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NCT01184287

A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT01184287

WITHDRAWN

The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.

NO

Non-Small Cell Lung Cancer

DRUG: Ranpirnase

Response, To determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy, 4 or more months

Progression Free Survival (PFS), To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy, 2 years|Survival, To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy, 2 years

Tamir Biotechnology, Inc.

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

P30-800

2010-08-18

2015-09-02

Tower Cancer Research Foundation, Beverly Hills, California, 90211, United States|Van Andel Research Institute, Grand Rapids, Michigan, 49503, United States|Sletten Cancer Specialists, Great Falls, Montana, 59405, United States|The Cancer Institute at NYU Langone Medical Center, New York, New York, 10016, United States|Tri-county Hematology-Oncology Associates, Inc, Canton, Ohio, 44718, United States|Northern Utah Associates, Ogden, Utah, 84403, United States

{ "Ranpirnase": [ { "intervention_type": "DRUG", "description": "Ranpirnase", "name": "Ranpirnase", "synonyms": [ "Ranpirnase" ], "drugbank_id": "DB04950", "generic_names": [ "Ranpirnase" ] } ] }

NCT05552287

Pharmacokinetic Infliximab Data in Pediatric Crohns Disease

https://clinicaltrials.gov/study/NCT05552287

ProRAPID

RECRUITING

Rationale: Crohns disease (CD) is a chronic, debilitating inflammatory bowel disease (IBD) which is diagnosed during childhood in up to one in ten patients. The use of anti-tumor necrosis factor (TNF)-α agents has significantly ameliorated CD management. Infliximab (IFX) is the first anti-TNF-α agent registered for pediatric CD. The current dosing recommendation of IFX is extrapolated from adult studies, and it is a weight-based dose (5 mg/kg) delivered during induction (infusion at weeks 0, 2, and 6) and maintenance (every 8 weeks). However, pediatric patients have a 25-40% lower drug exposure compared to adults, particularly children under 10 years of age, resulting in diminished efficacy and an increased risk of developing a complicated disease course. The investigators hypothesize that an intensified IFX induction scheme (instead of the current dosing recommendation) is more effective in the treatment of pediatric CD patients. Objective: The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule in improving drug exposure without treatment escalation in pediatric CD patients. Secondary objectives are clinical and biochemical remission without treatment escalation, development of antibodies to IFX (ATI) and adverse reactions. Study design: An international, multicenter, prospective, open-label trial. Study population: Anti-TNF-α naïve children (age 3-15 years) with CD and an indication to start IFX treatment. Intervention: IFX will be given intravenously at 10 mg/kg at week 0, and 5 mg/kg at weeks 2, 4, and 8 to all patients (induction). Maintenance will start at week 12, and then ideally continue every 6 weeks till week 24 (end of study). IFX trough levels will be measured at weeks 4, 12, and 24. During the maintenance, the IFX dose and/or interval adjustments, the IFX discontinuation or the start of a co-medication (i.e., an immunomodulator) will be possible on indication (i.e., primary nonresponse, secondary loss of response, intolerance to study medication) at the physicians discretion. Follow-up will continue for the duration of the study (week 24). Main endpoint: Proportion of patients with IFX TL ≥ 5 µg/mL at week 12 without treatment escalation.

NO

Crohn Disease|Child, Only|Biologic; Inadequate

DRUG: Infliximab

Proportion of patients with IFX Trough Levels ≥ 5 µg/mL at week 12 without treatment escalation, Treatment escalation is defined as any additional CD-related medication or IBD-related abdominal surgery, 12 weeks

Proportion of patients with IFX Trough Levels ≥ 5 µg/mL at week 24 without the need for treatment escalation, Treatment escalation is defined as any additional CD-related medication or IBD-related abdominal surgery, 24 weeks|Clinical and biochemical remission at weeks 4, 12, and 24 without the need for treatment escalation in patients with TL ≥ 5 µg/mL and in patients with TL < 5 µg/mL., Clinical remission is defined as wPCDAI <12.5 Biochemical remission is defined as CRP <5 mg/dL, FC <250 ug/g., 24 weeks|Predictors of IFX Trough Levels at weeks 4, 12, and 24. Factors included in this analysis will be sex, age, body mass index (BMI), wPCDAI, IBD laboratory values, antibodies to Infliximab (ATI), dose, and interval of IFX infusions., 24 weeks|Development of antibodies to IFX until week 24, ATIs will be assessed if IFX TL is <1 ug/ml at week 4, 12 or 24., 24 weeks|Prediction of reponders versus non-responders to IFX based on proteomic analysis., Responders will be defined as decrease of 17.5 in wPCDAI at week 6 from start of IFX. Serum immune proteins will be analysed using the OLINK technique. It will be investigated whether there are predictive immune proteins of IFX response, 24 weeks|Evaluation of quality of life, Quality of life will be assessed at baseline, weeks 12 and 24 in all patients., 24 weeks

Proportions of patients with primary non-response, Primary non-response: absence of response (wPCDAI decrease > 17.5) at week 6 compared to baseline, 24 weeks|Proportions of patients with secondary loss of response (LOR), Secondary LOR: either an increase in wPCDAI > 17.5 or a total wPCDAI score > 40 in a patient who previously responded to induction treatment rates over time., 24 weeks|Evaluation of number of adverse events, Adverse event rate over time.Adverse events are defined as any undesirable experience occurring to a subject during the study, whether considered related to the investigational product or not. All adverse events reported spontaneously by the subject or observed by the investigator, or his staff will be recorded., 24 weeks|Complications rate, Complication rate (fistulas, abscesses, strictures, surgery, extraintestinal manifestations) over time., 24 weeks|Baseline demographics, Age at diagnosis, age at start of IFX, ethnicity, sex, weight, height, 24 weeks|Baseline clinical covariates, Reason for starting IFX, Paris classification, concomitant drugs, IBD standard laboratory values (haemoglobin, haematocrit, leukocytes, thrombocytes, CRP, ESR, albumin), faecal calprotectin, wPCDAI score, comorbidity/extra-intestinal manifestations and, if available, magnetic resonance imaging and the simple endoscopic score for CD (SES-CD)., 24 weeks|Cost-effectiveness analysis of costs of treatment versus quality of life., In consultation with Department of Economics and Health, calculation of costs per QALY based on quality of life questionnaires will be made., 24 weeks|Height, Height will be measured in centimeters, 24 weeks|Weight, Weight will be measured in kilograms, 24 weeks|Body Mass Index, Height and height will be combined to report BMI in kg/m^2, 24 weeks|IMPACT-III, Disease-specific quality of life will be obtained with the IMPACT-III questionnaire (range 0-100) in patients (≥9 years old) at week 0, 12 and 24. A higher score indicates a higher quality of life. The questionnaire consists of 35 items encompassing 6 domains: bowel symptoms, systemic symptoms, emotional functioning, social functioning, body image and treatment/interventions, 24 weeks|EQ-5D-Y, Quality of life will be obtained with the EQ-5D-Y questionnaire. This questionnaire consists of 5 dimensions (range 1-3 per dimension) and a Visual Analogue Scale (range 0-100)., 24 weeks|Age, In years, 24 weeks|Weighted Paediatric Crohns disease activity index (wPCDAI), This is a clinical disease activity score with range 0-125. A higher score indicates worse disease activitiy., 24 weeks|Dose of Infliximab in miligrams, 24 weeks|Haemoglobin in mmol/L, 24 weeks|Haematocrit in L/L, 24 weeks|CRP in mg/L, 24 weeks|ESR in mm/h, 24 weeks|Thrombocytes x 10^9/L, 24 weeks|Leukocytes x 10^9/L, 24 weeks|Albumin in g/L, 24 weeks|Faecal calprotectin in ug/g, 24 weeks

Erasmus Medical Center

ALL

CHILD

PHASE4

OTHER

INTERVENTIONAL

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

ProRAPID

2023-08-02

2025-01

2025-01

2022-09-23

2023-09-08

Erasmus Medical Center, Rotterdam, 3015 GD, Netherlands

{ "Infliximab": [ { "intervention_type": "DRUG", "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" } ] }

NCT00517387

The Effects of Quetiapine XR on Cognition, Mood and Anxiety Symptoms in SSRI-Resistant Unipolar Depression

https://clinicaltrials.gov/study/NCT00517387

COMPLETED

Recently published work has examined the effects of atypical antipsychotics in SSRI-treatment resistant patients. In these studies, patients with unipolar depression who were treated with SSRIs, but not responsive to treatment after 4 or more weeks, were supplemented with an atypical. The atypical antipsychotics were found to diminish depression symptoms, as well as benefit sleep quality. We propose a similar study with Quetiapine XR, focusing on thinking processes, mood and anxiety. Patients with depression who are SSRI treatment resistant will be treated with Quetiapine. Cognition will be evaluated in the UBC Mood Disorders Clinic two times: first before Quetiapine addition, then after 8 weeks. Depression symptoms and other measurements will be done at the 9 time points: before Quetiapine, and each week after treatment has begun. The primary purpose of this study is to evaluate the superiority of Quetiapine XR compared to placebo as augmentation therapy in treatment of anxiety and depressive symptoms in SSRI-nonresponsive unipolar patients. Secondarily, we would like to evaluate the safety and tolerability of quetiapine as augmentation therapy in SSRI-nonresponsive unipolar patients.

NO

Unipolar Depression

DRUG: Quetiapine XR

Primary outcome will be measurements of cognitive function, determined both prior to treatment and after 8 weeks of treatment., 8 weeks

To evaluate Quetiapine XR compared to placebo, in SSRI-nonresponsive unipolar patients, in treatment of anxiety and depressive symptoms and biomarkers, improving patients overall quality of life, and to evaluate its safety and tolerability., 8 weeks

University of British Columbia

AstraZeneca

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

H07-00629

2007-09

2010-09

2010-09

2007-08-16

2010-11-16

University of British Columbia Hospital, Vancouver, British Columbia, V6T 2A1, Canada

{ "Quetiapine": [ { "intervention_type": "DRUG", "description": "Quetiapine XR", "name": "Quetiapine", "synonyms": [ "Quetiapine", "Qu\u00e9tiapine", "Zaluron", "Biquelle", "Seroquel", "Quetiapinum", "Atrolak", "Quetiapina", "2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol", "Sondate" ], "medline_plus_id": "a698019", "generic_names": [ "Quetiapine" ], "nhs_url": "https://www.nhs.uk/medicines/quetiapine", "drugbank_id": "DB01224" } ] }

NCT05216887

A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers

https://clinicaltrials.gov/study/NCT05216887

COMPLETED

The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.

NO

Healthy Volunteer

BIOLOGICAL: Aducanumab

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab, Predose and at multiple time points post-dose up to Day 99

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event., Up to Day 99|Number of Participants with Clinically Significant Abnormal Vital Sign Values, Up to Day 99|Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values, Day 1 and Day 99|Number of Participants with Clinically Significant Abnormal Laboratory Values, Up to Day 99|Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab, Predose and at multiple time points post-dose up to Day 99|Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab, Predose and at multiple time points post-dose up to Day 28|Maximum Observed Concentration (Cmax) of Aducanumab, Predose and at multiple time points post-dose up to Day 99|Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC, Predose and at multiple time points post-dose up to Day 99|Elimination Half-Life (t1/2) of Aducanumab, Predose and at multiple time points post-dose up to Day 99|Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab, Predose and at multiple time points post-dose up to Day 99|Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab, Predose and at multiple time points post-dose up to Day 99

Biogen

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

221HV104

2022-02-01

2022-07-27

2022-07-27

2022-02-01

2023-04-18

Anaheim Clinical Trials, Anaheim, California, 92801, United States|QPS-MRA, Miami, Florida, 33143, United States|QPS Missouri, Springfield, Missouri, 65802, United States

{ "Aducanumab": [ { "intervention_type": "BIOLOGICAL", "description": "Aducanumab", "name": "Aducanumab", "synonyms": [ "aducanumab-avwa", "Aducanumab", "Aduhelm", "Aducanumab-avwa", "Aduhelm", "Aducanumab-avwa", "Aduhelm", "Aducanumab-avwa", "Aduhelm" ], "drugbank_id": "DB12274", "generic_names": [ "Aducanumab", "Aducanumab-avwa", "Aducanumab-avwa", "Aducanumab-avwa" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Aducanumab" } ] }

NCT01998087

Proactive Breastfeeding Support in First Time Mothers

https://clinicaltrials.gov/study/NCT01998087

UNKNOWN

In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any human milk for their babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other pregnancy and parenting related written information is routinely provided to expectant couples. In our study we would like to find out whether providing written breastfeeding information in pregnancy and breastfeeding focused support phone calls during pregnancy and after the birth of the baby result in better outcomes than providing general pregnancy/parenting information and support phone calls. This will be tested by randomising women, attending their primary health care provider for routine antenatal visits between 20 and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an intervention focused on general pregnancy and parenting issues, and to a non-intervention control group. Women will be followed-up for 6 months after the birth of their baby and data will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy, breastfeeding difficulties, social support and attitudes toward infant feeding.

NO

Breastfeeding

BEHAVIORAL: Breastfeeding support

Exclusive breastfeeding, 3 months

Any breastfeeding, 3 & 6 months

Maternal attitudes toward infant feeding, Validated Iowa Infant Feeding Attitude Scale to be used., Before (at recruitment) and after (at 3 months)|Breastfeeding self-efficacy scale, Validated tool measuring a mothers confidence in her ability to breastfeed, At 3 months post birth|Breastfeeding difficulties, At 3 months postbirth

University Hospital of Split

FEMALE

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

2181-198-03-04-13-0027

2014-06

2017-06

2018-12

2013-11-28

2018-10-15

Cito Obstetrics and Gynaecology Clinic, Split, Outside AUS, 21000, Croatia

{ "Breastfeeding support": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00490087

Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women

https://clinicaltrials.gov/study/NCT00490087

COMPLETED

The study aims to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in fertile women.

NO

Atypical Endometrial Polyps|Atypical Endometrial Hyperplasia

DEVICE: Levonorgestrel intrauterine device (IUD)

Efficacy and prognosis of hysteroscopic resection of atypical polyps in terms of appearance of endometrial cancer or recurrence of atypical endometrial lesions, Five years

Recurrence rate of polyp in the two groups, Five years

IRCCS Burlo Garofolo

FEMALE

ADULT

PHASE3

OTHER

INTERVENTIONAL

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

RC 23/98

1999-01

2007-03

2007-03

2007-06-22

2011-09-02

Institute of Child Health, IRCCS Burlo Garofolo, Trieste, Friuli Venezia Giulia, 34137, Italy

{ "Levonorgestrel": [ { "intervention_type": "DEVICE", "description": "Levonorgestrel intrauterine device (IUD)", "name": "Levonorgestrel", "synonyms": [ "d(-)-Norgestrel", "Mirena", "Norplant", "duofem", "17alpha-Ethynyl-18-homo-19-nortestosterone", "NorLevo", "Microval", "13-beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one", "18,19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(-)-", "18-Methyl-17-alpha-ethynyl-19-nortestosterone", "13-Ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one", "Levonorgestrelum", "17-Ethynyl-18-methyl-19-nortestosterone", "17alpha-Ethynyl-17-hydroxy-18-methylestr-4-en-3-one", "(8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one", "l Norgestrel", "Norgeston", "18-Methylnorethisterone", "(-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one", "Cerazet", "D-Norgestrel", "Norplant-2", "Norplant2", "Fallback Solo", "L\u00e8vonorgestrel", "Opcicon", "17alpha-Ethynyl-13beta-ethyl-3-oxo-4-estren-17beta-ol", "13-Ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one", "17-alpha-Ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one", "17-alpha-Ethynyl-13-ethyl-19-nortestosterone", "Levonorgestrel", "Levonorgestrel Intrauterine System", "Mirena", "Kyleena", "hormonal IUD", "Levonorgestrel Intrauterine System", "Mirena", "Kyleena", "hormonal IUD" ], "medline_plus_id": "a610021", "generic_names": [ "Levonorgestrel", "Levonorgestrel Intrauterine System", "Levonorgestrel Intrauterine System" ], "mesh_id": "D000080066", "drugbank_id": "DB00367" } ] }

NCT03478787

Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

https://clinicaltrials.gov/study/NCT03478787

COMPLETED

The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

YES

Psoriasis

DRUG: risankizumab|DRUG: secukinumab

Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16, The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data., Week 16|Percentage of Participants With a PASI 90 at Week 52, The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100., Week 52

Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52, PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100., Week 52|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52, The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean > 0, < 1.5; Mild (2) = mean ≥ 1.5, < 2.5; Moderate (3) = mean ≥ 2.5, < 3.5; and Severe (4) = mean ≥ 3.5., Week 52|Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52, The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100., Week 52

AbbVie

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

M16-766|2017-004932-12

2018-05-08

2020-07-08

2020-07-08

2018-03-27

2021-07-13

2021-07-13

Advanced Research Associates - Glendale /ID# 204335, Glendale, Arizona, 85308, United States|Alliance Dermatology and MOHs /ID# 204336, Phoenix, Arizona, 85032, United States|Bakersfield Derma & Skin Cance /ID# 202115, Bakersfield, California, 93309, United States|Center for Dermatology Clin Res /ID# 202116, Fremont, California, 94538, United States|Dermatology Res. Assoc., CA /ID# 202170, Los Angeles, California, 90045, United States|UC Davis Health /ID# 202263, Sacramento, California, 95816, United States|Medderm Associates /ID# 202162, San Diego, California, 92103, United States|UConn Health Main /ID# 201745, Farmington, Connecticut, 06032, United States|Tory P Sullivan, MD PA /ID# 202177, North Miami Beach, Florida, 33162-4708, United States|Renstar Medical Research /ID# 202113, Ocala, Florida, 34470, United States|Progressive Medical Research /ID# 202183, Port Orange, Florida, 32127, United States|Integrated Clinical Research LLC /ID# 202152, West Palm Beach, Florida, 33406-6063, United States|Dermatology Specialists Resear /ID# 202145, Louisville, Kentucky, 40241, United States|Dermatology and Skin Cancer Specialists, LLC /ID# 203938, Rockville, Maryland, 20850, United States|ORA, Inc. /ID# 204342, Andover, Massachusetts, 01810, United States|Beth Israel Deaconess Medical Center /ID# 204340, Boston, Massachusetts, 02215-5400, United States|Minnesota Clinical Study Center /ID# 202369, New Brighton, Minnesota, 55112, United States|Central Dermatology, PC /ID# 202156, Saint Louis, Missouri, 63117, United States|Psoriasis Treatment Ctr of Central NJ /ID# 202107, East Windsor, New Jersey, 08520, United States|Synexus Research Cincinnati /ID# 202161, Cincinnati, Ohio, 45236, United States|Oregon Derm & Res. Ctr /ID# 201652, Portland, Oregon, 97210, United States|Oregon Medical Res Center PC /ID# 201651, Portland, Oregon, 97223, United States|Clinical Partners, LLC /ID# 201736, Johnston, Rhode Island, 02919, United States|Center for Clinical Studies - Houston (Binz) /ID# 202178, Houston, Texas, 77004-8097, United States|Progressive Clinical Research /ID# 202155, San Antonio, Texas, 78229, United States|Center for Clinical Studies - Webster TX /ID# 202154, Webster, Texas, 77598, United States|University of Utah /ID# 204035, Salt Lake City, Utah, 84112-5500, United States|Froedtert Mem Lutheran Hosp /ID# 204896, Milwaukee, Wisconsin, 53226, United States|Beacon Dermatology Inc /ID# 203054, Calgary, Alberta, T3E 0B2, Canada|Enverus Medical Research /ID# 203043, Surrey, British Columbia, V3V 0C6, Canada|Dr. Irina Turchin PC Inc. /ID# 203052, Fredericton, New Brunswick, E3B 1G9, Canada|Eastern Canada Cutaneous Resea /ID# 203045, Halifax, Nova Scotia, B3H 1Z2, Canada|Dermatrials Research /ID# 203051, Hamilton, Ontario, L8N 1Y2, Canada|Dre Angelique Gagne-Henley M.D. inc. /ID# 203053, Saint-Jerome, Quebec, J7Z 7E2, Canada|Dermatologique du Quebec /ID# 203050, Quebec, G1V 4X7, Canada|Charles Nicolle CHU Rouen /ID# 203590, Rouen CEDEX, Seine-Maritime, 76031, France|Centre Hospitalier Universitaire de Nice - Hopital lArchet 2 /ID# 203591, Nice, 06202, France|Hopital Saint-Louis /ID# 203586, Paris, 75010, France|Polyclinique Courlancy /ID# 203588, Reims, 51100, France|Hopital Larrey - CHU de Toulouse /ID# 203587, Toulouse, 31059, France|TU Uniklinik Munchen /ID# 203919, Munich, 80802, Germany|Policlinico A. Gemelli /ID# 203009, Roma, Lazio, 00168, Italy|Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982, Milan, Lombardia, 20122, Italy|Radboud Universitair Medisch Centrum /ID# 202560, Nijmegen, Gelderland, 6525 GA, Netherlands|Bravis Ziekenhuis /ID# 205232, Bergen op Zoom, Noord-Brabant, 4624 VT, Netherlands|Academisch Medical center Amsterdam /ID# 202556, Amsterdam, Noord-Holland, 1105 AZ, Netherlands|Dermed Centrum Medyczne Sp. z o.o /ID# 203171, Lodz, Lodzkie, 90-265, Poland|Klinika Dermatologii Pod Fortem /ID# 204180, Krakow, Malopolskie, 31-302, Poland|Przychodnia Specjalistyczna High-Med /ID# 203183, Warsaw, Mazowieckie, 01-817, Poland|Klinika Ambroziak Sp. z o.o. /ID# 203928, Warsaw, Mazowieckie, 02-758, Poland|KSW nr1 w Rzeszowie /ID# 203776, Rzeszow, Podkarpackie, 35-055, Poland|Osteo-Medic S.C. /ID# 203742, Białystok, Podlaskie, 15-351, Poland|Hospital de Manises /ID# 203757, Manises, Valencia, 46940, Spain|Hospital General Universitario Alicante /ID# 203764, Alicante, 03010, Spain|Hospital Universitario Clinico San Cecilio /ID# 203760, Granada, 18016, Spain|Hospital Universitario de la Princesa /ID# 203754, Madrid, 28006, Spain|Hospital Universitario 12 de Octubre /ID# 203756, Madrid, 28041, Spain|Hospital Universitario Arnau Vilanova /ID# 203763, Valencia, 46015, Spain|Whipps Cross Univ Hospital /ID# 204723, London, London, City Of, E11 1NR, United Kingdom|Guys and St Thomas NHS Found /ID# 204721, London, London, City Of, SE1 9RT, United Kingdom|The University of Manchester /ID# 204720, Salford, M6 8HD, United Kingdom

