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NCT06050187

Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch

https://clinicaltrials.gov/study/NCT06050187

ENROLLING_BY_INVITATION

This study will be conducted to compare between accuracy of 3D printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants.

NO

Prosthesis Durability

PROCEDURE: implant casts fabrication

accuracy of 3D printed casts, Accuracy of 3D printed casts will be evaluated digitally by geomagic software, 6 month

Mansoura University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT

A07030123

2022-12-21

2023-12-27

2024-12-17

2023-09-22

2023-12-20

Mansoura University, Mansoura, Dakahlia, 35516, Egypt

{ "implant casts fabrication": [ { "intervention_type": "PROCEDURE" } ] }

NCT02923687

Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain

https://clinicaltrials.gov/study/NCT02923687

COMPLETED

Objective: The aim of this study is to evaluate premedication with ketorolac infiltration on post endodontic pain in patients with symptomatic irreversible pulpitis. Design: Randomized double blind clinical trial Setting and conduct: Sixty adult volunteers with including criteria will be divided into two groups (n=30) based on random table. All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes one group will receive supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and the control group will receive buccal infiltration of normal saline. Endodontic access preparation will initiate after 15 minutes of initial IANB with two negative responses to the electric pulp test. The pain level will be recorded immediately and at the 2,4,6 and 24 hours following the treatment using Heft- Parker Visual Analog Scale (HP- VAS). Data will be evaluated using Repeated measured test (if possible) and otherwise non-parametric tests such as rival Friedman and X2 test. Participants including major eligibility criteria: all patients age ranged 18-65 with symptomatic irreversible pulpitis (HP VAS ≥54) and without pain on percussion on a mandibular molar tooth who need root canal treatment and are without systemic diseases; nonsmoking; non pregnant, non breast feeding without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration Main outcome measures: Pain level at immediately after the treatment, 2, 4, 6 and 24 hours following the root canal treatment using HP VAS.

NO

Irreversible Pulpitis

DRUG: Ketorolac Tromethamine|DRUG: Placebo

Premedication effect of Ketorolac buccal infiltration on post Endodontic pain, The pain level after the root canal therapy will be recorded using HP-VAS up to 24 hours in each of the case and control groups and will be compared., 24 hours

Azad University of Medical Sciences

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

AZadUMS-P/190/D

2016-09

2017-03

2017-06

2016-10-04

2019-01-15

Dental Branch, AZad UMS, Tehran, Iran, Islamic Republic of

{ "Ketorolac": [ { "intervention_type": "DRUG", "description": "Ketorolac Tromethamine", "name": "Ketorolac", "synonyms": [ "Ketorolac", "Toradol", "Acular", "Ketorolaco", "Ketorolacum", "rac-Ketorolac", "K\u00e9torolac", "Sprix" ], "medline_plus_id": "a601241", "generic_names": [ "Ketorolac" ], "mesh_id": "D016861", "drugbank_id": "DB00465" } ], "Tromethamine": [ { "intervention_type": "DRUG", "description": "Ketorolac Tromethamine", "name": "Tromethamine", "synonyms": [ "Tris Buffer", "Tris(hydroxymethyl)aminomethane", "Tris-Mg(II)-KCl Buffer", "Tris", "aminotris(hydroxymethyl)methane", "Trizma", "THAM", "Trometamol", "2-Amino-2-(hydroxymethyl)-1,3-propanediol", "1,1,1-tris(hydroxymethyl)methanamine", "Tri(hydroxymethyl)aminomethane", "Tromethamine", "Trisamine", "Tris-Magnesium(II)-Potassium Chloride Buffer" ], "mesh_id": "D005079", "generic_names": [ "Tromethamine" ], "drugbank_id": "DB03754" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT04874987

Impact of Simulation Based Learning on Gender, and Equity Dynamics Among Inter-health Professional Teams

https://clinicaltrials.gov/study/NCT04874987

Sim-Gender

UNKNOWN

At Mbarara University of Science and Technology and partner sites, the investigators will explore the role of simulation in gender and equity. African societies are largely patriarchal, and this spills over into professional practice and medical education. Simulation methodology is at risk of suffering from a patriarchal dominance. The male dominance has potential to introduce power relationships between men and women learners in a scenario setting and between physicians and nurses. In the presence of such power differentials, the less dominant party could develop a culture of silence, fail to take decisions on issues that affect them or their patients, fail to talk about these issues and take appropriate action.

NO

Simulation-based Methodology

OTHER: Simulation based learning with Advocacy inquiry and ladder of influence

Gender and inter-professional conflicts in simulation, Frequency of gender and inter-professional conflicts reported in simulation session and or clinical care spaces during debriefing sessions, Change in conflicts 24 months after introduction of simulation based techniques

Mbarara University of Science and Technology

University of Calgary|The ELMA Foundation|Alberta Childrens Hospital Research Institute

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2020/MUST-3/SIM-II

2019-06-01

2021-12-30

2022-12-30

2021-05-06

2021-05-06

Mbarara University of Science and Technology, Mbarara, Uganda

{ "Simulation based learning with Advocacy inquiry and ladder of influence": [ { "intervention_type": "OTHER" } ] }

NCT05742087

Neuropathy and Anti-GFAP Antibodies

https://clinicaltrials.gov/study/NCT05742087

Neuro-GFAP

ACTIVE_NOT_RECRUITING

Anti-Glial Fibrillary Acidic Protein (GFAP) are antibodies associated to inflammatory diseases of the central nervous system. The GFAP protein is highly expressed by astrocytes explaining these syndromes, but GFAP is also expressed by immature and non-myelinating Schwann cells. Thus, these antibodies could also lead to damages of the peripheral nervous system (PNS). Moreover, such damages have already been reported on small studies, and there is a need for larger cohorts. The investigators will use the cohort of patients with neurological syndromes and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the Reference center for paraneoplastic neurological syndromes and autoimmune encephalitis to determine the frequency of the PNS involvement in these patients.

NO

Neurological Diseases or Conditions|Neurological Diseases Associated to Anti GFAP Antibodies

OTHER: Clinical examination|OTHER: electroneuromyography (ENMG)

Cranial nerves abnormality at clinical examination of abnormal ENMG, Data concerning the clinical examination and the ENMG will be extracted from the cohort of patients with neurological syndroms and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the Centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes ., Immediately after diagnosis

Hospices Civils de Lyon

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

22-5018

2022-09-01

2022-10-01

2023-05-01

2023-02-23

2023-02-23

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes, Lyon, 69677, France

{ "Clinical examination": [ { "intervention_type": "OTHER" } ], "electroneuromyography (ENMG)": [ { "intervention_type": "OTHER" } ] }

NCT06325787

Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma

https://clinicaltrials.gov/study/NCT06325787

COMPLETED

To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma

NO

Papillary Thyroid Cancer

PROCEDURE: thyroid lobectomy|PROCEDURE: image-guided thermal ablation

disease progression, cervical lymph node metastases, recurrent tumors and persistent tumors, more than 5 years|disease-free survival, disease-free survival calculated from treatment initiation to disease progression or the last follow-up date, more than 5 years

complications, complications after surgery or ablation, 1 week|procedure time, Ablation procedure time was defined from US evaluation for the design of insertion way to treatment terminated. Lobectomy procedure time was defined from incision to closure, not including the anesthesia time., 1 hour after treatment|cost, The ablation cost included preoperative examinations, treatment, local anesthesia and ablation needle costs. The lobectomy cost included preoperative examinations, treatment, general anesthesia, hospital bed, nursing and postoperative medication, 1 week|estimated blood loss, estimated blood loss after surgery or ablation, 1 hour|hospitalization, hospitalization for surgery or ablation, 1 week

Chinese PLA General Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

S2021-211-02

2013-05-01

2017-01-31

2024-01-31

2024-03-22

2024-03-25

{ "thyroid lobectomy": [ { "intervention_type": "PROCEDURE" } ], "image-guided thermal ablation": [ { "intervention_type": "PROCEDURE" } ] }

NCT02224287

Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

https://clinicaltrials.gov/study/NCT02224287

COMPLETED

This is a prospective randomized trial to study the effect of assigning the control of the fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist. Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose parameters (cumulative absorbed dose and dose area product). From exposure data, entrance skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in this study will be total fluoroscopy time for the procedure. A secondary outcome will be the ESD. The investigators will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and ESD. It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating surgeon is controlling the activation of the x-ray beam.

NO

Urolithiasis|Kidney Stones

PROCEDURE: Technologist control of fluoroscopy|PROCEDURE: Surgeon control of fluoroscopy

The primary outcome in this study will be total fluoroscopy time for the procedure., The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed., 1-5 hours

A secondary outcome will be the entrance skin dose (mGy). We will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and entrance skin dose., The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed., 1-5 hours

Boston Childrens Hospital

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

P00003145

2013-01

2017-01

2017-01

2014-08-25

2020-06-29

Boston Childrens Hospital, Boston, Massachusetts, 02115, United States

{ "Technologist control of fluoroscopy": [ { "intervention_type": "PROCEDURE" } ], "Surgeon control of fluoroscopy": [ { "intervention_type": "PROCEDURE" } ] }

NCT02701387

Effect of Implant Thread Design on Implant Stability Quotient (ISQ) in Early Healing Period

https://clinicaltrials.gov/study/NCT02701387

COMPLETED

The purpose of this study is to determine whether implant thread design impacts bone remodeling and/or dental implant stability in the early healing period. The population of this study will consist of a group of subjects who are interested in replacing two or more missing teeth with dental implants. All implant sites will be healed and not require bone augmentation for the placement of a standard 4 mm diameter implant. Subjects first will undergo a brief screening exam. If accepted, comprehensive oral exam will be completed. Subsequently, enrolled subjects will be scheduled for dental surgery to place the implant(s). Subjects will return weekly for the first 8 weeks after placement for a brief post-operative appointment in order to conduct measurements for the study.

YES

Partial Edentulism

DEVICE: Megagen AnyRidge dental implant|DEVICE: Megagen EZ Plus dental implant

Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone, Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows: Tr0 = T0 (baseline) Tr1 = Average of follow-up week 1 (T1) and follow-up week 2 (T2) Tr2 = Average of follow-up week 3 (T3) and follow-up week 4 (T4) Tr3 = Average of follow-up week 5 (T5) and follow-up week 6 (T6) Tr4 = Average of follow-up week 7 (T7) and follow-up week 8 (T8), Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)

University of California, Los Angeles

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

UCLA Megagen AnyRidge ISQ

2014-08

2015-04

2015-04

2016-03-08

2016-12-29

2016-12-29

{ "Megagen AnyRidge dental implant": [ { "intervention_type": "DEVICE" } ], "Megagen EZ Plus dental implant": [ { "intervention_type": "DEVICE" } ] }

NCT02662387

External Nasal Dilator and Oxygen Therapy in Respiratory Failure

https://clinicaltrials.gov/study/NCT02662387

HFNC

COMPLETED

Acute respiratory failure secondary to bronchiolitis and asthma is one of the most common diagnoses in children admitted to pediatric intensive care unit. Objectives: The primary outcome of the study is to compare the respiratory parameters between patients on HFNC and HFNC with ENDs. Methods: This is a prospective randomized controlled trial. All children admitted to Loma Linda University Childrens Hospital due to acute respiratory failure secondary to bronchiolitis and asthma are eligible for inclusion in the study. Multiple respiratory parameters will be collected as part of the study. The investigators anticipate that use of END will have a positive impact on the respiratory status of children with acute respiratory failure. Appropriate statistical analysis of the data will occur after the data has been de-identified.

YES

Acute Respiratory Failure

DEVICE: External nasal dilator (END)|OTHER: High flow nasal cannula (HFNC)

Change of Respiratory Status Using the Modified Bronchiolitis Severity Score, in Children Using External Nasal Dilators as an Adjuvant to High Flow Nasal Cannula Oxygen Therapy Compared to Those Receiving High Flow Nasal Cannula Therapy Alone, Change of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status), Change from baseline to time of hospital discharge, no greater than 1 month

Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU, Actual length of stay in pediatric ICU from admission to discharge, From subject enrollment to hospital discharge, not >170 hr

Loma Linda University

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

5150128

2016-02-02

2016-05-19

2016-06-15

2016-01-25

2017-07-21

2017-08-21

LLUCH, Loma Linda, California, 92374, United States

{ "External nasal dilator (END)": [ { "intervention_type": "DEVICE" } ], "High flow nasal cannula (HFNC)": [ { "intervention_type": "OTHER" } ] }

NCT00289887

Obese Hypertension Study (0954-315)

https://clinicaltrials.gov/study/NCT00289887

COMPLETED

This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

YES

Hypertension

DRUG: Comparator: losartan +/- HCTZ|DRUG: Comparator: Placebo

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8, Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline., At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8, Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline., At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12, Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline., At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12, Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline., At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16, Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline., At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16, Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline., At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Organon and Co

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

0954-315|MK0954-315|2006_002

2006-02

2007-02

2007-03

2006-02-10

2010-05-27

2022-02-09

{ "Losartan": [ { "intervention_type": "DRUG", "description": "Comparator: losartan +/- HCTZ", "name": "Losartan", "synonyms": [ "(2-butyl-4-chloro-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-imidazol-5-yl)methanol", "MK954", "MK 954", "DuP753", "Losartan Potassium", "2-Butyl-4-chloro-1-((2'-(1H-etrazol-5-yl) (1,1'-biphenyl)-4-yl)methyl)-1H-imidazole-5-methanol", "DuP 753", "Losartan", "Monopotassium Salt, Losartan", "Potassium, Losartan", "2-n-butyl-4-chloro-5-hydroxymethyl-1-[(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]imidazole", "MK-954", "Losartan Monopotassium Salt", "Cozaar", "DuP-753", "Salt, Losartan Monopotassium" ], "medline_plus_id": "a695008", "generic_names": [ "Losartan" ], "nhs_url": "https://www.nhs.uk/medicines/losartan", "mesh_id": "D047228", "drugbank_id": "DB00678" } ], "Hydrochlorothiazide": [ { "intervention_type": "DRUG", "description": "Comparator: losartan +/- HCTZ", "name": "Hydrochlorothiazide", "synonyms": [ "Zide", "Hidroclorotiazida", "Sectrazide", "Dihydrochlorothiazide", "Hypothiazide", "Hydrochlorothiazidum", "Microzide", "Oretic", "Esidrix", "Apo-hydro", "Hydrochlorothiazide", "Dichlothiazide", "Esidrex", "HCTZ", "HydroDIURIL" ], "medline_plus_id": "a682571", "generic_names": [ "Hydrochlorothiazide" ], "mesh_id": "D049993", "drugbank_id": "DB00999", "wikipedia_url": "https://en.wikipedia.org/wiki/Hydrochlorothiazide" } ], "Comparator: Placebo": [ { "intervention_type": "DRUG" } ] }

NCT04170387

Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients

https://clinicaltrials.gov/study/NCT04170387

Fibrorilax

UNKNOWN

The aim of the study is to evaluate the differences in cognitive performance and quality of life, after a cycle of treatment with the relaxometer, between a group of patients affected by fibromyalgia and a control group.

NO

Fibromyalgia Syndrome|Fibromyalgia|Pain, Chronic|Impairment|Cognitive Impairment

OTHER: Relaxometer

Assessment of differences in cognitive performance of patients affected by fibromyalgia with cognitive impairment before and after a cycle of treatment with the relaxometer., Mini-Mental State Examination (MMSE) administered before the first treatment with the relaxometer (T0), after the last treatment with the relaxometer (T1, on the 10^ day from the first treatment) and on the 30^ day from the first treatment (T2). Mini-Mental State Examination is a 30 point questionnaire used to measure cognitive impairment. Normal cognition 24-30 points Mild cognitive impairment 19-23 points Moderate cognitive impairment 10-18 points Severe cognitive impairment <9 points The score is corrected for educational attainment and age, according to MMSE guidelines., 4 weeks

Evaluate the differences in cognitive performance obtained at the end of treatment, between the case group (patients affected by fibromyalgia with cognitive impairment) and the control group., Comparison of Mini-Mental State Examination (MMSE) results. Mini-Mental State Examination is a 30 point questionnaire used to measure cognitive impairment. Normal cognition 24-30 points Mild cognitive impairment 19-23 points Moderate cognitive impairment 10-18 points Severe cognitive impairment <9 points The score is corrected for educational attainment and age, according to MMSE guidelines., 52 weeks|Evaluate the differences in quality of life (QoL) of patients affected by fibromyalgia before and after a cycle of treatment with the relaxometer, comparing them with the control group., Fibromyalgia Impact Questionnaire revised (FIQ-R) administered before the first treatment with the relaxometer and during the last examination on the 30^ day from the first treatment. Fibromyalgia Impact Questionnaire revised (FIQ-R) explores three domains: function, overall impact, and symptoms. The score of each domain is divided by a specific number * Function domain sum (0-90) divided by 3 (upper limit 30) * Overall impact domain sum (0-20) divided by one (0-20) * Symptom domain sum (0-100) divided by 2 (upper limit 50) The three resulting domain scores are added together to obtain the total score of the Fibromyalgia Impact Questionnaire revised (FIQ-R) range 0-100. 75-100 Extreme fibromyalgia 60-74 Severe fibromyalgia 43-59 Moderate fibromyalgia 0-42 Mild fibromyalgia, 52 weeks

Azienda Ospedaliera Universitaria Integrata Verona

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

Fibrorilax

2019-12-15

2019-12-15

2020-10-14

2019-11-20

2019-12-16

{ "Relaxometer": [ { "intervention_type": "OTHER" } ] }

NCT06466187

A Study of SGN-MesoC2 in Advanced Solid Tumors

https://clinicaltrials.gov/study/NCT06466187

NOT_YET_RECRUITING

This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but havent spread, theyre called locally advanced. If your cancer has spread to other parts of your body, its called metastatic. When a cancer has gotten so big it cant easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that cant be treated with standard of care drugs. This clinical trial uses an experimental drug called SGN-MesoC2. SGN-MesoC2 is a type of antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will have 3 parts. Part A and Part B of the study will find out how much SGN-MesoC2 should be given to participants. Part C will use the information from Parts A and B to see if SGN-MesoC2 is safe and if it works to treat solid tumor cancers.

NO

Carcinoma, Non-Small-Cell Lung|Ovarian Neoplasms|Pancreatic Adenocarcinoma|Colorectal Neoplasms|Mesothelioma|Other Solid Tumors

DRUG: SGN-MesoC2

Number of participants with adverse events (AEs), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Through 30-37 days after the last dose of study treatment, 48 Months|Number of participants with laboratory abnormalities, Through 30-37 days after the last dose of study treatment, 48 Months|Number of participants with dose modifications, Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions and treatment discontinuations) due to AEs, Up to 4 months|Number of participants with dose-limiting toxicities (DLTs), Incidence of dose-limiting toxicities (DLTs), Cycle 1 (21 days)

Objective response rate (ORR), ORR is defined as the proportion of participants in the relevant analysis set with best response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1., Approximately 1 year 4 months|Best response, The best timepoint response achieved for the subject during the protocol specified period according to RECIST V1.1., Approximately 1 year 4 months|Duration of response (DOR), DOR is defined as the time interval from first occurrence of documented objective response to the time of progressive disease (PD) according to RECIST v1.1 or death from any cause, whichever comes first., Approximately 1 year 4 months|Disease control rate (DCR), DCR is defined as the proportion of participants with best response of CR, PR or stable disease (SD) according to RECIST v1.1., Approximately 1 year 4 months|Progression-free survival (PFS), PFS is defined as the time from first dosing to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first., Approximately 1 year 4 months|Overall survival (OS), Overall survival (OS) defined as the time from first dosing to death., Approximately 1 year 4 months|Pharmacokinetic (PK) parameter - Area under the serum concentration (AUC), Cycles 1, 2, and 3 (each cycle is up to 21 days)|Pharmacokinetic (PK) parameter - Maximum serum concentration (Cmax), Cycles 1, 2, and 3 (each cycle is up to 21 days)|Pharmacokinetic (PK) parameter - Time to reach maximum serum concentration (Tmax), Cycles 1, 2, and 3 (each cycle is up to 21 days)|Pharmacokinetic (PK) parameter - Half-life, Cycles 1, 2, and 3 (each cycle is up to 21 days)|Number of participants with antidrug antibodies, Cycles 1, 2, and 3 (each cycle is up to 21 days)

Seagen Inc.

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

SGNMesoC2-001|C5991001

2024-08-15

2028-11-01

2028-11-01

2024-06-20

2024-06-20

{ "SGN-MesoC2": [ { "intervention_type": "DRUG" } ] }

NCT01569087

Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer

https://clinicaltrials.gov/study/NCT01569087

COMPLETED

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.

