linjc16/ctgov huggingface dataset:
Assessement of the Prevalence of Lysosomal Acid Lipase Deficiency in Liver Post-transplant Patients

Study Overview
=================
Brief Summary
-----------------
Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked to decrease enzymatic activity of LAL, responsible for intracellular accumulation of cholesterol esters and triglycerides. The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty liver, hepatic fibrosis that can evolve up to cirrhosis. LAL deficiency is responsible for significant morbidity and early mortality in children, adolescents and adults in connection with a multi visceral disease reaching the liver, gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for the synthesis of the LAL. The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto blotting paper. Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease. Inclusion period of 12 to 18 months (100 patients).

Official Title
-----------------
Assessement of the Prevalence of Lysosomal Acid Lipase Deficiency in Liver Post-transplant Patients

Conditions
-----------------
Liver Post-transplant Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver post-transplant patient patients with cryptogenic cirrhosis, NASH Exclusion Criteria: Patients without metabolic syndrome clinical, biological or radiological.

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 |
| --- | --- | --- |
| Prevalence of Lysosomal Acid Lipase deficiency in liver post-transplant patients | Assessment of the prevalence of Lysosomal Acid Lipase deficiency in liver post-transplant patients | During the routine visit (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver, transplant, Lysosomal Acid Lipase
Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study

Study Overview
=================
Brief Summary
-----------------
The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that spirometry be performed on patients with asthma because they serve as an objective measure of airway obstruction. Unfortunately, most children under 5 years of age are unable to perform a forced expiratory maneuver making conventional spirometry unavailable in this age group in most venues. Furthermore, other population groups such as retarded people, elderly or physically handicapped share the same difficulty. Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. This usability study was designed to test independent home use and device interface effectiveness of the Personal WheezoMeter in order to validate its safe and effective use by intended users.

Official Title
-----------------
Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study

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

Intervention / Treatment
-----------------
* Device: Personal WheezoMeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female age 18 years and up. Subject is diagnosed as an asthmatic, or subject is parent/guardian of an asthmatic child age under 18 years. Subject understands the study procedure. Subject is able to read the User Manual. Signed Informed Consent form Compliance with study requirements. Exclusion Criteria: Major physical, motor, mental, behavioral, or psychiatric limitations. Concurrent additional major illness. Subject objects to the study protocol.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Usability study of the Personal Wheezometer | Device: Personal WheezoMeter<br>* pulmonary sounds analyzer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by success rate of task performance. |  | At the end of the study meeting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of questions addressed to the investigator required by the participant in order to complete tasks. |  | during the study | 
| User satisfaction will be evaluated by questionnaire that focuses on subjective impressions regarding usability and potential safety problems. |  | At the end of the study meeting. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Wheeze Rate, Respiratory Function Tests
MK0954A-264 Filter Study (0954A-264)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan-HCTZ Combination as Compared to Losartan Monotherapy in Patients With Essential Hypertension

Conditions
-----------------
Mild to Severe Hypertension

Intervention / Treatment
-----------------
* Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks
* Drug: losartan / Duration of Treatment: 6 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with mild to severe hypertension (SiDBP 90-120 mmHg) Exclusion Criteria: Systolic BP > 200 mmHg Secondary or malignant hypertension Taking more than 2 antihypertensive medications Hypertension induced by oral contraceptives Hx of cerebral vascular accident within 6 months Hx of angina, myocardial infarction, PCI, CABG, or decompensated CHF within 6 months Clinically significant AV conduction disturbance or potentially life threatening ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope History of angioedema Sensitivity to AII receptor antagonists or HCTZ, nephrotic syndrome,single kidney function Pregnancy or lactation.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks|nan|
|Drug: losartan / Duration of Treatment: 6 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment. |  | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Losartan-HCTZ 100-12.5 mg combination will be more effective in lowering mean through sitting systolic blood pressure (SiSBP) after 6 weeks of treatment compared to losartan 100-mg monotherapy, and will be safe and tolerable. |  | 6 Weeks |
Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

Official Title
-----------------
Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female pediatric end-stage renal disease (ESRD) patients. Predetermined TSAT and serum ferritin levels Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy. Receiving a stable epoetin (EPO) dosing regimen. Exclusion Criteria: Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing. Blood transfusion. Hypersensitivity to Ferrlecit®. Significant inflammatory conditions.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: dose level 1<br>1.5 mg/kg | Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)<br> <br> |
| Experimental: dose level 2<br>3 mg/kg | Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients. |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron Deficiency, Anemia in Pediatric Hemodialysis
Correlation Between Quality of Life and Severity of Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This study aim to evaluate the correlation between Quality of Life (QoL) and severity of Parkinson's Disease (PD) by assessing the presence of an optimal cut-off point on the Parkinson's disease questionnaire (PDQ-39) as related to the Hoehn & Yahr (H&Y) scale in a cohort of Italian adults with PD. A multicenter, cross-sectional study was performed in central and northern Italy. This study was conducted on a cohort of consecutive individuals at three neurologic outpatient clinics. All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H&Y scale by a neurologist. Receiver operating characteristic (ROC) curves and coordinates of the curve, which were visually inspected, were used to find cut-off points with optimal sensitivity and specificity. These were in turn used to determine the optimal PDQ-39 cut-off score for identifying disease severity according to H&Y stages.

