linjc16/ctgov huggingface dataset:
A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

Conditions
-----------------
Chronic Idiopathic Constipation

Intervention / Treatment
-----------------
* Drug: KWA-0711
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation Exclusion Criteria: Patients who have secondary constipation caused by systemic disorder Patients who have organic constipation Patients who received intestinal resection

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug:KWA-0711 dose 1<br> | Drug: KWA-0711<br> <br> |
| Experimental: Drug:KWA-0711 dose 2<br> | Drug: KWA-0711<br> <br> |
| Experimental: Drug:KWA-0711 dose 3<br> | Drug: KWA-0711<br> <br> |
| Experimental: Drug:KWA-0711 dose 4<br> | Drug: KWA-0711<br> <br> |
| Placebo Comparator: Drug: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of signs and symptoms associated with constipation |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Idiopathic Constipation (CIC), Constipation, Functional gastrointestinal disorders
Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at least one eye.

Official Title
-----------------
Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study

Conditions
-----------------
Patients Implanted With Monofocal Intraocular Lens

Intervention / Treatment
-----------------
* Device: Monofocal Intraocular Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients at least 18 years of age Patients who underwent routine cataract surgery with phacoemulsification and monofocal iol placement in the capsular bag in at least one eye within the last 36 months At least 1 month postop before follow-up evaluation All Patients must have a DCVA of 20/25 or better

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

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 |
| --- | --- |
| Near visual outcomes with Monofocal IOL<br>Evaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye. | Device: Monofocal Intraocular Lenses<br>* Monofocal Intraocular Lenses<br>|
| Intermediate Visual outcomes<br>Evaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye. | Device: Monofocal Intraocular Lenses<br>* Monofocal Intraocular Lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Previous Cataract patients, Monofocal IOL implant, Evaluation
Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate health status of uncontrolled Chronic Obstructive Pulmonary Disease (COPD) patients in response to treatments in clinical practice.

Detailed Description
-----------------
MC MD

Official Title
-----------------
Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Male or non-pregnant female aged >40 years A clinical diagnosis of COPD with FEV1/ FVC <0.70 and require combination or modified therapy Smoke > 10 Pack Year Exclusion Criteria: Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) Participation in a clinical study (precluding non-interventional study or registry) during the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 41 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 |
| --- | --- | --- |
| Changes in PEF and overall CCQ score |  | between the first visit and after 12 (plus or minus 1) weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of the changes of PEF and overall CCQ score comparing between various treatments |  | between the first visit and after 12 (plus or minus 1) weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD and CCQ score, Changes in PEF,overall CCQ score
Effect of Cranberry Juice on Endothelial Function

Study Overview
=================
Brief Summary
-----------------
A pilot study of 15 subjects will be completed to determine whether acute consumption of cranberry juice has an effect on endothelial function. We will then complete a randomized, double blind, placebo controlled crossover study designed to investigate the effects of cranberry juice consumption on endothelial function. Participants (n=40) will drink 480 ml of double strength cranberry juice or a similar appearing and tasting placebo per day for four weeks. After a two week rest period, they will cross over to the other beverage. We will examine endothelial function before and after each of the two treatment periods. The study will provide information about the chronic vascular effects of cranberry juice.

Official Title
-----------------
Long-Term Effects of Cranberry Juice on Endothelial Function in Patients With Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Cranberry juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery disease Exclusion Criteria: Pregnant and lactating women Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate Treatment with an investigational new drug within the last 30 days History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study. Treatment with Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 2 weeks of enrollment (subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the RDA will not be excluded).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Cranberry juice|480 ml of double strength cranberry juice daily for four weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow-mediated dilation |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid-femoral pulse wave velocity |  | 1 month | 
| Markers of inflammation |  | 1 month | 
| Serum anthocyanins |  | 1 month |
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Detailed Description
-----------------
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions

Conditions
-----------------
Parkinson's Disease, Restless Leg Syndrome

Intervention / Treatment
-----------------
* Drug: Ropinirole Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to ropinirole or any other comparable product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ropinirole Hydrochloride|Restless Leg Syndrome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two Period, seven day washout |
Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

Study Overview
=================
Brief Summary
-----------------
This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-L.

Official Title
-----------------
Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receipt of at least one dose of algenpantucel-L within the past 15 years Signed consent

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 |
| --- | --- | --- |
| Proportion of subjects with adverse events. |  | Up to 15 years | 
| Survival |  | Up to 15 years |
Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients

Study Overview
=================
Brief Summary
-----------------
This retrospective observational study included patients (pts) with percutaneous coronary intervention (PCI) of a de novo coronary bifurcation lesion in one German center between January 2008 - August 2011. The investigators included all consecutive patients where the side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded. Two different methods were compared: group A represents patients with a simple strategy without any treatment of the side branch (SB). Group B consisted of patients where the SB was treated (PCI and/or stenting). For the treatment of bifurcation lesions we used the concept of provisional stenting, indications for the treatment of the SB were residual stenosis > 50 %, TIMI flow reduction < 2. Final-kissing PCI was intended in all patients of group B. MACE during follow-up was evaluated in all patients.

