location state Hérault location zip 34295 location country France location contact list location contact location contact name Jean Paul CRISTOL, MD, PhD location contact role Contact location contact phone 04 67 33 83 14 location contact e mail jp-cristol@chu-montpellier.fr location facility AIDER Santé location status Recruiting location city Montpellier location country France location contact list location contact location contact name Cécile TURC-BARON, MD location contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007674 condition mesh term Kidney Diseases condition mesh id D000051436 condition mesh term Renal Insufficiency, Chronic condition ancestor list condition ancestor condition ancestor id D000014570 condition ancestor term Urologic Diseases condition ancestor id D000051437 condition ancestor term Renal Insufficiency condition browse leaf list condition browse leaf condition browse leaf id M9850 condition browse leaf name Kidney Diseases condition browse leaf as found Kidney Disease condition browse leaf relevance high condition browse leaf id M19054 condition browse leaf name Myocardial Stunning condition browse leaf relevance low condition browse leaf id M25871 condition browse leaf name Renal Insufficiency condition browse leaf relevance low condition browse leaf id M25870 condition browse leaf name Renal Insufficiency, Chronic condition browse leaf as found Chronic Kidney Disease condition browse leaf relevance high condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04831021
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full study rank 61709 study protocol section identification module n c t id NCT04832945 org study id info org study id 8953 organization org full name Grupo Rescue S.A.S República Dominicana org class NETWORK brief title SARS-CoV-2 Pre-exposure Prophylaxis With Ivermectin Retrospective Cohort Study official title Multicenter Retrospective Cohort Study of Ivermectin as a SARS-CoV-2 Pre-exposure Prophylactic Method in Healthcare Workers in Dominican Republic status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date June 29, 2020 start date type Actual primary completion date struct primary completion date September 20, 2020 primary completion date type Actual completion date struct completion date April 10, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 10, 2021 last update post date struct last update post date April 13, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Grupo Rescue S.A.S República Dominicana lead sponsor class NETWORK oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary This observational study, a multicenter retrospective cohort database study, carried out in two medical centers, Centro Medico Bournigal (CMBO) in Puerto Plata and Centro Medico Punta Cana (CMPC) in Punta Cana, Dominican Republic, sought to determine whether Ivermectin, at a weekly orally dose of 0.2 mg/kg, is an effective pre-exposure prophylactic method (PrEP) for the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in the healthcare workers. The study began on June 29, 2020 and ended on July 26, 2020 (4 weeks). conditions module condition list condition Covid19 keyword list keyword Ivermectin SARS-CoV-2 Coronavirus Prophylaxis PrEP Covid-19 design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 713 enrollment type Actual arms interventions module arm group list arm group arm group label Ivermectin Group arm group description Healthcare personnel receiving Ivermectin weekly PrEP arm group intervention list arm group intervention name Drug: Ivermectin 6 Mg Oral Tablet arm group label Control Group arm group description Healthcare personnel not receiving Ivermectin intervention list intervention intervention type Drug intervention name Ivermectin 6 Mg Oral Tablet intervention description Ivermectin weekly oral dose 0.2 mg/kg equivalent for 4 weeks intervention arm group label list intervention arm group label Ivermectin Group intervention other name list intervention other name Ivermectin outcomes module primary outcome list primary outcome primary outcome measure Number of participants RT-PCR positive for Covid-19 primary outcome description Workers confirmed Covid-19 through Reverse Transcription Polymerase Chain Reaction (RT-PCR) test primary outcome time frame 4 weeks secondary outcome list secondary outcome secondary outcome measure Number of sick participants who condition deteriorated secondary outcome description Workers infected with Covid-19, confirmed with RT-PCR and required hospitalization and/or ICU secondary outcome time frame 4 weeks secondary outcome measure Number of sick participants who died secondary outcome description Workers infected with Covid-19, confirmed with RT-PCR and died. secondary outcome time frame 4 weeks eligibility module eligibility criteria Inclusion Criteria: Active workers from Centro Medico Bournigal (CMBO) and Centro Medico Punta Cana (CMPC) during the study. Exclusion Criteria Workers with positive Covid-19 RT-PCR prior to the start of the study Those that did not take the first dose of Ivermectin the first week at the start of the study Those that did not complied with at least 2 out of 4 weekly doses Those that had greater than 14 days difference in days between two intakes Ivermectin healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Workers who was part of Ivermectin prophylaxis program and signed the informed consent at CMPC and CMBO in Dominican Republic was analyzed and included in the intervention group. Those who didn't participate in the prophylaxis program but were on active duty during the 4 weeks of the study were included in the control group. Workers excluded from Ivermectin prophylaxis program was: Pregnant or suspected pregnant women Women breastfeeding Patients receiving coumarin anticoagulants Those allergic to Ivermectin sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Jose Morgenstern, MD overall official affiliation Grupo Rescue overall official role Principal Investigator overall official name Jose Natalio Redondo, MD overall official affiliation Grupo Rescue overall official role Principal Investigator overall official name Alvaro Olavarria, Data Analyst overall official affiliation Grupo Rescue overall official role Principal Investigator location list location location facility Centro Medico Bournigal location city Puerto Plata location zip 57000 location country Dominican Republic location facility Centro Médico Punta Cana location city Punta Cana location zip 23000 location country Dominican Republic i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000007559 intervention mesh term Ivermectin intervention ancestor list intervention ancestor intervention ancestor id D000000977 intervention ancestor term Antiparasitic Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M9742 intervention browse leaf name Ivermectin intervention browse leaf as found Vincristine intervention browse leaf relevance high intervention browse leaf id M3446 intervention browse leaf name Antiparasitic Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832945
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full study rank 61519 study protocol section identification module n c t id NCT04835415 org study id info org study id 6777 organization org full name Zagazig University org class OTHER_GOV brief title Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy official title Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy status module status verified date January 2022 overall status Completed expanded access info has expanded access No start date struct start date April 10, 2021 start date type Actual primary completion date struct primary completion date November 15, 2021 primary completion date type Actual completion date struct completion date December 1, 2021 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date January 11, 2022 last update post date struct last update post date January 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dina Abdelhameed Elsadek Salem responsible party investigator title Principle investigator responsible party investigator affiliation Zagazig University lead sponsor lead sponsor name Zagazig University lead sponsor class OTHER_GOV oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy. detailed description To study the difference between the effects of ultrasound-guided bilateral retrolaminar block and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic cholecystectomy at Zagazig university hospitals. conditions module condition list condition Analgesia keyword list keyword Ultrasound Bilateral retrolaminar Thoracic epidural post operative analgesia Laparoscopic cholecystectomy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia. design primary purpose Treatment design masking info design masking Double design masking description Double (participant, outcomes assessor) Anesthetist not sharing in the study will assess patient. design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 52 enrollment type Actual arms interventions module arm group list arm group arm group label group T arm group type Active Comparator arm group description Group (T) (n=26): will receive ultrasound guided thoracic epidural analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000). arm group intervention list arm group intervention name Procedure: Thoracic epidural analgesia arm group label group R arm group type Active Comparator arm group description Group (R) (n=26): will receive bilateral ultrasound guided retrolaminar block analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000). arm group intervention list arm group intervention name Procedure: Bilateral retrolaminar block intervention list intervention intervention type Procedure intervention name Bilateral retrolaminar block intervention description in lateral position and after skin sterilization. The spine is palpated from cervical (C7) downward toT7 and point marked to identify the spinous process. The linear high frequency transducer (6-13 MHz) will be placed parasagittal plane 1 cm lateral to the midline. The needle (18 gauge) is inserted in the plane view of the ultrasound probe to target the T7 and needle is advanced from downward to upward until the needle tip contacted the lamina. After negative aspiration, a 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side. intervention arm group label list intervention arm group label group R intervention other name list intervention other name Ultrasound guided retrolaminar block intervention type Procedure intervention name Thoracic epidural analgesia intervention description In the lateral position, after skin sterilization, Ultrasound with high frequency linear probe (5-13 MHz). Thoracic intervertebral space (T7-8) will be identified by counting from the C7 to prominent thoracic spine (T7). The probe will be used in parasagittal plane 2 cm from midline. The probe will be directed medially to identify the dura matter at the T7-8 intervertebral space . the needle 18 gauage will be inserted in plane to target T7-8 intervertebral space ., after needle tip reached target space, loss of resistance technique then 20 ml bupivacaine 0.25% plus 5ug/ml adrenaline (1:200000) was injected after aspiration intervention arm group label list intervention arm group label group T intervention other name list intervention other name Ultrasound guided thoracic epidural outcomes module primary outcome list primary outcome primary outcome measure Pain intensity at rest and at cough using Numerical Rating Scales (NRS) primary outcome description measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain) primary outcome time frame 30 minutes postoperative primary outcome measure Pain intensity at rest and at cough using Numerical Rating Scales (NRS) primary outcome description measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain) primary outcome time frame at 1 hour postoperative primary outcome measure Pain intensity at rest and at cough using Numerical Rating Scales (NRS) primary outcome description measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain) primary outcome time frame at 2 hours postoperative primary outcome measure Pain intensity at rest and at cough using Numerical Rating Scales (NRS) primary outcome description measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain) primary outcome time frame at 4 hours postoperative primary outcome measure Pain intensity at rest and at cough using Numerical Rating Scales (NRS) primary outcome description measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain) primary outcome time frame at 6 hours postoperative primary outcome measure Pain intensity at rest and at cough using Numerical Rating Scales (NRS) primary outcome description measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain) primary outcome time frame at 8 hours postoperative primary outcome measure Pain intensity at rest and at cough using Numerical Rating Scales (NRS) primary outcome description measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain) primary outcome time frame at 10 hours postoperative primary outcome measure Pain intensity at rest and at cough using Numerical Rating Scales (NRS) primary outcome description measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain) primary outcome time frame at 12 hours postoperative secondary outcome list secondary outcome secondary outcome measure Time to first call of rescue analgesia secondary outcome description start from retrolaminar or epidural injection of the drug to the time of first call of naluphine secondary outcome time frame within 12 hours postoperative secondary outcome measure Total analgesic (Naluphine) consumption secondary outcome description Total consumption of rescue analgesia(Naluphine) post operative secondary outcome time frame within 12 hours postoperative secondary outcome measure The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture) secondary outcome description The numer of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture) secondary outcome time frame within 24 hours postoperative secondary outcome measure Patient satisfaction is recorded at the end of 24 hours postoperative secondary outcome description using 5-point Likert-like verbal rating scale by asking the patient about "how he/she evaluated their experience with the analgesic management after the surgery?"5=very satisfied, 4=satisfied, 3= neutral, 2= dissatisfied and 1= very dissatisfied". secondary outcome time frame 24 hours postoperative secondary outcome measure The number of participant with nausea, vomiting, hypotension and bradycardia. secondary outcome description the number of participant with nausea (sensation of being about to vomit), vomiting (the expelling of the food content from the stomach through mouth, it will be treated by 4 mg ondansetron), hypotension (if MAP decreases more than 20% of basal reading it will be treated by 12 mg ephedrine) and bradycardia (if HR less than 50 beats/min it will be treated by 0.5 mg atropine). secondary outcome time frame 24 hours postoperative eligibility module eligibility criteria Inclusion Criteria: Written informed consent from the patient. Age: 21-45 years old. Sex: both sex (males and females). Physical status: ASA 1& II. BMI = (25-35 kg/m2). Type of operation: elective laparoscopic cholecystectomy Exclusion Criteria: Altered mental state. Patients with known history of allergy to study drugs. Advanced hepatic, renal, cardiovascular, and respiratory diseases. Patients with chronic pain. Patients receiving anticoagulants. Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection. healthy volunteers Accepts Healthy Volunteers gender All minimum age 21 Years maximum age 45 Years std age list std age Adult contacts locations module overall official list overall official overall official name Dina Salem, MD. overall official affiliation faculty of medicine , Zagazig University overall official role Principal Investigator location list location location facility faculty of medicine, Zagazig university location city Zagazig location country Egypt i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000377 condition mesh term Agnosia condition ancestor list condition ancestor condition ancestor id D000010468 condition ancestor term Perceptual Disorders condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M2879 condition browse leaf name Agnosia condition browse leaf as found Analgesia condition browse leaf relevance high condition browse leaf id M12531 condition browse leaf name Perceptual Disorders condition browse leaf relevance low condition browse leaf id M20979 condition browse leaf name Neurobehavioral Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T241 condition browse leaf name Agnosia condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M4467 intervention browse leaf name Bupivacaine intervention browse leaf relevance low intervention browse leaf id T312 intervention browse leaf name Tea intervention browse leaf as found HIV-positive intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical
NCT04835415
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full study rank 61652 study protocol section identification module n c t id NCT04833686 org study id info org study id 0755-17 organization org full name Rabin Medical Center org class OTHER brief title The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial official title The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 1, 2018 start date type Actual primary completion date struct primary completion date February 28, 2019 primary completion date type Actual completion date struct completion date January 31, 2021 completion date type Actual study first submit date March 29, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name noa ziv responsible party investigator title MD responsible party investigator affiliation Schneider Children's Medical Center, Israel lead sponsor lead sponsor name Rabin Medical Center lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Bronchiolitis is an infectious disease, with no effective treatment. Music and Mozart's works specifically, has been shown to have a positive effect on physiological parameters, while environmental noise is considered to be harmful. We aimed to evaluate the short-time effect of listening to music and detachment from environmental noise on the severity of bronchiolitis in hospitalized children. detailed description MP3 player devices were uploaded with 3 different pieces: 1) sonata for 2 pianos in D major, K.488 by Mozart (2) instrumental music ("To the Point", by Dean Evenson & Tom Barabas) and (3) silence. All music or silence pieces were identical in length (24 minutes in accordance to the duration of the sonata). Music fragments were played using headphones suitable and approved for use in children - GSI (Grason-Standler) Insert Earphone TIP-50 (50 ohm) (Grason Standler Inc. Madison, WI, USA). Sound frequency and volume were adjusted to the age appropriate values33 Children were randomly divided into 3 groups according to the type of intervention. Randomization, numbering of the MP3 players and coding of the content were done by a research coordinator not involved in evaluation of the patients nor in analysis of the results. conditions module condition list condition Bronchiolitis keyword list keyword Double blind randomized controlled study Prospective design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 52 enrollment type Actual arms interventions module arm group list arm group arm group label Sonata for 2 pianos in D major, K.488 by Mozart arm group type Active Comparator arm group description An Mp3 player, upload with music by Mozart. Music was played using headphones suitable and approved for use in children. arm group intervention list arm group intervention name Behavioral: Mozart arm group label Instrumental music ("To the Point", by Dean Evenson & Tom Barabas) arm group type Active Comparator arm group description An Mp3 player, upload with instrumental music. Music was played using headphones suitable and approved for use in children. arm group intervention list arm group intervention name Behavioral: Instrumental music arm group label Silence arm group type Active Comparator arm group description An Mp3 player, upload with silence. Silence was played using headphones suitable and approved for use in children. arm group intervention list arm group intervention name Behavioral: Silence intervention list intervention intervention type Behavioral intervention name Mozart intervention description Music composed by Mozart, a musical piece 24 minutes long. intervention arm group label list intervention arm group label Sonata for 2 pianos in D major, K.488 by Mozart intervention type Behavioral intervention name Instrumental music intervention description Instrumental music , a musical piece 24 minutes long intervention arm group label list intervention arm group label Instrumental music ("To the Point", by Dean Evenson & Tom Barabas) intervention type Behavioral intervention name Silence intervention description Silence, a piece 24 minutes long. intervention arm group label list intervention arm group label Silence outcomes module primary outcome list primary outcome primary outcome measure Change in disease severity primary outcome description Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing) primary outcome time frame Evaluation was done before music playing and immediately after the end of the music session (At 0 minutes time, and at a maximum time of 24 minutes from the beginning of intervention - which is the length of the musical piece). eligibility module eligibility criteria Inclusion Criteria: Patients aged 0-24 months, with the clinical diagnosis of bronchiolitis. Exclusion Criteria: Children who failed neonatal hearing screening or in whom the results of the screening were not available were excluded from the study. Children who were not able to maintain listening for at least 10 minutes were excluded from data analysis healthy volunteers No gender All maximum age 2 Years std age list std age Child contacts locations module overall official list overall official overall official name Noa Ziv, MD overall official affiliation Schneider Children's Medical Center, Israel overall official role Principal Investigator location list location location facility Schneider Children's Medical Center of Israel location city Petach Tikva location zip 4920235 location country Israel references module reference list reference reference p m i d 25414585 reference type background reference citation Friedman JN, Rieder MJ, Walton JM; Canadian Paediatric Society, Acute Care Committee, Drug Therapy and Hazardous Substances Committee. 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Review. see also link list see also link see also link label WHO work on noise see also link u r l https://www.euro.who.int/en/health-topics/environment-and-health/noise i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001988 condition mesh term Bronchiolitis condition ancestor list condition ancestor condition ancestor id D000001991 condition ancestor term Bronchitis condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000001982 condition ancestor term Bronchial Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000008173 condition ancestor term Lung Diseases, Obstructive condition ancestor id D000008171 condition ancestor term Lung Diseases condition browse leaf list condition browse leaf condition browse leaf id M4416 condition browse leaf name Bronchiolitis condition browse leaf as found Bronchiolitis condition browse leaf relevance high condition browse leaf id M4419 condition browse leaf name Bronchitis condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M4410 condition browse leaf name Bronchial Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M10322 condition browse leaf name Lung Diseases, Obstructive condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M250662 intervention browse leaf name Zaleplon intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AntiConv intervention browse branch name Anticonvulsants intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04833686
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full study rank 61598 study protocol section identification module n c t id NCT04834388 org study id info org study id NL76607.091.21 organization org full name Radboud University Medical Center org class OTHER brief title Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke official title Anakinra in Cerebral Haemorrhage to Target Secondary Injury Resulting From Neuroinflammation - a Phase II Clinical Trial acronym ACTION status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 10, 2022 start date type Actual primary completion date struct primary completion date September 2023 primary completion date type Anticipated completion date struct completion date December 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 15, 2022 last update post date struct last update post date August 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Radboud University Medical Center lead sponsor class OTHER collaborator list collaborator collaborator name Dutch Heart Foundation collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Spontaneous intracerebral haemorrhage (sICH) is the deadliest stroke subtype yearly affecting over 6000 patients in the Netherlands. Treatment options are very limited. Inflammation plays a vital role in the development of sICH-related secondary brain injury (SBI). Within 4 hours after sICH onset, blood components and thrombin induce the release of cytokines and other inflammatory molecules, with subsequent microglial activation, blood brain barrier (BBB) damage and the formation of perihaematomal oedema (PHO). Among the released cytokines, interleukin 1 beta (IL-1β) has a pivotal role. Recombinant human interleukin-1 receptor antagonist (IL-1Ra, anakinra) effectively antagonizes IL-1β through competitive binding to the IL-1 receptor. Anakinra is available for treatment of rheumatoid arthritis, other inflammatory diseases and has been studied in acute sepsis. We hypothesize that anakinra safely reduces SBI after sICH, and that its effect is dose-dependent. Objective: To determine the effect of high-dose versus low-dose anakinra compared to standard medical management on oedema extension distance (OED) determined with MRI on day 7±1. Second, to study the safety profile of anakinra. Furthermore, to assess its effect on 1) serum inflammatory markers IL-1β, IL-6, hsCRP, neutrophil and total white blood cell counts at day 1, 3 and 7 compared to baseline; 2) DCE-MRI measurement of BBB transfer constant (Ktrans) on day 7±1, and; 3) to estimate an effect on functional outcome in patients with sICH. Study design: Multicentre, prospective, randomized, three-armed (1:1:1) trial with open label treatment and blinded end-point assessment (PROBE design) . Study population: 75 patients with supratentorial sICH admitted within 8 hours after symptom onset. Intervention: Patients will receive anakinra in either a high dose (loading dose 500mg i.v., followed by infusion with 2mg/kg/h over 3 days; n=25) or in a low dose (loading dose 100mg s.c.., followed by subcutaneous administration of 100mg twice a day for 3 days; n=25), started within 8 hours of symptom onset. The control group (n=25) will receive standard medical management. Main study parameters/endpoints: Primary objective is to test whether anakinra reduces subacute perihaematomal oedema after sICH, measured as OED on MRI at day 7±1. conditions module condition list condition Intracerebral Hemorrhage design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description PROBE design design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 75 enrollment type Anticipated arms interventions module arm group list arm group arm group label Anakinra High dose arm group type Experimental arm group description 500mg i.v. loading dose, followed by continuous iv infusion with 2mg/kg/h over 3 days arm group intervention list arm group intervention name Drug: Anakinra arm group label Anakinra Low dose arm group type Experimental arm group description 100mg s.c. loading dose, followed by subcuteanous administration of 100mg twice daily for 3 days. arm group intervention list arm group intervention name Drug: Anakinra arm group label Standard care arm group type No Intervention arm group description Standard care group intervention list intervention intervention type Drug