linjc16/ctgov huggingface dataset:
Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)

Study Overview
=================
Brief Summary
-----------------
An investigation where patients with chronic heart failure and cheyne stokes respiration, treated with adapitve servo ventilator, will improve their cardiac function and quality of life.

Detailed Description
-----------------
Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine. Several patients with chronic heart failure also has Cheyne Stokes respiration pattern. Earlier studies have shown that this respiration pattern improves with Adaptive servo ventilator. We wish to investigate wether this leads to improved cardiac function.

Official Title
-----------------
Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).

Conditions
-----------------
Heart Failure, Cheyne Stokes Respiration

Intervention / Treatment
-----------------
* Device: ASV
* Other: without Autoset CS2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ejection fraction <40% NYHA class III-IV Optimized therapy with drugs Cheyne stokes respiration pattern > 25% while sleeping Age < 85 years clinical stability the last month before inclusion. Exclusion Criteria: CABG less then 6 months ago PCI treatment less then 3 months ago Unstable angina pectoris Acute coronary syndrome less then 3 months ago Stroke less then 6 weeks ago Thoracal myopathy Advanced COPD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: A<br>The patients use ASV | Device: ASV<br>* Adaptive servo ventilator<br>* Other names: AutoSet CS2;Other: without Autoset CS2<br>* without Autoset CS2<br>|
| Active Comparator: B<br>Patients without ASV | Other: without Autoset CS2<br>* without Autoset CS2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection fraction (measured with echocardiography) and inflammatory markers |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, cheyne stokes respiration, adaptive servo ventilator
Exploring New Approaches in Reaching Behavior Post Stroke

Study Overview
=================
Brief Summary
-----------------
After 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct.

Detailed Description
-----------------
Analysis indicated that both methods improved reaching without trunk use Reaching performance scale (RPS), but the trunk -stabilized group led to more significant changes. Training under less restrictive conditions associated with Task-Related Training (TRT) (auditory feedback from trunk sensor) as compared to stabilized TRT, led to improved functional and impairment measure scores (WMFT, FM and shoulder flexion). Conclusion: Fading feedback with both training methods, during extended TRT reaching/grasping practice generally led to some improvements. However, as demonstrated by impairment and functional outcome measures, using TRT with an auditory feedback signals is a more effective approach than forcing the stabilization of the trunk during rehabilitation of the upper-limb.

Official Title
-----------------
Training With or Without Upper Body Restraint During Reaching in Individuals Post Stroke

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

Intervention / Treatment
-----------------
* Behavioral: stabilization training
* Behavioral: auditory training group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals all scored between 20 and 44 on the Upper-Arm subsection of the Fugl-Meyer Scale (FM- Poole & Whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (RPS, Levin 2006) Exclusion Criteria: Individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>stabilization training group | Behavioral: stabilization training<br>* training of arm function with the trunk stabilized<br>|
| Experimental: 2<br>auditory response training group | Behavioral: auditory training group<br>* response to an auditory signal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WMFT |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FM and shoulder flexion |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, reaching, stroke
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior

Study Overview
=================
Brief Summary
-----------------
The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).

Official Title
-----------------
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Cytarabine consolidation
* Drug: Allogeneic transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Able to give informed consent New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2 Exclusion criteria: Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up Pregnancy: Women of childbearing potential who are β- HCG+

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No Leukemia Stem Cells - Consolidation<br>Without LSC, standard cytarabine consolidation | Drug: Cytarabine consolidation<br>* Cytarabine-based consolidation per institutional standards.<br>* Other names: HiDAC;|
| Experimental: Leukemia Stem Cells - Consolidation<br>LSC present, randomized to cytarabine consolidation | Drug: Cytarabine consolidation<br>* Cytarabine-based consolidation per institutional standards.<br>* Other names: HiDAC;|
| Experimental: Leukemia Stem Cells - Transplant<br>LSC present, randomized to allogeneic transplant | Drug: Allogeneic transplant<br>* Allogeneic stem cell transplant per institutional standards.<br>* Other names: HSCT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse Free Survival | Percentage of participants alive and without relapsed disease at two years. | 2 years |
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates

Study Overview
=================
Brief Summary
-----------------
Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.

Detailed Description
-----------------
Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.

