linjc16/ctgov huggingface dataset:
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.

Detailed Description
-----------------
In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula without BSSL for the first 7 days. After a wash-out period of 2 days the patients will crossover to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

Official Title
-----------------
A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Infant Formula Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

Conditions
-----------------
Replacement Therapy in Preterm Infants

Intervention / Treatment
-----------------
* Drug: rhBSSL
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants less than or equal to 32 weeks of gestational age appropriate for gestational age enterally fed with infant formula

Ages Eligible for Study
-----------------
Maximum Age: 32 Weeks

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rhBSSL<br> | Drug: rhBSSL<br>* 0.15 g/L rhBSSL added to infant formula; one week treatment<br>* Other names: bucelipase alfa (INN);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* One week treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of Fat Absorption in stool |  | Stool collected for a 72-hour period during the final 3 days of each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in length and body weight between the start and end of each treatment period |  | Baseline and after one week of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm infants, Replacement therapy, Infant formula, BSSL, BSSL is present in fresh mother's milk but not in infant formula.
Periodic Versus Continuous IV Iron Supplementation in HD Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.

Official Title
-----------------
Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients

Conditions
-----------------
Anemia of Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Iron Sucrose Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Constant rHu-EPO and iron dose for at least 2 months before starting the study Hemoglobin ≥ 8,5g/dl and <12,5 g/dl Ferritin < 1000 mg/dl TSAT < 50% CRP < 5 mg/dl Exclusion Criteria: Malignant tumor disease Oral iron supplementation Active bleeding issues Surgical intervention within the last 8 weeks before study inclusion

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continuous iv administration of iron sucrose<br>Prior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session). | Drug: Iron Sucrose Supplement<br> <br> |
| Active Comparator: intermittent iv administration of iron sucrose<br>Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose. | Drug: Iron Sucrose Supplement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum hemoglobin level (g/dl) |  | Month 0, 1, 2, 3, 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron deficiency, hemodialysis
Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002

Study Overview
=================
Brief Summary
-----------------
This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002 and the routes and rates of excretion of [14C]-ETC-1002

Official Title
-----------------
A Phase 1, Open-Label,Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002 in Healthy Male Volunteers

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: [14C-ETC-1002]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male Volunteers BMI 10-35 kg/m2 Exclusion Criteria: Hx of CV, renal, hepatic, chronic respiratory or GI disease Hx of drug or alcohol abuse smoking within 12 mos of screening

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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: 1 dose of [14C-ETC-1002]<br> | Drug: [14C-ETC-1002]<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of [14C]-ETC-1002 in urine and feces after a single dose | using mass balance recovery | 11 days |
Passive Leg Raising and Fluid Responsiveness

Study Overview
=================
Brief Summary
-----------------
In the Intensive Care the Passive Leg Raising (PLR) test is a validated instrument to predict fluid responsiveness. In this study the investigators will try to prove the similarity of PLR test with a pillow and the PLR test with the patients bed in 45 degrees.

Detailed Description
-----------------
PLR test with pillow PLR test with bed to avoid a difference in results by the order of the measurements, the order of PLR testing is random.

Official Title
-----------------
Passive Leg Raising 3.0 and Fluid Responsiveness

Conditions
-----------------
Passive Leg Raising

Intervention / Treatment
-----------------
* Device: bed in 45 degrees for passive leg raising test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission on Intensive Care clinical signs as; mean arterial pressure < 60, lactate > 2.0 mmol/L Exclusion Criteria: age < 18

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: bed in 45 degrees for passive leg raising test|fluid responsiveness is tested by the passive leg raising test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid responsiveness expressed in volume | are both PLR tests similar / comparable on fluid responsiveness | from ICU admission until ICU discharge; test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days | 
| blood pressure expressed in mmHg | are both PLR tests similar / comparable on fluid responsiveness | test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days | 
| cardiac output | are both PLR tests similar / comparable on fluid responsiveness | test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluid responsiveness
Supplementary Intake of Vitamin D During 12 Weeks Strength Training in Younger and Older People

Study Overview
=================
Brief Summary
-----------------
The aim is to investigate the importance of vitamin D levels to achieve the effect of strength training. If we can show that vitamin D has an effect of training, the ultimate goal is to find out why and how vitamin D affects muscle. This would potentially have important implications for public health. Since a large number of populations, including elderly, are shown to have too little vitamin D and also has low muscle strength, it will be essential that these people added vitamin D in relation to training and rehabilitation.

Official Title
-----------------
The Importance of Supplementary Intake of Vitamin D on the Efficacy of 12 Weeks of Strength Training in Both Vitamin D Sufficient Younger and Older People

Conditions
-----------------
Muscle Strength, Tendon Elasticity, Muscle CSA, Tendon CSA, VDR Receptor

Intervention / Treatment
-----------------
* Other: 12 weeks Strength exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men 20-30 or 60-75 years old Exclusion Criteria: smokers Knee problems On medication affecting protein synthesis High exposure to sun light (ex. ski holiday) during the trial

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br> | Other: 12 weeks Strength exercise training<br>* Training 3 times a week, leg extensions and leg press<br>|
| Placebo Comparator: Calcium tablet<br> | Other: 12 weeks Strength exercise training<br>* Training 3 times a week, leg extensions and leg press<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-sectional area of thigh musculature and knee tendon |  | 12 weeks | 
| VDR potential target CYP27b1 |  | 12 weeks |
Venous Function in Cardiovascular Disease Patients

Study Overview
=================
Brief Summary
-----------------
The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects.

Detailed Description
-----------------
Compare the effect of 4 x 4 minutes at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate and moderate continuous exercise at 70 % of peak heart rate on venous function.

