linjc16/ctgov huggingface dataset:
Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan

Study Overview
=================
Brief Summary
-----------------
The broad, long-term objectives are to generate and test hypotheses leading to theories that guide improved care of patients with gestational diabetes. The purpose of this chart review study is to evaluate the Vanderbilt Gestational Diabetes Self-Management Education Program and Quality Improvement Plan in optimizing metabolic control and improving health outcomes during pregnancy with gestational diabetes.

Official Title
-----------------
Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan

Conditions
-----------------
Gestational Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with gestational diabetes who are referred to and followed in the Vanderbilt Eskind Diabetes Clinic and are participants in the gestational diabetes educational program. Exclusion Criteria: Refusal of consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gestational Diabetes<br>Women with gestational diabetes who are referred to and followed in the Vanderbilt Eskind Diabetes Clinic and are participants in the gestational diabetes educational program. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Monitoring of Blood Glucose |  | chart review quarterly during course of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational Diabetes, Self-Monitoring of Blood Glucose
Neuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO)

Study Overview
=================
Brief Summary
-----------------
In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES will be studied.

Official Title
-----------------
The Effect of Neuromuscular Electrical Stimulation on Post-prandial Muscle Protein Accretion in Healthy Elderly Men

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Device: Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)
* Device: No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age 65 - 85 years 18.5 < BMI < 30 kg∙m2 Exclusion Criteria: Type II diabetes All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery). Use of anticoagulants, blood diseases, allergy for lidocaine Use of NSAIDs and acetylsalicylic acid Patients suffering from PKU (Phenylketonuria) Presence of implantable cardioverter defibrillator and/or pacemaker Performed regular resistance type exercise in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Protein ingestion<br>Protein ingestion directly after the contralateral leg received NMES | Device: No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES<br>* No neuromuscular electrical stimulation (NMES) will be applied in the control leg<br>|
| Experimental: Protein ingestion after NMES<br>Ingestion of intrinsically labeled protein, directly after one hour of Neuromuscular electrical stimulation (NMES) | Device: Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)<br>* One our of one-legged neuromuscular electrical stimulation (NMES)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracer enrichment in the muscle biopsy |  | 4 hours after protein ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional synthetic rate (FSR) |  | 0-4 hours after protein ingestion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromuscular Electrical Stimulation, Ageing, Protein ingestion
Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women

Study Overview
=================
Brief Summary
-----------------
This study will implement and test a brief, tailored individual-level intervention to be used in two New Orleans adolescent clinics with female patients aged 16-24 who douche.

Detailed Description
-----------------
The study implements a client-centered behavioral intervention (CCBI) based on Prochaska's Transtheoretical Model of Change (TMC) and the intervention will use Miller's Motivational Interviewing (MI) techniques. This intervention will be evaluated using (1) an audio/computer-assisted self-administered interview (ACASI) survey to assess changes in respondents' douching knowledge, attitudes, and practices, and (2) biological testing for Bacterial Vaginosis.

Official Title
-----------------
Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women

Conditions
-----------------
Vaginal Douching, Bacterial Vaginosis

Intervention / Treatment
-----------------
* Behavioral: Brief, motivational interviewing intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women attending between the ages of 16 and 24 who have douched at least once in the last 180 days, agree to a test for Bacterial Vaginosis, and agree to allow us to contact you by telephone or in person for a follow-up interview and testing for bacterial vaginosis. Exclusion Criteria: currently pregnant, non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 24 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Brief, motivational interviewing intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Lung Herniation After Uniportal VATS

Study Overview
=================
Brief Summary
-----------------
During patient follow up the investigators noticed the occasional occurence of a lung herniation after uniportal Video assisted thoracoscopic surgery (VATS). Most of These patients were asymptomatic and didn't require any kind of treatment. To analyse the incidence of postoperative lung herniation after uniportal and the presence of symptoms the investigators decided to review every postoperative CT scan from January 2016 until March 2019 to radiologically identify postoperative lung herniations. Afterwards the investigators will contact the respective patient to ask for a follow-up physical examination and symptom evaluation (after consent was signed).

Official Title
-----------------
Lung Herniation After Uniportal VATS. Rarity or Common Finding?

Conditions
-----------------
Lung Hernia, Thoracoscopy, Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anatomical lung resection using uniportal VATS Exclusion Criteria: Non anatomical lung resection Open surgery Pneumonectomy Informed consent not signed

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung herniation | Presence of intercostal lung herniation after uniportal VATS | Postoperative follow-up up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Symptoms described by patients presenting an intercostal lung hernia | Postoperative follow-up to 5 years | 
| Risk factors | Presence of Risk factors associated with the development of intercostal lung hernia after uniportal VATS surgery | At the time of operation |
Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer is a common malignancy in Viet Nam. Laparoscopic surgery becomes a standard treatment in many centers. Today, robotic surgery is a new option for treating colorectal cancer with some advantages such as magnified 3D view, precise movements. Answer on safety and feasibility of robotic surgery for colorectal cancer are not available in Viet Nam. Therefore, the investigators conducted a study  Robotic versus Laparoscopic Approach for Rectal Cancer Surgery.

