linjc16/ctgov huggingface dataset:
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg.

Official Title
-----------------
A Double-Blind, Randomized, Dose-finding Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Conditions
-----------------
GERD, Erosive Esophagitis

Intervention / Treatment
-----------------
* Drug: CJ-12420
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 20-70 Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment Exclusion Criteria: Patients who cannot undergo EGD Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS Patients who took PPIs within 2 weeks prior to study drug administration Long-term use of nonsteroidal anti-inﬂammatory drugs throughout the study Clinically significant abnormal laboratory values during screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: CJ-12420 Amg<br>50 volunteers will be administered CJ-12420 Amg | Drug: CJ-12420<br>* Once daily, Oral administration<br>* Other names: Undecided;|
| Experimental: CJ-12420 Bmg<br>50 volunteers will be administered CJ-12420 Bmg | Drug: CJ-12420<br>* Once daily, Oral administration<br>* Other names: Undecided;|
| Experimental: CJ-12420 Cmg<br>50 volunteers will be administered CJ-12420 Cmg | Drug: CJ-12420<br>* Once daily, Oral administration<br>* Other names: Undecided;|
| Active Comparator: Esomeprazole 40mg<br>50 volunteers will be administered Esomeprazole 40mg | Drug: Esomeprazole<br>* Once daily, Oral administration<br>* Other names: Nexium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative healing rate of erosive esophagitis at 8-week |  | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rate of erosive esophagitis at 4-week |  | 4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
P-CAB, APA(Acid Pump Antagonist)
Pupillometry in Horner's Syndrome

Study Overview
=================
Brief Summary
-----------------
Horner's syndrome (HS) is a result of interruption of the sympathetic innervation to the eye and ocular adnexa, which can occur due to carotid artery dissection (CAD), along which the sympathetic nerve fibers travel to reach the eye. Dissection of the carotid artery is one of the etiologies for ischemic stroke in young patients. In our current study, we will explore the diagnostic accuracy of automated binocular pupillometry in the diagnosis or HS, and its potential in identifying dissection of the carotid artery in patients of young age who suffer ischemic stroke.

Official Title
-----------------
Automated Pupillometry for the Diagnosis of Horner's Syndrome in Acute Stroke Patients Due to Carotid Artery Dissection

Conditions
-----------------
Horner's Syndrome, Stroke, Dissection Carotid Artery

Intervention / Treatment
-----------------
* Device: Automated pupillometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 60 years of age or younger Acute stroke (less than 72 hours from admission) Informed Consent as documented by signature (Appendix Informed Consent Form) Ability to understand the study information and consent form Exclusion Criteria: known history of HS Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. Medications affecting pupillary response History of ocular surgery affecting the pupil

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pupillometry in stroke patients<br>All eligible patients will undergo pupillometry test for the finding of Horner's syndrome | Device: Automated pupillometry<br>* Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection |  | 1 day of initial visit |
Urgent Care for the Elderly: Impairment and Home Care Services

Study Overview
=================
Brief Summary
-----------------
Elderly population is increasing quickly and their need for health care ressources through emergency care is also growing. While these patients are ageing physical impairment often happens along the way. Apart from senior homes, different types and levels of home care services have been developped in order to overcome or to adapt to these situations. Our goals are: to assess mortality rate depending on home care services level for the elderly population consulting in the ED or being taken in charge by the Emergency Medical System in France. to describe this population in terms of autonomy, impairment and home care services

Official Title
-----------------
Urgent Care for the Elderly: Impairment and Home Care Services

Conditions
-----------------
Impaired

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 80 and over Exclusion Criteria: aged<80 years old

Ages Eligible for Study
-----------------
Minimum Age: 80 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 |
| --- | --- | --- |
| Mortality rate at hospital discharge | Mortality rate at hospital discharge | At hospital discharge or 30 days at most | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission rate | Admission in a medical, surgical or psychiatric unit are considered | Admission is decided on the first 24 hours after EMS or ED care, the day of the inclusion | 
| Level of home care services | Different items in a questionnaire are asked to the patient or family concerning weekly home care services use for patient usually (which type and how often) | Questionnaires given the day of the inclusion | 
| Level of health care ressources | Lab investigations, radiology, surgery, treatment administered | During the ED visit (less than 24 hours), the day of the inclusion |
Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.

Study Overview
=================
Brief Summary
-----------------
The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections

Official Title
-----------------
Study of the Safety and Efficacy of Piperacillin/Tazobactam in the Treatment of Patients With Complicated Urinary Infections.