intervention name Anakinra intervention description Anakinra treatment is started within 8 hours of symptom onset intervention arm group label list intervention arm group label Anakinra High dose Anakinra Low dose intervention other name list intervention other name Kineret outcomes module primary outcome list primary outcome primary outcome measure Perihematomal oedema primary outcome description Measured as Oedema Extension Distance (OED/EED) primary outcome time frame 7 days after ICH onset secondary outcome list secondary outcome secondary outcome measure Adverse events of special interest (AESI) and serious adverse events (SAE) secondary outcome time frame 90 days secondary outcome measure Blood brain barriere leakage secondary outcome description Measured as Ktrans on DCE-MRI secondary outcome time frame 7 days secondary outcome measure Levels of serum inflammatory markers secondary outcome description IL-1β, IL-6, hsCRP, neutrophil and total white blood cell counts secondary outcome time frame 7 days secondary outcome measure Functional outcome secondary outcome description Ordinal shift in functional outcome (comparing the intervention group to the controls), assessed with the modified Rankin Scale (mRS) at 3 months. This is a six point scale in which a score of 0 means no symptoms at all, a higher score means more impairment, and a score of 6 means the participant is dead. secondary outcome time frame 90 days eligibility module eligibility criteria Inclusion Criteria: Age ≥ 18 years; Supratentorial non-traumatic ICH confirmed by CT, without a confirmed causative lesion on admission CT-angiography (e.g. aneurysm, AVM, DAVF, cerebral venous sinus thrombosis) or other known underlying lesion (e.g. tumour, cavernoma); Minimal intracerebral haemorrhage volume of 10 mL; Intervention can be started within 8 hours from symptoms onset; Patient's or legal representative's informed consent. Exclusion Criteria: Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score < 6 at time of consent); Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct; Planned neurosurgical haematoma evacuation; Severe infection at admission, requiring antibiotic treatment; Known active tuberculosis or active hepatitis; Use of immunosuppressive or immune-modulating therapy at admission (see 15.1 Appendix A); Neutropenia (Absolute Neutrophil Count (ANC) <1.5 x 109/L ); Pre-stroke modified Rankin Scale score ≥ 3; Pregnancy or breast-feeding; Standard contraindications to MRI (see 15.2 Appendix B); Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration; Known allergy to anakinra or other products that are produced by DNA technology using the micro-organism E. coli; Live vaccinations within the last 10 days prior to this ICH; Severe renal impairment (eGFR <30ml/min/1.73m) Active malignancy healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Floris H.B.M Schreuder, MD PhD central contact role Contact central contact phone +31650155755 central contact e mail floris.schreuder@radboudumc.nl central contact name Maaike P. Cliteur, MD central contact role Contact central contact phone +31650155723 central contact e mail maaike.cliteur@radboudumc.nl location list location location facility Radboudumc location status Recruiting location city Nijmegen location country Netherlands location contact list location contact location contact name Radboudumc location contact role Contact i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002543 condition mesh term Cerebral Hemorrhage condition mesh id D000006470 condition mesh term Hemorrhage condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020300 condition ancestor term Intracranial Hemorrhages condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf relevance low condition browse leaf id M8708 condition browse leaf name Hemorrhage condition browse leaf as found Hemorrhage condition browse leaf relevance high condition browse leaf id M4359 condition browse leaf name Brain Injuries condition browse leaf relevance low condition browse leaf id M4944 condition browse leaf name Cerebral Hemorrhage condition browse leaf as found Intracerebral Hemorrhage condition browse leaf relevance high condition browse leaf id M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf relevance low condition browse leaf id M2405 condition browse leaf name Hemorrhagic Stroke condition browse leaf relevance low condition browse leaf id M21266 condition browse leaf name Intracranial Hemorrhages condition browse leaf relevance low condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev BC04 condition browse branch name Neoplasms intervention browse module intervention mesh list intervention mesh intervention mesh id D000053590 intervention mesh term Interleukin 1 Receptor Antagonist Protein intervention ancestor list intervention ancestor intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M26512 intervention browse leaf name Interleukin 1 Receptor Antagonist Protein intervention browse leaf as found Multi-center Study intervention browse leaf relevance high intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834388
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full study rank 61302 study protocol section identification module n c t id NCT04838236 org study id info org study id STUDY00000360 organization org full name University of Houston org class OTHER brief title Smoking, Stress, and Mobile Technology official title Improving Access to Cigarette Cessation Treatment Among African American Smokers: Development and Evaluation of an Integrated mHealth Application status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date December 20, 2021 start date type Actual primary completion date struct primary completion date March 31, 2025 primary completion date type Anticipated completion date struct completion date March 31, 2025 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 15, 2022 last update post date struct last update post date March 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Michael J. Zvolensky, Ph.D. responsible party investigator title Hugh Roy and Lillie Cranz Cullen Distinguished University Professor responsible party investigator affiliation University of Houston lead sponsor lead sponsor name University of Houston lead sponsor class OTHER collaborator list collaborator collaborator name University of Oklahoma collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary We seek to refine and evaluate the novel mobile intervention, Mobile Anxiety Sensitivity Program for Smoking (MASP) which was initially developed and previously tested by our team, targeting sensitivity to interoceptive stress, and to apply it among African American smokers. Our culturally adapted intervention is framed within a sociocultural context of interoceptive stress, which is supported by theory, empirical evidence, and characteristics of African American smokers. The MASP app contains educational content on the history of tobacco and the African American community. detailed description The objective of the current trial is to refine and conduct a comprehensive cultural adaptation of an initially tested novel, mobile intervention that targets anxiety sensitivity (AS) among African American smokers (MASP). The MASP app checks in with users throughout the day to assess their mood, whether or not they're experiencing any cravings or withdrawal symptoms, and their overall mental health. When users indicate they are struggling with staying abstinent, or if they are experiencing heighted levels of stress or anxiety, the app selects and delivers a tailored message from its library of hundreds of messages and videos. For instance, if a user indicates they are struggling with nicotine cravings, and feel as though they are about to smoke, they will receive an individually tailored suggestion on how to cope with the feeling, and strategies to act and overcome it. The app also contains videos that are designed to teach relaxation techniques, as well as training exercises that teach participants how to cope with uncomfortable feelings of stress and nicotine withdrawal they are likely to experience while quitting nicotine. The MASP app has the potential to deliver highly effective and accessible treatment to individuals who are looking to take that major step in their life, and quit smoking for good. Individuals interested in participating in the study will complete informed consent and a study screener via RedCap and phone call with study staff (signatures will be obtained digitally via RedCap). Those found eligible during the phone screener will download the Insight app onto their personal phone to confirm compatibility and complete the baseline assessment. Those who do not possess a phone that is compatible with the Insight platform will be mailed a compatible phone so they can complete the baseline assessment. Upon completion of the baseline survey, participants will be mailed a Bedfont Carbon Monoxide monitor (iCO) that can be used to remotely verify smoking status, a Greenphire Mastercard, and 4 weeks of NRT. Upon receipt of the iCO, participants will complete a brief phone call to walk them through the use of the iCO and study app. Participants (N=25) in phase II will be in the study for a total of 6 weeks. Upon completion of Phase II, we will analyze data and utilize feedback collected from phase II participants to create MASP 3.0. We will then begin phase III of the study. Participants (N=200) in the study will receive either the MASP 3.0 or QuitGuide plus EMA app following the completion of the baseline assessment. Specifically, following completion on the baseline assessment they will receive a unique code that they will type into the app to place them in the group that they were randomized to. All participants will complete app-based follow-up assessments 1, 2 (quit day), 3, 4, 5, 6, 28, and 54 weeks after the baseline visit. We expect phase III of the study will be completed within a period of 30-36 months. conditions module condition list condition Smoking, Tobacco design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 225 enrollment type Anticipated arms interventions module arm group list arm group arm group label MASP app + NRT arm group type Experimental arm group description MASP is an intervention designed to assist African American smokers with anxiety sensitivity quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal. arm group intervention list arm group intervention name Other: MASP app + NRT arm group label QuitGuide app + NRT arm group type Other arm group description The QuitGuide app is a standard of care app that allows users to track their nicotine cravings, and provides users with motivational messages. arm group intervention list arm group intervention name Other: QuitGuide app + NRT intervention list intervention intervention type Other intervention name MASP app + NRT intervention description MASP is a mobile intervention that targets anxiety sensitivity among African American smokers (Mobile Anxiety Sensitivity Program for Smoking: MASP). Our intervention is framed within the cultural context of interoceptive stress among African American smokers, which is supported by theory, empirical evidence, and characteristics of this group. The MASP app employs a variety of features to educate its users on how to deal with stress, anxiety, and nicotine withdrawal symptoms. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos. MASP also utilizes Ecological Momentary Assessments (EMAs) to gather information, and provide personalized messages to users in real time. intervention arm group label list intervention arm group label MASP app + NRT intervention type Other intervention name QuitGuide app + NRT intervention description Quitguide is a smartphone-based National Cancer Institute (NCI) app for standard mobile smoking cessation treatment. The app contains features that allows its' users to better understand their smoking patters, and build skills needed to becomes and stay smoke free. The app allows users to track their cravings, and delivers motivational messages to users for each craving they track. intervention arm group label list intervention arm group label QuitGuide app + NRT outcomes module primary outcome list primary outcome primary outcome measure A qualitative interview will be used to evaluate the mobile app for style and presentation, perceived utility, ease of use, usefulness of features, and willingness to refer to a friend. primary outcome description the Qualitative Interview is a 21-item interview that aims to assess participant experiences with the smartphone applications. This interview will be conducted at the 6-week follow-up phone interview (end-of-treatment) and will be recorded for qualitative data analysis. Patient adherence will be assessed through examination of treatment components that are used within each app (e.g., videos watched, compliance with homework and exposure exercises with a standardized rating scale). primary outcome time frame Week 6 follow-up (Phases II and III) primary outcome measure Levels of satisfaction and perceived treatment quality regarding the intervention, as assessed by the Treatment Quality and Satisfaction Survey primary outcome description The Treatment Quality and Satisfaction Survey was developed for the purposes of this study. This 22-item measure assesses participants' experiences during the treatment period and while using the smart phone application. primary outcome time frame Week 6 follow-up (Phases II and III) primary outcome measure Change in Carbon Monoxide levels at Baseline as measured by the Carbon Monoxide Analysis (Phone Bedfont iCO Smokerlyzer) at follow up appointments. primary outcome description Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of < 7 ppm. This will be used to verify smoking status, as well as change in smoking behaviors throughout the study. primary outcome time frame From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up) secondary outcome list secondary outcome secondary outcome measure Stage of ethnic identity attitudes expressed by participants as measured by the Black Racial Identity Attitude Scale secondary outcome description The Black Racial Identity Attitude Scale a 12-item scale that aims to identify the stage of racial