linjc16/ctgov huggingface dataset:
Differential Effects of a Diet Supplementation With Plant Sterol Esters on Human Monocytes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.

Detailed Description
-----------------
This study investigates effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.

Official Title
-----------------
Differential Effects of Functional Foods Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.

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

Intervention / Treatment
-----------------
* Dietary Supplement: margarine + plant sterol esters
* Dietary Supplement: margarine (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals without known cardiovascular diseases Exclusion Criteria: drugs that interfere with cholesterol metabolism other use of dietary supplements vegetarianism

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: plant sterol esters<br>Participants consume plant sterol ester supplemented margarine (3 g/day) | Dietary Supplement: margarine + plant sterol esters<br>* margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks<br>* Other names: plant sterols;|
| Placebo Comparator: Placebo<br>Placebo is a non-sterol ester supplemented margarine | Dietary Supplement: margarine (placebo)<br>* non-sterol ester supplemented margarine<br>* Other names: regular margarine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monocyte subpopulations |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum parameters (lipids, plant sterol concentrations, inflammation parameters) |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperlipidemia, plant sterols, monocytes
Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement

Official Title
-----------------
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss

Conditions
-----------------
Anemia, Orthopedic Surgery, High Risk of Blood Loss

Intervention / Treatment
-----------------
* Drug: Ferinject 50 mg/ml
* Drug: NaCl 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 years Patients scheduled to undergo hip or knee replacement 8 g/dl < Hb < 13 g/dl for men and 8 g/dl < Hb < 12 g/dl for women at screening (3-4 weeks prior to surgery) anemia signed written informed consent Exclusion Criteria: immunosuppressive or myelosuppressive therapy history of thromboembolic events a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient hypersensitivity to any component of the formulation transfusion within 1 month prior to study inclusion liver values 3 times higher than normal active severe infection/inflammation renal insufficiency

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: NaCl 0.9%<br> | Drug: NaCl 0.9%<br>* iv administration of max. 50 ml in 30 minutes<br>|
| Experimental: Ferinject<br> | Drug: Ferinject 50 mg/ml<br>* iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of RBC units |  | Until postoperative day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion rate | Number of patients with blood transfusions | Until postoperative day 7 | 
| Frequency of postoperative complications | Number of postoperative complications from baseline until postoperative day 7 | Until postoperative day 7 | 
| Frequency of postoperative complications | Number of postoperative complication from baseline until 6 weeks after surgical intervention | Until 6 weeks after surgical intervention | 
| Length of hospital stay |  | 6 weeks after surgical intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia, transfusion, intravenous ferric carboxymaltose
Trial of a Nationwide Cognitive-Affective Remediation Training Intervention in Depression

Study Overview
=================
Brief Summary
-----------------
The objective is to examine the efficacy of computerized interventions for increasing well-being and cognitive functioning. The study will seek to validate emerging online delivery methods of psychiatric assessment and treatment. This will allow us to test the efficacy of this intervention in a larger and more geographically broad sample than is possible through traditional recruitment and treatment, and to do so in a highly cost-effective manner.

Official Title
-----------------
Trial of a Nationwide Cognitive-Affective Remediation Training Intervention in Depression

Conditions
-----------------
Cognitive-affective Exercises, Engaging Exercises

Intervention / Treatment
-----------------
* Other: Therapeutic Computerized intervention
* Other: Nontherapeutic computerized intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: computer and broadband internet access 18 years of age Elevated anxiety and depression Native English speaker Exclusion Criteria:

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Participants randomized to receive remediation training intervention delivered online (60 days of online training) | Other: Therapeutic Computerized intervention<br>* Remediation training intervention<br>|
| Active Comparator: Control Group<br>Participants randomized to receive online gaming intervention (60 days of online play) | Other: Nontherapeutic computerized intervention<br>* Online gaming intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Behavioral measure of executive functions | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report mood and anxiety symptoms |  | 3 months |
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin

Study Overview
=================
Brief Summary
-----------------
Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix. Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.

Official Title
-----------------
Randomized Controlled Trial: Cervical Ripening Balloon With and Without Oxytocin for Cervical Ripening in Multiparas

Conditions
-----------------
Cervical Ripening, Induction of Labor, Multiparity

Intervention / Treatment
-----------------
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Gestational age > 34 + 0/7 weeks Prior spontaneous vaginal delivery Clinical or U/S EFW of <4500 grams Singleton gestation Cervical dilation <2 cm Exclusion Criteria: Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery Placenta within 2 cm of cervical os Placental abruption, chorioamninoitis, or systemic infection prior to induction Rupture of membranes prior to induction ->1 prior C/S

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cervical Ripening Balloon Alone<br>Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. | Drug: Oxytocin<br> <br> |
| Active Comparator: Cervical Ripening Balloon + Oxytocin<br>Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. | Drug: Oxytocin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Cervical Ripening to Delivery | Time from placement of cervical ripening balloon to delivery | Time to delivery |
36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds

Study Overview
=================
Brief Summary
-----------------
To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Official Title
-----------------
Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Recipients 2 to 10 Years of Age.

