linjc16/ctgov huggingface dataset:
Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3

Study Overview
=================
Brief Summary
-----------------
To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements. Trial with medical device

Official Title
-----------------
Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3

Conditions
-----------------
Glaucoma Patients and Healthy Controls

Intervention / Treatment
-----------------
* Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: for both groups (glaucoma study group and control group): men and women of at least 50 years of age for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG) Exclusion criteria: for both groups (glaucoma study group and control group): less then 18 years of age any pathology of the central retina any optic nerve disorder other then glaucoma retinal vascular disorder for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma for the control group: any diagnosis of glaucoma

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 |
| --- | --- |
| control group<br>age matched healthy controls | Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H<br>* Measurement of the peripapillar nerve fiber layer with different settings of ART<br>|
| Glaucoma<br>patients with diagnosis of primary open angle glaucoma | Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H<br>* Measurement of the peripapillar nerve fiber layer with different settings of ART<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COV |  | T0 |
Hospital for Special Surgery Shoulder Arthroplasty Cohort

Study Overview
=================
Brief Summary
-----------------
Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes. HSS is a world leader in total joint replacement including total shoulder arthroplasty. However, there is no systematic follow-up or evaluation of patients who have their shoulders replaced here. The purpose of this study is to establish a prospective cohort of HSS total shoulder arthroplasty to evaluate predictors of outcome, causes of failure and to allow ongoing evaluation of the results of our patients over time.

Official Title
-----------------
Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Shoulder Arthroplasty Cohort

Conditions
-----------------
Shoulder Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older and undergoing total shoulder arthroplasty at HSS Exclusion Criteria: No other exclusion criteria. Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.

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 |
| --- | --- | --- |
Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury

Study Overview
=================
Brief Summary
-----------------
This study use anterior segment spectral-domain optical coherence tomography (SD-OCT) to exam patients with closed globe injury, and compared with slit lamp examination. The results showed that OCT can identify features of closed globe injury that were otherwise not visible on slit lamp biomicroscopy.

Detailed Description
-----------------
The anterior segment architecture changes of closed globe injury patients include corneal damage, hyphema, angle recession and lens dislocation, which can be showed with OCT. OCT was superior to slit lamp biomicroscopy examination in detecting anterior segment architecture changes, especially in the presence of media opacities.

Official Title
-----------------
Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury

Conditions
-----------------
Eye Injuries

Intervention / Treatment
-----------------
* Device: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with closed globe injury were recruited; had hyphema at least 1/3 of anterior chamber volume Exclusion Criteria: can not cooperate with examination
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OCT|Anterior Segment Spectral-domain Optical Coherence Tomography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anterior segment spectral-domain optical coherence tomography (SD-OCT) findings in patients with closed globe injury |  | within 24 hours after patients were admitted |
Factors Affect Outcomes in Cardiovascular Surgery

Study Overview
=================
Brief Summary
-----------------
Identify factors that contribute to perioperative morbidity and mortality in patients undergoing cardiac surgery that involves cardiopulmonary bypass. Identify factors that affect perioperative morbidity and mortality in patients undergoing cardiac surgery.

Detailed Description
-----------------
Identify factors that affect perioperative morbidity and mortality in patients undergoing cardiac surgery. Here are some examples, but may not limited the following factors: demographic data perioperative medications comorbidity

Official Title
-----------------
Factors That Affect the Outcomes of Cardiothoracic and Vascular Surgery

Conditions
-----------------
Coronary Artery Disease, Valvular Diseases, Vascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients greater than or equal to 18 years old that underwent cardiovascular surgery at UC Davis Medical Center from 01/01/2001 to 07/15/2013. Patients will only be included that underwent cardiovascular surgeries with or without cardiopulmonary bypass. Exclusion Criteria: Patients that did not undergo cardiovascular surgeries and age< 18 years old will be excluded from the study.

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 |
| --- | --- | --- |
| all cause mortality | in hospital, 30 day, one year and longer | 12 years |
Evaluation of Patient Education in Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. They often feel frustrated and seek both their family doctors, specialists and alternative medicine for help. Many patients feel they do not know enough about their disease, and the uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information and education in these patients.

Detailed Description
-----------------
The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized to receive intervention now (intervention group) or in 6 months (control group). The intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced gastroenterologist at the local hospital. Elements in this school-day includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices. The patients are evaluated at time: 0 months and 6 months (intervention group and control group), 12 months (control group) and after 2 years (both groups).

Official Title
-----------------
Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Behavioral: patient education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria Must be able to participate in a education-group Exclusion Criteria: Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome Serious, untreated psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: patient education|Patient education group|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life |  | 6 months | 
| Change in Gastrointestinal symptom score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health related costs |  | 6 months | 
| Evaluation of further patient needs after education |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, Gastrointestinal symptoms, Health related costs
Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough

Study Overview
=================
Brief Summary
-----------------
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.

