linjc16/ctgov huggingface dataset:
Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.

Detailed Description
-----------------
This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.

Official Title
-----------------
Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial

Conditions
-----------------
Overactive Bladder, Urinary Incontinence, Children

Intervention / Treatment
-----------------
* Drug: Mictonetten 5 mg, coated tablet
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voiding frequency 8 or above per day at least one incontinence episode per day age between 5-10 years body weight between 17 and 45 kg Exclusion Criteria: normal age expected bladder capacity PVR more than 10 ml dysfunctional voiding neurogenic disorders UTI, constipation

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 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: 1<br> | Drug: Mictonetten 5 mg, coated tablet<br>* propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)<br>* Other names: Mictonetten;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* placebo corresponding to body weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| voiding frequency |  | before therapy and at end of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| voided volume |  | before and at end of treatment | 
| incontinence episodes per day |  | before and at end of therapy | 
| safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate |  | before and at end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antimuscarinics, children, overactive bladder, propiverine, urinary incontinence, urotherapy
Obesity and Psychotherapy as an Alternative to Treatment

Study Overview
=================
Brief Summary
-----------------
Adherence to obesity treatment programs has been a limiting factor to good results in loosing weight. This study aimed to verify if obese subjects submitted to a physical exercise program and group psychotherapy would have a greater adherence, than obese people exercising only.

Detailed Description
-----------------
The sample was forty people, both genders, mean age: 42,2 ± 10,7 years old. Physical exercise consisted of walking and stretching three times a week, during 50 minutes, with intensity verified by the Borg Scale, during three months. One of the days were supervised by the authors while two were freely chosen by the participant, without supervision. The verified variables were: total body mass, height, body mass index, physical activity level, caloric expenditure, waist circumference and fat percentile. Half of the sample participated of group psychotherapy once weekly.

Official Title
-----------------
Poor Patients Adherence to Exercise and Group Therapy as an Approach to Obesity Treatment

Conditions
-----------------
Obesity, Therapy

Intervention / Treatment
-----------------
* Behavioral: Group Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >= 30 kg/m2 Exclusion Criteria: Age less than 25 or more than 62

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 62 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: EO<br>Exercise three times a week, one under supervision and two freely chosen by the participant | |
| Experimental: EGT<br>Exercise three times a week, one under supervision and two freely chosen by the participant | Behavioral: Group Psychotherapy<br>* Group psychotherapy once a week, under a psychiatrist supervision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loose |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Exercise, Psychotherapy
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

Detailed Description
-----------------
This pilot study will be the first time that nicotine will be applied directly onto the surface of chronic diabetic ulcer. The goals of the study are to evaluate safety and tolerability (particularly at the wound site) of a gel formulation containing low-dose nicotine, and to obtain preliminary information on its effects on accelerating wound closure. The study will be carried out on a background of conventional wound therapy in patients with Type II diabetes mellitus. Patients will be randomized to receive either study medication (ATG002), vehicle gel, or standard-of-care.

Official Title
-----------------
A Multicenter, Randomized Study of the Safety and Preliminary Efficacy of Low-Dose Nicotine Gel (ATG002) in Patients With Plantar Diabetic Foot Ulcers

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Drug: ATG002 (study drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes mellitus type II Single non-healing uninfected partial or full-thickness foot ulcer secondary to diabetic neuropathy, in the absence of significant peripheral arterial disease. Exclusion Criteria: Patients who use tobacco in any form or who are on nicotine replacement therapy

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ATG002 (study drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of ulcer size as determined by weekly ulcer tracings |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment for complete wound closure. Complete wound closure will be defined as full epithelialization of the wound with the absence of drainage and lack of dressing requirement for an interval of at least 2 weeks. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, foot ulcers, nicotine gel, wound healing
Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.

Official Title
-----------------
A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
* Drug: Chemotherapy (docetaxel and prednisone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy Detectable metastases ECOG performance status ≤2 (Performance status of 3 if due to bone pain) Any Gleason score Only one prior treatment with systemic chemotherapy No prior treatment with gene therapy No prior immunotherapy for prostate cancer Taxane naïve Experiencing cancer-related pain

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine<br>* Immunotherapy allogeneic GM-CSF secreting cellular vaccine<br>|
| Other: 2<br> | Drug: Chemotherapy (docetaxel and prednisone)<br>* Chemotherapy (docetaxel and prednisone)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression. Time to pain progression. |  | 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Prostate Cancer, HRPC, Prostate, Cancer, Metastatic, Hormone-refractory, GVAX, Chemotherapy, Taxotere, Docetaxel, Prednisone, Vaccine, Allogeneic cells
Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.

