linjc16/ctgov huggingface dataset:
Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
This study evaluates the compliance of patients in a Phase 2 (outpatient clinic based) cardiac rehabilitation program, who are offered the opportunity to perform the rehab remotely (e.g. at home, not at the clinic), using a remote monitor and smart-phone application.

Detailed Description
-----------------
In spite of the fact that cardiac rehabilitation has been shown to be beneficial to patients who have had a cardiac event, such as a heart attack, only 5% of eligible patients complete this program. Some of the reasons cited include limited facility access, travel time and cost. We are testing the hypothesis that cardiac rehab compliance will be greater if patients are offered the opportunity, and associated technology, to perform cardiac rehab anywhere.

Official Title
-----------------
Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

Conditions
-----------------
Referred by Cardiologist for Phase 2 Cardiac Rehabilitation

Intervention / Treatment
-----------------
* Device: Remote Cardiac Rehab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referred to SLU cardiac rehab facility Exclusion Criteria: does not own app compatible smart phone dementia syncope valvular disease life expectancy < 1 year non-English speaking unstable angina decompensated congestive heart failure ventricular arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Remote Cardiac Rehab|Remote Cardiac Rehab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients completing remote rehab program compared to case controls |  | Immediately after cardiac rehab completion or stoppage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk test compared to case controls |  | Immediately after cardiac rehab completion or stoppage | 
| depression score vs case controls |  | Immediately after cardiac rehab completion or stoppage | 
| Average number of minutes in exercise rehab compared to case controls |  | Immediately after cardiac rehab completion or stoppage | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Rehabilitation
CGM Use in Poorly Controlled Youth With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.

Official Title
-----------------
IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes, Hypoglycemia, High Blood Sugar

Intervention / Treatment
-----------------
* Device: Dexcom G6 Continuous Glucose Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 1 diabetes for >3 months Exclusion Criteria: CGM use in the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexcom G6 Continuous Glucose Monitor<br>Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. | Device: Dexcom G6 Continuous Glucose Monitor<br>* Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Personal CGM Use | Evaluate whether there is any change in uptake of personal CGM after 10-day trial. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Percent Time in Range Glucose Control | Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM | 1-5 days and 6-10 days | 
| Change in Hemoglobin A1c | Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit | Baseline, 3-6 months | 
| Using Personal CGM | Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous Glucose Monitoring, Time in range, Hemoglobin A1c
Pulse Oximeter and Respiratory Rate Test

Study Overview
=================
Brief Summary
-----------------
Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry Health's Respiratory rate accuracy in normal conditions and profound hypoxia

Official Title
-----------------
Accuracy of Pulse Oximeters With Profound Hypoxia

Conditions
-----------------
Hypoxia, Hypercapnia, Hypocapnia

Intervention / Treatment
-----------------
* Device: Spry Loop Band


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult willing to participate Exclusion Criteria: Wrist size outside the indicated use Low perfusion Smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary<br> | Device: Spry Loop Band<br>* Loop band measures pulse oximetry and respiration rate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of SpO2 measurement | Pulse oximetry measurement accuracy vs. gold standard | duration of subject monitoring, usually up to one hour | 
| Accuracy of Respiratory Rate measurement | Respiratory rate measurement accuracy vs. gold standard | duration of subject monitoring, usually up to one hour |
Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
Craving is one of the most prominent reasons for relapse after smoking cessation. Mainly pharmacological aids (NRT, bupropion, varenicline) try to counter this condition. This project aims to evaluate the effect of stress-management and a short breathing technique, reinforced by means of visualisation , on the experience of craving in smokers who are prepared to stay abstinent for at least 3 hours before the start of the intervention. It is expected that this strategy can provide supplementary gains in craving control.

Official Title
-----------------
Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: breathing technique
* Behavioral: behavioral strategies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: smokers (at least 10 cigarettes/day); 18 years of age or older; prepared to stay abstinent for 3 hours before the start of the session; not prepared to stop smoking; Dutch speaking. Exclusion Criteria: acute health related problems; psychiatric co-morbidities; quit attempts in the past 3 months; participation in other clinical trials.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: breathing technique group<br>technique as a stress management technique, reinforced by biofeedback | Behavioral: breathing technique<br>* breathing technique as a stress management technique, reinforced by biofeedback<br>|
| Placebo Comparator: no breathing technique<br>the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving | Behavioral: behavioral strategies<br>* the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving at the end of each of two (learning) sessions; | Measurement by means of participant's estimation of feelings of smoking urge and smoking craving (by means of the Minnesota Nicotine Withdrawal Scale) before and immeadiately after each of two intervention sessions) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smokers
Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion time has not been fully studied for SETMI patients undergoing primary percutaneous coronary intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety of left radial approach for primary PCI in STEMI patients compared with right radial approach.

Detailed Description
-----------------
The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary PCI. Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be excluded if they are in cardiogenic shock.

Conditions
-----------------
Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: Left radial approach
* Procedure: Right radial approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset for primary PCI. Exclusion Criteria: Patients are excluded if they were in cardiogenic shock.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right radial approach<br>Primary PCI performed through right radial approach. | Procedure: Left radial approach<br>* Primary PCI performed through left radial approach.<br>|
| Experimental: Left radial approach<br>Primary PCI performed through left radial approach. | Procedure: Right radial approach<br>* Primary PCI performed through right radial approach.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle to balloon time |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose | Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP) | 7 days | 
| Fluoroscopy time |  | 7 days | 
| Contrast volume |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction
Vigorous Exercise for Depressed Smokers

Study Overview
=================
Brief Summary
-----------------
In this project the investigators will develop and pilot test a supervised, vigorous intensity exercise intervention for depressed female smokers. If the pilot intervention is successful the investigators will have a blueprint for a large randomized controlled trial. The long term objective is to develop interventions for depressed women that will ultimately reduce their risk of tobacco-caused disease and mortality.

