linjc16/ctgov huggingface dataset:
Zilver® PTX® in China

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.

Official Title
-----------------
Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: Zilver® PTX® Drug-Eluting Peripheral Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4 Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery Reference vessel diameter of 4-9 mm Lesion length up to 140 mm Exclusion Criteria: Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure Previous stent in the study vessel Bypass graft with an anastomosis in the study vessel Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion No patent vessel of runoff

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zilver® PTX® VI<br> | Device: Zilver® PTX® Drug-Eluting Peripheral Stent<br>* Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency as Assessed by Duplex Ultrasonography |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zilver® PTX® Drug-Eluting Peripheral Stent, Above-the-Knee Femoropopliteal Artery, Chinese patient
EUS-guided FNA in the Study of the Adrenal Gland

Study Overview
=================
Brief Summary
-----------------
To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS. A review of 205 EUS-FNA of AG in 200 patients is included.

Detailed Description
-----------------
INTRODUCTION: The EUS has proven useful in the study and evaluation of the adrenal gland (AG) by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), in both the left and right glands. OBJECTIVE: To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. MATERIALS AND METHODS: National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS. Variables reviewed: Demographic characteristics, clinical, extension studies, USE and pathological data. Comparison between variables; and estimation of multivariate logistic model for cytology, mortality and therapeutic change.

Official Title
-----------------
EUS-guided FNA in the Study of the Adrenal Gland: National Retrospective Multicenter Study

Conditions
-----------------
Adrenal Gland Disease, Adrenal Tumor

Intervention / Treatment
-----------------
* Diagnostic Test: Endoscopic Ultrasound-Guided FNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adrenal gland (Left / Right) punctured by endoscopic ultrasound

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 |
| --- |
|Diagnostic Test: Endoscopic Ultrasound-Guided FNA|Endoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy |  | retrospective analysis form 2003 to 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse events related to the procedure |  | retrospective analysis, last 10 years | 
| Predictors of malignancy | Predictors of malignancy and cyto-pathological correlation of the EUS-FNA with adrenal gland | retrospective analysis, last 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adrenal Gland, Endoscopic Ultrasound Guided FNA
Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of chronic LBP.

Detailed Description
-----------------
The purpose of this study is as follows: pain : VAS Function : Roland Disability Scale Side effect Validity

Official Title
-----------------
A Randomized, Single Blind, Controlled Clinical Trial to Evaluate the Pain Relief Efficacy, Functional Improvement and Safety of Acupuncture in Patients With Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Device: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having chronic, non-specific, LBP of at least 3 months' duration over 20 years old. Back pain must be the chief complaint Having normal neurological test Having signature voluntarily an IRB-approved consent form at enrollment Exclusion Criteria: Potential spinal disease (e.g. a spinal tumor, infection or fracture etc) Other diseases (e.g. bleeding disease, dementia,epilepsy, neurogenic disorder etc) Planned or got lumbar surgery The prior use of acupuncture within the past 6 months Inflammatory arthritis The current use of systematic corticosteroids, narcotics, anticoagulants, muscle relaxants The involvement in legal problem related to LBP Refusal to be randomized

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale, RDQ scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, RCTs, chronic LBP
Seoul National University Airway Registry

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, prospective observational cohort study, in which patients with chronic airway diseases including chronic obstructive pulmonary disease(COPD), asthma, asthma-COPD overlap syndrome (ACOS) will be recruited.

Official Title
-----------------
Airway Registry for Chronic Airway Diseases

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD), Asthma, Asthma With Chronic Obstructive Pulmonary Disease, Bronchiectasis, Inactive Tuberculosis of Lung, Chronic Obstructive Airway Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
COPD Inclusion Criteria: Postbronchodilator FEV1/FVC < 0.7 AND chronic respiratory symptom Exclusion Criteria: - Asthma Inclusion Criteria: Never smoker or <5PY of smoking history AND Recurrent episodes of asthma symptoms (wheezing, dyspnea, chest tightness, cough) AND (either Positive BDR OR positive metacholine/mannitol/exercise provocation test) Exclusion Criteria: - ACOS Inclusion Criteria: COPD AND Asthma (regardless of smoking status) Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| No predefined subgroups<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death (time to death) | death from any cause, death from COPD-specific cause, death from CVD, malignancy | upto 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-bronchodilator FEV1 change rates |  | upto 20 years (at least 3 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Asthma, ACOS, Bronchiectasis
CNAP™ Monitor Study

Study Overview
=================
Brief Summary
-----------------
A newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) provides beat-to-beat BP readings and is non-invasive. To make sure that anaesthesiologist can rely on and make clinical decisions based on values provided by the CNAP™ monitor, to demonstrate its reliability we will test it during the perioperative care of children.

Official Title
-----------------
Accuracy of the CNAP™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings

Conditions
-----------------
Cardiac Surgery, Spinal Surgery

Intervention / Treatment
-----------------
* Device: CNAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will already be having an indwelling arterial cannula placed for their surgical procedure. Exclusion Criteria: Patients with history of a peripheral neurologic or neuropathic disorder. Patients in whom an invasive arterial cannula cannot be placed. Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm). Edematous patients. Patients who are less than 20 kg.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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 |
| --- | --- |
| Arterial blood pressure line<br>Patients receiving an arterial blood pressure line | Device: CNAP<br>* Non-invasive blood pressure monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 1 Day (day of surgery) |
Vitamin D for Established Type 2 Diabetes (DDM2)

Study Overview
=================
Brief Summary
-----------------
This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).

Official Title
-----------------
Vitamin D for Established Type 2 Diabetes (DDM2)

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

Intervention / Treatment
-----------------
* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established type 2 diabetes, defined by one of the following two criteria: Age ≥ 25 years and ≤ 75 years BMI: 23 to 40 kg/m2 inclusive Provision of signed and dated written informed consent prior to any study procedures. Major Exclusion Criteria Severe diabetes defined by one of the following criteria: - (a) Symptoms of hyperglycemia; - (b) Screening HbA1c ≥ 7.5 [may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy] History of nephrolithiasis or hypercalcemia

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>One placebo pill daily for 1 year | Drug: Placebo<br> <br> |
| Active Comparator: cholecalciferol<br>One cholecalciferol pill daily for 1 year | Drug: Cholecalciferol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposition Index | Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change in Glycemia | Change in glycemia (categorical variable, composite outcome) defined as [1] a decrease in diabetes medications or [2] a reduction of equal to or more than 0.4 HbA1c units from baseline without increasing medications. | 12 months |
Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2

Study Overview
=================
Brief Summary
-----------------
The full program is focused on identifying and reducing risk factors surrounding falls. Based on previous research, we believe that occupational therapy group classes and adaptive yoga are an ideal pairing to reduce fall risk. The occupational therapy sessions will consist of lecture, group discussion, and activities designed to target biological, behavioral, environmental, and socioeconomic factors that contribute to fall risk specifically for people with Parkinson's disease.

Official Title
-----------------
Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Behavioral: Merging Yoga and Occupational Therapy for Parkinson disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with a diagnosis of Parkinson's disease OR their care partners Individuals who read and understand English Individuals who can stand with or without an assistive device People who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through Raintree Athletic Club (Scholarships are available if needed!) People who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge score of at least 4/6 on the short mini mental status exam Exclusion Criteria: less than 18 years of age

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Merging Yoga and Occupational Therapy for Parkinson disease<br>The group participates in three assessment periods: August, October, and December. Then in October-December the group will receive group occupational therapy and recommended community adaptive yoga programming 2x/week for 8 weeks. | Behavioral: Merging Yoga and Occupational Therapy for Parkinson disease<br>* The group occupational therapy portion focuses on lecture, group discussion, and activities to reduce fall risk. The yoga program is part of an ongoing community yoga program specifically designed for people with Parkinson disease.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fall Risk Factor Management | Self-report 5 scales measuring the ability to manage fall risk factors | Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment) |
Vinegar Co-ingestion in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to assess the acute effect of co-ingested vinegar on postprandial plasma glucose levels in type 2 diabetes patients.

Detailed Description
-----------------
Plasma glucose and insulin concentrations are assessed over the 2 hr period following ingestion of carbohydrate-rich beverage with or without added vinegar.

Official Title
-----------------
The Effect of Vinegar Co-ingestion on Postprandial Glucose Control in Type 2 Diabetes Patients

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

Intervention / Treatment
-----------------
* Dietary Supplement: placebo co-ingestion
* Dietary Supplement: vinegar co-ingestion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male type 2 diabetes overweight or obese 40-70 yrs Exclusion Criteria: incident cardiovascular events during last year peptic ulcer, duodenal ulcer, oesophageal reflux antacids, H2 receptor blocker, proton pump inhibitors, NSAIDS, prokinetic agents

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vinegar co-ingestion<br>25 ml vinegar is added to glucose containing beverage | Dietary Supplement: vinegar co-ingestion<br>* 25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage<br>* Other names: acetic acid;|
| Placebo Comparator: Placebo co-ingestion<br>25 ml vinegar is substituted by 25 ml water | Dietary Supplement: placebo co-ingestion<br>* 25 ml water co-ingested with a glucose-containing beverage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glycemic Incremental Area Under the Curve | area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages | 2 hr |
Influence of an App on Quality of Life of Women With Endometriosis

Study Overview
=================
Brief Summary
-----------------
Comparison of quality of life before and after 14 days of use of Endo App® in endometriosis patients compared to non-users

Detailed Description
-----------------
Introduction: Endometriosis can significantly impair the quality of life of those affected. Multimodal self-help measures are recommended but often difficult to access. Smartphone apps have been shown to improve quality of life for other conditions with chronic pain. The aim of this study was to examine whether there is evidence of beneficial effects of the Endo-App and whether a multicenter randomized controlled trial should be planned to substantiate these effects. Methods: In a sample of N=106 women affected by endometriosis the present study determined the influence of the use of a smartphone app (Endo-App ®) on their quality of life. Among others, the validated questionnaire Endometriosis Health Profile from Oxford University was used for this purpose.

Official Title
-----------------
Observational Study on the Influence of an App-based Self-management Program on the Quality of Life of Women With Endometriosis

Conditions
-----------------
Endometriosis, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: use of Endo App®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suffering from endometriosis 18 years or older willing and capable of using a smartphone Exclusion Criteria: minor under 18 years endometriosis excluded not capable of using a smartphone

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: users<br>app users | Behavioral: use of Endo App®<br>* use of Endo App® smartphone application containing endometriosis relevant exercises and educational material<br>|
| No Intervention: non-users<br>app non-users | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life of endometriosis patients | quality of life measured bei Endometriosis Health Profile 30 | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, quality of life, smartphone application