linjc16/ctgov huggingface dataset:
Determinants of Cardiac Risk Factor Modification in Latinos With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
This is an observational study among Latino patients who have coronary artery disease. The goal of the study is to determine the association between having depressive symptoms and the ability to modify one's health behavior. Specifically, participate in physical activity.

Detailed Description
-----------------
Specific aims: Among 213 Latino adult patients who have had coronary artery angioplasty within the past month, the specific aims of the proposed study are: To determine whether patients who have more depressive symptoms at the time of angioplasty are less likely to be active in physical activity at two years. Physical activity will be measured by a survey that asks patients to describe their activities including leisure activities or housework. To determine whether lower perceived social support, lower self-efficacy for engaging in physical activity, and greater perceived stress mediate the effects of depressive symptoms on participation in physical activity. Long-term objectives: The long-term objective of this study is to use these data to develop a culturally tailored intervention to increase participation in physical activity and ultimately improve the overall health and well being of Latino adults with coronary artery disease. Outcome: The outcome is being in the action or maintenance stage of physical activity two years after angioplasty The stage of physical activity participation will be based on the Stages of Change model. This model describes behavior change as a continuum from pre-contemplation to contemplation.

Official Title
-----------------
Determinants of Cardiac Risk Factors Modification

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must identify their ethnicity as Latino or Hispanic Patients must be able to complete a questionnaire in either English or Spanish. Patients must have angiographic evidence of coronary artery disease requiring angioplasty Patients must also be clinically stable for an interview Patient must be able to provide informed consent. Exclusion criteria Patients who are not clinically stable such as those who had cardiac arrest, who are intubated, who have active psychosis, or who are cognitively impaired. Patients who are unable to provide consent.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, Depressive symptoms, Latino American
Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)

Study Overview
=================
Brief Summary
-----------------
RIVOX-AF study is a prospective, multicenter, randomized controlled study in which patients with AF are allocated to medication-app group or conventional treatment group. The App based feed-back algorithm will provide the patients with check taking drug or reminding of taking drug.

Official Title
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The ReInforcement of Adherence Via Self-monitoring App Orchestrating Biosignals and Medication of RivoXaban in Patients With Atrial Fibrillation and Co-morbidities: Randomised Control Study(RIVOX-AF Study)

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

Intervention / Treatment
-----------------
* Device: MEDI-app
* Device: conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with atrial fibrillation with aged 19 years or older one or more of the following : heart failure, MI (3 month after onset), angina (3 month after PCI), hypertension or diabetes mellitus patients who already took or plan to take rivoxban patients who able to use smart phone Exclusion Criteria: creatinine clearance <15ml/min moderate or severe mitral stenosis mitral valve operation history current alcohol abuse or alcohol abus history Not eligible for study due to legal or psychiatric problem enrolled other clinical study within 4 weeks declined to enroll the study

Ages Eligible for Study
-----------------
Minimum Age: 19 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: MEDI-app<br>conventional treatment with MEDI-app feedback | Device: MEDI-app<br>* MEDI-app based feedback algorithm. The app based feedback algorithm will check and remind the patients of taking medication.<br>|
| Active Comparator: conventional treatment<br>conventional treatment | Device: conventional treatment<br>* conventional treatment with rivoxaban<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug adherence | Drug adherence by pill count | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of clinical composite end point | composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death.) | 24 week | 
| The occurrence of MACCE and hospitalization | MACCE plus hospitalization | 24 week | 
| The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism) | Stroke, TIA, Pulmonary embolism) | 24 week | 
| The occurrence of bleeding | bleeding event | 24 week | 
| Drug adherence | Drug adherence by pill count | 12 week |
Effect of Music Therapy on Patients Undergoing Intravitreal Injections

Study Overview
=================
Brief Summary
-----------------
Multiple studies in various specialties, including ophthalmology, are reported in the literature that show that playing music during a procedure (dubbed music therapy) increases patient satisfaction and may reduce patient anxiety and stress levels. There is no study in the literature that assesses the effects of listening to music in patients undergoing intravitreal injections. This study aims to assess whether listening to music improves patient satisfaction or reduces their anxiety levels in subjects undergoing intravitreal injections.

