linjc16/ctgov huggingface dataset:
Efficacy and Tolerability of Flunarizine for the Treatment of Schizophrenia: Comparison With Haloperidol

Study Overview
=================
Brief Summary
-----------------
Flunarizine is a calcium channel blocker traditionally used for the treatment of vertigo and migraine. It also has the mechanism of action associated with antipsychotic activity (D2 receptor blockade), but has never been tested as such. The investigators hypothesis is that flunarizine can be an atypical antipsychotic.

Detailed Description
-----------------
The main advantage of flunarizine over other D2 receptor blockers is its long half-life, so that it may be administered weekly or may delay relapse if medication is interrupted.

Official Title
-----------------
Is Flunarizine a Cheap, Well-Tolerated and Long-Acting Atypical Antipsychotic? A Randomized Double-Blind Flexible-Dose Clinical Trial Versus Haloperidol for the Treatment of Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Flunarizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV schizophrenic or schizoaffective patients between 18 and 55 years old with a PANSS score above 45. Exclusion Criteria: Clinical disease Pregnancy Drug dependence (except for nicotine) in the past month and history of being refractory to at least 2 antipsychotics taken appropriately.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Flunarizine|For 1 week, 40 mg/day. From week 2 to 3, 20 mg/day. Form week 4 onwards, dosage increment or reduction of 10mg/day was allowed according to efficacy and tolerability.|

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
-----------------
flunarizine, schizophrenia, antipsychotic
Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

Study Overview
=================
Brief Summary
-----------------
This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.

Official Title
-----------------
Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: Secukinumab
* Drug: Secukinumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old Patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week The criteria for receiving secukinumab were according to standard clinical practice. Exclusion Criteria: Patients younger than 18 years old Patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis) Pregnant women and women during breastfeeding

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 |
| --- | --- |
| Cases<br>Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning. | Drug: Secukinumab<br>* Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.<br>|
| Controls<br>Controls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. | Drug: Secukinumab<br>* Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI75 |  | week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI90 |  | week 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Secukinumab, loading dose, chronic plaque psoriasis, no loading dose
Artificial Intelligence-assisted Glaucoma Screening (AIAGS)

Study Overview
=================
Brief Summary
-----------------
This study will develop an artificial intelligence (AI) program for the screening of glaucoma.

Detailed Description
-----------------
We have realized that the glaucomatous optic neuropathy is irreversible. But if early detection and early intervention can be performed to control the development of the disease, it can greatly reduce the blindness rate of glaucoma, improve the life quality and physiological and mental health of patients, and alleviate the social burden. Therefore, screening and early diagnosis of glaucoma is the focus of glaucoma prevention. China has a population of 1.3 billion, which greatly increase the difficulty of disease screening. In recent years, the intersection of artificial intelligence (AI) technology and modern medicine has made efficient and rapid disease screening possible.

Official Title
-----------------
The Development of Artificial Intelligence-assisted Glaucoma Screening Program

Conditions
-----------------
Glaucoma Eye

Intervention / Treatment
-----------------
* Diagnostic Test: Fundus Image


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to complete fundus images Exclusion Criteria: unable to complete fundus images
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 |
| --- | --- |
| Fundus Image<br>Glaucomatous and Non-glaucomatous fundus images that have been taken from the last 5 years in Shanghai General hospital. | Diagnostic Test: Fundus Image<br>* Fundus image of optic nerve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The specificity of the algorithm for diagnosing glaucoma | The specificity of the algorithm for diagnosing glaucoma will be calculated ... | from January 2020 to March 2021 | 
| The sensitivity of the algorithm for diagnosing glaucoma | The sensitivity of the algorithm for diagnosing glaucoma will be calculated . | from January 2020 to March 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial Intelligence; Glaucoma
Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: elevated Troponin T is a marker of increased mortality in patients with peripheral arterial occlusive disease (PAOD).

Detailed Description
-----------------
Troponin T and I are established risk markers in patients with acute coronary syndrome. Only recently, troponin I was found to be elevated in patients with acute critical limb ischaemia. In another study, troponin I was associated with a higher mortality in patients with chronic critical limb ischaemia followed over two years. In a longitudinal study design we intend to follow all patients that were treated for symptomatic PAOD (Fontaine stages II-IV) from 01/2007 to 12/2007 in our department of angiology. Main outcome parameters are death and the occurrence of major vascular events and revascularization procedures during follow-up.

Official Title
-----------------
Troponin T as Risk Stratification Tool in Patients With Peripheral Arterial Occlusive Disease

Conditions
-----------------
Peripheral Arterial Occlusive Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic peripheral arterial occlusive disease aged >/= 18 years Exclusion Criteria: unstable angina or acute coronary syndrome < 14 days percutaneous coronary intervention < 14 days other interventions or disease associated with troponin T release (i.e., acute pulmonary embolism, aortic dissection, heart valve replacement, acute heart failure, non-ischemic cardiomyopathy, heart surgery, thoracic trauma, endocarditis, myocarditis

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 |
| --- | --- |
| Troponin T elevation<br> | |
| No troponin T elevation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral arterial occlusive disease, mortality, cardiovascular events, amputation, peripheral arterial revascularization
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).