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT03478787/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03478787/SAP_001.pdf

{ "Risankizumab": [ { "intervention_type": "DRUG", "description": "risankizumab", "name": "Risankizumab", "synonyms": [ "risankizumab-rzaa", "Skyrizi", "Risankizumab", "Risankizumab-rzaa", "Skyrizi", "Risankizumab-rzaa", "Skyrizi", "Risankizumab-rzaa", "Skyrizi" ], "drugbank_id": "DB14762", "generic_names": [ "Risankizumab", "Risankizumab-rzaa", "Risankizumab-rzaa", "Risankizumab-rzaa" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Risankizumab" } ], "Secukinumab": [ { "intervention_type": "DRUG", "description": "secukinumab", "name": "Secukinumab", "synonyms": [ "Secukinumab", "Cosentyx" ], "medline_plus_id": "a615011", "generic_names": [ "Secukinumab" ], "drugbank_id": "DB09029" } ] }

NCT04288687

A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects

https://clinicaltrials.gov/study/NCT04288687

ACTIVE_NOT_RECRUITING

This study is designed to evaluate the initial safety and effectiveness of an investigational drug, niraparib, given to patients who have recently received platinum-based chemotherapy for the treatment of prostate cancer. The study enrolls participants with history of advanced prostate cancer that is growing despite standard hormonal therapies, such as androgen-deprivation therapy.

NO

Prostate Adenocarcinoma

DRUG: Niraparib Pill

rPFS6, Assessment of the 6-month radiographic progression-free survival (rPFS) rate in patients with platinum-sensitive mCRPC harboring germline or somatic DNA repair defects as determined by Kaplan-Meier analysis., 6 months

PSA30, Proportion of patients achieving a ≥30% decline in PSA following the initiation of niraparib maintenance therapy, 3 months|PSA50, Proportion of patients achieving a ≥50% decline in PSA following the initiation of niraparib maintenance therapy, 3 months|Time to PSA progression, Time until the first PSA increase that is >25% (and an absolute increase of ≥ 2 ng/ml) from the nadir PSA value following the initiation of niraparib maintenance therapy, 6 months|Frequency and severity of adverse events (AEs), Frequency and severity of adverse events (AEs), as assessed by CTCAE version 5.0, following the initiation of niraparib maintenance therapy, 1 month|Overall survival (OS), Time from start of study therapy to death due to any cause. Patients who are alive will be censored on the most recent date of patient contact, 12 months

Abramson Cancer Center at Penn Medicine

MALE

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

UPCC 21819

2020-10-19

2024-06

2024-06

2020-02-28

2024-02-21

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

{ "Niraparib": [ { "intervention_type": "DRUG", "description": "Niraparib Pill", "name": "Niraparib", "synonyms": [ "Zejula", "Niraparib" ], "medline_plus_id": "a617007", "generic_names": [ "Niraparib" ], "drugbank_id": "DB11793", "wikipedia_url": "https://en.wikipedia.org/wiki/Niraparib" } ] }

NCT03145987

Effects of a Food Supplement on Cognitive and Neuropsychological Functioning in Older Adults.

https://clinicaltrials.gov/study/NCT03145987

COMPLETED

The increase in life expectancy is associated with a gradual aging of the population so creating new needs arising from this new situation. Memory ability declines with age and memory deficits are regarded as an initial symptom of dementia of Alzheimers Disease (AD) type, one of the most prevalent cognitive disorders in older people. States and scientific community have been called to find preventive strategies acting against the consequent physiological cognitive decline with the aim to attenuate the increase of dementia. Numerous studies have shown that polyphenolic compounds derived from multiple dietary sources, and more specifically the polyphenolic compounds found in grapes (GP), are able to attenuate the cognitive impairment and in reducing neuropathological lesions in the brain in experimental animal models for the study of Alzheimers Disease (AD) . In recent years, several in vivo studies have shown that oral administration of polyphenols from grapes improves antioxidant status in the brain and prevents neuronal damage induced by free radicals. The intake of proanthocyanidins, especially in the monomeric form, showed to produce an improvement of cognitive function in an Alzheimers disorder animal model. A randomized, double-blind, placebo-controlled clinical trial was designed by the investigators with the aim to evaluate potential beneficial effects of a Vitis vinifera-based food supplement on cognitive functioning and neuropsychological status in healthy older adults aging 55-75 years. For the enrollment, mental status was evaluated through the Mini-Mental State Exam, a test able to provide quickly a screen of orientation, providing a rapid screen of recall, language, orientation, registration, attention and calculation. 111 subjects were recruited and, after obtaining the informed consent, successively randomly divided in two groups: Group 1, N = 57 to be treated for 12 weeks with Vitis vinifera extract (verum 250 mg/day); Group 2, N = 54 to be treated for 12 weeks with placebo. Cognitive functioning and neuropsychological status were evaluated at the beginning (before treatment) and a the end of treatment by using Mini Mental State Examination (MMSE), Beck Depression Inventory (BDI), Hamilton Anxiety Rating Scale (HARS) and Repeatable Battery for the Assessment of Neuropsychological Status.

NO

Cognitive Decline|Neurophysiologic Abnormality

DIETARY_SUPPLEMENT: Vitis vinifera extract|OTHER: Placebo

Mini Mental State Examination, Mini Mental state Examination is composed of 12 items exploring through 22 trials verbal and performance, 7 cognitive functions: temporal and spatial orientation; immediate memory; attention and calculation; recall memory; language; praxia visuo-constructive., Up to 12 weeks|Beck Depression Inventory, It is a self-report instrument measuring the severity of depression. The Beck Depression Inventory (BDI) Short Form was used. BDI is a prominently and frequently cited, self-reported measure of depression. The 13-item questionnaire assesses 4 major components of depression: behavioral, affective, cognitive, and physiological. Numerical values assigned to each statement range from 0 to 3 indicating increasing severity. According to Becks clinical criteria, a score between 8 and 15 indicates moderate depression and 16 severe depression., Up to 12 weeks.|Hamilton Anxiety Rating Scale, Hamilton Anxiety Rating Scale is a scale evaluating anxiety through the investigation of 15 different areas (such as insomnia, mood, somatic symptoms). Each of the 15 areas is composed of a minimum of 3 to a maximum of 8 items to each of which is given a score from 0 to 6, depending on the severity of symptoms. Subsequently the total value is calculated for each area, using a score of 0 (absent), 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe) points, based on the overall severity of symptoms investigating each specific area. The total score, which has been called whole , is calculated by adding the points of each of the 15 areas surveyed. The rating of the scale may vary from 0 to 56. A total score around 18 is considered indicative of a pathological state., Up to 12 weeks.|Repeatable Battery for the Assessment of Neuropsychological Status, Repeatable Battery for the Assessment of Neuropsychological Status is a quick and complete neuropsychological battery, consisting of two forms ( A and B ) associated with identical difficulty degrees, each divided into 12 subtests administered to evaluate 5 different cognitive domains: attention, language, visuospatial/constructional abilities immediate memory and delayed memory., Up to 12 weeks.

Azienda Ospedaliera Universitaria Policlinico G. Martino

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

PhCT-3

2016-07

2017-04

2017-07

2017-05-09

2018-06-26

{ "Vitis vinifera extract": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Placebo": [ { "intervention_type": "OTHER" } ] }

NCT05744687

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

https://clinicaltrials.gov/study/NCT05744687

RECRUITING

This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer

NO

Locally Advanced or Metastatic Breast Cancer

DRUG: SPH4336 Tablets 400mg|DRUG: SPH4336 Tablets Placebo

response rate (ORR), tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1., Approximately 3years|Progression-free survival (PFS), from the start date of study treatment to the date of progression disease or death , whichever occurred first., Approximately 3years

Cmax, PK (Pharmacokinetics) parameters, Approximately 3years|Tmax, PK (Pharmacokinetics) parameters, Approximately 3years|Disease control rate (DCR), DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease., Approximately 3years|Duration of remission (DOR), DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause., Approximately 3years|Overall Survival (OS), Determination of the overall survival times of all patients., Approximately 8years|Incidence of Adverse event, Safety and tolerability, Approximately 3years

Shanghai Pharmaceuticals Holding Co., Ltd

FEMALE

ADULT, OLDER_ADULT

PHASE2|PHASE3

INDUSTRY

INTERVENTIONAL

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

SPH4336-301

2023-04-24

2024-08-18

2024-12-16

2023-02-27

2024-05-24

Fujian Cancer Hospital, Fuzhou, Fujian, 350014, China|Affiliated Cancer Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510060, China|The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, Guizhou, 550000, China|AnYang Tumor Hospital, Anyang, Henan, 455001, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 450052, China|Renmin Hospital of Wuhan University Hubei General Hospital, Wuhan, Hubei, 430060, China|The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215004, China|Pingxiang Peoples Hospital, Pingxiang, Jiangxi, 337099, China|The Second Norman Bethune Hospital of Jilin Univer, Chang chun, Jilin, 130022, China|General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750003, China|Taian Central Hospital, Taian, Shandong, 271099, China|Peking University Cancer Hospital, Beijing, 100142, China|Tianjin Medical University cancer Institute & Hospital, Tianjin, 300181, China

{ "SPH4336 Tablets 400mg": [ { "intervention_type": "DRUG" } ], "SPH4336 Tablets Placebo": [ { "intervention_type": "DRUG" } ] }

NCT02234687

A mGlu2/3 Agonist in the Treatment of PTSD

https://clinicaltrials.gov/study/NCT02234687

TERMINATED

In this study, we propose to employ a randomized, double-blind, placebo-controlled, outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40 mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating fear-potentiated startle response and behavior in adults with post-traumatic stress disorder (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160 mg vs placebo in a 1:1:1 ratio).

YES

Post-traumatic Stress Disorder

DRUG: Pomaglumetad Methionil 160mg|DRUG: Pomaglumetad Methionil 40mg|DRUG: Placebo

To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil, To evaluate the effect of 160mg and 40mg challenge of the mGlu2/3 receptor agonist pomaglumetad methionil relative to placebo in mitigating fear-potentiated startle using the neutral-predictable-unpredictable fear-potentiated startle paradigm in adults with post-traumatic stress disorder (PTSD). The primary index of unpredictable fear will be the difference score between startle magnitude in safe and unpredictable conditions in the absence of the cue., 6 months

NYU Langone Health

ALL

ADULT

PHASE1

OTHER

INTERVENTIONAL

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

13-00609

2014-09

2016-02-11

2016-09-11

2014-09-09

2018-11-02

2018-11-02

{ "Pomaglumetad Methionil 160mg": [ { "intervention_type": "DRUG" } ], "Pomaglumetad Methionil 40mg": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT02397187

Efficacy of a Structured, Dimension-based, STI in De-compensated Personality-disorder, Hospitalized, Patients

https://clinicaltrials.gov/study/NCT02397187

LOOP-PersDis

UNKNOWN

The assessment of the efficacy of a structured, dimension-based, STI (Short Term Intervention) in de-compensated Personality-disorder, hospitalized, patients

NO

Personality Disorders

BEHAVIORAL: LOOP

Questionnaires, Questionnaires filled upon being enrolled and at the end of the intervention, up to 28 days|Readmission rates, Readmission rates in the post-intervention period (3 months)., 3 months

Shalvata Mental Health Center

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

0003-15-SHA

2015-03

2015-12

2016-03

2015-03-24

2015-03-24

{ "LOOP": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00367887

A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects

https://clinicaltrials.gov/study/NCT00367887

COMPLETED

This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype 1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).

NO

Hepatitis C

DRUG: Peg-Intron|DRUG: REBETOL|DRUG: HCV 796|DRUG: Peg-Intron|DRUG: REBETOL|DRUG: HCV 796|DRUG: Peg-Intron|DRUG: REBETOL

Hepatitis C Virus (HCV) RNA concentrations in the blood., 72 weeks

Wyeth is now a wholly owned subsidiary of Pfizer

ViroPharma

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

3173A1-200|B3381001

2006-10

2008-07

2008-07

2006-08-23

2013-02-11

Pfizer Investigational Site, Anaheim, California, 92801, United States|Pfizer Investigational Site, La Jolla, California, 92037, United States|Pfizer Investigational Site, La Jolla, California, 92067, United States|Pfizer Investigational Site, Los Angeles, California, 90033, United States|Pfizer Investigational Site, Pasadena, California, 91105, United States|Pfizer Investigational Site, San Diego, California, 92123, United States|Pfizer Investigational Site, San Diego, California, 92161, United States|Pfizer Investigational Site, San Francisco, California, 94115, United States|Pfizer Investigational Site, San Francisco, California, 94121, United States|Pfizer Investigational Site, Washington, District of Columbia, 20010, United States|Pfizer Investigational Site, Gainesville, Florida, 32610, United States|Pfizer Investigational Site, Miami, Florida, 33136, United States|Pfizer Investigational Site, Atlanta, Georgia, 30309, United States|Pfizer Investigational Site, Louisville, Kentucky, 40202, United States|Pfizer Investigational Site, Boston, Massachusetts, 02215, United States|Pfizer Investigational Site, Worcester, Massachusetts, 01655, United States|Pfizer Investigational Site, Detroit, Michigan, 48202, United States|Pfizer Investigational Site, Plymouth, Minnesota, 55446, United States|Pfizer Investigational Site, St. Paul, Minnesota, 55117, United States|Pfizer Investigational Site, St. Louis, Missouri, 63104, United States|Pfizer Investigational Site, Albuquerque, New Mexico, 87131, United States|Pfizer Investigational Site, Bronx, New York, 10461, United States|Pfizer Investigational Site, Bronx, New York, 10468, United States|Pfizer Investigational Site, New York, New York, 10021, United States|Pfizer Investigational Site, New York, New York, 10032, United States|Pfizer Investigational Site, Chapel Hill, North Carolina, 27599-7209, United States|Pfizer Investigational Site, Durham, North Carolina, 27710, United States|Pfizer Investigational Site, Cincinnati, Ohio, 45219, United States|Pfizer Investigational Site, Cleveland, Ohio, 44195, United States|Pfizer Investigational Site, Philadelphia, Pennsylvania, 19141, United States|Pfizer Investigational Site, Houston, Texas, 77030, United States|Pfizer Investigational Site, Annandale, Virginia, 22003, United States|Pfizer Investigational Site, Fairfax, Virginia, 22031, United States|Pfizer Investigational Site, Richmond, Virginia, 23249, United States|Pfizer Investigational Site, Santurce, 00909, Puerto Rico

{ "Peginterferon Alfa-2b (PEG-Intron)": [ { "intervention_type": "DRUG", "description": "Peg-Intron", "name": "Peginterferon Alfa-2b (PEG-Intron)", "synonyms": [ "Peginterferon Alfa-2b (PEG-Intron)", "PEG-Intron" ], "medline_plus_id": "a605030", "generic_names": [ "Peginterferon Alfa-2b (PEG-Intron)" ] }, { "intervention_type": "DRUG", "description": "Peg-Intron", "name": "Peginterferon Alfa-2b (PEG-Intron)", "synonyms": [ "Peginterferon Alfa-2b (PEG-Intron)", "PEG-Intron" ], "medline_plus_id": "a605030", "generic_names": [ "Peginterferon Alfa-2b (PEG-Intron)" ] }, { "intervention_type": "DRUG", "description": "Peg-Intron", "name": "Peginterferon Alfa-2b (PEG-Intron)", "synonyms": [ "Peginterferon Alfa-2b (PEG-Intron)", "PEG-Intron" ], "medline_plus_id": "a605030", "generic_names": [ "Peginterferon Alfa-2b (PEG-Intron)" ] } ], "Ribavirin": [ { "intervention_type": "DRUG", "description": "REBETOL", "name": "Ribavirin", "synonyms": [ "Copegus", "Ribamide", "Ribovirin", "Ribavirinum", "Virazole", "Vilona", "Tribavirin", "Virazide", "tribavirin", "Viramide", "Ribamidil", "RBV", "1-beta-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide", "Ribavirin", "ICN-1229", "Ribamidyl", "Ribavirine", "Rebetol", "Ribavirina", "ICN1229", "ICN 1229", "Ribasphere", "1-beta-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide" ], "medline_plus_id": "a605018", "generic_names": [ "Ribavirin" ], "mesh_id": "D000998", "drugbank_id": "DB00811" }, { "intervention_type": "DRUG", "description": "REBETOL", "name": "Ribavirin", "synonyms": [ "Copegus", "Ribamide", "Ribovirin", "Ribavirinum", "Virazole", "Vilona", "Tribavirin", "Virazide", "tribavirin", "Viramide", "Ribamidil", "RBV", "1-beta-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide", "Ribavirin", "ICN-1229", "Ribamidyl", "Ribavirine", "Rebetol", "Ribavirina", "ICN1229", "ICN 1229", "Ribasphere", "1-beta-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide" ], "medline_plus_id": "a605018", "generic_names": [ "Ribavirin" ], "mesh_id": "D000998", "drugbank_id": "DB00811" }, { "intervention_type": "DRUG", "description": "REBETOL", "name": "Ribavirin", "synonyms": [ "Copegus", "Ribamide", "Ribovirin", "Ribavirinum", "Virazole", "Vilona", "Tribavirin", "Virazide", "tribavirin", "Viramide", "Ribamidil", "RBV", "1-beta-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide", "Ribavirin", "ICN-1229", "Ribamidyl", "Ribavirine", "Rebetol", "Ribavirina", "ICN1229", "ICN 1229", "Ribasphere", "1-beta-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide" ], "medline_plus_id": "a605018", "generic_names": [ "Ribavirin" ], "mesh_id": "D000998", "drugbank_id": "DB00811" } ], "HCV 796": [ { "intervention_type": "DRUG" }, { "intervention_type": "DRUG" } ] }

NCT02490787

Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

https://clinicaltrials.gov/study/NCT02490787

COMPLETED

This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.