Detailed Description
-----------------
This project will be the first to evaluate supervised vigorous exercise for depressed smokers

Official Title
-----------------
Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers

Conditions
-----------------
Nicotine Dependence, Depression

Intervention / Treatment
-----------------
* Behavioral: exercise
* Behavioral: health education


Participation Criteria
=================
Eligibility Criteria
-----------------
INclusion Criteria: depressed (CES-D) score 16 or above 18 years of age female gender sedentary current cigarette smoker Exclusion Criteria: smoking cessation medication Not able to exercise medically

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: health education<br>health education control | Behavioral: health education<br>* education<br>* Other names: health;|
| Experimental: exercise<br>vigorous supervised exercise | Behavioral: exercise<br>* vigorous intensity exercise<br>* Other names: physical activity;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking abstinence | Smoking cessation biochemically confirmed | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depressive symptoms | depressive symptoms (PHQ-9) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, depression, smoking
Study of Safety, Tolerability and Efficacy of MK0493 in Obese Patients (0493-008)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: MK0493


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is between 21 and 65 years Patient is able to read and understand and complete study questionnaires Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period Exclusion Criteria: Patient has a history of significant psychiatric disorder (such as major depression, bipolar disorder, bulimia, or anorexia nervosa Patient is HIV positive as determined by medical history Patient has undergone surgical treatment for obesity Patient plans to consume more than two 8 ounce glasses of grapefruit juice per day during the study Patient participated in another clinical study involving an investigational drug) within 3 months prior to Visit 1 Patient is currently a heavy consumer of alcohol (>2 drinks per day or >14 drinks per week [1 drink is defined as 2 oz hard alcohol, 5 oz wine, 12 oz beer], or uses (including recreational use) any illicit drugs, or has a history of drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0493|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Diet, Exercise, and Cardiovascular Health Among Ethnic Children

Study Overview
=================
Brief Summary
-----------------
To analyze data collected over a four year period on an initial cohort of 3 or 4 year old children and their parents in Galveston, Texas, and in Augusta, GA, in regard to cardiovascular disease (CVD) physical risk factors and risk related behaviors.

Detailed Description
-----------------
BACKGROUND: Little was known about tracking of cardiovascular disease (CVD) risk factors and risk related behaviors, or about predicting these variables in young children. Tracking was an important issue because it reflected the extent to which the disease processes found among adults start in childhood, and whether behavioral or social factors could be used to interrupt that tracking. DESIGN NARRATIVE: In Texas, physical risk factor data were collected at four annual clinics. Data on childrens' physical activity and diet were collected for up to four times per year for the three years between the annual measurement clinics. Similar data, although with some different measurement techniques, were collected in Georgia. For this data analysis, specific longitudinal research questions addressed whether these physical risk factors (blood pressure, lipids, lipoproteins and body composition) and risk related behaviors (diet and physical activity) tracked across the annual assessments, whether a variety of behavioral and social factors (demographic characteristics and family function) affected that tracking, and whether relationships obtained among adults between physical risk factors and these other variables could be found in this age child. The testing of these relationships was enhanced by the availability of multiple assessments of blood pressures and body composition at each point for more reliable assessments, and by multiple assessments of diet and physical activity within each year. It was further enhanced by the availability of observational data on physical activity and diet, which overcame the limitations of the more common self report approach to measurement. Models were developed in each data set and cross validated in the other. Procedures were employed to determine reasons for differences and to revise the models to produce maximal fit in both data sets. The results of these analyses contributed to a better understanding of at what age, and with what factors, it was most appropriate to intervene to mitigate CVD.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Measuring Patient Expectations for Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about what patients undergoing surgery for thyroid cancer expect from their surgery. Your input may help us to better prepare and inform patients about their disease and its treatment.

Official Title
-----------------
Measuring Patient Expectations for Thyroid Surgery: Development of a Patient-Reported Outcomes Instrument

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Behavioral: patient interviews
* Behavioral: CITSAV survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years English speaking Patients with confirmed thyroid malignancy confirmed by preoperative fine needle biopsy (any stage) planned for surgical excision Exclusion Criteria: Inability to speak or understand English Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability Prior thyroid surgery Prior radioactive iodine treatment, external beam radiation or chemotherapy

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 |
| --- | --- |
| patient interviews<br>We aim to interview 15 patients with confirmed thyroid malignancy both pre- and postoperatively, for a total of 30 interviews. For the expansion of this study, we will accrue 25 patients with biopsy-proven thyroid cancer undergoing thyroidectomy to be educated with the CITSAV application prior to surgery. | Behavioral: patient interviews<br>* The pre-operative interview will be within 4 weeks of planned surgery and the postoperative interview within 8 weeks of surgery completion. This initial study is designed to develop an instrument to measure patient preoperative expectations in this patient population.<br>Behavioral: CITSAV survey<br>* Individual semi-structured qualitative interviews will be conducted with a total of 10 patients and 5 clinicians during this phase to identify and discuss levels of satisfaction, level of burden, potential obstacles to implementation, as well as suggestions for improving the intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish a patient-reported outcomes tool for measuring preoperative expectations in patients undergoing surgery for thyroid cancer. | This will be done by conducting qualitative semistructured interviews with 15 thyroid cancer patients (pre- and postoperatively) to identify recurring themes about their expectations regarding thyroid surgery. | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, interview, 11-087