linjc16/ctgov huggingface dataset:
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Official Title
-----------------
A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Drug: solifenacin succinate
* Drug: tolterodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients willing and able to complete the micturition diary correctly Patients experiencing frequency of micturition as verified in the diary Patients experiencing significant post void residual volume OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more. Exclusion Criteria: Significant post void residual volume Patients with indwelling catheters or practicing intermittent self- catheterization Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: solifenacin succinate<br>* Oral<br>* Other names: YM905;|
| Active Comparator: 2<br> | Drug: tolterodine<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of micturitions per 24 hours |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean volume voided per micturition |  | 8 Weeks | 
| Change from baseline in mean number of incontinence episodes per 24 hours |  | 8 Weeks | 
| Change from baseline in mean urgency frequency per 24 hours |  | 8 Weeks | 
| Change from baseline in mean nocturia episodes per 24 hours |  | 8 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solifenacin, Overactive bladder, Urinary incontinence, Treatment outcomes, VESIcare
Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the concentrations of interleukin-2, interleukin-10, interferon-gamma, PD1+ lymphocytes, and the interleukin-10 receptor expression in malignant and benign effusions.

Detailed Description
-----------------
In this prospective trial, 80 patients with pleural effusions and indication for thoracocentesis, drainage, indwelling pleural catheter (IPC) management and/or video-assisted thoracoscopic surgery are enrolled. The pleural effusion will be examined for different cytokines, cytokine-receptors, PD1-lymphocytes and CD4+/CD25+/Foxp3+ regulatory T cell.

Official Title
-----------------
Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study

Conditions
-----------------
Pleural Effusion

Intervention / Treatment
-----------------
* Diagnostic Test: Pleural effusion will be examined for various cytokines and PD1-lymphocytes.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years radiologically confirmed pleural effusion with an indication for puncture, pleural drain insertion, or video-assisted thoracoscopy for diagnostic and/or therapeutic reasons Signed declaration of consent Exclusion Criteria: Withdrawal or cessation of participation

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with pleural effusion<br>In patients with pleural effusion and indication for diagnostic and/or therapeutic procedures (thoracocentesis, drainage of fluid, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery), pleural fluid will be examined for various cytokines and PD1-lymphoctyes. | Diagnostic Test: Pleural effusion will be examined for various cytokines and PD1-lymphocytes.<br>* Examination of pleural effusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions |  | 12 months |
Muscle Strength Loss In Stroke Individuals - Control Study

Study Overview
=================
Brief Summary
-----------------
ABSTRACT The muscle strength (MS) is necessary to overcome the resistance encountered during the activity. The present study aims to determine MS loss in stroke individuals (SI). 33 SI and 33 healthy individuals (HI) were included in this study. MS and handgrip force were assessed using a power track dynamometer and Jamar hand dynamometer, respectively. The total MS of the HI was calculated by summing the muscle strength of the trunk, lower and upper extremities. In the SI, the muscle strength of the trunk, unaffected upper and lower extremities were summed to calculate the total MS. To compare MS of unaffected sides (US) between groups, 27 SI who was dominant and not affected on the right side and 33 HI who was dominant on the right side were used.

Official Title
-----------------
Muscle Strength Loss In Stroke Individuals - Control Study

Conditions
-----------------
Stroke Rehabilitation

Intervention / Treatment
-----------------
* Other: assesment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for patient with stroke Between 30-65 ages Diagnosed with stroke chronic stroke patients (diagnosed with a stroke at least 6 months ago) for healthy individuals 30-65 ages healthy individuals Exclusion Criteria for patient with stroke patient with an additional neurological disease to stroke patients with orthopedic problems, patients with mental and communication impairments patients who scored more than 3 points for the Modified Rankin Scale for healthy individuals; who had active sporting life

