linjc16/ctgov huggingface dataset:
Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.

Official Title
-----------------
Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder

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

Intervention / Treatment
-----------------
* Drug: Darifenacin
* Drug: Darifenacin
* Behavioral: Behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of overactive bladder Capable of independent toileting and completing a micturition diary Able to comprehend English and follow study procedures and instructions Exclusion Criteria: Post void residual > 100ml/sec Urine flow rate (Qmax) <10ml/sec for males only Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Darifenacin | Drug: Darifenacin<br>* Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily<br>* Other names: Enablex;|
| Other: 2<br>Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder | Drug: Darifenacin<br>* Darifenacin tablets 7,5 mg or 15 mg once daily<br>Behavioral: Behavioral therapy<br>* Behavioral Modification Programme for symptoms of overactive bladder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average number of urinations per patient per day at Week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6 |  |  | 
| Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal urinations per day measured at Weeks 2, 6, 12 |  |  | 
| Quality of Life (baseline, Week 6, Week 12) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OAB, Overactive Bladder, Bladder hyperactivity, Urge Incontinence, Incontinence, Bladder
Erythropoietin Treatment in Patients With Systolic Left Ventricular Dysfunction, Mild Anemia and Normal Renal Function

Study Overview
=================
Brief Summary
-----------------
Erythropoietin Treatment in Patients with systolic left ventricular dysfunction, mild anemia and normal renal function

Official Title
-----------------
Phase 4 Study on the Efficacy of Erythropoietin Treatment in Patients With Systolic Left Ventricular Dysfunction, Mild Anemia and Normal Renal Function

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic heart disease Systolic lv dysfunction Mild anemia Normal renal function Stable condition Exclusion Criteria: Pregnancy Unstable condition Under 18 years old

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
How to Predict Lung Recruitment at the Bedside in Patients Affected by Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)

Study Overview
=================
Brief Summary
-----------------
The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis.

Detailed Description
-----------------
The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis: stress index technique peep test recruitment technique used in the EXPRESS study recruitment technique used in the LOV study

Official Title
-----------------
How to Predict Lung Recruitment at the Bedside in Patients Affected by Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome Mechanical ventilation Exclusion Criteria: Clinical diagnosis of chronic obstructive pulmonary disease Clinical diagnosis of pneumothorax Haemodynamic instability

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Different Frequencies Weekly Training in Overweight/Obese Women

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effects of a resistance training programme of one or three times a week on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women

Detailed Description
-----------------
This study aimed to determine the effects of supervised structured 6 months resistance training and a restricted caloric diet on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women. 45 women were randomly assigned to one of two groups: a group with a high-weekly frequency of three times a week (HIGH) and a group that performed only one weekly session (LOW).HbA1c, percentage of fat mass and handgrip strength were taken before and after the intervention period.

Official Title
-----------------
Comparison of the Effect of Different Frequencies Weekly Training on Body Composition, Cardiometabolic Risk Factors and Handgrip Strength in Overweight and Obese Women

Conditions
-----------------
Sensitivity Training Groups

Intervention / Treatment
-----------------
* Other: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overweight or obese Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High weekly training frequency<br>three sessions a week of resistance training | Other: Resistance training<br>* Physical activity<br>|
| Experimental: Low weekly training frequency<br>one workouts per week | Other: Resistance training<br>* Physical activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass | anthropometric measurements | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength | mechanical dynamometer | 24 weeks |
Validation of Swedish Short PROM för Venous Insufficiency

Study Overview
=================
Brief Summary
-----------------
Validation of a new short Swedish patient reported outcome measure for superficial venous insufficiency. Analysis of its capacity to measure quality of life and its responsiveness to change caused by treatment.

Official Title
-----------------
Validation of a Swedish Version of a Short Patient-Reported-Outcome-Measure for Superficial Venous Insufficiency

Conditions
-----------------
Superficial Venous Insufficiency, Quality of Life, Change After Treatment

Intervention / Treatment
-----------------
* Other: patient reported outcome measure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: agrees to participate, diagnosed with superficial venous insufficiency C2-C6 Exclusion Criteria: does not want to participate, less than C2, does not submit the answered questionnaires
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>test-retest at baseline and 7 days later | Other: patient reported outcome measure<br>* 2 questionnaires are tested against each other<br>|
| Cohort 2<br>test at baseline and 8 weeks post treatment | Other: patient reported outcome measure<br>* 2 questionnaires are tested against each other<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the short PROM is valid for measurement of quality of life and detects change caused by treatment |  | baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient reported outcome measure
Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media. (CLAVAMOX is a trademark of the GlaxoSmithKline group of companies.)