YES

Chemotherapy-induced Neutropenia

BIOLOGICAL: empegfilrastim|BIOLOGICAL: filgrastim

CTCAE Grade 3/4 Neutropenia Incidence, 21 days

Mean Duration of CTCAE Grade 4 Neutropenia, 21 days|The Duration of Any Grade Neutropenia, 21 days|Low Level (Nadir) ANC x 10^9/L, 21 days|Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy, 21 days|Incidence of Febrile Neutropenia, 21 days

Biocad

FEMALE

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

BCD-017-2

2012-05

2013-01

2013-02

2012-04-02

2016-10-24

2016-12-05

Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk, 163045, Russian Federation|Perm Region Oncology Dispensary, Perm, 614066, Russian Federation|N.N.Petrov Oncology Research Center, St.Petersburg, 197758, Russian Federation|Russian scientific center of radiology and surgery technologies, St.Petersburg, Russian Federation|Volgograd District Oncology Dispensary №1, Volgograd, 400138, Russian Federation

{ "empegfilrastim": [ { "intervention_type": "BIOLOGICAL" } ], "Filgrastim": [ { "intervention_type": "BIOLOGICAL", "description": "filgrastim", "name": "Filgrastim", "synonyms": [ "Granulocyte Colony Stimulating Factor", "Nivestym", "Granulocyte Colony-Stimulating Factor", "Filgrastim-aafi", "R metHuG CSF", "G-CSF Recombinant, Human Methionyl", "Fraven", "Recombinant Methionyl Human Granulocyte Colony Stimulating Factor", "Granix", "G-CSF", "Tbo Filgrastim", "Topneuter", "Filgrastim-sndz", "Zarxio", "Tbo-filgrastim", "R-metHuG-CSF", "Recombinant Methionyl Human G-CSF", "Tbo-Filgrastim", "Recombinant-Methionyl Human Granulocyte Colony-Stimulating Factor", "Filgrastim", "G CSF Recombinant, Human Methionyl", "Neupogen" ], "medline_plus_id": "a692033", "generic_names": [ "Filgrastim" ], "mesh_id": "D006401", "drugbank_id": "DB00099", "wikipedia_url": "https://en.wikipedia.org/wiki/Filgrastim" } ] }

NCT02863887

Lifestyle Changes Through Exercise and Nutrition

https://clinicaltrials.gov/study/NCT02863887

LEAN

COMPLETED

The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits, increased physical activity, improved blood glucose and cholesterol, and weight related quality of life in obese African American adults through a sustainable, technology enhanced, church-based program.

NO

Obesity|Diabetes

BEHAVIORAL: Weight loss intervention

Percent weight loss, Percent weight loss will be calculated at 6 and 12 months., Month 6 and Year 1

Change in Body Fat Percentage, The participants body fat percentage is measured using the portable Tanita Body Composition Analyzer (SC-240)., Screening, Month 6 and Year 1|Change in Blood Glucose, The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible glucose testing results. The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain., Screening, Month 6 and Year 1|Change in Blood Pressure, Blood pressure will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar). Participants will rest for approximately 5 minutes prior to blood pressure measurement to ensure accurate at rest reading., Screening, Month 6 and Year 1|Change in Food Intake, The National Cancer Institute (NCI) fat screener estimates the percentage of energy from fat by asking patients to report the frequency of consuming specific foods over the past 12 months. A standard 7-item fruit and vegetable screener developed by the NCI and National 5 a Day Program grantees asks how often fruit and vegetables were consumed in the past month., Screening, Month 6 and Year 1|Change in Physical activity, The International Physical Activity Questionnaire (IPAQ) questionnaire is a self-report measure of physical activity. The metabolic equivalent task (MET) minutes in each domain of leisure time activity, that is, sedentary, light, moderate, and vigorous intensity, will be calculated. The IPAQ has been shown to be a reliable and valid measure of physical activity and has been sensitive to changes in physical activity resulting from intervention programs., Screening, Month 6 and Year 1|Change in Quality of Life, . Each participants quality of life will be assessed using the Impact of Weight on Quality of Life Survey., Screening, Month 6 and Year 1|Satisfaction Questionnaire, Each participants satisfaction with the different elements of the study, including the community health coaches, the intervention, and the text messages, will be measured using a questionnaire developed by the investigators., Month 6 and Year 1|Change in Blood Cholesterol, The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible cholesterol testing results. The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain., Screening, Month 6 and Year 1|Change in Pulse, Pulse will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar). Participants will rest for approximately 5 minutes prior to pulse measurement to ensure accurate at rest reading., Screening, Month 6 and Year 1

Pennington Biomedical Research Center

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT

PBRC 2016-018

2016-06

2017-09-23

2017-09-23

2016-08-11

2018-06-06

Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States

{ "Weight loss intervention": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03252587

An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

https://clinicaltrials.gov/study/NCT03252587

COMPLETED

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

YES

Systemic Lupus Erythematosus

DRUG: BMS-986165|OTHER: Placebo

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32, SRI(4) responder is defined as a patient whose disease course fulfills all of the following: 1. A 4-point or greater reduction from baseline in SLEDAI-2K score 2. No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade 3. No worsening from baseline in the Physicians Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity, At week 32

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48, SRI(4) responder is defined as a patient whose disease course fulfills all of the following: 1. A 4-point or greater reduction from baseline in SLEDAI-2K score 2. No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade 3. No worsening from baseline in the Physicians Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity, At week 48|Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response, BICLA responder is defined as a patient whose disease course fulfills all of the following: 1. Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline 2. No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B 3. No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score) 4. No increase ≥ 10% in the Physicians Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity 5. No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment, At week 48|Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS), LLDAS is defined as follows: 1. SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System 2. No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters 3. Physicians Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity 4. A current prednisolone (or equivalent) dose ≤ 7.5 mg daily 5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, At Week 48|Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10, Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia, At week 48|Change From Baseline in the 40-Joint Count, Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of: 1. Tender joint count (0 to 40) 2. Swollen joint count (0 to 40) 3. Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease., Baseline and week 48|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment, From first dose to 30 days post last dose (Up to 52 weeks)|Number of Participants With Laboratory Abnormalities in Specific Liver Tests, Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following: 1. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN) 2. Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase) 3. No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic, From first dose to 30 days post last dose (Up to 52 weeks)|Number of Participants With Abnormalities in Vital Signs, Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure, From first dose to 30 days post last dose (Up to 52 weeks)|Number of Participants With Abnormalities in Electrocardiograms (ECGs), Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval, From baseline to up to week 48|BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax), Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported., Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12|BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax), Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261., Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12|BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough), Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported., Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48|Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels, Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose., From baseline to week 44|Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32, Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose., From baseline to week 32|Percent Change From Baseline in Complement Proteins C3 and C4 Levels, Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose., From baseline to week 52|Percent Change From Baseline in Complement (C3, C4) Levels at Week 32, Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose., From baseline to week 32|Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels, Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose., From baseline to week 52|Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32, Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose., From baseline to week 32|Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status, Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following: 1. A 4-point or greater reduction from baseline in SLEDAI-2K score 2. No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade 3. No worsening from baseline in the Physicians Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity, At week 32

Bristol-Myers Squibb

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

IM011-021|2017-001203-79

2017-09-21

2021-06-29

2021-10-28

2017-08-17

2022-09-10

2022-12-20

Local Institution - 0178, Birmingham, Alabama, 35205, United States|Little Rock Diagnostic Clinic, Little Rock, Arkansas, 72205, United States|Local Institution - 0023, El Cajon, California, 92020, United States|BioSolutions Clinical Research Center, La Mesa, California, 91942, United States|Los Angeles County Hospital and University of Southern California Medical Center, Los Angeles, California, 90033, United States|University of California at Irvine College of Medicine, Orange, California, 92868, United States|Local Institution - 0227, Palm Desert, California, 92260, United States|Millennium Clinical Trials - Thousand Oaks, Thousand Oaks, California, 91360, United States|The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California, 90502, United States|Inland Rheumatology Clinical Trials, Upland, California, 91786, United States|Local Institution - 0034, Farmington, Connecticut, 06030-5353, United States|Local Institution - 0195, New Haven, Connecticut, 06520-8018, United States|Local Institution - 0010, Aventura, Florida, 33180, United States|Local Institution - 0066, Brandon, Florida, 33511, United States|Local Institution - 0214, Gainesville, Florida, 32603, United States|Local Institution - 0233, Orlando, Florida, 32808, United States|Local Institution - 0057, Ormond Beach, Florida, 32174-1139, United States|Local Institution - 0002, Tamarac, Florida, 33321, United States|Local Institution - 0038, Tampa, Florida, 33613, United States|BayCare Medical Group, Tampa, Florida, 33614, United States|Local Institution - 0206, Atlanta, Georgia, 30303, United States|Local Institution - 0022, Decatur, Georgia, 30033, United States|Local Institution - 0083, Lawrenceville, Georgia, 30046, United States|Arthritis Research and Treatment Center, Stockbridge, Georgia, 30281, United States|Klein & Associates, Cumberland, Maryland, 21502, United States|Klein and Associates, Hagerstown, Maryland, 21740, United States|Advanced Rheumatology - Lansing, Lansing, Michigan, 48910, United States|University of Minnesota, Minneapolis, Minnesota, 55455-0341, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Local Institution - 0011, Brooklyn, New York, 11201, United States|SUNY Downstate Health Science University, Brooklyn, New York, 11203, United States|Local Institution - 0082, Lake Success, New York, 11042, United States|Local Institution - 0109, New York, New York, 10016, United States|Local Institution - 0232, New York, New York, 10032, United States|Local Institution - 0119, Chapel Hill, North Carolina, 27599-7280, United States|Local Institution - 0026, Charlotte, North Carolina, 28204, United States|Local Institution - 0180, Oklahoma City, Oklahoma, 73103, United States|Local Institution - 0197, Oklahoma City, Oklahoma, 73104, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15261, United States|Local Institution - 0174, Wyomissing, Pennsylvania, 19610, United States|Local Institution - 0190, Charleston, South Carolina, 29425, United States|Local Institution - 0001, Jackson, Tennessee, 38305, United States|University of Tennessee Health Science Center, Memphis, Tennessee, 38163, United States|Local Institution - 0087, Austin, Texas, 78731-3146, United States|Local Institution - 0086, Austin, Texas, 78745, United States|Pioneer Research Solutions, Cypress, Texas, 77429-5890, United States|Baylor Research Institute, Dallas, Texas, 75231, United States|Local Institution - 0193, Dallas, Texas, 75390, United States|Local Institution - 0204, Houston, Texas, 77084, United States|Local Institution - 0061, Houston, Texas, 77089, United States|Local Institution - 0047, Mesquite, Texas, 75150, United States|Arthritis and Osteoporosis Center of South Texas, San Antonio, Texas, 78232, United States|Local Institution - 0171, Chesapeake, Virginia, 23320-4985, United States|University of Washington, Seattle, Washington, 98195, United States|Arthritis Northwest, PLLC, Spokane, Washington, 99204, United States|Local Institution - 0166, Caba, Buenos Aires, C1114AAF, Argentina|Local Institution - 0139, Ciudad Autonoma de Buenos Aires, Buenos Aires, 1430, Argentina|Local Institution - 0185, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1046AAQ, Argentina|Local Institution - 0136, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1111AAL, Argentina|Local Institution - 0138, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC, Argentina|Local Institution - 0152, Rosario, Santa Fe, S2000PBJ, Argentina|Local Institution - 0097, San Miguel De Tucum, Tucuman, T4000AXL, Argentina|Local Institution - 0096, Cordoba, X5004FHP, Argentina|Hospital Privado Centro Medico de Cordoba, Cordoba, X5016KEH, Argentina|Local Institution - 0137, Mendoza, 5500, Argentina|Local Institution - 0241, Maroochydore, Queensland, 4558, Australia|Heidelberg Repatriation Hospital, Heidelberg West, Victoria, 3081, Australia|Local Institution - 0130, Salvador, Bahia, 40150150, Brazil|Local Institution - 0129, Goiania, Goias, 74110-120, Brazil|Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte, Minas Gerais, 30150-223, Brazil|Local Institution - 0125, Juiz de Fora, Minas Gerais, 36010-570, Brazil|Local Institution - 0126, Curitiba, Parana, 80030-110, Brazil|Local Institution - 0128, Porto Alegre, RIO Grande DO SUL, 90480-000, Brazil|Hospital de Clinicas de Porto Alegre, Porto Alegre, SAO Paulo, 90035-903, Brazil|Local Institution - 0151, Sao Bernardo do Campo, SAO Paulo, 09715-090, Brazil|CITIPA - Centro de Imunoterapia de Ipanema, Rio de Janeiro, 22221-020, Brazil|Local Institution - 0148, Sao Paulo, 01228-200, Brazil|Local Institution - 0247, Calgary, Alberta, T2N 4Z6, Canada|University of Alberta Hospital, Edmonton, Alberta, T6G 2G3, Canada|McMaster University Medical Centre, Hamilton, Ontario, L8S 4K1, Canada|Local Institution - 0245, Toronto, Ontario, M5T 2S8, Canada|Local Institution - 0098, Barranquilla, 080002, Colombia|Local Institution - 0099, Barranquilla, 0, Colombia|Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM), Bogota, Colombia|Medicity SAS, Bucaramanga, 680003, Colombia|Local Institution - 0161, Cali, Colombia|Local Institution - 0100, Chia, 250001, Colombia|Local Institution - 0159, Zipaquira, 250252, Colombia|Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi, Berlin, D-10117, Germany|Klinik fur Nieren- und Hochdruckerkrankungen, Hannover, 30625, Germany|Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin, Mainz, 55131, Germany|Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest, 1097, Hungary|Debreceni Egyetem Klinikai Kozpont, Debrecen, 4032, Hungary|Local Institution - 0035, Gyula, 5700, Hungary|Local Institution - 0123, Szeged, 6725, Hungary|Local Institution, Haifa, 33394, Israel|Local Institution, Jerusalem, 9122001, Israel|Local Institution, Kfar Saba, 4428164, Israel|Local Institution, Petah Tikva, 4941492, Israel|Local Institution, Tel-Hashomer, 52621, Israel|Local Institution - 0117, Chiba-shi, Chiba, 260-8712, Japan|Kameda Clinic, Kamogawa-shi, Chiba, 296-0041, Japan|Local Institution - 0177, Kitakyushu, Fukuoka, 807-8556, Japan|Local Institution - 0141, Sapporo-shi, Hokkaido, 0608604, Japan|Hokkaido University Hospital, Sapporo, Hokkaido, 060-8648, Japan|Tohoku University Hospital, Sendai City, Miyagi, 980-8574, Japan|Tomishiro Central Hospital, Tomigusuku-shi, Okinawa, 9010243, Japan|Dokkyo Medical University, Shimotsuga-gun, Tochigi, 3210293, Japan|Local Institution - 0183, Shimotsuke-city, Tochigi, 329-0498, Japan|Local Institution - 0154, Chuo-ku, Tokyo, 104-8560, Japan|Local Institution - 0144, Itabashi-ku, Tokyo, 1738610, Japan|Keio University Hospital, Shinjuku-Ku, Tokyo, 1608582, Japan|Kanazawa University Hospital, Ishikawa, 920-8641, Japan|Local Institution - 0162, Tokyo, 113-8431, Japan|Showa University Hospital, Tokyo, 142-8666, Japan|National Hospital Organization Tokyo Medical Center, Tokyo, 152-8902, Japan|Local Institution - 0133, Tokyo, 162-8655, Japan|Local Institution, Daegu, 41944, Korea, Republic of|Local Institution, Daegu, 42601, Korea, Republic of|Local Institution, Daejeon, 35015, Korea, Republic of|Local Institution - 0253, Gwangju, 61469, Korea, Republic of|Local Institution, Incheon, 400-711, Korea, Republic of|Local Institution - 0054, Seoul, 03080, Korea, Republic of|Local Institution - 0050, Suwon, 16499, Korea, Republic of|Local Institution - 0140, Mexico City, Distrito Federal, 11850, Mexico|Local Institution - 0173, Mexico, Distrito Federal, 06760, Mexico|Local Institution - 0163, Leon, Guanajuato, Guanajuato, 37000, Mexico|Local Institution - 0172, Leon, Guanajuato, 37160, Mexico|Local Institution - 0135, Guadalajara, Jalisco, 44160, Mexico|Local Institution - 0156, Zapopan, Jalisco, 45070, Mexico|Juan Alberto Rodriguez Ruiz, Zapopan, Jalisco, 45116, Mexico|Local Institution - 0134, Monterrey, Nuevo LEON, 64000, Mexico|Local Institution - 0149, San Luis Potosi, 78213, Mexico|Faicic S. de R.L. de C.V., Veracruz, 91900, Mexico|Local Institution - 0089, Bydgoszcz, 85-168, Poland|Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C, Bytom, 41-902, Poland|Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska, Elblag, 82-300, Poland|Centrum Medyczne Pratia w Gdyni, Gdynia, 81-338, Poland|Silmedic Sp. z o.o., Katowice, 40-282, Poland|Zespol Opieki Zdrowotnej w Konskich, Konskie, 26-200, Poland|Local Institution - 0182, Koscian, 64-000, Poland|Local Institution - 0211, Krakow, 30-363, Poland|Local Institution - 0222, Krakow, 31-011, Poland|Centrum Medyczne ProMiMed, Krak, 31-637, Poland|REUMED Sp. z o.o., Lublin, 20-607, Poland|Medyczne Centrum Hetmanska - Poznan, Poznan, 60-218, Poland|Solumed Centrum Medyczne, Poznan, 60-529, Poland|Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia, Poznan, 60-693, Poland|Local Institution - 0093, Sosnowiec, 41-200, Poland|SANUS Szpital Specjalistyczny, Stalowa Wola, 37-450, Poland|Local Institution - 0219, Warszawa, 00-660, Poland|Local Institution - 0192, Warszawa, 01-868, Poland|Local Institution - 0090, Warszawa, 02-691, Poland|Centrum Medyczne AMED Warszawa Targowek, Warszawa, 03-291, Poland|Local Institution - 0077, Wroclaw, 50-363, Poland|Local Institution - 0184, Wroclaw, 51-685, Poland|Local Institution - 0025, Wroclaw, 52-416, Poland|Neomed Research, Brasov, 500283, Romania|Centrul Medical Sana, Bucuresti, 011025, Romania|Spitalul Sfanta Maria, Bucuresti, 011172, Romania|Spitalul Clinic Dr. Ioan Cantacuzino, Bucuresti, 020475, Romania|Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Cluj-Napoca, 400006, Romania|Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei, Galati, 800578, Romania|Spitalul Judetean de Urgenta Valcea, Ramnicu Valcea, 240277, Romania|CjSC, Ekaterinburg, 620043, Russian Federation|Kemerovo State Medical University, Kemerovo, 650000, Russian Federation|Medical Center Maksimum Zdorovia, Kemerovo, 650066, Russian Federation|Local Institution - 0210, Novosibirsk, 630099, Russian Federation|Local Institution - 0006, Orenburg, 460018, Russian Federation|State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova, Petrozavodsk, 185019, Russian Federation|Local Institution - 0207, Saint - Petersburg, 191045, Russian Federation|Clinical Rheumatological Hospital Number 25, Saint Petersburg, 190068, Russian Federation|Polyclinic of Private Security Personnel, Saint Petersburg, 192007, Russian Federation|Private Healthcare Institution Clinical Hospital, Smolensk, 214025, Russian Federation|Local Institution - 0223, St. Petersburg, 197341, Russian Federation|Tolyatti city clinical hospital ߵ, Tolyatti, 445039, Russian Federation|Biomed, Vladimir, 600005, Russian Federation|Local Institution - 0208, Yaroslavl, 150002, Russian Federation|State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2, Yaroslavl, 150030, Russian Federation|Complejo Hospitalario Universitario A Coruna, A Coru, 15006, Spain|Hospital Universitari Vall dHebron, Barcelona, 08035, Spain|Hospital Regional Universitario de Malaga Hospital General, Malaga, 29010, Spain|Hospital de Merida, Merida, 06800, Spain|Corporacio Sanitaria Parc Tauli, Sabadell, 08208, Spain|Local Institution - 0228, Sevilla, 41014, Spain|Local Institution, Changhua City, 500, Taiwan|Local Institution - 0114, Taichung, 40201, Taiwan|Local Institution, Taipei City, 10630, Taiwan|Local Institution - 0088, Taipei, 10002, Taiwan|Local Institution, Taipei, 110, Taiwan|Local Institution, Taipei, 11217, Taiwan|Local Institution, Taoyuan, 333, Taiwan

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT03252587/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03252587/SAP_001.pdf

{ "BMS-986165": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "OTHER" } ] }

NCT06278987

Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture

https://clinicaltrials.gov/study/NCT06278987

NOT_YET_RECRUITING

The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter.