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: individuals with stroke and healthy subject
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stroke individuals<br> | Other: assesment<br>* muscle strength assessment in stroke individuals<br>|
| Active Comparator: healthy individuals<br> | Other: assesment<br>* muscle strength assessment in stroke individuals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength Loss In Stroke Individuals - Control Study | muscle strength of stroke individuals was assesed by power track hand held dynamometer and The Jamar Hand dynamometer, And recorded in newton. | 24 week |
Hemostatic Effect of Various Colloid Solutions

Study Overview
=================
Brief Summary
-----------------
Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. A newly market-released balanced HES (670/0.75) has physiologic pH and balanced electrolytes including calcium, which are beneficial to coagulation. Studies comparing balanced HES (670/0.75) with saline-based HES (130/0.4), previously known the least coagulopathic are rare. Therefore, we try to reveal the difference of coagulation, pH/electrolyte balance, and bleeding amount between the non-O and O blood types after infusion of these two newest HES. Methods: Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery involving 2 or 3 spinal levels were enrolled. 20 ml/kg of saline-based HES (130/0.4) or balanced HES (670/0.75) was administered during operation. Blood loss, coagulation and metabolic profiles were checked at pre-infusion (T0), 5 min after infusion (T1), 4 hrs after infusion (T2) and 24 hrs after infusion (T4).

Official Title
-----------------
Hemostatic Effect of Various Colloid Solutions According to Blood Types

Conditions
-----------------
Laminectomy

Intervention / Treatment
-----------------
* Drug: administration of hydroxyehtyl starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of ASA 1 or 2, and scheduled for posterior laminectomy and internal fixation at two or three spinal levels. Exclusion Criteria: the presence of cardiovascular diseases, cerebral vascular disease, hepatic, pulmonary, or renal disease, hemoglobin < 12 g/dl, platelet count < 150,000 /ml, coagulopathy, taking medication likely to alter coagulation less than 2 weeks before the study, or an allergic reaction to HES

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: administration of hydroxyehtyl starch|colloid is administered during operation according to blood loss.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss, coagulation and metabolic profiles |  | pre-infusion, 5 min after infusion, 4 hrs after infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hydroxyethyl starch, blood type, coagulation
Oral Ketorolac for Arthroscopic Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following arthroscopic rotator cuff repair. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following arthroscopic rotator cuff repair.

Official Title
-----------------
Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair

Conditions
-----------------
Rotator Cuff Tear, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients between the ages of 18 and 89 years old, male or female Patients undergoing primary shoulder arthroscopic rotator cuff repair Exclusion Criteria Patients below the age of 18 or above the age of 89 Illiterate or non-English speaking patients Patients with contraindications to Ketorolac History of alcohol of drug abuse Chronic use of analgesic or psychotropic drugs Known peptic ulcer disease or bleeding diathesis Renal dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Ketorolac<br> | Drug: Ketorolac<br>* Oral Ketorolac<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Visual Analog Scale Scores | The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome. | participants were assessed at one single time point up to 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Retear of Rotator Cuff Repair | Assessing retear of rotator cuff repair on postop MRI. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotator Cuff Tear, Postoperative Pain
Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program for Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.

Official Title
-----------------
Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program Entitled START-HPV (STudy of Primary Screening in the ARdennes Department by Testing for HPV Infection)

Conditions
-----------------
HPV Infection

Intervention / Treatment
-----------------
* Biological: Human papillomavirus genotyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to live in the Ardennes department (France) affiliation to a health insurance organism 31 to 65 years old Exclusion Criteria: current follow-up for cervical cytological abnormalities history of hysterectomy reimbursement for a Pap smear in the last 3 years

Ages Eligible for Study
-----------------
Minimum Age: 31 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women tested positive for hrHPV<br>All women participating in START-HPV pilot program for cervical cancer screening and tested positive for hrHPV with the Hybrid Capture 2 test (Qiagen). | Biological: Human papillomavirus genotyping<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV genotyping | DNA extraction from cervical smears (DNAPap Cervical Sampler device, Qiagen) or from self-collected vaginal lavages (Delphi-screener device, DelphiBioscience) and HPV genotyping with the Multiplex HPV Genotyping kit© (Multimetrix, Progen) based on a Luminex technology | Day 0 |
Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg

Study Overview
=================
Brief Summary
-----------------
This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.

