linjc16/ctgov huggingface dataset:
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler

Study Overview
=================
Brief Summary
-----------------
A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis

Official Title
-----------------
A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis

Conditions
-----------------
Relapsing-remitting Multiple Sclerosis, RRMS

Intervention / Treatment
-----------------
* Drug: AIN457
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: AIN457<br> | Drug: AIN457<br>* infusion 10 mg/Kg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment | Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting. | weeks 4,8,12,16,20,24,28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raw Number of Cumulative New Gd-T1 Lesions | The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24. | MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). | 
| Raw Number of Cumulative New Gd-T2 Lesions | The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24. | MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsing-remitting multiple sclerosis, RRMS
GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy

Study Overview
=================
Brief Summary
-----------------
This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their physician.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Fixed combination 0.3 mg bimatoprost and 5 mg timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary open angle glaucoma or ocular hypertension Prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POAG or OHT<br>Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry | Drug: Fixed combination 0.3 mg bimatoprost and 5 mg timolol<br>* Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. | Baseline, 18 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Assessment of Tolerability Using a 4-Point Scale | Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. | 18 Weeks | 
| Patient Assessment of Tolerability Using a 4-Point Scale | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. | 18 Weeks | 
| Physician Assessment of Adherence to GANfort® | Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as better compliance are reported. | 18 Weeks | 
| Patients Continuing With GANfort® After 18 Weeks | Patients continuing with GANfort® after 18 weeks was assessed as Yes or No. | 18 Weeks |
Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Losartan Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.

Official Title
-----------------
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide Tablets 100 mg/25 mg Under Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: losartan potassium / hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: losartan potassium / hydrochlorothiazide|100 mg / 25 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence determined by statistical comparison Cmax |  | 25 days |
Beijing Indoor Air Purifier Intervention Study

Study Overview
=================
Brief Summary
-----------------
This study aimed to assess the impact of air filtration on indoor air quality and cardio-pulmonary health in residents living in high outdoor pollution settings in Beijing.

Official Title
-----------------
Beijing Indoor Air Purifier Intervention Study

Conditions
-----------------
Pulmonary Disease

Intervention / Treatment
-----------------
* Other: air purifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Global Initiative for Chronic Obstructive Lung Disease criteria (mild to moderate, GOLD stage I II; severe to very severe, GOLD stage III IV) quit smoking for at least 1 year; a ratio of pre-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) equal to or less than 0.70 and an increase of FEV1 with the use of 400μg of albuterol of less than 12% of the pre-bronchodilator one; no history of asthma or any other active lung disease. Subjects were free from exacerbations for at least 6 weeks. Exclusion Criteria: Patients with heart pacemaker, heart failure with bundle-branch block, recent myocardial infarction (in the last 12 weeks) and anticoagulant therapy

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active-mode<br>Air purifier in active-mode | Other: air purifier<br>* filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks<br>|
| Sham Comparator: Sham-mode<br>Air purifier in sham-mode | Other: air purifier<br>* filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory inflammation | analyzed EBC pH and inflammation biomarkers 8-isoprostane and nitrite and nitrate | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic inflammation | analyzed systemic inflammation biomarkers C-reaction Protein, Blood coagulation factor fibrinogen (Fib), Interleukin (IL) -8, -1β, -6, -10, -12p70 and tumor necrosis factor-α (TNF-α) | 4 weeks | 
| oxidative stress | analyzed systemic oxidative stress biomarker urinary 8-hydroxy-2-deoxyguanosine (8-OHdG) | 4 weeks |
Perifollicular Doppler in Natural Cycle In Vitro Fertilization

Study Overview
=================
Brief Summary
-----------------
Perifollicular Doppler could reflect the quality of the follicle's vascularization and, consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the analysis, in ultrasound, of the blood flow in vessels surrounding the follicle. The goal of this study is to evaluate if there is a link, in natural cycle In Vitro Fertilization, between the quality of the vascularization and the one of the oocyte, the embryo and the pregnancy.

Official Title
-----------------
Perifollicular Doppler in Natural Cycle In Vitro Fertilization

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Doppler ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a natural In Vitro Fertilization cycle. Patient under 38 years old Body mass indice under 35 Ovulatory cycles between 20-35 days Exclusion Criteria: Patient with a stimulation In Vitro Fertilization cycle Patient with a naturalIn Vitro Fertilization cycle with egg donor Patient with a natural In Vitro Fertilization cycle with freezing embryo Smoking patient Diabetic patient Patient with treatment of antihypertensive drug, anticoagulant, antiplatelet, vasodilator Body mass indice over 35 Patient over 38 years old Patient without ovulation or cycle over 35 days Percutaneous Epididymal Sperm Aspiration (PESA), Testicular Sperm Extraction (TESE) or micro TESE

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| natural In Vitro Fertilization cycle<br>Patient doing following natural In Vitro fertilization cycle | Procedure: Doppler ultrasound<br>* Doppler Ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality perifollicular doppler and quality of the oocyte | The measurements are done twice; on days of induction and oocyte retrieval. During the blood sample collection on the day of the induction, there is also a measurement of progesterone, estradiol and luteinizing hormone (LH). | 2 weeks |
A Study of WF 10 IV Solution in Patients With Advanced HIV Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to patients with advanced HIV disease who cannot or will not take zidovudine, didanosine, zalcitabine, or stavudine. This study also examines how TCDO affects the levels of HIV in the body. TCDO is a solution delivered through a vein.

