linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.

Official Title
-----------------
A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of UISH001 for the Symptomatic Improvement of Urinary Incontinence

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: UISH001
* Drug: matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who have moderate to severe urge, stress or mixed Urinary Incontinence Exclusion Criteria: Medical history of migraines, neurologic problems, swallowing disorder, stroke or severe depression. Medical history of heart failure, peripheral edema or moderate to severe asthma or chronic obstructive pulmonary disease (COPD) Certain restricted medications Any other condition that would interfere with the safety of the subject

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UISH001<br> | Drug: UISH001<br>* sublingual dosing, 1 drop 3 times a day<br>|
| Placebo Comparator: Matching placebo<br> | Drug: matching placebo<br>* sublingual dosing,1 drop 3 times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Decrease in Leakage Events of 30% or More. | Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period. | Change from baseline after 4 weeks of treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary incontinence, stress incontinence, urge incontinence, mixed incontinence
Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of Local Anesthesics

Study Overview
=================
Brief Summary
-----------------
Check analgesia after tonsillectomy in adults

Detailed Description
-----------------
We hypothesize that a vaporization of local anesthetics in the tonsil lodge would reduce postoperative pain.

Official Title
-----------------
Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of NaCl 0,9%, Xylocaine 2% or Levobupivacaine 0,5%

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: levobupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tonsillectomy Exclusion Criteria: Gastric or duodenal ulcer Diabetes Kidney failure Chronic pain and fibromyalgia

Ages Eligible for Study
-----------------
Minimum Age: 14 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: NaCl 0,9%<br>patients receive 5ml of NaCl 0,9% at the level of the tonsils lodge | Drug: levobupivacaine<br>* Patient satisfaction and pain score using a visual anagogic scale (VAS)<br>* Other names: Nacl;|
| Active Comparator: Xylocaine 2%<br>patients receive 5ml of Xylocaïne 2% at the level of the tonsils lodge | Drug: levobupivacaine<br>* Patient satisfaction and pain score using a visual anagogic scale (VAS)<br>* Other names: Nacl;|
| Active Comparator: Levobupivacaine 0,5%<br>patients receive 5ml of Levobupivacaine 0,5% at the level of the tonsils lodge | Drug: levobupivacaine<br>* Patient satisfaction and pain score using a visual anagogic scale (VAS)<br>* Other names: Nacl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction and pain score | patient satisfaction and pain score using a visual anagogic scale from 0 (no pain) to 10 (intolerable pain) | until 10 days after the tonsillectomy. |
Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is (1) to provide quantitative information of the motor manifestations of Parkinson's disease and (2) to quantify the effect of high intensive antigravity locomotor exercise or Deep Brain Stimulation implantations in Parkinson's disease.

Official Title
-----------------
Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: High intensive antigravity locomotor exercise
* Procedure: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (exercise arm): Idiopathic Parkinson's disease A stable condition the last 6 months Hoehn and Yahr 2 - 3 Inclusion Criteria (Deep Brain Stimulation arm): Patients referred to Deep Brain Stimulation Exclusion Criteria: Cardiovascular disease Conditions that contraindicate physical exercise or the examination

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br> | Procedure: Deep Brain Stimulation<br>* Deep Brain Stimulation implantation<br>|
| Experimental: Locomotor Exercise<br> | Other: High intensive antigravity locomotor exercise<br>* High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Isometric Tremor Approximate Entropy | Approximate Entropy is a metric. When used to quantify isometric tremor irregularity, information of dominant/pathological CNS oscillators can be obtained. | Change from baseline up to 16 weeks |
Methods of Weight Loss in Overweight Coronary Patients

Study Overview
=================
Brief Summary
-----------------
We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

Detailed Description
-----------------
We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling. The study population consists of overweight (BMI >27) patients with established coronary heart disease. The exercise and counseling program was of 4 months duration with extended follow up at 1 year.

Official Title
-----------------
Methods of Weight Loss in Overweight Coronary Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: high caloric expenditure exercise
* Behavioral: low caloric expenditure exercise plus dietary counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary heart disease BMI > 27 Peak Vo2 > 14.4 ml/kg/min Exclusion Criteria: Presence of diabetes

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: high caloric expenditure exercise plus dietary counseling | Behavioral: high caloric expenditure exercise<br>* high caloric expenditure exercise plus dietary counseling<br>|
| Active Comparator: 2<br>Arm 2: low caloric expenditure exercise plus dietary counseling | Behavioral: low caloric expenditure exercise plus dietary counseling<br>* low caloric expenditure exercise plus dietary counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Mass |  | 4 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrabdominal (visceral) fat |  | 4 months | 
| Insulin stimulated glucose disposal |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, coronary heart disease, coronary risk factors, weight loss, exercise
Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors

Study Overview
=================
Brief Summary
-----------------
The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.

