linjc16/ctgov huggingface dataset:
The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The study investigates whether placing an antibiotic inside the eye at the end of cataract surgery in children will reduce the amount of fibrin formation (fibrin formation can block the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level infection and could be prevented by the antibiotic.

Detailed Description
-----------------
The study investigates whether using an antibiotic (cefuroxime) in the anterior chamber of the eye at the end of surgery for cataract in children will reduce the amount of fibrin formation.

Official Title
-----------------
The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery

Conditions
-----------------
Cataract, Endophthalmitis

Intervention / Treatment
-----------------
* Drug: cefuroxime
* Drug: Saline placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral congenital or developmental pediatric cataract Exclusion Criteria: traumatic cataract

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 15 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 |
| --- | --- |
| Active Comparator: 1<br> | Drug: cefuroxime<br>* intracameral cefuroxime 0.1 ml<br>* Other names: Zinacef;|
| Placebo Comparator: 2<br>Saline placebo | Drug: Saline placebo<br>* 0.1 ml of Ringers lactate<br>* Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrin formation in anterior chamber |  | 4th postoperative day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibrin, endophthalmitis, cataract extraction, Lens, implantation,, intraocular
Effect of Passive Smoking on Platelet Function and Endothelial Function

Study Overview
=================
Brief Summary
-----------------
Passive smoking is associated with an increased risk for cardiovascular events. However, the exact mechanisms by which passive smoking affects cardiovascular health are not entirely understood. In the present study, the researchers investigate the effects of short-term exposure to secondhand smoke on platelet function and peripheral microvascular endothelial function in healthy individuals. For this purpose, platelet function and endothelial function are measured before and after a 1-hour exposure to secondhand smoke in a concentration that is encountered in bars and restaurants without smoke-free policies. The researchers' hypothesis is that short-term exposure leads to platelet activation and impairment of endothelial function.

Official Title
-----------------
Acute Effects of Short-term Exposure to Secondhand Smoke on Platelet Activation and Endothelial Function

Conditions
-----------------
Endothelial Function, Platelet Aggregation

Intervention / Treatment
-----------------
* Other: secondhand smoke exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals nonsmokers no regular medication (in particular no drugs affecting platelet function or vascular function) Exclusion Criteria: exposition to secondhand smoke within 1 week before inclusion use of drugs affecting platelet function or vascular function within 1 week before study inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: secondhand smoke exposure|Participants will be exposed to secondhand smoke for one hour. As a measure of secondhand smoke exposition, room carbon monoxide concentration will be continuously measured using an Ambient Carbon Monoxide Monitor APMA-360 and kept constant between 4.5-6.0 ppm. Levels in this magnitude are typically seen in smoking areas of restaurants and bars.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet aggregation and/or endothelial function |  | 12-24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Secondhand smoke, passive smoking, platelet function, endothelial function
Clinical Follow-up of Pregnant Subjects Undergoing NIPT

Study Overview
=================
Brief Summary
-----------------
To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).

Detailed Description
-----------------
To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT) to analyze the performance of routine assay enhancements and to identify characteristics associated with adverse obstetric outcome.

Official Title
-----------------
Clinical Follow-up of Pregnant Subjects Undergoing NIPT

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Device: NIPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was pregnant and received NIPT from Sequenom/Integrated Genetics Subject was 18 years of age or older at the time of NIPT Pregnancy outcome is available Exclusion Criteria: None

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NIPT|Non-invasive pregnancy testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIPT clinical outcome performance | Sensitivity | 9 months | 
| NIPT clinical outcome performance | Specificity | 9 months | 
| NIPT clinical outcome performance | Positive predictive value | 9 months | 
| NIPT clinical outcome performance | Negative predictive value | 9 months |
Urinary Marker for Oxidative Stress in Human Cisplatin- Induced Renal Injury

Study Overview
=================
Brief Summary
-----------------
We previously reported early measurement of urinary MDA might be a useful marker for the prediction of CDDP-induced renal damage in rat. The purpose of this clinical study is to test whether the changes of human urinary excretion of MDA, and can be used as early biomarker for the prediction of development of CDDP-induced ARF.

Conditions
-----------------
Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients have neck cancer
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 |
| --- | --- | --- |
An Observational Study on Treatment Compliance by Children Treated With Growth Hormone

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.

Official Title
-----------------
IMprove PAtient Compliance sTudy: An Observational, Cross-sectional Study on Children Treated With Growth Hormone in France

Conditions
-----------------
Growth Hormone Disorder, Growth Hormone Deficiency in Children

Intervention / Treatment
-----------------
* Behavioral: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child treated for at least one year with growth hormone any growth hormone product Followed by the participating paediatrician for at least 1 year. Exclusion Criteria: Refusal to participate Child and/or parent unable to give consent or fill out the questionnaires Child participating in a therapeutic trial

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| A<br> | Behavioral: No treatment given<br>* No treatment given to study participants, only behaviorial patterns with respect to treatment compliance is observed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of injections omitted during the previous month |  | measured over the past 2 months (retrospective data collection) |
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.

Official Title
-----------------
A Phase 1, Open-Label Study to Determine the Effect of Calories and Fat Content on the Pharmacokinetics of Repeated Dose Lurasidone 120 mg in Subjects With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder.

