linjc16/ctgov huggingface dataset:
Telemedicine in HIV Care in Buenos Aires

Study Overview
=================
Brief Summary
-----------------
The aim of this investigation is to conduct an implementation research to facilitate and evaluate the implementation of VCT((Videoconsult through telemedicine) among HIV HCP(healthcare providers) and PLWH(people living with HIV)

Detailed Description
-----------------
Through prospective observational methodology the investigators are planning to evaluate VCT(Videoconsult through telemedicine) implementation. Both quantitative and qualitative analysis (mixed methods) will take part in the assessment. Quantitative data will be useful to obtain objective data in terms of proportion of subjects using the intervention, adoption by health care workers and measuring effectiveness. Additionally, qualitative methods will help to understand the outcomes focusing on the barriers and facilitators from both the HCW and patients, and their feedback on continuous implementation. Hence, perceptions of a vast group of patients and HCW will take a critical point in the qualitative analysis. Finally, by evidencing effectiveness, the investigators will be able to generalize and maintain this intervention as a good clinical practice. Due to the scope of the outcomes, the investigators will use RE-AIM framework.

Official Title
-----------------
Delivery of HIV Care Through Telemedicine in Public Hospitals in Buenos Aires, Argentina During COVID-19 Pandemic: Implementation Research

Conditions
-----------------
Telemedicine, HIV-1-infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years-old or older Access to internet Willing to participate Exclusion Criteria: do not understand the purpose and study procedures

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 |
| --- | --- | --- |
| Telemedicine Reach. RE-AIM framework | Proportion of included patients over all patients eligible | 18 months | 
| Telemedicine Effectiveness. RE-AIM framework | Proportion of treatment interruptions and undetectable HIV viral load | 18 months | 
| Telemedicine Adoption. RE-AIM framework | Proportion of physicians adopting VC, barriers and facilitators to adopt telemedicine | 18 months | 
| Telemedicine Implementation.RE-AIM framework | Time and cost needed to deliver the intervention | 18 months | 
| Telemedicine Manteinance. RE-AIM framework | Inclusion of VCT into routine activity, Satisfaction of HCP(healthcare proffesionals and patients with videoconsultation | 18 months |
Intravascular Stents Fracture Effects

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to evaluate long term durability and hemodynamic effect of implanted stents in the aortic arch and in pulmonary artery branches.

Detailed Description
-----------------
Patients who underwent trans-catheter implantation of balloon expanded stents in the aortic arch and in branch pulmonary arteries will be evaluated by physical examination with blood pressure values measurement of upper and lower limbs. Echo-Doppler cardiography will be performed for flow velocity analysis. Zoomed fluoroscopy will be performed and recorded in two orthogonal views to evaluate stent integrity or stent fracture. It is our intention to include 20 patients in this study from our follow-up clinic.

Official Title
-----------------
Evaluation of Implanted Aortic Arch and Branch Pulmonary Artery Stents Durability and Function

Conditions
-----------------
Durability of Implanted Intravascular Stents, Hemodynamic Effect of Implanted Intravascular Stents

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -patients who underwent stent implantation for coarctation of the aorta and for branch pulmonary artery stenosis Exclusion Criteria: -Pregnancy

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- | --- |
Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia

Detailed Description
-----------------
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia

Official Title
-----------------
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Procedure: SCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Critical Limb Ischemia Exclusion Criteria: Patients with other than Critical Limb Ischemia

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: SCT|SCT|

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
-----------------
Critical Limb Ischemia
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children

Study Overview
=================
Brief Summary
-----------------
Open-label, follow-up study for subjects who completed the EPITOPE study.