Detailed Description
-----------------
Rectal cancer is a common surgical disease

Official Title
-----------------
Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to provide written informed consent Diagnosis of rectal cancer amenable to curative surgery by anterior resection, low anterior resection, ultra-low anterior resection, abdominal perineal resection, staged T1-T4a, N0-2, M0 Exclusion Criteria: Advanced cancer not amenable to curative surgery patient did not agree to participate in research
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic surgery<br>Patients undergoing robotic surgery for removal of rectal cancer. | Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection<br>* we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer<br>* Other names: Robotic rectal cancer surgery;|
| Experimental: Laparoscopic surgery<br>Patients undergoing laparoscopic for removal of rectal cancer | Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection<br>* we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer<br>* Other names: Robotic rectal cancer surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to open surgery | the rate of conversion to open surgery | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of surgery | Time of surgery on the robot compare to laparoscopic surgery | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, robotic surgery, laparoscopic surgery
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.

Official Title
-----------------
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

Conditions
-----------------
Postural Orthostatic Tachycardia Syndrome (POTS)

Intervention / Treatment
-----------------
* Drug: Angiotensin II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center criteria Age between 18-64 years Male or females are eligible Able and willing to provide informed consent Healthy control subjects with no major medical problem (including postural tachycardia syndrome), free of medications during the study Exclusion Criteria: Overt cause of postural tachycardia e.g., dehydration Inability to give or withdraw informed consent Pregnancy Hypertension (BP > 140/90) Significant co-morbid condition Other factors which in the investigator's opinion would prevent the subject from completing the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Healthy controls | Drug: Angiotensin II<br>* Angiotensin II infusion for 1 hour<br>|
| Experimental: Postural Tachycardia Syndrome<br>Patients with Postural Tachycardia Syndrome | Drug: Angiotensin II<br>* Angiotensin II infusion for 1 hour<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Blood Pressure Change |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Renin Activity |  | 1 hour | 
| Aldosterone Level |  | 1 hour | 
| Cortisol Level |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POTS, Orthostatic intolerance
Scoliosis Shared Decision Making

Study Overview
=================
Brief Summary
-----------------
Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

Detailed Description
-----------------
For patients and parents who are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options. This video will then be sent to the shared decision making group at Mayo Clinic, Rochester, Minnesota to run analysis of the data (Shared Decision Making National Resource Center, Knowledge and Evaluation Research Unit, Mayo Clinic). Investigators will follow the patient's electronic medical records for 2 years after their decision of treatment option. No outcome forms will be specifically collected as part of the study, as outcomes forms are currently being collected clinically on all scoliosis patients. Based off of the initial video recordings, the first visual prototype of the shared decision making tool for scoliosis has been developed. This prototype of the shared decision making tool will be now be used to help test it's efficiency.

Official Title
-----------------
Scoliosis Shared Decision Making

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Other: Video recording of clinical visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scoliosis curve >40 degrees, < 65 degrees Risser score > 2 Age > 13 years Exclusion Criteria: Risser score of 0 or 1 Non-ambulatory scoliosis patients Ages 12 year and under

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Video recording of clinical visit<br>Investigators will enroll patients from the Department of Orthopedic Surgery for enrollment. The shared decision group will provide staff for data analysis. | Other: Video recording of clinical visit<br>* For patients and parents that are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who understand disease treatment as determined by analysis of video recording | Video will be recorded then be sent to the shared decision making group at Mayo Clinic, Rochester, Minnesota to run analysis of the data (Shared Decision Making National Resource Center, Knowledge and Evaluation Research Unit, Mayo Clinic). | Baseline |
Factors Contribute to Very Late Stent Thrombosis After New Generation DES Implantation in China

Study Overview
=================
Brief Summary
-----------------
The investigators sought to identify and verify the potential correlates and mechanisms of Very Late Stent Thrombosis (VLST) after the implantation of new generation drug eluting steng in China from an analysis of multicenter registries.

Detailed Description
-----------------
This study represents a patient-level pooled analysis of patients undergoing percutaneous coronary intervention with stent implantation for acute coronary syndrome. Multiple aspects including clinical, angiographic, procedural characteristics , intravascular imaging results and blood samples were collected at index PCI and the time of VLST or CAG during follow-up, in order to reveal the potential mechanisms or risk factors that contribute to the development of VLST.

Official Title
-----------------
Correlates and Mehcanisms Underlying Very Late Stent Thrombosis After Implantation of New Generation DES in China

Conditions
-----------------
Stent Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent. Exclusion Criteria: Expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al). There is a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued. Refusing to sign informed consent.Died prior to discharge. Poor compliance, unable to participate in regular follow-up.

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 |
| --- | --- |
| derivation cohort<br>no interventions will be administrated | |
| validation cohort<br>no interventions will be administrated | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Very Late Stent Thrombosis | very late stent thrombosis demonstrated by coronary angiography | Five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Very Late Stent Thrombosis, New generation DES
A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.

Detailed Description
-----------------
Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.

Official Title
-----------------
A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

Conditions
-----------------
Hypertrophic Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently or previously enrolled in 17-003514 and 16-009474 Adults age >18 years-old with a diagnosis of hypertrophic cardiomyopathy Both sexes Able to consent Exclusion Criteria: Vulnerable study population Known atrial fibrillation Pacemaker/ICD implantation Pregnancy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation incidence in hypertrophic cardiomyopathy | Define the incidence ratio of newly diagnosed atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea | Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring. | 
| Atrial fibrillation recurrence in hypertrophic cardiomyopathy | Determine the frequency of recurrent atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea | Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring. | 
| Ventricular arrhythmia incidence in hypertrophic cardiomyopathy | Define the incidence ratio of newly diagnosed ventricular arrhythmias in hypertrophic cardiomyopathy, with and without sleep apnea | Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Ventricular tachycardia, Arrhythmia, Hypertrophic cardiomyopathy