Official Title
-----------------
Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression

Intervention / Treatment
-----------------
* Procedure: genetic analysis
* Procedure: genetic assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the diagnoses of schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features, or volunteers with no history of a psychotic disorder. Exclusion Criteria: Patients with DSM-IV diagnoses other than schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Outcome in schizophrenia with certain antipsychotic<br>clozapine | Procedure: genetic analysis<br>* genetic assay of blood sample drawn with patient's consent<br>Procedure: genetic assay<br>* genetic assay of blood sample drawn with patient's consent<br>|
| Active Comparator: 2 Outcome in schizophrenia with other Antipsychotics<br>Other Antipsychotics | Procedure: genetic analysis<br>* genetic assay of blood sample drawn with patient's consent<br>Procedure: genetic assay<br>* genetic assay of blood sample drawn with patient's consent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We plan to compare the polymorphisms across schizophrenic patients and adults who do not have a diagnosed major mental illness. . |  | single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will also evaluate relationships between the polymorphism and past and current mental health among the non-diagnosed sample |  | single visit |
To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. Please note this study is not being conducted in the United States.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Compare the Effects of 12 Weeks Treatment With Vildagliptin 50 mg Bid to Voglibose 0.2 mg Tid in Patients With Type 2 Diabetes

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis as Type 2 Diabetes Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control Outpatients Exclusion Criteria: Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes Significant heart diseases Significant diabetic complications Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 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 in HbA1c after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FPG after 12 weeks |  |  | 
| Change in Fasting Lipids after 12 weeks |  |  | 
| Change in HOMA-IR after 12 weeks |  |  | 
| Change in HOMA-B after 12 weeks |  |  | 
| Safety Profile after 12 weeks treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Vildagliptin, HbA1c
Endometrial Lesions Predictions

Study Overview
=================
Brief Summary
-----------------
To explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(AUB).

Official Title
-----------------
Predictive Factors of Endometrial Lesions in Patients With Abnormal Uterine Bleeding

Conditions
-----------------
Endometrial Neoplasms

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) non-pregnancy related abnormal uttering bleeding（AUB） in women of 18-60 years old; 2)women who had indications for hysteroscopy and endometrial histology in the study period Exclusion Criteria: 1) postmenopausal women, 2) AUB due to other causes such as hormones or medications, coagulation disorders, and vascular malformation of the uterus; 3) final diagnosis outside the scope of this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal endometrial<br> | Other: no intervention<br>* no intervention<br>|
| endometrial lesions<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathology of endometrial lesions | Endometrial tissue was curettaged and sent for pathological examination in 10% formalin. A senior pathologist who was not blinded to clinical and ultrasound information examined the samples and determined the final diagnosis. The outcomes of histology are classified as normal endometrium and endometrial lesions, which include 1)endometrial polyps,2)endometrial hyperplasia without atypia, 3)endometrial atypical hyperplasia and 4) endometrial carcinoma. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic Examination | VS examinations were performed by an experienced physician with a vaginal probe of 5.5 MHz of a GE VolusonE10 Ultrasound device to look for endometrial thickness and abnormal echoes. Endometrial thickness (ET) was measured at the thickest part with double layers | 1 year |
Investigation of Chronic Intestinal Ischemia

Study Overview
=================
Brief Summary
-----------------
Patients suspected of chronic mesenteric ischemia shall be investigated with gastroscopy-assisted laser Doppler flowmeter and light spectroscopy (GALS).

Detailed Description
-----------------
Patients with suspected chronic mesenteric ischemia (included truncus coeliacus compression syndrome) referred to the vascular surgery department for investigation of splanchnic and mesenteric circulation shall be included in this study. In addition to CT angiography, patients shall be investigated with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS). Endoscopic ultrasound Transserosal laser Doppler flowmetry and light spectroscopy Ischemia bio-markers Health related quality of life

Official Title
-----------------
Investigation of Chronic Intestinal Ischemia

Conditions
-----------------
Chronic Mesenteric Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical chronic mesenteric ischemia Exclusion Criteria: Patients unable to gå through gastroscopy
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 |
| --- | --- |
| GALS symptomatic patients group<br>Patents With symptoms of chronic mesenteric ischemia shall be investigated with GALS. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow Laser Doppler flowmeter | Repeated measurments at baseline 3, and 12 months | Baseline, 3 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia biomarkers | Plasma levels of intestinal ischemia biomarkers | 1-2 years | 
| Health-related quality of life in the patients with chronic mesenteric ischemia | Quality of life assesment at baseline and after treatment with EQ-5D | 2 years | 
| Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia | Chronic mesenteric ischemia patients treated with either open vascular surgery or endovascular treatment shall be routinely followed-up at the out-patients department for post operative complications, effect of revascularization on the mesenteric ischemia symptoms, patency of endovascular or open revascularization procedure. Routine clinical follow-up shall be 30 days post operatively, 3 months, 12 months and yearly thereafter. | 6-7 years |
Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Official Title
-----------------
A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-78 years inclusive Type 2 diabetes diagnosis at least 2 months prior to study entry Body mass index in the range of 22-45 kg/m2 HbA1c in the range of 6.5 to 9% inclusive Fasting plasma glucose <270 mg/dL (15 mmol/L) Exclusion Criteria: A history of type 1 diabetes Evidence of significant diabetic complications Treatment with insulin or any other oral antidiabetic agents Congestive heart failure requiring pharmacologic treatment Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females) Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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 |
| --- | --- |
| Experimental: vildagliptin + metformin<br> | Drug: Vildagliptin<br> <br> |
| Active Comparator: Metformin<br> | Drug: metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile after 24 weeks of treatment |  | 24 weeks | 
| Gastrointestinal tolerability after 24 weeks of treatment |  | 24 weeks | 
| Patients with endpoint HbA1c <7% and <6.5% after 24 weeks |  | 24 weeks | 
| Patients with reduction in HbA1c >0.7% after 24 weeks |  | 24 weeks | 
| Change from baseline in fasting plasma glucose after 24 weeks |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin, hemoglobin A1c, metformin