linjc16/ctgov huggingface dataset:
Cardiovascular Effects of CART Cell Therapy

Study Overview
=================
Brief Summary
-----------------
This is an observational study aiming to prospectively define the rate of occurrence, natural history and progression of cardiac dysfunction in adults, and to identify the patients at high risk of developing cardiovascular events. The study enrolls patients prior to infusion with CART cell therapy and follows them with serial echocardiography, cardiac biomarkers, clinical data, and quality of life questionnaire.

Detailed Description
-----------------
Patients have echo, blood draw, and QoL survey prior to CART infusion, then 2 days, 1 week, 1 month and 6 months following CART infusion. If patients experiences CRS, study team acquires echo within 72 hours of onset. As part of an optional substudy, patients wear an event monitor for 10 days, starting day of CART infusion.

Official Title
-----------------
Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: An Observational Prospective Study

Conditions
-----------------
Leukemia, Lymphoma, Cardiotoxicity, Risk Factor, Cardiovascular, Immunotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Diagnosed with CD19+ malignancy undergoing treatment with CART cells Exclusion Criteria: Unable to provide informed consent

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Left Ventricular (LV) Dysfunction | LV dysfunction, defined as a decrease in LV ejection fraction of at least 10% to less than or equal to 53% | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cardiovascular Events | Cardiovascular events are defined as hospitalization for symptomatic congestive heart disease, nonfatal acute coronary syndrome, cardiovascular death, nonfatal stroke, and all-cause mortality | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiotoxicity of Cancer Therapy, Cardio-Oncology, CART Cell Therapy
Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Exercise training is recognized as effective in preventing and treating many chronic metabolic disorders (1), and long-term exercise programmes have similar effects on glucose control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise intensity and volume of aerobic exercise needed to produce the most wanted effects on targeted risk factors for subjects at risk of/with established type 2 diabetes, is still uncertain. In this study the investigators will investigate the acute effects of a single bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with and without gestational diabetes mellitus (GDM). The investigators think that very short bouts of high intensity exercise can be a way to reduce blood glucose in these women.

Official Title
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Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Pregnant Women With and Without Gestational Diabetes Mellitus

Conditions
-----------------
Diabetes, Gestational

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant Gestational diabetes mellitus or normal glucose tolerance able to exercise Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity exercise<br>High intensity, short duration exercise on bike | Behavioral: exercise<br> <br> |
| Experimental: Moderate exercise<br>Moderate intensity exercise training on bike | Behavioral: exercise<br> <br> |
| No Intervention: No exercise<br>No exercise, resting in the lab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity | insulin sensitivity index, as described by Matsuda and DeFronzo. This calculation uses the fasting plasma glucose and plasma insulin, and the average plasma glucose and insulin values over the 30, 60, 90, and 120 minutes after an oral glucose tolerance test (OGTT), and is calculated as:. 10 000/√[fasting glucose x fasting insulin) x (mean glucose during OGTT x mean insulin during OGTT)]. We will use a carbohydrate rich meal instead of a classic oral glucose tolerance test with glucose in water. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, exercise therapy, insulin resistance
Lupus Genetics Studies

Study Overview
=================
Brief Summary
-----------------
The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and the Virgin Islands that have one or more living members diagnosed with SLE.

Detailed Description
-----------------
SLE is an often crippling and potentially fatal autoimmune disease that is nine times more prevalent in women than in men, and four times more likely to affect African American females than Caucasian females. It is suspected that a genetic predisposition along with environmental factors contribute to the clinical manifestation of SLE. The Lupus Genetics Studies consist of several familial SLE studies, including the Lupus Family Registry & Repository (LFRR, formerly known as the Lupus Multiplex Registry & Repository, or LMRR). The Lupus Studies enroll families of all ethnicities with one or more members diagnosed with systemic lupus to determine what genes contribute to the development of the disease. Additionally, the Lupus Family Registry & Repository is the largest repository of its kind in North America. In addition to the research done on site, the Repository serves as a national resource for scientists interested in conducting research on SLE and families either simplex or multiplex for lupus. Data, serum samples, and DNA samples are available to researchers. By collecting families in which two or more living individuals have been diagnosed with SLE, the study is utilizing the genetic link between the affected family members to discover disease-associated genes. Records will be requested from the patients' treating physicians to document various lupus symptoms and related problems. One-time blood samples will be collected from the patients as well as from certain family members and an unrelated volunteer. There is no cost to participate and the study pays for sample draws and shipping.

Official Title
-----------------
Lupus Genetic Studies; Lupus Family Registry & Repository

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families in which one or more living members have been diagnosed with systemic lupus erythematosus
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus, Genetics
SynCardia Freedom Driver System Study

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.

Official Title
-----------------
SynCardia Freedom Driver System Study

Conditions
-----------------
Biventricular Failure

Intervention / Treatment
-----------------
* Device: CardioWest temporary Total Artificial Heart (TAH-t) System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are implanted with the TAH-t and are clinically stable. Exclusion Criteria: Patients who are implanted with the TAH-t and are not clinically stable.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CardioWest temporary Total Artificial Heart (TAH-t) System|The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) System is a pulsatile biventricular device that replaces a patient's native ventricles and valves, and pumps blood to both pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external pneumatic driver connected by drivelines.|

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
-----------------
Biventricular failure
Attitudes About Smoking: A Telephone Survey

Study Overview
=================
Brief Summary
-----------------
This study involves telephone surveys of parents of young urban children with and without asthma to assess attitudes about smoking including personal smoking bans in their homes and cars, and beliefs about public policies regarding smoking.

