linjc16/ctgov huggingface dataset:
Risk Factor Analysis for Coronary Atherosclerosis Measured by MDCT

Study Overview
=================
Brief Summary
-----------------
Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality for the coronary artery disease. Recently, novel adipokines and hepatokines as well as various inflammatory markers have been known as direct regulators of atherosclerosis. Therefore, the investigators examine the correlation of various metabolic risk factors including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT in apparently healthy people.

Conditions
-----------------
Atherosclerosis, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy people who underwent medical routine check up in Korea Health Promotion Center. age > 20 years Exclusion Criteria: History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) Diabetes Stage 2 hypertension Severe renal or hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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 |
| --- | --- |
| Healthy people<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT | to examine the correlation of serum concentration of various adipokine such as adiponectin, resistin, A-FABP with coronary atheroslcerosis measured by MDCT as AGATSTON score, modified Gensini score | 3month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT | to examine the correlation of serum concentration of various hepatokines such as FGF-21, fetuin- A and selenoprotein P with coronary atheroslcerosis measured by MDCT as AGATSTON score, modified Gensini score | 3months | 
| the correlation of various inflammatory markers with coronary atherosclerosis |  | 3months |
Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

Official Title
-----------------
Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures

Conditions
-----------------
Epilepsies, Partial, Epilepsy, Complex Partial

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening Be currently taking 1 to 3 AEDs. Exclusion Criteria: Have a treatable cause of seizures Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments are performed at quarterly visits up until the study is closed. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency is assessed throughout the study until the study is closed. |  |  |
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.

Official Title
-----------------
A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma

Conditions
-----------------
Dedifferentiated Liposarcoma

Intervention / Treatment
-----------------
* Drug: IPI-504


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age at the time of signing informed consent. Histologic diagnosis of dedifferentiated liposarcoma. Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading. At least one prior chemotherapy regimen for dedifferentiated liposarcoma. No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted. Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST (version 1.1) with at least one measurable lesion. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1. Life expectancy ≥6 months. Exclusion Criteria: Prior treatment with any heat shock protein 90 (Hsp90) inhibitor. Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease Patients with prior hepatic resections or hepatic-directed therapy Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPI-504<br>IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment | Drug: IPI-504<br>* IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma. |  | Every 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the clinical benefit rate and duration of overall response |  | Every 6 weeks |
Evaluation of Glistenings in Intraocular Lenses Implanted in Normal Patients Following Routine Cataract Extraction.

Study Overview
=================
Brief Summary
-----------------
Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company.

Official Title
-----------------
Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.

Conditions
-----------------
Glistenings

Intervention / Treatment
-----------------
* Device: Intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Bilateral cataracts requiring surgery Potential visual acuity of 20/40 or better in both eyes Require IOL power in range of 15-25 diopters Pupillary dilation of at least 6mm Willing and able to provide informed consent and attend follow-up appointments to 3 years Exclusion Criteria: Any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. Examples include Macular degeneration amblyopia and prior epiretinal membrane peel.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AcrySof MA50BM,AVS Model X-60<br>AcrySof MA50BM, AVS Model X-60 | Device: Intraocular lens<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company. | Each patient will have the same testing at each visit. Photos will be taken of the glistenings,sent off and counted. | The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataracts,glistenings,intraocular lenses.
Interaction of Statins and Nondepolarizing Muscle Relaxants

Study Overview
=================
Brief Summary
-----------------
provide evidence for prevention or reduction muscle pain.

Detailed Description
-----------------
The purpose of this study is to determine interaction of statins and nondepolarizing muscle relaxant,In order to provide evidence for prevention or reduction muscle pain.

Official Title
-----------------
Interaction of Statins and Nondepolarizing Muscle Relaxants

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with American Society of Anesthesiologists physical status I-III Patients taking statins for at least 3 months and those who had never used statins were considered to be eligible Exclusion Criteria: Orthopedic Spinal surgery Surgery involving extensive muscle manipulation History of liver and kidney failure Neuromuscular disease Susceptibility to or family history of malignant hyperthermia Extensive denervation of skeletal muscle Chronic pain syndromes Taking medications that might interact with the effect of rocuronium or serum myoglobin difficult intubation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Statin use group<br>patients taking statins for at least 3 months | Drug: Rocuronium<br>* Rocuronium 0.6mg/kg iv single dose<br>* Other names: http://www.msdchina.com.cn/;|
| non statin use<br>no history of taking statin | Drug: Rocuronium<br>* Rocuronium 0.6mg/kg iv single dose<br>* Other names: http://www.msdchina.com.cn/;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma myoglobin concentration |  | 20 minutes after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle pain |  | 2 and 24 hours postoperatively | 
| serum potassium concentration |  | 2 and 24 hours postoperatively | 
| plasma creatine phosphokinase concentration |  | 2 and 24 hours postoperatively | 
| urine myoglobin and onset plus duration of succinylcholine block |  | 2 and 24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statins, nondepolarizing muscle relaxants, rocuronium, myalgia
[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This open-label positron emission tomography (PET) study is designed to determine the effect of ABT-555 on translocator protein expression level in participants with relapsing forms of multiple sclerosis.

