linjc16/ctgov huggingface dataset:
To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether Al38583 Ophthalmic Solution is safe and effective in reducing tear eosinophil levels at 5-8 hours after Conjunctival Allergen Challenge (CAC).

Official Title
-----------------
A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge (CAC)

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: AL38583 Ophthalmic Solution
* Drug: Maxidex
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a positive bilateral CAC reaction (>2 itching and > conjunctival redness) to cat hair, cat dander, dust mites, cockroaches and/or dog dander within 10 minutes of instillation of the last titration of allergen at Visit 1 Exclusion Criteria: Have a known allergy to the study medication(s) or their components (ex., dexamethasone, benzalkonium chloride)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AL38583 Ophthalmic Solution<br>* Topical ophthalmic<br>|
| Active Comparator: 2<br> | Drug: Maxidex<br>* Topical ophthalmic<br>|
| Placebo Comparator: 3<br> | Drug: Vehicle<br>* AL38583 Vehicle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC. |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Conjunctivitis
Clinical Study of Endocardial Myocardial Biopsy

Study Overview
=================
Brief Summary
-----------------
In this study, patients with endocardial myocardial biopsy were selected to observe the safety of the operation, and pathological examination was performed. If necessary, special tests such as viral examination, mass spectrometry and molecular biology were performed to confirm the diagnosis, and follow-up was performed.

Official Title
-----------------
Clinical Study of Endocardial Myocardial Biopsy

Conditions
-----------------
Myocarditis, Cardiomyopathies, Heart Failure, Cardiac Tumor, Endocardiomyocardial Biopsy

Intervention / Treatment
-----------------
* Procedure: Endocardiomyocardial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with no gender restriction, age 18-80 years old, receiving endocardial myocardial biopsy in the Second Affiliated Hospital of Zhejiang University School of Medicine; Patients with myocarditis, cardiomyopathy, heart failure and cardiac tumor of unknown clinical cause; Have the ability to understand the test, can cooperate with investigators. Exclusion Criteria: Unable to understand or unwilling to fill in informed consent forms or follow visitors.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsy<br>patients | Procedure: Endocardiomyocardial biopsy<br>* Endocardiomyocardial biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MACE-4 | incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina) | 10 year |
Automated Quantitative Ulcer Analysis Study

Study Overview
=================
Brief Summary
-----------------
This is a multiple site observational study that will review patient features (clinical and morphologic) over a 90 day period during care of participants with microbial keratitis with presence of clinically significant ≥2mm stromal infiltrate compared with participants with other forms of keratitis.

Detailed Description
-----------------
The primary objective of this study is to determine associations between participant features (clinical and morphologic) and best corrected visual acuity at Day 90. Imaging, focused on slit lamp photography and supplemented by other imaging markers will be collected for review. A medical record review at one year following participants initial visit will record any corneal procedure and visual acuity testing that occurred during this window. Participants will complete demographic, clinical, and standardized health surveys.

Official Title
-----------------
Quantifying Microbial Keratitis to Predict Outcomes

Conditions
-----------------
Keratitis

Intervention / Treatment
-----------------
* Diagnostic Test: Visual Acuity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases- microbial keratitis (bacterial or fungal) with presence of clinically significant ≥2mm stromal infiltrate Controls- Inflammatory, viral, Acanthamoeba, or other keratitis Exclusion Criteria: Pregnancy Prior incisional corneal surgery No light perception vision Corneal perforation or impending perforation Inpatient status Institutional status Cognitively impaired Prisoner

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 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 |
| --- | --- |
| Microbial Keratitis<br>Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate | Diagnostic Test: Visual Acuity<br>* Best corrected visual acuity utilizing the Snellen method<br>|
| Viral or Inflammatory Keratitis<br>Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis | Diagnostic Test: Visual Acuity<br>* Best corrected visual acuity utilizing the Snellen method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual Acuity | 90 day follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal Ulcer
Persistent Pulmonary Artery Hypertension After Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome. Aims: (i) To define the prevalence of PH in patients after valve replacement and (ii) to identify factors predicting persistent PH. Methods: All patients which underwent valve replacement at our institution between the years 2008 -2010 will be screened retrospectively. Those patients with pre- procedural proven PH by means of right-heart catheterization will receive prospective follow-up with echocardiography. Diagnosis of persistent PH will be confirmed with right heart catheterization.

Official Title
-----------------
Persistence of Severe Pulmonary Artery Hypertension in Patients After vaLve replacemenT

Conditions
-----------------
Persistent Severe PH After Valve Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven pulmonary hypertension before valve replacement and informed consent for data acquisition Exclusion Criteria: patients do not meet inclusion criteria

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 |
| --- | --- |
| Valve replacement<br>Patients undergoing valve replacement for severe valve disease will be screened for study entry | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of pulmonary hypertension after valve replacement for treatment of severe valve disease |  | > 6 months after valve therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE, all cause mortality during FU |  | Within 24 months after valve therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valve replacement, pulmonary hypertension, long term follow up
Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment with standard agents will be considered for entry. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial. The research is being conducted at up to 20 clinical research sites in the US.

