linjc16/ctgov huggingface dataset:
Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Coronary Artery Disease (HERCET-Study)

Study Overview
=================
Brief Summary
-----------------
Patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (HDL)-cholesterol levels or HDL-cholesterol with modified vasculoprotective properties. The purpose of the present study is to characterize the quality of HDL-cholesterol in patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these patients. Additionally, the researchers aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with coronary artery disease and the changes dependent on physical activity of patients.

Official Title
-----------------
Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Coronary Artery Disease

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

Intervention / Treatment
-----------------
* Behavioral: physical exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery disease Normal HDL-cholesterol levels in blood: > 40 mg/dl (1.03 mmol/L) in males > 50 mg/dl (1.29 mmol/L) in females Exclusion Criteria: Type 1 or 2 diabetes mellitus Acute coronary syndrome Unstable angina pectoris Myocardial infarction during the last 8 weeks Therapy with niacin Active infections Ventricular arrhythmias Systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg Cancer Pregnant or lactating Alcoholism

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: physical exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, HDL-Cholesterol, Endothelial Function, Endothelial Progenitor Cells, normal blood HDL-Cholesterol level
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: AK106-001616
* Drug: AK106-001616
* Drug: Active comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of RA (class I to III) Stable dose of methotrexate (at least 12 weeks) Exclusion Criteria: Pregnant or breastfeeding Abnormal screening laboratory test values considered to be clinically significant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: 1<br> | Drug: AK106-001616<br> <br> |
| Experimental: 2<br> | Drug: AK106-001616<br> <br> |
| Active Comparator: 3<br> | Drug: Active comparator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Ageing on Airway Remodeling

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the relationship between aging and morphological changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for this trial.

Detailed Description
-----------------
Chest multidetector CT without injection and spirometry data will be obtained from a multicentric sample of individuals between 60 and 95 years of ageExclusion criteria were current smoking, history of smoking within the past 10 years, any known chronic or acute pulmonary disease. Individuals treated with Amiodarone, Bleomycin or methotrexate were excludedOutcome

Official Title
-----------------
Study of Bronchoalveolar Lung Remodeling in Subjects From 60 Years Free of Progressive Lung Disease: Structure-function Analysis

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Other: EFR and TDM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People from 60 to 95 years old free from chest disease or history of chest disease Exclusion Criteria: Chronic cough Dyspnea Sinonasal or chest infection during enrollment Myocardial infarction. Current smoker or past smoker with more than 10 pack year intoxication

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 95 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60 - 70 years old<br>EFR and TDM | Other: EFR and TDM<br>* EFR : Pulmonary function test TDM : tomodensitometry<br>|
| Experimental: 71 - 80 years old<br>EFR and TDM | Other: EFR and TDM<br>* EFR : Pulmonary function test TDM : tomodensitometry<br>|
| Experimental: 81 - 95 years old<br>EFR and TDM | Other: EFR and TDM<br>* EFR : Pulmonary function test TDM : tomodensitometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchial wall thickness | Bronchial wall thickness and remodeling associated with aging | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aging lung, Airway remodeling, Airway segmentation, Chest CT
Pilot Clinical Trial of Computer-based Motivational Intervention - 1

Study Overview
=================
Brief Summary
-----------------
Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.

Detailed Description
-----------------
Participants were randomized into brief intervention vs. assessment-only conditions, with follow-up to measure overall motivation to change.

Official Title
-----------------
Pilot Clinical Trial of Computer-based Motivational Intervention

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Brief computer-delivered intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Woman in immediate post-partum period Inclusion Criteria: Self-report of drug use prior to pregnancy Exclusion Criteria: Frank psychosis or other cognitive impairment; inability to communicate in English; fatigue; recent receipt of narcotic pain medication; grieving over medically compromised infant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief computer-delivered intervention<br>A 20-minute interaction with software designed to partially replicate the experience of a brief motivational intervention with a therapist or health care professional. Included decisional balance, normed feedback, and optional goal-setting. | Behavioral: Brief computer-delivered intervention<br>* 20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.<br>|
| No Intervention: Assessment only<br>Participants in this arm only completed assessment section, same as intervention group, but then was done. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation to Change Substance Use | An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change. | One month |
Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses

Study Overview
=================
Brief Summary
-----------------
Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the world. Approximately 1% of the population worldwide is affected by this disorder. Children with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on very rigid and predictable schedules and routines. Any changes in their schedules can often trigger negative emotional outbursts. The need to come to the hospital for procedures can be one such trigger. The purpose of this study is to examine the post anesthesia behavior outcomes of children with ASD.

