louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02562664: Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients
Official title: Insulin Sensitizing Agent (Metformin) Improves Clinical Pregnancy Rate and Insulin Parameters in Polycystic Ovarian Syndrome Patients With Acanthosis Nigricans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reproductive Endocrinology
Polycystic Ovarian Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 66
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically, PCOS can identify during the early adolescence. Insulin resistance is a common finding in the obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition of its more common connection to obesity and insulin resistance allows for diagnosis of related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular randomized, double-blind, placebo-controlled trial . The first pharmacological approach to induction of ovulation in women with PCOS is clomiphene citrate


Eligibility criteria: Inclusion Criteria:

* All patients with PCOS fulfilled at least 2 out of the three criteria of Rotterdam consensus 2003

Exclusion Criteria:

* liver disease
* heart or respiratory failure
* alcohol abuse
* kidney disease

Primary outcomes:
measure: Pregnancy rate
timeFrame: 6 months
Secondary outcomes:
measure: Fasting glucose (mg/dl)
timeFrame: 6 months
measure: Fasting insulin (mg/dl)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06903364: Association of Lifestyle With Complications in the Diabetic Population
Official title: Association of Lifestyle With Complications in the Diabetic Population: a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic patients with or without complications

Brief summary: This study is a prospective study of patients with diabetes. The main objective of this study is to investigate the relationship between lifestyle and long-term complications in diabetic patients, which will help to screen out the high-risk group at an early stage and provide scientific advice for the prevention of complications in diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. Patients with a normative diagnosis of type 2 diabetes
2. Age ≥20 years old, regardless of gender
3. From January 2022 to December 2025, he was treated in Nanfang Hospital

Exclusion Criteria:

1. In the acute infection phase
2. The researchers judged that it was not suitable to participate in this study

Primary outcomes:
measure: Number of Participants with Diabetes Complications
timeFrame: From enrollment to the end of the three-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
Study officials:
References:
Clinical trial NCT05158764: Efficacy and Safety of URGOBD001 Compression System
Official title: Evaluation of the Efficacy and Safety of the New URGO BD001 Compression System Versus a Reference Compression in the Local Treatment of Venous or Mixed Predominantly Venous Leg Ulcers: a Prospective Open-label RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: compression system
VLU
mixed VLU
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2021-12-15
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study

Detailed description: This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a leg ulcer of venous or mixed predominantly venous origin of stage C6 / C6r of the CEAP classification.

This study is carried out in around 55 French investigational centers. A total of 178 patients meeting the eligibility criteria will be included. The patients will be followed for 12 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers.

A planimetric survey of the studied VLU is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12).

Eligibility criteria: Inclusion Criteria:

* Adult patient (≥ 18 years old), having given free, informed and written consent
* Patient affiliated to a social security scheme
* Patient agreeing to wear the study compression system daily
* Patient with an ankle circumference between 18 and 25 cm
* Target wound: stage C6 / C6r leg ulcer of the CEAP classification with a 0.8≤ ABPI≤1.3
* Target wound with an area between 1 and 20 cm2
* Target wound with age of ≤24 months

Criteria exclusion:

* Patient with a systemic infection not controlled by appropriate antibiotic therapy
* Patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis
* Patient with advanced stage II or stage III lymphoedema
* Patient bedridden or spending less than an hour per day standing
* Clinically infected target wound
* Cancerized target wound

Primary outcomes:
measure: Complete closure of the Venous Leg Ulcer (VLU)
timeFrame: 12-week treament period
Secondary outcomes:
measure: Time to complete closure of the Venous Leg Ulcer (VLU)
timeFrame: 12-week treament period
measure: Safety analysis
timeFrame: 12-week treament period
Other outcomes:
Locations:
city: Paris
country: France
facility: Patricia SENET
Study officials:
affiliation: Hôpitaux Universitaires Paris Est (AP-HP) - Hopital TENON
name: Patricia Dr SENET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02189564: Rewarding Feedback in Motor Learning and Rehabilitation
Official title: Die Auswirkung Von Dopaminergen Belohnungsreizen Auf Das Lernen Einer Motorischen Fertikgeit Bei Gesunden Probanden "Effects of Dopaminergic Reward on Motor Skill Learning in Healthy Subjects"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Performance
Motor Learning
Lead sponsor: Cereneo AG
Sponsor class: INDUSTRY
Collaborators: name: University of Zurich
First posted: 2014-07-14
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of rewarding vs. non-rewarding feedback on acquisition of a motor skill is investigated in a single blinded parallel group design. Reward consists of performance dependent monetary reward, or of knowledge of performance in selected (above average) trials.