Official Title
-----------------
Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis

Conditions
-----------------
Primary Sclerosing Cholangitis

Intervention / Treatment
-----------------
* Drug: Mitomycin C
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 or older Previously established diagnosis of primary sclerosing cholangitis Exclusion Criteria: American Society of Anesthesiologists class 4 or greater Serum creatinine >= 1.7 mg/dL, eGFR <= 30 mL/min, or dialysis dependence Serum hemoglobin <= 7 g Left ventricular ejection fraction <= 30% Dyspnea with minimal exertion (or supplemental oxygen dependence) History of bone marrow disease Prior recipient of organ transplantation Ongoing chemotherapy Obstruction of the upper GI tract Pregnant or lactating Inability to provide informed consent

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitomycin C<br>Up to 10 mg administered during each standard of care endoscopic retrograde cholangiography. No more than five mitomycin C applications per every twelve months will be given. | Drug: Mitomycin C<br> <br> |
| Placebo Comparator: Normal saline<br>Given during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed. | Drug: Normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Adverse Events |  | Two years | 
| Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mitomycin C
Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine

Study Overview
=================
Brief Summary
-----------------
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.

Official Title
-----------------
Clinical Trial to Investigate the Influence of SK3530 on the Blood Pressure of Patients With Hypertension Taking Amlodipine

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: SK3530 100mg, Placebo, Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects 19-65 years of age inclusive Subjects with hypertension as defined 100 mmHg ≤ SBP<140 mmHg and 65 mmHg ≤ DBP < 90 mmHg after more than 5 minutes in the supine position Written informed consent Willing and able to comply with the requirements of the protocol Exclusion Criteria: Subjects with acute or chronic disease within 4 weeks of study initiation. Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.) Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors Subjects with clinically significant abnormalities on laboratory tests Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position Subjects with abnormal QTc interval(≥440ms) Subjects with color-blindness or weakness Subejcts with alcohol, drug or caffeine abuse Diet known to alter drug absorption, distribution, metabolism or elimination processes Subjects who participated in other clinical studies within 2 months before an administration Other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SK3530<br>Active Drug | Drug: SK3530 100mg, Placebo, Amlodipine<br> <br> |
| Placebo Comparator: Placebo<br>Tablet which has the same appearance and taste but doesn't contain active ingredient | Drug: SK3530 100mg, Placebo, Amlodipine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Change From Baseline in Standing SBP |  | within 8 hrs after SK3530 or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Change From Baseline in Standing DBP |  | within 8 hrs after SK3530 or placebo |
Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)

Study Overview
=================
Brief Summary
-----------------
To conduct a longitudinal, natural history study of cardiovascular disease risk factors in children. Growth curves were compared for levels of blood pressure, lipids, cardiac structures and function, and related to physical growth and maturation, nutrient intake, physical activity, body composition, puberty, and smoking.

Detailed Description
-----------------
BACKGROUND: Both the pathologic precursors of atherosclerosis and the development of its major risk factors -- blood pressure, blood lipids, and cigarette smoking -- are often far advanced before age 20 or within the period from birth or conception through adolescence. In 1990, there was growing interest in understanding these aspects of human biology and in devising appropriate preventive measures. In 1990, knowledge about the risk factors during childhood and adolescence was based mainly on cross-sectional surveys, from which very striking and consistent patterns of change with age were inferred, and from which reference values for screening and management were derived. Both growth and sexual maturation influence these patterns strongly, yet these risk factors had only recently been taken into account in 1990, only partially in screening recommendations for blood pressure and not at all for cholesterol. DESIGN NARRATIVE: Subjects were selected by simple random sampling. Data were collected on dependent variables including blood pressure, heart rate, echocardiography, Doppler flow, blood lipids, and smoking. Independent variables included growth, diet and nutrition, electrolytes, physical activity and fitness, personal, family, and social history, and bone age. Most observations were recorded at four month intervals. There was a six month pretest recruitment period, four years of cycled measurements and data collection, and six months of analysis and reporting. Curves for both velocity and acceleration of growth for attained levels of blood pressure, blood lipids, and smoking were determined as were longitudinal relationships between individual growth curves of blood pressure, echocardiographic measures, physical growth, sexual maturation, body composition, diet, physical activity, and social factors. Dr. Labarthe has several R03 grants to analyze data from Project Heartbeat. See also Study 4962. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Lubricant eye drop FID 115958D
* Other: GenTeal Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eye Exclusion Criteria: Must not have worn contact lenses within 12 hours preceding enrollment Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubricant eye drop<br>Lubricant eye drop | Other: Lubricant eye drop FID 115958D<br>* 1 drop in each eye, one time<br>|
| Active Comparator: GenTeal Gel<br>GenTeal Gel | Other: GenTeal Gel<br>* 1 drop in each eye, one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-minute visual blur profile |  | Through 3 minutes (post-instillation) | 
| Overall Acceptability |  | Immediately upon instillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop Comfort Upon Instillation |  | Immediately upon installation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, artificial tears
Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques

Study Overview
=================
Brief Summary
-----------------
To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention

Detailed Description
-----------------
This study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.

Official Title
-----------------
Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at > 18 years of age Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography Subject is willing and able to provide informed written consent Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention Exclusion Criteria: Subject is pregnant or suspected to be pregnant Subject is unable to provide informed consent Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS

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 |
| --- | --- | --- |
| MACCE |  | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near infrared spectroscopy; lipid core; vulnerable plaque