linjc16/ctgov huggingface dataset:
Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to constitute a cohort of healthy subjects in brain MRI, including functional and diffusion sequences, together with a language and cognitive assessment. This will make it possible to compare the data with those obtained in the same center and under the same examination conditions in brain tumor patients. The investigators seek to evidence general patterns of cerebral morphological and functional changes, correlated with behavioural scores, in brain-damaged patients.

Official Title
-----------------
Nice Healthy Brain - Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Other: Neurological assessments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebral and psychiatric healthy volunteer agreeing to participate in this research 30 and 50 years old or between 60 and 75 years old Exclusion Criteria: contra-indication to MRI refusal of patient participation pregnant, lactating or parturient women vulnerable people

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers<br>The participants will constitue a cohort of healthy volunteers, they will have a MRI, and language and cognitive assessment. | Other: Neurological assessments<br>* The participants will have a MRI, and language and cognitive assessments.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cerebral MRI |  | 6 months |
Cumulative Irritation Patch Test

Study Overview
=================
Brief Summary
-----------------
A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical agent or agents have the potential to cause contact irritation or contact allergy in the skin. Allergy is only elicited in immunologically competent individuals who have become sensitized through exposure to the chemical agent at a sufficient concentration and for a sufficient duration of time.

Official Title
-----------------
Exclusive Cumulative Irritation Patch Test (21 Day) With Challenge Patch Application

Conditions
-----------------
Allergy, Irritation, Sensitization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must not have any visible skin disease that might be confused with a skin reaction to the test trial; Subjects must not be participating in another clinical trial at this facility or any other facility; Subjects must be willing to avoid using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial; Subjects must understand and execute and Informed Consent Form; Subjects must be capable of understanding and following directions; Subjects must be considered reliable; Subjects must be aged 16 to 79 years, inclusive; Subjects aged less than 18 years must have a parent or legal guardian execute the Informed Consent Form. Exclusion Criteria: Subjects in ill health or taking medications, other than birth control, which could influence the purpose, integrity or outcome of the trial; Female subjects who report orally they are pregnant, planning to become pregnant or nursing during the course of the trial; Subjects who have a history of adverse reactions to adhesive tape, cosmetics, Over-The-Counter drugs or other personal care products; Subjects judged by the PI to be inappropriate for the trial.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 79 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary or Cumulative Irritation Potential of the skin | This will be measured by the evaluation of the test sites (skin)by a trained assessor with a predetermined scale for skin irritation. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic Contact Sensitization Potential | After the repeated application period of the test material, a rest period will be employed. The test material will be applied to a naïve site and then will be evaluated by a trained assessor with a predetermined scale for skin irritation. | 21 days |
Complementary and Alternative Care in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational study designed to describe disease progression, symptom change, quality of life, diet and lifestyle habits, and frequency of adverse events among patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM). In addition to describing the patterns of CAM use, this study will also identify and describe the positive deviants, those individuals with the highest quality of life and least amount of disease activity. Positive deviants will be compared to controls in order to describe medication, diet, and lifestyle patterns associated with a lack of MS disease progression and high quality of life.

Official Title
-----------------
Complementary and Alternative Medicine (CAM) in Multiple Sclerosis. A Prospective Observational Study of a CAM-using Cohort

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of multiple sclerosis (including relapsing remitting MS, secondary progressive MS, primary progressive MS, clinically isolated syndromes (CIS), radiologically-isolated syndromes (RIS), possible MS, or probable MS. Age 18-100 Exclusion Criteria: Inability to read/write in English Inability or unwillingness to complete surveys every six (6) months. (  90 min)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Individuals with MS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAM Therapies survey | This survey has been developed to identify the complementary and alternative therapies most commonly used by individuals with MS. Results will be reported with descriptive statistics. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Expanded Disability Severity Score (EDSS) | The EDSS will be used to capture disease severity and rates of progression in this cohort. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, MS, Complementary and Alternative, CAM
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose

Study Overview
=================
Brief Summary
-----------------
The epidemic nature of type 2 diabetes mellitus, along with the downsides of current treatments, has raised the need for therapeutic alternatives. The aim of this study is to evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral electrical stimulation (PES) as an alternative treatment for diabetes.