identity development a person is in. It consists of 3 subparts: Immersion/Emersion, Pre-encounter, and Encounter. Higher scores indicate more agreement with the items. The Black Racial Identity Attitude Scale will be utilized to explore whether perceived ethnic identity functions as a moderator of smoking outcomes. secondary outcome time frame Baseline secondary outcome measure Change from Baseline in depression related impairment on the 5-item Overall Depression Severity and Impairment Scale at subsequent follow-up appointments. secondary outcome description The Overall Depression Severity and Impairment Scale is a brief, five-item measure for assessing the frequency and intensity of depressive symptoms, as well as functional impairments related to depressive symptoms. Higher scores indicate higher levels of impairment related to depression symptoms. This scale will be used to evaluate the mechanisms underlying intervention effects, including depression symptoms, and the indirect effects of the intervention on smoking cessation via this mechanism of change. secondary outcome time frame From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up) secondary outcome measure Change from Baseline in anxiety related impairment on the 5-item Overall Anxiety Severity and Impairment Scale at follow-up appointments. secondary outcome description The Overall Anxiety Severity and Impairment Scale is a brief continuous measure of overall anxiety severity and impairment. Higher scores indicate higher impairment as a result of anxiety. It will be used to evaluate the mechanisms underlying intervention effects, including anxiety symptoms, and the indirect effects of the intervention on smoking cessation via this mechanism of change. secondary outcome time frame From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up) secondary outcome measure Levels of acculturation expressed by participants as measured by the African American Acculturation Scale. secondary outcome description The African American Acculturation scale is a 10-item scale that assesses cultural and media preferences, racial balance, and contexts of social interaction, and race-related attitudes and comfort with Whites versus Blacks. Lower scores represent higher levels of acculturation towards the dominant culture. secondary outcome time frame Baseline secondary outcome measure Items assessing stress levels related to the COVID-19 pandemic will be utilized to explore whether COVID-19 associated stress functions as a moderator of smoking outcomes. secondary outcome description Items will assess whether participants have received testing for the corona virus, whether they have been hospitalized because of COVID, and the severity of any symptoms they have experienced. Additionally, items will also assess fears and anxieties related to the COVID-19 pandemic. Higher scores for both of these scales indicate greater stress due to the COVID-19 pandemic. secondary outcome time frame Baseline secondary outcome measure Change from week 1 follow up in withdrawal symptoms as assessed by the Minnesota Nicotine Withdrawal Scale at subsequent follow up appointments. secondary outcome description The Minnesota Nicotine Withdrawal Scale is a 10-item scale used to assess severity of nicotine withdrawal symptoms. Higher scores indicate levels of nicotine withdrawal. It will be used to evaluate the mechanisms underlying intervention effects, including nicotine withdrawal, and the indirect effects of the MASP intervention on smoking cessation via this mechanism of change. secondary outcome time frame From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up) secondary outcome measure Change from Screener in levels of anxiety sensitivity on the 5-point Short Scale Anxiety Sensitivity Index at follow up appointments. secondary outcome description The Short Scale Anxiety Sensitivity Index utilizes a 5-item Likert scale to measure anxiety sensitivity. Higher score indicate higher levels of anxiety sensitivity. This index will be used to evaluate the mechanisms underlying intervention effects, including the intervention effect on reductions in anxiety sensitivity, and the indirect effects of the intervention on smoking cessation via this mechanism of change. secondary outcome time frame From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up) secondary outcome measure Change in discrimination burden using the section of the Jackson Heart Study Discrimination Instrument will be used to assess whether our intervention has underlying effects on stress-based burden from racial/ethnic discrimination. secondary outcome description This measure contains 4-items that assess perceptions of discrimination. Higher scores indicate higher difficulty living a productive and full life because of perceived experience of discrimination. The measure will be used to assess change in stressed based burden from racial discrimination. secondary outcome time frame From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up) secondary outcome measure Levels of perceived discrimination as measured by the Everyday Discrimination Scale. secondary outcome description The Everyday Discrimination Scale assesses perceptions of discrimination or unfair treatment. Higher scores indicate higher perceived discrimination. The Everyday Discrimination Scale will be utilized to explore whether perceived racial discrimination functions as a moderator of smoking outcomes. secondary outcome time frame Baseline secondary outcome measure Time to first lapse secondary outcome description Time to first will be measured via EMAs. Participants will press a button in the app (i.e. I Already Slipped), and once this is done, MASP will record the time and date the participant reported lapsing. secondary outcome time frame From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up) secondary outcome measure Longest time of quit secondary outcome description Longest time of quit will be measured via EMAs. Participants will press a button in the app (i.e. I Already Slipped), and once this is done, MASP will record the time and date the participant reported lapsing. secondary outcome time frame From Baseline to end of study (Phase II end of study = Week 6 follow up; Phase III end of study = 54 week follow up) eligibility module eligibility criteria Inclusion Criteria: 18 years of age or older, self-identify as African American, high Anxiety sensitivity defined as a SSASI score of ≥ 5 assessed during phone intake via the SSASI measure (cut-off score to identify high AS individuals), daily smoking (minimum of 10 cigarettes per day) for > 2 years (assessed at screening level by providing a picture of their pack of cigarettes in real-time to screen out non-smokers), motivated to quit smoking (> 5 on a 10-point scale), willing and able to complete all study surveys/assessments, willing to use NRT, and willing to quit smoking 2 weeks after completion of the baseline survey and receipt of study materials (e.g., iCO, nicotine replacement medications). Exclusion Criteria: Report of current or intended participation in a concurrent substance abuse treatment, ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression, current non-nicotine substance dependence, not being fluent in English, current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers (via self-report during the phone screen), legal status that will interfere with participation (provided via self-report during the phone screen), cognitive impairment (assessed via the 6-item Cognitive Impairment Test (6CIT), non-African American, and younger than. Those who participated in a previous stage of the study will not be eligible to participate in further study stages. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Cameron Matoska, B.S. central contact role Contact central contact phone 713-743-8056 central contact e mail ctmatosk@central.uh.edu central contact name Pam Nizio, B.S. central contact role Contact central contact phone 713-743-8056 central contact e mail niziopam@gmail.com location list location location facility TSET Health Promotion Research Center location status Recruiting location city Oklahoma City location state Oklahoma location zip 73104 location country United States location contact list location contact location contact name Michael Businelle, Ph.D. location contact role Contact location contact phone 405-271-8001 location contact phone ext 50460 location contact e mail Michael-Businelle@ouhsc.edu location contact name Krista Kezbers, Ph.D. location contact role Contact location contact phone (405)-271-8001 location contact phone ext 45042 location contact e mail krista-kezbers@ouhsc.edu location facility RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity location status Recruiting location city Houston location state Texas location zip 77204 location country United States location contact list location contact location contact name Cameron Matoska, B.S. location contact role Contact location contact phone 713-743-8056 location contact e mail ctmatosk@central.uh.edu location contact name Pam Nizio, B.S. location contact role Contact location contact phone 713-743-8056 location contact e mail Niziopam@gmail.com location contact name Michael Zvolensky, Ph.D. location contact role Principal Investigator references module reference list reference reference p m i d 35635746 reference type derived reference citation Businelle MS, Garey L, Gallagher MW, Hebert ET, Vujanovic A, Alexander A, Kezbers K, Matoska C, Robison J, Montgomery A, Zvolensky MJ. An Integrated mHealth App for Smoking Cessation in Black Smokers With Anxiety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 30;11(5):e38905. doi: 10.2196/38905. derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11630 intervention browse leaf name Nicotine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04838236
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full study rank 61696 study protocol section identification module n c t id NCT04833114 org study id info org study id Pola-R-ICE secondary id info list secondary id info secondary id MO40599 / GLA 2017-R2 secondary id type Other Identifier secondary id domain Financier organization org full name GWT-TUD GmbH org class OTHER brief title Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL) official title Open-label, Prospective Phase III Clinical Study to Compare Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) With Rituximab, Ifosfamide, Carboplatin and Etoposide (R-ICE) Alone as Salvage Therapy in Patients With Primary Refractory or Relapsed Diffuse Large B-cell Lymphoma (DLBCL) acronym Pola-R-ICE status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 30, 2021 start date type Actual primary completion date struct primary completion date October 31, 2024 primary completion date type Anticipated completion date struct completion date December 31, 2025 completion date type Anticipated study first submit date February 10, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date August 2, 2022 last update post date struct last update post date August 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name GWT-TUD GmbH lead sponsor class OTHER collaborator list collaborator collaborator name Hoffmann-La Roche collaborator class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL) detailed description The study is designed as an international, multicenter, open-label, two-arm, prospective phase III study to compare the treatment of polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with the combination of rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed DLBCL. The study will involve study sites in Germany, UK, Spain, and Austria. It is planned to include 324 patients who will be randomized 1:1 to receive either treatment in the experimental arm (Pola-R-ICE) or in the standard arm (R-ICE) to end up with 308 evaluable subjects for the randomized part of the trial. Further 10 patients will be treated with Pola-R-ICE during the safety run-in phase. The study consists of a screening/inclusion visit, three chemotherapy cycles, an end-of - treatment visit (EoT), and follow-up visits. For each subject, the total duration of the study will be approximately 3 months of treatment plus at least 21 months follow-up. The study will end when the last included patient will have passed the last follow-up visit (LPLFU). For the study as a whole, the primary outcome will be evaluated when the last included patient will have completed the 21 months follow-up period or has left the study prematurely. For the study as a whole, the primary outcome will be evaluated when the last included patient will have completed the 21 months follow-up period or has left the study prematurely. conditions module condition list condition Relapsed Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 334 enrollment type Anticipated arms interventions module arm group list arm group arm group label Experimental Arm: Pola-R-ICE arm group type Experimental arm group description combination of standard chemotherapy with polatuzumab vedotin (Pola-R-ICE) Application arm group intervention list arm group intervention name Drug: Polatuzumab Vedotin Drug: Mabthera Drug: Ifosfamide Drug: Carboplatin Drug: Etoposide arm group label Standard Arm: R-ICE arm group type Active Comparator arm group description conventional treatment with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) arm group intervention list arm group intervention name Drug: Mabthera Drug: Ifosfamide Drug: Carboplatin Drug: Etoposide intervention list intervention intervention type Drug intervention name Polatuzumab Vedotin intervention description Polatuzumab vedotin 1.8 mg/kg will be administered intravenously on Day 1 of each 21-day cycle for up to 3 cycles. intervention arm group label list intervention arm group label Experimental Arm: Pola-R-ICE intervention type Drug intervention name Mabthera intervention description Rituximab (Mabthera/Rituxan®) will be administered as per local practice at a dose of 375 mg/m2 intravenously on Day 1 of each 21-day cycle for up to 3 cycles. intervention arm group label list intervention arm group label Experimental Arm: Pola-R-ICE Standard Arm: R-ICE intervention type Drug intervention name Ifosfamide intervention