NO

Congenital Bleeding Disorder|Haemophilia A

DRUG: Concizumab|DRUG: placebo

Number of adverse events (AEs), From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Trough level of concizumab, Prior to the last s.c. dose administration (day 42)|Frequency of binding non-neutralizing anti-concizumab antibodies, From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Novo Nordisk A/S

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

NN7415-4159|2014-003793-16|U1111-1161-1501|NL53826.018.15

2015-09-10

2016-10-14

2016-10-14

2015-07-07

2017-07-21

Novo Nordisk Investigational Site, Torrance, California, 90502-2004, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46260, United States|Novo Nordisk Investigational Site, Iowa City, Iowa, 52242, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21287, United States|Novo Nordisk Investigational Site, New York, New York, 10065, United States|Novo Nordisk Investigational Site, Portland, Oregon, 97239, United States|Novo Nordisk Investigational Site, Houston, Texas, 77030, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53226, United States|Novo Nordisk Investigational Site, Camperdown, New South Wales, 2050, Australia|Novo Nordisk Investigational Site, Melbourne, Victoria, 3004, Australia|Novo Nordisk Investigational Site, Wien, 1090, Austria|Novo Nordisk Investigational Site, Zagreb, 10 000, Croatia|Novo Nordisk Investigational Site, Bron Cedex, 69677, France|Novo Nordisk Investigational Site, Nantes Cedex 1, 44093, France|Novo Nordisk Investigational Site, Rennes, 35033, France|Novo Nordisk Investigational Site, Berlin, 10249, Germany|Novo Nordisk Investigational Site, Duisburg, 47051, Germany|Novo Nordisk Investigational Site, Homburg, 66421, Germany|Novo Nordisk Investigational Site, Tel-Hashomer, 52621, Israel|Novo Nordisk Investigational Site, Kuala Lumpur, 50400, Malaysia|Novo Nordisk Investigational Site, Kuching, 93586, Malaysia|Novo Nordisk Investigational Site, Amsterdam, 1105 AZ, Netherlands|Novo Nordisk Investigational Site, Nijmegen, 6525 GA, Netherlands|Novo Nordisk Investigational Site, Utrecht, 3584 CX, Netherlands|Novo Nordisk Investigational Site, Warszawa, 02-776, Poland|Novo Nordisk Investigational Site, Madrid, 28046, Spain|Novo Nordisk Investigational Site, Bangkok, 10400, Thailand|Novo Nordisk Investigational Site, Bornova-IZMIR, 35100, Turkey|Novo Nordisk Investigational Site, Dnipropetrovsk, 49102, Ukraine|Novo Nordisk Investigational Site, Lviv, 79044, Ukraine|Novo Nordisk Investigational Site, London, NW3 2QG, United Kingdom|Novo Nordisk Investigational Site, London, SW17 0QT, United Kingdom|Novo Nordisk Investigational Site, Sheffield, S10 2JF, United Kingdom|Novo Nordisk Investigational Site, Southampton, SO16 6YD, United Kingdom

{ "Concizumab": [ { "intervention_type": "DRUG", "description": "Concizumab", "name": "Concizumab", "synonyms": [ "Concizumab" ], "drugbank_id": "DB12820", "generic_names": [ "Concizumab" ] } ], "placebo": [ { "intervention_type": "DRUG" } ] }

NCT03158987

Regional Differences in Human Immunodeficiency Virus (HIV) Testing

https://clinicaltrials.gov/study/NCT03158987

HIVRegional

COMPLETED

This retrospective observational study aims at the examination of regional differences in the procedure of referral for serological HIV testing between eastern (new) and western (old) German federal states.

NO

HIV Seropositivity|CD4+ T Lymphocytopenia

OTHER: Medical record review

Type of HIV-verifying medical institution, Medical Institution (university hospital, general practitioner, specialized medical office) which has diagnosed HIV seropositivity for the first time, 1 day

CD4+ lymphocyte counts, Number of CD4+ lymphocytes at the time of HIV diagnosis, 1 day|Symptoms of AIDS-related diseases, Presence of AIDS-related disease symptoms at the time of first HIV seropositivity diagnosis, 1 day

Jena University Hospital

University of Magdeburg|University of Leipzig|University of Rostock|Technische Universität Dresden|MUC Research GmbH

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

ZKS00

2017-06-01

2019-01-30

2019-01-30

2017-05-18

2021-09-02

University Hospital Jena, Jena, Thuringia, 07747, Germany

{ "Medical record review": [ { "intervention_type": "OTHER" } ] }

NCT01414387

Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting

https://clinicaltrials.gov/study/NCT01414387

TERMINATED

Carotid artery stenting (CAS) with cerebral embolic protection is the preferred treatment for narrowing of the carotid arteries in patients at high risk for open surgery. Special devices are used to protect the brain from particles(emboli) that may break off when the narrowing or blockage is cleared during the angioplasty and stenting procedure. Although filters are most frequently used, protection systems consisting of balloons and flow reversal are also available for cerebral embolic protection. However, there is little information about the effectiveness of filters compared with balloons and flow reversal for prevention of embolization during CAS. The aim of our study is to address this major problem. Our study was designed to answer two specific questions: First, the study will investigate whether balloon-based protection systems are more effective than filters in reducing the amount of particles that break off and travel to the brain during CAS. For this purpose two imaging techniques will be used: magnetic resonance imaging of the brain (MRI), and transcranial doppler (detection of microparticles in the small brain vessels using ultrasound). Second, it will be investigated whether the use of balloon-based protection devices are more effective than filters for prevention of stroke, heart attacks, and death after carotid stenting. The results of the study will provide important information to find out the best way to protect the brain from plaque fragments that may break off during CAS.

NO

Carotid Artery Disease|Stroke

PROCEDURE: Carotid filter|PROCEDURE: Carotid reversal of flow

Cerebral embolization, Number of cerebral macro and microembolic events assessed as the number of new ipsilateral brain lesions detected by brain diffusion-weighted magnetic resonance imaging within 24 hours post carotid artery stenting and number of intraoperative microembolic signals detected by transcranial Doppler in the middle cerebral artery ipsilateral to the procedure during carotid artery stenting., Within 24 hours post carotid artery stenting

Any Stroke, TIA, MI or death, Occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 30 days after carotid artery stenting., Within 30 days after carotid artery stenting|Technical success of carotid artery stenting, 4 weeks.|Stent thrombosis, Thrombosis of carotid artery stent implanted during the index procedure, assessed within 30 days after procedure, within 30 days post procedure

Dallas VA Medical Center

American Heart Association

ALL

ADULT, OLDER_ADULT

FED

INTERVENTIONAL

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

11GRNT7960035

2011-10

2016-02-12

2016-02-12

2011-08-11

2017-08-02

Dallas VA Medical Center, Dallas, Texas, 75216, United States

{ "Carotid filter": [ { "intervention_type": "PROCEDURE" } ], "Carotid reversal of flow": [ { "intervention_type": "PROCEDURE" } ] }

NCT04726787

RadiothErapy priMIng for CAR-T

https://clinicaltrials.gov/study/NCT04726787

REMIT

ACTIVE_NOT_RECRUITING

The REMIT trial will investigate radiotherapy as a preferred bridging method prior to Tisagenlecleucel infusion in patients with relapsed or refractory Diffuse Large B Cell Lymphoma

NO

Diffuse Large B Cell Lymphoma

RADIATION: Bridging Radiotherapy

Percentage of patients starting lymphodepletion on the planned start date without delay, To evaluate whether there is any delay in patients starting lymphodepletion, From planned start date of lymphodepletion until actual start date of lymphodepletion, assessed up to 2 weeks

Best overall response after Tisagenlecleucel infusion as per International Working Group 2014 criteria, Proportion of patients achieving a Complete Response (CR) or Partial Response (PR), After Tisagenlecleucel infusion through to study completion, an average of 24 months|Overall response rate at 3 months and 6 months after Tisagenlecleucel infusion, Overall response rate after Tisagenlecleucel infusion, At 3 and 6 months after Tisagenlecleucel infusion|Complete metabolic response at 3 months and 6 months after Tisagenlecleucel infusion, Complete metabolic response after Tisagenlecleucel infusion, At 3 and 6 months after Tisagenlecleucel infusion|Duration of response, Time from date of first response confirmation to the first date of progressive disease confirmation, From initial response until the date of first documented disease progression, assessed up to 24 months|Median progression free survival and progression free survival at 12 months, Progression Free Survival after Tisagenlecleucel infusion, 12 months after Tisagenlecleucel infusion|Median event-free survival and event-free survival at 12 months, Event-free survival after Tisagenlecleucel infusion, 12 months after Tisagenlecleucel infusion|Median overall survival and overall survival at 12 months, Overall Survival after Tisagenlecleucel infusion, 12 months after Tisagenlecleucel infusion|Treatment emergent adverse events, Adverse events being reported during and after treatment, From start of Tisagenlecleucel infusion until 30 days post Tisagenlecleucel infusion|Incidence of grade 3 or higher cytokine release syndrome and immune effector cell associated neurotoxicity syndrome, Percentage of grade 3 or higher cytokine relapse syndrome and immune effector cell associated neurotoxicity syndrome events, From start of Tisagenlecleucel infusion through to study completion, an average of 24 months|Neutrophil levels at 1, 3, 6 months after Tisagenlecleucel infusion, Neutrophil counts to be reported after Tisagenlecleucel infusion, At 1, 3 and 6 months after Tisagenlecleucel infusion|Platelet levels at 1, 3, 6 months after Tisagenlecleucel infusion, Platelet counts to be reported after Tisagenlecleucel infusion, At 1, 3 and 6 months after Tisagenlecleucel infusion

University College, London

Novartis Pharmaceuticals

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

UCL/137861

2022-08-18

2023-07-05

2024-05-31

2021-01-27

2023-11-28

St Jamess University Hospital, Leeds, United Kingdom|Kings College Hospital, London, United Kingdom|Freeman Hospital, Newcastle, United Kingdom

{ "Bridging Radiotherapy": [ { "intervention_type": "RADIATION" } ] }

NCT02471287

Genetics of Inherited Eye Disease

https://clinicaltrials.gov/study/NCT02471287

RECRUITING

Background: Research has identified some of the genes involved in inherited eye diseases. But for many of these diseases, the genes are not yet known. Researchers want to try to find these genes. They also hope to learn more about how symptoms differ in people with similar gene changes. Objective: To learn more about genes involved in eye diseases. Eligibility: People who have a known or suspected inherited eye disease, and their relatives. Design: * All participants will have a medical history, physical exam, and eye exam. They may have blood taken. * Participants with an eye disease may have eye cell samples taken using a swab or biopsy procedure. * Participants may have a skin biopsy. A (Omega)-inch piece of skin will be removed. * Participants may have blood drawn and the red blood cells removed. The remaining serum will be made into an eye drop solution for the participant. * Participants may provide samples of tears, urine, saliva, stool, hair, or inner cheek cells. * Participants may have a retina test. They may also have a test that uses light to measure retina thickness. * Participants may have an eye movement test. Electrodes will be placed on the skin next to both eyes. * Participants may have a fluorescein angiography. A dye will be given through an intravenous line in the arm. A camera will take pictures of the dye as it flows through the eyes blood vessels. * Participants may have microperimetry. They will sit at a computer screen and press a button when they see a light. * Participants may have an eye movement test. They will wear contact lenses or goggles and watch a series of spots on a computer screen.

NO

Genetic Eye Disease

Establish cohort, Establish an initial critical mass of participants and knowledge to develop disease-specific protocols for specific inherited eye conditions., Ongoing

Suggest best clinical outcome measures, Suggesting the best clinical outcome measures to follow patients with various inherited eye diseases, ongoing|Revealing systematic comorbidities, Revealing systemic comorbidities that occur in patients with various inherited eye diseases., ongoing|Provide a mechanism for collecting biological samples, Provide a mechanism for collecting biological samples from well-phenotyped subjects for basic laboratory research, ongoing|Determine the genetic cause(s) and molecular pathogenesis, Determine the genetic causes(s) and molecular pathogenesis of a known or suspected inherited disorder of vision in an individual patient and his/her family., ongoing

National Eye Institute (NEI)

ALL

CHILD, ADULT, OLDER_ADULT

NIH

OBSERVATIONAL

Observational Model: |Time Perspective: p

150128|15-EI-0128

2015-06-22

2024-09-01

2024-09-01

2015-06-15

2024-06-12

National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

{}

NCT05944887

Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

https://clinicaltrials.gov/study/NCT05944887

COMPLETED

The goal of this clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation during gastroscopy in healthy patients (ASA 1 and 2 patients). Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group. After the gastroscopy, patients will be asked to complete a satisfaction questionnaire

NO

Diagnostic Gastroscopy

DRUG: Lidocaine 2% Injectable Solution|DRUG: Saline administration as placebo|DRUG: Propofol injection|PROCEDURE: gastroscopy

total propofol dose in milligramme, total propofol dose consumed, procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)|total propofol dose in milligramme, total propofol dose consumed, Procedure (from the beginning of propofol infusion until endoscope removal)|propofol in site effet concentration in microgram per milliliter, AIVOC : Effect concentration of propofol, procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)|propofol in site effet concentration in microgram per milliliter, AIVOC : Effect concentration of propofol, Procedure (from the beginning of propofol infusion until endoscope removal)

number of participants with moderate hypoxemia, pulse saturation below 95%, Procedure (during propofol sedation and gastroscopy)|number of participants with hypotension, mean arterial pressure below 65 mmHg, Procedure (during propofol sedation and gastroscopy)|number of participants with severe hypoxemia, pulse saturation below 90%, Procedure (during propofol sedation and gastroscopy)|number of participants presenting cough, cough suggesting to light sedation, Procedure (during propofol sedation and gastroscopy)|number of participants presenting laryngospasm, laryngospasm suggesting to light sedation, Procedure (during propofol sedation and gastroscopy)|number of participants presenting involuntary movements, involuntary movements suggesting to light sedation, Procedure (during propofol sedation and gastroscopy)|number of participants presenting side effects of lidocaine administration, metallic taste, tinnitus, anaphylaxis, during gastroscopy procedure|score of Endoscopist satisfaction (1-5), Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent, completed procedure (before transfer to recovery room)|score of Patient satisfaction (1-5), Patient satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent, at recovery room discharge, an average of 1 hour after completed procedure|throat pain, analog digital scale from 1 to 10, at recovery room discharge, an average of 1 hour after completed procedure

Erasme University Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

P2023/236

2023-07-21

2023-08-21

2023-08-25

2023-07-13

2023-09-18

Erasme Hospital, Brussel, 1070, Belgium

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"Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort" ], "nhs_url": "https://www.nhs.uk/medicines/lidocaine-for-piles-and-itchy-bottom", "generic_names": [ "Lidocaine", "Lidocaine Patch", "Lidocaine Patch", "Lidocaine Viscous", "Lidocaine Viscous", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone" ], "mesh_id": "D061567", "drugbank_id": "DB00281", "wikipedia_url": "https://en.wikipedia.org/wiki/Lidocaine" } ], "Saline administration as placebo": [ { "intervention_type": "DRUG" } ], "Propofol": [ { "intervention_type": "DRUG", "description": "Propofol injection", "name": "Propofol", "synonyms": [ "Propofol MCT", "2,6-Diisopropylphenol", "Propofolum", "ICI-35868", "Fresofol", "2,6-bis(1-methylethyl)phenol", "ICI 35,868", "Ivofol", "Aquafol", "ICI-35,868", "Propofol Rovi", "Propofol Fresenius", "ICI 35868", "ICI35,868", "Disoprofol", "2,6 Diisopropylphenol", "Propofol Abbott", "Diprivan", "ICI35868", "Disoprivan", "Recofol", "Propofol", "Propofol-Lipuro", "2,6-Bis(1-methylethyl)phenol" ], "mesh_id": "D018686", "generic_names": [ "Propofol" ], "drugbank_id": "DB00818", "wikipedia_url": "https://en.wikipedia.org/wiki/Propofol" } ], "gastroscopy": [ { "intervention_type": "PROCEDURE" } ] }

NCT02137187

Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure

https://clinicaltrials.gov/study/NCT02137187

APAF-CRT

UNKNOWN

There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality

NO

Permanent Atrial Fibrillation

PROCEDURE: AV junction ablation|DEVICE: CRT|DRUG: Optimized drug therapy|DEVICE: ICD

Combined end-point, Morbidity trial end-points Primary end-point: a combined of (1) mortality due to heart failure, (2) hospitalization for heart failure or uncontrolled intolerable atrial fibrillation, or (3) worsening heart failure, Upto 3 years

Major clinical events, Morbidity trial end-points Secondary end-points: total mortality, total hospitalizations, hospitalization for heart failure and/or atrial fibrillation and worsening heart failure., Up to 3 years|Major clinical events, Mortality trial end-points Secondary end-point: cardiovascular mortality and hospitalization for heart failure or uncontrolled intolerable atrial fibrillation, Up to 5 years

Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

CPMCV-01-14

2014-10-15

2021-05-15

2021-07-31

2014-05-13

2021-01-20

Department of Cardiology, Ospedali del Tigullio, Lavagna, 16033, Italy

{ "AV junction ablation": [ { "intervention_type": "PROCEDURE" } ], "CRT": [ { "intervention_type": "DEVICE" } ], "Optimized drug therapy": [ { "intervention_type": "DRUG" } ], "ICD": [ { "intervention_type": "DEVICE" } ] }

NCT00825487

Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic Malignancies

https://clinicaltrials.gov/study/NCT00825487

COMPLETED

This is an open-label, dose escalation study of intravenous ARQ 621 administered to patients with late-stage solid tumors or hematologic malignancies.

NO

Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies

DRUG: ARQ 621

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 621 administered intravenously., 24 months estimated

To determine the pharmacokinetic profile of ARQ 621., 24 months estimated|To determine the pharmacodynamic profile (incl. biomarkers) of ARQ 621., 24 months estimated|To assess the preliminary anti-tumor activity of ARQ 621., 24 months estimated

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

ARQ 621-101

2009-08

2011-05

2011-09

2009-01-21

2011-10-19

Translational Genomics Institute, Phoenix, Arizona, 85004, United States|Premiere Oncology, Santa Monica, California, 90404, United States|Boston, Massachusetts, 02111, United States|Nevada Cancer Institute, Las Vegas, Nevada, 89135, United States

{ "ARQ 621": [ { "intervention_type": "DRUG" } ] }

NCT04478487

Novel Human Milk Based Human Milk Fortifier

https://clinicaltrials.gov/study/NCT04478487

MHMHMF

ENROLLING_BY_INVITATION

The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).