Official Title
-----------------
A [C-11]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT-555 on Central Nervous System Inflammation in Subjects With Relapsing Forms of Multiple Sclerosis

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

Intervention / Treatment
-----------------
* Drug: ABT-555


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of relapsing-remitting MS (RRMS) or relapsing secondary progressive MS (SPMS) Neurologically stable at Screening, in the investigator's judgment and not actively experiencing or recovering from a recent relapse in the 30 days preceding the Screening Visit A Kurtzke Expanded Disability Status Scale (EDSS) score of 1.0 to 6.0, inclusive at the Screening Visit High or mixed affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at screening Exclusion Criteria: Diagnosis of primary progressive or non-relapsing secondary progressive MS Smoking more than 10 cigarettes per day or use of a nicotine patch Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening Any type of live virus vaccine from 4 weeks before randomization History of abnormal laboratory results

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-555<br>ABT-555 will be administered at Visit 4 for Part 2 only | Drug: ABT-555<br>* ABT-555 will be administered on Visit 4 in Part 2 only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in translocator protein expression | Compare 2 dynamic positron emission tomography scans to examine the effect of a single administration of ABT-555 on translocator protein expression | Day 0 and 109 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing multiple sclerosis
A Randomized Trial of Vitamin D to Reduce Respiratory Infection

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.

Official Title
-----------------
Effect of Vitamin D3 Supplementation to Reduce Respiratory Infections in Children and Adolescents in Vietnam: A Blinded, Placebo-controlled Randomized Controlled Trial

Conditions
-----------------
Respiratory Infection

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D supplements
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 3 and 17 Residing in Thanh Liem District, Ha Nam Province, Vietnam Exclusion Criteria: Born prematurely at less than 32 weeks gestation Any chronic illness (except asthma) Currently using medication known to interfere with vitamin D metabolism Children with a sibling participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D supplements<br>children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months | Dietary Supplement: vitamin D supplements<br>* Participants will receive 7mls of D-drops (14,000U/week of vitamin D)<br>|
| Placebo Comparator: vitamin D placebo<br>children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months | Dietary Supplement: placebo<br>* 7mls of placebo drops per week for 8 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory-confirmed non-influenza infection |  | 12 months | 
| Laboratory-confirmed influenza infection |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human influenza children
Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma). II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended.

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Drug: relaxin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Progressive systemic sclerosis (scleroderma) No pregnant or nursing women

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: relaxin|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
-----------------
arthritis & connective tissue diseases, rare disease, systemic sclerosis
Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level

Study Overview
=================
Brief Summary
-----------------
The overall objective is to investigate, whether retinal blood vessel diameter change during the energy consuming dark adaptation process and if responses vary between low and high blood glucose.

Detailed Description
-----------------
All subjects are being studied using the same procedure. The study schedule takes place from 8 a.m. to 12 a.m. every time. Each subject shows up on one single day. Subjects are to show up fasting overnight with a break in insulin and/or oral antidiabetic treatment. The study eye of each subject will be selected by randomisation. We seek to have an equal distribution of right and left eyes overall. A first set of images will be taken after 5 minutes in standardised daylight, in a room without light from outside, which eliminates any concerns about weather variations. After this the room is completely darkened. 2 set of images will be taken in the dark adapted state after 20 and 40 minutes. Subsequently the patient ingests the OGTT and will reach maximum blood glucose level after about 60-90 minutes. At this time, the subjects undergo the same photo session as above with high blood glucose levels.

Official Title
-----------------
Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Glucose Tolerance Test (OGTT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic individuals. minimal or no diabetic retinopathy defined by no more than five microaneurysms or dot hemorrhages per eye on three non-stereoscopic 50 degree color fundus photographs Exclusion Criteria: Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 80 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 |
| --- | --- |
| Type 2 DM<br>This group includes subjects diagnosed with type 2 diabetes mellitus with none or minimal diabetic retinopathy. | Dietary Supplement: Oral Glucose Tolerance Test (OGTT)<br>* 75 g of glucose dissolved in 250 mL water.<br>* Other names: OGTT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel caliber |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose level | Capillary samples. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Retinal Vessels, Physiology