linjc16/ctgov huggingface dataset:
Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.

Official Title
-----------------
Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

Conditions
-----------------
Subluxation of Lens, Surgical Instruments，Cataract

Intervention / Treatment
-----------------
* Device: Multifunctional Cataract-assisted Retractor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of lens subluxation. Patients need to undergo lens subluxation surgery Exclusion Criteria: Active intraocular inflammation The intraocular pressure (IOP) was higher than 25 mmHg The endothelial cell count (ECC) was less than 1,200 cells/mm2 Combined with other eye diseases Combined with other serious systemic diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifunctional Cataract-assisted Retractor<br>Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor | Device: Multifunctional Cataract-assisted Retractor<br>* Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens<br>|
| Experimental: Capsule Retractor<br>Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor | Device: Multifunctional Cataract-assisted Retractor<br>* Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical success rate | Surgical success rate of operation with different retractor | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful implantation rate of intraocular lens | implantation rate of intraocular lens with different retractor | through study completion, an average of 1 year | 
| Visual function | Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart | 1day postoperation，1 week，1 month， 3month postoperation | 
| intraocular pressure | intraocular pressure | 1 day, 1 week, 1 month, and 3 month postoperation | 
| endothelial cell count | endothelial cell count | 1 week, 1 month, and 3 month postoperation |
New Ways of Doing Magnetic Resonance Imaging in Children and Adults

Study Overview
=================
Brief Summary
-----------------
This study is being done to see how we can prevent problems caused by movement during the MRI scan. Different ways of doing the scan (techniques) will be tested to see if they are practical and can prevent problems related to motion. For example, changes in the timing of the magnetic field and the radio waves will be examined, and at changes in the way a computer is used to process the images. The new techniques will be compared with the techniques that are usually used.

Official Title
-----------------
New Image Techniques for Magnetic Resonance Imaging in Children and Adults

Conditions
-----------------
Pediatric Disorder, Adult Disease

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any age, including males and females, who are being treated in the Department of Pediatrics and are already scheduled to undergo MRI Exclusion Criteria: Anyone who would normally be excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire for MRI (Appendix A). Subjects with pacemakers or aneurysm clips that are MRI conditional or MRI compatible may enroll in the study if the study is clinically indicated. Female patients who are pregnant Patients who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety Patients at higher risk due to age, frailty, or the emergent nature of their condition Patients who are undergoing MRI only of the head, neck or spine
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Participants<br>Patients of any age, including males and females, who are being treated in the Department of Pediatrics and are already scheduled to undergo MRI | Diagnostic Test: MRI<br>* Briefly, new MRI sequences will be used on a patient who is undergoing a scheduled, clinically necessary MRI exam. Any new research sequence will be scanned in addition to the clinically required sequences and will not interfere with the clinical scan other than requiring five to ten minutes of additional table time. There will be no invasive measures under this protocol.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Image Quality | To assess the new MRI sequences or MRI analysis methods and compare their image quality to current clinical ones. Specifically, we aim to compare the routine sequences with the experimental sequences. | Day of MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging, MRI, 20-482, Memorial Sloan Kettering Cancer Center
A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
To compare the intraocular pressure(IOP)-lowering efficacy of morning or evening instillations of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A 6-week Safety and Efficacy Study of Combination IOP-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension.

Conditions
-----------------
Glaucoma, Open-angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Combination IOP Lowering Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult patients of any race and either sex with open angle glaucoma or ocular hypertension.

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

| Intervention/Treatment |
| --- |
|Drug: Combination IOP Lowering Therapy|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
-----------------
Glaucoma, POAG, OAG, OHT
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.

Detailed Description
-----------------
The study objective is to clinically validate that the presence of recently discovered novel genetic variation adversely affects a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients using biobank samples.

