linjc16/ctgov huggingface dataset:
Emergency Department (ED) Triage of Alcohol Abuse

Study Overview
=================
Brief Summary
-----------------
Retrospective study of adult patients (> 16 y) admitted to Geneva University Hospitals with alcohol abuse. Triage criteria will be reviewed. Patients characteristics and patient flow in the ED will be described.

Detailed Description
-----------------
A retrospective analysis of triage notes and electronic medical records will be performed in order to identify how triage evaluation is performed accordingly to the Swiss Emergency Triage Scale criteria. The proportion of patients leaving without being seen will be computed. Caracteristics of these patients will be compared to patients with medical evaluation.

Official Title
-----------------
Evaluation of ED Triage of Adult Patients With Alcohol Abuse

Conditions
-----------------
Alcoholic Intoxication

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Triage code = alcohol abuse > 16 y Exclusion Criteria: No alcohol abuse identified at triage < 16 y

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

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triage questions asked | Number of questions asked at triage and proportion of patients with the full set of triage questions asked | participants will be followed for the duration of emergency department stay, an expected average of 12 hours | 
| Triage vital signs measured | Number of vital signs measured at triage and proportion of patients with the full set of triage vital signs measured | participants will be followed for the duration of emergency department stay, an expected average of 12 hours | 
| Number of undertriage | Number of patients with level 3 emergency levels attributed instead of level 2 | participants will be followed for the duration of emergency department stay, an expected average of 12 hours | 
| Number of mistriage | Number of patients with erroneous triage reason attributed | participants will be followed for the duration of emergency department stay, an expected average of 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients leaving without being seen |  | participants will be followed for the duration of emergency department stay, an expected average of 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
N04.452.442.422.336
A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers

Official Title
-----------------
An Open-label, Multiple-dosing, and Crossover Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Fimasartan
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20 - 40 years sex: male body weight: greater than 55 kg written informed consent Exclusion Criteria: known allergy to Fimasartan and amlodipine existing cardiac or hematological diseases existing hepatic and renal diseases existing gastrointestinal diseases acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 2 months prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part A<br> | Drug: Fimasartan<br>* Fimasartan (1d 7d) Amlodipine (12d 14d) Fimasartan + Amlodipine(15d 21d)<br>|
| Active Comparator: Part B<br> | Drug: Amlodipine<br>* Amlodipine (1d 10d) Amlodipine (25d 27d) Fimasartan + Amlodipine(28d 34d)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCss, Cmax,ss, Tmax,ss, CLss/F |  | Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fimasartan, Drug interaction
Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation

Study Overview
=================
Brief Summary
-----------------
The aim of the present clinical study is to evaluate the efficacy and safety of the DA-5515 (Circulan Soft Cap.) in patients with chronic fatigue symptoms due to impaired blood circulation.

Detailed Description
-----------------
This study is conducting to assess the efficacy and safety of the DA-5515 (Circulan Soft Cap.), which has been known to have a fatigue recovery effect due to impaired blood circulation.

Official Title
-----------------
A Placebo-controlled, Randomized, Double-blind, Parallel, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation

Conditions
-----------------
Fatigue Symptom

Intervention / Treatment
-----------------
* Drug: DA-5515
* Drug: Placebo of DA-5515


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rutherford's category 0/0 or Ⅰ/1 ABI <1.0 CIS greater than 76 HADS less than or equal to 10 Subjects who have fatigue symptoms more than 1 month Exclusion Criteria: Subjects who have diseases that can cause fatigue Subjects who are taking medication that can cause fatigue

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo of DA-5515 Capsule<br>Placebo of DA-5515 (three times a day) | Drug: Placebo of DA-5515<br>* Placebo (three times a day)<br>* Other names: Placebo capsule;|
| Experimental: DA-5515 Capsule<br>Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day) | Drug: DA-5515<br>* Crataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day)<br>* Other names: Circulan® Soft Capule;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIS(Checklist Individual Strength) less than or equal to 76 | Rate of subjects whose CIS score has improved less than or equal to 76 at 8weeks | 8weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic fatigue symptom, blood circulation
Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure

Study Overview
=================
Brief Summary
-----------------
The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.

Official Title
-----------------
Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure Evaluated at the Initiation of Intermittent or Peritoneal Dialysis

Conditions
-----------------
End-stage Chronic Kidney Failure

Intervention / Treatment
-----------------
* Biological: Blood sample
* Other: Retinal photography:
* Other: dialyse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who have been informed about the research Patients with national health insurance cover Patients aged between 18 and 75 years Patients with stage 3 kidney failure (30 ml/min < cl creat < 59 ml/min) diabetic or not Patients with stage 5 kidney failure (cl creat < 15 ml/mn) diabetic or not and requiring dialysis. Exclusion Criteria: Patients under guardianship Pregnant or breast-feeding women Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site), Neoplastic disease, Systemic diseases in flare, Patients positive for Human Immunodeficience Virus (HIV), Patients on immunosuppressants Patients taking antioxidants (selenium, vitamin C and/or E) Patient on statins

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group with stage 3 kidney failure (diabetic or not)<br> | Biological: Blood sample<br> <br> Other: Retinal photography:<br> <br> |
| Other: group with stage 5 kidney failure (diabetic or not)<br> | Biological: Blood sample<br> <br> Other: dialyse<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation of 5 proteins relocated in the membrane of monocytes (eNOS, iNOS, gp91phox and receptors of angiotensin II (AT1 and AT2)) within dynamic lipid structures, rafts, measured by western blot-dot blot. |  | at the beginning of the period Day 0, at 1 month and at 3 months. |
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

Study Overview
=================
Brief Summary
-----------------
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

Detailed Description
-----------------
This treatment protocol will serve as a mechanism to continue to provide ficlatuzumab to patient 0001-000412, who was previously enrolled under protocol P05538 and whom the investigator believes is deriving clinical benefit from ficlatuzumab treatment.

Official Title
-----------------
Expanded Access Protocol to Provide Ficlatuzumab to P05538 Patient 0001-000412

Conditions
-----------------
Mullerian Mixed Tumor of Ovary

Intervention / Treatment
-----------------
* Drug: ficlatuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Per original P05538 protocol Exclusion Criteria: Per original P05538 protocol

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ficlatuzumab|humanized anti-hepatocyte growth factor (HGF) monoclonal antibody IV administration at 16.5mg/kg every 2 weeks with a ±2 day window around dosing dates, as long as subject is deriving clinical benefit as determined by the Investigator|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Climatotherapy At The Dead Sea For Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the improvement in severity of Atopic Dermatitis and quality of life after 4 weeks of treatment in the Dead Sea.

Detailed Description
-----------------
28 days treatment period, sun exposure and possibly Dead Sea baths after an exact given plan, discontinuation of all local Cortisone preparations, unlimited use of maintenance drags, doctor visit twice a week, continuous checks by the nurse. Determination of the SCORAD index by the same doctor on arrival and departure. Before and after the treatment, the patient will answer written questionnaires regarding quality of life.

Official Title
-----------------
Evaluation of the Efficacy of Dead Sea Climatotherapy on Atopic Dermatitis Patients.

Conditions
-----------------
Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age of 18 years old Exclusion Criteria: Skin type - I Psoriasis patient in addition to Atopic Dermatitis Pregnancy Past malignancy Less then 2 weeks of treatment

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 |
| --- | --- |
| Before and after treatment<br>SCORAD of each patient before and after treatment. | |

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
-----------------
Atopic Dermatitis, Dead Sea, Climatotherapy, SCORAD
New Nasal Applicator / New Formulation - User Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: budesonide
* Device: Budesonide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids. A documented history of at least one year of seasonal allergic rhinitis. A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout the study. Exclusion Criteria: Primary or secondary adrenal insufficiency Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator. A diagnosis of asthma requiring treatment as specified in the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rhinocort | Drug: budesonide<br>* Current product<br>* Other names: Rhinocort AQUA;Device: Budesonide<br>* New type device<br>* Other names: Rhinocort Aqua;|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing) |  | 2 weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of device |  | End of study | 
| Safety assessment via adverse events and clinical measurements |  | 2 weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA
Registry for African Americans With Early Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand the causes of rheumatoid arthritis (RA), particularly in African Americans.

Detailed Description
-----------------
RA is an autoimmune disease in which the body's immune system attacks its own tissues. It occurs in all races and ethnic groups and affects about two to three times as many women as men. Variations in certain genes that play a role in the immune system are associated with a tendency to develop RA. Some individuals without these genetic variations may develop this disease, while others who possess the variations never develop RA. Scientists believe that some environmental factors may play a part in triggering the disease process in people whose genetic makeup makes them susceptible to RA. This registry of African Americans with early RA will provide clinical and x-ray data and DNA to help scientists analyze genetic and nongenetic factors that might predict disease course and outcomes of RA in this population. Participants in this registry will be enrolled in the study until they reach 5 years in their disease duration. For example, if a participant enters the study after 1 year of having RA, he or she will continue for 4 years. Participants will have three office visits (screening, 3 years' disease duration, and 5 years' disease duration) at which they will complete questionnaires and have blood samples taken, x-rays of their hands and feet, and DEXA scans. Between office visits, the study coordinator will call participants every 6 months to update any changes in medications or health problems.

Official Title
-----------------
Consortium for the Longitudinal Evaluation of African Americans With Early Rheumatoid Arthritis (CLEAR)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria African American Rheumatoid arthritis for less than 2 years

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 |
| --- | --- | --- |
| Radiographic severity of rheumatoid arthritis in African Americans | Initially seen at 5 yr disease duration. Later, became a cross-sectional (1 time visit). | 5 yr disease duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
African American, Rheumatoid Arthritis
Cardiac Resynchronization Therapy in Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.

Detailed Description
-----------------
This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.

Official Title
-----------------
Cardiac Resynchronization Therapy in Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy (CRT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization LVEF ≥ 50% Baseline 6MWT distant <400 meters Baseline NYHA Functional class ≥ III Exclusion Criteria: LVEF < 50% 6MWT duration > 400 meters NYHA Functional class < III Left bundle branch block Non-sinus rhythm Severe aortic stenosis (Aortic valve area < 1 cm2) Severe mitral regurgitation Acute cardiac failure Dependency on intravenous inotropies Severe obstructive pulmonary disease Hypertrophic obstructive cardiomyopathy Amyloidosis Dependence on pacing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Arms<br>Pacing wires used to stimulate ventricles in a synchronous matter | Device: Cardiac Resynchronization Therapy (CRT)<br>* A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15% increase in cardiac output at the optimal VV interval over baseline cardiac output | Primary Outcome | the procedure |