NO

Infant, Premature, Diseases

DIETARY_SUPPLEMENT: Medolac human milk based human milk fortifier (MHMHMF)

weight gain (gm/kg/day), Weights., Daily from first day of enrollment until 36 weeks post menstrual age or discharge

length increment (cm/kg/day), length, Weekly until 36 weeks post menstrual age or discharge|Head Circumference increment (cm/kg/day), Head circumference, Weekly until 36 weeks post menstrual age or discharge|Volume of Fortifier, Total intake of formula and fortifier, Daily until 36 weeks post menstrual age or discharge|Morbidity, Adverse Events-necrotizing enterocolitis, retinopathy of prematurity and bronchopulmonary dysplasia., weekly until 36 weeks post menstrual age or discharge

Northwest Health

Neolac Inc dba Medolac Laboratories

ALL

CHILD

OTHER

INTERVENTIONAL

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

MC-2018-01

2019-09-01

2024-09-30

2024-09-30

2020-07-20

2024-04-17

Willow Creek Womens Hospital, Johnson, Arkansas, 72741, United States

{ "Medolac human milk based human milk fortifier (MHMHMF)": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT06139887

Suicide Prevention Program for Veterans Discharged From Community Care Settings

https://clinicaltrials.gov/study/NCT06139887

RECRUITING

The goal of this pilot randomized controlled trial is to test an adapted suicide prevention program (the Building VA Engagement, Self-efficacy, and Social Support To Prevent Suicide or BESST) in rural Veterans discharged from community care mental health treatment settings. The main question it aims to answer is: * Does BESST combined with standard care improve suicide-related outcomes among this population compared to standard care alone? Participants will be assigned by change to a treatment group. Some will receive the BESST intervention combined with standard care, and some will receive standard care alone. All participants will be in this research study for up to three months. Those receiving the BESST intervention will have: * 1 one-hour brief educational session; * Seven follow-up check-ins (~30 minutes each) All participants will have three assessment interviews where they will be asked about their mental health and treatment received outside of the VA. The investigators will compare participants assigned to the BESST intervention combined with standard care vs participants assigned to standard care alone to see if the BESST intervention improves suicide-related outcomes.

NO

Suicide Prevention

BEHAVIORAL: BESST|OTHER: Standard Mental Health Care

Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS), The Beck Scale for Suicidal Ideation (BSS) ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant., Baseline to 3 months post-discharge

Patient Engagement: Suicide-Related Coping Scale (SRCS), The Suicide-Related Coping Scale (SRCS) includes 17 questions related to a patients perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. The score range for the entire scale is 0-68 with the External Coping being 0-28 and the Internal Coping being 0-28. Higher scores indicate increased perception of suicide-related coping., Baseline to 3 months post-discharge|Patient Engagement: General Self-Efficacy Scale (GSES), The General Self-Efficacy Scale (GSES) is a valid scale of self-efficacy that is designed for the general population (12 years or older) and it has been tested in various countries. It is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. Total scores range from 10 to 40, with higher scores suggesting increased self-efficacy., Baseline to 3 months post-discharge|Hopelessness: Beck Hopelessness Scale (BHS), The Beck Hopelessness Scale (BHS) is a 20-item self-report scale that assesses hopelessness over the past seven days. Patients report on feelings about the future, loss of motivation, and future expectations. Total scores range from 0 to 20, with higher scores suggesting more hopelessness. The BHS has good reliability and validity and is sensitive to change. There is some evidence that the BHS may be a measure of risk of suicide., Baseline to 3 months post-discharge|Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15), The Interpersonal Needs Questionnaire-15 (INQ-15) is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for perceived burdensomeness being 7-49., Baseline to 3 months post-discharge|Suicide Attempts: Columbia-Suicide Severity Rating Scale (C-SSRS), The Columbia-Suicide Severity Rating Scale (C-SSRS) is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors. The scale asks the assessor to document the actual and potential lethality of these behaviors. There are two subscales within the C-SSRS: suicidal ideation (range: 0-5, with higher scores suggesting increased suicidal ideation) and intensity of ideation (range: 0-25, with higher scores suggesting increased intensity)., Baseline to 3 months post-discharge|Substance Use: Timeline Follow Back (TLFB), The investigators will assess substance use at baseline and follow-up assessments using a timeline follow-back approach. This method is commonly used in research studies to assess substance use patterns. Numerical scores do not apply to this assessment., Baseline to 3 months post-discharge

White River Junction Veterans Affairs Medical Center

VHA Office of Rural Health

ALL

ADULT, OLDER_ADULT

FED

INTERVENTIONAL

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

1701666

2023-10-01

2024-09-30

2025-09-30

2023-11-18

2024-06-20

White River Junction VA Medical Center, White River Junction, Vermont, 05009, United States

Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/87/NCT06139887/ICF_000.pdf

{ "BESST": [ { "intervention_type": "BEHAVIORAL" } ], "Standard Mental Health Care": [ { "intervention_type": "OTHER" } ] }

NCT04997187

Effect of Bacillus Coagulans in Adults With With Functional Constipation

https://clinicaltrials.gov/study/NCT04997187

COMPLETED

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks.

NO

Constipation - Functional

DIETARY_SUPPLEMENT: Bacillus coagulans group|DIETARY_SUPPLEMENT: Control group

constipation visual analogue scale, using visual analogue scale (100 mm). The minimum value was 0 mm and the maximum value was 100 mm, and higher scores mean a worse outcome., 8 weeks

Bristol Stool Form Scale (BSFS) type 3 & 4 ratio (%), using Bristol Stool Form Scale. The minimum value was 0% and the maximum value was 100%, and higher scores mean a better outcome., 8 weeks|visual analogue scale for irritable bowel syndrome, using visual analogue scale (100 mm). The minimum value was 0 mm and the maximum value was 100 mm, and higher scores mean a better outcome., 8 weeks|irritable bowel syndrome-symptom severity scale, using IBS-Symptom Severity Scale questionnaire. The minimum value was 0 score and the maximum value was 500 score and higher scores mean a worse outcome., 8 weeks|irritable bowel syndrome-quality-of-life, using IBS-QOL questionnaire. The minimum value was 0 score and the maximum value was 5 score and higher scores mean a better outcome., 8 weeks|fecal microbial diversity, using gut microbiome analysis, 8 weeks

Pusan National University Yangsan Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

02-2021-008

2021-07-20

2022-02-27

2022-04-15

2021-08-09

2023-04-12

Pusan National University Yangsan Hospital, Yangsan, Gyeungsangnam-do, 50612, Korea, Republic of

{ "Bacillus coagulans group": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Control group": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT06455787

J-Valve Transfemoral Pivotal Study

https://clinicaltrials.gov/study/NCT06455787

JOURNEY

NOT_YET_RECRUITING

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).

NO

Aortic Valve Regurgitation|Aortic Valve Disease Mixed

DEVICE: J-Valve Transfemoral (TF) System

Rate of all-cause mortality at 1 year, 1-year post-procedure|The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3), Includes: * All-cause death; * All stroke; * VARC-3 type 2-4 bleeding; * Major vascular, access-related, or cardiac structural complication; * Acute kidney injury (AKI) stage 3 or 4; * New permanent pacemaker due to procedure-related conduction abnormalities; * Surgery or intervention related to the device., 30-days post-procedure

Rate of improvement in cardiovascular-specific health status, As measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS), Baseline to 1-year follow-up|Rate of the individual components of the composite early-safety endpoint at 30 days, Includes: * All-cause death; * All stroke; * VARC-3 type 2-4 bleeding; * Major vascular, access-related, or cardiac structuralcomplication * Acute kidney injury (AKI) stage 3 or 4; * New permanent pacemaker due to procedure-relatedconduction abnormalities; * Surgery or intervention related to the device., 30-days post-procedure

JC Medical, Inc.

Bright Research Partners|Minneapolis Heart Institute Foundation|Cardiovascular Research Foundation, New York

ALL

CHILD, ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

JCM-002

2024-07

2026-07

2030-07

2024-06-12

2024-06-12

{ "J-Valve Transfemoral (TF) System": [ { "intervention_type": "DEVICE" } ] }

NCT02579187

MicroRNA and MicroRNA Inhibitors Socket Study, Pilot Clinical Trial

https://clinicaltrials.gov/study/NCT02579187

WITHDRAWN

To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory response on the basis of different clinical, radiographic, histologic and biomolecular outcomes in post-extraction socket defects in humans.

NO

Tooth Extraction Status Nos

PROCEDURE: tooth extraction|RADIATION: CBCT scan|DRUG: Anesthesia|OTHER: clinical measurements|DRUG: Biodegradable sponge (type I bovine collagen)|DRUG: 10µg of pSil-miR200c|PROCEDURE: cross mattress suture|DRUG: 10µg of PMIS miR200a plasmids|DRUG: 5µg of pSil-miR200c and 5µg of PMIS miR200a|PROCEDURE: Blood|OTHER: Photos/videos|PROCEDURE: Wound fluid|PROCEDURE: saliva|RADIATION: periapical xray|OTHER: PVS impression

Percent of mineralized tissue upon histomorphometric analysis of bone core biopsies, compared using exact Wilcoxon rank sum tests, at 16 weeks postoperatively

Bucco-lingual width changes of the alveolar ridge (in mm), Fishers exact tests will be used to compare the treatment groups, up to 16 weeks postoperatively|Mid-buccal height changes of the alveolar ridge (in mm), compared using exact Wilcoxon rank sum tests, up to 16 weeks postoperatively|Mid-lingual height changes of the alveolar ridge (in mm), compared using exact Wilcoxon rank sum tests, up to 16 weeks postoperatively|Volumetric reduction of the alveolar ridge (in cc) via CBCT scan analyses, compared using exact Wilcoxon rank sum tests, at 16 weeks postoperatively|Expression of different biomarkers (VEGF, PDGF, TGF-b, IL-1b, TNF-a) in wound fluid expressed in pg/ml, compared using exact Wilcoxon rank sum tests, up to 4 weeks postoperatively

Gustavo Avila-Ortiz DDS, MS, PhD

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

201607780

2025-12-31

2030-09

2030-09

2015-10-19

2019-07-17

UIowa, Iowa City, Iowa, 52242, United States

{ "tooth extraction": [ { "intervention_type": "PROCEDURE" } ], "CBCT scan": [ { "intervention_type": "RADIATION" } ], "Anesthesia": [ { "intervention_type": "DRUG" } ], "clinical measurements": [ { "intervention_type": "OTHER" } ], "Biodegradable sponge (type I bovine collagen)": [ { "intervention_type": "DRUG" } ], "10\u00b5g of pSil-miR200c": [ { "intervention_type": "DRUG" } ], "cross mattress suture": [ { "intervention_type": "PROCEDURE" } ], "10\u00b5g of PMIS miR200a plasmids": [ { "intervention_type": "DRUG" } ], "5\u00b5g of pSil-miR200c and 5\u00b5g of PMIS miR200a": [ { "intervention_type": "DRUG" } ], "Blood": [ { "intervention_type": "PROCEDURE" } ], "Photos/videos": [ { "intervention_type": "OTHER" } ], "Wound fluid": [ { "intervention_type": "PROCEDURE" } ], "saliva": [ { "intervention_type": "PROCEDURE" } ], "periapical xray": [ { "intervention_type": "RADIATION" } ], "PVS impression": [ { "intervention_type": "OTHER" } ] }

NCT02134587

Educational Intervention in Pharmacovigilance for Hospital Health Professionals

https://clinicaltrials.gov/study/NCT02134587

EIPhv

COMPLETED

Spontaneous reports by health professionals generate the signals in pharmacovigilance. However, the passive method has limitations and the most important of them are the underreporting and the poor quality of data, hindering the causality assessment of adverse drug events (ADE). Therefore, the present study aimed to validate an educational intervention (EI) in pharmacovigilance for hospital health professionals, in order to analyze the impact on the knowledge, skill and attitude in ADE reporting. Investigators proposed a multifaceted EI which will be developed in four meetings with one hour each. The following activities will be carried out: application of a questionnaire to assess the knowledge, skill and attitude before and after EI; lecture; practical class and education material distribution. The answers of questionnaire are going to be analyzed using content analysis technique. The definitions of World Health Organization and the minimum and desired criteria to fill the ADE form, according to the Pan American Health Organization, are going to be considered gold-standard answers. The statistical test of Wilcoxon-Mann Whitney test for paired samples will be applied, in order to assess the impact of educational intervention on behavior of health professionals (ADE reporting). With the present study, the following hypotheses will be tested: H0= There is no difference between the numbers of ADE reported (behavior/attitudes) before and after the educational intervention. H1= The numbers of ADE reported before and after the educational intervention are different.

YES

Adverse Drug Reaction

OTHER: Multifaceted educational intervention

Absolute Number of ADE Reporting (Change Behavior of Health Professionals), Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals., 12 months

Knowledge (Awareness) Regarding Pharmacovigilance, Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals., Two days|Quality of ADE Reports, Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form., Two days

Universidade Estadual Paulista Júlio de Mesquita Filho

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

E015/10

2012-02

2013-09

2014-05

2014-05-09

2015-08-20

2023-06-05

Hospital Estadual Américo Brasiliense, Américo Brasiliense, São Paulo, 14820-000, Brazil

{ "Multifaceted educational intervention": [ { "intervention_type": "OTHER" } ] }

NCT03551587

Comparison Between the Vibringe and the Conventional Needle

https://clinicaltrials.gov/study/NCT03551587

COMPLETED

The Vibringe is the first endodontic sonic irrigation system that enables delivery and activation of the irrigation solution in the root canal, in only one step. The activation of the disinfectant by acoustic streaming, enriches and completes the irrigation procedure and improves the success rate of endodontic treatments. It has been shown that this system significantly improves debridement. It also improves the disruption of the smear layer and biofilm by activating irrigation solutions. As there are no previous studies comparing the Vibringe system with other irrigation techniques under clinical settings, in this regard, the aim of this study is to evaluate whether irrigation with Vibringe provides more or less benefit in terms of postoperative pain when compared with the conventional needle technique.

NO

Endodontic Inflammation

DEVICE: Vibringe

pain intensity ( post operative pain ), post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: severe pain, analgesic had no effect in relieving the pain ., 6 hours post- obturation.|pain intensity ( post operative pain ), post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: severe pain, analgesic had no effect in relieving the pain ., 12 hours post- obturation.|pain intensity ( post operative pain ), post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: severe pain, analgesic had no effect in relieving the pain ., 24 hours post- obturation.|pain intensity ( post operative pain ), post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: severe pain, analgesic had no effect in relieving the pain ., 48 hours post- obturation.

Cairo University

ALL

ADULT

OTHER

INTERVENTIONAL

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

Vibringe_Postoperative_pain

2017-11-28

2019-01-27

2019-02-28

2018-06-11

2019-08-02

Cairo university, Cairo, Egypt

{ "Vibringe": [ { "intervention_type": "DEVICE" } ] }

NCT05318287

Walk With Me for Perinatal Grief

https://clinicaltrials.gov/study/NCT05318287

PeriGrief

COMPLETED

This research will contribute to therapeutic technology to support bereaved parents who have experienced a perinatal loss. The proposed mobile application would accomplish this objective by providing a series of therapeutic modules to provide parents with tools to normalize their grief and additional coping skills to support the grieving process.

NO

Grief|Traumatic Stress|Usability

BEHAVIORAL: Walk with Me

Traumatic stress will be analyzed as change over time, Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs not at all ; 1, a little bit ; 2, moderately ; 3, quite a bit ; and 4, extremely. Higher scores indicate greater distress/trauma. Participants will be instructed to relate the IES-R items specifically to the loss of their child. The investigators will examine scores as a continuous variable and presence/absence of diagnosis using a cutoff score of 35 or more., Baseline (immediately following loss), 4 weeks and 8 weeks post loss|Grief intensity will be analyzed as change over time, The Perinatal Grief Intensity Scale is 14 items that asks about an individuals experiences with perinatal loss. Items are on a four-point scale (1 to 4) and is averaged across three scales with a total possible score of 4. Higher overall scores indicating higher intensity of grief., Baseline (immediately following loss), 4 weeks and 8 weeks post loss|Grief, The Perinatal Bereavement Scale is a 15-item scale designed as a measure of grief and yearning for the lost pregnancy and the lost baby. Respondents indicate how often the statement has been true in the past week, using a 4-point Likert-type scale ranging from rarely or none of the time, less than 1 day (scored 1) to most or all of the time, 5 to 7 days (scored 4). Responses are summed to yield a total score (possible range, 15-60), Baseline (immediately following loss)|Grief management self-efficacy will be analyzed as a change over time, Three items that rate the bereaved parents confidence in their ability to cope with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help coping. Scores are on a four-point scale (1 to 4) with a total available score of 12. Higher scores indicate greater self-efficacy., 4 weeks and 8 weeks post loss|Care experiences will be analyzed as a change over time, 11 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale (1 to 4) to indicate level of agreement with a total available score of 44. Higher scores indicating better experiences., Baseline (immediately following loss), 4 weeks and 8 weeks post loss|Usability, The System Usability Scale is commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert-scale. The participants scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores indicate the technology is more usable., Post-Treatment (8 weeks post loss)|Acceptability, Developed as part of the current study. Items developed to measure the degree, on a 7-point Likert-type scale, to which parents found the program helpful, acceptable, and suited to their needs. Higher scores will indicate greater acceptability., Post-Treatment (8 weeks post loss)

Oregon Research Behavioral Intervention Strategies, Inc.

ALL

CHILD, ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

MH126788

2021-02-01

2023-09-12

2023-09-30

2022-04-08

2023-12-06

Oregon Research Behavioral Intervention Strategies, Inc., Springfield, Oregon, 97477, United States

{ "Walk with Me": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03749187

BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas

https://clinicaltrials.gov/study/NCT03749187

PNOC017

RECRUITING

This phase I trial studies the side effects and best dose of BGB-290 and temozolomide in treating adolescents and young adults with IDH1/2-mutant grade I-IV glioma that is newly diagnosed or has come back. BGB-290 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BGB-290 and temozolomide may work better in treating adolescents and young adults with IDH1/2-mutant grade I-IV glioma.

NO

Glioblastoma|IDH1 Gene Mutation|IDH2 Gene Mutation|Low Grade Glioma|Malignant Glioma|Recurrent Glioblastoma|Recurrent WHO Grade II Glioma|Recurrent WHO Grade III Glioma|WHO Grade II Glioma|WHO Grade III Glioma

DRUG: PARP Inhibitor BGB-290|DRUG: Temozolomide

Proportion of participants with Dose Limiting Toxicities (DLTs), Events occurring on or after treatment on Day 1 will be classified using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events leading to treatment discontinuation will be listed., Up to 28 days

Progression free survival (PFS), The analyses of PFS will include patients who have received any amount of study treatment. PFS is defined as the time from the first day of study treatment with until documented disease progression or death, whichever occurs first. For patients who do not have documented progressive disease (PD) or death before the end of the study or who are lost to follow-up, PFS will be censored at the day of the last clinical assessment. Data will be summarized by Kaplan-Meier method., Up to 5 years|Overall survival (OS), The analyses of OS will include patients who have received any amount of study treatment. OS is defined as the time from the first dose of study treatment to the time of death from any cause on study. For patients who do not die before the end of the study or who are lost to follow-up, OS will be censored at the date of last contact. Data will be summarized by Kaplan-Meier method., Up to 5 years

University of California, San Francisco

BeiGene USA, Inc.|Pacific Pediatric Neuro-Oncology Consortium

ALL

CHILD, ADULT

PHASE1

OTHER

INTERVENTIONAL

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

18083|NCI-2018-02345|PNOC017

2019-04-03

2024-06-30

2029-07-30

2018-11-21

2024-05-20

Childrens Hospital Los Angeles, Los Angeles, California, 90027, United States|Rady Childrens Hospital - San Diego, San Diego, California, 92123, United States|University of California, San Francisco, San Francisco, California, 94143, United States|Yale University, New Haven, Connecticut, 06520, United States|Childrens National Medical Center, Washington, District of Columbia, 20010, United States|University of Florida Health Science Center - Gainesville, Gainesville, Florida, 32610, United States|Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, 21287, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Nationwide Childrens Hospital, Columbus, Ohio, 43205, United States|Oregon Health and Science University, Portland, Oregon, 97239, United States|Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|St. Jude Childrens Research Hospital, Memphis, Tennessee, 38105, United States|Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112, United States

{ "PARP Inhibitor BGB-290": [ { "intervention_type": "DRUG" } ], "Temozolomide": [ { "intervention_type": "DRUG", "description": "Temozolomide", "name": "Temozolomide", "synonyms": [ "Temozolomide", "Temodar", "Methazolastone", "3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide", "Temozolomida", "CCRG 81045", "Temozolomidum", "Temcad", "TMZA-HE", "3-methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide", "8-Carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one", "B-39831", "Temozolodida", "3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide", "(S)-perillyl alcohol temozolomide", "T\u00e9mozolomide", "TMZ", "Temodal", "Temozolomid", "8-carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one" ], "medline_plus_id": "a613002", "generic_names": [ "Temozolomide" ], "mesh_id": "D018906", "drugbank_id": "DB00853", "wikipedia_url": "https://en.wikipedia.org/wiki/Temozolomide" } ] }

NCT00587587

A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids

https://clinicaltrials.gov/study/NCT00587587

COMPLETED

This pilot study will assess the safety and efficacy of Apligraf in the healing and recurrence of keloids post surgical shave excision in patients with clinically diagnosed keloids.