Official Title
-----------------
Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)

Conditions
-----------------
Otitis Maedia

Intervention / Treatment
-----------------
* Drug: Amoxicillin and clavulanate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Maximum Age: 14 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 |
| --- | --- |
| Pediatrics patients prescribed amoxicillin and clavulanate<br>Pediatrics patients prescribed amoxicillin and clavulanate for treatment of diseases other than otitis media during study period | Drug: Amoxicillin and clavulanate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidence of adverse events in Japanese pediatric patients, with diseases other than otitis media, treated with amoxicillin and clavulanate based on prescribing information |  | 2 months | 
| Clinical symptoms after treatment with amoxicillin and clavulanate |  | 2 months |
Integrative Analysis of Large-cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Integrative analysis of LCLC

Detailed Description
-----------------
The investigators will analyzed proteomes of paired normal lung tissues and LCLC with or without liver metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary LCLC carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Official Title
-----------------
Integrative Analysis of Large-cell Lung Carcinoma

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: Normal lung tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 75 years with histologically proven LCLC No severe major organ dysfunction World Health Organization (WHO) performance status of 0 or 1 No prior cancer chemotherapy Exclusion Criteria: Age ≥ 76 Severe major organ dysfunction WHO performance status of >1 Prior cancer chemotherapy

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal lung tissue<br>Normal lung tissue from LCLC patients | Other: Normal lung tissue<br>* The investigators will extract total protein, DNA and RNA from LCLC patients.<br>|
| LCLC tissues<br>LCLC tissues from LCLC patients | Other: Normal lung tissue<br>* The investigators will extract total protein, DNA and RNA from LCLC patients.<br>|
| Metastasis tissues<br>Metastasis tissues from LCLC patients | Other: Normal lung tissue<br>* The investigators will extract total protein, DNA and RNA from LCLC patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 years overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 years disease-free survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LCLC; Integrative Analysis; Metastasis
Circulating-water Garment With Forced-air Warming and Circulating-water Mattress During Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the combination of a circulating water mattress beneath the patient combined with forced air warming over top of the patient will prevent hypothermia (low body temperature) just as well as a garment that circulates warm water around the patient, during your major abdominal surgery. Patients will be randomly assigned to one of these two groups.

Detailed Description
-----------------
Group A: This group will receive the circulating water garment Group B: This group will receive the circulating water mattress and be covered by a forced air warming device for both the upper body and lower body Once the patient is moved to the operating room table, the surface of the back will begin to be warmed using either the circulating-water garment for those in Group A or the circulating-water mattress for those in Group B. Following the start of anesthesia, additional warming will be done by covering the large parts of the legs and the upper and side of the chest using either the circulating-water garment for those in Group A or upper- and lower-body forced-air warmers for those in Group B. Patient involvement will last until the warming devices are removed prior to departure from the operating room. There is no follow-up to this study.

Official Title
-----------------
Comparison of a Circulating-water Garment With a Combination of Forced-air Warming and Circulating-water Mattress Warming During Major Abdominal Surgery

Conditions
-----------------
Hypothermia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MaJor abdominal surgery Age between 18 and 85 years. Exclusion Criteria: Fever (core temperature >38°C) Combined procedures (e.g.: simultaneous liver and kidney transplantation) Contraindication to forced-air or circulating-water warming which would be impacted by use of warming blanket Anticipated veno-venous bypass Current Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| A<br>This group will receive the circulating water garment | |
| B<br>This group will receive the circulating water mattress and be covered by a forced air warming device for both the upper body and lower body connected to two warmers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will comprise the difference between the pre-induction temperature and the intraoperative temperature |  | Every 15 minutes throughout surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal surgery, hypothermia, circulating water mattress
Ablation for ICD Intervention Reduction in Patients With CAD

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The patients will be randomized into ablation arm and conventional treatment. Number of appropriate ICD interventions is the primary endpoint of this study. All patients will have control follow-up visits every 3 months. The follow-up will be based on ICD memory.

Official Title
-----------------
Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial

Conditions
-----------------
Ventricular Tachycardia, Coronary Artery Disease, Implantable Cardioverter-Defibrillator

Intervention / Treatment
-----------------
* Procedure: ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary Artery Disease ICD implanted Appropriate ICD intervention during the 3 months prior to enrollment Coronary angiography during the 6 months prior to enrollment Possible revascularization Age over 18 years Signed informed consent Exclusion Criteria: Age less then 18 years Pregnancy Active participation in other trial Heart failure (NYHA IV) Contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access. Monomorphic, incessant, ventricular tachycardia Revascularization or other cardio-surgical procedure scheduled in the next 6 months

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

| Intervention/Treatment |
| --- |
|Procedure: ablation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of appropriate ICD interventions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality |  |  | 
| Cardiac mortality |  |  | 
| Hospitalization due to arrhythmia or heart failure |  |  | 
| Quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ablation, Ventricular tachycardia, coronary artery disease, Implantable cardioverter defibrillator interventions
Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain

Study Overview
=================
Brief Summary
-----------------
Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.

Official Title
-----------------
Phase II Double-Blind, Placebo-Controlled Study of the Safety and Preliminary Effectiveness of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)
* Drug: alcohol-based gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended. Hair that covers the scalp and is at least 1/4 inch in length Exclusion Criteria: Receiving chemotherapy known to cause alopecia within 60 days of study or during the study. Pre-existing alopecia Previous brain radiotherapy scalp metastases or scalp wounds use of hair dyes

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MTS-01 (7% Tempol gel) | Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)<br>* 200mL gel applied daily prior to radiation dose and removed immediately thereafter.<br>|
| Placebo Comparator: 2<br>Vehicle | Drug: alcohol-based gel<br>* 200mL gel applied daily prior to radiation dose and removed immediately thereafter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo. |  | Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alopecia, Hair loss, Radiation, Whole brain radiotherapy, Radiation-induced alopecia