Official Title
-----------------
Effect of Music Therapy on Patients Undergoing Intravitreal Injections

Conditions
-----------------
Intravitreal Injections, Patient Satisfaction, Patient Anxiety

Intervention / Treatment
-----------------
* Other: No Music
* Other: Music Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those patients at least 18 years old already scheduled for intravitreal injections. Exclusion Criteria: Those patients not interested in participating in the study or not capable of filling out the questionnaire secondary to limited mental capability. Non- English speaking subjects will be excluded from the study. Those patients that participated in the study will not be allowed to participate a second time.

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 |
| --- | --- |
| 1<br>Those patients receiving intravitreal injections who will be listening to classical music during injection. | Other: Music Therapy<br>* Classical music being played during intravitreal injection.<br>|
| 2<br>Those patients receiving intravitreal injections who will not be listening to any music during injection. | Other: No Music<br>* No music will be played in patients in arm 2 of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study aims to assess what affects music therapy has on patients receiving intravitreal injections. The subject will take a Satisfaction Survey after the procedure and an Anxiety Survey before and after the injection. |  | Before and after the subject's intravitreal injection. |
Analysis of Lung Sounds Collected by RESP Biosensor to Support Decision Making in Monitored Hospitalized Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
This observational clinical trial is designed to confirm whether RESP™ Biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians, and create a durable archive of the patient's lung sounds for longitudinal comparison within or across hospitalizations.

Official Title
-----------------
Spectrographic and Acoustic Analysis of Lung Sounds Collected by RESP™ Biosensor to Support of Cardiorespiratory Therapeutic Decision Making in Monitored Hospitalized Pediatric Patients

Conditions
-----------------
Asthma, Pediatric Respiratory Diseases, RSV Infection, COVID-19

Intervention / Treatment
-----------------
* Device: RESP™ Biosensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as RSV or COVID Hospitalization projected for at least 24 hours after device placement Patient and parent/guardian able and willing to provide informed consent/assent. Exclusion Criteria: Patient and parent/guardian unable or unwilling to provide informed consent Patient expected to undergo prolonged invasive radiology procedure(s) Plan for discharge within 24 hours Patient expected to undergo major thoracic surgery History of adverse reaction or allergy to TegaDerm ® or similar product

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 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 |
| --- | --- |
| Participants<br> | Device: RESP™ Biosensor<br>* The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.<br>* Other names: RESP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualification and verification of lung sounds in pediatric population using RESP Biosensor |  | Periodic recording over 24 hours for inpatient stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families |  | Periodic recording over 24 hours for inpatient stay | 
| Limitations such as age in pediatric patients |  | Periodic recording over 24 hours for inpatient stay |
Transient Elastography and Variceal Bleeding

Study Overview
=================
Brief Summary
-----------------
Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness. The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.

Official Title
-----------------
Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Device: Fibroscan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent form signed Social security affiliation Variceal bleeding with hematemesis or melena within 24 hours of inclusion Age > 18 years Scheduled to undergo endoscopy within 24 hours of hospital admission Exclusion Criteria: Hepatocarcinoma Upper Gastro Intestinal bleeding for other causes than variceal bleeding Concomitant disease with a life expectancy of less than 45 days Rebleeding within 24 hours after first endoscopy Technical failure of transient elastography

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibroscan<br> | Device: Fibroscan<br>* transient elastography measure - Liver stiffness<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding recurrence rate |  | J45 post first hemorrage | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
variceal bleeding, transient elastography
A Registered Cohort Study on Charcot-Marie-Tooth Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to analyze the natural history data data from Charcot-Marie-Tooth disease and related disorders in China, to assess the clinical, genetic, epigenetic features of patients with Charcot-Marie-Tooth disease, and to optimize clinical management.