YES

Keloid

DEVICE: Apligraf|OTHER: Standard dressing regimen

The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented., Summary of all reported adverse events (AE) in the intent to treat (ITT) population. AE was defined as any adverse change in the subjects medical status compared with the subjects baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subjects pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study., 52 weeks

Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS), Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported. BSS is a composite score where the individual scores from the following categories are summed: Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]). Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar)., Baseline to Week 52 or Last Visit|Cumulative Incidence of Keloid Recurrence at Week 52, Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome., 52 weeks|Degree of Recurrence (Scar Firmness), Scar firmness measured by Cutometer in millimeters., Week 52 or Last Visit|Degree of Recurrence (Scar Thickness), Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin., Week 52 or Last visit|Physician Global Assessment, Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor), Week 52 or Last Visit|Subject Global Assessment, Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor), Week 52 or Last Visit|Decreased Utilization of Intralesional Steroid Intervention, The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome., 52 weeks

Organogenesis

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

06-KEL-001-AG

2007-12

2010-03

2010-03

2008-01-07

2011-08-19

2011-08-19

University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology, Miami Beach, Florida, 33140, United States

{ "Apligraf": [ { "intervention_type": "DEVICE" } ], "Standard dressing regimen": [ { "intervention_type": "OTHER" } ] }

NCT01952587

X-linked Biological Response to HIV Sensing: the ANRS EP 53 Study

https://clinicaltrials.gov/study/NCT01952587

X LIBRIS

COMPLETED

Short title : X-linked biological response to HIV sensing: the ANRS EP 53 study. Main outcome : To demonstrate that HIV-infected women carry the TLR7 c.32A>T SNP at a higher frequency than uninfected women, arguing in favor of a role of impaired production of IFN-alpha by pDCs in the risk of becoming infected by HIV-1. Secondary outcome : To directly demonstrate at a single cell level that the TLR7 c.32A>T SNP is responsible for a reduce production of IFN-alpha by pDCs after activation of TLR7 by HIV-1 RNA. Short abstract (public dissemination) : Male and female display some differences in how their immune system responds to pathogens. This could be related to hormonal or genetic factors located on the X chromosome. This project aims at characterizing X-linked factors that can influence the innate immune response to HIV-1.

NO

Hiv Infection

BIOLOGICAL: A peripheral blood sample

Frequency (%) of subjects carrying the TRL7 c.32A>T SNP in HIV-infected and healthy women, arguing in favor of role of impaired production of IFN alpha by pDCs in the risk of becoming infected by HIV 1, day 1

Frequency (%) of cells expressing the A and T alleles of TRL7 in interferon-alpha producing cells, day 1 and month 3

ANRS, Emerging Infectious Diseases

FEMALE

ADULT, OLDER_ADULT

OTHER_GOV

INTERVENTIONAL

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

ANRS EP 53 X LIBRIS|2013-A00954-41

2013-11

2015-06

2015-06

2013-09-30

2015-07-01

Purpan Hospital, Toulouse, France

{ "A peripheral blood sample": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT03580187

Nebulized Morphine in Chest Trauma Patients: A Prospective Study

https://clinicaltrials.gov/study/NCT03580187

COMPLETED

This is a prospective study carried out from 2018 to 2020 including patients aged ≥ 18 years, admitted for isolated chest trauma. Each patient received a nebulization of 10 mg morphine. If Visual Analog Score (VAS) assessed after 10 minutes still> 4, nebulization was repeated every 10 minutes until pain relief. At 30 minutes, VAS> 4 means failure.

NO

Blunt Injury of Thorax

DRUG: Morphine (+)

analgesia evaluated with visual scale, morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization, 30 minuts

University Hospital, Mahdia

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

NMCT/1

2018-06-14

2020-04-15

2020-04-15

2018-07-09

2022-09-23

Mahdia Hospital, Mahdia, 5180, Tunisia

{ "Morphine": [ { "intervention_type": "DRUG", "description": "Morphine (+)", "name": "Morphine", "synonyms": [ "Anhydrous morphine", "Morphium", "MXL", "Morphine Chloride", "SDZ 202250", "Arymo", "Morphin", "(5\u03b1,6\u03b1)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "Contin, MS", "Morfina", "SDZ 202 250", "(5R,6S,9R,13S,14R)-4,5-epoxy-N-methyl-7-morphinen-3,6-diol", "(7R,7AS,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1H-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol", "(5\u03b1,6\u03b1)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Sevredol", "Oramorph", "SDZ202-250", "Morphine Sulfate (2:1), Anhydrous", "Chloride, Morphine", "Morphine", "Roxanol-T", "Morphgesic", "Oramorph SR", "Morphine Sulfate", "Morphia", "Astramorph", "Zomorph", "(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Infumorph", "MS Contin", "Sulfate, Morphine", "Morphine Sulfate (2:1), Pentahydrate", "Morphinum", "RMS", "MST", "Kadian", "Duramorph", "SDZ 202-250", "SDZ202250", "SDZ202 250", "(5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "(\u2212)-morphine" ], "medline_plus_id": "a606006", "generic_names": [ "Morphine" ], "nhs_url": "https://www.nhs.uk/medicines/morphine", "mesh_id": "D009294", "drugbank_id": "DB00295" } ] }

NCT05514587

Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)

https://clinicaltrials.gov/study/NCT05514587

MSVCAC

COMPLETED

Suicide is the highest mortality risk in psychiatry and about the only life-threatening risk associated with the evolution of mental illness. Worldwide, more than 800,000 people die by suicide each year. Although the number of deaths by suicide has decreased in France (from 11,000 in the 1990s to 9,000 today), suicide is still a major public health problem (the French rate is one of the highest in Europe). The World Health Organisation (WHO) has declared a state of emergency and is pushing each country to develop a global multisectoral strategy for effective suicide prevention. To this end, suicide risk assessment tools have been developed for predictive purposes. However, diagnosis remains difficult and the risk of recidivism remains the fear of the psychiatrist. Questioning the subjects about their vision of their existence and the meaning they give to their life would perhaps help to better understand the psychology of the suicidal person. In recent decades, there has been research on meaning and suicide, and more recently a few studies have attempted to quantitatively investigate meaning as a protective factor. More recently, the COVID epidemic has brought the issue of meaning and suicide prevention to the forefront.

NO

Suicide|Mental Suffering|Meaning of Life|Questionnaire

BEHAVIORAL: Meaning of Life Questionnaire (MLQ)

Psychometric validation of the French translation of Stegers Meaning in Life Questionnaire (MLQ) in adult patients admitted to the Crisis Centre (CAC), The Meaning of Life Questionnaire (MLQ) measures the presence of meaning in life, that is the subjective sense that ones life is meaningful, and the search for meaning in life, reflecting ones drive and orientation toward finding such meaning., 3 months

Convergent validity of MLQ with Becks hopelessness scale (BHS) in adult patients admitted to the Crisis Centre (CAC), Becks hopelessness scale (BHS) : 20 items, self-report scale, assesses current mental state with regard to thoughts about the future, motivation and expectations., 3 months|Convergent validity of MLQ with Beck Suicide Intent Scale (BSI) in adult patients admitted to the Crisis Centre (CAC), Beck Suicide Intent Scale (BSI): 20 items, assesses suicidal intent of the most recent episode of self-harm, 3 months|Convergent validity of MLQ with Satisfaction with Life Scale (SWLS) in adult patients admitted to the Crisis Centre (CAC), The Satisfaction with Life Scale (SWLS) is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with ones life. The scale usually requires only about one minute of a respondents time., 3 months|Convergent validity of MLQ with Satisfaction with Beck Depression Inventory Short Form (BDI-SF) in adult patients admitted to the Crisis Centre (CAC), The Beck Depression Inventory Short Form (BDI-SF, BDI-13) consists of 13 items assessing the severity of depression symptoms., 3 months

Centre Hospitalier Régional Metz-Thionville

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2022-01Obs-CHRMT

2022-09-29

2023-06-15

2023-09-15

2022-08-24

2023-11-07

Centre Hospitalier Jury, Metz, 57073, France|CHR Metz-Thionville/Hopital de Mercy, Metz, 57085, France

{ "Meaning of Life Questionnaire (MLQ)": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02016287

Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer

https://clinicaltrials.gov/study/NCT02016287

UNKNOWN

Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and majority of them were intolerable to combined chemotherapy in China. In the investigators phase II clinical trial proceeded before, the paclitaxel treatment showed good tolerance and efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (CTV) are not internationally defined. The investigators then initiated a prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in elderly metastatic esophageal carcinoma to observe the efficacy and safety of the combination.

NO

Esophageal Squamous Cell Cancer|Elderly Patients

OTHER: Sequential chemotherapy （paclitaxel 80mg/m2 d1,d8) and radiotherapy

progression free survival, the follow-up visit of PFS will be performed every 2 cycles, 1 year

overall survival, OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost, 2 years

disease control rate, 1 year|adverse events, 2 years|quality of life, 2 years

Shen Lin

ALL

OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

CGOG7002|CGOG7002

2013-12

2015-12

2016-07

2013-12-19

2013-12-19

Peking University Cancer Hospital, Beijing, Beijing, 100142, China

{ "Sequential chemotherapy \uff08paclitaxel 80mg/m2 d1,d8) and radiotherapy": [ { "intervention_type": "OTHER" } ] }

NCT01578187

Hair2Go Label Comprehension and Usability Study

https://clinicaltrials.gov/study/NCT01578187

OHR6-LCU

COMPLETED

The purpose of this study is to test label comprehension and usability of the hair removal device in 60 male and female participants. The study population will represent the US demographic distribution of skin types and will include varying levels of literacy.

YES

Hair Removal

DEVICE: Hair2Go

Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders), Label comprehension will be based on responses to a questionnaire. Questions will be based on a tiered system by level of importance in responding correctly according to the following: 1. Questions regarding safe use of the system. 2. Questions regarding correct use of the system(not related to safety). In order to demonstrate how well the label instruction, as a whole, was understood by all subjects, the proportion of subjects who correctly understood the label as a whole was calculated by classifying each subject as either a responder or non-responder based on the following criteria regarding all questions: A subject was considered a responder if he/she correctly answered 11/12 questions related to safety AND 5/6 low category questions not related to safety. The study was considered a success if the response rate (i.e., the proportion of subjects correctly understanding the label based on the responder criteria) was at least 90%., 1 hour|Percentage of Participants Performing Critical/Non-critical Errors, Study staff will record the number of errors according to the following: 1. Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence 2. Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event., 1-2 hours

Syneron Medical

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

OHR6-LCU

2012-03

2012-04

2012-06

2012-04-16

2013-10-11

2013-12-25

Consumer Product Testing Company, Fairfield, New Jersey, 07004, United States

{ "Hair2Go": [ { "intervention_type": "DEVICE" } ] }

NCT04664387

Somatic Symptom Disorders in Patients With Myocardial Bridge

https://clinicaltrials.gov/study/NCT04664387

COMPLETED

The purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with myocardial bridge and to describe the relationship between clinical features and the occurrence of somatic disorder.

NO

Myocardial Bridge|Somatic Symptom Disorder

DIAGNOSTIC_TEST: coronary angiography

the score of Somatic Symptom Scale-China (SSS-CN), to compare the score of Somatic Symptom Scale-China questionnaire between patients with and without myocardial bridge. SSS-CN is a self-administered questionnaire with 20 items and scoring 1, 2, 3, 4 to each item. The total score is from 20 to 80. The higher the score is, the higher frequency that the symptoms presented., within 24 hours before the coronary angiography.

RenJi Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

SSSCN202010

2016-10-30

2020-05-08

2020-05-08

2020-12-11

2022-11-17

Renji Hospital, Shanghai, 200127, China

{ "coronary angiography": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT00113087

Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network

https://clinicaltrials.gov/study/NCT00113087

ISV

COMPLETED

This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental and functional status, ventricular geometry, function, and atrioventricular (AV) valve regurgitation. In addition, the study will determine the relationship between genetic polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I therapy and compare the incidence of adverse events in subjects treated with ACE-I with those in subjects treated with placebo.

YES

Heart Defects, Congenital|Heart Failure, Congestive

DRUG: Enalapril|DRUG: Placebo

Weight-for-age Z-score at 14 Months of Age, Weight-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of weight z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values), Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age

Height-for-age Z-score, Height-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of height z-score at age 14 months based on longitudinal modeling (adjusted bor baseline value), Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|Head Circumference-for-age Z-score, Head circumference-for-age z-score at 14 months of age.In primary analysis outcome is defined as predicted mean of Head circumference z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values), Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|Number of Participants With Ross Heart Failure Class I, Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise., Just prior to the pre-Glenn surgery|Number of Participants With Ross Heart Failure Class I, Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise., Measured at 14 months of age|B-Type Natriuretic Peptide, B-Type Natriuretic Peptide (BNP) level., Measured just prior to the Glenn surgery|B-type Natriuretic Peptide Level, B-type natriuretic peptide (BNP) level., at the time of the 14 month visit|Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score, Neurodevelopmental status (PDI): the Bayley Scales of Infant Development: Psychomotor Development index z-score ., at 14 months of age|Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score, Neurodevelopmental status(MDI):Bayley Scales of infant development, Mental Developmental Index z-score ., at 14 months of age|Neurodevelopmental Status (FSII), Functional status II (Revised) Total Score. Scale ranges up to 100.00, the higher the better. The score presents an instrument for assessing health status for children surviving long term with chronic physcial disorders., at 14 months of age|MacArthur-Bates Inventory -Phrases Understood, MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score., at 14 months of age|MacArthur-Bates Inventory -Words Understood, MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score., at 14 months of age|MacArthur-Bates Inventory -Total Gestures, MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score., at 14 months of age|MacArthur-Bates Inventory -Words Produced, MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score., at 14 months of age|Ejection Fraction (%), Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction % is defined as the percentage of the stroke volume (i.e. difference between end-diastolic and end-systolic volumes) in a ventricle relative to end-diastolic volume., just before the Glenn surgery|Ejection Fraction (%), Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction (%) is defined as percentage of stroke volume of a ventricle (i.e. the difference between end diastolic and end systolic volumes)relative to end diastolic volume., at 14 months of age|Ventricular Mass, Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment., just before the Glenn surgery|Ventricular Mass, Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40, At 14 months of age|Ventricular Mass Z-score, Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment., just before the Glenn surgery|Ventricular Mass Z-score, Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment., at 14 months of age|End-diastolic Volume, Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment., just before the Glenn surgery|End-diastolic Volume, Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment., at 14 months of age|End Diastolic Volume Z-score, Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment., just before the Glenn surgery|End-diastolic Volume Z-score, Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment., at 14 months of age|Ventricular Mass to Volume Ratio, Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment., Measured just before the Glenn surgery|Ventricular Mass to Volume Ratio, Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment., Measured at 14 months of age|Ventricular Filling Pressure, Ventricular filling pressure measured by catherization, just before the Glenn surgery|Number of Participants With Moderate to Severe AV Valve Regurgitation, Number of participants with Moderate to severe AV valve regurgitation., just before the pre-Glenn surgery|Number of Participants With Moderate to Severe AV Valve Regurgitation, Number of participants with moderate to severe AV valve regurgitation., at age 14 months

National Heart, Lung, and Blood Institute (NHLBI)

Pediatric Heart Network

ALL

CHILD

PHASE3

NIH

INTERVENTIONAL

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

177|U01HL068270|U01HL068279|U01HL068281|U01HL068285|U01HL068288|U01HL068290|U01HL068292|U01HL068269

2003-08

2008-07

2008-07

2005-06-06

2010-09-16

2010-09-28

Childrens Hospital Boston, Boston, Massachusetts, 02115, United States|Columbia College of Physicians and Surgeons, New York, New York, 10032, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Primary Childrens Hospital, Salt Lake City, Utah, 84113, United States|Childrens Hospital of Wisconsin, Milwaukee, Wisconsin, 53226, United States|Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada

{ "Enalapril": [ { "intervention_type": "DRUG", "description": "Enalapril", "name": "Enalapril", "synonyms": [ "Maleate, Enalapril", "MK421", "(S)-1-{(S)-2-[1-((S)-Ethoxycarbonyl)-3-phenyl-propylamino]-propionyl}-pyrrolidine-2-carboxylic acid", "Enalaprilum", "Vasotec", "MK-421", "Renitec", "MK 421", "Enalapril Maleate", "Renitek", "\u00e1nalapril", "(S)-1-(N-(1-(ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-L-proline", "Enacard", "Enalaprila", "Innovace", "Enalapril", "[http://zada.ba/en/proizvod/kadril-en/ Kadril]", "1-(N-((S)-1-carboxy-3-phenylpropyl)-L-alanyl)-L-proline 1'-ethyl ester", "", "MK-422", "Enalaprilat Anhydrous", "1-(N-((S)-1-Carboxy-3-phenylpropyl)-L-alanyl)-L-proline dihydrate", "MK422", "Enalaprilat, (R)-Isomer, Anhydrous", "Vasotec", "Enalaprilic Acid", "Enalaprilat Citrate, Anhydrous", "Xanef", "MK 422", "Pres iv", "Enalaprilat", "Enalaprilat Dihydrate", "Enalaprilat anhydrous", "", "MK-422", "Enalaprilat Anhydrous", "1-(N-((S)-1-Carboxy-3-phenylpropyl)-L-alanyl)-L-proline dihydrate", "MK422", "Enalaprilat, (R)-Isomer, Anhydrous", "Vasotec", "Enalaprilic Acid", "Enalaprilat Citrate, Anhydrous", "Xanef", "MK 422", "Pres iv", "Enalaprilat", "Enalaprilat Dihydrate", "Enalaprilat anhydrous" ], "medline_plus_id": "a686022", "generic_names": [ "Enalapril", "Enalaprilat", "Enalaprilat" ], "nhs_url": "https://www.nhs.uk/medicines/enalapril", "mesh_id": "D000959", "drugbank_id": "DB00584", "wikipedia_url": "https://en.wikipedia.org/wiki/Enalapril" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT02895087

Study to Explore Natural Daily Variation and Impact of Stress in HIV Levels

https://clinicaltrials.gov/study/NCT02895087

CHRONOS

COMPLETED

Despite advances in AntiRetroviral Therapy (ART) leading to a rapid control of the HIV virus in individuals affected, HIV can persist indefinitely and there is no cure. The HIV virus has been shown to have a unique ability to hide within the human gene inside human cells and in tissues, remaining silent and rapidly reactivate waking up if ART is stopped. There are a number of ways to measure the silent HIV reservoir, including a common research-based laboratory test called Cell-Associated UnSpliced (CA-US) HIV RNA. This is an early marker of the HIV virus waking up. It is often used to test how well new drugs developed to eliminate the silent virus might work. This study is examining whether the diurnal variation (daily rhythm) and/or stress can affect CA-US HIV RNA levels in individuals diagnosed with HIV and receiving ART.

NO

HIV

OTHER: Diurnal Variation Group|OTHER: External Stress Group

Diurnal variation effects on HIV transcription, To determine if there are diurnal variations in cortisol and catecholamine in HIV transcription in latently-infected cells in HIV-infected participants on ART., 24 hours|Stress Factor effects on HIV transcription, To determine the effects of stress-induced changes in cortisol and catecholamine on HIV transcription, in latently infected cells in HIV-infected participants on ART., Baseline (visit 1) and visit 2 (approximately 1 - 7 days later)

University of Melbourne

University of California, San Francisco

MALE

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

U19AI096109

2015-03

2017-01

2018-01

2016-09-09

2021-11-04

Osher Center, University of California San Francisco, San Francisco, California, 94115, United States|Division of Infectious Diseases, Milwaukee, Wisconsin, 53226, United States

{ "Diurnal Variation Group": [ { "intervention_type": "OTHER" } ], "External Stress Group": [ { "intervention_type": "OTHER" } ] }

NCT04435587

Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection

https://clinicaltrials.gov/study/NCT04435587

IDRA-COVID19

UNKNOWN

This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.