The investigators hypothesize improved motor skill learning and higher involvement of the dopaminsrgic system under rewarding vs. non-rewarding conditions.


Eligibility criteria: Inclusion Criteria:

* neurologically healthy
* right handed

Exclusion Criteria:

* Contraindications against magnetic resonance imaging
* pregnancy

Primary outcomes:
measure: Motor skill learning using an arc pointing task
timeFrame: about 10 minutes pre-training, about 10 min post training, about 24h post training
Secondary outcomes:
Other outcomes:
Locations:
city: Vitznau
country: Switzerland
facility: Cereneo, Center For Rehabilitation and Neurology
state: Lucerne
Study officials:
References:
citation: Widmer M, Ziegler N, Held J, Luft A, Lutz K. Rewarding feedback promotes motor skill consolidation via striatal activity. Prog Brain Res. 2016;229:303-323. doi: 10.1016/bs.pbr.2016.05.006. Epub 2016 Jul 7.
Clinical trial NCT00919464: Natural History of Anterior Compartment Pressures of the Thigh Following Femur Fracture
Official title: Natural History of Anterior Compartment Pressures of the Thigh Following Femur
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Femur Fracture
Keywords: Compartment pressure
compartment syndrome
femur fracture
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to determine the natural history of compartment pressures in the anterior thigh secondary to a fracture of the femoral shaft.

Detailed description: Compartment syndrome is a painful condition where increased tissue pressure in a restricted area compromises circulation and endangers the tissue within that area possibly leading to surgery, amputation, major loss of function and in rare cases, death. Compartment syndrome of the thigh can be particularly devastating because of the size of the muscle and large amount of blood flow to the area, however it is one of the more rare and therefore least understood of all compartment syndromes. The purpose of this study is to determine the natural history of pressures of the anterior compartment of the thigh following femur fracture, which could help elucidate the diagnostic and treatment algorithms for thigh compartment syndrome. This small project is designed to be a non-randomized, investigational prospective trail to be conducted at the General Division of Charleston Area Medical Center. The target population consists of males and non-pregnant females age 18 and over who have suffered a mid-shaft femur fracture.

Eligibility criteria: Inclusion Criteria:

* femur fracture
* age 18 and older

Exclusion Criteria:

* patients who are not candidates for surgical repair of femur fracture
* patients not expected to survive more than 1 week

Primary outcomes:
measure: Compartment pressures
timeFrame: Pre-operative to 50 hours post operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: WVU Department of Surgery
name: John DeLuca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03211364: Comparing Mobilization Techniques for the Hemiplegic Shoulder
Official title: Comparing Mobilization Techniques for the Hemiplegic Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Shoulder
Mobility Limitation
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: One of the main complications after stroke is hemiplegic shoulder pain. It is known that one of the most frequent causes of hemiplegic shoulder pain is a restricted range of motion in the shoulder joint. Therefore, it is necessary to preserve the passive range of motion by using the most optimal mobilization technique. The aim of this study is to compare 2 different techniques in order to document their influence on shoulder range of motion and shoulder pain in stroke patients.


Eligibility criteria: Inclusion Criteria:

* First stroke
* Upper limb impairment

Exclusion Criteria:

* Shoulder pain on the hemiplegic side with onset before the stroke
* Surgery at the hemiplegic shoulder
* Active movement possible within the whole range of motion

