linjc16/ctgov huggingface dataset:
Lifestyle, Adiposity and Cardiovascular Health in Youths

Study Overview
=================
Brief Summary
-----------------
To determine the influences of diet and physical activity (PA) on total body fatness and regional fat distribution and the relationship of these to risk factors of cardiovascular disease during adolescence.

Detailed Description
-----------------
BACKGROUND: Adult studies have shown that adiposity, especially visceral adipose tissue, and cardiovascular (CV) fitness are key links between lifestyle factors like diet and exercise on one hand, and CV disease on the other. However, very little is known about these links during the juvenile years, when the processes leading to CV disease are at an early stage of development. The study is in response to a Program Announcement issued in March 1998 on Diet and Cardiovascular Disease Risk in Children and Adolescents. The Program Announcement, jointly issued by the National Institute of Nursing Research and the NHLBI, sought to encourage research relevant to the development and/or testing of dietary interventions to improve the cardiovascular disease (CVD) risk profiles in children and adolescents, especially those at increased risk for CVD or for development of CVD risk factors because of genetics, family history, socioeconomic status (SES), race/ethnicity, levels of blood cholesterol or blood pressure, or other factors. DESIGN NARRATIVE: The study determines the relations of free-living diet and exercise to total body percent fat ( percent BF), visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status (SES). The study also determines the relations of fatness and fitness to different CVD risk factors. A total of 800 15 to 18 year olds, 200 in each ethnic and gender subgroup will be recruited. Diet will be assessed with seven 24-hour recalls, and exercise with two seven-day recalls and heart rate monitoring. Percent body fat will be measured with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test. Measurements will be made of major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen). Multivariate and univariate analyses will be conducted to determine relationships.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

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

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders

Study Overview
=================
Brief Summary
-----------------
Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.

Official Title
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Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors

Conditions
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Severe Hemophilia

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Informed consent Validated coagulation disorder Exclusion Criteria: Not consenting to participate Multiple coagulopathies and comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 90 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 |
| --- | --- |
| Hemophilia<br>Patients with Hemophilia A OR B | |
| inhibitor patients<br>Hemophilia or FXI def with inhibitors | |
| anticoagulants<br>patients under therapy with various anticoagulant drugs | |
| thrombocytopenia<br>patients with ITP, chronic thrombocytopenia, chemotherapy induced thrombocytopenia | |
| platelet function disorders<br>Glanzmann, Bernard Soulier, antiplatelet therapy | |
| Fibrinogen disordsers<br>hyperfibrinogenemia, hypofibrinogenemia, dysfibrinogenemia | |
| acquired hemophilia<br>patients with autoimmune Ab's to FVIII | |
| RBD<br>FXIII DEF, FV+FVIII DEF, FVII DEF, FV DEF | |
| THROMBOLYTICS<br>Patients treated by thrombolytic agents | |
| Hypercoag<br>thrombophilias, thrombosis- inc under therapy, acquired high thrombotic risk (eg: cancer) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombin Generation Parameters pre and post therapy / spiking assays | Thrombin Generation Parameters (Peak height, ETP) before and after spiking assays with procoagulant drugs will be compared for each patient separately and within each group of patients diagnosed with similar coagulation disorder. | 1 year from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
response to various potential therapies as managed by lab assays
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children

Study Overview
=================
Brief Summary
-----------------
To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.

Detailed Description
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This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.

Official Title
-----------------
Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children

Conditions
-----------------
HIV-1 Infections

Intervention / Treatment
-----------------
* Other: lopinavir/ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection Age < 18 years old BW > 25 kg HIV RNA viral load < 50 copies within 6 months Written informed consent Exclusion Criteria: Active opportunistic infection Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion. Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour | Other: lopinavir/ritonavir<br>* standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%) | study drug Aluvia (lopinavir/ritonavir 100/25 mg) | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lopinavir/ritonavir, pharmacokinetic, low dose, HIV-infected children, pharmacokinetics of low-dose lopinavir/ritonavir in HIV-1 infected Thai children.
The Impact of the Fluid Resuscitation on the Venous Volume and Flow Characteristics in Hypovolemic Shock

Study Overview
=================
Brief Summary
-----------------
We hypothesis that in various situation when the effective blood volume decreased the venous volume flow characteristics change according to the fluid resuscitation

Detailed Description
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Patients with clinical signs of loss of the effective blood volume will undergo ultrasound examination of several major veins. The purpose of this examination is to determine vein volume(size) and flow. The ultrasound examination will be done before fluid resuscitation, after fluid administration,and three days after admission

Conditions
-----------------
the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old decreased effective blood volume Systolic blood pressure < 100 Pulse rate > 110 Exclusion Criteria: age <18 years old pregnancy patient requires urgent surgical intervention

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 |
| --- | --- |
| trauma patients<br>patients with decreased blood volume | |
| surgical patients<br>patients with decreased blood volume | |
| non surgical patients<br>patients with decreased blood voloume | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood volume |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decreased blood volume vein volume flow ultrasound exam
Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants

Study Overview
=================
Brief Summary
-----------------
In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.

