linjc16/ctgov huggingface dataset:
Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX

Official Title
-----------------
A Randomized, Double-blind, Active Controlled, Multi-center, Phase 1 Study to Investigate the Safety of MEDITOXIN® in Female Subjects With Idiopathic Overactive Bladder

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Meditoxin
* Drug: Botox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged more than 20 years Subject who has symptoms of Overactive Bladder for a period of at least 6 months immediately prior to screening Exclusion Criteria: - Patient not appropriate for participating in this study according to the investigator's opinion

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDITOXIN<br> | Drug: Meditoxin<br>* Meditoxin (Botulinum toxin type A)<br>|
| Active Comparator: BOTOX<br> | Drug: Botox<br>* Botox(Botulinum toxin type A)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in adverse events of MEDITOXIN at 12 week | safety profiles | baseline, week 12 follow up visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the daily average number of episodes of urinary incontinence | Urinary incontinence recorded by the participants in a bladder diary during the 3 consecutive days prior to the study visit. | baseline, week 12 follow up visits |
Effects in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo.

Official Title
-----------------
Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital admission for ACS with chest pain or discomfort occurring during rest or with minimal exertion, Percutaneous coronary intervention (PCI) planned, Evidence of coronary artery disease Exclusion Criteria: Hypersensitivity to statins Any cholesterol lowering medication taken within 1 month prior V1 Sustained ST-segment elevation on ECG

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|nan|
|Drug: Atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage changes in ApoB/ApoA-I levels |  | from Day 0 to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage changes in LDL-C |  | from Day 0 to 1 month and 3 months | 
| Percentage changes in the hs-CRP and AUC of hs-CRP levels |  | from Day -6 to Day 0 | 
| Percentage changes in ApoA-I |  | from Day 0 to 1 month |
Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.

Official Title
-----------------
A Phase 2 Randomized, Open-Label, Multicenter Study Evaluating Administration of Repeated Intravitreal Doses of ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Conditions
-----------------
Choroidal Neovascularization, Wet Macular Degeneration

Intervention / Treatment
-----------------
* Biological: ICON-1
* Biological: aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females of any race, ≥50 years of age Active primary CNV secondary to AMD in the study eye Exclusion Criteria: Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months Vitrectomy in the study eye

Ages Eligible for Study
-----------------
Minimum Age: 50 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: ICON-1 maintenance therapy<br>ICON-1 maintenance therapy after initial aflibercept treatment | Biological: ICON-1<br>* ICON-1 0.6 mg by intravitreal injection<br>* Other names: human Immuno-conjugate 1;Biological: aflibercept<br>* aflibercept 2 mg by intravitreal injection<br>* Other names: Eylea®;|
| Experimental: ICON-1 combination therapy<br>ICON-1 combination therapy with aflibercept treatment | Biological: ICON-1<br>* ICON-1 0.6 mg by intravitreal injection<br>* Other names: human Immuno-conjugate 1;Biological: aflibercept<br>* aflibercept 2 mg by intravitreal injection<br>* Other names: Eylea®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Choroidal Neovascularization (CNV) Over Time | Mean change from baseline in CNV area in the study eye | Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best Corrected Visual Acuity (BCVA) Over Time | Mean change from baseline in BCVA letter score in the study eye | Month 9 |
FFS - Far Field Sensing Test Study in Cardiac Dual Chamber Pacemakers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers.

Detailed Description
-----------------
Far-field R-wave sensing (FFS) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate mode switch from the DDD mode to the DDI or VDI mode. Inappropriate loss of atrioventricular synchrony due to false positive mode switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker Holter data. The aim of the study is to determine whether individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test is effective in avoiding inappropriate mode switch due to FFS when compared to standard programming of the PVAB

Official Title
-----------------
Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Individualized Programming of PVAB
* Device: Nominal PVAB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for dual chamber pacing Implantation of an Identity DR pacemaker (St. Jude Medical) Bipolar atrial pacing electrode Exclusion Criteria: Heart failure NYHA III and IV Unstable angina pectoris Indication for the implantation of an ICD Cardiac surgery within previous 6 months Cardiac surgery planed for the next 3 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Optimization of the postventricular atrial blanking period to avoid far-field R-wave sensing. | Device: Individualized Programming of PVAB<br>* Performance of a test to detect far-field R-wave sensing<br>|
| Experimental: 2<br>Programming of the nominal setting for the post-ventricular atrial blanking period (100 ms) | Device: Nominal PVAB<br>* nominal pacemaker settings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of inappropriate mode switch due to far field R-wave sensing |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position |  | 3 months |
Brava and Fat Transfer for Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
Breast reconstruction is one of the most challenging aspects in plastic surgery. One of the most sophisticated methods of breast reconstruction is using of autologous fat grafting. Brava is a device that invented by Dr Roger Khouri, and is intended to improve the final results of fat grafting.

Detailed Description
-----------------
The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.

Official Title
-----------------
Brava and Fat Transfer for Breast Reconstruction

Conditions
-----------------
Fat Necrosis of Breast

Intervention / Treatment
-----------------
* Device: Brava


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman after mastectomy Exclusion Criteria: smokers collagen disease low compliance

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brava and fat transfer<br>The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it. | Device: Brava<br>* The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients satisfied with breast reconstruction using Brava and fat transfer | patients undergoing breast mastectomy will undergo breast reconstruction using the Brava and fat transfer, and will be assessed by a certified plastic surgeon who will not be a part of the study. | 6 months |
Better tArgetting, Better Outcomes for Frail ELderly Patients

Study Overview
=================
Brief Summary
-----------------
The acronym for this proposal, BABEL, refers to the fact that a common language - the interRAI risk-stratification and decision-making tool - will be used in this project, allowing several measures of care quality in long-term care facilities to be compared with those in other provinces for the first time. The impact of the use of this assessment system and associated care planning protocols will also be investigated using usual practice as the point of reference.