NO

Hip Fractures

DRUG: PENG block and cryoablation|DRUG: fascia iliaca compartment block

Maximum pain score on Post-operative day 30, Maximum pain score on day 30 post surgery. Pain Scale is 0-10 with 0 meaning no pain (better outcome) and 10 meaning worst pain imaginable (worse outcome)., 30 days post surgery|Opioid use, Opioid use and Functional Pain scores on POD 0, 1, 2, 3, 4, 5, 6, 7 - measured in milligrams morphine equivalents, day 0, 1, 2, 3, 4, 5, 6, 7 post surgery|functional pain scores, Functional Pain Score on Post Operative Day 0, 1, 2, 3, 4, 5, 6, 7 - measured with Pain Scale 0-10 with 0 meaning no pain (better outcome) and 10 meaning worst pain imaginable (worse outcome), day 0, 1, 2, 3, 4, 5, 6, 7 post surgery post surgery|number of patients using opioids, measured in number of patients, 30 days post surgery|Length of Hospital Stay, measured in number of days, 30 days post surgery|Time to first ambulation, measured in Days:Hours:Minutes post operation, 30 days post surgery|Number of patients returned home by Post Operative Day 30, measured in number of patients, 30 days post surgery

University of Minnesota

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

ANES-2024-32661

2024-06-01

2026-06-01

2026-12-01

2024-02-26

2024-03-19

{ "PENG block and cryoablation": [ { "intervention_type": "DRUG" } ], "fascia iliaca compartment block": [ { "intervention_type": "DRUG" } ] }

NCT04861987

A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors

https://clinicaltrials.gov/study/NCT04861987

ACTIVE_NOT_RECRUITING

This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.

NO

Advanced Cancer|Refractory Cancer|Tumor Gastric

DRUG: PCS6422 and capecitabine

Number of participants with dose limiting toxicities (DLT) and incidence of adverse events as assessed by CTCAE v5.0, Frequency, duration, and severity of DLTs and adverse events (AEs), ~6 months|Maximum Plasma Concentration (Cmax) of capecitabine, To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine, ~14 days

QTc effect of PCS6422, To evaluate the effect of PCS6422 on QTc, ~6 months|Maximum Plasma Concentration (Cmax) of PCS6422, To evaluate the Maximum Plasma Concentration (Cmax) of PCS6422, ~14 days|Number of participants with Adverse Events of Special Interest (AESI), Frequency, duration and severity of AESIs, ~6 months

Processa Pharmaceuticals

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

PCS6422-GI-01

2021-06-18

2024-06-29

2024-08-10

2021-04-27

2024-06-12

Processa Clinical Site, Omaha, Nebraska, 68198, United States|Processa Clinical Site, New Brunswick, New Jersey, 08903, United States|Processa Clinical Site, Santa Fe, New Mexico, 87505, United States|Processa Clinical Site, New York, New York, 10467, United States|Processa Clinical Site, Cleveland, Ohio, 44106, United States|Processa Clinical Site, Fairfax, Virginia, 22031, United States

{ "Capecitabine": [ { "intervention_type": "DRUG", "description": "PCS6422 and capecitabine", "name": "Capecitabine", "synonyms": [ "Capecitabinum", "Xeloda", "(1-(5-Deoxy-beta-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-carbamic acid pentyl ester", "pentyl 1-(5-deoxy-\u03b2-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate", "Cap\u00e9citabine", "Capecitabina", "N(4)-pentyloxycarbonyl-5'-deoxy-5-fluorocytidine", "Capecitabine", "Pentyl [1-(5-deoxy-\u03b2-D-ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]carbamate", "Capecitabin" ], "medline_plus_id": "a699003", "generic_names": [ "Capecitabine" ], "mesh_id": "D000964", "drugbank_id": "DB01101" } ] }

NCT06154187

Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis

https://clinicaltrials.gov/study/NCT06154187

NOT_YET_RECRUITING

This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.

NO

Osteoporosis

DRUG: PBK_L2201|DRUG: Placebo

Bone mineral density (BMD) change rate, The % change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment., 12 month

Bone mineral density (BMD) change, The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment., 12 month|Bone mineral density (BMD) change, The change & % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment., 6 and 18 month|Bone mineral density (BMD) % change, The change & % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment., 6 and 18 month|Bone mineral density (BMD) change, The change & % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment., 6, 12 and 18 month|Bone mineral density (BMD) % change, The change & % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment., 6, 12 and 18 month|Bone mineral density (BMD) change, The change & % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment., 6, 12 and 18 month|Bone mineral density (BMD) % change, The change & % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment., 6, 12 and 18 month|% incidence of new non-vertebral fractures, The % incidence of new non-vertebral fractures over 12 months of treatment, 12 month

Pharmbio Korea Co., Ltd.

FEMALE

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

PBK_L2201_301

2024-02

2025-05

2025-11

2023-12-04

2023-12-04

The Catholic University of Korea Yeouido Saint Marys Hospital, Seoul, Korea, Republic of

{ "PBK_L2201": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT00000187

Ritanserin in Treatment of Cocaine Dependence - 1

https://clinicaltrials.gov/study/NCT00000187

COMPLETED

The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine dependence.

NO

Cocaine-Related Disorders

DRUG: Ritanserin

Cocaine use|Cocaine craving

University of Pennsylvania

National Institute on Drug Abuse (NIDA)

MALE

ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

NIDA-00144-1|3R01DA012268|K20-00144-1

1992-07

1994-06

1999-09-21

2015-05-28

University of Pennsylvania, Philadelphia, Pennsylvania, 19104 6178, United States

{ "Ritanserin": [ { "intervention_type": "DRUG", "description": "Ritanserin", "name": "Ritanserin", "synonyms": [ "ritanserina", "6-(2-(4-(Bis(4-fluorophenyl)methylene)-1-piperidinyl)ethyl)-7-methyl-5H-thiazolo(3,2-a)pyrimidin-5-one", "R55667", "R 55667", "R-55667", "Ritanserin Hydrochloride", "Ritanserin Tartrate", "Ritanserin" ], "mesh_id": "D018687", "generic_names": [ "Ritanserin" ], "drugbank_id": "DB12693" } ] }

NCT00259987

Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

https://clinicaltrials.gov/study/NCT00259987

COMPLETED

This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.

NO

Adenocarcinoma

DRUG: Lapatinib (GW572016) oral tablets

Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day), daily throughout the study

Safety and clinical benefit of lapatinib therapy, progression-free survival, and response duration in the two dose levels combined as well as for the two doses separately., throughout the study

GlaxoSmithKline

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

EGF102980

2005-11

2007-05

2005-12-01

2009-05-18

GSK Investigational Site, Los Angeles, California, 90095, United States|GSK Investigational Site, Ann Arbor, Michigan, 48109, United States|GSK Investigational Site, Buffalo, New York, 14263, United States|GSK Investigational Site, Amsterdam, 1105 AZ, Netherlands|GSK Investigational Site, San Isidro, Lima, Lima 27, Peru|GSK Investigational Site, Lima, 34, Peru

{ "Lapatinib": [ { "intervention_type": "DRUG", "description": "Lapatinib (GW572016) oral tablets", "name": "Lapatinib", "synonyms": [ "GW282974X", "Lapatinib", "GW572016", "N-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-4-quinazolinamine", "GW 572016", "N-(3-chloro-4-(((3-fluorobenzyl)oxy)phenyl)-6-(5-(((2-methylsulfonyl)ethyl)amino)methyl) -2-furyl)-4-quinazolinamine", "Tykerb", "Lapatinib Ditosylate", "GW-572016", "GW-282974X", "GW 282974X" ], "medline_plus_id": "a607055", "generic_names": [ "Lapatinib" ], "mesh_id": "D000092004", "drugbank_id": "DB01259" } ] }

NCT05288387

Spinal Cord Stimulation in Hypotensive Heart Failure Patients: Hemodynamic Assessment

https://clinicaltrials.gov/study/NCT05288387

TERMINATED

This is a prospective single-center study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation on systemic and pulmonary hemodynamics, assessed during right heart catheterization in patients with heart failure and persistent or transient hypotension subjected to be included into the heart transplantation waiting list.

NO

Heart Failure

PROCEDURE: Spinal cord stimulation

Systolic blood pressure elevation, It is suggested that spinal cord stimulation will elevate averaged systolic blood pressure by >5 mmHg within 10 minutes, as compared to tilt testing without stimulation, and as measured invasively through a vascular catheter. Number of participants with increase in systolic blood pressure by more than 5 mmHg within 10 minutes will be counted. The achievement of the primary outcome will be considered if >50% of patients will have an increase in systolic blood pressure., 10 minutes

Systemic vascular resistance elevation, It is suggested that spinal cord stimulation will elevate systemic vascular resistance by 10 percent (estimated using the standard equation method based on invasive hemodynamic measurements). Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated., 10 minutes|Pulmonary vascular resistance change, A statistically detectable decrease in pulmonary vascular resistance in the patient group based on invasive hemodynamic measurements, and estimated using the standard equation method based on invasive hemodynamic measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated., 10 minutes|Pulmonary capillary wedge pressure change, A statistically detectable change in pulmonary capillary wedge pressure in the patient group based on invasive measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated., 10 minutes|Pulmonary artery pressure change, A statistically detectable change in pulmonary artery systolic, diastolic, or mean pressure in the patient group based on invasive measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated., 10 minutes

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

HF-SCS-2022

2022-03-25

2024-01-09

2024-01-09

2022-03-21

2024-03-06

Almazov National Medical Research Centre, Saint-Petersburg, 197341, Russian Federation

{ "Spinal cord stimulation": [ { "intervention_type": "PROCEDURE" } ] }

NCT00114387

VEAPS: Vitamin E Atherosclerosis Prevention Study

https://clinicaltrials.gov/study/NCT00114387

COMPLETED

The purpose of this study is to examine whether vitamin E (DL-alpha-tocopherol) supplementation will reduce the progression of early atherosclerosis in healthy individuals over 40 years of age with low-density lipoprotein (LDL) cholesterol levels greater than or equal to 130mg/dL.

NO

Atherosclerosis

DRUG: DL-alpha-tocopherol

Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT)

National Institute on Aging (NIA)

Hoffmann-La Roche

ALL

ADULT, OLDER_ADULT

PHASE2|PHASE3

NIH

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: PREVENTION

AG0023|R01AG013860

1996-07

2000-09

2000-09

2005-06-15

2009-12-11

Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine, Los Angeles, California, 90033, United States

{ "DL-alpha-Tocopherol": [ { "intervention_type": "DRUG", "description": "DL-alpha-tocopherol", "name": "DL-alpha-Tocopherol", "synonyms": [ "all-rac-alpha-tocopherol", "DL-alpha-Tocopherol", "DL-alpha tocopherol" ], "drugbank_id": "DB14476", "generic_names": [ "DL-alpha-Tocopherol" ] } ] }

NCT01514487

Comparison of Three Liraglutide Formulations in Healthy Volunteers

https://clinicaltrials.gov/study/NCT01514487

COMPLETED

This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.

NO

Diabetes|Healthy

DRUG: liraglutide

Area under the Curve (0-t)|Cmax, maximum concentration

Area under the curve (0-infinity)|tmax, time to reach Cmax|t½, terminal half-life|Terminal elimination rate constant|Adverse events

Novo Nordisk A/S

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

NN2211-1636

2005-01-13

2005-03-30

2005-03-30

2012-01-23

2017-03-01

Novo Nordisk Investigational Site, Adelaide, 5000, Australia

{ "Liraglutide": [ { "intervention_type": "DRUG", "description": "liraglutide", "name": "Liraglutide", "synonyms": [ "Liraglutida", "NN 2211", "Liraglutide (rDNA origin)", "N\u00b2\u2076-(hexadecanoyl-gamma-glutamyle)-[34-arginine]GLP-1-(7-37)-peptide", "Liraglutide (genetical recombination)", "Liraglutide", "Saxenda", "Liraglutidum", "Liraglutide recombinant", "Arg34Lys26-(N-\u03b5-(\u03b3-Glu(N-\u03b1-hexadecanoyl)))-GLP-1[7-37]", "NN-2211", "Xultophy", "NN2211", "N\u00b2\u2076-(N-Hexadecanoyl-L-gamma-glutamyl)-[34-L-arginine]glucagon-like peptide 1-(7-37)-peptide", "Victoza", "Tresiba", "Insulin Degludec (rDNA Origin)", "Xultophy", "Insulin degludec/liraglutide", "Xultophy", "Tresiba", "Insulin Degludec (rDNA Origin)", "Xultophy", "Insulin degludec/liraglutide", "Xultophy" ], "medline_plus_id": "a611003", "generic_names": [ "Liraglutide", "Insulin Degludec (rDNA Origin)", "Insulin Degludec (rDNA Origin)" ], "mesh_id": "D000097789", "drugbank_id": "DB06655", "wikipedia_url": "https://en.wikipedia.org/wiki/Liraglutide" } ] }

NCT05606887

Identifying Mental Health Distress in EM Physicians

https://clinicaltrials.gov/study/NCT05606887

ACTIVE_NOT_RECRUITING

This project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. This will be done by investigating the feasibility and acceptability of wearable device and EMA feedback with personalized linkage to an evidence-based mental health platform at the University of Pennsylvania Health System.

NO

Burnout, Professional

OTHER: Wearable Device and Ecological Momentary Assessments

Feasibility of Intervention (FIM), Feasibility will be measured by the Feasibility of Intervention Measure (FIM), Through study completion, on average 6 months|Feasibility of Intervention (Study Retention), Feasibility will be measured by study retention, Through study completion, on average 6 months|Acceptability of Intervention (AIM), Acceptability will be measured by the validated Acceptability of Intervention Measure., Through study completion, on average 6 months|Acceptability of Intervention (EMA Completion Rates), Acceptability will be measured by the open/completion rates of ecological momentary assessment., Through study completion, on average 6 months

Anxiety, While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The GAD-7 will be used to measure anxiety., Through study completion, on average 6 months|Depression, While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The PHQ-8 will be used to measure depression., Through study completion, on average 6 months|Professional Burnout, While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The Stanford Professional Fulfillment Index will be used to measure burnout., Through study completion, on average 6 months|Post-Traumatic Stress Disorder, While the study will not be powered to detect effectiveness of the device on stress and other mental health indicators, secondary outcome measures will explore the potential for effect. The PC-PTSD-5 will be used to measure PTSD., Through study completion, on average 6 months

University of Pennsylvania

Emergency Medicine Foundation

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH

852220

2023-10-03

2025-03

2025-05

2022-11-07

2024-02-21

University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

{ "Wearable Device and Ecological Momentary Assessments": [ { "intervention_type": "OTHER" } ] }

NCT04113187

Propranolol for Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients

https://clinicaltrials.gov/study/NCT04113187

EPERO

COMPLETED

Hereditary Hemorrhagic Telangiectasia (HHT) is a genetic disorder of angiogenesis associated with disabling epistaxis. Management of these nose bleedings requires more effective treatment. Propranolol, a beta-blocker, is a potentially useful therapeutic considering its anti-angiogenic properties. Our objective is to explore the efficacy of propranolol, three months after its introduction, on the cumulative duration of epistaxis in HHT patients.

NO

Hereditary Hemorrhagic Telangiectasia|Osler Weber Rendu Disease

DRUG: Propranolol treatment|DRUG: Placebo

Cumulative duration of epistaxis (in minutes), 6 months after baseline (Day 0)

Frequency of epistaxis (number of episodes) per month, At baseline (Day 0), 3 months and 6 months after baseline|Number of cutaneous telangiectasia on hands and face, At baseline (Day 0), 3 months and 6 months after baseline.|Levels of hemoglobin, At baseline (Day 0), 3 months and 6 months after baseline.|Levels of ferritin, At baseline (Day 0), 3 months and 6 months after baseline.|Number of red blood cells transfusions, At baseline (Day 0), 3 months and 6 months after baseline.|Short Form (SF) 36 Health Survey, At baseline (Day 0), 3 months and 6 months after baseline.|Number of adverse events, 3 months and 6 months after baseline (Day 0).|Measurement of blood pressure, At baseline (Day 0), 1 month, 3 months and 6 months after baseline.|Measurement of heart rate, At baseline (Day 0), 1 month, 3 months and 6 months after baseline.

University Hospital, Bordeaux

AMRO-HHT-France - Association Maladie de Rendu-Osler

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

CHUBX 2015/32

2020-06-23

2022-05-19

2022-05-19

2019-10-02

2022-06-14

CHU de Bordeaux - service de médecine interne, Bordeaux, France

{ "Propranolol": [ { "intervention_type": "DRUG", "description": "Propranolol treatment", "name": "Propranolol", "synonyms": [ "AY-20694", "Propanolol", "Avlocardyl", "Propranololum", "AY20694", "AY 20694", "Obzidan", "Obsidan", "Dociton", "Propranolol Hydrochloride", "Inderal", "1-(isopropylamino)-3-(1-naphthyloxy)propan-2-ol", "Dexpropranolol", "Propanalol", "Anaprilin", "Propranolol", "\u03b2-Propranolol", "Half Beta-prograne", "Beta-prograne", "beta-Propranolol", "Propranololo", "Bedranol", "Rexigen", "Hydrochloride, Propranolol", "1-((1-Methylethyl)amino)-3-(1-naphthalenyloxy)-2-propanol", "Anapriline", "Betadren", "Inderal", "Propranolol (Cardiovascular)", "InnoPran", "Inderal", "Propranolol (Cardiovascular)", "InnoPran", "R (+)-Propanolol", "R-(+)-Propranolol", "D-Propranolol", "2R-Propranolol", "Dexpropranolol", "(+)-1-Isopropylamino-3-(1-naphthyloxy)-2-propanol", "(+)-Propranolol", "(R)-(+)-propranolol", "R (+)-Propanolol", "R-(+)-Propranolol", "D-Propranolol", "2R-Propranolol", "Dexpropranolol", "(+)-1-Isopropylamino-3-(1-naphthyloxy)-2-propanol", "(+)-Propranolol", "(R)-(+)-propranolol" ], "nhs_url": "https://www.nhs.uk/medicines/propranolol", "generic_names": [ "Propranolol", "Propranolol (Cardiovascular)", "Propranolol (Cardiovascular)", "Dexpropranolol", "Dexpropranolol" ], "mesh_id": "D014665", "drugbank_id": "DB00571" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT04787887

A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers

https://clinicaltrials.gov/study/NCT04787887

COMPLETED

Primary Objective: To compare the pharmacokinetics of Abcertin to the reference product, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg. Secondary Objective: To compare the safety, tolerability and immunogenicity of Abcertin to the reference formulation, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.

NO

Gaucher Disease

DRUG: Abcertin|DRUG: EU-sourced Cerezyme

AUC0-inf, Area under the concentration-time curve (AUC) from time zero to time infinity, Predose(0 minute), during infusion(10, 20, 40, 60, 90, 120 minutes), and after infusion( 5, 10, 20, 30, 40, 50, 60 ,70, 80, 90, 120 minutes)

Cmax, Maximum plasma concentration, Predose(0 minute), during infusion(10, 20, 40, 60, 90, 120 minutes), and after infusion( 5, 10, 20, 30, 40, 50, 60 ,70, 80, 90, 120 minutes)|tmax, Time to Cmax, Predose(0 minute), during infusion(10, 20, 40, 60, 90, 120 minutes), and after infusion( 5, 10, 20, 30, 40, 50, 60 ,70, 80, 90, 120 minutes)|AUC0-last, AUC from time zero to the time of the last measurable plasma concentration, Predose(0 minute), during infusion(10, 20, 40, 60, 90, 120 minutes), and after infusion( 5, 10, 20, 30, 40, 50, 60 ,70, 80, 90, 120 minutes)|t½, Terminal half-life, Predose(0 minute), during infusion(10, 20, 40, 60, 90, 120 minutes), and after infusion( 5, 10, 20, 30, 40, 50, 60 ,70, 80, 90, 120 minutes)|CL, Total body clearance, Predose(0 minute), during infusion(10, 20, 40, 60, 90, 120 minutes), and after infusion( 5, 10, 20, 30, 40, 50, 60 ,70, 80, 90, 120 minutes)|Vz, Volume of distribution based on the terminal phase, Predose(0 minute), during infusion(10, 20, 40, 60, 90, 120 minutes), and after infusion( 5, 10, 20, 30, 40, 50, 60 ,70, 80, 90, 120 minutes)

ISU Abxis Co., Ltd.