Official Title
-----------------
Correlation Between Quality of Life and Severity of Parkinson's Disease by Assessing an Optimal Cut-off Point on the Parkinson's Disease Questionnaire (PDQ-39) as Related to the Hoehn & Yahr (H&Y) Scale

Conditions
-----------------
Parkinson Disease, Quality of Life

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 50 but < 90 years, H&Y stages I, II, III, and IV, a mini-mental state examination > 22 points, a minimum level of five years of education. Exclusion Criteria: Individuals with emotional or psychiatric problems (as determined by clinical screening)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H&Y scale by a neurologist.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoehn & Yahr (H&Y) | severity of Parkinson's disease | at admission to the neurologic outpatient clinics | 
| Parkinson's Disease questionnaire (PDQ-39) | quality of life | at admission to the neurologic outpatient clinics |
Remote Ischemic Preconditioning in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Aim of the work : Evaluation of the role of Remote Ischemic Preconditioning (RIP) on liver function in patients undergoing on-pump cardiac surgery.

Official Title
-----------------
Implications of Remote Ischemic Preconditioning on Liver Function in Adults Undergoing Cardiac Surgery: Randomized Controlled Trial

Conditions
-----------------
Ischemia Reperfusion Injury

Intervention / Treatment
-----------------
* Procedure: remote ischemic preconditioning
* Procedure: Sham remote ischemic preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being candidate for on-pump cardiac surgery. Willing to participate in the study Ages eligible for the study: 18 to 70 years. Gender eligible for the study : both Exclusion Criteria: Patient refusal. Known cause of possible liver function disturbances that includes right heart failure, acute inflammation of gallbladder or any other complication of gallstone disease. Active viral and non viral hepatitis. Pregnant women. History of peripheral nerve disease or peripheral vascular disease of the extremities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote ischemic preconditioning<br> | Procedure: remote ischemic preconditioning<br>* 3 cycles of 5-minutes inflation of a blood pressure cuff to 200mmHg (or at least to a pressure 50mm Hg higher than the systolic arterial pressure) to one upper arm, followed by5-minutes reperfusion with the cuff deflated<br>|
| Sham Comparator: Sham remote ischemic preconditioning<br> | Procedure: Sham remote ischemic preconditioning<br>* 3cycles of upper limb pseudo ischemia (low pressure, 5-minutes blood pressure cuff inflation to a pressure of 20 mm Hg and 5-minutes cuff deflation).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver function test | Direct Bilirubin | 3 postoperative days |
Intrapartum Fever and Histopathological Placental Findings

Study Overview
=================
Brief Summary
-----------------
Intrapartum fever associated with epidural anesthesia is caused by non infectious causes therefore without histological findings

Official Title
-----------------
Intrapartum Fever and Histopathological Placental Findings

Conditions
-----------------
Histological Placental Inflamation With or Without Fever

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:epidural with and without fever - Exclusion Criteria: Patients with infectious backgroud or prilinged PROM

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EPIDURAL FEVER<br> | |
| EPIDURAL WITHOUT FEVER<br> | |
| GROUP 1: EPIDURAL FEVER . GROUP 2 EPIDURAL WITHOUT FEVER<br> | |

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
-----------------
evron
Effects of Water-soluble Olive Extract Supplementation

Study Overview
=================
Brief Summary
-----------------
Six weeks of supplementation of an olive extract will: Improve antioxidant status Reduce inflammation Reduce muscle damage Improve exercise performance Improve exercise recovery as compared to a placebo.

Official Title
-----------------
Effects of Water-soluble Olive Extract on Antioxidant Status, Exercise Performance, Muscle Metabolism, Muscle Damage and Inflammation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Olive Extract
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recreational exerciser BMI <= 30 Non-smoker Exclusion Criteria: Blood pressure over 140/90 Type I or Type II diabetes Renal, hepatic or cardiac disease Current infectious disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 150mg olive extract<br> | Dietary Supplement: Olive Extract<br>* Capsule form ingested 1x/day for 6 weeks<br>|
| Active Comparator: 50mg olive extract<br> | Dietary Supplement: Olive Extract<br>* Capsule form ingested 1x/day for 6 weeks<br>|
| Placebo Comparator: Placebo control<br> | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Antioxidant Status |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced Inflammation |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Olive, antioxidant, exercise, inflammation, recovery, Healthy men
Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents

Study Overview
=================
Brief Summary
-----------------
Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior compared to youth who do not receive the program.

Detailed Description
-----------------
Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior and fewer pregnancies compared to youth who do not receive the program.

Official Title
-----------------
Teen Pregnancy Prevention Among Native Youth of the Northern Plains

Conditions
-----------------
Teen Pregnancy Prevention

Intervention / Treatment
-----------------
* Behavioral: mCOL
* Other: AS+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10-12 years old at baseline A member of participating Native Boys and Girls Club Signed Parental Consent Form Signed Parental Permission Form Signed Child Assent Form Exclusion Criteria: None Noted

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mCOL<br>mCircle of Life is a culturally-based HIV-prevention intervention designed for American Indian and Alaska Native 10-12 year-olds. It includes both online and facilitated material. | Behavioral: mCOL<br> <br> * Other names: mCircle of Life;|
| Active Comparator: AS+<br>After-School Science Plus is a curriculum designed for youth to teach science and literacy using everyday materials. It helps youth see how science is a part of everyday life and provides role models of scientists who come from different backgrounds and ethnicities. | Other: AS+<br> <br> * Other names: After-School Science Plus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ever had sexual intercourse | Ever had sexual intercourse is measured by youth self-reported answers in an online survey to a question on lifetime sexual activity. Specifically, youth are coded 1 if they report having had sex ever before in their lifetimes, 0 otherwise. This question is repeated at each data collection point with youth. | Baseline, 3 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Teen pregnancy prevention, American Indian, Group-randomized trial