Official Title
-----------------
Attitudes About Smoking A Telephone Survey of Parents of Young Urban Children

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child with asthma OR a matched child without asthma from the Rochester City School District Exclusion Criteria: Non-english speaking family / parent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the present proposal was to investigate the predictive properties of markers in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home monitor assessments to measure asthma control will be examined.

Official Title
-----------------
Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study

Conditions
-----------------
Asthma, Children, Home Monitoring, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: already known with a diagnosis of asthma during at least 6 months age between 6 and 17 years reversibility to a bronchodilator (increase in FEV1 > 9% of predicted value and/or bronchial hyperresponsiveness to histamine < 8 mg/ml. Exclusion Criteria: cardiac abnormalities mental retardation, congenital abnormalities or existence of a syndrome active smoking no technical satisfactory performance of measurements no phone line or internet assess available at home.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- |
| Care as usual<br>Therapy is guided based on symptoms and lung function. Assessments: home monitoring, symptoms, lung function, FeNO, asthma control, quality of life and diagnostic assessments of non-invasive inflammatory markers in exhaled air and exhaled breath condensate. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of exacerbations | increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value. | 1 year | 
| asthma control | asthma control questionnaire | 1 year | 
| Quality of life | Asthma Quality of Life questionnaire for children | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness | incremental cost per exacerbation prevented | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, children, home monitoring, exhaled breath condensate, non-invasive inflammatory markers, volatile organic compounds
Effects of Fructose and Exercise on Hepatic Lipid Metabolism

Study Overview
=================
Brief Summary
-----------------
8 healthy male volunteers will be studied each on 3 occasions, ie after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity after 4 days on a weight maintenance diet containing 30% fructose + low physical activity after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured

Official Title
-----------------
Effects of a Weight Maintenance, High Fructose Diet and of Exercise on Hepatic Lipid Metabolism

Conditions
-----------------
Metabolism

Intervention / Treatment
-----------------
* Behavioral: weight maintenance, low sugar diet
* Behavioral: weight maintenance, high fructose diet
* Behavioral: weight maintenance, high fructose diet+ exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 30 years males BMI between 19 and 25 low to moderate physical activity (< 3 sessions/week) Exclusion Criteria: smoking consumption of alcohol>50g/week consumption of drugs or illicit substances food allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low fructose diet/no exercise<br> | Behavioral: weight maintenance, low sugar diet<br> <br> |
| Experimental: high fructose diet/no exercise<br> | Behavioral: weight maintenance, high fructose diet<br> <br> |
| Experimental: high fructose diet+exercise<br> | Behavioral: weight maintenance, high fructose diet+ exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic de novo lipogenesis | Measurement of 13C VLDL palmitate after ingestion of 13C fructose | after 4 days on controlled diet+exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma VLDL-triglyceride kinetics | Modelling of 2H5-glycerol incorporation in VLDL afetr administration of a bolus of 2H5 glycerol | after 4 days on controlled diet+exercise | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fructose, VLDL-triglycerides, de novo lipogenesis, Human metabolism
Brain SPECT Following Cialis (Tadalafil ) Administration

Study Overview
=================
Brief Summary
-----------------
The study will be an open label one and will include 30 patients who underwent ischemic stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose.

Official Title
-----------------
Brain SPECT Perfusion Imaging Following Cialis (Tadalafil ) Administration in Patients With Vascular Risk Factors

Conditions
-----------------
Change in Brain Perfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients in the age range of 35-75 years. Exclusion Criteria: known allergic reaction to TF Medical contraindication to use TF Hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage Acute stroke or cardiac ischemic event up to 3 month prior to study. Other neurological brain diseases including degenerative diseases, multiple sclerosis, brain tumors, post severe brain injury (TBI) and migraine headache. Sensory aphasia. Cognitive impairment with disability to sign a consent form.Patients' Assessment

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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 |
| --- | --- |
| One dose, Repeat doses<br>First group recives one dose Second group receives several doses | |
| One dose, several doses<br>15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Posterior Tibial Artery Catheterization

Study Overview
=================
Brief Summary
-----------------
Arterial catheterization in small children is challenging, even for experienced anesthesiologists. For successful arterial catheterization, the arterial diameter, cross-sectional area, and depth from the skin surface are important considerations, especially in pediatric patients. THe investigators examined the posterior tibial artery (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative arterial cannulation site to the radial artery (RA) in pediatric patients.

Official Title
-----------------
Real-time Ultrasound-guided Arterial Catheterization in Pediatric Patients: Comparison of Success Rate Among the Arteries

Conditions
-----------------
Arterial Catheterization

Intervention / Treatment
-----------------
* Procedure: posterior tibial artery
* Procedure: radial artery
* Procedure: dorsalis pedis artery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing general anesthesia needing invasive arterial monitoring Exclusion Criteria: Surgery involving the both hands or foots

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior tibial artery<br>real time ultrasound guided arterial catheterization on the posterior tibial artery | Procedure: posterior tibial artery<br> <br> |
| Active Comparator: Radial artery<br>real time ultrasound guided arterial catheterization on the radial artery | Procedure: radial artery<br> <br> |
| Active Comparator: Dorsalis pedis artery<br>real time ultrasound guided arterial catheterization on the dorsalis pedis artery | Procedure: dorsalis pedis artery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first access success rate |  | immediate after anesthetic induction, maximum 10 minutes |