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

ISU302-005|ACTRN12619001399189p

2020-01-29

2020-09-27

2020-10-26

2021-03-09

2021-04-05

Scientia Clinical Research Limited, Randwick, New South Wales, 2031, Australia

{ "Abcertin": [ { "intervention_type": "DRUG" } ], "Imiglucerase": [ { "intervention_type": "DRUG", "description": "EU-sourced Cerezyme", "name": "Imiglucerase", "synonyms": [ "Cerezyme", "Imiglucerase", "Imiglucerasa" ], "drugbank_id": "DB00053", "generic_names": [ "Imiglucerase" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Imiglucerase" } ] }

NCT05878587

Burger Allen Exercises in Knee OA With Type II Diabetes

https://clinicaltrials.gov/study/NCT05878587

COMPLETED

There is a potential link between diabetes mellitus (DM) and severity of osteoarthritis .Type 2 diabetes is a part of the metabolic syndrome (Mets) accompanied by ageing and mechanical stress are also a risk factor to osteoarthritis. Every anatomical component of the joint demonstrated faster joint deterioration and elevated inflammation at microcellular environment of individuals with DM. Normal chondrocytes capacity to adapt to the local glucose level is impaired by OA and there is a significant risk of glucose toxicity and increased glucose absorption. The most dependable and effective treatment for mild to early joint osteoarthritis is exercise. Active free exercises i.e. Buerger Allen exercises are used as a conservative perfusion therapy because they rely on how gravity affects the smooth muscles in the valves. Synovial fluid supports the joints ability to recover while also reducing inflammation and enhancing overall joint function. The aim of the study is to determine the effect of Buerger Allen exercise and low intensity high repetition exercises on pain, range of motion and disability in knee osteoarthritis with type 2 diabetes. The study would be randomized controlled trial. Total thirty-six subjects will be assigned randomly by using lottery randomization into two groups. Group A will receive conventional therapy and an additional Buerger Allen exercise while Group B will be a control group receiving only baseline treatment. Numeric pain rating scale (NPRS), Ankle Brachial Index, KOOS and Goniometer will be used as outcome measure tools for pain, range of motion and disability. Measure will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0.If data will be normally distributed then parametric if not normally distributed than non-parametric

NO

Knee Osteoarthritis|Type II Diabetes

OTHER: thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen|OTHER: thermotherapy+ TENS+ low intensity high repetition exercises

KOOS, An instrument to assess the patients opinion about their knee and associated problems., 10 months|Numeric Pain Rating Scale, NPRS is based on 11-point numerical rating scale for determining pain intensity, 0(no pain) to 10(worst pain imaginable) pain intensity., 10 months

Ankle Brachial Index, Ankle Brachial Index Will be measured with bp apparatus to measure Perfusion., 10 months

Goniometer, A universal goniometer is an instrument that measures the available range of motion at a joint. Knee flexion and extension will be measured., 10 months

Riphah International University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

REC/23/0109/Ayesha iftikhar

2023-03-31

2023-08-01

2023-08-07

2023-05-26

2023-09-25

Tehsil headquarter hospital, Barnala, Azad Kashmir, Pakistan

{ "thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen": [ { "intervention_type": "OTHER" } ], "thermotherapy+ TENS+ low intensity high repetition exercises": [ { "intervention_type": "OTHER" } ] }

NCT02360787

The Effects of Including Almonds in a Weight Loss Trial

https://clinicaltrials.gov/study/NCT02360787

COMPLETED

The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

NO

Overweight|Obesity

BEHAVIORAL: Energy restriction|BEHAVIORAL: Almonds (15% kcal/day)

Anthropometric measurements, Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks, 12 weeks|Blood pressure, Blood pressure measurements assessed at baseline, week-4, week-8 and week-12, 12 weeks|Post-lunch cognitive function, Cognitive function assessments will be performed after a standard lunch at baseline and week 12, 12 weeks

Fasting blood biochemistries, Fasting glucose, insulin, lipids and vitamin E over 12 weeks, 12 weeks|Dietary intake, Dietary intakes assessed at baseline, week-1, week-2, week-3, week-4, week-6, week-8 and week-10, 10 weeks|Appetite ratings, Appetite ratings assessed at baseline, week-4, week-8 and week-12, 12 weeks|Physical activity, Physical activity assessed at baseline, week-4, week-8 and week-12, 12 weeks

Purdue University

Almond Board of California

ALL

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE

055-030

2012-10

2016-05

2017-08

2015-02-11

2018-01-18

Purdue University, West Lafayette, Indiana, 47907, United States

{ "Energy restriction": [ { "intervention_type": "BEHAVIORAL" } ], "Almonds (15% kcal/day)": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05479487

Fluzoparib and Apatinib Versus Fluzoparib in Relapsed Ovarian Carcinoma Maintenance Treatment

https://clinicaltrials.gov/study/NCT05479487

NOT_YET_RECRUITING

This study is a Phase II randomized, open label, controlled, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib versus fluzoparib monotherapy for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma (including patients previous treated with a PARP inhibitor).

NO

Relapsed Ovarian Cancer

DRUG: Fluzoparib+Apatinib|DRUG: Fluzoparib Monotherapy

Progression Free Survival (PFS) in previous PARP inhibitor treated relapsed ovarian cancer patients., To determine the efficacy by progression free survival (PFS) of the maintenance treatment in previous PARP inhibitor treated platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined)., Up to 2 years

Progression Free Survival (PFS) in relapsed ovarian patients, To determine the efficacy by progression free survival (PFS) of the maintenance treatment in platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined)., Up to 2 years|Progression Free Survival (PFS) in BRCA1/2 mutated relapsed ovarian cancer patients., Up to 2 years|Objective Response Rate (ORR), Up to 2 years|Disease Control Rate (DCR）, Up to 2 years|Duration of Response (DoR), Up to 2 years|Overall survival (OS）, Up to 2 years|Adverse Events (AEs), Assese the safety and tolerability of Fluzoparib combined with apatinib maintenance in platinum sensitive relapsed ovarian cancer patients by record the number of participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc., From the first drug administration to within 30 days for the last treatment dose

Xiaohua Wu MD

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

MA-OC-II-005

2022-08-01

2023-11-01

2026-09-01

2022-07-29

2022-07-29

{ "Fluzoparib+Apatinib": [ { "intervention_type": "DRUG" } ], "Fluzoparib": [ { "intervention_type": "DRUG", "description": "Fluzoparib Monotherapy", "name": "Fluzoparib", "synonyms": [ "", "Fluzoparib" ], "drugbank_id": "DB15637", "generic_names": [ "Fluzoparib" ] } ] }

NCT00092287

Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome

https://clinicaltrials.gov/study/NCT00092287

TERMINATED

The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome.

NO

Malignant Carcinoid Syndrome

DRUG: lanreotide Autogel (somatostatin analogue)|DRUG: Sandostatin long acting release (LAR) Depot (somatostatin analogue)

Target symptom frequency (flushing or stool frequency).

Ipsen

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

2-47-52030-722|2004-001091-40

2004-07

2004-10

2004-09-27

2020-04-30

Larry Kvols, MD, Tampa, Florida, 33612, United States

{ "Lanreotide": [ { "intervention_type": "DRUG", "description": "lanreotide Autogel (somatostatin analogue)", "name": "Lanreotide", "synonyms": [ "Lanreotida", "Somatuline Depot", "Lanreotide" ], "medline_plus_id": "a615007", "generic_names": [ "Lanreotide" ], "drugbank_id": "DB06791" } ], "Octreotide": [ { "intervention_type": "DRUG", "description": "Sandostatin long acting release (LAR) Depot (somatostatin analogue)", "name": "Octreotide", "synonyms": [ "SM 201-995", "SM 201995", "SMS 201-995", "Octreotide Acetate", "SAN 201995", "Mycapssa", "Sandoz 201 995", "Sandostatin", "Sandostatine", "Octreotide", "SM 201 995", "Sandoz 201-995", "Octreotide Acetate Salt", "Bynfezia Pen", "Sandoz 201995", "Compound 201 995", "SAN 201-995", "Compound 201995", "Octreotida", "SMS 201 995", "Octrotide", "SMS 201995", "Compound 201-995", "Octreotidum", "SAN 201 995", "Bynfezia" ], "medline_plus_id": "a693049", "generic_names": [ "Octreotide" ], "mesh_id": "D018931", "drugbank_id": "DB00104", "wikipedia_url": "https://en.wikipedia.org/wiki/Octreotide" } ] }

NCT03151187

Evaluation of a Teaching Curriculum on Disruptive Behaviour Disorders

https://clinicaltrials.gov/study/NCT03151187

UNKNOWN

The investigators have initiated an education program for residents on the diagnosis and management of disruptive behavior disorders in children. These will be presented as two 2-hour modules to be delivered at an academic half-day for pediatric trainees across Canada. We plan to evaluate the effectiveness of the curriculum by administering a pre and post test. Pediatric residents in Canada all participate in a practical assessment of their skills (an Observed Structured Clinical Examination or OSCE). The investigators plan to develop on OSCE station which assesses the curriculum and randomize programs to do the curriculum either before or after the OSCE. This will help us determine how effective the curriculum is at teaching about disruptive behaviours.

NO

Disruptive Behavior

OTHER: Teaching intervention

OSCE scores, Observed Structured Clinical Encounter Score, OSCE scores will be obtained either between 1-6 months before or 1-6 months after the teaching intervention

Pre and Post test scores, A knowledge based multiple choice question test will be used, The first test will be done the day of the teaching intervention, 5 minutes prior to the intervention being given. The test will then be re-administered 5 minutes after the conclusion of the intervention.

Childrens Hospital of Eastern Ontario

University of Manitoba|University of Calgary|Dalhousie University|Childrens Hospital of Western Ontario|Northern Ontario School of Medicine|McMaster University|University of Alberta

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER

15/163X

2017-08-01

2018-05-31

2018-05-31

2017-05-12

2018-01-31

Childrens Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada

{ "Teaching intervention": [ { "intervention_type": "OTHER" } ] }

NCT05813587

To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19

https://clinicaltrials.gov/study/NCT05813587

COMPLETED

This trial was a randomized, double-blind, placebo-controlled, loading phase III clinical study.

NO

Post-COVID-19

BIOLOGICAL: Meplazumab for injection|OTHER: Normal saline

During the trial (28 days), the duration/degree of relief/recovery of four types of clinical symptoms of Post-COVID-19, The clinical symptoms of Post-COVID-19 mainly involved the nervous system and physical ability (insomnia, memory loss, olfactory changes, taste changes, fatigue or fatigue, headache, chest pain, muscle/joint pain), respiratory system (shortness of breath, cough), cardiovascular system (palpitation, arrhythmia), and aggravation of primary diseases. Clinical symptoms/restore definition: new crown sequela comprehensive score decline, and continue for at least 2 days. Patients with the above symptoms were evaluated according to the actual clinical symptoms, and the clinical symptoms that did not appear were evaluated as 0 (none) , Day28

Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

MPZ-III-02

2023-03-23

2023-09-14

2023-10-26

2023-04-14

2024-05-28

First Affiliated Hospital of the Air Force Medical University, Xian, China

{ "Meplazumab": [ { "intervention_type": "BIOLOGICAL", "description": "Meplazumab for injection", "name": "Meplazumab", "synonyms": [ "", "Meplazumab" ], "drugbank_id": "DB16465", "generic_names": [ "Meplazumab" ] } ], "Normal saline": [ { "intervention_type": "OTHER" } ] }

NCT03626987

Identification of Protein Markers of Epidemiological and Clinical Interest by MALDI-TOF

https://clinicaltrials.gov/study/NCT03626987

SPECTRASURV

UNKNOWN

Not all infectious agents have the same epidemic potential, and this can vary widely within the same species. Rapid determination of this potential is essential to optimize control of infectious diseases. It is now accepted that identification with the species is clearly insufficient to identify an epidemic and to carry out epidemiological analyzes. Indeed, if the same bacterial species can present a great diversity of strains, it is organized in clonal complexes having strong variations of clinical and epidemiological expression. More specifically, on a bio-epidemiological level, the clonal identification of the bacterial agent is a real asset because it can make it possible to identify the highly virulent strains or known to be resistant, the clones associated with nosocomial infections, the source of the infection. an epidemic and to follow its spatio-temporal extension, to know the epidemiological antiquity of the clone, to follow or rebuild a chain of transmission, to discover epidemic clusters. There are rapid identification techniques, for example by polymerase chain reaction (PCR), but which are targeted at particular genomic compositions previously identified. Routine bacterial identification now rests on the determination of the protein composition by mass spectrometry (MALDI-TOF). The bacterial spectrum is compared to a reference library of protein composition, thus obtaining an identification equivalent to that based on the 16s RNA (ribonucleic acid 16s) and can descend to an infra-species level. The aim of this work is to use the proteome part of the MALDI-TOF spectrum to identify peaks that signal clonality and to determine proteomic fingerprintings that can be used for epidemiological and clinical purposes. Instead of relying on expensive genomic methods, the identification of the clonal characteristics of the strains will rely on the bacterial proteome present on the MALDI-TOF spectrum that is produced during the routine identification of the bacterium. The results are intended to feed a complementary knowledge base

NO

Infectious Risk

DIAGNOSTIC_TEST: mass spectrometry (MALDI-TOF)

Ability to find protein peaks that mark epidemic clones, Ability to find protein peaks that mark epidemic clones Association of these clones with epidemic characteristics (age, antibacterial resistance, virulence), 36 months

Assistance Publique Hopitaux De Marseille

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2017-16|TPS 15219ter

2018-07-31

2022-07-31

2022-07-31

2018-08-13

2018-08-13

Assistance Publique Hôpitaux de Marseille, Marseille, 13354, France

{ "mass spectrometry (MALDI-TOF)": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT04195087

Perfusion Index and Pleth Variability Index in Cesarean Section.

https://clinicaltrials.gov/study/NCT04195087

COMPLETED

The aim of this study is to investigate the predictability of hypotension by using PI and PVI in pre-and post-spinal anesthesia periods in cesarean section cases in the sitting position.

NO

Cesarean Section Complications

DEVICE: Masimo Radical-7® Pulse CO-Oximeter®

Perfusion index, Perfusion index will be recorded from the monitor., Before spinal anesthesia in supine positon|Pleth variability index, Pleth variability index will be recorded from the monitor., Before spinal anesthesia in supine positon|Perfusion index, Perfusion index will be recorded from the monitor., Before spinal anesthesia in sitting positon|Pleth variability index, Pleth variability index will be recorded from the monitor., Before spinal anesthesia in sitting positon|Perfusion index, Perfusion index will be recorded from the monitor., 1 minutes after spinal anesthesia in supine positon|Pleth variability index, Pleth variability index will be recorded from the monitor., 1 minutes after spinal anesthesia in supine positon|Perfusion index, Perfusion index will be recorded from the monitor., Start of the surgery|Pleth variability index, Pleth variability index will be recorded from the monitor., Start of the surgery|Perfusion index, Perfusion index will be recorded from the monitor., 1 minutes after the umbilical cord clamping|Pleth variability index, Pleth variability index will be recorded from the monitor., 1 minutes after the umbilical cord clamping

Antalya Training and Research Hospital

FEMALE

ADULT, OLDER_ADULT

OTHER_GOV

OBSERVATIONAL

Observational Model: |Time Perspective: p

AntalyaEAH02

2019-12-02

2020-01-31

2020-02-28

2019-12-11

2020-07-09

University of Health Sciences, Antalya Training and Research Hospital, Antalya, 07100, Turkey

{ "Masimo Radical-7\u00ae Pulse CO-Oximeter\u00ae": [ { "intervention_type": "DEVICE" } ] }

NCT03006887

Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Participants With Selected Solid Tumors

https://clinicaltrials.gov/study/NCT03006887

COMPLETED

This is an open-label Phase 1b study designed to confirm the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with selected solid tumors (non-small cell lung cancer, predominantly clear cell renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma [excluding uveal melanoma]).

YES

Solid Tumors

DRUG: lenvatinib|DRUG: pembrolizumab

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria., From the first dose until 30 days after the last dose (approximately 2 years 7 months)|Number of Participants With Dose-limiting Toxicities, A DLT is defined as any of the following: any of the hematological or nonhematological toxicities specified in the protocol that are considered to be at least possibly related to lenvatinib and/or pembrolizumab occurring during Cycle 1; failed to administer greater than or equal to 75 percent (%) of the planned dosage of lenvatinib as a result of treatment-related toxicity during Cycle 1; participants who discontinued due to treatment-related toxicity in Cycle 1; greater than a 2-week delay in starting pembrolizumab in Cycle 2 because of a treatment-related toxicity, even if the toxicity does not meet DLT criteria., Cycle 1 (Cycle length=21 days)

Objective Response Rate (ORR) Based on Modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1, ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) for target and non-target lesions. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The tumor assessment was done using number of lesions based on modified RECIST 1.1 for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ., From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or up to approximately 2 years 7 months|Duration of Response (DOR) Based on Modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1, DOR was defined as time from the first documented of CR or PR to the date of first documentation of disease progression (PD) (based on modified RECIST 1.1) or death (whichever occurs first). CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD for target lesion, was defined as a minimum 20% increase and a minimum 5 mm absolute increase in sum of diameters compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir was defined as lowest measure sum of diameters of target lesions at any time point from baseline onward. The tumor assessment was done using number of lesions based on modified RECIST 1.1 for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ. DOR = Date of PD/death (whichever occurs first) - Date of first CR or PR + 1., From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or up to approximately 2 years 7 months.|Cmax: Maximum Plasma Concentration of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours|T1/2: Terminal Half-life of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours; Cycle 1 Day 15: 0-24 hours|AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours; Cycle 1 Day 15: 0-24 hours|AUC(0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours|Vz/F: Apparent Volume of Distribution at Terminal Phase of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours; Cycle 1 Day 15: 0-24 hours|CL/F: Apparent Total Clearance Following Oral Dosing of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours|MRT: Mean Residence Time of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours; Cycle 1 Day 15: 0-24 hours|Css,Max: Maximum Observed Plasma Concentration at Steady State of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 15: 0-24 hours|Css,Min: Minimum Observed Plasma Concentration at Steady State of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 15: 0-24 hours|Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 15: 0-24 hours|AUC(0-tau): Area Under the Plasma Concentration-time Curve Over the Dosing Interval of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 15: 0-24 hours|Clss/F: Apparent Total Clearance Following Oral Administration at Steady State of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 15: 0-24 hours|Css,Av: Average Steady State Plasma Concentration of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 15: 0-24 hours|Rac (Cmax): Accumulation Index of Cmax for Lenvatinib in Combination With Pembrolizumab, Rac (Cmax) was calculated as the ratio of drug concentrations observed during a dosing interval at steady state divided by drug concentrations seen during the dosing interval after a single (first) dose. Rac (Cmax) = Css,max on Cycle 1 Day 15 / Cmax on Cycle 1 Day 1, Cycle 1 Day 1: 0-24 hours and Cycle 1 Day 15: 0-24 hours|Rac (AUC): Accumulation Index of AUC for Lenvatinib in Combination With Pembrolizumab, Rac (AUC) was calculated as the ratio of drug concentrations observed during a dosing interval at steady state divided by drug concentrations seen during the dosing interval after a single (first) dose. Rac (AUC) = AUC(0-t) on Cycle 1 Day 15 / AUC(0-t) on Cycle 1 Day 1., Cycle 1 Day 1: 0-24 hours and Cycle 1 Day 15: 0-24 hours|Lambda z: Terminal Phase Elimination Rate Constant of Lenvatinib in Combination With Pembrolizumab, Cycle 1 Day 1: 0-24 hours; Cycle 1 Day 15: 0-24 hours|PTF: Peak-trough Fluctuation Ratio of Lenvatinib in Combination With Pembrolizumab, The peak trough fluctuation within complete dosing interval at steady state, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100, Cycle 1 Day 15: 0-24 hours|Number of Participants Positive for Serum Anti-drug Antibodies (ADA) Status for Pembrolizumab, Day 1 of Cycles 1, 2, 4, 6, and 8 and every 4 cycles thereafter; within 30 days after discontinuation or until the initiation of other anticancer treatment, whichever is earlier (Cycle length=21 days); up to 31 months

Eisai Co., Ltd.

Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

E7080-J081-115|KEYNOTE 523

2017-01-12

2020-04-15

2020-04-15

2016-12-30

2021-05-20

2021-05-20

Eisai Trial Site 1, Chuo-ku, Tokyo, Japan

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT03006887/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03006887/SAP_001.pdf

{ "Lenvatinib": [ { "intervention_type": "DRUG", "description": "lenvatinib", "name": "Lenvatinib", "synonyms": [ "4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide", "Lenvatinib", "Lenvima" ], "medline_plus_id": "a615015", "generic_names": [ "Lenvatinib" ], "drugbank_id": "DB09078" } ], "Pembrolizumab": [ { "intervention_type": "DRUG", "description": "pembrolizumab", "name": "Pembrolizumab", "synonyms": [ "Keytruda", "Lambrolizumab", "Pembrolizumab" ], "medline_plus_id": "a614048", "generic_names": [ "Pembrolizumab" ], "drugbank_id": "DB09037", "wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab" } ] }

NCT03079687

Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

https://clinicaltrials.gov/study/NCT03079687

APPROVED_FOR_MARKETING

This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other treatment options or eligible for an olaparib clinical trials.

NO

Ovarian Cancer

DRUG: Olaparib tablets

AstraZeneca

Parexel

FEMALE

ADULT, OLDER_ADULT

INDUSTRY

EXPANDED_ACCESS

D0816R00014

2017-03-14

2017-10-25

Research Site, Duarte, California, 91010, United States|Research Site, Newport Beach, California, 92663, United States|Research Site, Roseville, California, 95661, United States|Research Site, Gainesville, Florida, 32608, United States|Research Site, Scarborough, Maine, 04074, United States|Research Site, Baltimore, Maryland, 21201, United States|Research Site, Rochester, Minnesota, 55905, United States|Research Site, Columbia, Missouri, 65212, United States|Research Site, Albuquerque, New Mexico, 87106, United States|Research Site, Durham, North Carolina, 27710, United States|Research Site, Winston-Salem, North Carolina, 27157-1023, United States|Research Site, Cleveland, Ohio, 44195, United States|Research Site, Portland, Oregon, 97239, United States

{ "Olaparib": [ { "intervention_type": "DRUG", "description": "Olaparib tablets", "name": "Olaparib", "synonyms": [ "Lynparza", "4-(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorobenzyl)phthalazin-1(2H)-one", "Olaparib" ], "medline_plus_id": "a614060", "generic_names": [ "Olaparib" ], "drugbank_id": "DB09074", "wikipedia_url": "https://en.wikipedia.org/wiki/Olaparib" } ] }

NCT00279487

Preanalgesic Effect of Gabapentin in Total Knee Repair

https://clinicaltrials.gov/study/NCT00279487

COMPLETED

The purpose of this study is to determine whether gabapentin, as a one time administration prior to a total knee replacement procedure, has opioid sparing effects and a reduction in pain scores.

NO

Pain

DRUG: Gabapentin|DRUG: Placebos

Texas Health Resources

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

P768

2007-08

2006-01-19

2016-10-26

Presbyterian Hospital of Dallas, Dallas, Texas, 75231, United States

{ "Gabapentin": [ { "intervention_type": "DRUG", "description": "Gabapentin", "name": "Gabapentin", "synonyms": [ "Gabapentina", "Gabapentin", "Gabapentinum", "Gabapentino", "Gabapentine", "Gralise", "Neurontin", "1-(Aminomethyl)cyclohexaneacetic acid" ], "medline_plus_id": "a694007", "generic_names": [ "Gabapentin" ], "nhs_url": "https://www.nhs.uk/medicines/gabapentin", "drugbank_id": "DB00996", "wikipedia_url": "https://en.wikipedia.org/wiki/Gabapentin" } ], "Placebos": [ { "intervention_type": "DRUG" } ] }

NCT05080387

Neopterin in Acute Coronary Syndrome Patients

https://clinicaltrials.gov/study/NCT05080387

RECRUITING

Measurement of neopterin in ACS patients

NO

Neopterin in Acute Coronary Syndrome Patients

OTHER: Blood sample

To detect whether there is association between neopterin and ACS or not, To detect whether there is association between neopterin and ACS or not, 72 hours

Detection of relation between neopterin and cardiac enzymes as CK and troponine in ACS and detection of relation between neopterin level and in hospital events, Detection of relation between neopterin and cardiac enzymes as CK and troponine in ACS and detection of relation between neopterin level and in hospital events, 72 hours

Assiut University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Neopterin

2022-11-01

2023-10-01

2024-10-01

2021-10-15

2022-02-15

Assiut university, Assiut, AssiutU, Egypt

{ "Blood sample": [ { "intervention_type": "OTHER" } ] }

NCT02702687

Childhood Asthma Perception Study

https://clinicaltrials.gov/study/NCT02702687

CAPS

COMPLETED

This randomized controlled trial will include Latino and Black adolescents with asthma ages 10-17 years old and their caregivers. Participants will be recruited from clinics in the Bronx, New York. The primary aims are to examine the efficacy of peak expiratory flow (PEF) prediction with feedback versus control feedback on 1) under-perception of asthma symptoms 2) controller medication adherence and 3) asthma control and emergency health care use. These aims will be examined across a 1-year follow-up. An exploratory aim examines the hypothesized pathway that the PEF intervention reduces under-perception of symptoms, shifts illness representations toward the professional model and increases adolescents and parents asthma management self-efficacy, resulting in greater medication adherence and improved asthma control.

NO

Asthma|Childhood Asthma

BEHAVIORAL: PEF Feedback|BEHAVIORAL: Control Feedback

Asthma Symptom Perception with Asthma Monitor (AM2) as percentage of guesses in the Under-Perception zone, The percentage of times a child under-perceives the severity of asthma symptoms, Change from Pre-intervention to 12-month-follow-up (15 months)

Asthma Illness Representation Scale (AIRS), 37-item scale measuring risk factors for the underutilization of controller medications, Change from Pre-intervention to 12-month-follow-up (15 months)|Asthma Management Self-Efficacy (ASE) scale: Parent and child versions, 13-item scale measures parents confidence in their ability to help manage childs asthma, Change from Pre-intervention to 12-month-follow-up (15 months)|Pediatric Asthma Quality of Life Questionnaire (PAQLQ), 23-item self report questionnaire assessing childs overall functioning in relation to asthma, Change from Pre-intervention to 12-month-follow-up (15 months)|Medication Adherence - percentage of total doses taken per day/prescribed per day, Self report of daily medication use, in relation to the prescribed use, Change from Pre-intervention to 12-month-follow-up (15 months)|Health Care Use - Electronic Medical Record (EMR) review of asthma-related Emergency Department visits and hospitalizations, Quantity of asthma-related emergency visits throughout the duration of the study, Change from Pre-intervention to 12-month-follow-up (15 months)|Asthma Control Test (C-ACT), Self-report questionnaire for adolescents and parents, Change from Pre-intervention to 12-month-follow-up (15 months)

Albert Einstein College of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2014-3257|1R01HL128260-01

2016-05

2022-07-28

2022-07-28

2016-03-09

2023-02-06

Jacobi Medical Center, Bronx, New York, 10461, United States|Montefiore Medical Center, Bronx, New York, 10461, United States

Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/87/NCT02702687/ICF_000.pdf

{ "PEF Feedback": [ { "intervention_type": "BEHAVIORAL" } ], "Control Feedback": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04724187

Prevention of Primary Postpartum Haemorrhage

https://clinicaltrials.gov/study/NCT04724187

UNKNOWN

Postpartum hemorrhage, is one of the most deadly complication of pregnancy worldwide and major cause of maternal mortality especially in third world countries .1 PPH affects about 5% of all women giving birth around the world 2 .Primary PPH is defined as ≥500 mL blood loss after vaginal delivery or ≥1000 mL after CS delivery within 24 hours after birth1 . Globally, almost one quarter of all maternal deaths are linked with PPH 2. Due to the high prevalence of anemia among pregnant women in low-resource settings, the outcome of PPH is often deteriorated, resulting in damaging health consequences 3. Roughly in 70% of cases of primary pph are due to uterine atony11. Uterine atony is due to loss of contraction and retraction of myometrial muscle fibers can lead to severe hemorrhage and shock. There are several reasons behind uterine atony including maternal anemia, fatigue due to prolong labour and rapid forceful labour. Blood loss is double in caesarean section due to use of increased anesthetic agents4. According to WHO use of oxytocin (10 IU, IM /IV) is recommended for prevention of PPH for all births2. Despite its effectiveness, 10-40% of cases need additional uterotonics to ensure good uterine contraction.5 After oxytocin , Misoprostol is increasingly known as a potential treatment option for PPH 5 .Misoprostol is easily available , rapid acting , and cost effective with minimal side effects, however in caesarean section owing to the effect of anesthesia limits its use . In recent study conducted at Egypt, oxytocin plus misoprostol (study group) is compared with oxytocin alone (control group). Incident of pph was significantly lower in study group (p=0.018), as in study group (1.33%) than control group (6.67%)8. Misoprostol is an autacoid substance and act better if placed closed to target organ 9. Several routes of misoprostol, with or without oxytocin, and its result on intrapartum and postpartum hemorrhage are described in the literature. The practice of misoprostol by the intrauterine route during caesarean section is under trial.10. Aim of study is to observe the effectiveness of intrauterine misoprostol in addition to oxytocin to minimize the blood loss during caesarean section.

NO

Primary|Post Partum Hemorrhage

DRUG: Misoprostol|DRUG: Oxytocin

measurement of haemoglobin level to assess the blood loss, haemoglobin will be measured preoperatively and postoperatively to minimize the blood loss during cesarean section, six months

Islamabad Medical and Dental College

FEMALE

ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION

ARizwan

2021-02-03

2021-08-30

2021-08-30

2021-01-26

2021-02-25

Islamabad medical and Dental College, Islamabad, Federal, 44000, Pakistan

{ "Misoprostol": [ { "intervention_type": "DRUG", "description": "Misoprostol", "name": "Misoprostol", "synonyms": [ "Misoprostol, (11alpha,13Z)-(+-)-Isomer", "Misoprostol, (11beta,13E,16S)-Isomer", "Misoprostol, (11beta,13E,16R)-Isomer", "Glefos", "SC30249", "Misoprostol, (11alpha.13E,16S)-Isomer", "Apo-Misoprostol", "SC 30249", "Apo Misoprostol", "Novo-Misoprostol", "SC 29333", "Misoprostol, (11beta,13E)-(+-)-Isomer", "Novo Misoprostol", "Misoprostolum", "SC-30249", "Misoprostol, (11alpha,13E)-Isomer", "SC-29333", "SC29333", "Cytotec", "Misoprostol, (11alpha,13E,16R)-Isomer", "Misoprostol" ], "medline_plus_id": "a689009", "generic_names": [ "Misoprostol" ], "mesh_id": "D010120", "drugbank_id": "DB00929" } ], "Oxytocin": [ { "intervention_type": "DRUG" } ] }

NCT01572987

Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barretts Esophagus

https://clinicaltrials.gov/study/NCT01572987

ERADICATE

TERMINATED

This clinical trial will evaluate a patient population with Barretts esophagus(BE) containing high grade dysplasia or intramucosal cancer and compare the effects of endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise endoscopic mucosal resection(S-EMR).

NO

Barretts Esophagus|Esophageal Neoplasms

DEVICE: Radiofrequency Ablation(RFA) by HALO device.|DEVICE: Endoscopic mucosal resection(EMR) by mucosectomy kit.

Complete histological eradication of Barretts esophagus, 12 months

Complete histological clearance of dysplasia, 12 months|Complication rates, 12 months

Midwest Biomedical Research Foundation

American Society for Gastrointestinal Endoscopy|Cook Group Incorporated|Washington University School of Medicine|Columbia University|University of Chicago

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

PS0058

2011-09

2017-05

2017-05

2012-04-06

2017-05-30

University Of Chicago, Chicago, Illinois, 60637, United States|Barnes-Jewish Hospital, Saint Louis, Missouri, 63141, United States|Columbia University, New York, New York, 10032, United States

{ "Radiofrequency Ablation(RFA) by HALO device.": [ { "intervention_type": "DEVICE" } ], "Endoscopic mucosal resection(EMR) by mucosectomy kit.": [ { "intervention_type": "DEVICE" } ] }

NCT01454687

Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes

https://clinicaltrials.gov/study/NCT01454687

WITHDRAWN

The term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases associated with skin weakness, blisters, and chronic wounds. Revertant mosaicism means that there are two genetically different populations of cells due to spontaneous mutations. Some EB patients have normal, non-fragile skin patches which may be areas of revertant mosaicism. In the revertant areas, the proteins function normally, like non-EB skin. In this study, we plan to culture cells from the revertant areas and graft them on to the wounded areas.

NO

Epidermolysis Bullosa

PROCEDURE: Grafting of Autologous Cultured Revertant Keratinocytes

Expression of the correct protein at the basement membrane zone, Week 52|Engraftment and healing of wounds with genetically revertant keratinocytes, Week 52

Engraftment and healing of wounds with genetically revertant keratinocytes, Week 8-12|Engraftment and healing of wounds with genetically revertant keratinocytes, Week 25|Expression of correct protein at the basement membrane zone, Week 8-12|Expression of the correct protein at the basement membrane zone, Week 25

Stanford University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

IRB # 22005

2011-10

2014-04

2011-10-19

2014-04-11

{ "Grafting of Autologous Cultured Revertant Keratinocytes": [ { "intervention_type": "PROCEDURE" } ] }

NCT06147687

Machine Learning for Early Diagnosis of Endometriosis(MLEndo)

https://clinicaltrials.gov/study/NCT06147687

MLEndo

RECRUITING

The project aims to create a large prospective data bank using the Lucy medical mobile application and collect and analyze patient profiles and structured clinical data with artificial intelligence. In addition, authors will investigate the association of removed or restricted dietary components with quality of life, pain, and central sensitization.

NO

Endometriosis|Pelvic Pain|Infertility, Female

DIAGNOSTIC_TEST: Self reported data collection

Patient- profiling using the Lucy app, Establish a comprehensive and extensive prospective big data repository using the Lucy app. This initiative aims to identify unique clinical cohorts by leveraging various factors such as digital footprints, symptoms, patient experiences, comorbidities, clinical severity, and lifestyle patterns. By employing Using ML for big data analysis, authors can build patient profiles and structured clinical data that facilitate the early detection of endometriosis with pelvic pain. Self-reported data of the participants will be measured as follows: * Evaluating the quality of life using the 5-level EQ-5D (EQ-5D-5L) * Endometriosis Health Profile 5 (EHP-5) . * Pain scores using the Visual Analogue Scale (VAS) . * Central pain sensitization using the short version of Central Sensitization Inventory (CSI-9), 24 month

Impact of diet and lifestyle on the development of endometriosis, Additionally, authors can identify nutritional components that may worsen the quality of life and pain in women with endometriosis; thus, they can create evidence-based dietary recommendations. The changes in quality of life will be assessed by using Self-reported data of the participants will be measured as follows: Change From Baseline in Pain Scores on the Visual Analog Scale at 12 months. Changes from baseline values on EHP5 at 12 months, 24 month

Economical burden of endometriosis, Economical burden taking into account the cost of diet and healthcare use. The exact cost of endometriosis related diet will be reported per month in EUR., 24 month

Semmelweis University

University of Aarhus

FEMALE

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Semmelweis

2022-01-01

2024-12-31

2024-12-31

2023-11-28

2023-11-28

Bokor Attila, Budapest, 1028, Hungary|Semmelweis University, Budapest, 1088, Hungary

{ "Self reported data collection": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT05417087

Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

https://clinicaltrials.gov/study/NCT05417087

COMPLETED

An open label, randomized, three-period, three-treatment [Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)], six-sequence, crossover, balanced, single dose oral bioequivalence study.

NO

Major Depressive Disorder (MDD)

DRUG: Vortioxetine Hemihydrobromide Orally Disintegrating Tablets|DRUG: Vortioxetine Hydrobromide Tablets

Plasma samples will be tested. PK parameter Cmax will be reported. Ratios of PK parameters on SF001 ODT and Trintellix fall within 80.00% to 125.00%, PK parameters will be determined using a non-compartmental analysis. T/R ratio will be reported for Cmax. Ln-transformed Cmax should be within 80.00% to 125.00% with 90% confidence intervals as bioequivelence, In each period, total 28 blood samples will be collected at pre-dose (0.0 hour) and until 240 hours post dose|Plasma samples will be tested. PK parameter AUCi will be reported. Ratios of PK parameters on SF001 ODT and Trintellix fall within 80.00% to 125.00%, PK parameters will be determined using a non-compartmental analysis. T/R ratio will be reported for AUCi. Ln-transformed AUCi should be within 80.00% to 125.00% with 90% confidence intervals as bioequivelence, In each period, total 28 blood samples will be collected at pre-dose (0.0 hour) and until 240 hours post dose

Seasons Biotechnology (Taizhou) Co., Ltd.

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT

C1B01561

2022-06-27

2022-09-02

2022-09-02

2022-06-14

2023-04-13

Cliantha Research Limited, Ahmedabad, Gujarat, 382210, India

{ "Vortioxetine": [ { "intervention_type": "DRUG", "description": "Vortioxetine Hemihydrobromide Orally Disintegrating Tablets", "name": "Vortioxetine", "synonyms": [ "Lu-AA21004", "Vortioxetine Hydrobromide", "Vortioxetine", "Vortioxetina", "Trintellix", "Brintellix", "Vortiox\u00e9tine", "1-(2-(2,4-Dimethylphenylsulfanyl)phenyl)piperazine", "Lu AA21004", "vortioxetinum", "LuAA21004" ], "medline_plus_id": "a614003", "generic_names": [ "Vortioxetine" ], "mesh_id": "D058831", "drugbank_id": "DB09068" }, { "intervention_type": "DRUG", "description": "Vortioxetine Hydrobromide Tablets", "name": "Vortioxetine", "synonyms": [ "Lu-AA21004", "Vortioxetine Hydrobromide", "Vortioxetine", "Vortioxetina", "Trintellix", "Brintellix", "Vortiox\u00e9tine", "1-(2-(2,4-Dimethylphenylsulfanyl)phenyl)piperazine", "Lu AA21004", "vortioxetinum", "LuAA21004" ], "medline_plus_id": "a614003", "generic_names": [ "Vortioxetine" ], "mesh_id": "D058831", "drugbank_id": "DB09068" } ] }

NCT00315887

The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.

https://clinicaltrials.gov/study/NCT00315887

COMPLETED

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.

NO

Chronic Low Back Pain

DRUG: Buprenorphine transdermal delivery system

Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.

Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)|incidence of and time to early discontinuation due to lack of efficacy|investigators assessment of therapeutic response|dose level at the end of titration

Purdue Pharma LP

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT

BP98-1201

1999-04

1999-10

2006-04-19

2006-05-03

Rheumatology Associates of North Alabama, Huntsville, Alabama, 35801, United States|Arizona Research Center, Phoenix, Arizona, 85023, United States|Arthritis Center of Connecticut, Waterbury, Connecticut, 06708, United States|University Clinical Research, Deland, Florida, 32720, United States|Gainesville Clinical Research Center, Gainesville, Florida, 32605, United States|Miami Research Associates, Miami, Florida, 33173, United States|Sarasota Arthritis Center, Sarasota, Florida, 34239, United States|Coastal Medical Research, South Daytona Beach, Florida, 32119, United States|Palm Beach Research Center, West Palm Beach, Florida, 33409, United States|Private Practice, Weston, Florida, 33331, United States|Pain Management & Rehabilitation, Terre Haute, Indiana, 47807, United States|Mid-America Rheumatology Consultants, Overland Park, Kansas, 66209, United States|Riverhills Healthcare, Crestview Hills, Kentucky, 41017, United States|Arthritis & Osteoporosis Treatment & Research Center, Jackson, Mississippi, 39216, United States|Center for Pharmaceutical Research, Kansas City, Missouri, 64114, United States|PrecisionMed, Inc., Las Vegas, Nevada, 89128, United States|Cornerstone Research Care, High Point, North Carolina, 27262, United States|Consultants for Clinical Research, Cincinnati, Ohio, 45219, United States|Center for Clinical Research, Austin, Texas, 78758, United States|The Arthritis Clinic of Northern Virginia, Arlington, Virginia, 22206, United States|Evergreen Clinical Research, Edmonds, Washington, 98026, United States|Private Practice, Wauwatosa, Wisconsin, 53226, United States

{ "Buprenorphine": [ { "intervention_type": "DRUG", "description": "Buprenorphine transdermal delivery system", "name": "Buprenorphine", "synonyms": [ "Prefin", "Subutex", "Buprenorfina", "Buprenorphine Hydrochloride", "RX-6029-M", "Espranor", "17-cyclopropylmethyl-4,5\u03b1-epoxy-7\u03b1-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6-methoxy-6,14-endo-ethanomorphinan-3-ol", "Buprenorphine", "6029-M", "21-cyclopropyl-7\u03b1-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine", "2-(N-cyclopropylmethyl-4,5\u03b1-epoxy-3-hydroxy-6-methoxy-6,14-endo-ethanomorphinan-6\u03b1-yl)-3,3-dimethyl-2-butanol", "Suboxone", "Butec", "Temg\u00e9sic", "RX6029M", "(\u2212)-buprenorphine", "Buprenex", "Buprex", "RX 6029 M", "2-[3-cyclopropylmethyl-11-hydroxy-15-methoxy-(14R)-13-oxa-3-azahexacyclo[13.2.2.12,8.01,6.06,14.07,12]icosa-7,9,11-trien-16-yl]-3,3-dimethyl-2-butanol", "Hydrochloride, Buprenorphine", "Temgesic", "Buprenophine", "Sublocade", "6029M", "Buprenorphinum", "6029 M", "Buvidal", "Sixmo", "Subutex", "Buprenorphine Sublingual and Buccal (opioid dependence)", "Subutex", "Buprenorphine Sublingual and Buccal (opioid dependence)", "Buprenorphine/naloxone", "Suboxone", "Zubsolv", "Bunavail", "Buprenorphine/naloxone", "Suboxone", "Zubsolv", "Bunavail" ], "medline_plus_id": "a618015", "generic_names": [ "Buprenorphine", "Buprenorphine Sublingual and Buccal (opioid dependence)", "Buprenorphine Sublingual and Buccal (opioid dependence)" ], "nhs_url": "https://www.nhs.uk/medicines/buprenorphine-for-pain", "mesh_id": "D009294", "drugbank_id": "DB00921", "wikipedia_url": "https://en.wikipedia.org/wiki/Buprenorphine" } ] }

NCT02226887

Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

https://clinicaltrials.gov/study/NCT02226887

ILEOCLOSE

UNKNOWN

Design Prospective , randomized, parallel phase IV. Objectives Main objective * Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of incisional hernia of the abdominal wall at the site of a loop ileostomy when it is closed to rebuild the intestinal transit. The effectiveness evaluation is done by tracking with scheduled patient visits for 12 months, assessing the physical examination the presence or absence of an incisional hernia and an abdominal tomography at the end of the 12 months . Secondary objectives Comparison of complications(morbidity and mortality) to assess safety and tolerability of the placement of the mesh described .

NO

Loop Ileostomy Closure

PROCEDURE: MESH|PROCEDURE: NO MESH|RADIATION: Post-operative Imaging|RADIATION: Pre-operative Imaging|OTHER: Blood Test and C-reactive protein at 4th day

Eventration, Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery., 1 year

Occlusive problems, Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),.... * This is a Clinical measure supported by image if necessary * All the morbidity problems are reported independently. * 1 patient can suffer a prolonged ileus and Anastomotic stenosis and both will be reported., 30 days after surgery|Iatrogenic problems, Damage to structures such as ureters, bowel loops artery / iliac vein .... * This is a Surgical and Clinical measure supported by image if necessary. * All the morbidity problems are reported independently., 30 days after surgery|Impaired healing, Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis... * This is a Clinical measure always supported by image tests. * All the morbidity problems are reported independently., 30 days after surgery|Bleeding problems, Hemoperitoneum, abdominal hematoma,anastomotic bleeding .... * This is a Clinical measure supported by image if necessary. * All the morbidity problems are reported independently. * The amount of blood loss wont be specified, 30 days after surgery|Cardiac complications, acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema * This is a Clinical measure supported by more specific tests if necessary. * All the morbidity problems are reported independently. * Cardiologist report will be required for including this items, 30 days after surgery|Nephro-urinary complications, Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ... * This is a Clinical measure supported by more specific tests if necessary. * All the morbidity problems are reported independently., 30 days after surgery|Respiratory complications, Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ... * This is a Clinical measure always supported by image . * All the morbidity problems are reported independently., 30 days after surgery|Vascular Complications, Deep venous thrombosis, phlebitis, thrombophlebitis, ... * This is a Clinical measure supported by more specific test if necessary . * All the morbidity problems are reported independently, 30 days after surgery|Gastrointestinal complications, Liver failure, gastrointestinal bleeding, severe malnutrition, ... * This is a Clinical measure supported by blood test and further test if necessary * All the morbidity problems are reported independently., 30 days after surgery|Neurological complications, Disorientation, cerebral vascular accident, ... * This is a Clinical measure. * All the morbidity problems are reported independently. * Neurologist report will be required beyond disorientation., 30 days after surgery|Local infection, Superficial, deep, body-cavity * This is a Clinical measure supported by image if necessary * All the morbidity problems are reported independently, 30 days after surgery|Local complications, Hematoma, seroma, evisceration * This is a Clinical measure * All the morbidity problems are reported independently, 30 days after surgery|Hospital stay, Hospital stay since surgery is done, Days

Hospital Universitari Vall dHebron Research Institute

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION

PR(AG)288/2013

2014-04

2018-05

2019-06

2014-08-27

2017-04-13

Hospital General Universitario Vall d´Hebron, Barcelona, 08035, Spain

{ "MESH": [ { "intervention_type": "PROCEDURE" } ], "NO MESH": [ { "intervention_type": "PROCEDURE" } ], "Post-operative Imaging": [ { "intervention_type": "RADIATION" } ], "Pre-operative Imaging": [ { "intervention_type": "RADIATION" } ], "Blood Test and C-reactive protein at 4th day": [ { "intervention_type": "OTHER" } ] }

NCT04981587

Effects of Strength Exercise on Fall Risk in Elderly With Alzheimers Disease

https://clinicaltrials.gov/study/NCT04981587

COMPLETED

Interventional study to show the effects of strength exercise on fall risk in elderly with Alzheimers disease

NO

Alzheimer Disease|Dementia; Alzheimers Type (Etiology)|Fall Risk|Elderly|Resistance Training

PROCEDURE: Strength exercise|OTHER: Usual treatment

Change from baseline Short physical performance battery (SPPB) at 3 and 6 months, Informs about fall risk and mobility Score: 0-12 High score means better result, Baseline, 3 and 6 months (3 months after intervention)

Change from baseline Activities specific balance confidence scale (ABC scale) at 3 and 6 months, This questionnaire allows to measure the balance of a person Score: 0-100% High percentage means better result, Baseline, 3 and 6 months (3 months after intervention)|Change from baseline Lawton Instrumental Activities of Daily Living Scale (IADL) at 3 and 6 months, This tool gives us information about performance in activities of daily living Score: 0-8 High score means better result, Baseline, 3 and 6 months (3 months after intervention)|Change from baseline Quality of life Alzheimer Disease (QoL-AD) at 3 and 6 months, Through this test we can know the level of quality of life of users who suffer from this disease Score: 0-52 High score means better result, Baseline, 3 and 6 months (3 months after intervention)|Change from baseline FRAIL test at 3 and 6 months, This rapid test allows to determine the state of frailty of older people Score: 0-5 High score means worst result, Baseline, 3 and 6 months (3 months after intervention)|Change from baseline Mini Mental State Examination (MMSE) at 3 and 6 months, This test gives us information about the cognitive performance of the participants Score: 0-30 High score means better result, Baseline, 3 and 6 months (3 months after intervention)|Change from baseline Neuropsychiatric Inventory (NPI-Q) at 3 and 6 months, This tool allows to specify the neuropsychiatric symptoms patients present Score: 0-36 High score means worst result, Baseline, 3 and 6 months (3 months after intervention)|Change from baseline Manual dynamometry at 1,2,3 and 6 months, This test allows to quantify force an individual presents in a simple way Score: 0-∞ High score means better result, Baseline, 1, 2, 3 and 6 months (3 months after intervention)|Modified Borg scale, In this way we can measure the level of perceived exertion during the intervention with strength exercise Score: 0-10 High score means more fatigue, 3 times/week during strength exercises sessions|Change from baseline One Maximum repetition strength test (1 MR) at 1,2,3 and 6 months, Allows you easily to assess maximum strength Score: 0-∞ High score means more strength level, Baseline, 1 , 2 , 3 and 6 months (3 months after intervention)

University of Jaén

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

CEIH/FEB.21/8.TES

2021-05-01

2021-12-10

2022-03-04

2021-07-29

2022-03-07

A.F.A La Estrella, Jaén, Andalucía, Spain|Alexander achalandabaso, Alcalá De Henares, Madrid, 28805, Spain

{ "Strength exercise": [ { "intervention_type": "PROCEDURE" } ], "Usual treatment": [ { "intervention_type": "OTHER" } ] }

NCT03225287

Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study

https://clinicaltrials.gov/study/NCT03225287

TERMINATED

The purpose of this study is to enable continued access to zilucoplan (RA101495) for patients with paroxysmal nocturnal hemoglobinuria (PNH) after they complete a zilucoplan clinical study.

YES

Paroxysmal Nocturnal Hemoglobinuria (PNH)

DRUG: Zilucoplan (RA101495)

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs were defined as an AE that occurs after a participants initial treatment zilucoplan start for this study (RA101495-01.202) that was not present at the time of treatment start, or an AE that increases in severity after treatment start in this study, if the event was present at the time of treatment start., From Day 1 until the Final Study Visit (up to Month 49)|Percentage of Participants With Serious TEAEs, Serious Adverse event (SAE) was defined as any untoward medical occurrence that:• results in death, • is life-threatening threatening (note that this refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe), • requires hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, and • results in a congenital anomaly/birth defect., From Day 1 until the Final Study Visit (up to Month 49)

Number of Participants With Anti-drug Antibodies (ADA), Blood samples collection were planned to analyze for the presence/absence of ADAs to zilucoplan for immunogenicity assessments., At Day 1, Month 1, 2, 3, 6, 9, and 12|Change From Baseline in Serum Lactate Dehydrogenase (LDH) Levels at Each Time Point, Serum LDH levels were measure of intravascular hemolysis. As high level of LDH in the blood was indicative of hemolysis in participants with PNH., Baseline, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and Final Study Visit (Month 49)|Change From Baseline in Total Bilirubin Values at Each Time Point, Total Bilirubin was monitored for signs and symptoms of hepatic or biliary dysfunction., Baseline, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and Final Study Visit (Month 49)|Change From Baseline in Total Hemoglobin Values at Each Time Point, Total Hemoglobin Values were analyzed for hematology assessments., Baseline, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and Final Study Visit (Month 49)|Change From Baseline in Free Hemoglobin Values at Each Time Point, Free Hemoglobin Values were analyzed for hematology assessments., Baseline, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and Final Study Visit (Month 49)|Change From Baseline in Haptoglobin Values at Each Time Point, Haptoglobin values were analyzed for hematology assessments., Baseline, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and Final Study Visit (Month 49)|Change From Baseline in Reticulocytes at Each Time Point, Reticulocytes values were analyzed for hematology assessments., Baseline, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and Final Study Visit (Month 49)|Change From Baseline in Hemoglobinuria Values at Each Time Point, Hemoglobinuria was assessed using a urine colorimetric scoring system with a score of 1 through 10 where 1 represents no hemoglobinuria and 10 represents maximum hemoglobinuria., Baseline, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and Final Study Visit (Month 49)|Plasma Concentrations of RA101495 and Its Major Metabolite(s), Blood samples of RA101495 (zilucoplan) and its metabolites (RA102758 and RA103488) were collected for Plasma concentration analysis., Predose: At Day 1 (Screening), Month 1, 2, 3, 6, 9, 12, and Final Study Visit (Month 49)|Maximum Plasma Concentration (Cmax) of RA101495, Cmax is the maximum plasma concentration., At Day 1, Month 1, 2, 3, 6, 9, and 12|Time Corresponding to Cmax (Tmax) of RA101495, tmax is the time to corresponding Cmax., At Day 1, Month 1, 2, 3, 6, 9, and 12|Area Under the Drug Concentration-time Curve (AUC0-t) of RA101495, AUC0-t is area under the drug concentration-time curves., At Day 1, Month 1, 2, 3, 6, 9, and 12|Total Complement (CH50) Levels, Blood samples collection were planned to assess complement (CH50) levels. The planned analysis of CH50 was not performed because the CH50 assay was not able to be validated due to lack of reproducibility of the manufacturers kits., At Day 1, Month 1, 2, 3, 6, 9, and 12|Change From Baseline in Sheep Red Blood Cell (sRBC) Values at Each Time Point, Blood samples were collected for measurement of sRBC lysis for the Classical Complement Pathways., Baseline, Month 1, 2, 3, 6, 9, 12 and Final Study Visit (Month 49)|Change From Baseline in Wieslab Enzyme-linked Immunosorbent Assay (ELISA) Values for Alternative Complement Pathway at Each Time Point, Blood samples were collected for measurement of membrane attack complex (MAC) by Wieslab ELISA for alternative complement pathway., Baseline, Month 1, 2, 3, 6, 9, 12 and Final Study Visit (Month 49)|Change From Baseline in Complement Component 5 (C5) Values at Each Time Point, Blood samples were collected for measurement of Complement component 5 (C5) levels., Baseline, Month 1, 2, 3, 6, 9, 12 and Final Study Visit (Month 49)

Ra Pharmaceuticals, Inc.

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

RA101495-01.202|2016-003523-34

2017-07-17

2021-09-07

2021-10-26

2017-07-21

2022-10-27

2023-09-28

Investigative Site 4, Los Angeles, California, 90033, United States|Investigative Site 19, Dallas, Texas, 75390, United States|Investigative Site 3, Gosford, Australia|Investigative Site 5, Melbourne, Australia|Investigative Site 10, Toronto, Canada|Investigative Site 14, Helsinki, Finland|Investigative Site 9, Ulm, Germany|Investigative Site 17, Budapest, Hungary|Investigative Site 13, Christchurch, New Zealand|Investigative Site 12, Hamilton, New Zealand|Investigative Site 6, Leeds, United Kingdom|Investigative Site 7, London, United Kingdom

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT03225287/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03225287/SAP_001.pdf

{ "Zilucoplan": [ { "intervention_type": "DRUG", "description": "Zilucoplan (RA101495)", "name": "Zilucoplan", "synonyms": [ "N2-ACETYL-L-LYSYL-L-VALYL-L-.ALPHA.-GLUTAMYL-L-ARGINYL-L-PHENYLALANYL-L-.ALPHA.-ASPARTYL-N-METHYL-L-.ALPHA.-ASPARTYL-3-METHYL-L-VALYL-L-TYROSYL-3-(1H-PYRROLO(2,3-B)PYRIDIN-3-YL)-L-ALANYL-L-.ALPHA.-GLUTAMYL-L-TYROSYL-L-PROLYL-(2S)-2-CYCLOHEXYLGLYCYL-N6-(3", "", "Zilucoplan", "POLY(OXY-1,2-ETHANEDIYL), .ALPHA.-(2-(((4S)-4-CARBOXY-1-OXO-4-(1-OXOHEXADECYL)BUTYL)AMINO)ETHYL)-.OMEGA.-HYDROXY-, 15-ETHER WITH N-ACETYL-L-LYSYL-L-VALYL-L-.ALPHA.-GLUTAMYL-L-ARGINYL-L-PHENYLALANYL-L-.ALPHA.-ASPARTYL-N-METHYL-L-.ALPHA.-ASPARTYL-3-METHYL-" ], "drugbank_id": "DB15636", "generic_names": [ "Zilucoplan" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Zilucoplan" } ] }

NCT02286687

Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes

https://clinicaltrials.gov/study/NCT02286687

ACTIVE_NOT_RECRUITING

This phase II trial studies how well talazoparib works in treating patients with cancers that have returned after a period of improvement, do not respond to treatment, or have spread to other parts of the body, and have alterations in the breast cancer, early onset (BRCA) genes. Talazoparib may cause tumor cells to die by blocking an enzyme that protects the tumor cells from damage.

NO

Advanced Malignant Neoplasm|ATM Gene Mutation|BRCA1 Gene Mutation|BRCA2 Gene Mutation|Metastatic Malignant Neoplasm|PALB2 Gene Mutation|Recurrent Malignant Neoplasm|Refractory Malignant Neoplasm

OTHER: Laboratory Biomarker Analysis|OTHER: Pharmacological Study|DRUG: Talazoparib

Clinical benefit by Response Evaluation Criteria in Solid Tumors 1.1, Evaluated separately in each cohort. Calculated using posterior probabilities along with corresponding credible intervals., Up to 1 year

Progression free survival, Calculated using the Kaplan-Meier method., Up to 1 year|Overall survival, Calculated using the Kaplan-Meier method., Up to 1 year|Duration of response, Calculated using the Kaplan-Meier method., Up to 1 year

Molecular markers that may predict clinical benefit, Marker values will be compared between patients with and without clinical benefit using chi-squared or Fisher exact tests for categorically-scaled markers and Wilcoxon rank sum tests for interval- and ordinal-scaled markers. Only those significant on univariate analysis will be combined into a single logistic regression model to assess their independent effects on clinical benefit. Analyses will be performed both within and across the five cohorts., Baseline|Pharmacodynamic markers in blood and plasma that may predict outcome, Regulation of poly-adenosine triphosphate ribose activity in peripheral blood mononuclear cells will be correlated with response. Effect of treatment on proteomic profile and cell-free deoxyribonucleic acid will be assessed as exploratory endpoints., Up to week 4|BRCA1/2 alterations in archival tissue, Concordance between archival tissue and pre-treatment biopsies will be assessed using kappa statistics., Baseline|BRCA1/2 alterations in pretreatment biopsies, Concordance between archival tissue and pre-treatment biopsies will be assessed using kappa statistics., Baseline|Genomic alterations in tumor deoxyribonucleic acid, Concordance between tumor and circulating free deoxyribonucleic acid will be assessed using kappa statistics., Baseline|Genomic alterations in circulating free deoxyribonucleic acid, Concordance between tumor and circulating free deoxyribonucleic acid will be assessed using kappa statistics., Up to week 4|Change in marker levels, The markers described yield interval-scaled values that may not be normally distributed, so differences between baseline and 2-week values will be assessed using the Wilcoxon signed-rank test., Baseline to 2 weeks|Baseline proteomic signature and pharmacodynamic response by reverse phase protein array, Pharmacodynamic effect of talazoparib on proteomic signature will be assessed by reverse phase protein array and correlated with response, clinical benefit, as well as best response as percentage tumor change., Baseline|Archival immunohistochemistry staining, Immunohistochemistry staining will be assessed via the H-score which can be treated as an interval-scaled variable. The concordance correlation coefficient as well as the Altman-Bland approach will be used to assess the concordance between archival immunohistochemistry staining and baseline biopsy immunohistochemistry staining. In addition, PTEN will be assessed (PTEN loss, no loss). Concordance between archival tissue and pre-treatment biopsies will be assessed using kappa statistics., Baseline|Baseline biopsy immunohistochemistry staining, Immunohistochemistry staining will be assessed via the H-score which can be treated as an interval-scaled variable. The concordance correlation coefficient as well as the Altman-Bland approach will be used to assess the concordance between archival immunohistochemistry staining and baseline biopsy immunohistochemistry staining. In addition, PTEN will be assessed (PTEN loss, no loss). Concordance between archival tissue and pre-treatment biopsies will be assessed using kappa statistics., Baseline

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2013-0961|NCI-2014-02494|2013-0961

2014-12-22

2025-12-31

2025-12-31

2014-11-10

2024-04-05

M D Anderson Cancer Center, Houston, Texas, 77030, United States

{ "Laboratory Biomarker Analysis": [ { "intervention_type": "OTHER" } ], "Pharmacological Study": [ { "intervention_type": "OTHER" } ], "Talazoparib": [ { "intervention_type": "DRUG", "description": "Talazoparib", "name": "Talazoparib", "synonyms": [ "Talazoparib", "Talzenna" ], "medline_plus_id": "a618070", "generic_names": [ "Talazoparib" ], "drugbank_id": "DB11760", "wikipedia_url": "https://en.wikipedia.org/wiki/Talazoparib" } ] }

NCT01630187

Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section

https://clinicaltrials.gov/study/NCT01630187

COMPLETED

The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.