Official Title
-----------------
Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses

Conditions
-----------------
Autism Spectrum Disorder, Anesthesia

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 2 years through 17 years of age scheduled for a procedure with anesthesia at Boston Children's Hospital Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM IV and DSM V (autism group) or an ASA score of I or II and no history of neurodevelopmental concerns (control group) Exclusion Criteria: -Families who are not able to read and speak English well enough to complete the validated surveys

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- |
| Autism Spectrum Disorder<br>Patients with a diagnosis of autism spectrum disorder | Other: Observation<br>* Patients will be observed before and after they receive anesthesia<br>|
| Controls<br>Patients with no developmental diagnoses | Other: Observation<br>* Patients will be observed before and after they receive anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative behavioral changes in the participants |  | up to two weeks following anesthesia |
Tai Chi Exercise in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
This is a pilot randomized controlled trial of feasibililty and prelimnary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease

Official Title
-----------------
Tai Chi Exercise in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: Tai chi exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physician diagnosis of COPD FEV1<65% of predicted and FEV1/FVC<70% of predicted ≥45 years old Exclusion Criteria: COPD exacerbation requiring ER visit or hospitalization within past month planned major pulmonary intervention in coming 3 months severe peripheral vascular disease/claudication or other physical condition precluding walk test inability to perform bicycle ergometry severe cognitive dysfunction (MMSE ≤ 24) inability to speak English current participation in a pulmonary rehabilitation or regular practice of tai chi

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Experimental: Tai Chi Exercise<br> | Other: Tai chi exercise<br> <br> |
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study feasibility |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  |  | 
| exercise capacity |  |  |
Comparison Study of the McGrath MAC Video Laryngoscope With the King Vision

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators compare the effectiveness of two relatively new video laryngoscopes, McGrath MAC (Covidien, Dublin Ireland) and the King Vision (King Systems, Noblesville, IN), by practitioners experienced in airway management but with limited exposure to these two devices. Our hypothesis was that, the McGrath MAC device would require fewer intubation attempts and shorter intubation times than the King Vision when performed by novice users.

Official Title
-----------------
Randomized Controlled Trial Comparing the McGrath MAC Video Laryngoscope With the King Vision Video Laryngoscope in Adult Patients.

Conditions
-----------------
Video Laryngoscopic Device Usage in Novice Users

Intervention / Treatment
-----------------
* Procedure: King Vision video laryngoscope
* Procedure: McGrath MAC video laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All interested airway providers (Residents, Attendings, Certified Nurse Anesthetist and Student Registered Nurse Anesthetist) will be eligible to be included. - Exclusion Criteria: All patients with difficult airways as determined by history or physical exam (limited oral opening, limited cervical extension, receding chin, Mallampati class III or IV).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: King Vision Video Laryngoscope<br>Patient intubated with the King Vision Video Laryngoscope | Procedure: King Vision video laryngoscope<br>* Patient intubated with the King Vision Video Laryngoscope<br>|
| Active Comparator: McGrath MAC Video Laryngoscope<br>Patient intubated with the McGrath MAC Video Laryngoscope | Procedure: McGrath MAC video laryngoscope<br>* Intubation with the McGrath MAC video laryngoscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide |  | participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation | Number of patients intubated in less than 90 seconds | Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point. |
Cytokine Profiling Post-Heart Transplant

Study Overview
=================
Brief Summary
-----------------
Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction.

Official Title
-----------------
Cytokine Profiling of Cardiac Transplant Recipients

Conditions
-----------------
Cardiac Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1 18 years and older Cardiac Transplant recipient with graft dysfunction of unknown etiology Group 2 18 years or older No history of heart failure or cardiac transplantation Group 3 18 years or older Class II-IV heart failure Group 4 18 years or older Heart Transplant 6 months or greater prior to blood draw No graft dysfunction Exclusion Criteria: Group 1 Heart Transplant with Unexplained Graft Dysfunction Cellular or antibody-mediated cardiac allograft dysfunction Group 2 Normal Control group Active infection within 1 month of blood draw Known Inflammatory Disease Group 3 Heart Failure Group Active infection within 1 month of blood draw Known Inflammatory Disease Group 4 Heart Transplant with Normal Graft Function Group Active infection within 1 month of blood draw Known graft dysfunction Known Inflammatory Disease

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Heart Transplant Recipients with Unexplained Graft Dysfunction | |
| Group 2<br>Normal Control | |
| Group 3<br>Class III-IV Heart Failure | |
| Group 4<br>Heart Transplant Recipients with Normal Graft Function | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection | Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplant, Cytokines, Graft Dysfunction
OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this compassionate use study, for two patients with thrombotic microangiopathy, is to provide expanded access to patients who have participated in the clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed while on treatment or to patients who could otherwise benefit from the treatment. This is a treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001 deemed eligible by the investigator may participate.

Detailed Description
-----------------
The study is open-label, expanded access study to provide continued OMS721 treatment for compassionate use to patients who have participated in clinical trial OMS721-TMA-001. Patients will be eligible if markers of disease activity, such as platelet count, LDH, and haptoglobin, were observed to improve during the study or if the patients disease activity remained stable, but they could be treated with a higher dose that may be beneficial. Safety measures of adverse events and laboratory measures will be monitored. Markers of disease activity, pharmacokinetics and ex vivo pharmacodynamics will also be monitored.

Official Title
-----------------
Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use

Conditions
-----------------
Thrombotic Microangiopathy

Intervention / Treatment
-----------------
* Biological: OMS721


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of thrombotic microangiopathy related to aHUS, TTP or stem cell transplant. Have completed treatment in clinical trial OMS721-TMA-001. Investigator determined that continued treatment with OMS721 could be beneficial. Aged 18 years or older. Exclusion Criteria: Hypersensitivity to OMS721 or any excipients. Have a serious medical condition that increases the risk of OMS721 treatment to the patient.

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 |
| --- |
|Biological: OMS721|Human IgG4 MASP-2 Monoclonal Antibody|

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
-----------------
TMA, aHUS, TTP, stem cell transplant-associated TMA