Official Title
-----------------
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates

Conditions
-----------------
Blood Transfusion Complication, Oxidative Stress

Intervention / Treatment
-----------------
* Biological: packed red blood cells transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature neonates ≤36 weeks in need for blood transfusion. Exclusion Criteria: Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies) Extremely low birth weight neonates(<1000gm birth weight ) Recipient of blood transfusion before enrollment in the study. Neonates planned for exchange transfusion .

Ages Eligible for Study
-----------------
Minimum Age: 35 Weeks
Maximum Age: 37 Weeks

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fresh PRBCs<br>Neonates will receive fresh packed red blood cells transfusion within 7 days of donation | Biological: packed red blood cells transfusion<br>* packed red blood cells transfusion<br>|
| Active Comparator: Old PRBCs<br>Neonates will receive fresh packed red blood cells transfusion older than 7 days yet within the standard range accepted universally will be transfused to this group. | Biological: packed red blood cells transfusion<br>* packed red blood cells transfusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malondialdehyde | MDA | 2-3 hours posttransfusion | 
| total antioxidant capacity | TAC | 2-3 hours posttransfusion | 
| serum Copper | s.Cu | 2-3 hours posttransfusion | 
| serum Zinc | s.Zn | 2-3 hours posttransfusion | 
| serum magnesium | s.Mg | 2-3 hours posttransfusion | 
| serum iron | s.Fe | 2-3 hours posttransfusion | 
| serum Calcium | s.Ca | 2-3 hours posttransfusion |
Cardiovascular Epidemiology in Russian Federation

Study Overview
=================
Brief Summary
-----------------
The study addresses epidemiology of cardiovascular risk factors and major cardiovascular diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants in each will be included.

Detailed Description
-----------------
Plasma lipids and fasting glucose, heart rate and blood pressure, anthropometry, smoking and alcohol questionaries, nutrition, sleep quality, stress will be assessed. ECG records are obtained form all participants. Subclinical target organ damage (carotid and periferal atherosclerosis, pulse wave velocity) will be measured in selected sites. Brain natriuretic peptide, adipose tissue cytokines, hsCRP and genetic markers are also under evaluation

Official Title
-----------------
Multicenter Observational Study of Epidemiology of Cardiovascular Diseases and Risk Factors in Different Regions of Russian Federation

Conditions
-----------------
Hypertension, Coronary Artery Disease, Diabetes, Heart Failure, Smoking, Lifestyle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - informed consent Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| all cause mortality | all cause motality registered by official statistics | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | ischemic and heamorragic stroke | 10 years | 
| Miocardial infarction |  | 10 years | 
| Cardiovascular mortality |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
body mass index, hypertension, epidemiology, glucose, lipids, smoking, coronary artery disease, arterial stiffness, carotid ultrasound
Ambulatory Versus Home Blood Pressure Measurement

Study Overview
=================
Brief Summary
-----------------
This is a prospective study comparing the three blood pressure monitoring methods on the diagnosis of arterial hypertension. Blood pressure of each subject will be evaluated with clinic, home and 24h ambulatory blood pressure measurements in three visits

Official Title
-----------------
EVALUATION OF BLOOD PRESSURE MEASUREMENTS OUTSIDE OFFICE: COMPARISON OF DIAGNOSIS BASED ON EITHER AMBULATORY OR HOME BLOOD PRESSURE MEASUREMENTS

Conditions
-----------------
Arterial Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 20 yrs Patients referred to an outpatient clinic for high blood pressure Patients with no treatment or with antihypertensive treatment stable for at least 4 weeks. Patients capable of performing home blood pressure measurements. Signed informed consent Exclusion Criteria: Hypertension stage III (SBP>180 mmHg or DBP>110mmHg) Secondary hypertension Resistant hypertension Arrhythmia Pregnancy Symptomatic heart disease Renal disease (Cr>2mg/dl) Uncontrolled diabetes mellitus (HbA1c>8.5%)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Blood pressure monitoring methods | Comparison among clinic, home and ambulatory blood pressure measurements. | Baseline |
The Effect of Parathyroidectomy on Renal Function, Endothelial Function, and Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure. Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play an important role in the development of structural abnormalities of both large arteries and the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years there has been increasing evidence from animal studies that the endothelium is a target organ of PTH. Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and endothelial function. Aims: To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal transplant recipients To evaluate the effect of PTX on endothelial function in stable renal transplant recipients/chronic kidney disease (CKD) stage 5 patients To evaluate the effect of PTX on blood pressure in stable renal transplant recipients/CKD stage 5 patients

