linjc16/ctgov huggingface dataset:
Mobile Technology for Blood Pressure Management

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the feasibility and effectiveness of a mobile-technology based system that integrates patient-facing and clinician-facing components to assist the management of hypertension.

Official Title
-----------------
Implementing a Mobile Technology-Based System for Physician-Directed Remote Management of Hypertension: A Pilot Study

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

Intervention / Treatment
-----------------
* Combination Product: Mobile technology intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older with an established diagnosis of essential hypertension Exclusion Criteria: Patients on more than 2 antihypertensives at time of enrollment Clinical diagnosis of secondary hypertension, that is, hypertension due to a secondary cause, including but not limited to the following: Renal artery stenosis Primary hyperaldosteronism Cushing syndrome Coarctation of the aorta Drug-induced hypertension Pheochromocytoma Obstructive sleep apnea Hospitalization for malignant hypertension or severe hypertension (including stroke, cardiac events, acute kidney injury) in the preceding 6 months Hospitalization for unstable angina or myocardial infarction in the preceding 6 months Prior diagnosis of heart failure or cardiomyopathy Stroke or transient ischemic attack within prior 6 months Prior organ transplantation Failure to obtain informed consent Pregnant or currently trying to become pregnant Patients who are enrolled in other research studies

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm: Blood pressure intervention<br>Participants will use a mobile technology system comprising of a remote home blood pressure monitoring cuff and a mobile application integrated with a clinician-facing component to view and manage remote blood pressures. Participants will use this for 12 weeks, with assessment of blood pressure outcomes and anonymous surveys regarding the technology at 12 weeks. | Combination Product: Mobile technology intervention<br>* Home blood pressure cuff used by patients twice a week, with blood pressures transmitted to providers remotely<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressures for each participant measured by home blood pressure monitoring | 12 weeks | 
| Participant survey | A survey regarding usability and feedback about the intervention completed by participants | 12 weeks |
The Use of DHEA in Women With Premature Ovarian Failure

Study Overview
=================
Brief Summary
-----------------
DHEA supplementation has been used in women with infertility and diminished ovarian reserve. There is a small report in 5 women with POF that benefited from the use of DHEA over several months. The investigators aim to evaluate further the use of DHEA in women with Premature ovarian failure (POF).

Official Title
-----------------
The Use of DHEA in Women With Premature Ovarian Failure

Conditions
-----------------
Premature Ovarian Failure

Intervention / Treatment
-----------------
* Drug: DHEA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with POF Exclusion Criteria: women without ovaries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHEA<br> | Drug: DHEA<br>* DHEA 25 mg tid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Use of DHEA in Women With Premature Ovarian Failure | The following outcomes will be evaluated: FSH, AMH, estradiol, ovarian volume, antral follicle count, pregnancy in women seeking to conceive | 3 years |
Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies in 30 high schools in 2017 on students binge drinking.

Detailed Description
-----------------
In August 2017, 13 high schools in Zealand and all of Funen's 11 high schools and 6 high schools in Ringkøbing introduced new mutual alcohol policy for alcohol on study trips, parties, cafes and other social events. The background for the introduction of the alcohol policies was the aim of reducing alcohol intake among students and that alcohol should have a less dominant role. By setting the same framework, the alcohol policies aims at promoting community, responsibility and respect. The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies on students binge drinking. The analysis is a natural experiment that compare binge drinking among students at schools after the introduction of the policy with binge drinking among students a schools that did not introduce the policy.

Official Title
-----------------
Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment

Conditions
-----------------
Alcohol Policy, Binge Drinking

Intervention / Treatment
-----------------
* Other: Alcohol policy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High school student Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 25 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 |
| --- | --- |
| alcohol policy group<br>High schools that introduced the policy | Other: Alcohol policy<br>* Introduction of new mutual alcohol policy<br>|
| control group<br>High schools that did not introduce the policy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge drinking 4 or more times within the last month | Reduction in the number of students that drink 5 or more drinks on the same occasion 4 or more times within the last month | january 2019 |
Resistive/Cardiovascular Training Study