Official Title
-----------------
EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children

Conditions
-----------------
Peanut Allergy

Intervention / Treatment
-----------------
* Biological: DBV712 250 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: completion of the EPITOPE study Exclusion Criteria: Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches. Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

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

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

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: DBV712 250mcg<br> | Biological: DBV712 250 mcg<br>* DBV712 250 mcg, once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects reaching an ED ≥1000 mg |  | 12 months | 
| Proportion of subjects reaching an ED ≥1000 mg |  | 24 months | 
| Proportion of subjects reaching an ED ≥1000 mg |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) |  | Throughout the study during 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EPIT, Epicutaneous, Immunotherapy, Viaskin
Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the incidence of adverse events for patients with rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences in injection site reactions based on whether health care professionals or patients administer Enbrel will be assessed and evaluated.

Official Title
-----------------
Observational Study With Enbrel in Patients With Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: Enbrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven diagnosis of rheumatoid arthritis Exclusion Criteria: Contraindications according to Summary of Product Characteristic (SmPC)of Enbrel® the following points will prevent or restrict participation: Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel® Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localized infections Patients with sepsis or risk of sepsis should not be treated

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

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

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

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

Arms and Interventions

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

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
-----------------
Rheumatoid Arthritis
Pilot Evaluation of the JHI Platform

Study Overview
=================
Brief Summary
-----------------
The main purpose of this pilot study is to evaluate an impact of JHI CR Platform on patient referral, recruitment and retention rates and overall patient satisfaction in cardiovascular rehabilitation programs at the HFHS.

Official Title
-----------------
Pilot Evaluation of the Janssen Healthcare Innovation Integrated Cardiovascular Rehabilitation Management Platform (JHI PLATFORM).

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age 18 years old (inclusive) and older Recent hospitalization at HFHS Main Campus hospital with one of the following diagnosis Stable angina with medical management Myocardial infarction (MI)/Acute coronary syndrome Percutaneous Coronary Intervention (PCI) Coronary Artery Bypass Graft (CABG) surgery Heart valve surgical repair or replacement Patients must be attending outpatient CR program at the HFHS Detroit location. Willingness to participate in the study and follow study requirements Willingness to respond to several surveys at the baseline and periodically during the study Exclusion Criteria: Active substance abuse per medical record Unstable psychiatric condition Inability to exercise Unstable medical condition that would prevent safe and regular exercise training Uncorrected Severe Aortic Stenosis or Severe Mitral Stenosis Inpatient referring physician feels that exercise in contra-indicated due to safety reasons or is ill advised due to other patient specific factors LVAD, Heart Transplant. Although these patients qualify for CR, HFHS is not recruiting them due to difficulty in coordinating with surgical patients and their providers. In addition, there may also be surgical issues (infection, wound dehiscence, bone healing etc) that may reasonably interfere with exercise.

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 |
| --- | --- | --- |
| Patient referral, recruitment and retention rates and overall patient satisfaction. |  | Beginning, middle, and end of participation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Cardiac Rehabilitation
Observational to Investigate the Efficacy of CRESTOR 5mg in Reaching LDL-C Target Goals in Patients Who Are at High Risk for a Cardiovascular Event

Study Overview
=================
Brief Summary
-----------------
Observational study to investigate the use and efficacy of CRESTOR 5 mg in reaching LDL-C target goals in both statin naïve and statin treated primary and secondary prevention patients at high risk for a cardiovascular event.

Official Title
-----------------
An Observational Study Into the Usage and Efficacy of Crestor 5mg as a Start Dosage in Achieving the LDL-C Target Level in Both Statin-naive and Treated Primary and Secondary Prevention Patients With a High Risk of a Cardiovascular Event.

Conditions
-----------------
Hypercholesteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has a high risk of a cardiovascular event as defined by the European guidelines. The patient is statin-naive (i.e. has not used a statin > 2 months), or is currently treated with atorvastatin, pravastatin or simvastatin. An LDL-C level is known for the statin-naive patient or for the statin used during visit 1. It has been decided to start the patient on CRESTOR 5 mg. The patient is prepared to give permission to the coded data being made available to AstraZeneca Exclusion Criteria: The patient is known to have complaints of myalgia, myopathy or liver function impairment (including elevated levels of serum transaminases) where there is a causal relationship with the statin treatment. Contraindications for treatment with CRESTOR (see 1 B1 text). Patients with a family history of dyslipidemias, for instance familiar (combined) hypercholesterolemia
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, rosuvastatin, LDL-C goal, observational study, primary prevention, secondary prevention
Beta2-adrenergic System and Training