Official Title
-----------------
Better tArgetting, Better Outcomes for Frail ELderly Patients: A Quality Improvement Initiative in Long-term Care Facilities Using interRAI Long-term Care Assessment in Quebec

Conditions
-----------------
Residents in Longterm Care Facilities

Intervention / Treatment
-----------------
* Other: interRAI LTCF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All nursing home residents in a particular unit where standardized evaluations are being introduced (for example, all residents in a particular floor or wing of the longterm care facility) Exclusion Criteria: Residents who are admitted to a nursing home unit for less than 1 week.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| interRAI LTCF<br>Nursing homes in Quebec where interRAI evaluations and care plans will be introduced. | Other: interRAI LTCF<br>* Standardized evaluations (interRAI LTCF) will be introduced to selected nursing homes in Quebec.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression prevalence | Depression rating scale score of 3 or more (from interRAI LTCF) | Every 3 months, for a minimum of 6 months and a maximum of 36 months | 
| Change in prevalence of potentially inappropriate antipsychotic use | Use of antipsychotics in the absence of an appropriate diagnosis | Every 3 months, for a minimum of 6 months and a maximum of 36 months | 
| Change in falls prevalence | Prevalence of falls among residents under study | Every 3 months, for a minimum of 6 months and a maximum of 36 months | 
| Change in prevalence of pain | Using interRAI pain scale scores greater than 0 | Every 3 months, for a minimum of 6 months and a maximum of 36 months | 
| Change in the prevalence of physical restraints use | Use of physical restraints on residents as assessed using interRAI LTCF | Every 3 months, for a minimum of 6 months and a maximum of 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in prevalence of pressure ulcers | Stage 2 pressure ulcer on the interRAI pressure ulcer scale | Every 3 months, for a minimum of 6 months and a maximum of 36 months |
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.

Official Title
-----------------
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration

Conditions
-----------------
Exudative Macular Degeneration, Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Avastin
* Drug: Avastin
* Drug: Lucentis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female age 18 to 85 with diabetes and hemoglobin A1C </= 10, or exudative macular degeneration. Diabetic macular edema with average retinal thickness central subfield >/= 290um. Exclusion Criteria: Macular atrophy/fibrosis. Ocular anti-VEGF treatment within 3 months. Treatment with topical or oral carbonic-anhydrase inhibitor within one month Laser photocoagulation within 3 months (diabetic cohort)

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Avastin for Diabetic Macular Edema<br>1.25 mg avastin monthly for 4 months | Drug: Avastin<br>* 1.25 mg monthly for 4 months<br>|
| Active Comparator: Avastin for Exudative Macular Degeneration<br>1.25 mg Avastin monthly for 4 months | Drug: Avastin<br>* 1.25 mg monthly for 4 months<br>|
| Active Comparator: Lucentis for Exudative Macular Degeneration<br>0.5 mg Lucentis monthly for 4 months | Drug: Lucentis<br>* 0.5 mg monthly for 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of collected vitreous samples to identify biomarkers. | Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema. | End of study |
The Effects of Sex and Age Differences on Gastric Cancer : a Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Gastric cancer (GC) is more prevalent in males than in females. One of these differences could be the effect of sex hormones such as estrogens. However, few reports have been reported regarding sex and age differences of incidence and survival of GC. The aim of this study was to evaluate the effect of sex and age on the incidence and survival of GC. And we would like to further analyze single GC and synchronous multiple GC, EBV, etc.

Official Title
-----------------
The Effects of Sex and Age Differences on Gastric Cancer in Terms of Incidence of Histologic Subtypes and Survival Rate: a Retrospective Study

Conditions
-----------------
Sex, Age, Gastric Cancer

Intervention / Treatment
-----------------
* Genetic: Sex, Age


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Gastric cancer exclusion criteria: Gastric MALTOMA Gastric Lymphoma Gastrointestinal stromal tumors (GISTs)
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Sex, Age|Evaluate the effect of sex and age on the incidence and survival of GC.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival rate of gastric cancer on sex and age | up to 120 months | 
| histologic type | histologic type of gastric cancer on sex and age | about 18 years |
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)

Study Overview
=================
Brief Summary
-----------------
Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain

Conditions
-----------------
Recurrent Low Back Pain

Intervention / Treatment
-----------------
* Drug: MK0663, Etoricoxib / Duration of Treatment : 12 Weeks
* Drug: Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain for previous 3 months and majority of days in last month Regular use of acetaminophen or NSAID to treat low back pain in past month Judged to be in otherwise good health Exclusion Criteria: Low back pain that is due to secondary causes Radicular/myelopathic pain Surgery for low back pain within the past 6 months Active lawsuit or claim pertaining to their low back pain Disease that may confound the results of the study or pose risk to the patients Corticosteroid use in past month Previous participation in MK0663 study

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0663, Etoricoxib / Duration of Treatment : 12 Weeks|nan|
|Drug: Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo |  |  |