linjc16/ctgov huggingface dataset:
Efficacy and Safety of D-chiro-inositol in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet

Detailed Description
-----------------
Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides. However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects. It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome. Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.

Official Title
-----------------
Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Dietary Supplement: TECADRIOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 25 and 40 years old Diagnosis of insulin resistance (HOMA ≥2.5) 26≤ BMI ≤32 Exclusion Criteria: Subjects with no indication for treatment Pregnancy and breastfeeding Treatment with drugs or supplements that interfere with the mechanism of action of insulin

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Hypocaloric balanced diet | |
| Experimental: TECADRIOL<br>Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin | Dietary Supplement: TECADRIOL<br>* Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA index | Reduction of HOMA index | Three time points: change in HOMA index from the baseline to 2 and 4 months |
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.

Detailed Description
-----------------
A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Official Title
-----------------
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Tretinoin cream 0.1%
* Drug: RETIN-A® Cream
* Drug: Vehicle of the test product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA). Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tretinoin cream 0.1%<br>Once daily at home, to apply the entire affected areas of the face. | Drug: Tretinoin cream 0.1%<br>* Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)<br>* Other names: Tretinoin;|
| Active Comparator: RETIN-A® Cream<br>Once daily at home, to apply the entire affected areas of the face. | Drug: RETIN-A® Cream<br>* RETIN-A® (Tretinoin) Cream (Valeant)<br>* Other names: Tretinoin;|
| Placebo Comparator: Vehicle of the test product<br>Once daily at home, to apply the entire affected areas of the face. | Drug: Vehicle of the test product<br>* Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of Bioequivalence | Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts | 12 weeks |
Pain During Injection With Botulinum Toxin in Post-stroke Spasticity Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to analyze which step of the procedure of toxin botulinum injection is the most painful between skin break-in, electric stimulation, injection and needle withdrawal.

Detailed Description
-----------------
Post-stroke spasticity management by botulinum toxin injections may be limited by pain or discomfort at the injection side. Particularly tracking by electrostimulation, but also skin puncture, toxin injection or needle withdrawal may be painful. The objective of this study is to define an individual injection strategy in order to limit pain.

Official Title
-----------------
Evaluation of Pain Intensity in Different Steps of Injection With Botulinum Toxin in the Treatment of Spasticity in Post-stroke Patients

Conditions
-----------------
Post-stroke Spasticity

Intervention / Treatment
-----------------
* Other: pain rating during injection with botulinum toxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke severe upper or lower limb spasticity (Ashworth score ≥ 2 for at least one muscle) patients requiring a treatment by botulinum toxin patients refusing analgesia for injections. Exclusion Criteria: severe aphasia (severity subscore of the BDAE <3) cognitive impairment or psychiatric disease altering the reliability of pain evaluation patient medically unstable.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| spasticity post-stroke<br>pain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale | Other: pain rating during injection with botulinum toxin<br>* The pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of pain intensity during injection with botulinum toxin | Pain intensity in different steps of the procedure of toxin botulinum injection: skin break-in, electric stimulation, injection and needle withdrawal. | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoesthesia | Semmes Weinstein Monofilament Evaluation | 30 min | 
| Neuropathic pain | DN4 (Neuropathic pain 4 questions) | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, spasticity, stroke, injection, botulinum toxin A
Thalamic Deep Brain Stimulation for Tourette Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.

Official Title
-----------------
Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial

Conditions
-----------------
Tourette Syndrome

Intervention / Treatment
-----------------
* Device: Thalamic deep brain stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or older Diagnosis of Tourette Syndrome by DSM-IV Tic frequency at least one per minute at screening prior failure of at least two dopamine receptor or presynaptic blockers negative impact on quality of life Exclusion Criteria: significant structural brain lesion (on imaging studies) significant dementia severe head trauma preceding onset of tics use of dopamine receptor blockers prior to recognition of tics prior implanted electrical device electroconvulsive therapy (ECT) within 24 months suicide attempt within 12 months significant sociopathic personality current or planned pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Thalamic deep brain stimulation|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rush Video Rating Scale (mRVRS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tic counts (on video recording) |  |  | 
| Yale Global Tourette Severity Scale (YGTSS) |  |  | 
| Tourette Syndrome Symptom List (TSSL) |  |  | 
| Quality of Life Visual Analog Scale (VAS) |  |  | 
| SF-36 |  |  | 
| Neuropsychological battery |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourette Syndrome, Deep Brain Stimulation, Video assessment, YGTSS, TSSL
The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers

Study Overview
=================
Brief Summary
-----------------
Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to hold surgical instruments is widely used in surgery. The use of this drape on pacemaker patients has not yet been tested. Our objective is to conduct a clinical study to evaluate the potential interference of the surgical magnetic drape on patients with cardiac pacemakers. We are testing the magnetic drape on forty patients in the pacemaker clinic. The totality of the drape is applied over the pacemaker and depending on the result, the drape is either folded in two over the pacemaker or the magnets are applied individually up to the totality of the drape, 70 magnets. Thereafter, the drape is pulled in increments of 3 cm caudally until the interference is ceased. Results are in process as we are presently actively recruiting.