Official Title
-----------------
Observational Study to Evaluate the Effect of Parathyroidectomy on Renal Function, Endothelial Function and Blood Pressure

Conditions
-----------------
Hyperparathyroidism, Hypertension

Intervention / Treatment
-----------------
* Procedure: parathyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable renal transplant recipients/CKD stage 5D patients. Age between 18 years and 85 years. Signed informed consent. PTX scheduled because of severe hyperparathyroidism (day 0)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: parathyroidectomy|parathyroidectomy|

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
-----------------
parathyroidectomy, arterial stiffness, renal function
A Study Evaluating the Treatment Selection and Outcome When Changing Antipsychotic Treatment in Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the outcome of treatment switch defined as an improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit).

Official Title
-----------------
A Non-interventional, Prospective, Open-label Study for the Evaluation of the Selection and Outcome of the Antipsychotic Treatment Switch in Outpatients With Schizophrenia - ETOS Study

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia (as per DSM-IV), at least 6 months prior to enrolment in the study Subjects who have initiated a new antipsychotic treatment within the preceding 2 weeks Subjects whose prior and current antipsychotic treatment consists of any typical or atypical antipsychotic monotherapy Exclusion Criteria: Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from schizophrenia), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria and not in full remission Female subjects who are pregnant or lactating

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antipsychotic outpatients with schizophrenia<br>Switched treatment of antipsychotic outpatients with schizophrenia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-CB scale score of subjects achieving a score of < 4. |  | At Week 18 - once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PANSS scale |  | Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks | 
| Change in BARS scale |  | Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks | 
| Changes in CGI-S and CGI-I scales |  | Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Switch of antipsychotic treatment, Outcome evaluation, monotherapy, Greece
Utilizing Augmented Artificial Intelligence for Aminoacidopathies

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to interpret metabolic profiles of plasma amino acid (PAA) and compare reference intervals (RI) of PAA data from Pakistan with data from other countries using Clinical Laboratory Integrated Reports (CLIR). One-year data (reference and cases data) of twenty-two PAA, analyzed by ion exchange high performance chromatography at Biochemical Genetics Laboratory (BGL) of Aga Khan University Pakistan, was compiled in a comma-separated values (.csv) file and uploaded on CLIR Software using AAQP (Amino Acid in Plasma) application for statistical analysis. Among total of 2081 PAA profiles, 92% (n=1913) were completely normal with all PAA values falling within the age-specific reference range. A concordance of 98.8% was noted between the reporting done by the BGL at AKU and then after applying CLIR tools.

Official Title
-----------------
Utilizing Augmented Artificial Intelligence for Aminoacidopathies: Experience of Collaborative Laboratory Integrated Reporting From Pakistan

Conditions
-----------------
Inborn Errors of Metabolism

Intervention / Treatment
-----------------
* Diagnostic Test: Plasma amino acid assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All plasma samples during 1 year received at Biogenetic Lab Exclusion Criteria: Subjects with age greater than 16 years

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases Data<br>subjects having abnormal plasma amino acid profiles with either one or more amino acid concentrations beyond (high or low) the locally defined age-specific reference ranges | Diagnostic Test: Plasma amino acid assay<br>* Plasma amino acid analysis was performed on all the blood samples received in biogenetics lab at Aga khan university, Karachi during one year period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postanalytical interpretation of concentration of plasma leucin, isoleucine and valine in nmol/L using Clinical Laboratory Integrated Reports (CLIR) | Clinical Laboratory Integrated Reports (CLIR, formerly Region 4 Stork) is a post-analytical software that compares the amino acid results against a large database of reference ranges, disease-specific cutoffs, and ratios of diagnostic markers. Among 168 subjects having abnormal PAA profiles in our lab, 10.1% were correctly classified as MSUD and 100% concordance with CLIR reporting. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Laboratory Integrated Reports (CLIR), Inherited metabolic disorders (IMDs)