linjc16/ctgov huggingface dataset:
Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to analyze changes in cardiac function using Doppler echocardiogram in critical patients during weaning from mechanical ventilation using two different weaning methods (pressure support and T-tube) and to compare a subgroup of patients: success vs. failure in weaning and patients with vs. without heart disease.

Detailed Description
-----------------
Weaning from mechanical ventilation (MV) involves physiological changes that can overload the cardiorespiratory system due to changes in the interaction between patient and ventilator. This was a randomized crossover clinical trial that included patients in an intensive care unit (ICU) who had been on MV for more than 48 hours and who were considered ready for weaning. Cardiorespiratory variables, oxygenation, electrocardiogram (ECG) and Doppler echocardiogram findings were analyzed at baseline and after 30 minutes in each trial weaning method (PSV and T-tube). Comparisons were made between PSV and T-tube, weaning success and failure and patients with and without heart disease, using ANOVA and Student's t test. The level of significance was set at p < 0.05.

Official Title
-----------------
Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation: a Randomized Crossover Clinical Trial

Conditions
-----------------
Critical Care, Weaning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients hemodynamically stable conscious (Glasgow scale ≥ 13) with adequate gaseous exchange (O2 saturation ≥ 95%, fraction of inspired oxygen (FiO2) ≤ 40% and positive end-expiratory pressure (PEEP) = 5 with no acidosis or alkalosis) normal electrolyte levels presence of respiratory drive informed consent was signed by the patients and/or family members Exclusion Criteria: hemodynamic instability severe intracranial disease barotrauma

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weaning, echocardiogram, diastolic dysfunction, Mechanical ventilation
Quality Control of Ventral Hernia Surgery by Prospective Registration

Study Overview
=================
Brief Summary
-----------------
Quality Control of ventral hernia surgery in 21 Belgian hospitals by prospective registration in close collaboration with the Danish Hernia Database.

Official Title
-----------------
Quality Control of Ventral Hernia Surgery in 21 Belgian Hospitals by Prospective Registration in Close Collaboration With the Danish Hernia Database.

Conditions
-----------------
Ventral Incisional Hernia

Intervention / Treatment
-----------------
* Procedure: Hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Consecutively all patients with an elective or emergency repair of every ventral/incisional hernia (including parastomal hernia) Male and female 18 years or older Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of one of the 18 participating Belgian hospitals, but by specific surgeons) Elective and emergency surgery Signed informed consent form Exclusion criteria Younger than 18 years Not operated or supervised by participating surgeon Pregnant at inclusion in the registry No signed informed consent form

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 |
| --- | --- |
| All consecutive patients with primary ventral or incisional hernia<br> | Procedure: Hernia repair<br>* Primary or mesh repair of primary ventral or incisional hernia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation | reoperation and readmission rate for (mesh-related) complications or recurrence related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh related) complications or recurrence reoperation and readmission rate for (mesh-related) complications or recurrence | through study completion, an average of 2 years |
Effects of Red Wine on Cardiovascular Risk Factors in Humans

Study Overview
=================
Brief Summary
-----------------
Fifty healthy human subjects are randomized to not to consume any alcohol at all or to drink 1 glass of red wine/day for women or 2 glasses for men for three months. Outcomes are changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Dietary Supplement: red wine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects 25 years of age and older Exclusion Criteria: alcoholic first degree relatives

Ages Eligible for Study
-----------------
Minimum Age: 25 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: red wine<br>intervention: dietary supplement intake of red wine on a daily basis, 1 glass/day for women, 2 for men | Dietary Supplement: red wine<br>* intake of red wine on a daily basis<br>|
| No Intervention: total abstention from alcohol<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects on laboratory variables, mood and body composition | changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects on liver fat amount |  | 3 months |
Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.

Conditions
-----------------
COPD, Inspiratory Muscle Weakness

Intervention / Treatment
-----------------
* Other: Inspiratory Muscle Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COPD Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks Pi,max <60 centimeters of water or <50% of the predicted normal value Exclusion Criteria: Major comorbidities preventing successful participation in an 8 week exercise training intervention use of non-invasive ventilation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory Muscle Training<br>Procedure: Inspiratory Muscle Training Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max | Other: Inspiratory Muscle Training<br> <br> |
| Sham Comparator: Sham Inspiratory Muscle Training<br>Twice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O) | Other: Inspiratory Muscle Training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute walking distance |  | change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity (constant work rate test) |  | change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program | 
| maximal inspiratory pressure (PImax) |  | change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program | 
| inspiratory muscle endurance capacity |  | change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program | 
| dyspnea | measured via Borg-scale at rest, during 6-minute walking distance, during constant work rate test at iso-time, during inspiratory muscle endurance capacity test | change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program |
A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A research study to see how safe and effective MK0217 is when taken weekly for the prevention and treatment of steroid induced bone loss.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of Oral Alendronate Sodium Once Weekly for the Prevention and Treatment of Glucocorticoid-Induced Bone Loss

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: MK0217/Duration of Treatment : 12 Months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman aged 18 to 80 years, being treated with oral glucocorticoid (steroid), without vertebral fracture or prior osteoporotic fracture Exclusion Criteria: Mentally or legally incompetent, pregnant, alcohol or drug dependence, history of heart disease, kidney disease, hypertension, upper gastrointestinal disease, cancer, being treated with hormone replacement therapy, or life expectancy of less than 3 years

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0217/Duration of Treatment : 12 Months|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effect of patients taking MK0217 once weekly along with steroids for a 12 month period by checking the percentage change of bone mineral density as compared to patients taking placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucocorticoid
Systolic Hypertension in the Elderly Program (SHEP)

Study Overview
=================
Brief Summary
-----------------
The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.

Detailed Description
-----------------
BACKGROUND: More than 3 million persons in the United States over the age of 60 have isolated systolic hypertension. They face an excess risk (2-3 fold) of stroke, other cardiovascular disease and death. Population-based data show that the prevalence rises from approximately 8 percent in the age group 60-69 years to approximately 20 percent over the age of 80. Based on available data, an annual stroke rate of 2.0 percent has been estimated in this population. The full-scale clinical trial followed a pilot study conducted from 1980 to 1983. Recruitment in the trial began in March 1985 and was finished in January 1988. Follow-up ended in February 1991. Data analysis continued through October 1996. DESIGN NARRATIVE: A randomized, double-blind trial in which 2,365 subjects were assigned to active treatment and 2,371 to placebo. For the active treatment group, a stepped-care regimen was used which included chlorthalidone 12.5 or 25 mg/day, and as needed, addition of atenolol 25 or 50 mg/day or reserpine, 0.05 or 0.10 mg/day. Treatment goal was to reduce systolic blood pressure by at least 20 mm Hg from baseline and to below 160 mm Hg with minimal amounts of study medication. The primary endpoint was the incidence of fatal and non-fatal stroke. Secondary endpoints were cardiovascular and coronary morbidity and mortality, all-cause mortality, and quality-of-life measures.

Conditions
-----------------
Cardiovascular Diseases, Cerebrovascular Disorders, Heart Diseases, Hypertension

Intervention / Treatment
-----------------
* Drug: chlorthalidone
* Drug: atenolol
* Drug: reserpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women, aged 60 or over, with isolated systolic hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chlorthalidone|nan|
|Drug: atenolol|nan|
|Drug: reserpine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Changes in Body Composition and Nutritional Status in Patients Undergoing Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Liver transplant is the goal treatment for every patient with end-stage chronic liver disease. Quality of life improves after transplant because the main complications of end-stage liver disease disappear, but due to immunosuppression other alterations appear such as metabolic alterations, weight gain, among others. Body composition and nutritional status can be affected do to post-transplant pharmacologic therapy.

Detailed Description
-----------------
Body composition and nutritional status can be affected due to post-transplant pharmacologic therapy. This is a prospective cohort study, patients from liver transplant waiting list will be assessed, pre and post-transplant measures of body composition and nutritional status will be obtained.

