linjc16/ctgov huggingface dataset:
Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review

Study Overview
=================
Brief Summary
-----------------
Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.

Detailed Description
-----------------
Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity. However, the association between IBD and arterial thromboembolic events such as cases of myocardial infarction, stroke, aortic thrombus, mesenteric ischemia, peripheral arterial disease and members senior, was described less and remains a subject of debate. These arterial complications occur in young subjects accountability of IBD remains debated, and no clear pathophysiology. Here the investigators describe a series of 6 cases of patients with IBD who developed severe arterial complications, and whose cause was retained digestive inflammatory underlying disease. This study is report of six (6) cases that will be described

Official Title
-----------------
Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review

Conditions
-----------------
Arterial Thrombosis

Intervention / Treatment
-----------------
* Other: No intervention. Description study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with arterial Thrombosis and Inflammatory Bowel Disease admitted in Paris Saint Joseph Hospital Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention. Description study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of change of the number of thromboembolic events or venous or arterial |  | Month 6, year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the relevance of anti thrombosis treatment | Is the anti thrombosis treatment adequate or have been changed during the monitoring? The answer to this question should be :yes or no | Month 6, year 2 |
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy

Study Overview
=================
Brief Summary
-----------------
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan

Official Title
-----------------
Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration Exclusion Criteria: Patients who use the DCV Trio off label
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 |
| --- | --- | --- |
| Incidence of Aspartate Aminotransferase (AST) elevation | measured by immunoassay | Up to 36 weeks | 
| Incidence of Alanine Aminotransferase (ALT) elevation | measured by immunoassay | Up to 36 weeks | 
| Incidence of Total Bilirubin (tBili) elevation | measured by immunoassay | Up to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan | measured by adverse events | Up to 36 weeks | 
| Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) | measured by number of patients | Up to 24 weeks | 
| Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24) | measured by number of patients | Up to 36 weeks | 
| Percentage of patients to experience virologic breakthrough | measured by percentage of patients | Up to 36 weeks |
Biomarker Breast Pap Test

Study Overview
=================
Brief Summary
-----------------
This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically detectable tumors, and those who have detectable tumors, 2) identify all the detectable markers and 3) establish that biomarkers detected in NAF could also be detected in the biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable tumors.

Conditions
-----------------
Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any female subject aged 18 years or older Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects who have no mammographically detectable tumors<br>This group will be evaluated for marker presence in NAF. no drugs administered | |
| Subjects who have non-cancerous growths<br>This group will be evaluated to study whether marker(s) detected in NAF are also expressed in non-cancerous tumors. No drugs administered | |
| subjects who have cancerous growths<br>In this group, any markers detected in NAF could also be detected in tumor tissues. No drugs administered. | |

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
-----------------
biomarker,, NAF, Subjects
Pathway to Diagnosis of Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the prediagnostic symptoms and the events along the pathway to diagnosis of women with ovarian cancer, referred for first-line chemotherapy.

Official Title
-----------------
Pathway to Diagnosis of Ovarian Cancer: Observational Retrospective Multicenter Study

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of ovarian cancer Indication for chemotherapy Age > 18 years Signed informed consent Exclusion Criteria: Previous chemotherapy Unable or unwilling to participate in interview

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

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

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 |
| --- | --- | --- |
| the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis |  | at baseline | 
| time intervals in weeks between prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) |  | at baseline | 
| description of prediagnostic patient experiences according to modified Andersen's model of 'total patient delay' |  | at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prediagnostic symptoms, sentinel events, pathway to diagnosis
18750-Sun Protection Factor Assay

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

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

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987517)


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 or female Aged between 18-70 years old. Good health Signed and dated Informed Consent Form Signed and dated Health Insurance Portability and Accountability Authorization (HIPAA) Form An unambiguous MED 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: BAY987517<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 (BAY987517)<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 - SR16-01.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose(MED) |  | Up to 15 minites | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minites |
A Blind Maneuver to Position an Endobronchial Blocker

Study Overview
=================
Brief Summary
-----------------
One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice. We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic bronchoscopy.

Detailed Description
-----------------
The use of a fiberoptic bronchoscopy (FOB) appears to be fundamental to adjusting position of the bronchial blocker in the targeted mainstem bronchus. However, there can be occasions when a FOB is unavailable or inapplicable. Therefore, we will try to devise a blind method to locate the blocker without the aid of FOB in patients undergoing thoracic surgery. After intubation of endotracheal tube (ETT), the Uniblocker® is inserted into the ETT and is advanced until the blocker balloon comes out of the ETT tip. At this time, the blocker balloon is inflated with air and the peak inspiratory pressure (PIP) will abruptly increase. And then, the blocker is rotated to the thoracotomy side and advanced to the carina step by step at 0.5 cm intervals. When the PIP drops abruptly, the blocker cuff is deflated completely and advanced to 3 cm further. The blocker cuff is inflated again. Using a FOB, the position of the blocker is recorded and we will evaluate the success rate of proper blocker position.

Official Title
-----------------
A Blind Maneuver to Position an Endobronchial

Conditions
-----------------
Endobronchial Blocker, One Lung Ventilation, Thoracic Surgery, Fiberoptic Bronchoscopy

Intervention / Treatment
-----------------
* Procedure: endobronchial blocker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing thoracic surgery who need one lung ventilation Exclusion Criteria: patients who have a lesion in trachea or mainstem bronchi severe tracheal deviation patients who do not agree to informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| thoracic surgery<br>Patients undergoing thoracic surgery in which one lung ventilation is needed. | Procedure: endobronchial blocker<br>* After intubation of endotracheal tube, the Uniblocker® was inserted into the endotracheal tube and advanced step by step with inflation of the blocker balloon until the peak inspiratory pressure dropped abruptly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of AV650 in healthy subjects given single and multi-doses under fasted and fed conditions.

Official Title
-----------------
A Phase 1 Double-Blind, Placebo-Controlled Single Center Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Dose and Multiple Dose Escalations of AV650 in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: AV650


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking Body mass index between 18.5 and 29.9 kg/m2 or body mass index greater than 29.9 kg/m2 with good to excellent body fat percentage Exclusion Criteria: Known hypersensitivity to lidocaine or non-steroidal anti-inflammatory agents (NSAIDS) History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease History of HIV or Hepatitis B History of symptomatic hypotension History of mental illness, drug addiction, drug abuse or alcoholism History of cancer History of inflammatory arthritis (rheumatoid, lupus, psoriatic arthritis) Current use of immunosuppressive therapy (systemic steroids, cyclosporine) or use of nasal or topical steroids History of gastric or duodenal ulcer disease History of severe physical injury, direct impact trauma or neurological trauma within 6 months of Study Day 1 Female subjects who are pregnant or nursing Have donated blood within 90 days of Study Day -1 Have received an investigational drug within 90 days of Screening Require regular use of antihistamines, H2 blockers (such as cimetidine, ranitidine), TCAs or SSRIs or who have taken these medications witin 14 days of Study Day 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AV650|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile |  |  | 
| Sedation and reaction time changes |  |  |
Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the existence of an increased risk of cataracts among interventional cardiologists as compared to cardiologists not exposed to X-rays.

Detailed Description
-----------------
This cross-sectional study includes cardiologists aged > 40 years: a group of interventional cardiologists (coronary interventionists and electrophysiologists) and a group of unexposed workers (including cardiologists). Individual information, including risk factors of cataracts (age, diabetes, myopia, etc. ...), are collected during a telephone interview. For the exposed group, a specific section of the questionnaire is focused on the occupational history, the description of the procedures (type, frequency, radiation protection tool) and will be used for the classification into comparable exposure level groups according to estimates of cumulative dose. For all participants, eye examinations are performed to specifically detect cataracts even in the early stages (lens opacities, LOCS III according to the international standard classification).

Official Title
-----------------
Study of the Occupational Risk of Radiation-induced Cataracts Among Cardiologists

Conditions
-----------------
Cataracts, Lens Opacities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged at least 40 yrs old for interventional cardiologists: cumulated number of procedures > 2000 Exclusion Criteria: previous history of medical radiation exposure for radiotherapy or brain scans for non-interventional cardiologists: occupational history of interventional cardiologist

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- |
| Exposed group<br>French coronary interventional cardiologists and cardiologists specializing in cardiac arrhythmias treatments (electrophysiologists), occupationally exposed to X-Rays | |
| Unexposed group<br>French non-interventional cardiologists and non medical workers, not occupationally exposed to X-Rays | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens opacities |  | up to 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | up to 1.5 year | 
| Major eye disorders (glaucoma, etc…) |  | up to 1.5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation cataracts, Lens opacities, X-rays, Interventional Cardiologists, Electrophysiologists
Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, myositis, or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, may affect multiple organ systems. Occasionally, patients deteriorate acutely requiring advanced care in an intensive care unit (ICU). In an ICU setting, mortality is estimated with scoring systems, such as APACHE or SAPSII. Since there are limited data available on their use in autoimmune diseases, with the current study, we aim to assess the usefulness of these ICU scores and analyze predictors of mortality in this particular group of patients.

Official Title
-----------------
Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit - Retrospective Analysis at a Single Tertiary Care Center

Conditions
-----------------
Vasculitis, Systemic Lupus Erythematosus, Myositis

Intervention / Treatment
-----------------
* Other: ICU Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the ICU at the University Medical Center Göttingen Exclusion Criteria: Patients with incomplete or missing data

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| ANCA-associated Vasculitis<br>Patients with ANCA-associated vasculitis admitted to the ICU | Other: ICU Care<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | From date of admission to the ICU until the date of death from any cause assessed up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of renal replacement therapy |  | From date of admission to the ICU until the date of event assessed up to 52 weeks | 
| Need for catecholamines |  | From date of admission to the ICU until the date of event assessed up to 52 weeks | 
| Need for ventilation |  | From date of admission to the ICU until the date of event assessed up to 52 weeks | 
| Need for cardiopulmonary resuscitation |  | From date of admission to the ICU until the date of event assessed up to 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive Care Unit, Mortality, Autoimmune Diseases