description Ifosfamide 5000 mg/m² will be administered i.v. over a 24 hr period starting on cycle Day 2. intervention arm group label list intervention arm group label Experimental Arm: Pola-R-ICE Standard Arm: R-ICE intervention type Drug intervention name Carboplatin intervention description Carboplatin AUC 5 max 800 mg will be administered i.v. on cycle Day 2. intervention arm group label list intervention arm group label Experimental Arm: Pola-R-ICE Standard Arm: R-ICE intervention type Drug intervention name Etoposide intervention description Etoposide 100 mg/m² will be administered i.v. on cycle Days 1, 2 and 3. intervention arm group label list intervention arm group label Experimental Arm: Pola-R-ICE Standard Arm: R-ICE outcomes module primary outcome list primary outcome primary outcome measure Assessment of the event-free survival of patients with DLBCL at first progression and the occurrence of any of the following events: primary outcome description Failure to achieve sufficient response in PET-CT (Deauville score 3 or less) at end of study treatment (metabolic CR) Disease progression (PD) Start of additional unplanned anti-tumor treatment (radiation therapy allowed) Relapse after achieving CR Death due to any cause primary outcome time frame Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) secondary outcome list secondary outcome secondary outcome measure Assessment of the rate of metabolic complete response. secondary outcome description Number of complete remissions. secondary outcome time frame Day of randomization until end weeks 12 treatment. secondary outcome measure Evaluation of the partial response rate. secondary outcome description Number of partial responses. secondary outcome time frame Day of randomization until end of 12 weeks treatment. secondary outcome measure Assessment of the overall response rate. secondary outcome description Number of complete and partial responses. secondary outcome time frame Day of randomization until end of 12 weeks treatment. secondary outcome measure Assessment duration of response. secondary outcome description Time from documentation of tumor response to disease progression or relapse. secondary outcome time frame Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) secondary outcome measure Assessment of the rate of progressive disease. secondary outcome description Number of progressive diseases. secondary outcome time frame Day of randomization until end of 12 weeks treatment. secondary outcome measure Assessment of disease relapse. secondary outcome description Number of relapses. secondary outcome time frame Day of randomization until end of 12 weeks treatment. secondary outcome measure Assessment of progression free survival. secondary outcome description Occurence of disease progression, relapse or death due to any cause. secondary outcome time frame Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) secondary outcome measure Assessment of overall survival. secondary outcome time frame Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) secondary outcome measure Assessment of the rate of patients proceeding to transplantation. secondary outcome time frame Day of randomization until week 12. secondary outcome measure Assessment of the rate of patients with non-relapse mortality. secondary outcome time frame Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up) secondary outcome measure Evaluation of the frequency of adverse and serious adverse events including the incidence and duration of the adverse events neutropenia and thrombocytopenia with grade 4. secondary outcome time frame Day of Randomization until 28 days after start of last cycle or start of further therapy secondary outcome measure Assessment of the number of patients with treatment-related death. secondary outcome time frame Day of Randomization until up week 12 or 2 months after week 12 but before start of further therapy secondary outcome measure To determine the number of patients with occurence of second malignancies secondary outcome time frame Day of Randomization until Day of randomization until end of follow up (at least 21 months follow up) secondary outcome measure Assessment of the protocol adherence by the rate and duration of chemotherapy cycles patients received. secondary outcome time frame Day of Randomizaton until week 12. secondary outcome measure Assessment of the cumulative and relative dose of each IMP( ifosfamide, carboplatin and etoposide, rituximab and of the polatuzumab vedotin) by quantitative measurement. secondary outcome time frame Day of Randomizaton until week 12. secondary outcome measure Assessment of the change in health related quality of life by generic questionnaire. secondary outcome description Scale scores to be obtained for the multi-items scales. Range in score from 0 to 100. A high scale score represents a higher response level. secondary outcome time frame Day of Randomization until weeks 12 and months 3 and 12 in follow up. secondary outcome measure Assessment of the change in health related quality of life by five-item questionnaire. secondary outcome time frame Day of Randomization until weeks 12 and months 3 and 12 in follow up secondary outcome measure Assessment visual analogue scale to measure health state. secondary outcome description This scale is provided with numbers from 0 to 100.100 is the best health state and 0 (zero) is the worst health state. secondary outcome time frame Day of Randomization until weeks 12 and months 3 and 12 in follow up secondary outcome measure Functional assessment of the cancer therapy-lymphoma by general questions and specific questions for lymphoma. secondary outcome description Assessment how lymphoma-specific symptoms impact quality of life. secondary outcome time frame Day of Randomization until weeks 12 and months 3 and 12 in follow up. eligibility module eligibility criteria Inclusion Criteria: The informed consent form must be signed before any study specific tests or procedures are done Adult male and female patients ≥18 years (≥16 years in the UK*) at the time of inclusion in the study (* In the UK an "adult" means a person who has attained the age of 16 years, according to The Medicines for Human Use (Clinical Trials) Regulations 2004, Part 1 Point 2.) Ability to understand and follow study-related instructions Risk group: All patients with one of the following histologically defined entities: Histological diagnosis of primary refractory or relapsed aggressive B-cell non-Hodgkin lymphoma (B-NHL), confirmed by a biopsy of involved nodal or extranodal site. Patients with any of the following histologies can be included: DLBCL not otherwise specified (NOS) T-cell/histiocyte-rich large B-cell lymphoma Primary cutaneous DLBCL, leg type Epstein-Barr virus (EBV)-positive DLBCL, NOS DLBCL associated with chronic inflammation Primary mediastinal (thymic) large B-cell lymphoma High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements High-grade B-cell lymphoma, NOS Refractory disease is defined as no complete remission to first line therapy; subjects who are intolerant to first line therapy are excluded. Three groups of patients are eligible: Progressive disease (PD) as best response to first line therapy (biopsy not mandatory if diagnostic sample available). Stable disease (SD) as best response after at least 4 cycles of first line therapy (e.g., 4 cycles of R-CHOP) (biopsy not mandatory if diagnostic sample available). Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease or disease Progression after the partial response. Relapsed disease is defined as complete remission to first line therapy followed by biopsy proven disease relapse. Performance Status ECOG 0-2 at time of randomization or ECOG 3 at screening if this is DLBCL-related and has improved to ECOG 2 or less with a 7-day steroid treatment during the screening Phase (e.g. 1 mg/kg prednisone). Information on all 5 International Prognostic Index (IPI) factors Staging (PET-CT based-staging according to Lugano criteria 2014). Patients must have PET-positive lesions. Subjects must have received adequate first line therapy including at a minimum: i) anti-CD20 monoclonal antibody unless Investigator determines that tumor is CD20 negative, and ii) an anthracycline containing chemotherapy Regimen Intent to proceed to high-dose therapy (HDT) and stem cell transplantation (SCT) if response to second line therapy Adequate hematological function, as defined by: hemoglobin ≥ 8 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 109/L OR ≥ 0.5 x 109/L if neutropenia is attributable to underlying disease and before the administration of steroids, and platelet count ≥ 75 x 109/L OR ≥ 50 x 109/L if thrombocytopenia is attributable to Underlying disease Women of childbearing potential must have a negative pregnancy test result within 7 days prior to the first study drug Administration For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: (1) Serious accompanying disorder leading to impaired organ function causing significant clinical problems and reduced life expectancy of less than 3 months. In particular, patients with the following organ dysfunction caused by accompanying disorders are to be excluded: Heart failure with left ventricular ejection fraction (LVEF) < 45% Impaired pulmonary function with vital capacity (VC) or forced expiratory volume (FEV1) < 50% of normal (only in case of history of significant pulmonary disease) Impaired renal function with glomerular filtration rate (GFR) < 50 mL/min (calculated) Impaired liver function with alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) or Bilirubin > 1.5 x upper limit of normal (ULN). If elevation is caused by the disease, threshold of 2.5 x ULN is accepted Peripheral neuropathy > Grade II (2) Human immunodeficiency virus (HIV)-positivity with detectable viral load and/or a CD4+ count below 0.3/nL (3) Hepatitis B and C as defined by seropositivity (HBsAG and anti HBe/ anti HBc; anti-Hc); in case of false positive serology (transfused antibodies) negative PCR-results will allow patient inclusion. Patients with occult or prior HBV infection (defined as negative HBsAg and positive hepatitis B core antibody [HBcAb]) may be included if HBV DNA is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle and monthly for at least 12 months after the last cycle of study Treatment (4) Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study inclusion or any unresolved major episode of infection (as evaluated by the investigator) within 1 week prior to Cycle 1 Day 1 (5) Patients with suspected or latent tuberculosis. Latent tuberculosis needs to be confirmed by positive interferon-gamma release Assay (6) Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment (7) Richter's transformation or prior chronic lymphocytic leukemia (CLL) (8) Vaccination with a live vaccine within 4 weeks prior to Treatment (9) Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis (10) Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1 (11) Received more than one line of therapy for DLBCL (12) Received polatuzumab vedotin as part of the first line therapy (13) Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications (14) Ongoing treatment or study procedures within any other Investigational Medicinal Product (IMP) clinical trial with the exception of follow-up. In case of a preceding clinical trial, last application of the respective IMP(s) must have been done more than five elimination half-lives before start of study medication in this trial. (15) History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies (16) History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure (17) Contraindications according to the Investigator´s Brochure (IB) of polatuzumab vedotin or the local Summary of Product Characteristics (SmPCs) of the used rituximab, ifosfamide, carboplatin or etoposide products (18) Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's Safety (19) Pregnancy or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug (20) Close affiliation with the investigator (e.g. a close relative) or persons working at the study site (21) Subject is an employee of the sponsor or involved Contract Research Organization At study inclusion, any organ impairment due to lymphoma infiltration is NOT regarded as an exclusion criterion. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Carsta Köhler, Dr. central contact role Contact central contact phone 0049 351 25933 central contact phone ext 190 central contact e mail polarice@g-wt.de overall official list overall official overall official name Bertram Glaß, Prof. overall official affiliation HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation overall official role Principal Investigator location list location location facility UK Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie location status Recruiting location city Graz location zip 8036 location country Austria location facility LKH Hochsteiermark Standort Leoben Abteilung für Innere Medizin Department für Hämato-Onkologie location status Not yet recruiting location city Leoben location zip 8700 location country Austria location facility Ordensklinikum Linz GmbH- Elisabethinen: I. Interne Abteilung Hämato-Onkologie location status Recruiting location city Linz location zip 4020 location country Austria location facility Kepler Universitätsklinikum Med Campus III, Univ.