Official Title
-----------------
Venous Function in Cardiovascular Disease Patients; The Neglected Part of Circulatory Regulation

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Behavioral: interval training day 1
* Behavioral: Moderate exercise day 2
* Behavioral: Control day 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: myocardial infraction (MI) revascularization (PCI) coronary artery bypass graft surgery (CABG) Exclusion Criteria: unstable angina pectoris uncontrolled hypertension orthopedic and/or neurological limitations participation in other studies MI (closer than 4 weeks)

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interval training<br>4 x 4 minutes exercise at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate | Behavioral: interval training day 1<br> <br> * Other names: aerobic interval training;Behavioral: Moderate exercise day 2<br> <br> Behavioral: Control day 3<br> <br> |
| Active Comparator: moderate exercise<br>moderate continuous exercise at 70 % of peak heart rate on venous function. | Behavioral: interval training day 1<br> <br> * Other names: aerobic interval training;Behavioral: Moderate exercise day 2<br> <br> Behavioral: Control day 3<br> <br> |
| Other: control<br>routine measurements, no exercise | Behavioral: interval training day 1<br> <br> * Other names: aerobic interval training;Behavioral: Moderate exercise day 2<br> <br> Behavioral: Control day 3<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Compliance change | Measured by echocardiography | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery bypass, Exercise therapy, Revascularization (PCI)
Short-course Preoperative Chemoradiotherapy for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.

Official Title
-----------------
Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Radiation: short-course radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed adenocarcinoma distal margin of the tumor located < 8 cm above the anal verge cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT patient older than age 18 years Karnofsky performance score >= 70 Exclusion Criteria: distant metastasis identified during staging workup previous or concurrent malignancy pregnant or breast-feeding women impending rectal obstruction familial adenomatous polyposis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: short-course<br> | Radiation: short-course radiation<br>* 33Gy/10 fractions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| downstaging effect of tumor | Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+) | an expected average of 6 weeks after chemoradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bladder and small bowel toxicity after chemoradiation | The incidence of grade 3 or higher small bowel and bladder toxicity according to the RTOG and EORTC toxicity criteria (reference: Cox JD et al. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6) | Participants will be followed for an expected average of 3 months after chemoradiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locally advanced rectal cancer
Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap

Study Overview
=================
Brief Summary
-----------------
To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard HD end caps compared to the Tego® connector with the CurosTM for Tego disinfecting port protector.

Detailed Description
-----------------
Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.

Official Title
-----------------
Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap

Conditions
-----------------
End Stage Renal Disease (ESRD)

Intervention / Treatment
-----------------
* Device: ClearGuard HD End Cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients dialyzing with a central venous catheter Exclusion Criteria: Known allergy to chlorhexidine

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 |
| --- | --- |
| Experimental: Treatment<br>ClearGuard HD End Cap | Device: ClearGuard HD End Cap<br>* The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub<br>|
| No Intervention: Control<br>Tego® connector with the CurosTM for Tego disinfecting port protector | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days | This was calculated by dividing the cumulative number of PBCs by cumulative time at-risk as follows. The National Healthcare Safety Network (NHSN) Center for Disease Control (CDC) 21-day outpatient hemodialysis patient rule is as follows: A PBC is considered a new event and counted only if it occurred 21 days or more after a previously reported PBC in the same patient; new PBC events are based on blood cultures drawn as an outpatient or within one calendar day after a hospital admission. Following a PBC additional same-type events were counted beginning 21 days following the initial event; the CVC-days were counted during this period. The CVC-days were calculated by summing the number of days each patient was at-risk of accruing a PBC. This analysis included all subjects that participated in the study that were not otherwise censored to more accurately count CVC-days. | Through the 13-month intervention period. |
Increased Expression of Adiponectin Receptor 2 in the Mononuclear Cells in Children With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
The inflammatory process is involved in the pathogenesis of obesity. Prader-Willi syndrome (PWS) is a genetic model of syndromic obesity. Adiponectin is an adipokine with potent anti-inflammatory properties, and its effect is mediated through adiponectin receptors 1 (adipoR1) and 2 (adipoR2). Objective of this study is to compare the expression of adipoR1, adipoR2, and adiponectin in peripheral blood mononuclear cells (PBMCs) in PWS children and obese control and to correlate receptor expression with insulin sensitivity and obesity-related parameters.

Official Title
-----------------
Increased Expression of Adiponectin Receptor 2 in the Mononuclear Cells in Children With Prader-Willi Syndrome

Conditions
-----------------
Obesity, Prader-Willi Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with Prader-willi syndrome children with simple obesity Exclusion Criteria: subjects with diabetes mellitus (fasting plasma glucose > 126 mg/dL with a 2-h oral glucose tolerance test value of >200 mg/dl)

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adiponectin, adiponectin receptor, Prader-Willi syndrome
Screening for Hip and Knee Osteoarthritis in the General Population: Predictive Value of a Questionnaire and Prevalence Estimates

Study Overview
=================
Brief Summary
-----------------
Objective: To study the feasibility and validity of a two-step telephone screening procedure for symptomatic knee and hip osteoarthritis (OA) in the general population. Method: The screening questionnaire was based on signs and symptoms, previous diagnosis of OA, and validated OA criteria. A random sample of telephone numbers was obtained and, at each number, one individual aged 40 to 75 years was included. A physical examination and knee or hip radiographs were offered when the screen was positive. A sample of individuals with negative screens was also examined. The diagnosis of hip/knee OA was based on either American College of Rheumatology criteria for signs and symptoms and Kellgren-Lawrence radiographic stage 2 or greater. Prevalence rates were estimated with correction for the performance of the screening procedure.

Official Title
-----------------
Screening for Hip and Knee Osteoarthritis in the General Population: Predictive Value of a Questionnaire and Prevalence Estimates

Conditions
-----------------
Hip and Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individual aged 40 to 75 years

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- | --- |