linjc16/ctgov huggingface dataset:
J-Valve Compassionate Use

Study Overview
=================
Brief Summary
-----------------
J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA

Detailed Description
-----------------
The J-Valve is designed to treat patients with aortic valve disease requiring replacement. There are certain patient subsets that the J-Valve TF is uniquely able to treat and where there are no good alternative treatments for patients at high surgical risk. Physicians have applied for individual approval to treat patients with the J-Valve in certain clinical conditions.

Official Title
-----------------
J-Valve Compassionate Use Cases

Conditions
-----------------
Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: Transcatheter Aortic Valve Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter Aortic Valve Replacement|Minimally invasive replacement of the aortic valve through a catheter.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Prospective Trial of Ayurveda for Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk factors in patients with coronary artery disease.

Detailed Description
-----------------
Patients with established coronary artery disease will be treated with 90 days of Ayurvedic therapy to include yoga, meditation, breathing exercises,and herbs. Arterial stiffness, weight, BMI, BP, medications, cholesterol, LDL, HDL, triglyceride, HS-CRP will be measured at baseline and after 90 days of therapy.

Official Title
-----------------
A Prospective Trial of Ayurveda for Coronary Artery Disease

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

Intervention / Treatment
-----------------
* Other: Ayurveda


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable coronary artery disease (prior mi, coronary angioplasty or stent, coronary bypass surgery) Exclusion Criteria: age < 18 years life expectancy < 6 months pregnancy or breast feeding unwilling or unable to complete 90 days of therapy already receiving/taking Ayurvedic therapy unable to converse in or understand English language

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ayurveda<br>Ayurvedic therapy | Other: Ayurveda<br>* Ayurveda includes meditation, yoga, breathing exercises, herbs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness, measured as pulse wave velocity meters/second |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) |  | 3 months | 
| Blood pressure in mm Hg |  | 3 months | 
| Total cholesterol in mg/dl |  | 3 months | 
| LDL cholesterol in mg/dl |  | 3 months | 
| HDL cholesterol in mg/dl |  | 3 months | 
| Triglyceride in mg/dl |  | 3 months |
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

Study Overview
=================
Brief Summary
-----------------
To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.

Detailed Description
-----------------
Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.

Official Title
-----------------
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

Conditions
-----------------
Limited Scleroderma, Diffuse Scleroderma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Documented diagnosis of scleroderma Willing and able to provide written informed consent Exclusion Criteria: Use of experimental therapies within 28 days prior to Screening. Aspirin use > 81 mg daily within 1 week prior to Screening. Any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study

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 |
| --- | --- |
| Limited Scleroderma<br> | |
| Diffuse Scleroderma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarized the number and percentage of subjects with elevated LOXL2 levels |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
limited scleroderma, diffuse scleroderma, Sclerosis, Progressive, Limited
P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI

Study Overview
=================
Brief Summary
-----------------
Prasugrel and ticagrelor were both associated with a significant reduction in the risk of MACE in patients undergoing PCI for an ACS, mostly through a reduced stent thrombosis. The 1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials. The incidence of biologically active stent (DES or BVS) thrombosis is largely variable according to different lesion settings. We aim to verify the translation of the postulated different reduction in thrombosis rate among various P2Y12 inhibitors (clopidogrel, prasugrel and ticagrelor) in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating lesions.

Detailed Description
-----------------
All patients aged 18-80 who underwent PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with biologically active stents (DES or BVS) between January 2012 and december 2014 at participating centers will be deemed eligible to enter the registry. In-hospital outcomes will be recorded; all patients discharged alive will be followed up with a telephone interview (minimum follow-up 6 months). The primary end-point will be the occurrence of a cluster of major adverse cardiovascular events at 1 year: Death from any cause. Myocardial infarction. Stent thrombosis, defined as definite, probable or possible following the Academic Research Consortium. Sample size 3150 patients.

Official Title
-----------------
P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI With Biologically Active Stents (P2BiTO) Registry

Conditions
-----------------
Coronary Arteriosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-80 years old PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with biologically active stents Exclusion Criteria: -none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Death, Myocardial infarction, Stent Thrombosis | Death from any cause. Myocardial infarction, defined as an elevation of the creatine kinase MB fraction or cardiac troponins by a factor of 3 or more, or the development of new Q waves in 2 or more contiguous leads at surface ECG7. Levels of total creatine kinase and the creatine kinase MB fraction will be measured in all patients between 12 and 24 hours after PCI. Stent thrombosis, defined as definite, probable or possible3 following the Academic Research Consortium | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI,, CTO,, bifurcation,, clopidogrel,, prasugrel,, ticagrelor
Laryngomalacia Exposed

Study Overview
=================
Brief Summary
-----------------
Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of stridor in infants and children. Symptoms usually appear within the first 2 weeks of life. Its severity increases up to 6 months. 15-60% of infants with laryngomalacia have synchronous airway anomalies.

Detailed Description
-----------------
The most common health complications associated with laryngomalacia were: 1. Gastroesophageal reflux which was presented by arching, choking, gagging, feeding aversion and continuous crying 2. Frequent unilateral eye infections 3. Repeated choking, frequent vomiting and poor weight gain 4. Repeated upper respiratory tract infections (viral and bacterial), coughing and cyanosis 5. Repeated secretory otitis media 6. Aspiration pneumonia

Official Title
-----------------
Laryngomalacia Exposed

Conditions
-----------------
Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 500 full term babies ≥ 37 weeks of both sexes were delivered by different modes of delivery, with birth weights of ≥ 2.5 kg, with no history of natal complications and from the same community. Mothers of these babies are from different socioeconomic standards with different educational levels.

