linjc16/ctgov huggingface dataset:
Anticoagulants Comparative Benefit-risk Ratio in Real Life

Study Overview
=================
Brief Summary
-----------------
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication. The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013

Official Title
-----------------
Engel 2: REal-life aNticoaGulants Comparative bEnefit-risk in Nonvalvular Atrial fibrilLation (NVAF) in France

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with NVAF with a first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA in 2013, with no other identified indication for anticoagulation; Without any VKA or NOAC (Pradaxa®, Xarelto®, or Eliquis®) reimbursed dispensation for the last 3 years before the first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA Exclusion criteria: None

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NOAC<br>New oral anticoagulant groups | |
| VKA<br>VKA group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Relevant Bleeding | First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of: Hemorrhagic stroke, Other critical organ or site bleeding, Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype). | One year | 
| Major Bleeding | First hospitalization with primary diagnosis (ICD-10 codes) of: Hemorrhagic stroke, Other critical organ or site bleeding, Other bleeding with transfusion, or acute post-hemorrhagic anemia or death during hospital stay. | 1 year | 
| Arterial Thrombotic Event | First hospitalization with primary diagnosis (ICD-10 codes) of: Ischemic or undefined stroke, Systemic arterial embolism. | 1 year | 
| Acute Coronary Syndrome | First hospitalization with primary diagnosis (ICD-10 codes) of: Myocardial infarction (ST-segment elevation Myocardial infarction (STEMI) and non-ST-segment elevation Myocardial infarction(NSTEMI)), Unstable angina. | One year | 
| Death (All-cause) | All-cause death (cause of death not available in the database). | 1 year | 
| Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death) | First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above. | One year |
Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation

Study Overview
=================
Brief Summary
-----------------
This study will determine rates of first pass success without hypoxemia in emergency department intubations with and without the use of apneic oxygenation by nasal cannula.

Official Title
-----------------
Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Other: Apneic oxygenation
* Other: Pre-oxgenation with NRB, NIPPV, BVM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients requiring emergent Rapid Sequence or Delayed Sequence endotracheal intubation with administration of a neuromuscular blocker (Succinylcholine, Rocuronium) Exclusion Criteria: Known prisoners Patients in cardiac arrest Patients who are intubated without the use of neuromuscular blockade (i.e., cardiac arrest, awake intubation).

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apneic oxygenation<br> | Other: Apneic oxygenation<br>* Nasal cannula apneic oxygenation<br>|
| Active Comparator: non-apneic oxygenation<br> | Other: Pre-oxgenation with NRB, NIPPV, BVM<br>* Pre-oxygenation with non-rebreather mask, non-invasive positive pressure ventilation, or bag-valve mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First pass success without hypoxemia |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peri-intubation saturation |  | 0, 30, 60 and 120 seconds | 
| Saturation at time of tube placement |  | 10 minutes | 
| Time to desaturation <93% |  | measured time until saturations drop below 93% during the peri-intubation period, up to 10 minutes | 
| Saturation at post intubation |  | 0, 30, 60, and 120 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoxemia, intubation, apneic oxygenation
A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra

Study Overview
=================
Brief Summary
-----------------
Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

Detailed Description
-----------------
Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

Official Title
-----------------
A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent

Conditions
-----------------
Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: G2 and G3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg Exclusion Criteria: Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200

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
Intervention Model: Single Group Assignment
Interventional Model Description: G2 and G3
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: G2 and G3 implantation<br>Two iStent inject stents and one iStent Supra stent | Device: G2 and G3<br>* Two iStent inject devices and one iStent supra device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% IOP reduction | IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP less than or equal to 18 mm Hg | IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg | Month 12 |
Oral Mucosal Lesions Among Smokers in an Egyptian Population Study.

Study Overview
=================
Brief Summary
-----------------
This cross-sectional study will assess the prevalence of oral changes among smokers in an Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo University), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in Egypt

Detailed Description
-----------------
The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Official Title
-----------------
Prevalence of Oral Mucosal Lesions Among Smokers in an Egyptian Cohort: A Hospital-based Cross-Sectional Study (I)

Conditions
-----------------
Smokers

Intervention / Treatment
-----------------
* Other: printed questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: males and females. Age: all age groups. Smokers. Individuals who agreed to sign the informed consent. Exclusion Criteria: Individuals suffering from any systemic disease. Individuals on medications. Non-Egyptians.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: printed questionnaire|For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral mucosal lesions | Identifying and recording oral mucosal lesions | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health-related quality of life (OH-QoL) evaluation | using Oral Health Impact Profile (OHIP) | one year | 
| dysplasia | Histopathological evaluation of clinically suspicious oral lesions to detect dysplasia | one year |
Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells

Study Overview
=================
Brief Summary
-----------------
Patients with hepatitis C show impaired neutrophil function. It is not known whether this is a direct of an indirect phenomenon. Using bone marrow biopsies from patients with hepatitis C it is possible to see whether neutrophil granulocyte progenitors are already infected with hepatitis C.