NO

Asymptomatic Infections|SARS-CoV2 Infection

DRUG: Ivermectin Pill|DRUG: Combined ART/hydroxychloroquine

Adverse event rates, Comparison of adverse event rates between treatment arms, after first dose until day 28 of follow up|Efficacy for shortening duration of SAR-CoV2 detection by PCR, comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm, weekly after treatment until 4th week

Antibody detection rates, comparison of median duration for total antibody detection in each arm, weekly after treatment until 4th week

Mahidol University

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

323/2563 (IRB3)

2020-07-13

2021-06

2021-11

2020-06-17

2021-01-11

Siriraj Hospital, Bangkok Noi, Bangkok, 10700, Thailand|Siriaj Hospital, Bangkok, N/A = Not Applicable, 10700, Thailand|Sireethorn Nimitvilai, Amphoe Maueng, Nakhonpathom, 73000, Thailand|Golden Jubilee Medical Center, Phutthamonthon District, Nakhonpathom, 73170, Thailand

{ "Ivermectin": [ { "intervention_type": "DRUG", "description": "Ivermectin Pill", "name": "Ivermectin", "synonyms": [ "Stromectol", "Ivomec", "Ivermectine", "MK933", "Eqvalan", "MK-933", "Ivermectina", "Ivermectinum", "MK 933", "Sklice", "Ivermectin", "Mectizan" ], "medline_plus_id": "a613011", "generic_names": [ "Ivermectin" ], "mesh_id": "D007306", "drugbank_id": "DB00602" } ], "Combined ART/hydroxychloroquine": [ { "intervention_type": "DRUG" } ] }

NCT04629287

Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

https://clinicaltrials.gov/study/NCT04629287

UNKNOWN

to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects

NO

Healthy

DRUG: KPCXM18|DRUG: Placebo

Number of subjects with abnormal vital signs, To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs, through study completion, an average of 2 week|Number of subjects with abnormal laboratory, To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory, through study completion, an average of 2 week|Number of subjects with abnormal physical examination, To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal physical examination, through study completion, an average of 2 week|Number of subjects with abnormal electrocardiogram, To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal electrocardiogram, through study completion, an average of 2 week|Number of subjects with adverse events, To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal adverse events, through study completion, an average of 2 week

Pharmacokinetics of KPCXM18 in plasma: Cmax, To characterize the pharmacokinetic parameters：Cmax of KPCXM18 after the first day administer, Time Frame: Between Day 1 to 7 days|Pharmacokinetics of KPCXM18 in plasma: Tmax, To characterize the pharmacokinetic parameters：Tmax of KPCXM18 after the first day administer, Time Frame: Between Day 1 to 7 days|Pharmacokinetics of KPCXM18 in plasma: AUC0-∞, To characterize the pharmacokinetic parameters： AUC0-∞ of KPCXM18 after the first day administer, Time Frame: Between Day 1 to 7 days|Pharmacokinetics of KPCXM18 in plasma:t1/2, To characterize the pharmacokinetic parameters： t1/2 of KPCXM18 after the, Time Frame: Between Day 1 to 7 days|Pharmacokinetics of KPCXM18 in plasma: Cmax,ss, To characterize the pharmacokinetic parameters：Cmax,ss of KPCXM18 after the 14th day administer, Time Frame: Between Day 1 to 14 days|Pharmacokinetics of KPCXM18 in plasma: AUC0-∞,ss, To characterize the pharmacokinetic parameters：AUC0-∞,ss of KPCXM18 after the 14th day administer, Time Frame: Between Day 1 to 14 days|Pharmacokinetics of KPCXM18 in plasma: Tmax,ss, To characterize the pharmacokinetic parameters：Tmax,ss of KPCXM18 after the 14th day administer, Time Frame: Between Day 1 to 14 days

Kunming Pharmaceuticals, Inc.

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

KPCXM18/C101|CTR20202022

2020-11

2021-12

2022-02

2020-11-16

2020-11-19

{ "KPCXM18": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT06133387

PARADIGM - En Bloc Trial With the EndoQuest ELS System

https://clinicaltrials.gov/study/NCT06133387

NOT_YET_RECRUITING

The objective of this study is to evaluate the safety and effectiveness of the EndoQuest Robotics Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo partial thickness resection with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon (up to 7 cm in size and up to 75% of the colorectal circumference). The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.

NO

Colorectal Lesions

DEVICE: ELS System

En Bloc Resection Rate, The percentage of target lesions across all subjects that are excised in a single specimen on Day 0., 1 day

EndoQuest Robotics, Inc.

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

CIP-0001-Rev A

2024-04-15

2024-11-30

2024-12-31

2023-11-15

2023-11-15

{ "ELS System": [ { "intervention_type": "DEVICE" } ] }

NCT04946487

Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery

https://clinicaltrials.gov/study/NCT04946487

UNKNOWN

To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF)

NO

Lumbar Spinal Stenosis

PROCEDURE: total laminectomy

the Incidences of adjacent segment degeneration, the Incidences of adjacent segment degeneration, From the end of treatment to more than 8 years

Peking University Third Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

M2019232

2021-07-01

2022-12-30

2022-12-30

2021-06-30

2021-06-30

{ "total laminectomy": [ { "intervention_type": "PROCEDURE" } ] }

NCT01088087

Effect of Colostrum on Gut Permeability and Endotoxin Level in Chronic Alcoholic Disease

https://clinicaltrials.gov/study/NCT01088087

UNKNOWN

Chronic alcohol ingestion is related with leaky gut syndrome. Colostrum is well-studied that it has a effect of decreasing the degree of leaky gut syndrome. So the investigators are planning to find out whether Colostrum has a effect of decreasing the degree of leaky gut syndrome.

NO

Leaky Gut Syndrome

DIETARY_SUPPLEMENT: colostrum

endotoxin, 1st visit and 3 weeks after 1st visit

lactulose/mannitol ratio, 3 weeks

Gangnam Severance Hospital

Cell Biotech Co., Ltd.

MALE

ADULT, OLDER_ADULT

PHASE2|PHASE3

OTHER

INTERVENTIONAL

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

GangnamSH

2010-03

2010-09

2010-12

2010-03-17

2010-03-17

Gangnam Severance Hospital : Family medicine department, Seoul, Korea, Republic of

{ "colostrum": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT00287287

REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas

https://clinicaltrials.gov/study/NCT00287287

COMPLETED

The primary objective of the study is to assess the anti-tumor activity of REVLIMID® (lenalidomide), administered as a single agent, in patients with distantly metastatic thyroid carcinomas which are unresponsive to systemic radioiodine, in terms of tumor response and response duration.

YES

Thyroid Neoplasms

DRUG: Lenalidomide

Response Rate, Percentage of patients who responded to treatment (either stable disease or complete response) based on total tumor volume measurements from CT scans., 4 years

Kenneth Ain

Celgene Corporation

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

05-701-F3R

2006-02

2010-07-06

2010-07-06

2006-02-06

2020-06-12

2020-06-12

University of Kentucky Markey Cancer Center, Lexington, Kentucky, 40536, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT00287287/Prot_SAP_000.pdf

{ "Lenalidomide": [ { "intervention_type": "DRUG", "description": "Lenalidomide", "name": "Lenalidomide", "synonyms": [ "Revimid", "CC-5013", "Lenalidomida", "CC5013", "Revlimid", "3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione", "IMiD3 Cpd", "2,6-Piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H- isoindol-2-yl)-", "1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline", "CC 5013", "Lenalidomide" ], "medline_plus_id": "a608001", "generic_names": [ "Lenalidomide" ], "mesh_id": "D020533", "drugbank_id": "DB00480" } ] }

NCT02527187

Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

https://clinicaltrials.gov/study/NCT02527187

T502

COMPLETED

The main objective is to evaluate the concentration of allergen extract of Betula verrucosa that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride 10 mg / ml in size.

YES

Immune System Diseases

BIOLOGICAL: 10 HEP/mL Betula verrucosa allergen extract|BIOLOGICAL: 25 HEP/mL Betula verrucosa allergen extract|BIOLOGICAL: 50 HEP/mL Betula verrucosa allergen extract|BIOLOGICAL: 100 HEP/mL Betula verrucosa allergen extract

Sensitivity for 100 HEP/mL, Sensitivity for 100 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease, 1 hour|Sensitivity for 50 HEP/mL, Sensitivity for 50 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease, 1 hour|Sensitivity for 25 HEP/mL, Sensitivity for 25 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease, 1 hour|Sensitivity for 10 HEP/mL, Sensitivity for 10 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease, 1 hour|Specificity for 100 HEP/mL, Specificity for 100 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease., 1 hour|Specificity for 50 HEP/mL, Specificity for 50 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease., 1 hour|Specificity for 25 HEP/mL, Specificity for 25 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease., 1 hour|Specificity for 10 HEP/mL, Specificity for 10 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease., 1 hour

Inmunotek S.L.

ALL

CHILD, ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

T502-SSP-007|2013-005368-24

2015-09

2016-04

2016-11

2015-08-18

2022-05-05

2022-05-05

Hospital Lucus Augusti, Lugo, Galicia, 27003, Spain

{ "10 HEP/mL Betula verrucosa allergen extract": [ { "intervention_type": "BIOLOGICAL" } ], "25 HEP/mL Betula verrucosa allergen extract": [ { "intervention_type": "BIOLOGICAL" } ], "50 HEP/mL Betula verrucosa allergen extract": [ { "intervention_type": "BIOLOGICAL" } ], "100 HEP/mL Betula verrucosa allergen extract": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT05003687

Safety and Tolerability of Lu AG06474 in Healthy Young Men

https://clinicaltrials.gov/study/NCT05003687

COMPLETED

The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.

NO

Healthy

DRUG: Lu AG06474|DRUG: Placebo

Parts A and B: Number of participants With Treatment-Emergent Adverse Events, From Baseline to Day 8|Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1, Day 1|Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1, Pre-dose Baseline (Day -1), Day 1|Part A: Bond-Lader VAS Dimension Scores at Day 4, Day 4|Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4, Pre-dose Baseline (Day -1), Day 4|Part A: Percentage of Peripheral Blood Mononuclear Cells (PBMC)-Mediated Hydrolysis of 2-arachidonolylglycerol (2-AG) Ex Vivo (% of Pre-Dose Measurement of Arachidonic Acid [AA]), From pre-dose to Day 4|Parts A and B: AUC0-inf of Lu AG06474, Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf), From pre-dose to Day 4|Parts A and B: Cmax of Lu AG06474, Maximum observed plasma concentration for Lu AG06474, From pre-dose to Day 4|Parts A and B: Tmax of Lu AG06474, Nominal time corresponding to the occurrence of Cmax of Lu AG06474, From pre-dose to Day 4|Part A: t1/2 of Lu AG06474, Apparent elimination half-life of Lu AG06474, From pre-dose to Day 4

H. Lundbeck A/S

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

19702A

2021-08-04

2022-12-22

2022-12-22

2021-08-12

2023-01-09

Quotient Sciences Miami, Miami, Florida, 33126, United States

{ "Lu AG06474": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT00237887

Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

https://clinicaltrials.gov/study/NCT00237887

COMPLETED

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis

NO

Psoriasis

DRUG: adalimumab

Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score, Week 16

Safety parameters

Abbott

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

M03-656

2004-12

2005-10-13

2007-08-29

{ "Adalimumab": [ { "intervention_type": "DRUG", "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" } ] }

NCT04887987

Effects of Lumbar Strengthening Training Plus Photobiomodulation on Non-specific Low-back Pain.

https://clinicaltrials.gov/study/NCT04887987

COMPLETED

The present project aims to investigate the effects of lumbar strengthening training combined with photobiomodulation therapy (PBMT) on functional and psychological aspects in young and older adults with chronic non-specific low back pain. We hypothesized that lumbar strengthening training combined with PBMT should promote greater improvement on functional and psychological variables compared to strengthening training alone (placebo PBMT).

NO

Strengthening Training|Photobiomodulation|Low Back Pain|Quality of Life|Kinesiophobia

RADIATION: strengthening training and LED PBMT|RADIATION: strengthening training and placebo PBMT

Change in postural balance, Postural balance will be assessed on a force platform at pre- and post-training, Baseline and after 8 weeks|Change in low back pain, Low back pain will be assessed with a visual analogue scale (VAS) at pre- and post-training, Baseline and after 8 weeks

Tampa Scale of kinesiophobia (TSK), The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or injury., Baseline and after 8 weeks|Fear-Avoidance Beliefs Questionnaire (FABQ), The FABQ is a patient reported questionnaire which specifically focuses on how a patients fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability., Baseline and after 8 weeks|Pain Catastrophizing Scale (PCS), PCS is a instrument used for measuring catastrophic thinking related to pain., Baseline and after 8 weeks|Oswestry Disability Index (ODI), ODI is a questionnaire used to assess the subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain., Baseline and after 8 weeks|Roland Morris Disability Questionnaire (RMDQ), RMDQ questionnaire is designed to assess self-rated physical disability caused by low back pain, Baseline and after 8 weeks

Universidade Norte do Paraná

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

Photobiomodulation project

2022-02-01

2022-07-30

2022-11-30

2021-05-17

2023-09-13

Universidade Norte do Paraná, Londrina, Paraná, 86.041-140, Brazil

{ "strengthening training and LED PBMT": [ { "intervention_type": "RADIATION" } ], "strengthening training and placebo PBMT": [ { "intervention_type": "RADIATION" } ] }

NCT05727787

vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC

https://clinicaltrials.gov/study/NCT05727787

vGRID SBRT

RECRUITING

This trial will provide the maximum tolerated dose for radiation therapy for liver tumors and describe the toxicity profile using the vGRID therapy technique. Based on trials using this type of radiation in other cancers demonstrating low toxicity rates even with very high radiation doses and high efficacy, it is likely that vGRID therapy in this trial will be well tolerated and allow dose escalation beyond currently common doses for liver tumors.

NO

Liver Cancer

RADIATION: Stereotactic Body Radiation Treatment

Maximum tolerated dose (MTD) of Single Fraction GRID SBRT, Safely identify MTD of Single Fraction GRID SBRT and CTCAE v5.0 related toxicity: Irreversible grade 3 hepatotoxicity, grade 4 or 5 hepatotoxicity, grade 4 or 5 gastrointestinal toxicity., First day of post-GRID SBRT through 3 month post-radiation

Local control utilizing RECIST v1.1 for HCC., Local control (irradiated tumor) utilizing modified RECIST criteria for HCC., End of treatment through 3 month post-radiation|Regional failure utilizing RECIST v1.1 for HCC., Regional failure (intrahepatic non-irradiated progression) utilizing modified RECIST criteria for HCC., End of treatment through 3 month post-radiation|Progression free survival (PFS), Progression free survival (PFS), defined as the time from dose level assignment to the first occurrence of disease progression or death from any cause up to 3 months after the end of immunotherapy treatment (disease progression is determined by the investigator according to RECIST v1.1), Enrollment through 3-months after end of immunotherapy treatment|Time to Progression (TTP), Time to Progression (TTP), defined as the time from dose level assignment to the first occurrence of disease progression (disease progression is determined by the investigator according to RECIST v1.1), Enrollment through 3-months after end of immunotherapy treatment|Molecular correlatives: TCR repertoire analysis., T cell receptor Beta Chain sequencing to evaluate TCR repertoire expansion, Pre-vGRID vs Day 7-12 after vGRID (day 0) and 4-8 weeks after vGRID

University of Kansas Medical Center

Varian Medical Systems

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

IIT-2021-GRID-SBRT-HCC

2023-02-23

2025-02-28

2025-02-28

2023-02-14

2023-12-21

University of Kansas Medical Center, Kansas City, Kansas, 66160, United States

{ "Stereotactic Body Radiation Treatment": [ { "intervention_type": "RADIATION" } ] }

NCT04947787

Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System

https://clinicaltrials.gov/study/NCT04947787

BewegtVersorgt

RECRUITING

The BewegtVersorgt project involved co-producing a physical activity referral scheme (PARS) for inactive persons with underlying non-communicable diseases. Various relevant actors of the German healthcare system (e.g., representatives of physicians, health insurance providers, sports organizations, exercise representatives of exercise professions, representatives of patients) participated in the co-production process. The purpose of this study is to evaluate the effectiveness of co-produced PARS in the Erlangen-Nuremberg-Fürth region. Local general practitioners and exercise professionals will carry out the implementation of the PARS in standard care. The cluster-randomized study includes two intervention arms; one group will receive specific support from physical activity experts to increase physical activity (PARS). The control group will receive only the physicians advice and then continue to engage in physical activity on their own (PAA). The participants will be followed up at 12 and 24 weeks.

NO

Non-Communicable Chronic Diseases

BEHAVIORAL: Physical activity referral scheme (PARS)|BEHAVIORAL: Physical activity advice (PAA)

Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire, The Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen; BSA-F) is a German questionnaire that assesses the amount of physical activity during the last four weeks. It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score). Participants are required to report the frequency and duration of activities executed during the last four weeks. Minutes of leisure-time physical activity per week and sport-/exercise-related activity per week are calculated to get the physical activity and the sports score. Both scores can be combined to receive the overall volume of physical activity completed during leisure-time/transportation and sport-/exercise-related activities., Baseline (T0), 12 weeks (T1), and 24 weeks (T2)|Changes in physical activity-related health competence: BGK Questionnaire, This will be measured by the German version of the Physical Activity-Related Health Competence questionnaire. The questionnaire consists of 44 total items that measure three sub-competencies necessary for a health-promoting physical activity behavior: movement competence (20 items; min = 0, max = 17.6), control competence (10 items; min = 0, max = 10.8), physical activity-related self-regulation competence (14 items; min = 0, max = 14.8). Higher scores indicate higher competencies., Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Changes in quality of life: EuroQol (EQ-5D-5L), The EQ-5D-5L is a self-administered quality of life scale that consists of a descriptive system and a visual analog scale. The descriptive system contains five well-being dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems), each coded with numbers from one to five. The result obtained is a 5-digit code that represents the health state profile of the participant. The visual analog scale assesses the overall current health., Baseline (T0), 12 weeks (T1), and 24 weeks (T2)|Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale), This will be measured by a German instrument (Selbstwirksamkeit zur sportlichen Aktivität; SSA-Scale), including 12 items that assess the confidence someone has to perform a planned physical activity in the face of various conditions that may act as barriers. Each item is scored on a seven-point Likert scale representing the level of confidence from 1 meaning not sure at all and 7 meaning the participant is very confident of performing the physical activity as planned even in the face of a particular challenge. The total scores range from 12 to 84, where the higher the score, the greater the self-efficacy., Baseline (T0), 12 weeks (T1), and 24 weeks (T2)|Changes in participants perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D), We will use the German version of the Health Care Climate Questionnaire (HCCQ-D) to measure the participants perception of autonomy support from the general practitioner. It incorporates 15 statements with seven-point response options that indicate the level of agreement ranging from strongly disagree to strongly agree. Higher scores indicate higher perceived autonomy support., Baseline (T0), 24 weeks (T1; only intervention group)|Changes in stages of change: transtheoretical model (TTM), We will use one German question that is based on the transtheoretical model of behavior change. The five response options represent five stages of change: pre-contemplation, contemplation, preparation, action, and maintenance., Baseline (T0), 12 weeks (T1), and 24 weeks (T2)|Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale), This will be evaluated with the self-administered German scale (Sport- und bewegungsbezogenen Selbstkonkordanz-Skala; SSK-Scale) that measures the self-concordance. The SSK-Scale contains 12 items grouped into four subscales: intrinsic, identified, introjected, and extrinsic motivation. The subscales scores for introjected and extrinsic motivation will be subtracted from the sum of the identified and intrinsic motivation subscales to receive the overall score. Thus, the overall score ranges from minus ten (-10) to ten, where a higher score suggests a higher level of sports- and movement-related self-concordance., Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Experience of participating actors (general practitioners, exercise professionals): (semi-) structured interviews, The (semi-) structured interview is based on RE-AIM and asks specifically about adoption, implementation, and maintenance., Through study completion, an average of 1 year

University of Erlangen-Nürnberg

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

BewegtVersorgt

2022-02-01

2023-12

2023-12

2021-07-01

2022-11-08

Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, 91058, Germany

{ "Physical activity referral scheme (PARS)": [ { "intervention_type": "BEHAVIORAL" } ], "Physical activity advice (PAA)": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT01609387

Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

https://clinicaltrials.gov/study/NCT01609387

COMPLETED

This study is a double blind randomized controlled trial.