Official Title
-----------------
A Phase II, Multicenter Clinical Trial Evaluating the Use of Humanized Monoclonal Anti-CD3 Antibody Visilizumab(Nuvion) as Second-line Therapy for Glucocorticoid-Refractory, Acute Graft-Versus-Host Disease

Conditions
-----------------
Graft-vs-Host Disease

Intervention / Treatment
-----------------
* Drug: Visilizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Grade II to IV GVHD Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea. History of allogeneic hematopoietic cell transplant (HCT). Patients must have failed to respond or clearly progress to previous therapy on or before day +100 posttransplant. Patients must have adequate renal, hepatic, cardiac function and hematologic values

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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: Visilizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.

Official Title
-----------------
Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes Exclusion Criteria: positive history for taking anti-diabetes medications of any class in the past positive current history for taking over-the-counter vitamin or anti-oxidant supplements presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>patients receiving fixed dose metformin 1000 mg daily | Drug: Metformin<br>* metformin 1000 mg daily in two divided doses of 500 mg tablets<br>|
| Active Comparator: Pioglitazone<br>patients receiving fixed dose pioglitazone 30 mg daily | Drug: Pioglitazone<br>* pioglitazone 30 mg daily in two divided doses of 15 mg tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of YKL-40 |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YKL-40, Chronic low grade inflammation, type 2 diabetes mellitus, pioglitazone, metformin
Tumor Hypoxia of Head-and-neck Cancer Underwent Radiation Therapy Measured With F-18-FMISO

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the regional and global tumor hypoxia in head-and-neck cancer during percutaneous radiation therapy

Official Title
-----------------
Tumor Hypoxia of Head-and-neck Cancer Underwent Radiation Therapy Measured With F-18-FMISO

Conditions
-----------------
Head and Neck Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed head-and-neck cancer not curable by surgery Karnofsky > 70% tumor volume and localisation allow curative radiotherapy written consent Exclusion Criteria: metastases earlier radiation therapy of head and neck pregnancy secondary malignancy excluding dermal carcinoma and Tis-carcinoma of cervix uteri psychiatric impairment

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?
-----------------
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
-----------------
head-and-neck cancer, radiation therapy, F-18-FMISO
Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study

Study Overview
=================
Brief Summary
-----------------
This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).

Official Title
-----------------
Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Early onset PD patients and late onset PD patients with siblings available PD patients with or without impulse control disorders Current or past treatment with dopamine agonists or levodopa PD patients without dementia Age < 80 ans Exclusion criteria : Early onset PD patients and late onset PD patients without siblings available PD patients with dementia Age > 80 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PD patients<br> | Other: magnetic resonance imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barratt Impulsiveness Scale |  | up to three months |
Electronic Study for Anastrozole Pharmacovigilance Evaluation

Study Overview
=================
Brief Summary
-----------------
Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer

Official Title
-----------------
Electronic Study for Anastrozole Pharmacovigilance Evaluation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal Early Invasive Breast Cancer Patients who are under anastrazole treatment, who have normal renal and hepatic functions. Exclusion Criteria: Metastatic breast cancer patients, previous hormonal therapy, other malignancies.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anastrazole, safety, early breast cancer
Neurological Outcomes of Primary Intracerebral Haemorrhage

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to determine the one-year neurological outcome of patients admitted to an intensive care unit (ICU) for a primary and spontaneous supratentorial intracerebral hemorrhages (ICH).

Detailed Description
-----------------
ICH represent a diagnostic and therapeutic emergency. ICH account for 20% of strokes with a one-year mortality of more than 45% and an uncertain neurological outcome. For ICH patients, the main initial challenge is to determine the long term neurological outcomes and adapt the therapeutic strategy. The majority of primary and spontaneous ICH studies involve patients in stroke units. The study is an observational type 3 research with all the patients admitted in all the University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for a primary and spontaneous supratentorial ICH

Official Title
-----------------
Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes

Conditions
-----------------
Intracranial Hemorrhage, Hypertensive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission in one of the four University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for primary and spontaneous supratentorial ICH. Not opposed to participate in a research protocol (asked by phone call) Exclusion Criteria: Pediatric patient Infra-tentorials ICH No spontaneous ICH (after head trauma) Secondary ICH (anevrisum, arteriovenous malformation, tumor, hemorrhagic transformation, vascularitis) Persons referred to in Articles L1121-5 to L1121-8 of the french public health code

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 |
| --- | --- | --- |
| Neurological outcomes | Collection of the Modified Ranking Scale (mRS) at one year by patients phone call or with the medicale file. | One year after the stroke |