Official Title
-----------------
Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of WF 10 IV Solution ( TCDO ) in the Management of Patients With Advanced HIV Disease

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

Intervention / Treatment
-----------------
* Drug: WF10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Approved drugs at a stabilized dose except those specifically excluded. Aerosolized pentamidine (300 mg) once a month for PCP prophylaxis. Patients must have: HIV positivity. Absolute CD4 count < 200 cells/mm3. Intolerance to or refusal to take AZT, ddI, ddC, or d4T. No active opportunistic infection requiring ongoing therapy. Life expectancy at least 3 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Neoplasm other than basal cell carcinoma of the skin. Clinically significant cardiac disease. Anemia. Concurrent Medication: Excluded: Cytotoxic chemotherapy. Corticosteroids. Patients with the following prior conditions are excluded: History of myocardial infarction or arrhythmias. Prior Medication: Excluded within 2 weeks prior to study entry: Any antiretroviral agent. Interferon. Systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic drugs. Excluded within 30 days prior to study entry: Investigational drugs. Prior Treatment: Excluded within 2 weeks prior to study entry: Radiation therapy. Active drug or alcohol abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: WF10|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
-----------------
Acquired Immunodeficiency Syndrome, Antiviral Agents
Local Radiotherapy for Residual Tumor Lesions During the First-line Treatment

Study Overview
=================
Brief Summary
-----------------
This study aimed to confirmed that local radiotherapy for residual lesions can significantly prolong the efficacy of chemotherapy combined with immunotherapy in the initial treatment of advanced non-small cell lung cancer.

Official Title
-----------------
Efficacy and Safety of Local Radiotherapy for Residual Tumor Lesions During the First-line Treatment of Advanced Non-small Cell Lung Cancer: a Retrospective-real World Study

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18，Advanced Non-small Cell Lung Cancer Confirmed by Histopathology Patients received platinum-based chemotherapy combined with immunotherapy Exclusion Criteria: EGFR/ALK/ROS1 driver gene mutation Chemotherapy only Concurrent radio-chemotherapy Surgery Single-agent immunotherapy No treatment information available

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival time | January 2018 to June 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RT | radiotherapy control time | January 2018 to June 2021 |
Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)

Study Overview
=================
Brief Summary
-----------------
This study aims to test the efficacy of the EverydayMatters Multiple Sclerosis (MS) program for individuals age 45 or older living with multiple sclerosis. The program involves a 6-week telephone-delivered program to promote resilience and happiness for individuals living with MS.

Official Title
-----------------
Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: EverydayMatters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 45 years of age Diagnosis of multiple sclerosis regular access to the phone and internet willing to join a moderated group on MSConnection.org Exclusion Criteria: under 45 years of age no diagnosis of multiple sclerosis no access to the phone or internet unwilling to join moderated group on MSConnection

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>6-weeks of telephone-delivered sessions, moderated by a trained clinician offering EverydayMatters MS. | Behavioral: EverydayMatters<br> <br> |
| No Intervention: Control<br>Wait-list control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Resilience using Connor Davidson Resilience Scale (brief) | 10-item self-report measure of resilience. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in positive affect and well being using the Quality of Life in Neurological Disorders (NeuroQoL) Positive Affect and Well-Being Short Form | 9-item self report measure | 6 weeks | 
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles Short Form | 4-item self-reported measure of satisfaction with participation in social roles and activities | 6 weeks | 
| Change in disease-management self-efficacy using the University of Washington Self-Efficacy Scale | 6-item self-report measure of self-efficacy for disability management | 6 weeks |
Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean patients with schizophrenia. Primary objective: • To investigate the prevalence of the MetS in Korean patients with schizophrenia Secondary objectives: • To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more antipsychotics group (polypharmacy)

Conditions
-----------------
Schizophrenia, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia according to DSM-IV-TR Age between 18-65 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| prevalence of metabolic syndrome (MetS) | MetS will be diagnosed according to NCEP ATP III with the Asian-Pacific abdominal obesity criterion (≥90 cm in men, ≥85 cm in women) 3 or more of the following criteria fasting plasma glucose >= 100 mg/dl or drug use to treat elevated glucose serum triglyceride (TG) >= 150 mg/dl or drug use to treat elevated TG HDL cholesterol level < 40mg /dl in males, < 50 mg/dl in female or drug use to treat low HDL Systolic BP >=130 mmHg, diastolic BP >=85 or drug use to treat hypertension Abdominal obesity : above described |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevalence, Korea