Official Title
-----------------
The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers

Conditions
-----------------
Cardiac Pacemaker, Artificial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac pacemaker Exclusion Criteria: Unstable angina Hemodynamic instability Subjects whom the cardiologist believes are unsuitable for asynchronous pacing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pacemaker with magnets<br>Patients with pacemakers who will be tested for magnetic interference with a magnetic drape. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchronous pacing |  | Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker, Magnets, Drape, Ferrite, Magnetic field, Pacemaker interference
Effects of Regular Brisk Walking in Chronic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3 months. The physical training program was based on walking.

Detailed Description
-----------------
Participants had been evaluated 4 times during a long follow-up period of 7 months. Activity limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months later.

Official Title
-----------------
Effects of Regular Brisk Walking in Chronic Stroke Patients

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: physical training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke onset > or = 6 months Able to walk without human assistance (may use walking aid) Sign informed consent form Approval from physician for participation in study Live in Belgium or in Benin Exclusion Criteria: cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure orthopedic, circulatory, or chronic pain conditions restricting exercise; dementia; severe receptive or global aphasia with inability to follow 2-step commands; co-morbid non-stroke neurological disorder that impairs mobility (e.g. MS or Parkinson's);

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: walking<br>a cohort of stroke patients trained during 3 month, based on walking | Behavioral: physical training<br>* walking many times a week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACTIVLIM-Stroke (Activity limitations measures) | mainly self-reported outcomes measures | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impairment | Stroke related impairment are assessed with specific outcomes measures (SIAS, BBS, ...). | 7 months | 
| Walking ability | Walking ability is assessed throuht walking speed and walking endurance | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
walking, Activity limitations, restriction of participation, chronic stroke survival, physical activity
Caloric Restriction, Exercise, and Glucoregulation in Humans

Study Overview
=================
Brief Summary
-----------------
Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in similar effects on blood glucose and insulin. The purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin action than similar weight losses through CR or EX alone.

Detailed Description
-----------------
Participants are randomized into caloric restriction, exercise, and caloric restriction plus exercise weight loss groups. Measurements of blood glucose and insulin, oral glucose tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6% of body weight. Other tests include maximal oxygen uptake (VO2max), strength tests, blood pressure, blood lipids, serum inflammatory markers, dual X-ray absorptiometry (DEXA) for bone density and body composition, physical activity levels, dietary intakes, and measures of arterial stiffness.

Official Title
-----------------
Caloric Restriction, Exercise, and Glucoregulation in Humans

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Calorie Restriction
* Other: Exercise
* Other: Calorie Restriction and Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females postmenopausal no diabetes, cardiovascular disease, cancer no orthopedic problems not currently exercising BMI between 25 and 29.9 nonsmokers Exclusion Criteria: current regular exercisers premenopausal women cardiovascular disease, lung disease, cancer, diabetes

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calorie restriction<br> | Other: Calorie Restriction<br>* This group will undergo a 20% reduction in energy intake without any change in energy expenditure.<br>|
| Active Comparator: Exercise<br> | Other: Exercise<br>* This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.<br>|
| Experimental: Calorie restriction and exercise<br> | Other: Calorie Restriction and Exercise<br>* This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucoregulatory function |  | 3-4 months |
Study of Diaphragm Mobility on Tissue Doppler

Study Overview
=================
Brief Summary
-----------------
Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery. In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Its use in the analysis of diaphragm function must be evaluated to determine its interest as a diagnostic tool. Better understanding of diaphragm dysfunction following heart surgery will lead to earlier management of post-operative respiratory complications and the implementation of preventive pre-operative measures. We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in the assessment of diaphragm mobility.

Official Title
-----------------
Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)

Conditions
-----------------
Heart Surgery

Intervention / Treatment
-----------------
* Other: Diaphragm ultrasonography
* Other: Tissue Doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-operative period following heart surgery Exclusion Criteria: Patients younger than 18 years old Existence of a neuro-muscular disease Widened surgical approach Refusal of the patient Impossibility to see diaphragm movement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br> | Other: Diaphragm ultrasonography<br>* Spontaneously breathing patients in the ½ seated position Heart transducer at the medio axillary position, parallel to the axis of the body, last intervertebral spaces US mode: 2D = Evaluation of the pulmonary parenchyma Time-Movement (TM) = Evaluation of diaphragm muscle shortening in the apposition zone + Evaluation of diaphragm mobility in the posterior 1/3 of the diaphragm dome Tissue Doppler Imaging (TDI) = Evaluation of diaphragm mobility in the diaphragm dome Collection of different daily clinical data<br>|
| Healthy volunteers<br> | Other: Tissue Doppler<br>* Determine the threshold value for diaphragm mobility<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure diaphragm movement in TM (Time-Movement), in tissue Doppler |  | At baseline |