NO

Obesity|Vitamin Deficiency

DIETARY_SUPPLEMENT: Fit For me|DIETARY_SUPPLEMENT: Davitamon

Reduction of iron deficiency in obese patients, one year

Reduction of vitamin D and vitamin B12 deficiency, one year

Rijnstate Hospital

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

LTC 745

2011-07

2015-10

2015-12

2012-06-01

2016-05-03

Rijnstate Hospital, Arnhem, Wagnerlaan 55, 6815 AD, Netherlands

{ "Fit For me": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Davitamon": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT00946387

To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions

https://clinicaltrials.gov/study/NCT00946387

COMPLETED

To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under fasting conditions.

NO

Nausea|Vomiting

DRUG: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)|DRUG: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

Bioequivalence based on AUC and Cmax, 9 days

Sandoz

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

B043712

2004-09

2004-09

2004-09

2009-07-27

2017-03-28

{ "Ondansetron": [ { "intervention_type": "DRUG", "description": "Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)", "name": "Ondansetron", "synonyms": [ "4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-", "SN307", "Ondansetron", "ODT, Zofran", "SN-307", "Hydrochloride, Ondansetron", "Zofran ODT", "Ondansetron Monohydrochloride Dihydrate", "Ondansetron, (R)-Isomer", "Ondansetron Hydrochloride", "Zofran", "GR38032F", "Ondansetron Monohydrochloride", "GR 38032F", "Ondansetron, (+,-)-Isomer", "Zuplenz", "Monohydrochloride, Ondansetron", "Monohydrochloride Dihydrate, Ondansetron", "Dihydrate, Ondansetron Monohydrochloride", "SN 307", "GR-38032F", "Ondansetron, (S)-Isomer" ], "medline_plus_id": "a606022", "generic_names": [ "Ondansetron" ], "mesh_id": "D058831", "drugbank_id": "DB00904", "wikipedia_url": "https://en.wikipedia.org/wiki/Ondansetron" }, { "intervention_type": "DRUG", "description": "Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)", "name": "Ondansetron", "synonyms": [ "4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-", "SN307", "Ondansetron", "ODT, Zofran", "SN-307", "Hydrochloride, Ondansetron", "Zofran ODT", "Ondansetron Monohydrochloride Dihydrate", "Ondansetron, (R)-Isomer", "Ondansetron Hydrochloride", "Zofran", "GR38032F", "Ondansetron Monohydrochloride", "GR 38032F", "Ondansetron, (+,-)-Isomer", "Zuplenz", "Monohydrochloride, Ondansetron", "Monohydrochloride Dihydrate, Ondansetron", "Dihydrate, Ondansetron Monohydrochloride", "SN 307", "GR-38032F", "Ondansetron, (S)-Isomer" ], "medline_plus_id": "a606022", "generic_names": [ "Ondansetron" ], "mesh_id": "D058831", "drugbank_id": "DB00904", "wikipedia_url": "https://en.wikipedia.org/wiki/Ondansetron" } ] }

NCT00122187

Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention

https://clinicaltrials.gov/study/NCT00122187

COMPLETED

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States. Results from randomized clinical trials and intervention studies have suggested that implementation of a CRC screening program for men and women over age 50 results in reduced CRC mortality. However, for this reduction to be fully realized, it is imperative that all positive screening tests are followed by complete diagnostic evaluation (CDE). Numerous intervention programs have been used to improve initial CRC screening rates, but data indicate that outside the research setting, less than half of patients with a positive fecal occult blood test (FOBT) screening result undergo CDE. To enhance the translation of this best practice recommendation to clinical practice, the investigators propose to implement an electronic event notification intervention (CRC-ENS) directed at making physician and system level changes to increase the proportion of patients with an abnormal FOBT that undergo CDE.

YES

Colorectal Cancer

DEVICE: Electronic Consult System

Percent of Patients Receiving GI Consult for FOBT+ Results, Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results, 6 months|Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results, Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results, 6 months

US Department of Veterans Affairs

ALL

CHILD, ADULT, OLDER_ADULT

FED

INTERVENTIONAL

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

CRT 02-059

2005-08

2008-05

2008-05

2005-07-21

2014-01-27

2015-04-24

Phoenix VA Health Care System, Phoenix, AZ, Phoenix, Arizona, 85012, United States|Southern Arizona VA Health Care System, Tucson, Arizona, 85723, United States|VA Eastern Colorado Health Care System, Denver, CO, Denver, Colorado, 80220, United States|Overton Brooks VA Medical Center, Shreveport, Louisiana, 71101-4295, United States|Minneapolis, Minneapolis, Minnesota, 55417, United States|Durham VA Medical Center, Durham, NC, Durham, North Carolina, 27705, United States|VA Portland Health Care System, Portland, OR, Portland, Oregon, 97239, United States|Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee, 37212-2637, United States|VA Medical & Regional Office Center, White River, White River Junction, Vermont, 05009-0001, United States

{ "Electronic Consult System": [ { "intervention_type": "DEVICE" } ] }

NCT04655287

A Register Study of Effects Following Local Variation in Rates of Involuntary Care

https://clinicaltrials.gov/study/NCT04655287

COMPLETED

Involuntary mental health care is permitted because it is believed to make people with severe mental disorders (SMD) better and prevent them from getting worse or even dying In this study we will investigate whether low levels of coercion in an area is connected with poorer outcomes in Norway. It can be assumed that too little involuntary care might lead to the opposite outcomes to those intended by the Norwegian Mental Health Act. The same law applies all over Norway, but the rate of involuntary care varies: there is up to five-fold difference between the catchment areas of the 69 Community Mental Health Centers. The investigators will estimate rates of involuntary care and adjust for age, sex, urbanity and area deprivation. The data source is the Norwegian Patients Registry, and all patients in treatment for a severe mental disorder in 2015 and their use of mental health care until 2018 will be followed. Model 1 follows all patients who were treated for a severe mental disorder in 2015. The model will test whether the rates of involuntary care in the area they live can predict the length of time to death. Model 2 follows patients with treatment for severe mental disorders that had no episode of voluntary care in 2015. The model will test whether the rate of involuntary care in their area predicts their use of mental health inpatient care in 2016 and 2017. Model 3 tests how long time patients with severe mental disorders that received only voluntary care in 2015 remain without a period of involuntary care in 2016-17, as a function of the rate of involuntary care in their area. Model 4 estimates changing the total number of patients with severe mental disorders in the catchment area in 2016-17 as a function of time and the rate of involuntary in 2015. Model 5 tests whether suicide rates for a catchment area varies as a function of its rate of involuntary care. Because suicides are rare, we will observe the variables over longer time periods, using involuntary care rates from 2015 to 2018 and suicide rates for 2015-2019. The study was evaluated by the Research Ethics Committee (ref 2018/795), who approved use of registry data, and by the Privacy Ombudsman at Akershus University Hospital (ref 2018-090).

NO

Schizophrenia and Related Disorders|Bipolar Disorder

Time to death, Time to death for patients with a severe mental disorder in 2015, as a function of the rate of involuntary care for the patients area of residence in 2015, 2015-2017|Mental health inpatient days, Time trends in mental health inpatient days from 2015-2017 for patients with a severe mental disorder but no involuntary care in 2015, as a function of the rate of involuntary care for the patients area of residence in 2015, 2015-2017|Episode of involuntary care, Time to an episode of involuntary care for patients with a severe mental disorder and no involuntary care in 2015, as a function of the rate of involuntary care for the patients area of residence in 2015, 2015-2017|Number of patients with severe mental disorders, Time trends in the rate of severe mental disorders in 69 catchment areas as a function of their rates of involuntary care in 2015-2018, 2015-2017|Number of suicides, Standardized rate of suicides in 60 catchment areas in 2015-2019, as a function of rates of involuntary care in 2015-2018, 2015-2019

University Hospital, Akershus

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2018/795(REK)|2018-090

2015-01-01

2018-12-31

2018-12-31

2020-12-07

2021-01-15

{}

NCT00942487

Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol

https://clinicaltrials.gov/study/NCT00942487

ENESYS

COMPLETED

Summary: * Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A comparative study against Metoprolol. (ENESYS study) * Study phase: 3 * Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type of control (placebo or active): randomised, parallel, active-controlled, open label * Study treatment(s)/drug(s): Nebivolol versus Metoprolol * Patients: * characteristics: patients with hypertension and left ventricular hypertrophy * planned total number: 50 * Study duration: * total enrolment period (months): 18 * treatment period (months): 6 * follow up period (months): 6 * Total study duration (months): 24 * Number of Centres: 1 * Country(ies): Romania (RO)

NO

Primary Arterial Hypertension

DRUG: Nebilet|DRUG: Corvitol

Changes of: longitudinal myocardial velocities at rest (assessed by TDE), systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest), NT-proBNP, 6 months

Global systolic function (ejection fraction), 6 months|Radial myocardial velocities, 6 months|Right ventricular function, 6 months|Global diastolic function, 6 months|Left ventricular mass index, 6 months

Berlin-Chemie Menarini

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

MeRo/04/Neb-LVD/003

2005-04

2008-12

2009-07

2009-07-21

2009-07-21

University and Emergency Hospital, Bucharest, 050098, Romania

{ "Nebivolol": [ { "intervention_type": "DRUG", "description": "Nebilet", "name": "Nebivolol", "synonyms": [ "Hydrochloride, Nebivolol", "Narbivolol", "Nebivololum", "Lobivon", "67555, R", "R-67555", "R67555", "Bystolic", "Silostar", "Nebivolol Hydrochloride", "Nebilet", "Nebivolol", "Alpha,Alpha'-(Iminobis(Methylene))bis(6-Fluoro-3,4-dihydro)-2H-1-benzopyran-2-methanol", "R 67555" ], "medline_plus_id": "a608029", "generic_names": [ "Nebivolol" ], "mesh_id": "D058665", "drugbank_id": "DB04861" } ], "Corvitol": [ { "intervention_type": "DRUG" } ] }

NCT03799887

Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinsons Disease

https://clinicaltrials.gov/study/NCT03799887

COMPLETED

Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinsons disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD.

NO

Parkinson Disease

BEHAVIORAL: 0% unweighed BWSTT|BEHAVIORAL: 10% unweighed BWSTT|BEHAVIORAL: 20% unweighed BWSTT

6 Minute Walk Test (6MWT), Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response ., 6 weeks|Berg Balance Scale (BBS):, It contains 14 instructions and 0 - 4 points is given for each instruction according to the performance of the patients. 0 points are given when the patient totally could not do the activity while 4 points are given when the patient completes the activity independently., 6 weeks|Unified Parkinsons Disease Rating Scale (UPDRS):, It is used to follow the clinical status of PD. It consists of four main parts (totally 183 points): mentation, behavior and mood (UPDRS I: 16 points), activities of daily living (UPDRS II: 52 points), motor examination (UPDRS III: 92 points), treatment complications (UPDRS IV: 23 points)., 6 weeks

Nottingham Health Profile (NHP):, It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life., 6 weeks|Fatigue Impact Scale (FIS):, This scale assesses the cognitive, physical and social effects of fatigue during the last one week in a total of 40 - item questionnaire (0 = no problem, 4 = maximum problem)., 6 weeks|Fatigue Severity Scale (FSS):, This scale assesses the severity of fatigue during the last one week in a total of 9 - item questionnaire (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 - 63, in which higher score means higher severity of fatigue ., 6 weeks

Hitit University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2010-171

2010-10-20

2010-10-20

2012-11-20

2019-01-10

2019-01-10

Tuğba Atan, Çorum, 19100, Turkey

{ "0% unweighed BWSTT": [ { "intervention_type": "BEHAVIORAL" } ], "10% unweighed BWSTT": [ { "intervention_type": "BEHAVIORAL" } ], "20% unweighed BWSTT": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02779387

Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy

https://clinicaltrials.gov/study/NCT02779387

UNKNOWN

This study is a multicenter, randomized-control-trial. This study select 1184 Infertile patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a. Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted reproductive treatment rate, miscarriage rate, live birth rate will be recorded.

NO

Infertility Associated With Endometriosis

DRUG: Goserelin Acetate

Cumulative pregnancy rate, Cumulative pregnancy rate of 18 month after surgery, 18 month after surgery|Time interval between surgery and natural pregnancy, Time interval between surgery and natural pregnancy, 18 month after surgery|miscarriage rate, miscarriage rate of patients who get natural pregnancy, 18 month after surgery

Peking University Peoples Hospital

FEMALE

ADULT

OTHER

INTERVENTIONAL

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

PKU01001

2016-05

2020-05

2021-05

2016-05-20

2016-05-20

{ "Goserelin": [ { "intervention_type": "DRUG", "description": "Goserelin Acetate", "name": "Goserelin", "synonyms": [ "Goserelin", "ICI118630", "Acetate, Goserelin", "ICI 118630", "Goserelina", "ICI-118630", "Zoladex", "Goserelin Acetate", "Zoladex", "Goserelin Implant", "Decapeptide I", "Zoladex", "Goserelin Implant", "Decapeptide I" ], "mesh_id": "D018931", "generic_names": [ "Goserelin", "Goserelin Implant", "Goserelin Implant" ], "drugbank_id": "DB00014" } ] }

NCT02204787

Treatment of Negative Symptoms and Schizophrenia

https://clinicaltrials.gov/study/NCT02204787

STICCS

COMPLETED

The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tDCS (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.

NO

Schizophrenia

DEVICE: transcranial direct current stimulation

Scale for the Assessment of Negative Symptoms, up to 3 months after intervention

University Hospital, Montpellier

ALL

ADULT

PHASE1|PHASE2

OTHER

INTERVENTIONAL

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

9257

2014-04-01

2018-10-26

2018-10-26

2014-07-30

2022-12-14

UH Montpellier, Montpellier, 34295, France

{ "transcranial direct current stimulation": [ { "intervention_type": "DEVICE" } ] }

NCT03248687

Distal Radius Buckle Fracture Follow up Study

https://clinicaltrials.gov/study/NCT03248687

COMPLETED

The investigators will be enrolling children with distal radius buckle fractures, treating them with a removable splint and randomizing them to follow up as needed vs required follow up with a primary care physician 1-2 weeks after the ED visit.

NO

Distal Radius Fracture

OTHER: Follow up

Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a childs physical function, The Activity Scales for Kids is a validated activity scale that measures a childs physical function, Three weeks post injury

Proportion of children with splint use almost all of the time > 3 weeks duration, The investigators will ask parents at three weeks if they use the splint, almost never, sometimes, frequently, or almost all of the time. , 12 weeks|Proportion of children who received unscheduled visits to a physician for the index wrist injury, obtained by parental report and Canadian Institute of Health Information data, At 12 weeks, the investigators will determine which children visited a physician for the index wrist injury as per parental report and/or data available from CIHI, 12 weeks|Proportion of parents who rated the satisfaction with their care as very satisfied/satisfied. , The investigators will ask parents to rate the satisfaction with their care at 4 weeks on the following scale: unsatisfied, somewhat satisfied, and very satisfied. , 4 weeks|Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups., The investigators will determine costs of patient and health care events using available sources for this information., 12 weeks

The Hospital for Sick Children

Physician Services Incorporated

ALL

CHILD

OTHER

INTERVENTIONAL

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

1000053044

2018-04-01

2019-11-30

2019-11-30

2017-08-14

2020-05-12

Kathy Boutis, Toronto, Ontario, M5G1X8, Canada

{ "Follow up": [ { "intervention_type": "OTHER" } ] }

NCT05692687

A Post-market Clinical Study to Evaluate the Safety and Performance of the Carbon Fibre Reinforced Polyetheretherketone Metatarso-Phalangeal (MTP) Plate (CoLink® PCR MTP Plate) for the Treatment of Hallux Rigidus

https://clinicaltrials.gov/study/NCT05692687

RECRUITING

The clinical study involves the routine treatment of skeletally mature patients who have been diagnosed with hallux rigidus (stiffness of the first metatarso-phalangeal joint in the foot due to arthritis and degeneration of cartilage). It follows standard practice surgery to treat this condition. This type of degenerative arthritis affects the joint of the big toe (hallux) which is attached to the foot. Taking part in this research will involve collecting data of the surgery to remove damaged cartilage and fix the two bones together with screws and a plate (called the CoLink® PCR MTP Plate).

NO

Hallux Rigidus

Bone Fusion, Successful radiographic union: where union is defined as evidence of bridging between the metatarsal bone and proximal phalanx bone by an independent imaging company., 6 months

Invibio Ltd

In2Bones

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

IN2B01

2023-03-15

2024-07

2025-11

2023-01-20

2023-05-06

South Florida Foot and Ankle Center, Lake Worth, Florida, 33462, United States|University of Kansas Medical Centre, Kansas City, Kansas, 66160, United States|Mississippi Sports Medicine and Orthopedic Center,, Jackson, Mississippi, 39202, United States

{}

NCT00449787

Comparing Naproxen to Sumatriptan for Emergency Headache Patients

https://clinicaltrials.gov/study/NCT00449787

HEDNet2

COMPLETED

2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department (ED) treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for the treatment of recurrent headache within 24 hours of emergency department discharge.

