linjc16/ctgov huggingface dataset:
Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

Study Overview
=================
Brief Summary
-----------------
Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy

Detailed Description
-----------------
Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. A variety of findings are seen by Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of the retinal structure by OCT will be examined.

Official Title
-----------------
Evaluation of Pars Plana Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

Conditions
-----------------
Myopic Traction Maculopathy, Pars Plana Vitrectomy, Internal Limiting Membrane Peeling

Intervention / Treatment
-----------------
* Procedure: Pars Plana Vitrectomy with Internal Limiting Membrane peel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm. Best Corrected Visual Acuity less than 0.1 Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane At least 6 months follow-up Exclusion Criteria: Eyes with diffuse chorioretinal macular atrophy Concomitant presence of a choroidal neovascular membrane Young patients less than 21 years old. History of trauma Dense media opacity (corneal/ lenticular)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Procedure: Pars Plana Vitrectomy with Internal Limiting Membrane peel|Pars plana vitrectomy with staining and peeling of internal limiting membrane|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of best corrected visual acuity |  | 6 months |
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.

Official Title
-----------------
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System

Conditions
-----------------
Bradycardia

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning Patient who fulfils MRI solutions conditions Patient who provides signed and dated informed consent Exclusion Criteria: Implanted or planned to be implanted non MR-compatible device or material Permanent Atrial Fibrillation (for DR devices) Diaphragmatic/phrenic stimulation Claustrophobia Incessant ventricular tachyarrhythmia Inability to understand the purpose of the study or refusal to co-operate Unavailability for scheduled follow-ups at the implanting centre Already included in another clinical trial that could affect the results of this study Patient is minor (less than 18-years old) Patient is pregnant - Patient is forfeiture of freedom or under guardianship

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pacemaker + leads<br>all patients must have a MRI exam after pacemaker implantation | Device: MRI<br>* at least 6 weeks after the implantation of the pacemaker a MRI exam is performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker, leads and MRI exam
Familial Hypercolerstremia as Risk Factor in Stemi Patient Who Underwent Ppci

Study Overview
=================
Brief Summary
-----------------
Famulial hypercolerstremia as risk factor

Detailed Description
-----------------
Familial hypercolerestremia ad risk factor in stemi patient who underwent Ppci

Official Title
-----------------
Familial Hypercoleresremia as Risk Factor in Stemi Patient Underwent Ppci

Conditions
-----------------
Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Genetic: Genetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -all patient that underwent Ppci Exclusion Criteria: Previous ischemic patient Patient with raised renal chemistry Patient for CABG
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stemi patient<br>Stemi patient who underwent Ppci | Genetic: Genetic<br>* Lipid profile<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between familial hypercolerstremia and prognosis of patients in PPCI | Correlation between familial hypercolerstremia and prognosis of patients in PPCI | One year | 
| Correlation between non familial hypercolerstremia and prognosis of patients in PPCI | Correlation between non familial hypercolerstremia and prognosis of patients in PPCI | One year |
Increased Rate of Prophylaxis Against Venous Thromboembolism Due to eAlerts

Study Overview
=================
Brief Summary
-----------------
Now, after a cluster randomized controlled trial, eAlerts providing evidence-based guidelines on venous thromboembolism prophylaxis will be rolled out and evaluated hospital-widely.

Detailed Description
-----------------
An eAlert is displayed in the electronic patient chart if no prophylaxis has been ordered within 6 h after admission or transfer. The eAlerts provide evidence-based guidelines on venous thromboembolism prophylaxis. Now, after a cluster randomized controlled trial, the eAlerts will be rolled out and evaluated hospital-widely.

Official Title
-----------------
Increased Rate of Prophylaxis Against Venous Thromboembolism Due to eAlerts

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Behavioral: electronic alerts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: all in-patients hospitalized in a ward with computerized physician order entry (CPOE), staying at least 24 h in a ward Exclusion criteria: outpatients, ward without CPOE, patients transferred from an intervention to a control ward and vice versa

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: roll out of eAlerts<br>Roll out of eAlerts providing evidence-based guidelines on prophylaxis against venous thromboembolism. An eAlert is displayed in the electronic patient chart if no prophylaxis has been ordered within 6 h after admission or transfer. | Behavioral: electronic alerts<br>* An eAlert is displayed in the electronic patient chart if no prophylaxis has been ordered within 6 h after admission or transfer.<br>* Other names: eAlert;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of prophylaxis against venous thromboembolism | patients with prophylaxis/total patients | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ordering time after admission or transfer of a patient | time when physicians order a venous thromboembolism prophylaxis | 3 months | 
| acceptance of the eAlerts | survey of compliant and incompliant physicians | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous thromboembolism/prevention & control
Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia

Study Overview
=================
Brief Summary
-----------------
Preconditioning of regional skin is known to reduce post surgery complications due to increased perfusion and better skin condition. The aim of this study is to prove that local heating through a standardized device in patients with spinal cord injury induces no burnings or other relevant side effects. The investigators expect an increased regional perfusion, temperature and redness.

Official Title
-----------------
Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia

Conditions
-----------------
Perfusion; Complications

Intervention / Treatment
-----------------
* Device: HydroSun
* Device: Hilotherm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women aged from 18 to 65 years paraplegia Th2-Th12 spinal cord injury had occurred >12 weeks ago Exclusion Criteria: infections fever diabetes heart failure stadium III renal insufficiency stadium III. scars, wounds or other injuries in the area of treatment skin type V and VI on Fitzpatrick scale

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HydroSun<br>application of ultraviolet light for 30 minutes | Device: HydroSun<br>* a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp<br>|
| Active Comparator: Hilotherm<br>application of heat (maximum of 43°C) for 30 minutes | Device: Hilotherm<br>* a skin area of the lower limb will be treated three times with heat applied by a sleeve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of burn injury | grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis) | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood perfusion | perfusion (PeriFlux System 5000) in perfusion units | before and 1min after the application of light or heat | 
| skin surface temperature | measuring surface temperature with thermometer | before and 1min after the application of light or heat | 
| skin redness | visual inspection | before and 1min after the application of light or heat | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complete paraplegia
A New Active Vitamin D, ED-71 for Osteoporosis

Study Overview
=================
Brief Summary
-----------------
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence

Official Title
-----------------
A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: ED-71
* Drug: Alfacalcidol
* Drug: ED-71 placebo
* Drug: Alfacalcidol placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporotic patients who meet any of the following condition: with at least one fragility fracture, above 70 year-old with bone mineral density below 70% young adult mean, with bone mineral density below 60% young adult mean Women three years or more after menopause or men Exclusion Criteria: Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis A history or suspicion of active urolithiasis at any time Use of bisphosphonates in the past 12 months Use of medications known to affect bone in the past 2 months Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests
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 |
| --- | --- |
| Experimental: 1<br> | Drug: ED-71<br>* 0.75μg/day(p.o.)for 144 weeks<br>Drug: Alfacalcidol placebo<br>* 0 μg/day(p.o.)for 144 weeks<br>|
| Active Comparator: 2<br> | Drug: Alfacalcidol<br>* 1.0μg/day(p.o.)for 144 weeks<br>Drug: ED-71 placebo<br>* 0 μg/day(p.o.)for 144 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of vertebral fracture |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Lumbar Spine and total hip bone mineral density |  | throughout study |
Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins

Study Overview
=================
Brief Summary
-----------------
The study consists to Identify viral variants involved in the transmission of hepatitis C and characterize the antigenic and functional properties of their envelope glycoproteins at very early stage of infection (before seroconversion).

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Procedure: Blood sample (act specific of blood withdrawal for the study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years agree to participate in this study (signing the consent form or information form signed and letter of no objection for subjects contaminated by blood exposure). These criteria are specific to contaminated subjects: primary infection before development of HCV antibody (seroconversion): nucleic acid testing positive in the absence of HCV antibodies. These criteria are specific to individual sources : HCV antibody positive. Exclusion Criteria: refusal to participate private about freedom under guardianship under justice minor or major person unable to consent

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Recently infected subjects<br>Actual population of blood donors primo-infected with HCV with specific intervention for the study : one blood sample during the inclusion visit | Procedure: Blood sample (act specific of blood withdrawal for the study)<br>* Specific intervention : blood sample (3x7 ml in total)<br>|
| No Intervention: Retrospective cases<br>Population of infected blood donors in 2007, 2008 and 2009 No blood sample | |
| Other: Individuals sources<br>Specific intervention for the study : one blood sample during the inclusion visit | Procedure: Blood sample (act specific of blood withdrawal for the study)<br>* Specific intervention : blood sample (3x7 ml in total)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV serological markers | Immunoblot analysis from blood samples collected during the study | up to 30 months |
Prognosis and Course of COVID-19 Infection in Hospitalised Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the cohort prospective observational study is to define the major factors influencing the course of COVID-19 infections and its prognosis in hospitalised patients. The investigators plan to include 300 patients hospitalised with COVID-19 infection. The phone contacts with patients are due after 90 and 180 days after discharge.

Official Title
-----------------
Prognosis and Course of COVID-19 Infection in Hospitalised Patients

Conditions
-----------------
Covid19, SARS-CoV Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Chitotriosidase activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalisation with COVID-19 Exclusion Criteria: History of hospitalisation with COVID-19 infection Discharge from the hospital before the end of the treatment course Transfer to another hospital

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 |
| --- |
|Diagnostic Test: Chitotriosidase activity|The chitotriosidase activity will be measured in all the subjects|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need in biological therapy or/and respiratory support | The primary endpoint is the need in biological therapy or/and respiratory support including noninvasive ventilation during hospital stay | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days spent in hospital | The investigators plan to assess the overall length of hospitalisation due to COVID-19 infection as an outcome measure | Up to 1 month | 
| All-cause death | To assess the all-cause death 90 days after discharge | 90 days | 
| All-cause death | To assess the all-cause death 180 days after discharge | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, chitotriosidase, SARS-CoV Infection
18615 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment - Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987704)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coppertone (BAY987704)<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987704)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number: X71-109)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |