linjc16/ctgov huggingface dataset:
Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty acid supplementation on the vascular structure and function in hypertensive patients with hypertriglyceridemia.

Detailed Description
-----------------
Hypertensive patients aged 40-65 years, both genders, presenting serum triglycerides levels higher than 150 mg/dl will be randomized into two groups. The first group will be receiving ciprofibrate 100mg/day and the second group will be receiving fish oil 1800mg/day. All patients will be evaluated with brachial flow-mediated dilation and with EndoPAT to assess endothelial function before and after supplementation. SPHYGMOCOR and pulse wave velocity (PWV) measurements will also be obtained.

Official Title
-----------------
Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia

Conditions
-----------------
Hypertension, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Dietary Supplement: DHA-EPA
* Drug: Ciprofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous diagnosis of hypertension Patients with serum triglycerides levels ≥ 150 mg/dl and <500 mg/dl Patients on stable antihypertensive medication for at least 4 weeks Patients with food consumption maintained for at least 4 weeks Exclusion Criteria: Smoking Secondary hypertension Hormone replacement therapy Diabetes mellitus Chronic kidney disease Known coronary artery disease Previous stroke Dyslipidemia severe, with LDL cholesterol> 160 mg/dL or triglycerides ≥ 500 mg/dl Use of statins or beta blockers

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 fatty acid<br> | Dietary Supplement: DHA-EPA<br>* 1800 mg/day<br>* Other names: OMEVITS;|
| Active Comparator: Ciprofibrate<br> | Drug: Ciprofibrate<br>* 100 mg/day<br>* Other names: LIPLESS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Endothelial dysfunction, Vascular stiffness
Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model

Study Overview
=================
Brief Summary
-----------------
This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize technology-based approaches for implementing large-scale change. Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.

Official Title
-----------------
Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model

Conditions
-----------------
Evidence Based Practice

Intervention / Treatment
-----------------
* Behavioral: SIC Coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project Exclusion Criteria: none

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Consultation<br>Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors | |
| Experimental: SIC Coaching Consultation<br>In addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP. | Behavioral: SIC Coaching<br>* Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stages of Implementation Completion (SIC) | The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). | Baseline through month 60 |
A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.

Official Title
-----------------
An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: tocilizumab [RoActemra/Actemra]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/=18 years of age Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study Patients successfully completed studies WA17823 and WA18696 in South Africa Body weight <150 kg Exclusion Criteria: Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696 Previous treatment with any cell depleting therapies Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tocilizumab [RoActemra/Actemra]<br>* 8 mg/kg intravenously every 4 weeks in combination with allowed DMARDs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (incidence of adverse events) |  | 104 weeks | 
| Safety (laboratory assessments e.g. hematology) |  | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Change in Disease Activity Score (DAS28) |  | 104 weeks |
Genetic Study of the FBN1 Gene and Fibrillin-1 Abnormalities in Choctaw Native Americans and Other Patients With Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether defects in fibrillin-1 cellular processing are present in the tsk1 mouse model that carries a known FBN1 gene rearrangement and in a population of Choctaw Native American patients with systemic sclerosis who have a strong genetic predisposition to the disease. II. Determine the ultrastructural features of fibrillin-1 in these patients. III. Screen the FBN1 gene for mutations beginning at the regions homologous to the tsk1 duplication and latent transforming growth factor binding proteins in these patients and in an unaffected Choctaw control group. IV. Determine the correlation between fibrillin-1 abnormalities and clinical presentation, autoantibodies, and ethnicity.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo punch skin biopsy obtained from the upper arm or back. Studies of fibrillin-1 synthesis and cellular processing, and FBN1 mutational analysis, linkage analysis, and genetic mapping are performed on the tissue samples. Patients from all major US ethnic groups (Caucasian, Hispanic, African Americans) will be recruited for the study in the next 2 years.

Official Title
-----------------
Genetic Study of the FBN1 Gene and Fibrillin-1 Abnormalities in Choctaw Native Americans and Other Patients With Systemic Sclerosis

Conditions
-----------------
Systemic Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of systemic sclerosis in accordance with the American College of Rheumatology preliminary criteria Positive for systemic sclerosis antibodies (e.g., anticentromere, antitopo, antifibrillarin, or antiRNA polymerase)

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
arthritis & connective tissue diseases, rare disease, systemic sclerosis
AI Evaluation of COVID-19 Sounds (AI-EChOS)

Study Overview
=================
Brief Summary
-----------------
In this study the investigators record sounds of voice, breaths and cough of subjects who tested positive for COVID19. The investigators then feed these sounds into an artificial intelligence and see if it can learn to recognise features to make COVID19 diagnosis from these sounds in order to avoid to use swabs to test the general population.

Official Title
-----------------
AI Evaluation of COVID-19 Sounds

Conditions
-----------------
COVID-19, COVID-19 Respiratory Infection, Cough, Breathing Sound, Breathing, Mouth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults who tested positive for SARS-CoV-2 currently admitted to hospital at the study site Adults who tested negative for SARS-CoV-2 and are admitted for any respiratory condition (eg COPD or asthma flare-up, pneumonia..) Healthy volunteers Exclusion Criteria: Patients under the age of 18. Patients unable to read in Italian. Patients unable to give informed consent to participate. Patients requiring life support (including, but not limited to, mechanical cardiac support, ventilation, etc.) Patients who are pregnant

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy evaluation | The investigators will evaluate the accuracy of the ML algorithm in terms of sensitivity and specificity and ROC-AUC | September 2022-December 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, artificial intelligence, machine learning, sound, cough, breath, voice, diagnosis, automation, AI, ML, pneumonia, symptoms, airways, SARS-CoV-2
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

Study Overview
=================
Brief Summary
-----------------
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders

Official Title
-----------------
Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.

Conditions
-----------------
Parenteral Nutrition Associated Cholestasis

Intervention / Treatment
-----------------
* Drug: intravenous lipid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study Exclusion Criteria: If does not need TPN by 72 hours; Direct hyperbilirubinemia within the first 72 hours after birth; TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc); Biliary tract disorders leading to direct hyperbilirubinemia; Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc

Ages Eligible for Study
-----------------
Maximum Age: 72 Hours

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 |
| --- | --- |
| Experimental: low dose intravenous lipids<br> | Drug: intravenous lipid<br>* intravenous given daily for 6 weeks<br>|
| Placebo Comparator: high dose of intravenous lipids<br> | Drug: intravenous lipid<br>* intravenous given daily for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Parenteral Nutrition Associated Cholestasis | Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Rate of Change in Direct Bilirubin | Amount of direct (conjugated) bilirubin was measured from sera samples. | baseline, weeks 1, 2, 3, 4, 5 and 6 |
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.

Detailed Description
-----------------
Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in bypass vein grafts, and drug-eluting devices might be beneficial in this field as well. In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon. The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.

Official Title
-----------------
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study

Conditions
-----------------
Peripheral Artery Occlusive Disease, Peripheral Artery Restenosis, Peripheral Artery Stenosis

Intervention / Treatment
-----------------
* Device: Conventional PTA
* Device: Drug-eluting balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any venous bypass with stenosis warranting intervention Exclusion Criteria: Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-eluting balloon<br> | Device: Drug-eluting balloon<br>* After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon<br>* Other names: DEB;|
| Active Comparator: Conventional PTA<br> | Device: Conventional PTA<br>* After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon<br>* Other names: Balloon angioplasty;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLR (Target lesion revascularization) | Any reintervention to the same lesion. | 12 months | 
| Graft occlusion | Occlusion of the bypass graft | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major amputation | Above or below knee amputation of the treated leg | 0-12 months | 
| Death |  | 0-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restenosis, Drug-eluting balloon, Vein graft
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the treatment of postoperative dental pain in male patients.

Official Title
-----------------
A Randomized Double-blind, Placebo-and Active Comparator-Controlled 2-Part Study to Evaluate the Efficacy of MK2295 in Patients With Postoperative Dental Pain

Conditions
-----------------
Pain, Postoperative, Tooth Extraction

Intervention / Treatment
-----------------
* Drug: MK2295


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in generally good health who are scheduled to have two or more third molars removed, at least one of which is partially or completely embedded in bone and is a mandibular impaction Exclusion Criteria: Patient has a temperature of 37.5C or greater prior to dosing Patient has participated in another clinical study within the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK2295|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak analgesic response, safety, and tolerability |  | Over 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of analgesia, duration of analgesia |  | Over 24 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Pain, Postoperative
Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy

Study Overview
=================
Brief Summary
-----------------
Previously studied peer-based educational videos on LARC (long-acting reversible contraceptive) devices will be incorporated into a high school health curriculum. This will then be administered to the intervention high school. Outcomes including LARC knowledge, attitudes and uptake will be compared to a control high school.

Official Title
-----------------
Investigating an Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy

Conditions
-----------------
Contraception Behavior

Intervention / Treatment
-----------------
* Behavioral: LARC peer-based curriculum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female, never used LARC, attending high school, less than 20 yo Exclusion Criteria: used LARC

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: case-control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Will receive adjusts curriculum | Behavioral: LARC peer-based curriculum<br>* Peer-based educational videos and supplemental activities<br>|
| No Intervention: Control<br>Will receive unadjusted curriculum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inquiries made of provider | Incidence of teenagers initiating LARC discussion or asking provider questions about LARC when visiting the school-based healthcare clinic provider. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LARC uptake | Incidence of teenager using IUD or subnormal implant. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
teen pregnancy, adolescent contraception