Study Overview
=================
Brief Summary
-----------------
This project aims to examine the trainability of the beta2-adrenergic system with respect to the individual performance response

Official Title
-----------------
Trainability of the beta2-adrenergic System With Respect to Performance

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

Intervention / Treatment
-----------------
* Behavioral: Training
* Drug: Formoterol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 45 years of age Trained individuals with a maximal oxygen uptake above 55 ml/min/kg Body mass index lower than 26 Exclusion Criteria: Allergy towards study drug Unacceptable side effects to the study drug Chronic disease deemed by the MD to interfere with the study Smoking Use of prescription medicine

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: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SET-HIGH<br>High volume speed endurance training | Behavioral: Training<br>* 6 weeks of training<br>Drug: Formoterol<br>* inhalation of 54 microg formoterol<br>Drug: Placebo<br>* inhalation of placebo<br>|
| Experimental: SET-LOW<br>Low volume speed endurance training | Behavioral: Training<br>* 6 weeks of training<br>Drug: Formoterol<br>* inhalation of 54 microg formoterol<br>Drug: Placebo<br>* inhalation of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sprint performance | Change in power output during maximal cycling in response to formoterol | ½ hour after administration of formoterol or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycling endurance performance | Change in 4-min time trial performance in response to formoterol | ½ hour after administration of formoterol or placebo |
A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947). Primary Objectives: Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination. Safety: To follow-up the long-term safety up to 5 years post-vaccination.

Detailed Description
-----------------
None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).

Official Title
-----------------
A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

Conditions
-----------------
Smallpox

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Subject vaccinated and who completed the Phase II VVL04 trial. Informed consent form signed. Subject able to comply with all trial procedures. Subject entitled to national social security. Exclusion Criteria : Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| Smallpox Vaccine (LISTER Strain) Group<br>Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination. |  | 1 to 5 years post-vaccination | 
| To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain). |  | 1 to 5 years post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus
Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression

Detailed Description
-----------------
Purpose: To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression. Methods: Thirthyfive eyes of 22 consecutive pediatric patients (mean age 14.3±2.5 years) with keratoconus are evaluated in this retrospective study. Subgroup A and B are made up in function of progression in maximum K (Kmax,) defined as steepening of 1.0 diopter or more recorded three year after CXL. Corrected distance visual acuity (CDVA), spherical equivalent, topographic cone location, Kmax, posterior elevation of the thinnest point and thinnest point are evaluated. A paired Student t test is used to compare preoperative and 12, 24, and 36 month postoperative da-ta. A P value <0.05 was considered significant.

Official Title
-----------------
Factors Influencing Keratoconus Progression After Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients: Three Year Follow up

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: corneal cross linking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Keratoconus age < 18 years at the treatment iontophoretic corneal cross linking performed at least 3 years before Exclusion Criteria: age > 18 years at the treatment I

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: corneal cross linking|Iontophoretic corneal cross linking|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| : Preoperative Kmax | Simulated maximum K (Kmax) is calculated by a Sirius Scheimpflug camera (CSO, Firenze, Italy) by averaging the axial curvature from the fourth to the eighth Placido rings of the flattest and steepest meridians (the amplitude of the zone taken into consideration, therefore has a vari-able diameter depending on the curvature of the cornea, and the principal meridians are not nec-essarily 90 degrees away) | 3 years | 
| posterior elevation of the thinnest point | posterior elevation of the thinnest point is measured by a Sirius Scheimpflug camera (CSO, Firenze, Italy) | 3 years | 
| cone location | The topographic cone location is assessed at the preoperative visit as follows : central for cor-neas having maximum K located within the central 3 mm and paracentral for corneas having maximum K located within the central 3 to 5 mm. | 3 years |