Study Overview
=================
Brief Summary
-----------------
This is a training study in healthy volunteers to characterize gains in lower-body resistive strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD) we have developed for the National Space Biomedical Research Institute. The CCD is a single platform which contains interchangeable modules for cardiovascular stepping exercises and lower body resistive exercises including squats, heel raises, abductor and adductor exercises and knee extension and flexion. The platform has the capability to tilt, yaw and pitch, and to translate in three dimensions in order to challenge the neurovestibular system. The underlying goal of the project is to provide a compact and efficient exercise modality that will prevent deterioration of the cardiovascular and musculoskeletal systems, and the neurovestibular system, in long-duration spaceflights. The goal of the current study is simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed for the device will improve strength and VO2 max. Subjects are tested for lower body resistive strength and V02max at baseline, then are trained for 12 weeks, and tested again at followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows sufficient power to detect 95% percent confidence intervals in the changes in the strength and V02max measures of roughly 10-20%. If we observe gains in these indices which are similar to those reported in the literature for simultaneous cardiovascular and resistive strength protocols, then we believe that there is sufficient evidence to test CCD in a bedrest model of long-duration spaceflight.

Official Title
-----------------
An Integrated Musculoskeletal Countermeasure Battery for Long-Duration Lunar Missions

Conditions
-----------------
Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women 25-55 years old Do not exercise on a regular basis Exclusion Criteria: Have not been diagnosed with hypertension, diabetes, high cholesterol, cardiovascular disease or asthma and other pulmonary disorders

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| VO2max |  | 6-12 weeks | 
| Leg Press Strength |  | 6-12 weeks |
Endoscopic Breast Surgery in Treating Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.

Official Title
-----------------
Endoscopic Breast Surgery Feasibility Study

Conditions
-----------------
Male Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

Intervention / Treatment
-----------------
* Procedure: endoscopic surgery
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer or prophylactic mastectomy requiring axillary nodal staging Breast disease (e.g., fibroadenoma, ADH) Ability to read and/or comprehend consent form and questionnaires Ability to follow-up per protocol Not pregnant or breastfeeding Exclusion Criteria: Pregnant or breastfeeding Evidence of chest wall or skin* involvement NOTE: *may be endoscopy-assisted

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Arm I<br>Patients undergo endoscopic breast surgery. | Procedure: endoscopic surgery<br>* Undergo endoscopic breast surgery<br>* Other names: surgery, endoscopic;Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety, breast cosmesis and patient quality of life following EBS |  | After completion of study treatment |
Prevalence and Clinical Spectrum of the 22q11 Deletion

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to conduct population based surveillance for prenatally diagnosed congenital defects amount residents of the five counties to: improve the comprehensiveness of the Metropolitan Atlanta Congenital Defects Program (MACDP) to (1) better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and elective termination on the birth prevalence of congenital defects in Atlanta (3) develop a registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in evaluation prevention programs and in monitoring prenatal diagnostic technology.

Detailed Description
-----------------
Since 1967, The Centers for Disease Control and Prevention (CDC) has conducted surveillance of birth defects in metropolitan Atlanta through review of hospital delivery and newborn medical records and records from various other medical sources in the five central counties of the metropolitan area (Clayton, Cobb, DeKalk, Fulton and Gwinnett, and has been expanded to include prenatal records. The project was begun n the aftermath of thalidomide and rubella epidemics as a kind of early-warning system for new or resurgent teratogens. The voluntary participation of Atlanta hospitals was sought and obtained at the inception of the system (the original system was a joint effort of the CDC, the Georgia Institute of Mental Health and Emory University). A case must be diagnosed by the child's sixth birthday or within six years of the date of elective termination. Children's Healthcare is one retrospective source of medical records reviewed for discharge summaries and disease indices.

Official Title
-----------------
Prevalence and Clincial Spectrum of the 22q11 Deletion: A Population Based Study of Children and Congenital Heart Defects

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: birth defect diagnosed by the child's sixth birthday birth defect diagnosed within 6 years of the elective date of termination Exclusion Criteria: those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 6 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant, prenatal, birth defects, 22Q11 deletion
Assessment of a Skin Barrier

Study Overview
=================
Brief Summary
-----------------
This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.