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Intervention / Treatment
-----------------
* Drug: Lurasidone HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 18 to 65 years of age BMI >= 19.5 and <= 37 kg/m2 No clinically relevant abnormal laboratory values Exclusion Criteria: History or presence of renal or hepatic insufficiency Participated in a clinical trial in the past 30 days Use of con meds that prolong the QT/QTc taken within 14 days prior to study drug administration

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lurasidone HCl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.

Study Overview
=================
Brief Summary
-----------------
During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.

Detailed Description
-----------------
We developed a new artificial intelligence for quality improving during the operation of magnet controlled endoscopy. The AI can help operators screen every part of gastric and then evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than that ,we compared the performancce of AI with experts.

Official Title
-----------------
Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.

Conditions
-----------------
Magnet Controlled Capsule Endoscopy

Intervention / Treatment
-----------------
* Other: AI-Box


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients between 18 and75 patients who can sign informed consent Exclusion Criteria: patients who are unsuitable to accept the check

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: AI-Box|AI-box is a system fixed adjacent to magnet controlled capsule endoscopy. Patients who accept the check of magnet controlled capsule endoscopywill be enrolled .|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The integrity of the magnet controlled capsule endoscopy | The performance of the operator developing the MCE in screen the gastric without omissions | 2 months | 
| The visibilty of the gastric | Evaluating the performance of AI to recognize the visibility of gastric mucosa | 2 months | 
| The time of operation in gastric | Calculating the time of the magnet controlled capsule endoscapy | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial intelligence, Magnet controlled capsule endoscopy
Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose

Study Overview
=================
Brief Summary
-----------------
The overall objective of this ancillary study is to obtain skeletal muscle and subcutaneous adipose tissue biopsies from women with polycystic ovary syndrome enrolled in the PULSE Study (NCT01482286).

Detailed Description
-----------------
Muscle and adipose tissues will be appropriately collected and banked for future studies such as to measure expression of candidate genes involved with carbohydrate and fat oxidation and mitochondrial function by RT-PCR, protein content by western blot, enzyme activity by enzymatic assays and to perform functional studies under varying conditions (for example before and after treatment with insulin, testosterone, serum) to quantify insulin signaling and carbohydrate and fat oxidation in primary human cultures.

Official Title
-----------------
Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome: Studies in Skeletal Muscle and Adipose Tissue 'PULSE Ancillary Study'

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in PULSE NCT01482286 Exclusion Criteria: Withdraw from PULSE NCT01482286

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Polycystic Ovary Syndrome<br>Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusiveBody mass index ≥ 25kg/m2History of irregular menstrual cycles (fewer than 8 regular cycles in the past year)Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8)Anovulatory menstrual cycles (determined during screening) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bio specimens for future research |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Weight, Insulin Sensitivity, Reproductive Function
Improving Housing Outcomes for Homeless Veterans

Study Overview
=================
Brief Summary
-----------------
Many homeless Veterans with serious mental illness (SMI) enroll in the VA's Supported Housing (VASH) program but struggle to obtain and sustain housing. Social skills are an important-but underappreciated-determinant of housing outcomes for homeless adults. The investigators hypothesize that homeless Veterans with SMI who participate in a social skills training program, tailored for housing-related social skills, will obtain housing quicker, retain housing longer, and show improved mental health outcomes compared to Veterans with similar needs not participating in such a program.

Official Title
-----------------
Improving Housing Outcomes for Homeless Veterans (CDA 15-074)

Conditions
-----------------
Veterans, Homeless Persons, Mentally Ill Persons

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Identified by VA Greater Los Angeles homeless program staff as a participant in Housing Skills Training: Must have a history of homelessness Must be a Veteran over the age of 18 years Must have a serious mental illness (mood disorder, anxiety disorder, psychotic disorder) Exclusion Criteria: None

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 |
| --- | --- |
| Housing Skills Training Group<br>Homeless Veterans with serious mental illness who are inpatient at the VA Greater Los Angeles Domiciliary or enrolled in a VA Supported Housing (VASH) program and participating in a Housing Skills Training Group as part of routine clinical care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire - 8 | Acceptability of the intervention to participants Scores range from 8 to 32, with higher values indicating higher satisfaction (no specific cut-offs to indicate specific levels of satisfaction) | 1 Year | 
| Perceived characteristics of the intervention scale | Acceptability and appropriateness of the intervention to interventionists Scores range from 8-40, with higher values indicating higher levels of acceptability and appropriateness (no specific cut-offs to indicate specific levels of satisfaction) | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent days housed for one year after intervention completion | We will use the medical record, augmented by the residential time line follow back, to assess longitudinal housing outcomes for Veterans receiving this intervention | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Skills, Housing
Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation

Study Overview
=================
Brief Summary
-----------------
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.

Official Title
-----------------
Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: BSC Deep Brain Stimulation System with Directional Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia. UPDRS III score of >25 in the meds OFF condition Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score Key Exclusion Criteria: Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator Any current drug or alcohol abuse as determined by the investigator Any history of recurrent or unprovoked seizures Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ring mode followed by Unrestricted mode<br>omni-directional stimulation followed by unrestricted Mode stimulation | Device: BSC Deep Brain Stimulation System with Directional Lead<br> <br> |
| Active Comparator: Unrestricted mode followed by ring mode<br>Unrestricted Mode stimulation followed by omni-directional stimulation | Device: BSC Deep Brain Stimulation System with Directional Lead<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase | Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state | Up to 12 months post-implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parkinson disease, deep brain stimulation, directional stimulation