linjc16/ctgov huggingface dataset:
Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults

Study Overview
=================
Brief Summary
-----------------
A 24-month, placebo controlled, double dummy, parallel-design outpatient trial in generally healthy elderly men and women who are at risk of becoming frail.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Five Parallel Group Study Of The Effect Of CP-424,391 On Physical Performance And Body Composition In Older Subjects

Conditions
-----------------
Aging, Frail Older Adults

Intervention / Treatment
-----------------
* Drug: CP-424,391


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65-84 years old, BMI < 30, at risk for functional decline based on SF-36, Instrumental Activities of Daily Living (per Nagy's), or 2 or more falls in prior 2 years Exclusion Criteria: Significant history or symptoms of acute medical conditions, currently in an exercise program, pain or other conditions that would prevent participating in exercise testing

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 84 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-424,391|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent increase in lean (non fat) body mass. |  | Measured by DXA at BL 3, 6, 12, and 24 months | 
| Change in functional performance (speed to climb stairs, walking speed and feet walked in 6 min). |  | Measured at BL, 3, 6, 12, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics, blood hormones and biomarkers |  | (BL,3,6,12,24 months) | 
| Tape measurement of size of arm and leg muscles, waist, and hip |  | (BL,3,6,12,24 months) | 
| IGF-1 and GH levels |  | (1,2,18 months) | 
| Overnight GH profile in a subset |  | (2,18 months) | 
| Muscle strength |  | (BL,3,6,12,24 months) | 
| Questionnaires on general health, depression, mental status, sleep and activities of daily living |  | (BL,3,6,12,24 months) | 
| Other physical performance tests including time to rise from a chair 5 times, balance tests (walking a straight line) |  | (BL,3,6,12,24 months) |
Improving Preventive Service Delivery at Adult Complete Health Check-Ups

Study Overview
=================
Brief Summary
-----------------
To determine the effectiveness of a single checklist reminder form to improve the delivery of preventive health services at adult health check-ups in a family practice setting.

Official Title
-----------------
Improving Preventive Service Delivery at Adult Complete Health Check-Ups: the Preventive Health Evidence-Based Recommendation Form (PERFORM) Cluster Randomized Controlled Trial

Conditions
-----------------
Preventive Health Care

Intervention / Treatment
-----------------
* Device: Preventive Care Checklist Form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults older than 21 years of age who had an complete health check-up completed at the clinic during the study period. Exclusion Criteria: Charts were excluded if the patient was younger than 21, an investigator completed the assessment or the encounter was disease/illness specific.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Preventive Care Checklist Form|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates and relative risks (RR) of the performance of 13 preventive health maneuvers at baseline and post-intervention and the percentage of up-to-date preventive health services delivered per patient were compared between the two groups. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preventive Health Care, Annual Health Check-up, Primary Care, Reminders
BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Official Title
-----------------
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Drug: BLI4700


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. At least 18 years of age If female, and of child-bearing potential, is using an acceptable form of birth control. Negative urine pregnancy test at screening, if applicable In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Primary Exclusion Criteria: Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. Subjects who had previous significant gastrointestinal surgeries. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. Subjects with a prior history of renal, liver or cardiac insufficiency Subjects with impaired consciousness that predisposes them to pulmonary aspiration. Subjects undergoing colonoscopy for foreign body removal and/or decompression. Subjects who are pregnant or lactating, or intending to become pregnant during the study. Subjects of childbearing potential who refuse a pregnancy test. Subjects allergic to any preparation components. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI4700<br>BLI4700 Bowel Preparation (Investigational Regimen) | Drug: BLI4700<br>* BLI4700 Bowel Preparation (Investigational Regimen)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Successful Bowel Preparation | Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor). | Day of colonoscopy |
Cervical Device Contraception-2 (Nanopaz)

Study Overview
=================
Brief Summary
-----------------
Measure blood progesterone by using cervical device contraception.

Detailed Description
-----------------
A very small cervical device that releases small amount of progesterone 20 mcgm/day. The target of the research is to measure blood progesterone by using the cervical device. This small device delivers progesterone by nanotechnology method.

Official Title
-----------------
Cervical Device Contraception

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Nanopaz contraception device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10 healthy women are candidate for hysterectomy Exclusion Criteria: Women with neoplastic malignancy disease or thrombophylia

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 2 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Nanopaz contraception device|levonorgestrel and levonorgestrel device for cervical contraception-nantechnolgy method|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood progesterone measure in blood |  | one to two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nanopaz device, Blood progesterone measure in using the device, Delivery progesterone, Progesterone levonorgestrel
Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Study

Study Overview
=================
Brief Summary
-----------------
There are controversies about the best sites -biopsy based -tests for H pylori associated gastritis. The study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

Detailed Description
-----------------
. The study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia. 400 patients with dyspepsia are planned to be enrolled in this study. in addition to the routine antral biospy, corpus biospies are taken to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

Official Title
-----------------
Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Multicenter Study

Conditions
-----------------
Helicobacter Pylori, Gastric Antrum, CORPUS BIOPSIES

Intervention / Treatment
-----------------
* Other: ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included in this study are those with peptic ulcer disease, previous upper gastrointestinal surgery, a known or a suspected past history of H.pylori eradication therapy, a personal or first-degree family history of gastric cancer Exclusion Criteria: those having received antibiotic or proton pump inhibitor treatment one month beforehand
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Other: ENDOSCOPIC GASTRIC BIOPSIES<br>ENDOSCOPIC BIOPSEIS TAKEN FROM BOTH ANTRUM AND CORPUS FOR H PYLORI DETECTION | Other: ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY<br>* ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H PYLORI POSITIVITY |  | 2 YEARS |
Mindfulness Based Stress Reduction in COPD

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test the efficacy of a Mindfulness Based Stress Reduction program in COPD on quality of life, dyspnea, daily physical activity and mindfulness during daily life.