NO

Uterine Atony|Post-partum Hemorrhage

DRUG: Carbetocin|DRUG: Carbetocin

Utilization of a second uterotonic drug, First 48 hours of the postpartum

Incidence of side effects, During the fifteen minutes following the administration of carbetocin|Incidence of major complications, First 48 hours of the postpartum|Drop in hemoglobin measurement, on the second post-partum day

Laval University

FEMALE

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

CARB-011

2012-04

2012-07

2012-07

2012-06-28

2013-05-29

Hôpital Saint-François-dAssise (CHUQ), Quebec, G1L 3L5, Canada

{ "Carbetocin": [ { "intervention_type": "DRUG", "description": "Carbetocin", "name": "Carbetocin", "synonyms": [ "1-butyric acid-2-(3-(p-methoxyphenyl)-L-alanine)oxytocin", "Carbetocina", "Carbetocin", "1-butanoic acid-2-(O-methyl-L-tyrosine)-1-carbaoxytocin", "deamino-2-O-methyltyrosine-1-carbaoxytocin", "Carbetocino", "Carbetocinum" ], "drugbank_id": "DB01282", "generic_names": [ "Carbetocin" ] }, { "intervention_type": "DRUG", "description": "Carbetocin", "name": "Carbetocin", "synonyms": [ "1-butyric acid-2-(3-(p-methoxyphenyl)-L-alanine)oxytocin", "Carbetocina", "Carbetocin", "1-butanoic acid-2-(O-methyl-L-tyrosine)-1-carbaoxytocin", "deamino-2-O-methyltyrosine-1-carbaoxytocin", "Carbetocino", "Carbetocinum" ], "drugbank_id": "DB01282", "generic_names": [ "Carbetocin" ] } ] }

NCT00834587

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting

https://clinicaltrials.gov/study/NCT00834587

COMPLETED

This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under non-fasting conditions.

YES

Healthy

DRUG: 5 mg/500 mg METAGLIP™ Tablets|DRUG: 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets

Cmax (Maximum Observed Concentration) - Glipizide in Plasma, Bioequivalence based on Cmax, Blood samples collected over 36 hour period|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glipizide, Bioequivalence based on AUC0-inf, Blood samples collected over 36 hour period|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide, Bioequivalence based on AUC0-t, Blood samples collected over 36 hour period|Cmax (Maximum Observed Concentration) - Metformin in Plasma, Bioequivalence based on Cmax, Blood samples collected over 36 hour period|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin, Bioequivalence based on AUC0-inf, Blood samples collected over 36 hour period|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin, Bioequivalence based on AUC0-t, Blood samples collected over 36 hour period

Teva Pharmaceuticals USA

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:

R04-0477

2004-06

2004-06

2004-06

2009-02-03

2009-08-18

2009-09-15

PRACS Institute Ltd., East Grand Forks, Minnesota, 56721, United States|PRACS Institute, Ltd., Fargo, North Dakota, 58104, United States

{ "5 mg/500 mg METAGLIP\u2122 Tablets": [ { "intervention_type": "DRUG" } ], "Metformin": [ { "intervention_type": "DRUG", "description": "5 mg/500 mg Glipizide Metformin Hydrochloride Tablets", "name": "Metformin", "synonyms": [ "Dimethylbiguanidine", "Dimethylguanylguanidine", "Fortamet", "Metabet", "Metformin HCl", "Hydrochloride, Metformin", "Metformin", "Metformin Hydrochloride", "Diagemet", "Metformina", "Glumetza", "Trijardy", "Metforminum", "Glucient", "Glucophage", "Axpinet", "Dimethylbiguanid", "Metformine", "1,1-Dimethylbiguanide", "HCl, Metformin" ], "medline_plus_id": "a696005", "generic_names": [ "Metformin" ], "nhs_url": "https://www.nhs.uk/medicines/metformin", "mesh_id": "D007004", "drugbank_id": "DB00331", "wikipedia_url": "https://en.wikipedia.org/wiki/Metformin" } ], "Glipizide": [ { "intervention_type": "DRUG", "description": "5 mg/500 mg Glipizide Metformin Hydrochloride Tablets", "name": "Glipizide", "synonyms": [ "Mindiab", "Glipizida", "N-{4-[\u03b2-(5-methylpyrazine-2-carboxamido)ethyl]benzenesulphonyl}-N'-cyclohexylurea", "Glypidizine", "K4024", "Minodiab", "Glupitel", "Glipizide", "Glipizidum", "Glucotrol", "Minidiab", "Glidiazinamide", "K-4024", "Glydiazinamide", "Melizide", "K 4024", "1-cyclohexyl-3-({p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl}sulfonyl)urea", "Ozidia" ], "medline_plus_id": "a684060", "generic_names": [ "Glipizide" ], "mesh_id": "D007004", "drugbank_id": "DB01067" } ] }

NCT05271487

A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome

https://clinicaltrials.gov/study/NCT05271487

UNKNOWN

The purpose of this study is to analyze changes in acne and changes in the gut and skin microbiome with the use of a multi-step botanical skin care regimen in those with mild to moderate acne.

NO

Acne Vulgaris

OTHER: Multi-Step Botanical Skin Care Regimen

Total lesion count, Number of of inflammatory lesions, and open and closed comedones, 8 weeks

Inflammatory lesion count, Number of inflammatory lesions, 4 weeks|Inflammatory lesion count, Number of inflammatory lesions, 8 weeks|Non-inflammatory lesion count, Number of open and closed comedones, 4 weeks|Non-inflammatory lesion count, Number of open and closed comedones, 8 weeks|Investigator global assessment (IGA) of acne, Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne, 4 weeks|Investigator global assessment (IGA) of acne, Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne, 8 weeks|Sebum excretion, Measure of skin sebum via sebumeter, 4 weeks|Sebum excretion, Measure of skin sebum via sebumeter, 8 weeks|Gut microbiome assessment, Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample, 4 weeks|Gut microbiome assessment, Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample, 8 weeks|Skin microbiome diversity, Shift in Shannon diversity of the skin microbiome, 4 weeks|Skin microbiome diversity, Shift in Shannon diversity of the skin microbiome, 8 weeks|Positive and Negative Affect Schedule (PANAS-SF), Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect, 4 weeks|Positive and Negative Affect Schedule (PANAS-SF), Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect, 8 weeks|Diurnal Cortisol Slope, 4 salivary cortisol collections to assess diurnal slope, 4 weeks|Diurnal Cortisol Slope, 4 salivary cortisol collections to assess diurnal slope, 8 weeks|Salivary Sex Hormone Levels, 1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS, 4 weeks|Salivary Sex Hormone Levels, 1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS, 8 weeks

Integrative Skin Science and Research

Codex Beauty Corporation

ALL

CHILD, ADULT

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

CB_Acne_01

2022-03-07

2022-07-01

2023-03-01

2022-03-09

2022-03-09

Integrative Skin Science and Research, Sacramento, California, 95819, United States

{ "Multi-Step Botanical Skin Care Regimen": [ { "intervention_type": "OTHER" } ] }

NCT05864287

Pac-12 Bodies in Motion

https://clinicaltrials.gov/study/NCT05864287

RECRUITING

In the proposed study, the investigators will examine the effectiveness of Bodie in Motion (BIM) program in improving the body image, eating concerns, and overall psychological well-being, in a racially/ethnically diverse group of female and male-identifying athletes with body image concerns. Based on previous research, participating athletes should have direct and immediate Well-Being (i.e., mental health) benefits from their involvement in BIM.

NO

Effectiveness of BIM in Reducing Disordered Eating Among Student Athletes|Effectiveness of BIM in Reducing Body Image Concerns Among Student Athletes|Effectiveness of BIM Improving Psychological Well-Being Among Student Athletes

BEHAVIORAL: Bodies in motion intervention program

Change between baseline and post intervention Weight Pressures in Sport (WPS) Scale, Self-reported weight loss pressures from the external environment., pre-intervention, 1-2 weeks, 4 months and 12 months post intervention|Change between baseline and post intervention Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4, Self-reported thinness and muscularity internalization., pre-intervention, 1-2 weeks, 4 months and 12 months post intervention|Change between baseline and post intervention Sociocultural Attitudes Toward Appearance Questionnaire, Self-reported weight loss, thinness and muscularity perceived from outside pressures., pre-intervention, 1-2 weeks, 4 months and 12 months post intervention|Change between baseline and post intervention Body Parts Satisfaction Scale-Revised (BPSS-R), Self-reported body part satisfaction, pre-intervention, 1-2 weeks, 4 months and 12 months post intervention|Change between baseline and post intervention Self-Compassion Scale - Short Form (SCS-SF), Self-reported frequency of self-compassionate attitudes and behaviors., pre-intervention, 1-2 weeks, 4 months and 12 months post intervention

Patient Health Questionnaire-2 Item (PHQ-2, Self-reported frequency of depressed mood and anhedonia., Baseline|Generalized Anxiety Disorder-2 Item (GAD-2), Self-reported severity of frequency of nervous/anxious/on edge/worry behaviors., Baseline|Eating Disorder Examination Questionnaire-Short Form (EDE-QS), Self-reported eating disorder symptoms., Baseline

University of Arizona

University of North Texas Health Science Center

ALL

ADULT

PHASE3

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

STUDY00000865

2022-09-20

2024-07-01

2024-07-01

2023-05-18

2023-05-18

The university of Arizona, Tucson, Arizona, 85712, United States

{ "Bodies in motion intervention program": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03114787

Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service?

https://clinicaltrials.gov/study/NCT03114787

KISEVEN

TERMINATED

Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation

NO

Respiratory Physiotherapy|Resuscitation

OTHER: Study on patients with respiratory resuscitation

Time between initiation of weaning protocol and extubation., 8 months

Centre Hospitalier Universitaire, Amiens

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER

PI2015_843_0014

2016-08-30

2017-04-27

2017-04-27

2017-04-14

2018-10-04

CHU Amiens Picardie, Amiens, Picardie, 80054, France

{ "Study on patients with respiratory resuscitation": [ { "intervention_type": "OTHER" } ] }

NCT05103787

Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery

https://clinicaltrials.gov/study/NCT05103787

UNKNOWN

This study aims to assess the impact of bilateral deep parasternal intercostal plane block on intraoperative opioid consumption in open heart surgery

NO

Opioid Use

PROCEDURE: deep parasternal intercostal plane block|PROCEDURE: control

Total intraoperative fentanyl dose, Total intraoperative fentanyl dose will be calculated after surgery, intraoperatively

Time to first intraoperative fentanyl, Investigators will record time to first fentanyl dose after incision, intraoperatively|extubation time, Investigators will record time to extubation after surgery, Up to 72 hours after surgery|opioid side effects, Incidence of nausea and vomiting, within 24 hours after surgery|Intensive care unit length of stay, Investigators will record total time from intensive care unit admission until patient transferred to surgical wars, Up to 7 days after surgery

Indonesia University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT

IndonesiaUAnes119

2021-10-04

2022-04-04

2022-07-04

2021-11-02

2021-11-02

Cipto Mangunkusumo Cental National Hospital, Jakarta, DKI Jakarta, 10430, Indonesia|Universitas Indonesia, Central Jakarta, 10430, Indonesia

{ "deep parasternal intercostal plane block": [ { "intervention_type": "PROCEDURE" } ], "control": [ { "intervention_type": "PROCEDURE" } ] }

NCT06230887

Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study

https://clinicaltrials.gov/study/NCT06230887

NOT_YET_RECRUITING

Moral Injury Syndrome (MIS) affects up to 35-60% of Veterans managing combat-related PTSD; it results from experiences that challenge deeply held values or spiritual beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of spiritual beliefs, difficulty with forgiveness, loss of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Veterans managing MIS have difficulty responding to mental health treatment, and are at increased risk for suicide ideation or attempts. To date evidence-based interventions for MIS are not widely available in VA. This study will implement an evidence-based intervention for MIS in four VA facilities, collect data on the effectiveness of the intervention, and develop an implementation toolkit. This data will inform national dissemination in collaboration with the Office of Mental Health and Suicide Prevention and the National Chaplain Service.

NO

Moral Injury Syndrome

BEHAVIORAL: Building Spiritual Strength|BEHAVIORAL: Present Centered Group Therapy

Change in Moral Injury and Distress Scale, Full Scale Name: Moral Injury and Distress Scale Score Range: 0-90, with higher scores indicating more symptoms., 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Change in Moral Injury Outcomes Scale, Full Scale Name: Moral Injury and Distress Scale Score Range: 0-56, with higher scores indicating more symptoms., 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Change in Expressions of Moral Injury Scale, Full Scale Name: Expressions of Moral Injury Scale Score Range: 10-100, with higher scores indicating more symptoms., 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Change in Religious and Spiritual Struggles Scale, Full Scale Name: Religions and Spiritual Struggles Scale Score Range: 0=4 with higher scores indicating more symptoms, 8 weeks (end of treatment) and 20 weeks (long-term follow-up)

Change in Patient Health Questionnaire-9, Full Scale Name: Patient Health Questionnaire-9 Score range: 1-27, with higher scores indicating more symptoms, 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Change in Sheehan Disability Scale, Full Scale Name: Sheehan Disability Scale Score Range: 0-30, with higher scores indicating more functional disability, 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Change in Inventory of Community Participation, Full Scale Name: Inventory of Community Participation Score Range: 0-15, with higher scores indicating greater community participation, 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Change in Beck Scale for Suicide Ideation, Full Scale Name: Beck Scale for Suicide Ideation Score Range: 0-38, with higher values indicating a greater risk of suicide, 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Change in Reasons for Living Inventory, Full Scale Name: Reasons for Living Inventory Score Range: 48-288, with higher scores represent more reasons to live., 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Change in Multiscale Measure for Postconventional Religious Functioning, Full Scale Name: Multiscale Measure for Postconventional Religious Functioning. Four Subscales (Conventional Affiliate, Conventional Disaffiliate, Postconventional Affiliate, Postconventional Disaffiliate), each with a range of 12-48. Higher scores indicate religious functioning consistent with that subscale., 8 weeks (end of treatment) and 20 weeks (long-term follow-up)|Client Satisfaction Questionnaire-8, Full Scale Name: Client Satisfaction Questionnaire-8 Score Range 8-32, with higher numbers indicating greater satisfaction., 8 weeks (end of treatment)

VA Office of Research and Development

VA Central Alabama Health Care System|VA Atlanta Healthcare System|Michael E. DeBakey VA Medical Center|Minneapolis Veterans Affairs Medical Center

ALL

ADULT, OLDER_ADULT

FED

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH

IIR 22-132

2024-08-01

2027-07-01

2028-01-31

2024-01-30

2024-01-30

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR, North Little Rock, Arkansas, 72114-1706, United States|Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, 30033-4004, United States|Maine VA Medical Center, Augusta, ME, Augusta, Maine, 04330, United States|Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, 55417-2309, United States|Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas, 77030-4211, United States

{ "Building Spiritual Strength": [ { "intervention_type": "BEHAVIORAL" } ], "Present Centered Group Therapy": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04646187

De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease

https://clinicaltrials.gov/study/NCT04646187

FREE

ENROLLING_BY_INVITATION

BACKGROUND/RATIONALE: Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied. OBJECTIVE: To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval.

NO

Inflammatory Bowel Diseases|Crohn Disease|Colitis, Ulcerative

BIOLOGICAL: Infliximab|BIOLOGICAL: Adalimumab

cumulative incidence of out-of-range fecal calprotectin results at 48 weeks follow-up, Out-of-range FC results are defined as fecal calprotectin above the target range (i.e. >250 μg/g for CD patients; >150 μg/g for UC patients) and at least 100 μg/g increase compared with the previous result, unless the previous result was already above the target range., 48 weeks

Time to get out-of-range fecal calprotectin results, The time from study baseline until the first out-of-range fecal calprotectin result, up to 48 weeks|Cumulative incidence of anti-TNF-associated respiratory infections and dermatological adverse effects at 48 weeks follow-up, Dermatological adverse effect include skin infections, new-onset or worsening of psoriasis, psoriasiform lesions, eczema, acne and alopecia, 48 weeks|Evolution of FC and anti-TNF trough levels in the first 16 weeks after reverting to previous dosing interval, Proportion of patients with return of FC levels to target range without switch to out-of-class biological, Up to 48+16 weeks|Proportion of patients developing loss-of-response in the first 16 weeks after reverting to the previous dosing interval, Loss-of-response is defined as the appearance of symptoms of active IBD in combination with persistent out-of-range fecal calprotectin results, Up to 48+16 weeks|Identification of predictors of successful de-escalation., Predictors of successful de-escalation will be assessed by calculating odds ratios with the use of univariate logistic regression analysis. Candidate predictors with p<0.10 in univariate analysis will be selected for use in the multivariate analysis., 48 weeks

Patients attitudes towards deprescribing anti-TNF agents, We will use the revised Patients Attitudes Towards Deprescribing (rPATD) questionnaire, 48 weeks

University Medical Center Groningen

European Crohn´s and Colitis Organisation|Bühlmann Laboratories AG

ALL

CHILD, ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

202000261|2020-001811-26

2021-03-11

2025-03

2025-03

2020-11-27

2023-11-30

Universitair Ziekenhuis Gent, Gent, 9000, Belgium|Centre hospitalier universitaire de Liège, Liège, B-4000, Belgium|Centre hospitalier régional de la Citadelle, Liège, Belgium|Rijnstate Hospital, Arnhem, 6816 AD, Netherlands|Catharina Hospital Eindhoven, Eindhoven, 5623 EJ, Netherlands|University Medical Center Groningen, Groningen, 9700 RB, Netherlands|Zuyderland Medical Center, Heerlen, 6419 PC, Netherlands|Hospital Universitari de Bellvitge, LHospitalet De Llobregat, 08907, Spain

{ "Infliximab": [ { "intervention_type": "BIOLOGICAL", "description": "Infliximab", "name": "Infliximab", "synonyms": [ "cA2", "Infliximab-qbtx", "Infliximab abda", "Remsima", "Infliximab-axxq", "Infliximab-dyyb", "Inflectra", "Infliximab (genetical recombination)", "Renflexis", "Infliximab dyyb", "Remicade", "Antibody cA2, Monoclonal", "cA2, Monoclonal Antibody", "Infliximab", "Monoclonal Antibody cA2", "Anti-tumor Necrosis Factor-alpha", "MAb cA2", "Infliximab-abda", "Avsola" ], "medline_plus_id": "a604023", "generic_names": [ "Infliximab" ], "mesh_id": "D000079424", "drugbank_id": "DB00065", "wikipedia_url": "https://en.wikipedia.org/wiki/Infliximab" } ], "Adalimumab": [ { "intervention_type": "BIOLOGICAL", "description": "Adalimumab", "name": "Adalimumab", "synonyms": [ "adalimumab-atto", "Adalimumab-atto", "Antibody, D2E7", "Exemptia", "Hyrimoz", "Yuflyma", "Adalimumab (genetical recombination)", "adalimumab-adaz", "adalimumab-adbm", "adalimumab-afzb", "Amgevita", "D2E7 Antibody", "Idacio", "adalimumab-bwwd", "Adalimumab", "Mabura", "Humira", "Amjevita", "Imraldi", "adalimumab-fkjp", "Adalimumab-adbm", "Cyltezo" ], "medline_plus_id": "a603010", "generic_names": [ "Adalimumab" ], "nhs_url": "https://www.nhs.uk/medicines/adalimumab", "mesh_id": "D000079424", "drugbank_id": "DB00051", "wikipedia_url": "https://en.wikipedia.org/wiki/Adalimumab" } ] }

NCT05922787

The Effect of Reiki on Sexual Function and Sexual Self-Confidence

https://clinicaltrials.gov/study/NCT05922787

COMPLETED

Background and Purpose: This study aimed to determine the effect of Reiki on sexual function and sexual self-confidence in women with sexual distress. Materials and Methods: This randomized controlled study was conducted with women between the ages of 15-49 years who were registered at a family health center in the eastern region of Turkey and had sexual distress. The sample of the study consisted of 106 women, 53 in the experimental group and 53 in the control group. Women in the experimental group received Reiki once a week for four weeks, while no intervention was applied to those in the control group. Data were collected using the Female Sexual Distress Scale-Revised (FSDS-R), the Arizona Sexual Experiences Scale (ASEX), and the Sexual Self-confidence Scale (SSS).