Official Title
-----------------
Pharmacogenomic Analysis of 6-mercaptopurine in Pediatric Acute Lymphoblastic Leukemia

Conditions
-----------------
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric acute lymphoblastic leukemia (ALL) subjects Received 6-mercaptopurine Available biobank (bone marrow or blood) sample(s) from which deoxyribonucleic acid (DNA) can be extracted White blood cell (WBC) levels Exclusion Criteria: Pediatric ALL subjects who did NOT receive 6-mercaptopurine No biobank sample No WBC level

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| Pediatric ALL patients on 6-mercaptopurine<br>Pediatric ALL patients treated with 6-mercaptopurine who did not experience neutropenia. | |
| Pediatric ALL patients on 6-mercaptopurine with neutropenia<br>Pediatric ALL patients treated with 6-mercaptopurine who experienced neutropenia. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Novel genetic variants impact on 6-mercaptopurine adverse drug reactions | Objective is to clinically validate the presence of novel genetic variants and its impact on adverse drug reactions in a population of pediatric ALL patients treated with 6-MP | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating relationship of genetic variants to ancestry | A secondary objective of this study is to compare the impact of the novel genetic variants with other known genetic variants contributing to ADR risk. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adverse drug event, acute lymphoblastic leukemia, mercaptopurine, pharmacogenomics
Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to understand the relationship between inflammatory bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been established to have an association with IBD with clinical and histologic features that mirror those of Crohn disease. Development of the disease seems to be related to the defect of neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation. In the last decade, it has become a standard for patients with GSD type Ib and gastrointestinal symptoms to be evaluated for IBD. Patients with GSD type Ia were not recognized to have similar gastrointestinal symptoms until recently. The prevalence of IBD is greater in patients with GSD type Ia versus the general population.

Detailed Description
-----------------
The purpose of this research study is to understand the relationship between IBD and GSD type Ia. The Investigators will be attempting to develop a blood test which will be aimed at the participants diagnosis of IBD. As a participant in this research study, a blood sample will be collected during your admission to the University of Florida. This will not affect the length of stay of your scheduled visit. There will be no scheduled clinic follow-up.

Official Title
-----------------
Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease: A New Comorbidity or Secondary Consequence

Conditions
-----------------
Inflammatory Bowel Disease, Glycogen Storage Disease Type Ia

Intervention / Treatment
-----------------
* Other: Glycogen Storage Disease type Ia patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone with Glycogen Storage Disease type Ia Exclusion Criteria: Anyone where the amount of blood needed to complete the Prometheus test exceeds 3ml/kg.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glycogen Storage Disease type Ia patients<br>The participants will have one blood draw for this study. The test will be performed on the blood. | Other: Glycogen Storage Disease type Ia patients<br>* The participants will have one blood draw for this study. The test will be performed on the blood.<br>* Other names: GSD Type Ia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease | Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table. | 2 weeks |
RECAB-ASA; Treatment of Recurrent Abortion With Aspirin

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy is detected on transvaginal ultrasound (around gestational week 6+) and continues to week 35/36. The study is a single center, randomized, placebo-controlled, double blind and stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are enrolled, 200 in each arm aspirin / placebo.

Official Title
-----------------
Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial

Conditions
-----------------
Abortion, Habitual

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent abortion (≤ 3 consecutive abortions in first trimester) unknown etiology after work-up willingness to be randomized Exclusion Criteria: previous participation in the study known cause of recurrent abortion, requiring specific management age ≥ 40 BMI above 35 IVF pregnancy if the reason for IVF was recurrent spontaneous abortion ongoing treatment with aspirin for other reason Sjoegren syndrome