Primary outcomes:
measure: Range of motion of the shoulder using goniometry
timeFrame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol
measure: Shoulder pain using visual analogue scale
timeFrame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol
Secondary outcomes:
measure: Spasticity of the shoulder muscles using the Modified Ashworth Scale
timeFrame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol
measure: Trunk Impairment Scale to assess trunk stability
timeFrame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol
measure: Fugl-Meyer Assessment - upper limb part to assess voluntary muscle activity
timeFrame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Vakgroep Revaki - Ghent University
Study officials:
affiliation: University Ghent
name: Dirk Cambier, Prof
role: STUDY_CHAIR
affiliation: University Hospital, Ghent
name: Kristine Oostra, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02280564: Study of A Cell-Phone System to Improve Health of Youth With Diabetes
Official title: Pilot Study of A Cell-Phone System to Improve Health of Youth With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: motivational interviewing
problem solving skills
family communication
technology support
cell phone system
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-10-31
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: FL3X is an integrated diabetes self-management system that incorporates modern cell phone technology with behavioral modification approaches to improve diabetes self-management in high-risk youth. Utilizing such approaches will increase adherence to diabetes management behaviors and improve glucose control by providing increased autonomy over diabetes care.

Detailed description: FL3X utilizes diabetes care providers (diabetes educators) as health coaches to employ behavioral modification techniques including motivational interviewing and problem solving skills training. Coaches help adolescents and their families learn these techniques to improve diabetes self management behaviors and diabetes care.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes with duration at least 12 months
* between ages 12-16 years at registration
* poor glycemic control (A1c 8.0-13.0%)
* parent/guardian willing to also participate
* minority race/ethnicity
* low income

Exclusion Criteria:

* pregnant (if female)
* diabetes type 2 or gestational
* no health insurance
* Pre-existing systemic chronic disease (drug abuse, cancer, psychiatric conditions)

Primary outcomes:
measure: Change from Baseline in HbA1c at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Change from Baseline in Quality of Life measures at 4 months
timeFrame: 4 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Raleigh
country: United States
facility: WakeMed Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: UNC-CH
name: Elizabeth Mayer-Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06509464: Response Of Metabolic Syndrome Severity Score To High Intenisty Interval Training In Women With Central Obesity.
Official title: Response Of Metabolic Syndrome Severity Score To High Intenisty Interval Training In Women With Central Obesity.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrom
Keywords: Metabolic syndrom severity score
Metabolic syndrom
Central obesity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 48
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate any significant effect of high intensity interval training on metabolic syndrome severity score in women with central obesity.

Detailed description: RESPONSE OF METABOLIC SYNDROME SEVERITY SCORE TO HIGH INTENISTY INTERVAL TRAINING IN WOMEN WITH CENTRAL OBESITY

forty eight women with age ranges from 25 to 45 years old will be selected from nutrition-outpatient clinic; they will participate in the study for 6 weeks, and randomly be assigned into two equal groups.

Study group A (n =24) will receive low volume High-intensity interval training (HIIT) three times /week for 6 weeks , study group B (n =24) will receive caloric restriction diet

For evaluation Physical efficiency index using Modified Harvard Step test It is a powerful indicator for aerobic fitness. The Fitness Index score is determined according to the following equation

Fitness Index (long form) = (100 x test duration in seconds) divided by (2 x sum of heart beats in the recovery periods).

Metabolic syndrome severity score Metabolic syndrome severity score will be calculated through MetS Calculator (MetSCalc).

-3Laboratory investigation before \& after treatment: for fasting blood glucose level and Lipid profile (total cholesterol, LDL, HDL, TAGs).

4- The 45-item Diet Satisfaction Questionnaire (DSat-45)

B) For treatment

1- Grand II Treadmill: (AC999- for maximum weight 150 Kg-

Eligibility criteria: Inclusion Criteria:

- 1. 48 Women subjects with age ranges from 25to 45 years.

2. Waist height ratio ranges from 49-58 (overweight and seriously overweight).

Exclusion Criteria:

* 1. Uncontrolled Diabetes 2. Uncontrolled hypertension 3. Cognitive impaired patients 4. Severe Anemic women 5. Subjects with physical or musculoskeletal disabilities 6. Pregnancy 7. Recent cardiothoracic surgery

Primary outcomes:
measure: Metabolic syndrome severity score
timeFrame: 6weeks
measure: Physical efficiency index using Modified Harvard Step test
timeFrame: 6weeks
measure: The 45-item Diet Satisfaction Questionnaire (DSat-45
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy cairo university
Study officials:
affiliation: Cairo University
name: Nesreen Ghareeb Elnahas, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01794364: Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: T2DM
Diabetes Mellitus Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Primary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0-72/dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]
timeFrame: 0-72/dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0-72/dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0-72/dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0-72/dose
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0-72/dose
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0-72/dose
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: