linjc16/ctgov huggingface dataset:
A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema

Study Overview
=================
Brief Summary
-----------------
This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: Dexamethasone Intravitreal Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Retinal disease involving macular edema Received at least one OZURDEX® injection Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice. | Drug: Dexamethasone Intravitreal Implant<br>* Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.<br>* Other names: OZURDEX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement. | Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement. | Baseline, 2 to 26 weeks following last injection (up to 6.5 months) |
TRANSFIX Zenith® Transection Clinical Study

Study Overview
=================
Brief Summary
-----------------
The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury.

Official Title
-----------------
TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury

Conditions
-----------------
Thoracic Aorta, Thoracic Injuries, Blunt Injuries

Intervention / Treatment
-----------------
* Device: Zenith® TX2® Low Profile Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vessels suitable for endovascular access and stent graft placement Blunt thoracic aortic injury of the descending thoracic aorta At least 16 years of age Informed consent given by patient or legally authorized representative Exclusion Criteria: Clinical considerations that would compromise patient safety or study outcomes Unsuitable arterial anatomy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular Repair<br> | Device: Zenith® TX2® Low Profile Endovascular Graft<br>* Treatment of Blunt thoracic aortic injuries (BTAIs)<br>* Other names: Zenith Alpha Thoracic™ Endovascular Graft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality |  | 30 days | 
| Aortic Injury-related Mortality | Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta. | 30 days | 
| Device Success | Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blunt thoracic aortic injury, Transection, Endovascular graft
Exact Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is an exact preoperative 3D-localisation of impacted and supernumerary teeth in the maxilla using Cone Beam Computer Tomography

Detailed Description
-----------------
An exact localisation of impacted teeth is often difficult to assume by using conventional radiological techniques like OPT or dental films. In contrast to these two-dimensional imaging methods the Cone Beam Computer Tomography (CBCT) respectively the Digital Volume Tomography (DVT) offers a three-dimensional imaging of the maxillofacial region, providing the opportunity to study objectives in all standard plans with 3D-reconstruction in multisection views. A preoperative radiological investigation using CBCT on patients who are supposed to undergo surgery for impacted and supernumerary teeth in the frontal maxilla shall clarify the certainty and safeness of this 3D-imaging method. Therefore a comparison between the findings on the CBCT, on eventually former conventional x-rays and the intraoperative finding as gold standard is done.

Official Title
-----------------
Exact Three-dimensional Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography

Conditions
-----------------
Impacted Teeth

Intervention / Treatment
-----------------
* Device: CBCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: supernumerary and impacted teeth in the maxilla (wisdom teeth excluded) need for surgical removement uncertain clinical and conventional radiological finding Exclusion Criteria: refused approval CBCT not practicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Digital Volume tomography<br>three-dimensional digital imaging using cone beam tomography (CBCT) | Device: CBCT<br>* Cone Beam Computer Tomography. 3D-imaging Digital Volume Tomography, compared with gold standard intraoperative findings.<br>* Other names: digital volume tomography (DVT);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exact localisation of impacted teeth | Cone Beam Computer Tomography, vs gold standard intraoperative finding | preoperative and under surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital Volume Tomography, Cone Beam CT, impacted and supernumerary teeth, dental and maxillofacial radiology
Longitudinal Study of Covid-19 Infection Among HCW in a French University Hospital

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine the incidence o of SARS-cov2 infection among health care workers highly exposed to covid 19 during 10 weeks et to analyze the determinants of their occupational and environmental exposure. Every 14 days, we performed SARS-Cov2 RT- PCR, serological testing and clinical questionnaire among a cohort of 100 HCW with a high degree of exposure to covid19 infection. Information about occupational exposure as the workplace, the activity of care, the characteristics of patient infected are captured, as well as environmental or personal exposure. The results will support the design of a new care organization and will define new ways of protection for patients (covid or not covid 19) and prevention for HCW.

Official Title
-----------------
Incidence of SARS-Cov2 Infection Among HCW in Lille University Hospital

Conditions
-----------------
Sars-CoV2

Intervention / Treatment
-----------------
* Other: self-administered questionnaire
* Diagnostic Test: SARS-Cov2 testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Health Care workers with covid high exposure during the care activities Exclusion Criteria: Heath Care Worker with SARS-Cov2 infection ( RT-PCR +) or SARS-Cov2 immunity in serological testing HCW off work Subjects on leave

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: self-administered questionnaire|Every14 days, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure|
|Diagnostic Test: SARS-Cov2 testing|Every14 days, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing |  | at 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing |  | once every 14 days for an average of 14 weeks | 
| Occupational exposures associated with the SARS-Cov2 infection |  | once every 14 days for an average of 14 weeks | 
| Environmental exposures associated with the SARS-Cov2 infection |  | once every 14 days for an average of 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incidence, Health Care Workers, occupational exposure, environmental exposure, serological testing, RT-PCR
Genetic Determinants of Warfarin Anticoagulation Effect

Study Overview
=================
Brief Summary
-----------------
The response to warfarin varies greatly among individuals. Some of this variability can be ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1, factor VII) have been shown to account for some of the variability in the response to warfarin irrespective of CYP2C9.The present study has several segments: Evaluation of the relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study is a confirmation of previous data in our own population. Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period. Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9, VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects.

Official Title
-----------------
Warfarin Induction Regimen Based Upon CYP2C9, VKORC1 Factor VII Genotyping, PMR and INR Monitoring, as Compared to the Conventional Regimen: a Prospective Controlled Study

Conditions
-----------------
Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in whom warfarin is about to be initiated Desired therapeutic range >2 and <3 Exclusion Criteria: Refusal to participate in the study

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genetic<br> | Drug: Warfarin<br> <br> |
| Experimental: Control<br> | Drug: Warfarin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic end points: |  | 1-4 months | 
| Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state |  | 1-4 months | 
| Pharmacodynamic. |  | 1-4 months | 
| Maintenance dose of warfarin at steady state. |  | 1-4 months | 
| Time to reach INR > 2. |  | 1-4 months | 
| Time to reach pharmacodynamic steady state. |  | 1-4 months | 
| Time spent at therapeutic INR <3 and >2. |  | 1-4 months | 
| Time spent at INR >3. |  | 1-4 months | 
| Time spent at INR <2. |  | 1-4 months | 
| The incidence of minor and major bleeding episodes. |  | 1-4 months |
Weight Variation During Chemotherapy in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied. Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.

Official Title
-----------------
Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: blood test/ additional measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menopausal women breast cancer patients requiring chemotherapy treatment WHO performance status 0-2 Exclusion Criteria: diabetics patients with metastases other cancer

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: additional examinations/measurements<br> | Other: blood test/ additional measurement<br>* blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body composition |  | within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in energy balance | resting energy expenditure, physical activity, food records. | within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. | 
| Change from baseline in muscle strength |  | within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. | 
| Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors) |  | within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy, metabolism, weight, body composition
Visual and Auditory Breathing-swallowing Coordinated Training

Study Overview
=================
Brief Summary
-----------------
Dysphagia is caused by multiple factors, and respiratory-swallowing discoordination is considered to be one of the factors. The investigators recently developed a visual and auditory breathing-swallowing coordinated training device. In this study, investigators examined the validity of a this device for healthy subjects. The investigators will examine which respiratory phase the swallowing occurs when the swallowing is started in accordance with the signal lighting and voice of this device.

Official Title
-----------------
Validation of Visual and Auditory Breathing-swallowing Coordinated Training Equipment in Healthy Individuals

Conditions
-----------------
Breathing-Swallowing Coordination, Dysphagia Rehabilitation

Intervention / Treatment
-----------------
* Device: Visual and Auditory Breathing-swallowing Coordinated Training device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with written informed consent to participate in the study Exclusion Criteria: Subjects with an apparent swallowing disorder Subjects with clinically evident cerebrovascular diseases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Visual and Auditory Breathing-swallowing Coordinated Training device<br> | Device: Visual and Auditory Breathing-swallowing Coordinated Training device<br>* This device has a structure in which a band wrapped around the chest detects the respiratory phase from changes in the lung volume, and the connected device lights a signal and sounds a sound.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from signal lighting and sounding to start swallowing |  | Day 1 |
AML Cell Immunotherapy Using Chimeric Antigen Receptor T-cells

Study Overview
=================
Brief Summary
-----------------
AML is one of the most aggressive forms of leukemia, where bone marrow transplantation remains the gold standard treatment, with its known associated toxicities and related mortality. Despite progress in the treatment of leukemic malignancies, especially the emergence of targeted- and immuno-therapies arising from biological genomic knowledge, there remains a need to provide additional strategies for refractory/relapsing (R/R) patients Aim of this study is to collect biological samples of AML patients in order to validate our Chimeric Antigen Receptor T-cells immunotherapy approach

Official Title
-----------------
Targeting Interleukin 1 Receptor Accessory Protein (IL1RAP) Expressing Acute Myeloid Leukemic (AML) Cells by Chimeric Antigen Receptor (CAR) Engineered T-cells

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: Sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AML patients adults and pediatrics Exclusion Criteria: AML3
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AML patients at diagnosis<br>AML patients at diagnosis (except AML3) | Other: Sample collection<br>* Sample collection blood and/or bone marrow<br>|
| Experimental: AML patients at relapse<br>AML patients at relapse after chemotherapy, targeted therapy or allograft | Other: Sample collection<br>* Sample collection blood and/or bone marrow<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL1RAP protein expression | Cytometry analysis | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AML, Chimeric Antigen Receptor T Cells, Immunotherapy