louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01668485: Mechanisms of Glucose Counterregulation in Pancreatic Islet Transplantation
Official title: Metabolic Studies in Type 1 Diabetic Patients After Allogenic Intraportal Islet Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
hypoglycemia counterregulation,
pancreatic islet transplantation
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. However, the extent and underlying metabolic pathways of this improvement are unknown. Investigators therefore compare systemic glucose turnover including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring islet transplant recipients, matched type 1 diabetic subjects who did not receive islet transplantation, and matched healthy non-diabetic subjects.

Detailed description: Subjects (n=12 each group) undergo a hypoglycemic and a euglycemic hyperinsulinemic clamp in a randomized fashion. Systemic and skeletal muscle glucose and lactate kinetics are assessed using a combination of isotopic and forearm balance techniques.

Eligibility criteria: T1DM/ITX+

Inclusion Criteria:

* Type 1 Diabetes
* Pancreatic islet transplantation

Exclusion Criteria:

* Type 2 Diabetes

Primary outcomes:
measure: Whole body glucose counterregulation
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Systemic glucose release
timeFrame: 6-8 weeks
measure: Skeletal muscle glucose disposal
timeFrame: 6-8 weeks
measure: Gluconeogenesis from lactate
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Justus Liebig University
state: Hessia
Study officials:
affiliation: Justus Liebig University
name: Thomas Linn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ang M, Meyer C, Brendel MD, Bretzel RG, Linn T. Magnitude and mechanisms of glucose counterregulation following islet transplantation in patients with type 1 diabetes suffering from severe hypoglycaemic episodes. Diabetologia. 2014 Mar;57(3):623-32. doi: 10.1007/s00125-013-3120-9. Epub 2013 Dec 5.
Clinical trial NCT02059785: Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke
Official title: Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: Pinocembrin for Injection
Placebo
mRS
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 216
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.

Detailed description: Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.

Eligibility criteria: Inclusion Criteria:

* 35-75 hospitalized patients
* Patients with acute stroke ≤24h
* NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6
* For the first time or always without obvious sequelae of stroke disease(mRS≤1）
* Informed consent

Exclusion Criteria:

* The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms
* Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study
* TIA
* Symptoms of disease rapidly improving during the randomized
* Severe hypertension(SBP \> 200 mmHg or DBP \>110 mmHg)
* Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance \<60ml/min）
* Severe system or viscera organic disease
* Have used other neuroprotectant or other experimental drugs
* Patient who are unlikely to complete the study that due to a severe clinical condition
* Pregnant or breast-feeding
* Participation in a previous clinical study within 30 days
* Meets all other exclusion criteria

Primary outcomes:
measure: To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days
timeFrame: 90 days
Secondary outcomes:
measure: To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital affilliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital affilliated to Capital Medical University
name: Wang Yong Jun, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01027585: The Effects of Cinnamon on Postprandial Blood Glucose, and Insulin in Subjects With Impaired Glucose Tolerance
Official title: Effects of Cinnamon on Postprandial Blood Glucose, and Insulin in Subjects With Type 2 Diabetes or Impaired Glucose Tolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2009-12-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects were recruited from the population in southern Sweden.

Brief summary: To study the effect of cinnamon on postprandial blood glucose, and plasma concentrations of insulin in subjects with impaired glucose tolerance.

Detailed description: Ten subjects with impaired glucose tolerance were assessed in a crossover trial. A standard 75 g oral glucose tolerance test (OGTT) was served with placebo or cinnamon capsules. Finger-prick capillary and venous blood samples were taken before and 15, 30, 45, 60, 90, 120, 150, and 180 min after the start of the OGTT to measure glucose, and insulin.

Eligibility criteria: Inclusion Criteria:

* Patients were selected for the study on the basis of the following inclusion criteria: diagnosis of impaired glucose tolerance for \< 12 months before enrollment. Glucose tolerance status and fasting blood glucose levels were evaluated using the criteria established by the American Diabetes Association.

Exclusion Criteria:

* Subjects who had thyroid disorders, or used insulin, oral hypoglycemics, and insulin-sensitizing drugs within 60 days before enrollment were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Skane University Hospital
name: Joanna Hlebowicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01616485: Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo
Official title: A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2012-06-11
Enrollment: 106
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent
* Willing to comply with all study requirements and clinic schedules
* Male between 30 to 60 years of age
* Non-smoker
* No history of alcohol abuse
* Normal screening laboratory values

Exclusion Criteria:

* Allergy or hypersensitive to PDE5 inhibitors
* Evidence of clinically significant disease
* Supine systolic/diastolic blood pressure level
* History of cardiovascular disease
* Previously participated in TA-1790 within the past 30 days

Primary outcomes:
measure: Change in hemodynamic measurements
timeFrame: Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services
state: Arizona
Study officials:
affiliation: VIVUS LLC
name: Craig Peterson, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05170685: Expanded Access for Fixed-Dose Combination of Nivolumab Plus Relatlimab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-12-28
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access designed to provide access to fixed-dose combination of nivolumab plus relatlimab for eligible participants.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00055185: Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Acquired Immune Deficiency Syndrome
Keywords: Treatment Experienced
Lead sponsor: Progenics Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2003-02-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine any adverse effects of PRO 542 after administration and to determine the anti-HIV effects of PRO 542 in the patient.

Detailed description: A 2 arm study involving a series of 3 triweekly doses of PRO 542. One arm will involve patients on a stable dose of anti-retroviral therapy and the other arm will consist of patients not receiving anti-retroviral therapy. Three patients will be enrolled in each arm followed by a safety evaluation. Following the safety evaluation, 3 more patients may be enrolled in each arm. After the first 12 patients, an additional 12 patients may be enrolled pending safety data.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of HIV
* Patients must be on a stable dose of acceptable anti-HIV therapy or receiving no anti-HIV therapy for at least four (4) weeks prior to the start of this study
* HIV-1 determination by RNA-PCR greater than or equal to 100,000 copies/ml
* CD4 count \>50/cubic mm at screening

Exclusion Criteria:

* Patients who have previously received PRO 542
* Patients with active, significant infection (other than HIV) not controlled by antibiotics
* Pregnant or lactating women
* Patients with an estimated life expectancy of \<3 months
* Patients currently receiving steroids or other immunosuppressive therapy or immunoglobulin therapy except for topical or inhaled steroids
* Patients with known allergy or hypersensitivity to PRO 542 or immunoglobulin preparations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Jeffery M Jocbson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00749385: A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
Official title: A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 500mg Alone, and Enteric-Coated Esomeprazole 20mg Alone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis
Lead sponsor: POZEN
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.

Detailed description: This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.

Eligibility criteria: Inclusion Criteria:

* Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.

Exclusion Criteria:

* Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.

Primary outcomes:
measure: To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments
timeFrame: 12-72 hour PK assessments
Secondary outcomes:
measure: To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments.
timeFrame: 72-hour PK assessments
measure: To evaluate the safety of each of the single-dose treatments
timeFrame: Entire study duration (48 days)
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
References:
Clinical trial NCT06458985: Disclosure Intervention for People in Treatment for Opioid Use Disorder
Official title: Disclosure Intervention to Reduce Social Isolation and Facilitate Recovery Among People in Treatment for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: disclosure
social isolation
stigma
social support
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Brandywine Counseling and Community Services
First posted: 2024-06-14
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test a disclosure intervention among people in treatment for opioid use disorder. The main question it aims to answer is whether people who receive a disclosure intervention have better treatment- and recovery-related outcomes one year after receiving the intervention. Participants will complete a brief disclosure intervention designed to help them (1) make key disclosures related to disclosure and (2) build skills to disclose. Researchers will compare results to participants in a waitlist comparator condition, who receive the intervention at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Client of Brandywine Counseling \& Community Services
* Receiving opioid use disorder treatment at Brandywine Counseling \& Community Services
* Considering disclosing one's opioid use disorder history and/or treatment to someone new

Exclusion Criteria:

* Diagnosis of schizophrenia
* Participation in pilot study of intervention

Primary outcomes:
measure: Retention in treatment
timeFrame: 1 year
measure: Illicit opioid use
timeFrame: 1 year
Secondary outcomes:
measure: Recovery capital score
timeFrame: 1 year
measure: Quality of life score
timeFrame: 1 year
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Brandywine Counseling & Community Services
state: Delaware
Study officials:
References:
Clinical trial NCT00460785: Bioequivalence Trial of a New Opioid Combination Compared to Reference
Official title: Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference


Eligibility criteria: Inclusion Criteria:

* Standard Phase I
* Cyp 2D6 extensive metabolizers

Exclusion Criteria:

* Standard Phase I
* Contraindications of current reference tablet SmPC

Primary outcomes:
measure: Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.
Secondary outcomes:
measure: Descriptive, e. g. safety/tolerability of Test comparable to Reference
Other outcomes:
Locations:
Study officials:
affiliation: CRS Mannheim
name: Wolfgang Timmer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04670185: Internet-based Parent Training for Parents of Children With Externalising Behavior Problems
Official title: Internet-based Parent Training for Parents of Children With Externalising Behavior Problems: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problem
Parenting
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the efficacy of a 5-week, therapist-guided, internet-delivered parent management training program (BIP SAMBA) targeting children aged 5 - 11 years with externalising behavior problems. The study is a randomised controlled trial with parents of N=30 children participating. The intervention BIP SAMBA is compared with a waitlist control condition. Participants in the control condition will be crossed over to the active treatment after 5 weeks. The primary outcome measure is the Eyberg Child Behavior Inventory (ECBI) at the post treatment (5 weeks after baseline assessment).


Eligibility criteria: Inclusion Criteria:

* Being parent of a child between 5 and 11 years
* This child has externalising behavior problems
* The parent has access to the internet
* The parent speaks and write Swedish

Exclusion Criteria:

* The child has an autism diagnosis
* The child has severe conduct problems
* There is domestic violence occurring within the family
* There alcohol or substance abuse occurring within the family

Primary outcomes:
measure: Eyeberg Child Behavior Inventory (ECBI)
timeFrame: Change in conduct problems from baseline (week 0) to post-treatment (week 6)
Secondary outcomes:
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: Change in mental health issues from baseline (week 0) to post-treatment (week 6)
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: Change in parenting strategies from baseline (week 0) to post-treatment (week 6)
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: At post-treatment (week 6)
measure: Weekly questions about frequency of and impairment from behavior problems
timeFrame: Changes in behavior problems from baseline to week 5
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: BUP CPF
Study officials:
References:
Clinical trial NCT01687985: A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults
Official title: A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2012-09-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.


Eligibility criteria: Inclusion Criteria:

Male or female subjects at least 18 years of age

Constipated, defined by ROME definition:

Otherwise in good health, as determined by physical exam and medical history

Exclusion Criteria:

Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon

Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments

Subjects who are allergic to any BLI801 component

Subjects currently taking narcotic analgesics or other medications known to cause constipation

Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures

Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Subjects with an active history of drug or alcohol abuse

Primary outcomes:
measure: Treatment Success
timeFrame: 4 weeks
Secondary outcomes:
measure: serum chemistry
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Chattanooga
country: United States
facility: Clinsearch
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology
state: Tennessee
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References: