linjc16/ctgov huggingface dataset:
Question Prompt List for Common Hand Conditions

Study Overview
=================
Brief Summary
-----------------
Patients with common hand conditions will be randomized to one of two groups- one will receive a question prompt list, the other will receive a list of 3 questions

Official Title
-----------------
Does Giving a Question Prompt List to Patients With Common Hand Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial

Conditions
-----------------
Carpal Tunnel Syndrome, Trigger Finger, Trigger Thumb, Dupuytren Contracture, Ganglion Cysts

Intervention / Treatment
-----------------
* Other: Question Prompt List
* Other: 3 questions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with common hand conditions Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Question Prompt List<br>Participants will be given a Question Prompt list that has been developed by the research team | Other: Question Prompt List<br>* Question prompt list<br>|
| Active Comparator: 3 questions list<br>Participants will be given 3 questions from the AskShareKnow method | Other: 3 questions<br>* 3 questions from the AskShareKnow model<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Involvement in Care scale | This scale measures perceived involvement in care, with higher scores indicating higher perceived involvement | Immediately after visit |
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges

Study Overview
=================
Brief Summary
-----------------
The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system during meal challenges.

Official Title
-----------------
An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus During Meal Challenges

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: AID System
* Drug: Insulin Lispro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months Have a body mass index of 18.5 to 37 kilogram per meter squared Have a hemoglobin A1c level ≥6.0% and ≤9.0% Exclusion Criteria: Have known allergies or history of hypersensitivity to insulin lispro Have had an episode of severe hypoglycemia within the past 6 months Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AID System Containing Insulin Lispro<br>The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. | Device: AID System<br>* AID System<br>* Other names: LY8888AU;Drug: Insulin Lispro<br>* Individualized doses of insulin lispro administered via the AID system to maintain glycemic control except during meal challenges.<br>* Other names: LY275585;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) | Number of AEs | In-Patient Period (3 Days) | 
| Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL | CGM measured percentage of time <70 milligrams per deciliter (mg/dL) | In-Patient Period (3 Days) |
Atopy Patch Test in Normal Population : Pilot Study

Study Overview
=================
Brief Summary
-----------------
Atopy patch test in normal population

Detailed Description
-----------------
The initial diagnostic work up of suspected food allergy includes patient's history, skin prick test (SPT), measurement of food specific immunoglobulin E (IgE) with serological assays, and more recently the atopy patch test. A positive SPT seems to reflect early reactions to food challenges, whereas the atopy patch test has a high diagnostic efficacy for late phase clinical reactions. The purpose of this study was to evaluate atopy patch test reaction in non-atopic population.

Official Title
-----------------
Atopy Patch Test in Normal Population : Pilot Study

Conditions
-----------------
Normal

Intervention / Treatment
-----------------
* Device: Atopy patch test with food allergen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer Age 18-40 yrs Volunteer sign for informed consent Exclusion Criteria: who have dermographism who have chronic disease eg.autoimmune disease, immune deficiency, cancer or allergic disease pregnant women who have severe eczema who receive antihistamine, topical steroid and systemic steroid > 20 mg/day within 7 days prior study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atopy patch test<br>Atopy patches were applied on healthy volunteer's back for 48 hrs then the patches were removed. Reaction was evaluated 48 and 72 hrs after applying atopy patch test | Device: Atopy patch test with food allergen<br>* Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate reaction one day later(72 hrs after applying atopy patch test)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction of atopy patch test | To evaluate outcome of atopy patch test reaction in non-atopic subject | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen | To compare outcome of atopy patch test reaction using lyophilized allergen and commercial allergen | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopy patch test
Estrogen Treatment in Acromegalic Women

Study Overview
=================
Brief Summary
-----------------
Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.

Detailed Description
-----------------
This will be a canadian multicenter study with a randomized, double-blind, placebo-controlled design, to assess the efficacy and safety of adjuvant alesse in female acromegalic patients with suboptimal response to sandostatin LAR treatment.

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Alesse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years and older treated with somatostatin analogs Active acromegaly Exclusion Criteria: Cardiovascular or cerebrovascular disease Thrombophlebitis or thromboembolism Breast cancer Non-controlled arterial hypertension Smoking Pregnancy or lactation

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alesse|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Outcome, Recuperation and Hemodynamics in Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.

Official Title
-----------------
PRognosis of Outcome and Recuperation of Cardiac Hemodynamic Function After Aortic Valve REplacement in Aortic Valve Stenosis

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Diagnostic Test: CPET, 6MWT, QOL assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient above 18 years of age with an echocardiographic established moderate to severe AS A guideline indication for aortic valve replacement therapy Exclusion Criteria: Unable to perform exercise testing Previous aortic valve intervention More than moderate other valvular disease Patients refusing participation or unwilling to sign the informed 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?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TAVI<br>Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment | Diagnostic Test: CPET, 6MWT, QOL assessment<br>* Preoperative and postoperative (6 months + 18 months) assessment<br>|
| Other: AVR<br>Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment, Myocardial + aortic valve biopsy | Diagnostic Test: CPET, 6MWT, QOL assessment<br>* Preoperative and postoperative (6 months + 18 months) assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome defined by the occurrence of a major cardiac event | either Death of cardiovascular origin, or Hospitalization for heart failure, or Deterioration of hemodynamic function during an 18 month follow-up period after AVR. | 18 months |
Cardiometabolic Risk in Children With Type 1 Diabetes.

Study Overview
=================
Brief Summary
-----------------
To access the relationship between metabolic control of children and adolescents with type 1 diabetes and cardiometabolic risk through noninvasive imaging modalities to assess the early vasculature changes.

Official Title
-----------------
Association Between Metabolic Control and Cardiometabolic Risk in Children With Type 1 Diabetes.

Conditions
-----------------
Type1 Diabetes Mellitus, Metabolic Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for more than 0.5 year Age ≥ 10 years up to 25 years (inclusive) The subject/carer is willing to follow study specific instructions Exclusion Criteria: Youth with maturity-onset diabetes of the young, hybrid, other, or missing type Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 25 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 |
| --- | --- | --- |
| Carotid Intima-Media Thickness | Non-invasive (Doppler Ultrasound) measurement of Carotid Intima-Media Thickness | 24 months |
Continuous Positive Airway Pressure Effect on Air Trapping in Chronic Obstructive Pulmonary Disease Patients

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease is a disease characterized by small airways inflammation and obstruction. The small airways disease produces hyperinflation (air trapping), which increases with exercise. Continuous positive airways pressure may reduce small airways obstruction and therefore air trapping. Pulmonary function tests including lung volumes at rest and and after exercise will be measured. In addition, exercise endurance time before treatment and after treatment will be measured.

Detailed Description
-----------------
Continuous positive airways pressure which prevent small air ways collapse and may also clear secretions. At first stage the optimal pressure for reducing air trapping will be determined. In addition, all patients will undergo a maximal exercise test. A baseline complete pulmonary function test is performed followed by continuous positive air way pressure at the pre-determined pressure. This will be followed by exercise at 60% of maximal obtained previously.

Official Title
-----------------
Continuous Positive Airway Pressure Effect on Air Trapping, Endurance Time in Chronic Obstructive Pulmonary Disease Patients

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

Intervention / Treatment
-----------------
* Device: positive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic obstructive lung disease stage 2-3 GOLD FRC > 120% Exclusion Criteria: active ischemic heart disease heart failure peripheral vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 45 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
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: ventilation<br> | Device: positive ventilation<br>* 10 minutes of increased 4,7,12 positive pressure ventilation<br>* Other names: CPAP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved small airways obstruction | Following CPAP ventilation measurement be repeated for 3 hrs | 2-3 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved respiratory symptoms | CAT score | 2-3 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, CPAP, Sham, FEV1, IC, RV/TLC
Depressive State After Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Obesity is an epidemic disease that continues to increase causing morbidity and mortality to those who suffer. Obese patients suffer, frequently, from a depressive state, anger, and emotional disturbances. It cannot be recognized and depression causes obesity affecting eating habits or obesity causes depression based on physical, social and occupational limitations. Many times we see that obese patients are discriminated in every sense of daily life increasing their depressive state. The best treatment for obesity is bariatric surgery that causes a sufficient weight loss to correct sleep apnea, diabetes, hypertension, and many other co-morbidity. The study is based on elucidating the effect of sleeve gastrectomy in obese patients suffering from depression

Detailed Description
-----------------
The patients were classified as suffering from a depressive state before the bariatric surgery and followed until 3 years after surgery, the data was collected by personal interview or telephone survey.

Official Title
-----------------
Effect of Laparoscopic Sleeve Gastrectomy in Obese Patients With Depressive State

Conditions
-----------------
Obesity, Morbid, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older No any type of complication after surgery No difficult to drink, eat or take medicaments Exclusion Criteria: Any surgical complication Previous gastrointestinal surgery schizofrenia

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


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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Depression<br>patients characterize with morbid obesity or obesity type 2 with co-morbidities and depression | |
| No-depression<br>patients characterize with morbid obesity or obesity type 2 with co-morbidities without depression | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss 3 years after laparoscopic sleeve gastrectomy | Measure of weight calculating Delta body mass index between preoperative measurement and three years after surgery | 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression state changes after Sleeve gastrectomy | Telephonic Questionnaire about feeling satisfaction (Very satisfied, satisfied, indifferent ,unsatisfied), eating mode (Volume-eater, sweet-eater, snack eater, binge eater, healthy-eater), occupations (Unemployed, employed, type of employment). | 36 month |
Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions

Detailed Description
-----------------
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fed conditions

Official Title
-----------------
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Sarpogrelate HCL 300mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, non-smoking, male and female subjects, 19 years of age or older BMI ≥ 18.0 and ≤ 30.0 kg/m2. Females who participate in this study will be of childbearing or non- childbearing potential Exclusion Criteria: Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anpl-one SR Tab. 300mg<br>a single oral dose administration in healthy volunteers under fed condition | Drug: Sarpogrelate HCL 300mg<br>* a single oral dose administration in healthy volunteers under fed condition<br>|
| Active Comparator: Sarpodipil SR Tab. 300mg<br>a single oral dose administration in healthy volunteers under fed condition | Drug: Sarpogrelate HCL 300mg<br>* a single oral dose administration in healthy volunteers under fed condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration | Maximum Plasma Concentration | 0 24hours | 
| Area under the plasma concentration versus time curve | Area under the plasma concentration versus time curve | 0 24hours |