Official Title
-----------------
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with type II diabetes, for at least one year prior to randomization Body mass index BMI < 35 Kg/m2 Stable glucose lowering drugs regimen for at least one month prior to randomization Capable of giving informed consent Exclusion Criteria: Pregnancy, or nursing 10< HbA1c < 6 Permanent pacemakers Metal prosthesis Resting blood pressure > 160/ 100 mmHg Skin disease Treatment with steroids or beta-blockers treatment with psychiatric medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PES Treatment<br>Eligible patients will receive daily 5 min PES treatment for two weeks. Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) continuous glucose monitor (CGM) System | Device: Stimulator<br> <br> * Other names: BEAC Biomedical Intellistim BE-28TC;|
| No Intervention: Control<br>Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with hypoglycemia, and/ or adverse events that are related to treatment |  | Baseline through 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of minor side effects related to treatment |  | Baseline through 2 months | 
| Changes in mean interstitial glucose levels measured by CGM |  | Baseline, 1, 2, 5, and 6 weeks |
Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

Study Overview
=================
Brief Summary
-----------------
The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.

Official Title
-----------------
Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

Conditions
-----------------
Polymyalgia Rheumatica

Intervention / Treatment
-----------------
* Drug: Betamethasone
* Drug: isotonic sodium chloride solution (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of polymyalgia rheumatica Exclusion Criteria: decompensated diabetes mellitus decompensated arterial hypertension
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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: betamethasone<br>patients treated with a single intramuscular injection of betamethasone | Drug: Betamethasone<br>* betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection<br>* Other names: diprospan injection;Drug: isotonic sodium chloride solution (placebo)<br>* 4 ml intramuscular<br>|
| Placebo Comparator: isotonic sodium chloride solution<br> | Drug: isotonic sodium chloride solution (placebo)<br>* 4 ml intramuscular<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a total dose of glucocorticoids used in the course of the disease |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polymyalgia rheumatica
CivaDerm(TM) Surface Therapy Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.

Official Title
-----------------
CivaDerm(TM) Surface Therapy Pilot Study

Conditions
-----------------
Basal Cell Carcinoma, Squamous Cell Carcinoma of the Skin

Intervention / Treatment
-----------------
* Device: CivaDerm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject signed informed consent Confirmed superficial or nodular basal cell or squamous cell carcinoma Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities) >5 mm of residual tumor tumors < 3 cm Capable of complying with Patient Release Instructions Exclusion Criteria: Is unable or unwilling to comply with the protocol requirements Pregnant or breast feeding Metastases

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
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Radioactive bandage applied to surface of the body worn for approximately one week. | Device: CivaDerm<br>* radioactive bandage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin toxicity events | grade 3+ events | within 2 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose delivered to target | calculated radiation dose | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation, brachytherapy, skin cancer
Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value

Study Overview
=================
Brief Summary
-----------------
Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value

Detailed Description
-----------------
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.

Official Title
-----------------
Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value

Conditions
-----------------
Renal Stones

Intervention / Treatment
-----------------
* Procedure: SWL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones) radio-opaque stone high attenuation value (≥ 1000 HU) stone Exclusion Criteria: Abnormal renal anatomy renal insufficiency solitary kidney coagulopathies uncontrolled hypertension renal artery or aortic aneurysm active urinary tract infection pregnancy severe skeletal malformations (spinal deformity) precluding proper stone localization skin to stone distance (SSD) > 11 cm BMI > 30 Kgm/m2

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultraslow shock wave lithotripsy (SWL)<br>SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power). | Procedure: SWL<br>* Shock wave lithotripsy<br>* Other names: ESWL;|
| Active Comparator: Slow power-ramping SWL<br>SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW. | Procedure: SWL<br>* Shock wave lithotripsy<br>* Other names: ESWL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | Complete clearance of stones in addition to clinically insignificant residual fragments | 3 months following last session of SWL | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Comparison of complications in both groups | 1 year following last session of SWL | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal stones, SWL, High density stones, Ultraslow SWL, Slow SWL, Ramping, Pause
A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

Official Title
-----------------
A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of study CLAF237A2307 within 4 weeks of entering into the extension Written informed consent Ability to comply with all study requirements Blood glucose criteria must be met Exclusion Criteria: Premature discontinuation from study CLAF237A2307

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 108 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile after 108 weeks of treatment |  |  | 
| Change in HbA1c from week 52 to week 108 |  |  | 
| Change from baseline in fasting plasma glucose at week 108 |  |  | 
| Change in fasting plasma glucose from week 52 to week 108 |  |  | 
| Change from baseline in body weight at week 108 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Vildagliptin