-Klinik für Hämatologie und Internistische Onkologie location status Recruiting location city Linz location zip 4021 location country Austria location facility Landeskrankenhaus Salzburg location status Recruiting location city Salzburg location zip 5020 location country Austria location facility AKH Meduni Wien Universitätsklinik für Innere Medizin I: location status Not yet recruiting location city Vienna location zip 1090 location country Austria location facility Klinikum Wels-Grieskirchen Abteilung für Innere Medizin IV location status Recruiting location city Wels location zip 4600 location country Austria location facility Hanusch Krankenhaus location status Recruiting location city Wien location zip 1140 location country Austria location facility Universitätsklinikum RWTH-Aachen location status Recruiting location city Aachen location country Germany location facility HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation location status Recruiting location city Berlin location zip 13125 location country Germany location facility Städtisches Klinikum Braunschweig location status Recruiting location city Braunschweig location country Germany location facility DIAKO Ev.Diakonie-Krankenhaus gemeinnützige GmbH location status Recruiting location city Bremen location country Germany location facility Klinikum Chemnitz gGmbH location status Recruiting location city Chemnitz location country Germany location facility St. Johannes Hospital Dortmund location status Recruiting location city Dortmund location country Germany location facility Universitätsklinikum Dresden location status Recruiting location city Dresden location country Germany location facility Helios St. Johannes Klinik location status Recruiting location city Duisburg location country Germany location facility Klinik für Onkologie, Hämatologie und Palliativmedizin location status Recruiting location city Düsseldorf location zip 40479 location country Germany location facility Universitätsklinikum Frankfurt location status Not yet recruiting location city Frankfurt location country Germany location facility Georg-August-Universität Göttingen Universitätsmedizin Göttingen location status Recruiting location city Göttingen location country Germany location facility Universitätsklinikum Hamburg-Eppendorf location status Not yet recruiting location city Hamburg location country Germany location facility Universitätsklinikum Jena location status Recruiting location city Jena location country Germany location facility Westpfalz-Klinikum GmbH location status Recruiting location city Kaiserslautern location country Germany location facility Städtisches Krankenhaus Kiel location status Not yet recruiting location city Kiel location country Germany location facility Klinikum Ludwigshafen location status Recruiting location city Ludwigshafen location country Germany location facility Universitätsklinikum Magdeburg location status Recruiting location city Magdeburg location country Germany location facility Universitätsmedizin der Johannes Gutenberg-Universität Mainz location status Recruiting location city Mainz location country Germany location facility Philipps-Universität Marburg location status Recruiting location city Marburg location country Germany location facility Universitätsklinikum Münster location status Not yet recruiting location city Münster location country Germany location facility Klinikum Nürnberg location status Withdrawn location city Nürnberg location country Germany location facility Klinikum Oldenburg location status Recruiting location city Oldenburg location country Germany location facility Universitätsklinikum Regensburg location status Withdrawn location city Regensburg location country Germany location facility Unversitätsmedizin Rostock location status Recruiting location city Rostock location country Germany location facility Klinikum Stuttgart location status Recruiting location city Stuttgart location country Germany location facility Klinikum Mutterhaus location status Recruiting location city Trier location country Germany location facility Universitätsklinikum Ulm location status Recruiting location city Ulm location country Germany location facility Helios Universitätsklinikum Wuppertal location status Recruiting location city Wuppertal location country Germany location facility Hospital Universitario Son Espases location status Recruiting location city Palma location state Islas Baleares location zip 07120 location country Spain location facility Hospital Germans Trias I Pujol location status Recruiting location city Badalona location zip 08916 location country Spain location facility Hospital Universitari Vall d'Hebron location status Recruiting location city Barcelona location zip 8035 location country Spain location facility Hospital Universitario de Donostia location status Recruiting location city Donostia location zip 20014 location country Spain location facility Hospital Universitario de Cabueñes location status Recruiting location city Gijón location zip 33394 location country Spain location facility Institut Català d'oncologia de L'Hospitalet (ICO-L'Hospitalet) location status Recruiting location city Hospitalet de Llobregat location zip 08908 location country Spain location facility Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín location status Recruiting location city Las Palmas De Gran Canaria location zip 35012 location country Spain location facility Hospital Universitario Fundación Jimenez Díaz location status Recruiting location city Madrid location zip 28040 location country Spain location facility Hospital Universitario La Paz location status Recruiting location city Madrid location zip 28046 location country Spain location facility Hospital Universitario Ramón y Cajal location status Recruiting location city Madrid location country Spain location facility Hospital Universitario Virgen de la Arrixaca location status Recruiting location city Murcia location zip 30003 location country Spain location facility Complejo Asistencial Universitario de Salamanca location status Recruiting location city Salamanca location zip 37007 location country Spain location facility Hospital Universitario Marqués de Valdecilla location status Recruiting location city Santander location zip 39908 location country Spain location facility Hospital Universitario Virgen del Rocío location status Recruiting location city Sevilla location zip 41013 location country Spain location facility Hospital Clínico Universitario de Valencia location status Recruiting location city Valencia location zip 46010 location country Spain location facility Belfast City Hospital location status Not yet recruiting location city Belfast location zip BT9 7AB location country United Kingdom location facility Blackpool Victoria Hopsital location status Not yet recruiting location city Blackpool location zip FY3 8NR location country United Kingdom location facility Beatson West of Scotland Cancer Centre location status Not yet recruiting location city Glasgow location zip G12 0YN location country United Kingdom location facility St James University Hospital location status Not yet recruiting location city Leeds location zip LS9 7TF location country United Kingdom location facility Aintree University Hospital location status Not yet recruiting location city Liverpool location zip L9 7AL location country United Kingdom location facility University London College Hospitals location status Not yet recruiting location city London location zip NW1 2PG location country United Kingdom location facility The James Cook University Hospital location status Not yet recruiting location city Middlesbrough location zip TS4 3BW location country United Kingdom location facility Freeman Hospital location status Not yet recruiting location city Newcastle upon Tyne location zip NE7 7DN location country United Kingdom location facility Nottingham City Hospital location status Not yet recruiting location city Nottingham location zip NG5 1PB location country United Kingdom location facility Churchill Hospital location status Not yet recruiting location city Oxford location zip OX3 7LE location country United Kingdom location facility Royal Hallamshire Hospital location status Not yet recruiting location city Sheffield location zip S10 2JF location country United Kingdom location facility Royal Cornwall Hospital location status Not yet recruiting location city Truro location zip TR1 3LQ location country United Kingdom derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008223 condition mesh term Lymphoma condition mesh id D000016393 condition mesh term Lymphoma, B-Cell condition mesh id D000016403 condition mesh term Lymphoma, Large B-Cell, Diffuse condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000008228 condition ancestor term Lymphoma, Non-Hodgkin condition browse leaf list condition browse leaf condition browse leaf id M10372 condition browse leaf name Lymphoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id M17980 condition browse leaf name Lymphoma, B-Cell condition browse leaf as found B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id M17983 condition browse leaf name Lymphoma, Large B-Cell, Diffuse condition browse leaf as found Diffuse Large B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M10374 condition browse leaf name Lymphoma, Non-Hodgkin condition browse leaf relevance low condition browse leaf id T3543 condition browse leaf name Lymphosarcoma condition browse leaf as found Lymphoma condition browse leaf relevance high condition browse leaf id T640 condition browse leaf name B-cell Lymphoma condition browse leaf as found B-Cell Lymphoma condition browse leaf relevance high condition browse leaf id T1866 condition browse leaf name Diffuse Large B-Cell Lymphoma condition browse leaf as found Diffuse Large B-Cell Lymphoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000016190 intervention mesh term Carboplatin intervention mesh id D000005047 intervention mesh term Etoposide intervention mesh id D000069283 intervention mesh term Rituximab intervention mesh id D000007069 intervention mesh term Ifosfamide intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000000972 intervention ancestor term Antineoplastic Agents, Phytogenic intervention ancestor id D000059005 intervention ancestor term Topoisomerase II Inhibitors intervention ancestor id D000059003 intervention ancestor term Topoisomerase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000018906 intervention ancestor term Antineoplastic Agents, Alkylating intervention ancestor id D000000477 intervention ancestor term Alkylating Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M17802 intervention browse leaf name Carboplatin intervention browse leaf as found Program intervention browse leaf relevance high intervention browse leaf id M373 intervention browse leaf name Rituximab intervention browse leaf as found Part of intervention browse leaf relevance high intervention browse leaf id M7343 intervention browse leaf name Etoposide intervention browse leaf as found Infection intervention browse leaf relevance high intervention browse leaf id M341694 intervention browse leaf name Etoposide phosphate intervention browse leaf relevance low intervention browse leaf id M9269 intervention browse leaf name Ifosfamide intervention browse leaf as found 3D intervention browse leaf relevance high intervention browse leaf id M230809 intervention browse leaf name Isophosphamide mustard intervention browse leaf relevance low intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M20095 intervention browse leaf name Antineoplastic Agents, Alkylating intervention browse leaf relevance low intervention browse leaf id M2972 intervention browse leaf name Alkylating Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents
NCT04833114
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full study rank 61220 study protocol section identification module n c t id NCT04839302 org study id info org study id STUDY02000905 organization org full name Dartmouth-Hitchcock Medical Center org class OTHER brief title Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore official title Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore: A Pilot Study status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 5, 2021 start date type Actual primary completion date struct primary completion date April 4, 2024 primary completion date type Anticipated completion date struct completion date April 4, 2025 completion date type Anticipated study first submit date April 8, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date June 16, 2022 last update post date struct last update post date June 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Eric R. Henderson responsible party investigator title Associate Professor of Orthopaedics responsible party investigator affiliation Dartmouth-Hitchcock Medical Center lead sponsor lead sponsor name Dartmouth-Hitchcock Medical Center lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary The primary objective of this work is to determine if fluorescence signal intensity changes from a vascular perfusion fluorophore (indocyanine green) can be associated with the presence of necrotizing fasciitis. Hypothesis - Tissue regions affected with necrotizing fasciitis will demonstrate reduced fluorescence intensity compared to an unaffected region without clinical evidence of necrotizing fasciitis. detailed description Necrotizing fasciitis (NF)-commonly known as 'flesh-eating bacteria'-is an aggressive soft-tissue infection that has a high mortality rate (30-50%). NF is generally associated with traumatic inoculation of extremely aggressive bacteria into the soft-tissues surrounding the fascial layer of connective tissue, just deep to the subcutaneous fat. This tissue layer provides an ideal environment for bacterial growth and also facilitates rapid advancement of the bacteria along the fascia. The result is a soft-tissue infection that often spreads centrally prior to detection and/or adequate management, leading to systemic sepsis, multi-organ failure, and death. Further complicating NF management is that there is no definitive diagnostic test. Patients with NF present generally with pain, fever, and elevated inflammatory labs (white blood cell count (WBC), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP)), other lab abnormalities (elevated glucose and creatinine; reduced sodium and hemoglobin); however, these are non-specific findings that are associated with numerous other-nonfatal-conditions. For this reason, a diagnosis of NF is often missed until the condition has progressed too far. Medical fluorescence is a nascent form of medical imaging that seeks to improve the recognition of important anatomical structures and disease processes through machine-assisted, visual identification using fluorescent probes called fluorophores. Several types of fluorophores exist: targeted fluorophores, enzyme-activated fluorophores, and simple intravascular fluorophores. Intravascular fluorophores, primarily indocyanine green (ICG), have been available for ~100 years. ICG is FDA approved and has an excellent safety record with no demonstrable toxicity. When injected intravenously and viewed with an appropriate fluorescence imager, ICG effectively maps out the local vasculature, enabling the viewer to distinguish perfused and non-perfused tissues. ICG's FDA-approved indications and uses include angiography to determine cardiac output, hepatic function, liver blood flow, and ophthalmic anatomy. Upon histological examination of tissues affected by NF, there exist four commonly observed features: 1) the presence of bacteria; 2) robust neutrophil infiltration; 3) tissue necrosis; 4) vascular thrombosis. DH-H Department of Pathology currently reviews tissue biopsies with respect to these criteria when evaluating tissue for the presence of necrotizing fasciitis (Soloman et al, Modern Pathology, 2018, pp 546-552). While useful to guide clinical decision-making, histological review is not considered to be a definitive diagnostic finding, but these observations do have moderate sensitivity and specificity with culture data, which is considered to be the ultimate determinant of an NF diagnosis. Because of the profound pro-thrombotic effects of necrotizing fasciitis within the subcutaneous tissues, we hypothesize that the administration of ICG and subsequent imaging of a bodily region affected with NF will demonstrate substantially reduced fluorescence compared to the patient's unaffected tissues. If we can demonstrate that ICG fluorescence voids are characteristic of NF, this could potentially lead to a more rapid, and potentially more accurate, diagnosis of NF that would lead to more rapid definitive management and-likely-improved outcomes. The goal of this pilot study is to evaluate whether ICG fluorescence may be used as a non-invasive method of identifying the presence of NF. conditions module condition list condition Necrotising Fasciitis keyword list keyword indocyanine green Necrotising Fascitis design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 15 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients with possible nectrotizing fascitis arm group description Patients with clinical suspicion of necrotizing fasciitis would receive a weight-appropriate IV dose of indocyanine green (ICG, FDA-approved) with immediate fluorescence imaging of the affected body part and simultaneous imaging of an unaffected region arm group intervention list arm group intervention name Drug: Indocyanine green solution intervention list intervention intervention type Drug intervention name Indocyanine green solution intervention description Patients with clinical suspicion of necrotizing fasciitis would receive a weight-appropriate IV dose of indocyanine green (ICG, FDA-approved) with immediate fluorescence imaging of the affected body part and simultaneous imaging of an unaffected region intervention arm group label list intervention arm group label Patients with possible nectrotizing fascitis outcomes module primary outcome list primary outcome primary outcome measure Diagnosis of Necrotising Fascitis using indocyanine green primary outcome description Administration of ICG and subsequent imaging of a bodily region affected with NF will demonstrate substantially reduced fluorescence compared to the patient's unaffected tissues. Demonstration that ICG fluorescence voids are characteristic of NF. primary outcome time frame One Day eligibility module eligibility criteria Inclusion Criteria: Age 18 years or older Clinical suspicion of necrotizing fasciitis based on physician or mid-level provider assessment. Clinical suspicion would be based upon the presence of one or more of these findings: Pain out of proportion to visible findings Temperature 100.4 F LRINEC (Laboratory Risk INdicator for NECrotizing fasciitis) score of ≥6 (https://pubmed.ncbi.nlm.nih.gov/15241098/) Tense soft tissues Determined to be a candidate for soft-tissue biopsy and/or surgical debridement by the on-call emergency department, orthopaedic, and/or general surgical trauma teams. The ability to give written informed consent Exclusion Criteria: History of allergy to ICG and/or iodine Pregnant women or nursing mothers No comparator region available for imaging control healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Subjects presenting to the Emergency Department (ED) with clinical suspicion for necrotizing fasciitis (history, exam, lab studies, imaging studies). sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Amy E Hall, MS central contact role Contact central contact phone 603-653-3306 central contact e mail amy.e.hall@hitchcock.org central contact name Melanie L Christian central contact role Contact central contact phone 6036503556 central contact e mail melanie.l.christian@hitchcock.org overall official list overall official overall official name Eric R Henderson, MD overall official affiliation Dartmouth-Hitchcock Medical Center overall official role Principal Investigator location list location location facility Dartmouth-Hitchock location status Recruiting location city Lebanon location state New Hampshire location zip 03766 location country United States location contact list location contact location contact name Eric R Henderson location contact role Contact location contact phone 603-650-5133 location contact e mail eric.r.henderson@hitchcock.org location contact name Amy M Hall location contact role Contact location contact phone 16036533306 location contact e mail amy.e.hall@hitchcock.org references module reference list reference reference p m i d 29243739 reference type background reference citation Solomon IH, Borscheid R, Laga AC, Askari R, Granter SR. Frozen sections are unreliable for the diagnosis of necrotizing soft tissue infections. Mod Pathol. 2018 Apr;31(4):546-552. doi: 10.1038/modpathol.2017.173. Epub 2017 Dec 15. reference p m i d 19036663 reference type background reference citation Betz CS, Zhorzel S, Schachenmayr H, Stepp H, Havel M, Siedek V, Leunig A, Matthias C, Hopper C, Harreus U. Endoscopic measurements of free-flap perfusion in the head and neck region using red-excited Indocyanine Green: preliminary results. J Plast Reconstr Aesthet Surg. 2009 Dec;62(12):1602-8. doi: 10.1016/j.bjps.2008.07.042. Epub 2008 Nov 25. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005208 condition mesh term Fasciitis condition mesh id D000019115 condition mesh term Fasciitis, Necrotizing condition ancestor list condition ancestor condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M7503 condition browse leaf name Fasciitis condition browse leaf as found Fasciitis condition browse leaf relevance high condition browse leaf id M20281 condition browse leaf name Fasciitis, Necrotizing condition browse leaf as found Necrotising Fasciitis condition browse leaf relevance high condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id T4056 condition browse leaf name Necrotizing Fasciitis condition browse leaf as found Necrotizing Fasciitis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04839302
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full study rank 61308 study protocol section identification module n c t id NCT04838158 org study id info org study id PolishMMHRI 23/06/2010 organization org full name Polish Mother Memorial Hospital Research Institute org class OTHER brief title Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability official title Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability and Its Clinical Implication in Non-surgical Treatment of Patients After First Patella Dislocation. status module status verified date January 2021 overall status Completed expanded access info has expanded access No start date struct start date January 10, 2015 start date type Actual primary completion date struct primary completion date January 30, 2016 primary completion date type Actual completion date struct completion date January 30, 2016 completion date type Actual study first submit date March 22, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Polish Mother Memorial Hospital Research Institute lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6 patients with bilateral involvement. In the study group, both side hamstring muscle were evaluated at the velocities of 60 and 180 deg/s for the following parameters: peak torque, torque in 30 degree of the knee flexion, angle of peak torque and peak torque hamstring to quadriceps ratio (H/Q ratio). detailed description The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6 patients with bilateral involvement. The study group consisted of 20 girls and 13 boys with average age at the time of the study 16.2 years (range: 8 to 17 years, SD 2.7). For the purpose of the study, a control group of 18 healthy subjects (12 girls and 6 boys) aged on the average 15.7 years (range:13 to 17 years, SD 1.5), was recruited. The following study inclusion criteria were applied: recurrent patellar dislocation, correctly completed testing protocol, age under 18 years at the time of testing. Subjects with osteochondral fracture and those with a history of the knee surgery were excluded. Each patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio). Isokinetic measurements were made by a trained, experienced physiotherapist. After a proper warm-up and instruction, the test performed 10 full repetitions, the best result was recorded. The results of the peak torque (PT) of both test and control limbs were then compared with the normative data for age and gender available in the literature. In addition, we compared the peak torque (PT), torque in 30 degrees of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio) of involved and uninvolved knee flexor strength in the study group. Depending on the data distribution, the nonparametric Wilcoxon's test or the parametric t-test for the related data was applied. Statistical significance was assumed for p<0.05. The study was approved by our Institutional Review Board. Informed consent was obtained and the rights of subjects were protected. conditions module condition list condition Patella Dislocation Recurrent Children, Only design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 51 enrollment type Actual arms interventions module arm group list arm group arm group label Intervention group arm group type Active Comparator arm group description Those cases who underwent operative treatment and isokinetics evaluation. arm group intervention list arm group intervention name Diagnostic Test: Isokinetic measurements arm group label Control group arm group type Other arm group description Those who were control group of healthy subjects to compare to normative data arm group intervention list arm group intervention name Diagnostic Test: Isokinetic measurements intervention list intervention intervention type Diagnostic Test intervention name Isokinetic measurements intervention description Each patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio). intervention arm group label list intervention arm group label Control group Intervention group outcomes module primary outcome list primary outcome primary outcome measure hamstrings peak torque primary outcome description measured on Biodex System primary outcome time frame up to 18 months primary outcome measure torque in 30 degrees of the knee flexion primary outcome description measured on Biodex System primary outcome time frame up to 18 months primary outcome measure angle of peak torque primary outcome description measured on Biodex System primary outcome time frame up to 18 months primary outcome measure peak torque hamstring to quadriceps ratio (H/Q ratio) primary outcome description measured on Biodex System primary outcome time frame up to 18 months eligibility module eligibility criteria Inclusion Criteria: recurrent patellar dislocation, correctly completed testing protocol, age under 18 years at the time of testing Exclusion Criteria: osteochondral fracture those with a history of the knee surgery healthy volunteers Accepts Healthy Volunteers gender All minimum age 8 Years maximum age 17 Years std age list std age Child contacts locations module overall official list overall official overall official name Krzysztof Małecki, Ph.D. overall official affiliation Polish Mother's Memorial Hospital Research Institute overall official role Study Director overall official name Jarosław Fabiś, prof. overall official affiliation Medical University of Lodz overall official role Study Chair overall official name Paweł Flont, Ph.D. overall official affiliation Polish Mother's Memorial Hospital Research Institute overall official role Principal Investigator overall official name Anna Fabiś-Strobin, Ph.D. overall official affiliation Polish Mother's Memorial Hospital Research Institute overall official role Principal Investigator overall official name Kryspin Niedzielski, prof. overall official affiliation Polish Mother's Memorial Hospital Research Institute overall official role Study Chair references module reference list reference reference p m i d 34454460 reference type derived reference citation Malecki K, Fabis J, Flont P, Fabis-Strobin A, Niedzielski K. Assessment of knee flexor muscles strength in patients with patellar instability and its clinical implications for the non-surgical treatment of patients after first patellar dislocation - pilot study. BMC Musculoskelet Disord. 2021 Aug 28;22(1):740. doi: 10.1186/s12891-021-04636-4. i p d sharing statement module i p d sharing Yes i p d sharing description Research protocol, personal results, informed consent i p d sharing info type list i p d sharing info type Study Protocol Informed Consent Form (ICF) i p d sharing time frame April 2021 - December 2023 i p d sharing access criteria Upon reasonable request on e-mail krzynormal@wp.pl derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004204 condition mesh term Joint Dislocations condition mesh id D000031222 condition mesh term Patellar Dislocation condition ancestor list condition ancestor condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000007718 condition ancestor term Knee Injuries condition ancestor id D000007869 condition ancestor term Leg Injuries condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf relevance low condition browse leaf id M6537 condition browse leaf name Joint Dislocations condition browse leaf as found Dislocation condition browse leaf relevance high condition browse leaf id M22957 condition browse leaf name Patellar Dislocation condition browse leaf as found Patella Dislocation condition browse leaf relevance high condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M9890 condition browse leaf name Knee Injuries condition browse leaf relevance low condition browse leaf id M10033 condition browse leaf name Leg Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries
NCT04838158
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full study rank 61357 study protocol section identification module n c t id NCT04837521 org study id info org study id Pro00108029 secondary id info list secondary id info secondary id 5P30AG064201-03 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/5P30AG064201-03 secondary id DBSR-11068 secondary id type Other Grant/Funding Number secondary id domain Duke Roybal Center organization org full name Duke University org class OTHER brief title Unified Protocol for Older Adults official title Adapting the Unified Protocol to Facilitate Activity in Older Adults status module status verified date December 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date January 15, 2023 start date type Anticipated primary completion date struct primary completion date December 30, 2023 primary completion date type Anticipated completion date struct completion date December 30, 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date December 1, 2022 last update post date struct last update post date December 2, 2022 last update post date type Estimate sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Duke University lead sponsor class OTHER collaborator list collaborator collaborator name National Institute on Aging (NIA) collaborator class NIH oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Research suggests older adults report wide-ranging emotional distress (e.g., symptoms of anxiety, depression) that negatively impacts their physical and mental health, and is associated with a reduction in daily activity. The overarching goal of this proposal is to adapt an existing evidence-based intervention, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), to increase activity in older adults by reducing emotional distress. The primary aim of the proposed study is to adapt a 5-session version of the UP for use with older adults reporting emotional distress and reduced engagement in daily activities, and to also develop a self-guided version of this intervention. This aim will be accomplished in two phases. In Phase 1, patient will receive the UP as written via telehealth. At the end of treatment they will provide feedback on the treatment, including any suggested changes as well as provide suggestions for changing the treatment that might allow an individual to successfully complete it on their own. This information will be used to iteratively change the treatment and develop a self-guided version of the treatment. In Phase 2, the study team will compare the therapist-delivered and self-guided version of treatment to see if patients find them acceptable. In this phase, patients will be randomized to receive one of these two treatments. detailed description The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP21) is an optimal intervention to adapt for older adults to increase their engagement in daily activities. The UP is an evidence-based CBT. As a transdiagnostic treatment, it can be applied across diagnostic categories to address a wide range of presenting problems. A systematic literature review, conducted by the Principal Investigator, indicated the UP is efficacious for anxiety, depression, and related emotional problems and has been used with older adults. The UP contains five core skills that are relevant to increasing activity engagement -Session 1 (Motivation & Psychoeducation about Emotions); Session 2 (Breaking down Emotions & Mindfulness); Session 3 (Cognitive Flexibility); Session 4 (Countering Emotion-Driven Behaviors); Session 5 (Exposure and Relapse Prevention). Transdiagnostic treatments, like the UP, are advantageous with regard to dissemination and implementation because they are adaptable and reduce clinician training burden. The UP has demonstrated adaptability for underserved patient populations and has been successfully abbreviated to meet the needs of unique patient populations. Further, it has been successfully delivered by clinicians without previous CBT experience, increasing its potential for dissemination. A five session version of this treatment (UP-5) was developed that includes the core skills and showed acceptability in adults with acute suicide risk. The primary aim of this study is to adapt the UP-5 for use with older adults reporting emotional distress to increase their daily activity. Because research indicates the proportion of older adults who access and receive evidence-based treatments is low, the study team is proposing to develop therapist-delivered and self-guided versions of the treatment. Self-guided interventions may be ideal for older adults because they do not compete with other healthcare demands and they have potential for significant public health impact for older adults where access to services is low. The secondary aim of this study is to compare the self-guided and therapist-delivered versions to begin identifying the minimum level of intervention needed to increase activity in older adults. This project is significant because it will produce an implementable, evidence-based treatment to increase access to evidence-based interventions designed to increase daily activity in older adults. Phase 1. The purpose of Phase 1 is to adapt self-guided and therapist-delivered versions of the UP from the existing UP-5 using stakeholder feedback. The study will use a successive cohort design and deliver the UP-5 to two cohorts of two patients (total of 4). This treatment is a manualized, 5 session cognitive behavioral therapy. Treatment will be provided via telehealth by the interventionist, who has expertise delivering evidence-based psychological treatments to older adults. All sessions will be audio or video recorded in order to be rated for therapist adherence. Patients will be asked for consent to record. Those who do not consent to recording will still be allowed to participate in the study. Participants will be provided with a pedometer to keep track of their step count over the course of treatment and report to their interventionist on a weekly basis. During each treatment session, starting at session 2, the interventionist will complete a Clinical Global Impressions-Improvement (CGI-I) rating and document how much of the homework they think the participant completed since the last session (0-100%). One week after the fifth session, patients will provide feedback about the treatment in exit interviews. Interviews will inquire about topics including modifications needed to develop the self-guided UP-5 (e.g., automatic prompts) and whether/how to include a support person (e.g., caregiver) in treatment. Patients will also complete post-treatment measures at this visit: PSFS, PROMIS-anxiety, PROMIS-depression, CFS, BEAQ, SMQ, and the Credibility and Expectancy of Improvement Scale (CEIS). At the end of Phase 1, a self-guided version of the UP-5 will be developed. After each cohort, the UP-5 will be adapted to reflect the stakeholder feedback and the revised treatment will be delivered the subsequent cohort. Phase 2. Phase 2 will be a pilot randomized controlled trial comparing the adapted self-guided and therapist-delivered versions of the UP-5. Patients will be randomized to complete one of these two treatments using the randomization module in REDCap. Per established guidelines, each arm will have 8 patients. Therapist-delivered treatment will be provided by telehealth via the study interventionist. All sessions will be audio or video recorded in order to be rated for therapist adherence. Patients will be asked for consent to record. Those who do not consent to recording will still be allowed to participate in the study. Participants will be provided with a pedometer to keep track of their step count over the course of treatment and report to their interventionist on a weekly basis. During each therapist-delivered, treatment session, starting at session 2, the interventionist will complete a Clinical Global Impressions-Improvement (CGI-I) rating and document how much of the homework they think the participant completed since the last session (0-100%). Outcomes will be evaluated pre/post treatment and include measures of daily activity (PSFS), depression (PROMIS-depression), and anxiety (PROMIS-anxiety), CFS, BEAQ, and SMQ. Treatment satisfaction (Client-Satisfaction Questionnaire) will be evaluated post-treatment as well as the Credibility and Expectancy of Improvement Scale (CEIS). The post-treatment visit will be 1 week after completing self-guided or therapist-driven treatment. Five weeks after completing the final treatment session, measures and reporting of daily step count will be collected remotely, one final time. The PI will rate all sessions for therapist adherence. In regards to the time between the consent visit and the first therapist-delivered therapy session, participants will be allowed to start treatment up to 1month after time of consent, however, on a case by case basis, this window may go longer than 1 month if they maintain contact with the study team and there is a viable reason for the delay. For the 5 sessions of UP-5 treatment, there will be a minimum of 3 days between therapy sessions and all participants will complete the 5 sessions within 2 months (~8 weeks). conditions module condition list condition Emotional Distress Anxiety Depression design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Phase 1 is Single Group. However Phase 2 is parallel comparison to self-guided and therapist-delivered versions of the UP-5 design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Therapist Delivered Unified Protocol arm group type Experimental arm group description This is a five session psychotherapy designed to help people with problems such as anxiety and depression. arm group intervention list arm group intervention name Behavioral: Unified Protocol arm group label Self-Guided Unified Protocol arm group type Experimental arm group description This is a five session treatment that patients can complete independently. arm group intervention list arm group intervention name Behavioral: Unified Protocol intervention list intervention intervention type Behavioral intervention name Unified Protocol intervention description Five session psychotherapy intervention arm group label list intervention arm group label Self-Guided Unified Protocol Therapist Delivered Unified Protocol outcomes module primary outcome list primary outcome primary outcome measure Change in Patient Specific Functional Scale (PSFS) primary outcome description The PSFS is measured on a scale of 0-10 where higher scores indicate higher functioning primary outcome time frame Baseline (pre-treatment), 7 weeks (post treatment) primary outcome measure Change in PROMIS-anxiety primary outcome description The PROMIS-anxiety is measured on a scale of 7-35, with higher scores indicating higher levels of anxiety primary outcome time frame Baseline (pre-treatment), 7 weeks (post treatment) primary outcome measure Change in PROMIS-depression primary outcome description The PROMIS-anxiety is measured on a scale of 8-40, with higher scores indicating higher levels of depression primary outcome time frame Baseline (pre-treatment), 7 weeks (post treatment) primary outcome measure Client Satisfaction Questionnaire (CSQ) primary outcome description The CSQ is measured on a scale of 8-32, with higher scores indicating higher levels of treatment satisfaction primary outcome time frame Post treatment, up to 7 weeks eligibility module eligibility criteria Inclusion Criteria: are age 65+ report moderate or higher emotional distress report reduced engagement in daily activities are willing to engage in telehealth. Exclusion Criteria: present with conditions requiring immediate prioritization (e.g., suicide attempt within past 6months, suicidal ideation with intent/plan, diagnosed with mania/bipolar I, psychosis) are currently receiving psychotherapy have been diagnosed with dementia or has significant concerns with memory as per online/phone screener have changed their psychiatric medications in the past six weeks cannot read are blind cannot speak English healthy volunteers No gender All minimum age 65 Years std age list std age Older Adult contacts locations module central contact list central contact central contact name Andrada Neacsiu, PhD central contact role Contact central contact phone 919-684-6714 central contact e mail andrada.neacsiu@duke.edu central contact name Lisalynn D Kelley, CCRP central contact role Contact central contact phone 919-684-6701 central contact e mail lisalynn.kelley@duke.edu overall official list overall official overall official name Andrada Neacsiu, PhD overall official affiliation Duke University overall official role Principal Investigator location list location location facility Duke University Medical Center location city Durham location state North Carolina location zip 27710 location country United States location contact list location contact location contact name Andrada Neacsiu, PhD location contact role Contact location contact phone 919-684-6714 location contact e mail andrada.neacsiu@duke.edu location contact name Lisalynn Kelley, CCRP location contact role Contact location contact phone 919-684-6701 location contact e mail lisalynn.kelley@duke.edu location contact name Andrada Neacsiu, PhD location contact role Principal Investigator i p d sharing statement module i p d sharing No i p d sharing description Data will be available on request and in compliance with IRB regulations. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf relevance low condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf relevance low condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04837521
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