Official Title
-----------------
Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients

Conditions
-----------------
Coronary Bifurcation Lesions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients with a bifurcation lesion, where the side branch was covered with a stent placed inside the main branch. Exclusion Criteria: Patients with an in-stent-restenosis, patients with a therapy using a drug coated balloon during the procedure (inside the main branch and/or the side branch) and patients where the side branch was not covered by the stent inside the main branch.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| PCI without treating the side branch<br> | |
| PCI with treating the side branch<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac outcome |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary intervention, PCI of the side branch
Validity and Reliability of The Turkish Version of Assessment of Burden of COPD Scale

Study Overview
=================
Brief Summary
-----------------
In our study, we aimed to evaluate the validity and reliability of the Turkish version of theAssessment of Burden of COPD (ABC) Scale.

Detailed Description
-----------------
Chronic obstructive pulmonary disease (COPD) is a common pulmonary disease characterized by airway limitation, irreversible, preventable, and treatable (1,2). COPD is a major health problem that affects the entire world and is expected to be the fourth, the seventh, cause of death in 2030 (3). The concept of holistic assessment of disease burden is widely used to support the personalized care management of COPD patients. Disease burden; physical, psychological, emotional and / or social burden felt by the patient. When the questionnaires in the literature evaluating the quality of life / health status in COPD patients were examined, it was seen that none of these questionnaires included all aspects of COPD burden definition (4). Clinical COPD Questionnaire (CCQ) is a 10-question questionnaire that assesses COPD burden in most aspects and situations. Assessment of Burden of COPD (ABC) Scale was developed to evaluate the burden of disease in COPD patients by adapting this questionnaire. The ABC scale was formed by combining three items (a short tool for early identification of distress) and a substance that measures fatigue with the questions of the CCQ scale. As a result, a scale of 14 items with 5 fields was formed.

Official Title
-----------------
Validity and Reliability of The Turkish Version of Assessment of Burden of COPD Scale

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FEV1/FVC<%70 To be able to read and understand Turkish Exclusion Criteria: Having undergone a COPD exacerbation in the last 6 weeks Having comorbidities affecting ambulance Having cognitive disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Burden of COPD (ABC) Scale | The ABC scale is a 14-item newly developed COPD burden assessment questionnaire that the person responds to on their own. The scale includes questions that are objective determinants of COPD disease burden integrated with the health status of the patient. There is a total score and 5 subtitle scores; symptoms (4 items), functional status (4 items), mental condition (2 items), emotional condition (3 items) and fatigue (1 item). Scoring is done between 0 and 6 (0 = no disease burden, 6 = high disease burden). | 3 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Burden of disease
Evaluation of Acute Post-thrombectomy Complications for Stroke

Study Overview
=================
Brief Summary
-----------------
Retrospective study to assess the incidence of acute complications after thrombectomy for stoke.

Detailed Description
-----------------
Research in the computerized medical file of patients admitted to intensive care unit (ICU) in the last 5 years for a stroke. Searching for acute complications during the ICU stay. Looking for hemorrhagic, acute renal failure, hemodynamic support, neurologic degradation.

Official Title
-----------------
Evaluation of Acute Post-thrombectomy Complications for Stroke

Conditions
-----------------
Stroke, Complication, Stroke, Acute, Stroke Hemorrhagic

Intervention / Treatment
-----------------
* Procedure: Thrombectomy for stroke


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 year old ICU admitted patient for stroke and received thrombectomy Exclusion Criteria: missing data

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

| Intervention/Treatment |
| --- |
|Procedure: Thrombectomy for stroke|Patients who have had thrombectomy for acute stroke.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | death during ICU stay | day 0 to day 5 | 
| hemorrhagic complication | hemorrhagic complication base on CT scan at day 1 | day 1 | 
| Neurological evaluation | Neurological evaluation based on Glasgow coma scale (from 3 pejorative to 15/15 good) | day 0 to day 5 | 
| Evolution of renal function | Evaluation based on biological analyses : creatinine value based on daily routine blood analysis (in mg/dL). | day 0 to day 5 |
Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?

Study Overview
=================
Brief Summary
-----------------
Diseased left Anterior descending coronary artery (LAD) is one of the most challenging conditions in Bypass surgery. we investigate whether on-pump coronary artery bypass grafting (CABG) is more beneficial in those critical patients or off-pump surgery.

Official Title
-----------------
Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?

Conditions
-----------------
CAD - Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: On-Pump CABG
* Procedure: Off-Pump CABG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient with diffuse LAD disease indicated for open heart surgery Exclusion Criteria: no concomitant valve disease any patient can be treated by medical treatment or PCI

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Case<br>Patients with extensive LAD disease treated with off-pump CABG | Procedure: Off-Pump CABG<br>* coronary artery grafting by beating heart technique<br>|
| Other: Control<br>Patients with extensive LAD disease treated with on-pump CABG | Procedure: On-Pump CABG<br>* coronary artery grafting by using cardiopulmonary bypass machine<br>* Other names: CABG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | follow up post-operative track of the patient for any noticed mortality rate | 30 days post operative | 
| Morbidity | follow up post-operative track of the patient for any noticed complications | 60 days post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
On-pump, off-pump, CABG, LAD