NO

Therapeutic Touch|Sexuality

OTHER: Reiki

Female Sexual Distress Scale-Revised (FSDS-R), The FSDS-R was assesses various aspects of sexual distress in women, including subjective stress and psychological impact associated with sexual dysfunction and is used to identify women with and without sexual dysfunction. The scale consists of 13 items on a five-point Likert scale ranging from never (0) to always. Total scale score ranges between 0 and 52. A higher score indicates higher levels of sexual distress. A cutoff score of ≥11.5 has been recommended to detect the presence of sexually-related personal distress in Turkish women., Change from Sexual Distress at 4 weeks

Arizona Sexual Experiences Scale (ASEX), The ASEX assess changes and disorders in sexual function. It was validated in Turkish in 2004. This six-point Likert type scale consists of five items on sexual desire, psychological arousal, physiological arousal (vaginal lubrication), orgasmic capacity, and orgasmic pleasure. Each item is scored from 1 to 6, with a total score ranging from 5 to 30. A lower score indicates a stronger, easier, and more satisfying sexual response, while a higher score suggests sexual dysfunction., Change from Sexual Experiences at 4 weeks|Sexual Self-confidences Scale (SSS), This four-point Likert type scale consists of 13 items to measure sexual self-confidence. Each item is scored from never (1) to always. Total scale score ranges between 13 and 52. A higher score indicates higher levels of sexual self-confidence., Change from Sexual Self-confidences at 4 weeks

Inonu University

FEMALE

CHILD, ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE

2022/3795

2022-09-20

2023-04-20

2023-06-01

2023-06-28

2023-07-17

Fırat University, Elazığ, Province, 23119, Turkey

{ "Reiki": [ { "intervention_type": "OTHER" } ] }

NCT00896987

Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

https://clinicaltrials.gov/study/NCT00896987

COMPLETED

The purpose of this study is to compare the effect of anti-epileptic drugs (AEDs) long-term treatment on cognitive function. This study is an open-label, randomized, multicenter comparative trial of lamotrigine versus carbamazepine. The planned enrollment is 100 patients.

NO

Epilepsy

DRUG: lamotrigine (Lamictal)|DRUG: Carbamazepine (Tegretol)

To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients, 48 weeks

Seizure outcome and tolerability, 48 weeks

Korean Epilepsy Society

GlaxoSmithKline

ALL

CHILD, ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

106172

2006-05

2008-12

2008-12

2009-05-12

2009-05-12

Asan Medical Center, Seoul, Korea, Republic of

{ "Lamotrigine": [ { "intervention_type": "DRUG", "description": "lamotrigine (Lamictal)", "name": "Lamotrigine", "synonyms": [ "BW 430C", "3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine", "BW-430C", "BW430C", "Lamiktal", "Labileno", "Lamotrigine", "Lamictal", "Crisomet", "3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine", "Lamotrigina", "Lamotriginum", "3,5-Diamino-6-(2,3-dichlorophenyl)-as-triazine" ], "medline_plus_id": "a695007", "generic_names": [ "Lamotrigine" ], "nhs_url": "https://www.nhs.uk/medicines/lamotrigine", "mesh_id": "D026941", "drugbank_id": "DB00555", "wikipedia_url": "https://en.wikipedia.org/wiki/Lamotrigine" } ], "Carbamazepine": [ { "intervention_type": "DRUG", "description": "Carbamazepine (Tegretol)", "name": "Carbamazepine", "synonyms": [ "Carbamazepine Anhydrous", "Molecusol-Carbamazepine", "Carbamazepine Sulfate (2:1)", "5-Carbamoyl-5H-dibenzo(b,f)azepine", "Epitol", "Carbamazepine L-Tartrate (4:1)", "Neurotol", "Carbamazepine Phosphate", "Amizepine", "Equetro", "Carbatrol", "5-Carbamoyl-5H-dibenz(b,f)azepine", "Carbamazepine Dihydrate", "Carbamazepen", "Curatil", "Finlepsin", "CBZ", "Tegretol", "Carbamaz\u00e9pine", "5-Carbamyl-5H-dibenzo(b,f)azepine", "Carbamazepinum", "Carbamazepine Hydrochloride", "Carbazepin", "5H-Dibenz(b,f)azepine-5-carboxamide", "Carbamazepine Acetate", "Carbamazepina", "Carbamazepin", "Carbamazepine", "5-carbamoyl-5H-dibenz[b,f]azepine" ], "medline_plus_id": "a682237", "generic_names": [ "Carbamazepine" ], "nhs_url": "https://www.nhs.uk/medicines/carbamazepine", "mesh_id": "D065701", "drugbank_id": "DB00564" } ] }

NCT05281887

Correlation Between the Changes of Retinal Structure and Function and Ischemic Stroke

https://clinicaltrials.gov/study/NCT05281887

RECRUITING

Ischemic stroke is the most common type of stroke, accounting for 60%-80% of all types of strokes, and is one of the leading global causes of death and severe disability. In the risk factors of stroke, carotid atherosclerosis have higher incidence.As the only visible microvessels in vivo, retinal can provides an accurate window into cerebrovascular and systemic vascular conditions. Optical coherence tomography angiography (OCTA) and electroretinogram (ERG) can be used to quantitatively analyze the retinal structure and function in patients with ischemic stroke, and find out the valuable parameters. Electroencephalogram(EEG) can collect the electrical activity of cerebral cortex in patients with ischemic stroke and find the correlation between EEG and ERG. Finally, it is of great significance to establish a non-invasive, more objective, convenient and safe risk prediction model for stroke in combination with carotid atherosclerosis, retinal structural and functional parameters and EEG.

NO

Ischemic Stroke

Optical coherence tomography angiography (OCTA), Quantitatively analyzing the retinal microcirculation and structure in patients with ischemic stroke by using OCTA., 1year|Electroretinogram (ERG), The amplitude(μV) and implicit time(ms) of a-wave, b-wave and oscillatory potentials in dark-adapted and light-adapted., 1year

Electroencephalogram(EEG), Collecting the electrical activity of cerebral cortex in patients with ischemic stroke, including the electroencephalogram frequency(Hz) and amplitude(μV) of δ-wave, θ-wave, α-wave and β-wave. In addition, the pattern of these waves will be observed to find the signatures of ischemic stroke., 1year

Guangdong Provincial Peoples Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

GDREC2020207H(R1)

2021-12-01

2022-12-31

2032-01

2022-03-16

2022-08-09

Guangdong Provincial Peoples Hospital, Guangzhou, Guangdong, 510080, China

{}

NCT02776787

DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory

https://clinicaltrials.gov/study/NCT02776787

DEBUT

COMPLETED

Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last decade, the use of elective colon resection has increased by more than 50%, and diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike have a difficult time deciding if surgery is the best choice to treat diverticulitis. The goal of the DEBUT study is to improve the understanding about how doctors and patients make decisions to have elective surgery for diverticulitis, and the global impact of diverticulitis on patients lives.

NO

Diverticulitis

Patient-reported symptom burden and quality of life measured by the Diverticulitis Quality of Life scale (DV-QOL), Patient-reported burden of disease (diverticulitis symptoms and quality of life, as measured by the Diverticulitis Quality of Life scale (DV-QOL)) will be measured over time among patients that do and do not undergo elective colon resection., 3 months - 4 years

Number of patients who report non-clinical factors as reason for deciding to have surgery, Patient-reported factors (clinical and non-clinical) for deciding to have elective colon surgery, or deciding to have medical management for diverticulitis will be analyzed across surgical and non-surgical patients., 3 months - 4 years

University of Washington

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

STUDY00003708|1R01DK103915-01A1

2016-03

2021-01

2022-04

2016-05-18

2022-12-05

UCLA Ronald Reagan, Los Angeles, California, 90095, United States|Olive View - UCLA Medical Center, Sylmar, California, 91342, United States|NYU Langone Health, Brooklyn, New York, 11220, United States|Legacy Health, Portland, Oregon, 97210, United States|Skagit Regional Health, Mount Vernon, Washington, 98274, United States|Valley Medical Center, Renton, Washington, 98055, United States|Harborview Medical Center, Seattle, Washington, 98104, United States|Northwest Hospital and Medical Center, Seattle, Washington, 98133, United States|University of Washington, Seattle, Washington, 98195, United States

{}

NCT04643587

Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)

https://clinicaltrials.gov/study/NCT04643587

COMPLETED

This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after administrations of single (SAD) ascending doses in healthy subjects and multiple (MAD) ascending doses in subjects with NCFB.

NO

Noncystic Fibrosis Bronchiectasis (NCFB)

BIOLOGICAL: CSL787|DRUG: Placebo

Number of subjects with treatment emergent adverse events (TEAEs) - overall, severity and causality, Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients)|Percent of subjects with TEAEs - overall, severity and causality, Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients)

Maximum concentration (Cmax) of CSL787 in sputum and serum in healthy subjects, Up to 8 days from inhalation|Time of maximum concentration (Tmax) of CSL787 in sputum and serum in healthy subjects, Up to 8 days from inhalation|Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) of CSL787 in sputum and serum in healthy subjects, Up to 8 days from inhalation|Area under the concentration-time curve from time 0 to last quantifiable time point (AUC0-last) of CSL787 in sputum and serum in healthy subjects, Up to 8 days from inhalation|Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of CSL787 in sputum and serum in healthy subjects, Up to 8 days from inhalation|Apparent total clearance of the drug (CL/F) of CSL787 in sputum and serum in healthy subjects, Up to 8 days from inhalation|Apparent volume of distribution during the elimination phase (V/F) of CSL787 in sputum and serum in healthy subjects, Up to 8 days from inhalation|Terminal elimination half-life (T1/2) of CSL787 in sputum and serum in healthy subjects, Up to 8 days from inhalation|Cmax of CSL787 in sputum and serum of NCFB subjects, On Day 1, after dosing|Tmax of CSL787 in sputum and serum of NCFB subjects, On Day 1, after dosing|Ctrough of CSL787 in sputum and serum of NCFB subjects, On Day 1, after dosing|AUCtau of CSL787 in sputum and serum of NCFB subjects, On Day 1, after dosing|Cmax of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|Tmax of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|Ctrough of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|AUCtau of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|T1/2 of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|CL/F of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|V/F of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|Accumulation Ratio (AR) for Cmax of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|AR for Ctrough of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose|AR for AUCtau of CSL787 in sputum and serum of NCFB subjects, On Day 14, after last dose

CSL Behring

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

CSL787_1001|2020-002684-66

2020-12-07

2023-03-12

2023-03-12

2020-11-25

2023-12-15

IKF Pneumologie Institute, Frankfurt, Germany|Medicines Evaluation Unit (MEU), Manchester, England, M23 9QZ, United Kingdom|Celerion, Belfast, Northern Ireland, BT9 6AD, United Kingdom

{ "CSL787": [ { "intervention_type": "BIOLOGICAL" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT02787187

Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

https://clinicaltrials.gov/study/NCT02787187

COMPLETED

The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer

NO

Pancreatic Ductal Adenocarcinoma

PROCEDURE: Pancreaticoduodenectomy with Standard lymphadenectomy|PROCEDURE: Pancreaticoduodenectomy with Extended lymphadenectomy

All-cause mortality, 3yrs post-operation

all-cause mortality, 1yr post-operation

Ruijin Hospital

Shanghai Zhongshan Hospital|Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

HBP-RCT-001

2016-07-01

2021-10

2021-10

2016-06-01

2021-11-23

Shanghai Ruijin Hospital, Shanghai, Shanghai, 200032, China

{ "Pancreaticoduodenectomy with Standard lymphadenectomy": [ { "intervention_type": "PROCEDURE" } ], "Pancreaticoduodenectomy with Extended lymphadenectomy": [ { "intervention_type": "PROCEDURE" } ] }

NCT02306187

The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis

https://clinicaltrials.gov/study/NCT02306187

RECRUITING

In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.

NO

Osteoporosis

DRUG: Edirol

Number of Participants with bone turnover markers as a Measure of bone quality, Bone formation and bone absorption markers will be evaluated at each time point, At 4 months after the initial treatment|Number of Participants with bone turnover markers as a Measure of bone quality, Bone formation and bone absorption markers will be evaluated at each time point, At 1 year after the initial treatment

Number of Participants with bone mineral density as a Measure of bone quality, Bone mineral density will be evaluated at each time point, At 4 months after the initial treatment|Number of Participants with bone mineral density as a Measure of bone quality, Bone mineral density will be evaluated at each time point, At 1 year after the initial treatment

Shinshu University

ALL

CHILD, ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT

BP-ED study 2014

2014-12

2022-12

2024-12

2014-12-03

2021-09-21

Yukio Nakamura, Matsumoto, Nagano, 3908621, Japan

{ "Eldecalcitol": [ { "intervention_type": "DRUG", "description": "Edirol", "name": "Eldecalcitol", "synonyms": [ "Eldecalcitol", "Edirol", "1\u03b1,25-dihydroxy-2\u03b2-(3-hydroxypropoxy)cholecalciferol" ], "drugbank_id": "DB05295", "generic_names": [ "Eldecalcitol" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Eldecalcitol" } ] }

NCT03467087

Safety and Feasibility of Electrical Muscle Stimulation During Stem Cell Transplantation or Intensive Chemotherapy

https://clinicaltrials.gov/study/NCT03467087

COMPLETED

Intensive chemotherapy, with or without following autologous or allogeneic stem cell transplantation (HSCT), is often the only curative treatment option for patients with haematological malignancies, leave many survivors physically and psychologically impaired because of side effects, many caused by weeks of immobilisation. Electrical muscle stimulation (EMS) is a proven training tool to improve physical performance in seniors and patients with chronic disease. The investigators therefore intend to evaluate the safety and feasibility of EMS in patients undergoing autologous HSCT, allogeneic HSCT and intensive chemotherapy. To assess feasibility all patients are asked to document training time during hospitalization in an EMS diary. Furthermore, physical Performance will be measured using the 6-minute-walking distance (6MWD) and Short Physical Performance Battery (SPPB) as well as psychological performance using the Multidimensional Fatigue Inventory (MFI) and EORTC QLQ-C30 at the start of chemotherapy (T1) and when patients are discharged from hospital (T2). At the time intensive chemotherapy is started and all inclusion and no exclusion criteria are met, patients will receive an EMS device with electrodes and will be instructed on how to use the device. After that, baseline tests using the above mentioned tools will be performed. EMS will be conducted with a Myopuls 2000 (Curatec Services GmbH, Moers, Germany) device using 13 cm x 5 cm electrodes. Electrodes are placed subsequently on both thighs and upper arms with instructions to stimulate each limb for at least 15 minutes on at least 5 days per week. Stimulation settings were as follows: 300 µs pulse width, 60 Hz frequency, 5 seconds on, 5 seconds off. The amplitude is initially set to elicit a visible muscle contraction and patients are encouraged to increase the amplitude as much as tolerated. After an initial training session, patients are to use the devices on their own and document their activities in an EMS diary. Patients are then asked to use EMS throughout their therapy in addition to physical therapy until the day of their discharge when the initially performed tests are repeated. The investigators hypothesis is, that EMS can be safely applied in patients undergoing intensive chemotherapy regimens and that patients are able to administer EMS by themselfs.

NO

Electric Stimulation Therapy

DEVICE: Myopuls 2000D

Occurence of adverse events caused by EMS, Possible adverse events: bleeding events (defined according to the WHO Bleeding Scale ), arrhythmias, CK elevation, skin irritation, through study completion, an average of 30 days|Feasibility of self administered EMS, Percentage of patients able to complete at least 2/3 of the pre-set training time, At the time of discharge of every patients, after an average of 30 days

Physical performance as assessed by the 6 minute walking distance, Patients were told to walk on a 40-meter floor with instructions to cover as much distance as possible in 6 minutes. Patients were allowed to stop and rest as often as necessary. Time was stopped by a technician who was also allowed to encourage participants with standardized phrases during the walk., At the time of discharge of every patients, after an average of 30 days|Physical performance as assessed by the Short Physical Performance Battery, The Short Physical Performance Battery as developed by Guralnik and colleagues ranges from 0 - 12 points with 0 points indicating the worst possible performance and 12 points as best result. The battery consists of 3 objective tests of lower body function with maximally 4 points to be reached in one test: 1. A timed walk of 8 feet 2. The time it takes to rise from a chair 5 times 3. A standing balance test, At the time of discharge of every patients, after an average of 30 days|Psychological performance as assessed by the Multidimensional Fatigue Inventory, The Multidimensional Fatigue Inventory (MFI-20) consists of 5 subscales including general, physical and mental fatigue, reduced motivation and reduced activity with 20 items in total (4 items per subscale). Each item is rated on a 5-point scale (1-5) and each subscale ranges from 4 to 20. Patients were asked to fill out the test form before or within 3 days from start of treatment (timepoint 1) and at the day of discharge (timepoint 2). Contrary to physical assessment, high scores in the MFI subscales mean greater fatigue and therefore worse psychological functioning., At the time of discharge of every patients, after an average of 30 days|Psychological performance as assessed by the EORTC QoL 30 questionnaire, The EORTC QOL-C30 questionnaire contains 30 items that are divided into five functional scales, three symptom scales, a global health status / Quality of Life (QoL) scale, and six single items. Functional scales assess physical function (ability to manage daily life), role function (at work and daily activities), emotional function (tension, anxiety, irritability and depression), social function (family life or social activities) and cognitive function (concentration and memory). Symptom scales ask for fatigue, nausea or pain and single items measure dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial impact. The global health status / QoL scale rates overall health and quality of life. Original data was processed according to the EORTC scoring manual into a 0- to 100-point scale. High scores in functional scales and QoL indicate adequate function and QoL. Patients with high scores on symptom scales and single items show more severe symptoms and impairments., At the time of discharge of every patients, after an average of 30 days

University Hospital, Saarland

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

EMS-ICT-001

2016-02-03

2017-02-16

2017-03-16

2018-03-15

2018-03-15

{ "Myopuls 2000D": [ { "intervention_type": "DEVICE" } ] }

NCT05777187

Mitigation of Postoperative Delirium in High-Risk Patients

https://clinicaltrials.gov/study/NCT05777187

RECRUITING

Among patients with cognitive impairment (CI) that undergo surgery, the risk for developing postoperative delirium (POD) is high (50%) and associated with further morbidity and mortality. Yet, 30-40% of POD cases are preventable with perioperative management. This randomized pragmatic clinical trial aims to assess incidence of POD in adult surgical patients with CI, as well as provider adherence to a set of 12 perioperative best practice recommendations for perioperative management. Electronic health record (EHR) data will be used to identify patients as high risk for developing POD and clinical decision support (CDS) prompts within the EHR will display best practices. Cases will be randomized to either the control group, usual care or the intervention which includes the high-risk alert and best practice prompts.

NO

Post-operative Delirium|Decision Support Systems, Clinical|Cognitive Impairment

OTHER: Clinical Decision Support

4AT Delirium Score, Incidence of Postoperative Delirium measured using the 4AT delirium assessment documentation Scoring: 4 or above: possible delirium +/- cognitive impairment 1-3: possible cognitive impairment 0: delirium or severe cognitive impairment unlikely (but delirium still possible if [4] information incomplete), Postoperative days 0-7

Perioperative Best Practices proportion, For each of the 12 practices, adherence will be measured as a binary variable; overall protocol adherence will be defined as the proportion of the 12 practices performed by the anesthesia team. The 12 perioperative best practices are grouped in 5 intervention domains including, avoid potential inappropriate medication, perioperative glycemic control, avoid hypotension, maintain normothermia, and titrate anesthetic depth. Within avoid potential inappropriate medication is avoid diphenhydramine, scopolamine, and midazolam. Within perioperative glycemic control is check pre-op glucose, check glucose every 2 hours, maintain glucose <200 mg/dL, and check post-anesthesia care unit glucose. Within avoid hypotension is Mean Arterial Pressure >65 mmHg. Within maintain normothermia is use temperature probe and maintain temperature >36 degrees Celsius. Within titrate anesthetic depth is age adjusted MAC<1 and monitor anesthesia depth., Day 1

Icahn School of Medicine at Mount Sinai

University of California, Los Angeles|National Institute on Aging (NIA)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION

GCO 22-0012|22-00920|5U54AG063546

2023-06-20

2024-09

2024-09

2023-03-21

2023-10-03

Mount Sinai Health System, New York, New York, 10029, United States

{ "Clinical Decision Support": [ { "intervention_type": "OTHER" } ] }

NCT02021487

Prokinecitine in Acute Myocardial Infarction

https://clinicaltrials.gov/study/NCT02021487

Prok-Idm

TERMINATED

The study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. The usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.

NO

ST Elevatation Myocardial Infarction (STEMI)

Infarct size by MRI necrotic myocardial mass, Infarct size by MRI necrotic myocardial mass, 7 days

University Hospital, Strasbourg, France

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

5515

2013-11

2019-02

2019-02

2013-12-27

2019-08-21

University Hospital, Strasbourg, 67000, France

{}

NCT05028387

Telemedicine Medical Abortion Service Using the No-test Protocol in Ukraine and Uzbekistan.

https://clinicaltrials.gov/study/NCT05028387

UNKNOWN

The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.

NO

Pregnancy

DRUG: medical abortion

Incidence rate of adverse events resulting from remote provision of medical abortion, Adverse events such as regimen non-compliance or medically unnecessary interventions associated with remote provision of medical abortion., 6 weeks