Detailed Description
-----------------
Neutrophil granulocytes are important components of the innate immune system and pioneers in the fight against both fungal and bacterial infections. If pathogens enter the body, they are marked as foreign by antibodies and the complement system. Afterwards receptors on the neutrophils recognize and bind on these foreign substances to make them harmless. This process is called phagocytosis. Hepatitis C virus (HCV) and neutrophils are rarely associated. The HCV belongs to the Flaviviridae. It is a single-stranded, enveloped RNA virus with a positive polarity, which cause chronic hepatitis C (CHC) in approximately 170 million people worldwide. Subsequently, such an infection leads to liver cirrhosis and carcinoma in a significant proportion of patients. The virus infects mainly hepatocytes, but extrahepatic replication has also been shown. HCV usually enters the cell through receptor-mediated endocytosis (claudin-1, cluster of differentiation (CD)81, occludin and scavenger receptor 1), before it abuses the cell's own infrastructure for the viral protein synthesis. The aim of this study is to determine neutrophil function in chronic hepatitis C infected patients. Furthermore the investigators want to examine if neutrophils or their precursor cells are infected with HCV and if this leads to their dysfunction.

Official Title
-----------------
Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic hepatitis C Genotype 1-4 Exclusion Criteria: acute hepatitis C

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| viral RNA | hepatitis C virus RNA | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neutrophil phagocytic capacity | function of neutrophil granulocytes in hepatitis C patients | day 1 | 
| hepatitis C virus proteins | presence of hepatitis C virus proteins in neutrophils | day 1 |
Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of these effects are unknown. Thus management of antithrombotics and hemostasis during thrombectomy and surgery is an issue. Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis, coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to evaluate the time required for the normalization of these disorders. Methods : Observational monocentric study including rtPA-treated patients requiring endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA administration to assess of fibrinolysis, coagulation and platelet functions with point of care devices and specific laboratory tests. Record of clinical and biological data.

Official Title
-----------------
Assessment of Hemostasis Disorders in Tissue Plasminogen Activator Treated (rtPA-treated) Patients Requiring Endovascular Treatment for Ischemic Stroke

Conditions
-----------------
Stroke, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient over 18 treatment with rtPA for an acute stroke endovascular treatment required Exclusion Criteria: opposition to participate in the study long term anticoagulant-treated patient pregnant patient

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 |
| --- | --- | --- |
| fibrinolysis activity | Time required for normalization of fibrinolysis | until normalization of fibrinolytic activity, up to 48 hours |
HMGB1 in ICU-survivors

Study Overview
=================
Brief Summary
-----------------
Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?

Official Title
-----------------
Cognitive Impairment After Critical Illness, Links Between Sepsis, Cognitive Function and Non-resolving Inflammation

Conditions
-----------------
Sepsis, Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female age 18-17 Expected ICU-stay more than 24 hours Exclusion Criteria: Dont understand the language Substance abuse, alcohol or drugs Blind, deaf or suffering from aphasia Ongoing psychiatric illness or psychopharmacological treatment Suffering from dementia och mentally impaired Structured brain damage or meningitis Palliative Care ICU-treated for more than 48 hours Transferred from other ICU Being treated with ECMO Not having residency in Stockholm

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sepsis<br>Patients suffering from Severe sepsis or Septic chock at the ICU. | |
| Non-Sepsis<br>Patients being treated at ICU but not suffering from severe sepsis/septic chock | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is HMGB1 elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? |  | 2 years | 
| Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis? |  | 4 years |
Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn

Study Overview
=================
Brief Summary
-----------------
The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.

Detailed Description
-----------------
The potential of acellular dermal matrix (ADM) had been proved to improve cosmetic and functional outcomes, nevertheless, there had been few reports about the long term results of the morphological, histological and functional changes after placement. The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.

Official Title
-----------------
Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn

Conditions
-----------------
Burn, Traumatic Implants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patient's skin with ADM implant Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 52 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 |
| --- | --- | --- |
| Function of the region covered by human acellular dermal matrix allograft |  | March, 2012 to May, 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical characteristics of the transplanted human acellular dermal matrix allograft |  | March, 2012 to May, 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burns, Wound repair, Skin substitutes
The Effects of Pentoxifylline on PAI-1 in an Obese Population

Study Overview
=================
Brief Summary
-----------------
PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human subjects.

Detailed Description
-----------------
Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8.

Official Title
-----------------
The Effects of Pentoxifylline on PAI-1 in an Obese Population

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Pentoxifylline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusions: 1. A Body Mass Index of ≥ 30.0 2. Age 21 or older 3. Few or no medical problems 4. PAI-1 level ≥ 10 ng/dl Exclusions: 1. Cigarette use 2. Present use of angiotensin converting enzyme (ACE) Inhibitors 3. Recent cerebral and/or retinal hemorrhage 4. Intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine 5. Presently on warfarin therapy 6. Pregnancy or breast-feeding 7. Recent surgery 8. Recent diagnosis/treatment for peptic ulcer

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentoxifylline<br>Patients receive Pentoxifylline 400 mg po TID for 8 weeks. | Drug: Pentoxifylline<br>* 400mg PO TID x 8 weeks<br>* Other names: Trental;|
| Placebo Comparator: Placebo<br>Patients take a placebo TID for 8 weeks. | Drug: Placebo<br>* PO TID x 8 weeks<br>* Other names: Sugar Pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PAI-1 Level |  | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CRP Level |  | Baseline and 8 weeks | 
| Change in TNF-alpha Level |  | Baseline and 8 weeks | 
| Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy. |  | Baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plasma PAI-1 level at 0, 4, 8 weeks, Plasma hsCRP level at 0, 4, 8 weeks, Plasma TNF-a level at 0, 4, 8 weeks