Conditions
-----------------
Urinary Infections

Intervention / Treatment
-----------------
* Drug: piperacillin/tazobactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients over 16 years of age with complicated urinary infection produced by bacteria that are suspected to be susceptible to treatment with Piperacillin-tazobactam. Exclusion Criteria: Patients known, or thought to be hypersensitivity to beta-lactams Patients with an uncomplicated urinary tract infection

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 |
| --- |
|Drug: piperacillin/tazobactam|nan|

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
-----------------
Urinary Infections
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

Study Overview
=================
Brief Summary
-----------------
This study examined the effects of two commonly prescribed HIV drugs on the way the body metabolizes glucose, insulin and fat.

Official Title
-----------------
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Atazanavir/Ritonavir/Lopinavir/ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atazanavir/Ritonavir/Lopinavir/ritonavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity by euglycemic hyperinsulinemic clamp method |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity by oral glucose tolerance |  |  | 
| Lipids and lipoproteins |  |  |
A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.

Official Title
-----------------
Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Adult patients (>= 18 years old) Patients who can understand all study information and literature to provide fully informed consent Atrial fibrillation (AF) as the primary diagnosis Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment Receiving oral anticoagulation therapy for AF Exclusion Criteria: Pregnant women Patients with active cancer Patients unable to consent for themselves Patient on concomitant antiplatelet therapy

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 |
| --- | --- |
| Cohort 1<br>Participants with atrial fibrillation (AF) experiencing a bleed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of characteristics of AF participants: Quality of life (QoL) data |  | Up to 90 days | 
| Distribution of characteristics of AF participants: Impact of the anticoagulation treatment |  | Up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of outcomes of AF participants: Timing of bleeding occurrence |  | Up to 90 days | 
| Distribution of outcomes of AF participants: Nature of the bleed |  | Up to 90 days | 
| Distribution of outcomes of AF participants: Current Bleeding treatment |  | Up to 90 days | 
| Distribution of outcomes of AF participants: Location of bleed |  | Up to 90 days | 
| Distribution of outcomes of AF participants: Documented cause of bleed |  | Up to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMS-562247, Atrial Fibrillation, Oral Anticoagulant, Prospective Study, Quality of Life (QoL), United Kingdom
The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
In our study, we aimed to investigate how whole blood viscosity (WBV) affects the development of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary intervention (PCI).

Detailed Description
-----------------
In our study, 500 patients who applied to the cardiology clinic and underwent PCI for elective procedure, ST segment elevation myocardial infarction (STEMI), and non-STEMI were prospectively included. Before the procedure, we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.

Official Title
-----------------
The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Elective Percutaneous Coronary Intervention

Conditions
-----------------
Percutaneous Coronary Intervention Patients

Intervention / Treatment
-----------------
* Other: Blood Viscosity Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients between ages 18 and 90 underwent PCI in our hospital between Exclusion Criteria: Patients with chronic kidney disease (CKD) who underwent hemodialysis or peritoneal dialysis Patients who underwent to coronary bypass surgery within 48 h were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood Viscosity Testing|we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Induced Nephropathy | CIN was defined as an increase in serum creatinine levels greater than 0.5 mg/dl or 25% or more increase compared to basal serum creatinine levels 48 to 72 h after exposure. | 48 to 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Viscosity, Contrast, Nephropathy, Coronary Intervention
Open-label Safety Extension Study of Gevokizumab in Erosive Osteoarthritis of the Hand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety of gevokizumab in the treatment of active inflammatory, erosive osteoarthritis of the hand.

Official Title
-----------------
An Open-label Safety Extension Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of hand osteoarthritis Joint tenderness and/or redness At least one erosion by X-ray (as determined by the central reader) Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: History of inflammatory disease other than hand erosive osteoarthritis (EOA) including: secondary post-traumatic osteoarthritis (OA); rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia History of gout, pseudogout, or hemochromatosis History of allergic or anaphylactic reactions to monoclonal antibodies History of recurrent or chronic systemic infections Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gevokizumab<br> | Drug: gevokizumab<br>* Solution for subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events | Safety analyses will involve examination of the incidence, severity, and type of treatment-emergent adverse events reported. | Up to two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erosive Osteoarthritis, Osteoarthritis, Osteoarthritis of the Hand
Doxil and Gemcitabine in Recurrent Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study investigates using a lower dose given more frequently in combination with a second drug Gemcitabine.

Detailed Description
-----------------
This study will evaluate the toxicities of Doxil and Gemcitabine given on an every two week basis. Our hypothesis is that toxicity will be less than that with standard dosing without any negative effect on survival. Patients will also be evaluated with CT scans every 3 months. Toxicity will be assessed with every cycle of treatment. Treatment will continue until toxicity or signs of progression.

Official Title
-----------------
A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer

Conditions
-----------------
Ovarian Carcinoma

Intervention / Treatment
-----------------
* Drug: liposomal doxorubicin and gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent platinum resistant ovarian cancer measurable disease Exclusion Criteria: prior treatment with Doxil or Gemzar life expectancy <3months cardiac ejection fraction <50%

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: liposomal doxorubicin and gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of hand-foot syndrome |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, recurrent, progressive