Ages Eligible for Study
-----------------
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose aspirin<br>75 mg aspirin orally daily from gestational week 7-35 | Drug: Aspirin<br>* Daily medication<br>* Other names: ASA;|
| Placebo Comparator: Placebo<br>Placebo pill orally daily from gestational week 7-35 | Drug: Placebo<br>* Daily intake<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth |  | delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous abortion |  | up to 22 weeks | 
| Vaginal bleeding |  | up to 42 weeks | 
| Premature delivery |  | At delivery | 
| intrauterine growth retardation, measured by ultrasound as percentage deviation |  | up to 42 weeks | 
| Preeclampsia |  | up to 42 weeks | 
| Pregnancy induced hypertension |  | up to 42 weeks | 
| Placenta praevia |  | up to 42 weeks | 
| Perinatal mortality |  | Third trimester and 28 days after delivery | 
| Perinatal morbidity |  | 28 days after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent pregnancy loss, Habitual abortion
Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)

Study Overview
=================
Brief Summary
-----------------
This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.

Official Title
-----------------
Post - Marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Vytorin (R) (Ezetimibe + Simvastatin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient men or women, age 18 years and above Patients with primary (heterozygous familial and non-familial) hypercholesterolemia Exclusion Criteria: Known hypersensitivity to Ezetimibe and Simvastatin Moderate to severe hepatic insufficiency Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal Pregnancy or lactation Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine

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 |
| --- | --- |
| Filipino Patients with Hypercholesterolemia<br> | Drug: Vytorin (R) (Ezetimibe + Simvastatin)<br>* Vytorin (R) (Ezetimibe + Simvastatin) 1 tablet once daily to be taken by mouth in the evening for 28 days<br>* Other names: SCH 465981;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had an Adverse Event (AE). | The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE. | Throughout study up to Day 29 (Final Visit) |
Comparison of Manual Cardiopulmonary Resuscitation (CPR) Versus Automatic CPR Machine During Ambulance Transport.

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled prospective study which assigned patient to receive manual CPR or automatic CPR machine use. The quality and efficacy between manual CPR and machine CPR will be evaluated.

Official Title
-----------------
Comparison of Manual Cardiopulmonary Resuscitation (CPR) Versus Automatic CPR Machine on the CPR Performance for Out-of-Hospital Cardiac Arrest During Ambulance Transport.

Conditions
-----------------
Cardiac Arrest, Cardiopulmonary Resuscitation

Intervention / Treatment
-----------------
* Device: Automatic CPR machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-traumatic out-of-hospital cardiac arrest patient in Taipei distric Patients sent to National Taiwan University Hospital (NTUH) through Jhongsiao Emergency medical service (EMS) team Exclusion Criteria: Younger than 15 years old Traumatic cardia arrest Patients not sent to NTUH by Jhongsiao EMS team

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Automatic CPR machine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of CPR |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-tidal CO2 on arrival at ER |  |  | 
| Recovery of spontaneous circulation (ROSC) rate |  |  | 
| Survival rate at 1hr, 24hr, and discharge from hospital |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resuscitation, Out-of-hospital cardiac arrest, cardiac arrest, CPR
Safety Study of Airway Clearance Techniques in Infants.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.

Official Title
-----------------
Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months

Conditions
-----------------
Gastro-esophageal Reflux

Intervention / Treatment
-----------------
* Other: Assisted Autogenic Drainage (AAD)
* Other: bouncing and AAD
* Other: bouncing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants < 1 year acid reflux monitoring Exclusion Criteria: gestational age <24 w anti-reflux medication Nissen fundoplication no parental consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 365 Days

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assisted Autogenic Drainage (AAD)<br>airway clearance technique for infants :Assisted Autogenic Drainage | Other: Assisted Autogenic Drainage (AAD)<br> <br> |
| Experimental: bouncing and AAD<br>airway clearance technique for infants : bouncing combined with AAD | Other: bouncing and AAD<br> <br> |
| Experimental: bouncing<br>bouncing . intervention to relax the infant | Other: bouncing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Refluxes | number of refluxes will be counted over a period of 15 minutes ( treatment time ) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Reflux Episodes | duration of reflux episodes will be measured during 15 min of treatment time | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastro-esophageal reflux, GOR, GER, airway clearance techniques