Official Title
-----------------
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple-Dose, Proof-of-Concept Study to Evaluate the Efficacy of N-acetylcysteine Capsules in the Treatment of the Common Cold (Viral URTI) Associated With Cough in an Adult Population

Conditions
-----------------
Common Cold Associated With Cough

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cold/URTI symptoms occurring no more than 4 days cough due to a cold or acute viral (URTI) with an onset of no more than 3 days cough frequency with specified cut-off Exclusion Criteria: A subchronic, or chronic cough (cough duration > 2 months) due to any condition other than a cold/URTI Diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma, cystic fibrosis Taking any medications known to induce cough Fever of greater than 39°C (102°F) orally Complication of the common cold like otitis media, severe sinusitis, or pneumonia Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A N-acetylcysteine<br>N-acetylcysteine | Drug: N-acetylcysteine<br> <br> |
| Placebo Comparator: B Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) | Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) | Number of patients with adverse advents | 7 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
N-acetylcysteine, adults, cough and cold
Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

Official Title
-----------------
A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy Age in the 20 years or over inclusive HbA1c in the range of ≥ 6.5 to ≤ 10% Exclusion Criteria: Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes Significant heart diseases Significant diabetic complications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Met add-on vildagliptin<br> | Drug: Vildagliptin<br> <br> |
| Other: Open TZD add-on vildagliptin<br> | Drug: Vildagliptin<br> <br> |
| Other: Open α-GI add-on vildagliptin<br> | Drug: Vildagliptin<br> <br> |
| Other: Glinides add-on vildagliptin<br> | Drug: Vildagliptin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure AEs, vital signs, laboratory evaluations |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBA1c |  | 52 weeks | 
| Fasting Plasma Glucose |  | 52 weeks | 
| Fasting Insulin |  | 52 weeks | 
| Fasting C-peptide |  | 52 weeks | 
| HOMA-B |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety
VEIN Health - CVD Prevalence and Characteristics

Study Overview
=================
Brief Summary
-----------------
Epidemiology Study to learn prevalence and characteristics of CVD at Primary and Specialized healthcare level

Detailed Description
-----------------
Cross sectional study that will evaluate prevalence, characteristics, diagnostic and treatment status of the patients with Chronic Venous Disease at primary or specialized healthcare level during 2 week period. No interventions are made. Information on patient demographic, physical, clinical parameters, medical history data and procedures performed during visit in routine daily practice of physicians is registered and analyzed.

Official Title
-----------------
VEIN Health Chronic Venous Disease at Primary and Specialized Healthcare Level -Update on Prevalence and Characteristics

Conditions
-----------------
Chronic Venous Disease

Intervention / Treatment
-----------------
* Other: No intervention provided


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years Patient consented to participate Exclusion Criteria: Patient applying due to emergency situation

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 |
| --- | --- |
| Patients applying to Primary Healthcare Consultation<br>Consequent patients applying to the Primary healthcare to consult for any reason during 2 week period | Other: No intervention provided<br>* Study is provided in the usual daily practice of the physicians without interventions made in their practice<br>|
| Patients applying to Specialized Healthcare Consultation<br>Consequent patients applying to the Specialized healthcare to consult for any reason during 2 week period | Other: No intervention provided<br>* Study is provided in the usual daily practice of the physicians without interventions made in their practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of CVD | Percent of CVD symptomatic patients among patients applying to consultation for any reason | 2 weeks | 
| Distribution of CEAP stages | Percent of CVD patients with various CEAP stages | 2 weeks | 
| Prevalence of risk-factors associated with CVD | Frequency of risk-factors associated with CVD | 2 weeks | 
| Management tactics | Tactics chosen by physicians to manage CVD | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Venous Disease, Prevalence, Characteristics, Management tactics evaluation, Risk-factors, Distribution of CEAP stages
Prognosis in the Elderly Chinese: the Northern Shanghai Study

Study Overview
=================
Brief Summary
-----------------
The Northern Shanghai Study is a prospective community-based study, which is aimed to investigate the prognostic factors, including conventional cardiovascular risk factors and asymptomatic target organ damage, for mortality and cardiovascular diseases, in 5,000 elderly Chinese.

Official Title
-----------------
Prognosis Factors of Mortality and Cardiovascular Diseases in the Elderly Chinese: the Northern Shanghai Study

Conditions
-----------------
Cardiovascular Risk Factor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age≥65 years old(depending on identity card); informed consent should be signed voluntarily; the individuals are long-term residents in northern Shanghai. Exclusion Criteria: is diagnosed serious heart disease (NYHA>IV) or end stage renal disease (CKD > 4); suffered with cancer and life expectancy was less than 5 years; has stroke within 3 months; is not willing to participate in the clinical study; suffered with other disease to quite the trial; violated the protocol; lost contact with laboratory staff.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Several communities in the north of Shanghai<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause and cardiovascular mortality, cardiovascular events |  | one year | 
| Cardiovascular diseases |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular risk factors, Prospective study, Mortality, Cardiovascular events, Asymptomatic target organ damage, elderly Chinese