Official Title
-----------------
A Randomized, Open-label, Parallel, Multi-Center Phase IV Study to Compare of the Efficacy and Safety of Lipilou 20 mg and Lipilou 10 mg in High-risk Patients With Hypercholesterolemia(PEARL Study)

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Lipilou®(generic atorvastatin drug) 20 mg
* Drug: Lipilou®(generic atorvastatin drug) 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia. Exclusion Criteria: Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction. Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: Experimental group<br> | Drug: Lipilou®(generic atorvastatin drug) 20 mg<br>* Patients assigned to experimental group are treated with Lipilou® 20 mg<br>|
| Active Comparator: Comparator group<br> | Drug: Lipilou®(generic atorvastatin drug) 10 mg<br>* Patients assigned to comparator group are treated with Lipilou® 10 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rate in LDL-C | compare experimental group with comparator group | 12 weeks of treatment |
The Neurological Pupil Index (NPi) on Intensive Care Unit (ICU) Trial

Study Overview
=================
Brief Summary
-----------------
The trial will evaluate the use of the Neurological Pupil index NPi, measured with the digital pupillometer (NeurOptics) compared to clinical examination for better reliability. The investigators hypothesize that digital evaluation will offer a higher sensitivity/ specificity compared to clinical examination.

Detailed Description
-----------------
Absent pupillary reaction after cardiac arrest might indicate a severe hypoxic encephalopathy. Because the examination of the pupillary reaction is easy it is part of the clinical routine but due to the different medication and the dynamic process of reperfusion injury to the brain a clinical evaluation might be not precise enough. The NPi has been shown to be superior to clinical evaluation in different settings but without regard towards cardiac arrest survivors. The Pupillometer is a hand-held, cordless, and simple to use device which removes subjectivity in the measurement of pupil size and the pupillary light reflex.

Official Title
-----------------
Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest

Conditions
-----------------
Hypoxic Encephalopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all survivors after cardiac arrest Exclusion Criteria: underlying disease limiting the pupillary reflex

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neurological Pupil index<br>The NPi will be measured during treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Pupil index (NPi) on a scale from 0-5 | NPi values by the device on a scale by 0-5; >3 indicates normal reaction; <3 abnormal. | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral performance category (CPC) | cerebral performance category; 1-2 good outcome; 3-5 poor outcome | Patients will be followed for the duration of hospital stay, an expected average of 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoxic encephalopathy, cardiac arrest, outcome, pupillary reflex
Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.

Official Title
-----------------
Neuropsychiatric Effects of Deep Brain Stimulation in Patients With Parkinson's Disease

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

Intervention / Treatment
-----------------
* Procedure: Stimulation of the subthalamic nucleus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants diagnosed with idiopathic Parkinson's disease that meet criteria for treatment of their disease with STN-DBS. Participants will be selected for this study without regard for age (provided they are older than 18), gender or ethnic background. Participants must have undergone subthalamic nucleus DBS surgery and be receiving treatment at the Scripps Clinic in La Jolla, CA Exclusion Criteria: Patients under 18 years old. Patients with mini-mental status scores below 26/30. Patients with known psychiatric disease. Patients who are too infirm, demented or dysarthric to clearly understand the consenting process, task instructions, or to communicate verbally regarding participation or non-participation.

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: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>Parkinson's patients with deep brain stimulation in the subthalamic nucleus. | Procedure: Stimulation of the subthalamic nucleus<br>* Stimulation is delivered to the subthalamic nucleus at experimentally prescribed settings.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| behavioral task performance | Participants will complete behavioral tasks at each of three visits to assess the effects of stimulation settings on task performance. At each research visit, behavior will be assessed beginning at 1 hour after the stimulation is adjusted to the experimental settings. Stimulation settings will be returned to each patient's treatment levels at the culmination of each visit. | 1 to 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep brain stimulation, subthalamic nucleus