Official Title
-----------------
A Registered Observational Cohort Study of Charcot-Marie-Tooth Disease

Conditions
-----------------
Charcot-Marie-Tooth Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the clinical diagnosis of Charcot-Marie-Tooth disease Genetic diagnosis of patients with Charcot-Marie-Tooth disease Unrelated healthy controls Exclusion Criteria: Decline to participate. Other peripheral neuropathy caused by trauma, immunity and toxicosis.
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Charcot-Marie-Tooth Neuropathy Score (CMTNS) during 6 month | Charcot-Marie-Tooth Neuropathy Score (CMTNS) was first proposed and validated by Shy et al (Neurology, 2005). to provide a reliable measure of impairment in Charcot-Marie-Tooth (CMT). The CMTNS is composed of 9 items evaluating different functions related to the disease: 5 of impairment ('Sensory Symptoms', 'Pin Sensibility', 'Vibration', 'Strength Arms' and 'Strength Legs'), 2 of activity limitations ('Motor Symptoms Arms' and 'Motor Symptoms Legs') and 2 electrophysiological measures. Each item is scored from 0 to 4 and the total sum of the item scores provides a global measure of disease severity, with higher scores indicating worsening function. | Up to 6 months |
Fluid Responsiveness Using Forehead Sensor in Children

Study Overview
=================
Brief Summary
-----------------
Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in children

Detailed Description
-----------------
The investigator hypothesized that the forehead sensor can predict the fluid responsiveness more accurate than the finger sensor in pediatric patients.

Official Title
-----------------
Study on TFA-1 Adhesive Forehead Sensors to Predict Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia

Conditions
-----------------
Hypovolemia

Intervention / Treatment
-----------------
* Other: fluid resuscitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients undergoing general anesthesia for neurosurgery, major abdominal surgery, and cardiac surgical procedures. Exclusion Criteria: preoperative Ejection fraction <30% underlying lung disease cardiac arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 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: hypovolemia<br> | Other: fluid resuscitation<br>* when the patients showed the clinical signs of hypovolemia, the fluid resuscitation with 10ml/kg crystalloid solution was performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Receiver operating characteristic(ROC) curve (AUC) | the predictability of fluid responsiveness was calculated using ROC analysis | before fluid resuscitation |
Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease.

Detailed Description
-----------------
OMT sessions are designed to improve chest wall compliance and diaphragmatic function which produce an immediate positive change in pulmonary function parameters and chest wall mobility. This research project will be a significant step in expanding the understanding of the role of OMT in the treatment of chronic lung disease. It is expected to yield evidence that OMT is an important adjunctive modality that improves pulmonary function, increases exercise tolerance, relieves dyspnea, and improves quality of life in those with COPD, and that would have widespread clinical application plus significant economic benefits. Participants in this study will be randomly assigned to receive either OMT or sham treatments once a week for 13 weeks. Outcome measures will be obtained at baseline; immediately following the first treatment; at 4, 8, and 12 weeks after initiation of treatment; and 4 weeks after termination of the treatment. Outcome variables include pulmonary function tests; quality-of-life questionnaires (including emotional functioning, fatigue, and dyspnea); and measurements of exercise tolerance and chest wall mobility.

Official Title
-----------------
Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Procedure: osteopathic manipulative treatment


Participation Criteria
=================

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: osteopathic manipulative treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emphysema, chronic obstructive pulmonary disease, combination therapy,, exercise, human therapy evaluation, rehabilitation, respiratory disease /disorder therapy, respiratory function, biomechanics, body movement, diaphragm, dyspnea, muscle tension, musculoskeletal system, outcomes research, quality of life, somatic reflex
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation.

Official Title
-----------------
A Randomized Open-Label Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in De Novo Renal Allograft Recipients

Conditions
-----------------
Graft Rejection, Kidney Failure, Kidney Transplant

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years. End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match. Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment. Other inclusions apply. Exclusion Criteria: Evidence of active systemic or localized major infection. Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, TAC or MMF. Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant). Other exclusions apply.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function at 52 weeks after transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function at 26, 78 and 104 weeks after transplantation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Failure, Kidney Transplant