YES

Migraine|Tension-type Headache|Primary Headache Disorder

DRUG: Sumatriptan 100 mg|DRUG: Naproxen

Numerical Rating Scale, Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable. Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief, Baseline, two hours

Headache-related Functional Disability, This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patients answers were dichotomized into some impairment or no impairment., Baseline, two hours|Patient Satisfaction, At the 48 hour assessment, patients were asked, The next time you go to an emergency room with a headache, do you want to receive the same medication . This outcome tabulates the number of affirmative responses., 48 hours after ER discharge

Montefiore Medical Center

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

06-11-472

2007-03

2009-07

2009-07

2007-03-21

2012-11-29

2018-05-31

Montefiore Medical Center, Bronx, New York, 10467, United States|Columbia University Medical Center, New York, New York, 10032, United States

{ "Sumatriptan": [ { "intervention_type": "DRUG", "description": "Sumatriptan 100 mg", "name": "Sumatriptan", "synonyms": [ "GR-43175", "Sumatriptan Succinate", "(3-[2-(dimethylamino)ethyl]-1H-indol-5-yl)-N-methylmethanesulfonamide", "Boots Migraine Relief", "Sumavel", "3-(2-(dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide", "Sumatript\u00e1n", "1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]-N-methyl-methanesulfonamide", "Sumatriptanum", "Imigran", "3-(2-(Dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide", "GR 43175", "Imitrex", "Alsuma", "Succinate, Sumatriptan", "3-[2-(dimethylamino)ethyl]-N-methylindole-5-methanesulfonamide", "GR43175", "Sumatriptan", "Migraitan", "Imitrex", "Tosymra", "Sumatriptan Nasal", "Imitrex", "Tosymra", "Sumatriptan Nasal" ], "medline_plus_id": "a696023", "generic_names": [ "Sumatriptan", "Sumatriptan Nasal", "Sumatriptan Nasal" ], "nhs_url": "https://www.nhs.uk/medicines/sumatriptan", "mesh_id": "D058825", "drugbank_id": "DB00669" } ], "Naproxen": [ { "intervention_type": "DRUG", "description": "Naproxen", "name": "Naproxen", "synonyms": [ "(+)-(S)-Naproxen", "Aleve", "(S)-(+)-Naproxen", "(+)-2-(6-Methoxy-2-naphthyl)propionic acid", "(S)-Naproxen", "Synflex", "Naprox\u00e8ne", "(S)-(+)-2-(6-Methoxy-2-naphthyl)propionic acid", "Naproxenate, Sodium", "(+)-Naproxen", "(+)-2-(Methoxy-2-naphthyl)-propionic acid", "Methoxypropiocin", "(S)-2-(6-Methoxy-2-naphthyl)propionic acid", "Sodium, Naproxen", "Naprolag", "Proxen", "Naproxenum", "Naprosyn", "Naprosin", "Sodium Naproxenate", "Naproxen Sodium", "(+)-(S)-6-Methoxy-\u03b1-methyl-2-naphthaleneacetic acid", "Flanax", "Anaprox", "(+)-2-(Methoxy-2-naphthyl)-propions\u00e4ure", "(S)-2-(6-Methoxy-2-naphthyl)propanoic acid", "Stirlescent", "(S)-6-Methoxy-alpha-methyl-2-naphthaleneacetic acid", "Naproxen", "Naproxeno" ], "medline_plus_id": "a681029", "generic_names": [ "Naproxen" ], "nhs_url": "https://www.nhs.uk/medicines/naproxen", "mesh_id": "D016861", "drugbank_id": "DB00788", "wikipedia_url": "https://en.wikipedia.org/wiki/Naproxen" } ] }

NCT01338987

Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation

https://clinicaltrials.gov/study/NCT01338987

COMPLETED

Background: * One way to treat certain cancers of the blood and immune system is to give a patient stem cells from the bone marrow of a donor whose genes are very similar but not identical to the patients. One problem with these transplants is that the new immune cells may not work as well in the recipient as they did in the donor. The result may be that the immune system will not work as well. This can increase the risk of severe infections and other complications. * Researchers are studying the use of drugs that lower hormone levels and may allow the immune system to recover in a way that improves white blood cell function. In this study they will be looking at the drug leuprolide, a drug that lowers estrogen or testosterone levels, to see if it might improve the function of the newly transplanted cells. Objectives: * To determine whether leuprolide improves immune system function after bone marrow transplant from a donor with similarities in their immune cells (matched to each other). * To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug 3-deoxy-3 18F-fluorothymidine (FLT) in imaging studies. FLT will be used to image the immune system function in patients who have received bone marrow from the donor. Eligibility: * People between 15 (or as young as 9 in those who have gone through puberty) and 55 years of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia, high-risk myelodysplastic syndrome, chronic myelomonocytic leukemia, or chronic myeloid leukemia. They must also be eligible for a bone marrow transplant. * Genetically similar donors for the patients who are eligible for a transplant. Design: * People taking part in the study will be screened with a physical examination, medical history, blood and urine tests, and imaging studies. Patients who are not in remission or who require a bone marrow donor search may receive chemotherapy first. * Donors will provide bone marrow for transplant according to standard bone marrow transplant (BMT) procedures. * All women and half of the men will receive regular leuprolide doses 2 weeks before BMT to suppress hormone function. * All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy before the bone marrow transplant (depending on age). Recipients will also receive other drugs to prevent transplant rejection and other complications of transplantation. * Recipients will be monitored in the hospital for 4 weeks after transplant with blood tests and other studies. * Some recipients will have an imaging study with FLT during the protocol. These imaging studies will take place before the transplant, on days 5 and 28 after transplant, and at a later time to be determined by the study researchers. * Following discharge, participants will be monitored closely for up to 6 months, with regular but less frequent followup visits for at least 5 years. Study-related medications, including vaccinations for the new immune system, will be provided by the National Institutes of Health during the hospital stay and after discharge.

YES

Myelodysplastic Syndrome|Acute Lymphocytic Leukemia|Acute Myelogenous Leukemia|Chronic Myelogenous Leukemia|Chronic Myelomonocytic Leukemia

PROCEDURE: First Allogeneic Bone Marrow Transplant (BMT)|DRUG: Leuprolide|DRUG: 18F FLT|DRUG: Cyclophosphamide|DRUG: Methotrexate|DRUG: Tacrolimus|RADIATION: Total Body Irradiation|DRUG: Busulfan|DRUG: Fludarabine|PROCEDURE: Second Allogeneic Bone Marrow Transplantation

Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT), B cell percentage is defined as the percentage of lymphocytes that are B cells., after first Bone Marrow Transplant, approximately 12 months post-transplant|Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUVs Less Than 1.4, 18F-FLT imaging was performed serially on patients post transplant to identify the level of uptake of 18F-FLT at a day +5 to +12 scan and the day at which neutrophils recover to >500 (i.e., subclinical bone-marrow recovery within 5 days of Bone Marrow Transplantation (BMT infusion)). On each image for each patient, the region of interest was drawn within each thoracic medullary space (n=12), generating the SUV for each space. The mean of these was calculated for each scan. The analysis was the median of the means of the SUV of the thorax values of the day 5-12 scan (averaged the SUV of the thorax for each patient and then took the medians of these)., 18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measured|Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT), Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned., 12 months after second BMT

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0), Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned., Date treatment consent signed to date off study, approximately 79 months and 11 days.

National Cancer Institute (NCI)

ALL

CHILD, ADULT

PHASE2

NIH

INTERVENTIONAL

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

110136|11-C-0136

2011-04-19

2017-12-01

2020-11-19

2011-04-20

2019-04-23

2021-03-18

Childrens National Medical Center, Washington, District of Columbia, 20010, United States|National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States|University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT01338987/Prot_SAP_000.pdf|Informed Consent Form: Donor consent, https://cdn.clinicaltrials.gov/large-docs/87/NCT01338987/ICF_003.pdf|Informed Consent Form: Recipient consent, https://cdn.clinicaltrials.gov/large-docs/87/NCT01338987/ICF_004.pdf

{ "First Allogeneic Bone Marrow Transplant (BMT)": [ { "intervention_type": "PROCEDURE" } ], "Leuprolide": [ { "intervention_type": "DRUG", "description": "Leuprolide", "name": "Leuprolide", "synonyms": [ "Leuprolide Monoacetate", "Leuprolide, (DL-Leu)-Isomer", "Leuproreline", "Leuprorelinum", "A43818", "TAP144", "Monoacetate, Leuprolide", "Lucrin", "Acetate, Leuprolide", "Eligard", "Lupron Depot-PED", "Lupron", "Enantone", "A 43818", "Leuprorelin", "A-43818", "Leuprolide Acetate", "TAP-144", "Leuprolide, (L-Leu)-Isomer", "Leuprorelin Acetate", "Leuprolide", "TAP 144", "Leuprorelina" ], "medline_plus_id": "a685040", "generic_names": [ "Leuprolide" ], "mesh_id": "D018931", "drugbank_id": "DB00007", "wikipedia_url": "https://en.wikipedia.org/wiki/Leuprorelin" } ], "18F FLT": [ { "intervention_type": "DRUG" } ], "Cyclophosphamide": [ { "intervention_type": "DRUG", "description": "Cyclophosphamide", "name": "Cyclophosphamide", "synonyms": [ "(+-)-Cyclophosphamide", "Cyclophosphamid", "Procytox", "NSC26271", "CPM", "Cytophosphane", "Cyclophosphamide Monohydrate", "Endoxan", "Neosar", "(+,-)-2-(bis(2-Chloroethyl)amino)tetrahydro-2H-1,3,2-oxazaphosphorine 2-Oxide Monohydrate", "N,N-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide", "Ciclofosfamida", "Cyclophosphane", "NSC-26271", "Cytophosphan", "Cyclophosphamide anhydrous", "Anhydrous cyclophosphamide", "Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester", "Ciclofosfamide", "(RS)-Cyclophosphamide", "(\u00b1)-2-(BIS(2-CHLOROETHYL)AMINO)TETRAHYDRO-2H-1,3,2-OXAZAPHOSPHORINE 2-OXIDE MONOHYDRATE", "B 518", "CYT", "B518", "Cytoxan", "Cyclophosphamide Anhydrous", "2-[Bis(2-chloroethylamino)]-tetrahydro-2H-1,3,2-oxazaphosphorine-2-oxide", "Cyclophosphamide, (R)-Isomer", "Sendoxan", "NSC 26271", "B-518", "Cyclophosphamidum", "Cyclophosphamide, (S)-Isomer", "Cyclophosphamide" ], "medline_plus_id": "a611044", "generic_names": [ "Cyclophosphamide" ], "mesh_id": "D019653", "drugbank_id": "DB00531" } ], "Methotrexate": [ { "intervention_type": "DRUG", "description": "Methotrexate", "name": "Methotrexate", "synonyms": [ "Methotrexate, Dicesium Salt", "Nordimet", "Amethopterin", "Hydrate, Methotrexate", "Dicesium Salt Methotrexate", "Methotrexate, (DL)-Isomer", "Sodium, Methotrexate", "Zlatal", "4-amino-10-methylfolic acid", "Methotrexate", "Metoject", "N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-L-glutamic acid", "Methotrexatum", "Methotrexate Hydrate", "Abitrexate", "Methotrexate, (D)-Isomer", "M\u00e9thotrexate", "MTX", "Rasuvo", "Methotrexat", "Methotrexate Sodium", "Jylamvo", "Methotrexate, Disodium Salt", "Methofill", "Mexate", "Maxtrex", "Rheumatrex", "Metotrexato", "Methotrexate, Sodium Salt", "4-amino-N(10)-methylpteroylglutamic acid" ], "medline_plus_id": "a682018", "generic_names": [ "Methotrexate" ], "nhs_url": "https://www.nhs.uk/medicines/methotrexate", "mesh_id": "D019384", "drugbank_id": "DB00563" } ], "Tacrolimus": [ { "intervention_type": "DRUG", "description": "Tacrolimus", "name": "Tacrolimus", "synonyms": [ "Anhydrous Tacrolimus", "Tacrolimus, anhydrous", "FR900506", "Astagraf XL", "FR 900506", "Tacrolimus", "Prograft", "FK506", "Anhydrous, Tacrolimus", "FR-900506", "Advagraf", "Tacrolimus Anhydrous", "Protopic", "Prograf", "FK-506", "Tacrolimus, Anhydrous", "Anhydrous tacrolimus", "FK 506", "Tacrolimus anhydrous" ], "medline_plus_id": "a602020", "generic_names": [ "Tacrolimus" ], "mesh_id": "D065095", "drugbank_id": "DB00864", "wikipedia_url": "https://en.wikipedia.org/wiki/Tacrolimus" } ], "Total Body Irradiation": [ { "intervention_type": "RADIATION" } ], "Busulfan": [ { "intervention_type": "DRUG", "description": "Busulfan", "name": "Busulfan", "synonyms": [ "n-Butane-1,3-di(methylsulfonate)", "1,4-Dimethanesulfonoxybutane", "Myl\u00e9ran", "1,4-Dimesyloxybutane", "Busulfano", "Glyzophrol", "Busulfex", "Busulphan", "Wellcome, Busulfan", "Mylecytan", "1,4-Butanediol dimethanesulfonate", "Busulfan", "Myelosan", "Busulfanum", "Busulfan Wellcome", "Tetramethylene bis(methanesulfonate)", "Myleran", "1,4-Bis(methanesulfonoxy)butane" ], "medline_plus_id": "a611033", "generic_names": [ "Busulfan" ], "mesh_id": "D019653", "drugbank_id": "DB01008" } ], "Fludarabine": [ { "intervention_type": "DRUG", "description": "Fludarabine", "name": "Fludarabine", "synonyms": [ "Fludara", "Fludarabina", "Fludarabine", "2-Fluoro-ara-A Monophosphate, 2-Fluoro-ara AMP, FAMP", "Fludarabinum", "2-fluoro ARA-A", "2-F-ARAA" ], "medline_plus_id": "a692003", "generic_names": [ "Fludarabine" ], "drugbank_id": "DB01073" } ], "Second Allogeneic Bone Marrow Transplantation": [ { "intervention_type": "PROCEDURE" } ] }

NCT03346187

A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337

https://clinicaltrials.gov/study/NCT03346187

COMPLETED

A randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetic characteristics of CKD-337 in healthy male volunteers

NO

Dyslipidemias

DRUG: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)|DRUG: Test drug(CKD-337)

Atorvastatin AUCt(Area under the plasma drug concentration-time curve), Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration]|Atorvastatin Cmax(Maximum plasma concentration), Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|Fenofibric acid AUCt, Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration|Fenofibric acid Cmax, Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

Atorvastatin AUCinf(Area under plasma concentration-time curve from time point of administration to infinite), Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|Atorvastatin Tmax(Time taken to reach the maximum concentration), Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|Atorvastatin t1/2(Terminal half-life, Time for Cmax to drop in half), Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|Atorvastatin CL/F(Apparent total body clearance after extravascular administration, calculated as Dose/AUC), Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|Atorvastatin Vd/F(Apparent volume of distribution/Bioavailability), Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|Fenofibric acid AUCinf, Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration|Fenofibric acid Tmax, Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration|Fenofibric acid t1/2, Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration|Fenofibric acid CL/F, Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration|Fenofibric acid Vd/F, Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration|2-hydroxy atorvastatin AUCt, Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|2-hydroxy atorvastatin Cmax, Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|2-hydroxy atorvastatin AUCinf, Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|2-hydroxy atorvastatin Tmax, Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|2-hydroxy atorvastatin t1/2, Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|2-hydroxy atorvastatin CL/F, Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration|2-hydroxy atorvastatin Vd/F, Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

Chong Kun Dang Pharmaceutical

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

146BE16007

2017-05-19

2017-05-31

2017-06-13

2017-11-17

2017-12-19

Dong-A University Hospital, Busan, Seo-gu, 602-812, Korea, Republic of

{ "Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)": [ { "intervention_type": "DRUG" } ], "Test drug(CKD-337)": [ { "intervention_type": "DRUG" } ] }

NCT04811287

PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

https://clinicaltrials.gov/study/NCT04811287

UNKNOWN

This study assesses the potential benefit of adjuvant platelet-rich plasma (PRP) with carpal tunnel release (CTR) for patients with severe carpal tunnel syndrome (CTS). CTR is a rather common procedure performed and seems to be quite effective for those with moderate CTS, but a number of patients with severe CTS do not have quite the same response post-CTR. The investigators will recruit patients who fall into the severe CTS category and compare CTR with and without adjuvant PRP to see if PRP can improve outcomes of this common surgery.

NO

Carpal Tunnel Syndrome|PRP

DEVICE: Carpal Tunnel Release with Platelet-Rich Plasma|PROCEDURE: Carpal Tunnel Release without Platelet-Rich Plasma

Boston Carpal Tunnel Questionnaire, Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome., up to 1 month pre-op|Boston Carpal Tunnel Questionnaire, Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome., 3 months post-op|Boston Carpal Tunnel Questionnaire, Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome., 6 months post-op|Boston Carpal Tunnel Questionnaire, Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome., 12 months post-op|Grip Strength, Measured with a dynamometer., up to 1 month pre-op|Grip Strength, Measured with a dynamometer., 12 months post-op

Patient-Reported Outcomes Measurement Information System (PROMIS), Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome., up to 1 month pre-op|Patient-Reported Outcomes Measurement Information System (PROMIS), Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome., 3 months post-op|Patient-Reported Outcomes Measurement Information System (PROMIS), Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome., 6 months post-op|Patient-Reported Outcomes Measurement Information System (PROMIS), Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome., 12 months post-op|2 Point Discrimination at Thumb, Minimal distance that the patient feels 2 separate points of touch., up to 1 month pre-op|2 Point Discrimination at Thumb, Minimal distance that the patient feels 2 separate points of touch., 12 months post-op|2 Point Discrimination at Index Finger, Minimal distance that the patient still feels 2 separate points of touch., up to 1 month pre-op|2 Point Discrimination at Index Finger, Minimal distance that the patient still feels 2 separate points of touch., 12 months post-op|2 Point Discrimination at Middle Finger, Minimal distance that the patient still feels 2 separate points of touch., up to 1 month pre-op|2 Point Discrimination at Middle Finger, Minimal distance that the patient still feels 2 separate points of touch., 12 months post-op|Key Pinch, Measured with a pinch meter., up to 1 month pre-op|Key Pinch, Measured with a pinch meter., 12 months post-op|3 Finger Pinch, Measured with a pinch meter., up to 1 month pre-op|3 Finger Pinch, Measured with a pinch meter., 12 months post-op|Median Motor Latency, From EMG/NCS data., up to 1 month pre-op|Median Motor Latency, From EMG/NCS data., 12 months post-op|Median Motor Amplitude, From EMG/NCS data., up to 1 month pre-op|Median Motor Amplitude, From EMG/NCS data., 12 months post-op|Median Sensory Latency, From EMG/NCS data., up to 1 month pre-op|Median Sensory Latency, From EMG/NCS data., 12 months post-op|Median Sensory Amplitude, From EMG/NCS data., up to 1 month pre-op|Median Sensory Amplitude, From EMG/NCS data., 12 months post-op|EMG of Abductor Pollicis Brevis, From EMG/NCS data - looking at spontaneous activity., up to 1 month pre-op|EMG of Abductor Pollicis Brevis, From EMG/NCS data - looking at spontaneous activity., 12 months post-op

Michael Fredericson, MD

Factor Medical

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

59044

2021-10-15

2023-03-31

2023-06-30

2021-03-23

2022-04-20

Stanford University, Redwood City, California, 94063, United States

{ "Carpal Tunnel Release with Platelet-Rich Plasma": [ { "intervention_type": "DEVICE" } ], "Carpal Tunnel Release without Platelet-Rich Plasma": [ { "intervention_type": "PROCEDURE" } ] }

NCT02307487

Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients

https://clinicaltrials.gov/study/NCT02307487

COMPLETED

A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients (3 patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations.

NO

Bladder Cancer|Neoplasms|Urinary Bladder Diseases|Urologic Diseases

DRUG: 120 mg MMC in 90ml gel|DRUG: 140 mg MMC in 90ml gel|DRUG: 160 mg MMC in 90ml gel|DRUG: 120 mg MMC in 60ml gel|DRUG: 140 mg MMC in 60ml gel|DRUG: 160 mg MMC in 60ml gel

Rate of Adverse Events (AE) findings considered to be dose limiting according to the CTCAE V 4.0, 6 weeks|Vital signs findings considered to be dose limiting according to the CTCAE V 4.0, 6 weeks|Clinical evaluation findings considered to be dose limiting according to the CTCAE V 4.0, 6 weeks|Lab results considered to be dose limiting according to the CTCAE V 4.0, 6 weeks

Rates of all adverse events or clinically relevant physical examination, 15 months|Vital signs and laboratory findings, 15 months|MMC maximum plasma concentration and concentration time curve during 6 hr post instillation, 15 months|Duration of MMC retention in the bladder as detected by urine MMC levels post instillation (6-7 hours), 15 months

Rate of patients with Complete Response (CR) to treatment, Complete Response (CR) rate defined as percent of patients with CR at the Primary Disease Evaluation (PDE) Visit, 8-10 weeks post treatment|Rate of patients with durable Complete Response (CR) to treatment, Durable Complete Response (CR) rate defined as percent of patients who continue to display CR at 3, 6, 9 and 12 months following the last treatment., 3, 6, 9 and 12 months post PDE visit

UroGen Pharma Ltd.

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

TC-BC-10

2014-12

2016-04

2017-06

2014-12-04

2017-06-16

Wolfson Medical Center of Holon, Department of Urology, Holon, Israel|Meir Medical Center, Kfar Saba, Israel

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NCT00743587

A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb

https://clinicaltrials.gov/study/NCT00743587

COMPLETED

The purpose of this study is to determine if the measurement of pressure pain thresholds, in patients suffering osteoarthritis of the thumb, can be used to assess the activity of potential analgesic agents after a single dose. The study will use agents known to give pain relief in osteoarthritis as positive controls. These agents are: tramadol, naproxen and oxycodone.

NO

Osteoarthritis Thumbs

DRUG: Placebo|DRUG: Oxycodone|DRUG: Tramadol|DRUG: Naproxen

Pressure pain threshold - area under the curve, 0 to 4 hours

Pressure pain threshold - at specific time points, 0 to 12 hours|Present pain intensities - at specific time points, 0 to 12 hours

Pfizer