Official Title
-----------------
A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy

Conditions
-----------------
Kidney Stone, Renal Stone, Urolithiasis

Intervention / Treatment
-----------------
* Device: SURE
* Device: Standard Ureteroscopy (Basketing)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for ureteroscopy with laser lithotripsy; Presence of renal stone(s); Be willing and able to return for all study-related follow up procedures; and, Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent. Exclusion Criteria: BMI > 45; Significant comorbidities; Bladder, ureteral or kidney abnormalities; Pregnant individuals; or Unable to meet the treatment and follow up protocol requirements.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SURE<br> | Device: SURE<br>* The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.<br>|
| Active Comparator: Standard Ureteroscopy (Basketing)<br> | Device: Standard Ureteroscopy (Basketing)<br>* This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SFR | Stone Free Rate | 30 days |
Validity Of Turkish Version Of ABC Scale In Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
Activities-specific Balance Confidence (ABC) scale is a well-known tool to evaluate functional balance. Diabetic patients suffer more often from balance disorders than the rest of the population. The aim is to investigate the validity of the Turkish version of ABC short form in patients with diabetes mellitus (DM).

Detailed Description
-----------------
Thirty patients with DM will be included according to the inclusion and exclusion criteria. All the participants will be evaluated by ABC form and Timed Up and Go Test (TUG). The Cumulative Illness Rating Scale (CIRS ) will be used for all the patients. ABC scale is a self-assessment test with 16 items that helps assess balance impairments and falling risk, and it also investigates how confident people are while they are in some specific activities both indoors, and outdoors. Total score changes between 0-100. The HbA1c values of all patients will be noted if a blood test will be performed in the last three months.

Official Title
-----------------
Validity Of The Turkish Version Of Activities-Specific Balance Confidence Scale In Patients With Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Balance; Distorted, Evaluations, Diagnostic Self

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 45-75 years old Diabetes mellitus The complete existence of the data to be used in the study in the records of our hospital Exclusion Criteria: Not having any other additional disease that will affect balance coordination No lower extremity joint replacement or lower extremity amputation at any level

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| The patients with diabetes mellitus<br>When patients with diabetes mellitus admitted to our outpatient clinic if they have inclusion criteria, we have used the ABC questionnaire. And we have done perform Time Up And Go Test twice respectively. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of the Turkish Version of Activities-specific Balance Confidence Scale in Patients With Diagnosis of the Diabetes Mellitus Before. | The Activities-specific Balance Confidence Scale (ABC Scale) is a structured questionnaire that measures an individual's confidence in performing activities without losing balance. Total score ranges from 0% to 100%. Lower than 50 %: low level; 50-80 %: moderate level above 80 %: high level of physical functioning | A single point in time (1 day) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, balance
Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus

Official Title
-----------------
An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: MT-1303 Low dose
* Drug: MT-1303 High dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of SLE based on the American College of Rheumatology (ACR) criteria Presence of at least one of the following items: positive anti ds-DNA antibodies, low complement levels, and so on. Stable doses of corticosteroids Exclusion Criteria: Severe active lupus nephritis, neuropsychiatric SLE

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

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

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

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: Part 1<br>MT-1303 Low dose+Corticosteroid | Drug: MT-1303 Low dose<br> <br> |
| Experimental: Part 2-A<br>MT-1303 High dose+Corticosteroid | Drug: MT-1303 High dose<br> <br> |
| Experimental: Part 2-B<br>MT-1303 Low dose+Corticosteroid+Immunosuppressant | Drug: MT-1303 Low dose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Adverse Events |  | up to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in anti-dsDNA and complement |  | baseline and 24 weeks | 
| Change from Baseline in Lymphocyte counts |  | baseline and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic lupus erythematosus
Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.

Official Title
-----------------
An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin aspart
* Drug: human soluble insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IDet + IAsp users<br> | Drug: insulin detemir<br>* Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any<br>Drug: insulin aspart<br>* Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any<br>|
| IDet + HI users<br> | Drug: insulin detemir<br>* Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any<br>Drug: human soluble insulin<br>* Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 7-point blood glucose variability |  |  | 
| Change in body weight |  |  | 
| Insulin dose |  |  | 
| Number of injections |  |  | 
| Number of hypoglycaemic episodes |  |  | 
| Number of adverse events |  |  |