linjc16/ctgov huggingface dataset:
The Healthy Lifestyle Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an internet-based intervention will be effective in improving the lifestyle and weight of an obese employee population. The intervention will last 12 months, and includes a weight tracker, a food intake tracker, an activity tracker, a calorie balance tool, an electronic discussion board, and electronic greeting cards.

Detailed Description
-----------------
The study will compare two groups over time, one of which will utilize the electronic tools, and one of which will not. The samples will be drawn from the employees of a metro-Milwaukee hospital, and will consist of obese (Body Mass Index, or BMI, of 30 or greater) employees only. The primary outcome will be change in weight over the study time period as measured by the BMI. Secondary outcome measures will include quality of life, blood pressure, tests of blood sugar, cholesterol, presence of depression, lifestyle wellness score, health care costs and productivity.

Official Title
-----------------
Weight Management for a Defined Employee Population Using an Interactive eHealth Portal

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

Intervention / Treatment
-----------------
* Behavioral: internet based weight management tools


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obesity as defined by a BMI of 30 or greater The ability to speak and understand english Health insurance coverage through First Health (Aurora's employee insurance plan) Not currently on another formal weight management program Not currently taking any weight loss medications Not currently disabled in such a way that participation would be precluded

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: internet based weight management tools|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body mass index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  |  | 
| blood pressure |  |  | 
| hemoglobin A1c |  |  | 
| total cholesterol |  |  | 
| HDL cholesterol |  |  | 
| HANDS depression score |  |  | 
| wellness score on Summex Health Risk Appraisal |  |  | 
| health care costs |  |  | 
| unscheduled paid time off |  |  |
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.

Official Title
-----------------
A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: etanercept
* Drug: sulphasalazine (SSZ)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ankylosing spondylitis Active ankylosing spondylitis Exclusion Criteria: Complete ankylosis of spine Previous treatment with etanercept

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: etanercept<br>* 50 mg<br>|
| Active Comparator: B<br> | Drug: sulphasalazine (SSZ)<br>* Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline | ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a Yes (scored as 1) or No (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL). | Baseline and 16 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankylosing Spondylitis (AS)
Prediction of Kidney Injury After Hyperthermic Intraperitoneal Chemotherapy (HIPEC)* With Machine Learning

Study Overview
=================
Brief Summary
-----------------
Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy (CRS with HIPEC) are prone to postoperative kidney dysfunction. Previous models predicting kidney injury after CRS with HIPEC did not include intraoperative physiologic data. This study is designed to include not only mean arterial pressure but other parameters such as systolic, diastolic arterial pressure, heart rate, oxygen saturation, body temperature, cardiac index, stroke volume variation and many other physical parameters using a data collection system that can record them every 1-7 seconds. The data will be analyzed using machine learning algorithms.

Official Title
-----------------
Application of Machine Learning to Predict Postoperative Acute Kidney Injury in Patients Undergoing Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy Using High-resolution, Time-synchronized Physiological Data From Vital Recorder

Conditions
-----------------
Acute Kidney Injury, Chemotherapy

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy Exclusion Criteria: patients under 19

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| HIPEC<br>patients undergoing cytoreductive surgery and hyperthermic intraoperative chemotherapy due to carcinomatosis. | Other: Data collection<br>* This study is an observational study collecting perioperative data. There is no intervention regarding this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with postoperative acute kidney injury staged by Kidney Disease: Improving Global Outcomes (KDIGO) | Stage 1: Increased sCr × 1.5 to 1.9 baseline or ≥ 0.3 mg/dl from baseline or urine output < 0.5 ml/kg/h for 6 to 12 h, Stage 2: Increased sCr × 2.0 to 2.9 baseline or urine output < 0.5 ml/kg/h for 12 h, Stage 3: Increased sCr × 3 baseline or ≥ 4 mg/dl or initiation of RRT, or GFR decrease < 35 ml/min/1.73 m2 for patients < 18 years of age or urine output < 0.3 ml/kg/h for 24 h or anuria for 12 h | during postoperative day 7 |
Cold Water Immersion Stirring in Hyperthermic Individuals

Study Overview
=================
Brief Summary
-----------------
The best way to cool a very hot person is using cold water immersion, however, the optimization of this technique has not been established. The goal of this study is to determine differences in cooling rates among two types of cold water immersion and passive cooling following immersion.

Official Title
-----------------
Cold Water Immersion Stirring in Hyperthermic Individuals

Conditions
-----------------
Hyperthermia

Intervention / Treatment
-----------------
* Other: Water Stirring
* Other: No Water Stirring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-39 y old men and women Self-reported to be healthy Currently completes aerobic exercise at least 30 minutes a day, at least 2 days per week Exclusion Criteria: History of any cardiovascular, neurologic, renal, or metabolic disease History of any contraindications on the CoreTemp contraindications and warnings document Current tobacco use or regular use within the last 2 years Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.) History of exertional heat stroke Currently pregnant or breastfeeding Inability to follow the rules of the protocols or understand the consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, counterbalanced, crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Water stirring<br> | Other: Water Stirring<br>* Following an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion.<br>|
| Experimental: No water stirring<br> | Other: No Water Stirring<br>* Following an active heating protocol, the cooling intervention includes no water stirring throughout cold water immersion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cooling rate | The core temperature cooling rate | 20 minutes |
Renal Denervation for the Treatment of Hypertension: A Pilot Safety and Efficacy Study

Study Overview
=================
Brief Summary
-----------------
A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.