Conditions
-----------------
Meningitis, Meningococcal Disease

Intervention / Treatment
-----------------
* Biological: None administered in this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receipt of Menactra vaccine during the study period. Exclusion Criteria: None
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 |
| --- | --- |
| Menactra Vaccine Recipients<br>Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses. Menactra vaccine was administered according to routine clinical practice. | Biological: None administered in this study<br>* N/A in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital. | Day 0 up to Day 30 post-vaccination | 
| Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. | Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital. | Day 31 up to Day 180 post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meningitis, Meningococcal disease, Menactra vaccine
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

Study Overview
=================
Brief Summary
-----------------
The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.

Official Title
-----------------
PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

Conditions
-----------------
Patients Undergoing High Risk PCI.

Intervention / Treatment
-----------------
* Device: High Risk PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft EF <35% Exclusion Criteria: ST Myocardial Infarction Cardiac Arrest Cardiogenic Shock Thrombus Left Ventricle

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: High Risk PCI|High Risk Percutaneous Coronary Intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE Events at 30 days or discharge, whichever is longer | Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer. | 30 days or discharge | 
| Freedom from Hemodynamic compromise during PCI procedure | Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other intra-procedural and peri-procedural adverse events |  | During treatment and out to 90 days | 
| Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion | Freedom from the following procedural-related events: i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion | During procedure | 
| Angiographic Success | Angiographic success defined as residual stenosis <30% after stent implantation or <50% after balloon angioplasty. | Post-PCI |
Evaluation of COVID-19 Fear, Anxiety and Their Effects in Physiotherapy Technician Students

Study Overview
=================
Brief Summary
-----------------
80 participants studying in the physiotherapy technician department were included in this cross-sectional study. Participants' age, gender, year of being a student, the people they live with, the precautions they take regarding COVID-19, whether there is a history of COVID-19 in them or their immediate surroundings, and whether they have COVID-19 transmission and / or contagion fears during their vocational training, whether there are fears of achieving professional goals and competence because of COVID-19 and / or its consequences were recorded. Afterwards, the participants were asked to answer the questions on the coronavirus anxiety scale, the fear of COVID-19 scale and the cognitive and behavioral avoidance subscales of the Avoidance Attitudes from COVID-19 scale.

Official Title
-----------------
Evaluation of COVID-19 Fear, Anxiety and Their Effects in Physiotherapy Technician Students

Conditions
-----------------
Covid19, Anxiety and Fear

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being between the ages of 18-65 Being a physiotherapy technician student Exclusion Criteria: 1. Being under the age of 18, over the age of 65

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

| Intervention/Treatment |
| --- |
|Other: Survey|Survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronavirus anxiety scale | It is a 5-item scale developed by Lee at all. to evaluate coronavirus-related anxiety. Participants indicate how often they have experienced the situations stated in each item with a 5-point Likert-type scale (0 = none, 1 = rare [less than 1 or 2 days], 2 = several days, 3 = more than 7 days, 4 = last 2 almost everyday a week). The total score is obtained by adding the item scores. The higher total score is higher coronavirus-related anxiety. | 2 months | 
| The Fear of COVID-19 Scale | It is a 7-item scale developed by Ahorsu et all. to evaluate coronavirus-related fear. Participants indicate how often they experience the situations stated in each item with a 5-point Likert-type scale (1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree). The total score is obtained by summing the item scores, the higher total score is higher the coronavirus-related fear. | 2 months |
Effect of Avastin in Juxtafoveal Telangiectasias

Study Overview
=================
Brief Summary
-----------------
Evaluation of efficacy of Intravitreal Injection of Bevacizumab in patients with Yuxtafoveal Telangiectasias

Detailed Description
-----------------
After diagnose Yuxtafoveal telangiectasias secondary to Branch Retinal Vein Occlusion and with Idiopathic Ethiology by clinical signs and Fluorescein angiogram (FA)findings we treated patients with Intravitreal Injection of Bevacizumab (2.5mg/0.1ml). We performed a complete ophthalmological evaluation and at baseline and follow-up (1 and 3 months) we evaluate ETDRS Best Corrected visual acuity (BCVA), fluorescein angiogram (FA) and Optical Coherence Tomography (OCT)findings. We found an improvement in visual acuity and reduction of FA leakage and decrease retinal thickness in OCT.

Official Title
-----------------
Does Avastin Change Evolution in Juxtafoveal Telangiectasias?

Conditions
-----------------
Telangiectasis

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Procedure: Intravitreal injection of Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Telangiectasias secondary to Branch Retinal Vein Occlusion Patients with Idiopathic Juxtafoveal Retinal Telangiectasias Exclusion Criteria: Diabetic Retinopathy and Diabetic Macular Edema Hypertensive Retinopathy Choroidal Neovascularization

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bevacizumab|nan|
|Procedure: Intravitreal injection of Bevacizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected Visual Acuity |  |  | 
| Fluorescein Angiogram: Leakage |  |  | 
| Optical Coherence Tomography: Retinal thickness |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leakage, Telangiectasias, Bevacizumab, Telangiectasias secondary to Branch Retinal Vein Occlusion (BRVO), Idiopathic juxtafoveal retinal telangiectasias