Official Title
-----------------
Changes in Body Composition and Nutritional Status Assessed by Bioelectrical Impedance Vector Analysis in Cirrhotic Patients Undergoing Liver Transplantation

Conditions
-----------------
Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis (any etiology) Enrolled in waiting list for tliver transplant Exclusion Criteria: Hepatocellular carcinoma Chronic renal failure Congestive cardiac failure Extremity amputation Pregnancy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nutritional assessment<br>Nutritional assessment will be performed by bioelectrical impedance vector analysis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Body composition will be assessed through bioelectrical impedance vector analysis graph. | Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function tests |  | Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplant, liver cirrhosis, nutritional status, bioelectrical impedance vector analysis
Patient-Centered PD Ambulatory Monitoring System

Study Overview
=================
Brief Summary
-----------------
This a usability study of a wearable sensor platform that utilizes a smartwatch to periodically record motion data. That data is processed in a connected smartphone and translated into symptom scores for dyskinesia, slowness, and tremor. The research subjects will use the wearable system over the course of five weeks, during which a change in therapy regimen is prescribed by the physician. Research analysis will be focused on patient and clinician experiences with the app and its reports.

Official Title
-----------------
ParkinPal: Patient-Centered PD Ambulatory Monitoring System

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: ParkinPal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Existing Patient of Collaborating Physician (David E. Riley, MD) Diagnosed With Parkinson's Disease Hoehn & Yahr Scale I-III Ambulatory and capable of using the ParkinPal system Able to understand and follow instructions regarding using the device Exclusion Criteria: Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.

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 |
| --- | --- |
| Parkinson's Disease<br>Smartwatch-based sensor assessment of PD symptoms during standard care | Device: ParkinPal<br>* Wear and periodic recording of motion data during daily wear<br>* Other names: KinesiaU motor assessment system;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Useability | Following the study, patients will complete questionnaires on their experience with the wearable system. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores | The recorded scores will be and timing of medication and exercise diary entries will be examined to measure the effect of therapy and therapy regimen change on symptom scores. | 6 weeks |
Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions

Study Overview
=================
Brief Summary
-----------------
Through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results.

Official Title
-----------------
Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions and Study of Its Application for Diagnosis, Treatment and Prognosis

Conditions
-----------------
Pancreatic Cyst, Molecular, Chemical Analysis of Cystic Fluid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who diagnosed with pancreatic cystic lesion patients who are able to acquire cystic fluid through EUS-FNA or surgery patients aged 18 years and older Exclusion Criteria: patients who did not want to participate in this study patients aged under 18 years old severely mentally ill patients 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy by cystic fluid analysis | diagnostic accuracy by cystic fluid analysis in comparison with pathologic diagnosis | up to 5 years after cystic fluid analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | overall survival until death | up to 5 years after cystic fluid analysis or surgical resection | 
| Disease free survival | Period till tumor recurrence after surgical resection or intervention | up to 5 years after cystic fluid analysis or surgical resection | 
| Malignant transformation rate | the prevalence of malignant transformation during follow-up period (percent) | up to 5 years after cystic fluid analysis | 
| Prediction for treatment response in case of surgical resected or EUS-guided ethanol ablated pancreatic cysts | evaluation of treatment response for surgery of EUS guided therapy according to RECIST criteria v1.1 | up to 5 years after cystic fluid analysis or EUS guided ablative therapy | 
| Cytology of cystic fluid | result of cytology of cystic fluid | within 2 months after study enrollment | 
| Chemical profile of CEA in cystic fluid | level of CEA in cystic fluid | within 2 months after study enrollment | 
| Chemical profile of Amylase in cystic fluid | level of amylase in cystic fluid | within 2 months after study enrollment | 
| Chemical profile of glucose in cystic fluid | level of glucose in cystic fluid | within 2 months after study enrollment | 
| DNA mutation profile of cystic fluid | targeted NGS for KRAS, NRAS, CDKN2A, TP53, SMAD4, RNF43, PTEN, PIK3CA, VHL, Aneuploid | within 2 months after study enrollment |