Official Title
-----------------
The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Radio frequency renal denervation system (Golden Leaf GL-06E15A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages of 18 to 75, male or female; Main renal artery, with or without accessary renal arteries, with length 20mm; Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and 180mmHg based on at least 3 office blood pressure measurements, or ASBP≥135mmHg and ≤170mmHg based on 24 hr blood pressure monitoring; Agrees to take part in the trial and signs the written, informed consent. Exclusion Criteria: Renal artery abnormalities that are inappropriate for the procedure; Pregnant or plan to become pregnant; History of orthostatic hypotension; Type I diabetes; Estimated GFR<40mL/min/1.73m2; Only one kidney or prior kidney transplantation; Bleeding tendency or other coagulation related diseases; Acute or severe systemic infection; Prior renal artery interventional procedures or prior RDN treatment; History of stroke or TIA; Malignant tumor or end-stage illnesses; Secondary hypertension; Acute coronary events within 2 weeks; Other conditions that deem unsuitable for the procedure, in the opinions of investigators.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation<br> | Device: Radio frequency renal denervation system (Golden Leaf GL-06E15A)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 6 months |
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

Official Title
-----------------
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Sentinel® Cerebral Protection System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery. Subject (or legal representative) provides written informed consent. Exclusion Criteria: Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery. Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium. Subject has compromised blood flow to the right upper extremity. Subject has access vessels with excessive tortuosity. Subject has uncorrected bleeding disorders. Subject is contraindicated for anticoagulant and antiplatelet therapy.
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: TAVR with Sentinel<br>Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. | Device: Sentinel® Cerebral Protection System<br>* cerebral embolic protection system<br>|
| No Intervention: TAVR without Sentinel<br>Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) | All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions. | <=72 hours |
The Histological Analysis in Renal Transplantation Patients With Deterioration of Graft Function

Study Overview
=================
Brief Summary
-----------------
Identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplant recipients, then to identify the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual impact of both immunologic and nonimmunologic (primarily calcineurin inhibitor [CNI]nephrotoxicity) injury. In previous, CNI nephrotoxicity is overstated and considered one of the major causes of CAD, however, recently there has been found most death-censored graft losses to be the result of alloimmune or autoimmune injury, with only a minority of cases attributable to CNI toxicity. Unfortunately, Situation of objective CNI toxicity in CAD in China is not well analyzed. To improve perception of Neo safety with more local evidence, we want to do a retrospective study to identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplantation recipients.

Conditions
-----------------
Chronic Allograft Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Kidney transplant recipients, only including recipients of living-donor grafts Underwent an allograft biopsy between January 2005 and December 2011 because of developing deterioration of graft function*. Deterioration of function was defined as (1) an unexplained and persistent greater than or equal to 25% increase of CR over baseline (in the absence of potential confounding factors) or (2) new onset proteinuria (defined as albumin/CR ratio ≥0.2 or a protein/CR ratio >0.5). Exclusion Criteria: Multiple organ transplants, prior transplant with any other organ or tissue Patients who did not have the information regarding the pathological diagnosis Patients who did not have the histological sections of the allograft biopsy

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 |
| --- | --- | --- |
| the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function |  | up to 6 years |
The Effect of Somatosensory Cue on Postural Stability in Blinded Persons

Study Overview
=================
Brief Summary
-----------------
Blind Adults that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate in the movement and Rehabilitation Laboratory at Ben-Gurion University. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins & De Luca, 1993). the subjects will be tested in 3 task conditions (eyes blindfolded, eyes blindfolded holding stick, eyes blindfolded holding a dog). Participants will be required to stand on the platform 10 times for 30 s For each trial, they will be instructed to sway as little as possible.

Official Title
-----------------
The Effect of Somatosensory Cue on Postural Stability in Blinded Persons

Conditions
-----------------
Visual Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blind persons Able to stand safely for 30 seconds Able to walk independently Hip OA prior THA Exclusion Criteria: Stroke or other neurological diseases Orthopedic surgery at the past year

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SDF parameters |  | baseline |
National Survey on Gastroesophageal Reflux Disease (GERD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms .

Official Title
-----------------
Evaluation of the Impact of Abdominal Fat on GERD Severity and GERD Frequency in General Practice

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female > or = 18 years old Patient with symptomatic GERD Without PPI or H2 antagonist treatment during the 3 previous months Agree to take part in this study Exclusion Criteria: Pregnant women

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> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference |  | Once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of GERD symptoms |  | Once | 
| GERD impact scale |  | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD symptoms- Waist circumference, Patients with symptomatic GERD