Official Title
-----------------
Mindfulness Based Stress Reduction in COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, COPD

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Stress Reduction Program (MBSR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: clinical diagnosis of COPD clinically significant dyspnea, as determined by a score of >=2 on the Medical Research Council of Dyspnea Score questionnaire (0-4). Exclusion criteria: patients with a high likelihood of not completing the program (active chemical dependency) patients with an inability fo provide good data or to follow commands (neurologic or psychiatric condition). poor motivation or lack of interest in program

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 99 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: MBSR<br> | Behavioral: Mindfulness Based Stress Reduction Program (MBSR)<br>* Traditional eight-week MBSR Program.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We hypothesize that the perception of well being will increase after participants go through the MBSR program for COPD. |  | Baseline and at eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants in the MBSR for COPD will have an increase in their physical activity level. |  | Baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, COPD
AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Study Overview
=================
Brief Summary
-----------------
A multi-center, retrospective, single arm post market registry to evaluate procedural outcomes data using the Cardiva VASCADE MVP Venous Vascular Closure System (VVCS) for the management of the femoral venotomy after catheter-based atrial fibrillation interventions with or without another arrythmia performed via 6-12F procedural sheaths with single or multiple access sites per limb for patients who are discharged the same day.

Official Title
-----------------
AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

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

Intervention / Treatment
-----------------
* Device: VASCADE MVP VVCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age; Underwent catheter-based ablation for atrial fibrillation with or without another arrythmia. VASCADE MVP was the only closure device utilized. Were discharged the same calendar day as the index procedure. Completed a SOC follow-up > 7 days post-procedure. Exclusion Criteria: 1. Any additional procedure(s) involving femoral arterial or venous access in either limb within the SOC follow up period as defined by each site (minimum 7 days post-procedure)

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 |
| --- | --- |
| Same Day Discharge<br>Patients undergoing a-fib ablation procedures who were closed with VASCADE MVP and were discharged the same day. | Device: VASCADE MVP VVCS<br>* The VASCADE MVP Venous Vascular Closure System (VVCS) is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6 - 12F inner diameter (maximum 15F OD) procedural sheaths, with single or multiple access sites in one or both limbs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from next day access site closure-related complications requiring hospital intervention | Primary Performance Outcome | 1 day | 
| rate of major venous access site closure-related complications | Major Complication rate | ≥7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from next day procedure-related complications requiring hospital intervention | Secondary Performance Outcome | 1 day | 
| Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact | Secondary Performance Outcome | ≥7 days | 
| minor venous access site closure-related complications | Minor Complication rate | ≥7 days |
Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term Usage

Study Overview
=================
Brief Summary
-----------------
A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.

Detailed Description
-----------------
A retrospective, open-label, follow-up study assessing the long-term safety and efficacy of vestibular electrical stimulation as delivered by the Vestal DM Device.

Official Title
-----------------
Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Safety Assessment of Long-Term Usage

Conditions
-----------------
Safety Issues

Intervention / Treatment
-----------------
* Device: Vestal DM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vestal DM user (more than 6 months) Exclusion Criteria: Vestal DM device user (less than 6 months)

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: Vestal DM|Battery powered non-invasive neurostimulation device (1.5mA)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of hearing function as reported by formal audiometry testing | Formal audiometry testing to be conducted using the AMTAS Flex Device | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of device related adverse events |  | Baseline | 
| Inspection of the skin behind the ears (mastoid area) | Photographic inspection of the skin behind the ears to confirm no skin irritation has been caused at the mastoid area where the electrode pads are placed | Baseline | 
| Otoscope examination of the inside of both ear canals and tympanic membranes | Photographs to be taken of both ear canals and both tympanic membranes using the Awelor Wireless Smart Otoscope (Model Number: T1). | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vestibular, Neuromodulation, Safety
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap

Study Overview
=================
Brief Summary
-----------------
To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.

Official Title
-----------------
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap

Conditions
-----------------
End Stage Renal Disease (ESRD)

Intervention / Treatment
-----------------
* Device: ClearGuard HD end cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients dialyzing with a central venous catheter Exclusion Criteria: Known allergy to chlorhexidine

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ClearGuard HD end cap<br>Treatment | Device: ClearGuard HD end cap<br>* The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub<br>|
| No Intervention: Standard hemodialysis end cap<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days | This was calculated by dividing the cumulative number of PBCs by cumulative time at-risk as follows. The National Healthcare Safety Network (NHSN) Center for Disease Control (CDC) 21-day outpatient hemodialysis patient rule is as follows: A PBC is considered a new event and counted only if it occurred 21 days or more after a previously reported PBC in the same patient; new PBC events are based on blood cultures drawn as an outpatient or within one calendar day after a hospital admission. Following a PBC additional same-type events were counted beginning 21 days following the initial event; the CVC-days were counted during this period. The CVC-days were calculated by summing the number of days each patient was at-risk of accruing a PBC. This analysis included all subjects that participated in the study that were not otherwise censored to more accurately count CVC-days. | Up to 12 months |