Official Title
-----------------
A Placebo-controlled, Double-blind Randomized Study to Evaluate the Efficacy of a follow-on Milk Formula Supplemented With Fructo-oligosaccharides on Immune Response in Healthy Infants

Conditions
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Infant

Intervention / Treatment
-----------------
* Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides
* Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants aged of 4 months at randomization not breast-fed infants Exclusion Criteria: infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria infants suffering from a disease associated with gastro-intestinal disorder infants who have taken antibiotic during the 2 months preceding randomization

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 5 Months

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fructo-oligosaccharides<br> | Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides<br>* Follow-on formula supplemented with fructo-oligosaccharides<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)<br>* Follow-on formula enriched with placebo (maltodextrins)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration |  | 1 month |
Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia

Official Title
-----------------
Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease

Conditions
-----------------
Interstitial Lung Disease

Intervention / Treatment
-----------------
* Procedure: Lung biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IIP suspected on clinical and radiologic grounds Exclusion Criteria: Age >80y and <18y FVC< 55%, DCO<35% Platelet count <100000/µl acetylsalicylic acid, clopidogrel or equivalent during the last 5 days INR > l,3, elevated PTT (> 40 s) documented pulmonary hypertension PAPS >50mmHg HR-CT highly suspicious for sarcoidosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung biopsy<br>assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS | Procedure: Lung biopsy<br>* transbronchial lung biopsy. First kryobiopsy, second open biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numer of bleeding events |  | 1 day | 
| Rate of pneumothoraxes |  | 1 day | 
| numer of exacerbations after biopsy |  | 6 weeks | 
| Contribution of BAL and cryobiopsy to diagnosis |  | 2 weeks | 
| Size of specimen |  | 2 weeks | 
| Quality of specimen |  | 2 weeks | 
| Distribution of histological changes in the specimen |  | 2 weeks | 
| Influence of the size of the cryoprobe in the primary endpoint |  | 2 weeks | 
| Comparative group (out of trial) - who are referred for VATS directly ['positive control group'] |  | 6 weeks | 
| Rate of exacerbations after cryobiopsy and after surgical biopsy |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryobiopsy, lung biopsy, interstitial lung disease
Understanding the Physiological Implications of Scanning Kelvin Probe Measurements

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements.

Detailed Description
-----------------
The Scanning Kelvin Probe measures the electrical potential of material surfaces without actually touching it. Although this technology has been applied to non-living materials (e.g. metal and semiconductors) before, it has not been effectively applied to biological materials, much less to live human skin . This project aims to evaluate the use of Scanning Kelvin Probe to live human skin by investigating the effects of skin thickness, skin moisture, and sweat glands on Kelvin Probe measurements of electrical potential. Testing will be performed on the arms and hands of twenty four healthy individuals under different study conditions.

Official Title
-----------------
Measuring Skin Electrical Potential With the Kelvin Probe: Underlying Physiology

Conditions
-----------------
Healthy Individuals, Skin Electrical Potential

Intervention / Treatment
-----------------
* Other: Skin Moistening, Skin Denuding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy is defined as not having a chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc) Exclusion Criteria: autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Healthy Volunteers<br>Human subjects without chronic medical conditions, defined as conditions requiring chronic medication use. | Other: Skin Moistening, Skin Denuding<br>* Application of normal saline to skin and Tape stripping of the superficial skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface Electrical Potential | The electrical potential of skin obtained from the Scanning Kelvin Probe | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical Impedance | Electrical impedance (measurement) obtained through another, more conventional measurement device. | One day |
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure

Study Overview
=================
Brief Summary
-----------------
We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF).

Official Title
-----------------
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure

Conditions
-----------------
Acute Renal Failure

Intervention / Treatment
-----------------
* Drug: TPN nutritional supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years of age admitted to the intensive care unit New onset acute renal failure (ARF) or ARF superimposed on chronic kidney disease ARF will be defined by a sustained (over 24 hours) increase in serum creatinine > 0.5 mg/dl from baseline Patients will be recruited for the study within 3-5 days following establishment of ARF Exclusion Criteria: Institutionalized patient Previous kidney transplant Pregnancy Unable to obtain consent from subject or legally recognized representative ARF from urinary tract obstruction or a volume responsive pre-renal state. Liver Failure Recent cerebrovascular accident (CVA) Coagulopathy defined as: Platelets < 50, PT > 20, INR > 2.0 if the patient requires the placement of an arterial or venous catheter; if the patient does not require the placement of an arterial or venous catheter for the study, coagulopathy will not be a basis for exclusion. Life expectancy < 48 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: 1<br>supplement contains protein content of 1.4 g/kg/day | Drug: TPN nutritional supplement<br>* intravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%)<br>|
| Active Comparator: 2<br>supplement contains protein content of 2.0 g/kg/day | Drug: TPN nutritional supplement<br>* intravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole-body net protein balance |  | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net skeletal muscle protein balance |  | 10 hours |