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 2 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
-----------------
Factors Predisposing or Causing
Optimizing the Evaluation of Awareness in Disorders of Consciousness

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether personalized stimulations can improve the detection of electrophysiological signs of awareness in patients with disorders of consciousness.

Official Title
-----------------
Using High-resolution Electroencephalography to Optimize the Evaluation of Awareness in Patients With Disorders of Consciousness

Conditions
-----------------
Disorders of Consciousness

Intervention / Treatment
-----------------
* Device: high-density electroencephalography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in a vegetative state or a minimally conscious state agreement from families Exclusion Criteria: patients with akinetic mutism or locked-in syndrome patients in a coma patients with damages in the inner or middle ear contraindication to a high-density electroencephalography exam

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroencephalography recording<br>Cerebral measurements from high-density electroencephalography after the presentation of personalized stimulations | Device: high-density electroencephalography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols | Depending of the personalized stimulation protocol, the differences of electrophysiological activity can the presence of event-related potentials (N100, mismatch negativity, P300, etc.) or alterations of neural oscillations. The personalized stimulation protocol will be chosen according to the families' feeling of a presence. | standard stimulations: 28 days after recruiting patients |
EMBARK Follow-up Project

Study Overview
=================
Brief Summary
-----------------
The purpose of the EMBARK Follow-up Project (EFP) is to determine if there is a significant correlation between post-study massage-seeking and changes in pain reported by participants during the Exploring Massage Benefits for Osteoarthritis of the Knee (EMBARK) parent study (NCT00970008). The EFP hypothesizes that a positive correlation exists between pain relief during the parent study and post-study massage-seeking behavior.

Official Title
-----------------
Exploring Massage Benefits for Arthritis of the Knee (EMBARK): Post-study Massage Questionnaire

Conditions
-----------------
Osteoarthritis of the Knee

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed in the EMBARK parent study. Exclusion Criteria: Did not complete the EMBARK parent study.

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- | --- |
| EMBARK Follow-up Project Questionnaire (EFPQ) | The EFPQ is an original set of questions, designed and validated by Dr. Jerger under the supervision of NCCAM and Dr. Ruth Wolever to be administered by email or phone to address the specific aims of this project. | Eight weeks |
The Church as a Bridge to Deliver Health Resources Via Telehealth

Study Overview
=================
Brief Summary
-----------------
The proposed Church Bridge intervention project will provide an innovative, evidence-based and technology supported, health intervention model for Southern, African American, and rural populations who continue to be disparately burdened by obesity and associated co-morbidities (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50 years of age) with families, the project will contribute to the long-term reduction of preventable chronic disease and related health care costs for the public.

Official Title
-----------------
The Church as a Bridge to Deliver Health Resources Via Telehealth to Alleviate Obesity and Chronic Disease Disparities in Rural African Americans of Mississippi

Conditions
-----------------
Obesity, Diet, Food, and Nutrition, Church, Healthcare Disparities, Minority Health, Mobile Health, Telehealth, Community-based Participatory Research, Primary Health Care, Weight Loss Programs, Health Behavior

Intervention / Treatment
-----------------
* Behavioral: Church Bridge Project


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >/=30 Must have elementary aged child (5-11 years) in household Exclusion Criteria: Any health condition where weight loss is contraindicated Complicated disease states (ie., advanced renal disease or heart failure)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss program<br>Participants will attend a 12 session weight loss program accompanied by maintenance support delivered by a church. Program will include peer education, telenutrition counseling and mobile health feedback. | Behavioral: Church Bridge Project<br>* Community-based participatory research combining efforts of academic researchers, church leaders, primary care providers and community stakeholders.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight at six months |  | 6 months |
Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Background: Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. The purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population. Methods: This is a prospective, matched cohort analysis with a consecutive series of patients with CP who underwent PSF, with two attending surgeons, in 2012. These are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests (significance set a p<0.05).

Official Title
-----------------
The Effect of Two Surgeons on Blood Loss and Operative Time in Cerebral Palsy (CP) Patients Undergoing Posterior Spinal Fusion

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Procedure: The use of two attending surgeons during posterior spinal fusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral palsy neuromuscular scoliosis requiring posterior spinal fusion (>50 degree Cobb) PSF from 2008-2012 at Phoenix Children's Hospital GMFCS IV or V Exclusion Criteria: Diagnosis other than CP GMFCS I-III Previous spine deformity surgery

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CP who underwent PSF by two attendings in 2012<br> | Procedure: The use of two attending surgeons during posterior spinal fusion<br>* Patients in the experimental group received posterior spinal fusion with two attending surgeons. Patients in the control group received posterior spinal fusion with one attending surgeon and one first assist, which could be a resident, PA, or nurse.<br>|
| CP who underwent PSF by a single surgeon from 2008-2010<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications due to PFS surgery |  | Post-operative hospital stay (up to 12 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time |  | intraoperative | 
| Estimated blood loss |  | intraoperative | 
| Length of Stay |  | During hospitalization (up to 12 days) |
A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.

Conditions
-----------------
Foot Ulcers, Diabetic

Intervention / Treatment
-----------------
* Device: PriMatrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type I or Type II diabetes with investigator-confirmed reasonable metabolic control Peripheral neuropathy A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening Exclusion Criteria: Suspected or confirmed signs/symptoms of wound infection Wounds with exposed bone or tendon Hypersensitivity to bovine collagen

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

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of study ulcers healed |  | Week 12 |