Detailed Description
-----------------
Design: This is a multi-site, unblinded, historically controlled assessment of a one-piece flat skin barrier. Study barriers are CE-marked. Approximately 30 subjects are enrolled in the UK.

Official Title
-----------------
User Assessment of a One-Piece Skin Barrier

Conditions
-----------------
Ileostomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: is at least 18 years of age. has an ileostomy. is at least six weeks postoperative. lives and cares for their stoma independently in the community. currently uses a Dansac Nova or NovaLife 1-piece flat skin barrier. currently uses a drainable pouch. is able to wear a 1-piece flat cut-to-fit 10-55 mm. Has a peristomal skin irritation score of 2 or less. is willing to follow the protocol as demonstrated by signing the informed consent and who in the opinion of the investigator is qualified to participate. Exclusion Criteria: has a fistula on or near the stoma. has been involved in a study involving stoma care with in the last 30 days. is pregnant or lactating, as determined by interview only. is undergoing chemotherapy, radiation or steroid therapy. has an existing medical condition that would compromise their participation in 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| barrier adhesion | Questionnaire will be provided to subject to assess barrier adhesion. | 10 days | 
| barrier tack | Questionnaire will be provided to subject to assess barrier tack. | 10 days | 
| comfort | Questionnaire will be provided to subject to assess comfort. | 10 days | 
| leakage | Questionnaire will be provided to subject to assess leakage. | 10 days | 
| ease of barrier removal | Questionnaire will be provided to subject to assess ease of barrier removal. | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ileostomy, 1-piece, assessment, Nova, NovaLife, Dansac
Resolution of Neuro-muscular Block in Great Obese Patients: Neostigmine vs Sugammadex

Study Overview
=================
Brief Summary
-----------------
It is a observational prospective study. The aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients.

Official Title
-----------------
Resolution of Neuro-muscular Block in Great Obese Patients: Neostigmine vs Sugammadex

Conditions
-----------------
Resolution of Neuromuscular Blockade

Intervention / Treatment
-----------------
* Drug: Two different types of drug for resolution of neuro-muscular blockade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Great obese Videolaparoscopic surgery Exclusion Criteria: Age under 18 No acceptation of informed consent New York Heart Association > 2

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 |
| --- | --- |
| Sugammadex<br>Patients treated with Sugammadex | Drug: Two different types of drug for resolution of neuro-muscular blockade<br> <br> |
| Neostigmine<br>Patients treated with Neostigmine | Drug: Two different types of drug for resolution of neuro-muscular blockade<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in neuro-muscular block resolution time between two groups |  | up to 36 months |
IMMUNOPHENOTYPE ROLE IN THE EVALUATION OF CLINICAL RESPONSE

Study Overview
=================
Brief Summary
-----------------
The study proposed by SSCVD Allogeneic Stem Cells of this Hospital provides for the collection of a series composed of patients with multiple myeloma undergoing allogeneic stem cell transplants at our center in the period 2000-2011. This collection is carried out with retrospective investigation , through the review of paper and electronic records and data cards already collected as part of clinical trials conducted by our own Division and approved by the Ethics Committee of Management. The purpose of data collection is particularly retrospective analysis of the incidence of extramedullary relapse , the response in flow cytometry immunophenotypic and clinical response of the disease , will also be taken into consideration for overall survival ( OS) , event-free survival (EFS) , the cumulative incidence of treatment-related mortality and graft- versus-host disease ( GVHD ), acute and chronic. The data were processed in a completely anonymous and as provided by law. The results of the study will not result in any diagnostic or therapeutic intervention on patients still alive.

Conditions
-----------------
Multiple Myeloma, Post Allografting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with multiple myeloma undergoing allogeneic stem cell transplantation in the period 2000-2011 at the University Transplant Center of the Division of Hematology. Were taken into account both donor transplants voluntary blood relative. Exclusion Criteria: Patients who died early after allogeneic transplantation (<3 months) in which has not been evaluated disease status. In the evaluation of the response of immunophenotypic disease were excluded from the analysis of bone marrow aspirate samples with low cellularity.

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 |
| --- | --- | --- |
| Overall survival |  | 5 years | 
| Event free survival |  | 5 years |