linjc16/ctgov huggingface dataset:
Mechanism of Thrombocytopenia in Infants

Study Overview
=================
Brief Summary
-----------------
This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting. The purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are small for gestational age.

Detailed Description
-----------------
Thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. There have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. One mechanism suggests that thrombocytopenia in these populations may be secondary to underproduction of platelets. Other studies have implied that low platelet levels may be due to endothelial activation causing platelet consumption. This study is being performed to help determine the mechanism causing thrombocytopenia in infants born to mothers with preeclampsia and comparing it to the mechanism of thrombocytopenia in infants who are small for gestational age.

Official Title
-----------------
Mechanism of Thrombocytopenia in Small for Gestational Age Infants Versus Infants With Maternal Preeclampsia Exposure

Conditions
-----------------
Thrombocytopenia, Small for Gestational Age (SGA), Preeclampsia

Intervention / Treatment
-----------------
* Procedure: Cord blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants who are less than 34 weeks gestation Infants born to mothers with preeclampsia Infants who are born small for gestational age whose mother did not have preeclampsia Exclusion Criteria: Infants who are greater than 34 weeks gestation Infants with known congenital anomalies or known congenital infections
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 |
| --- | --- |
| SGA infants<br>Infants who are thought to be small for gestational age (SGA) | Procedure: Cord blood<br>* Cord blood will be obtained at the time of delivery.<br>|
| Pre-eclampsia exposed<br>Infants who are born to mothers who had pre-eclampsia | Procedure: Cord blood<br>* Cord blood will be obtained at the time of delivery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the mechanism of thrombocytopenia in small for gestational age infants versus infants with maternal preeclampsia exposure |  | Each infant will only be enrolled during the time of birth until cord blood is collected. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preeclampsia, Thrombocytopenia, Small for Gestational Age (SGA)
Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: MK0928, gaboxadol / Duration of Treatment - 6 weeks
* Drug: Comparator: placebo / Duration of Treatment - 6 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly patients with a diagnosis of primary insomnia and in good physical and mental health

Ages Eligible for Study
-----------------
Minimum Age: 65 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: MK0928, gaboxadol / Duration of Treatment - 6 weeks|nan|
|Drug: Comparator: placebo / Duration of Treatment - 6 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time spent awake and time to fall asleep at night after two days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time spent awake and time to fall asleep at night after 30 days |  |  | 
| Amount of deep sleep after two days |  |  |
Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.

Detailed Description
-----------------
Each subject will be placed in a comfortable position in a temperature regulated room. Participants will have two consecutive non invasive (NBM) measurements taken which involves inserting the thumb into a ring shaped sensor. After each non invasive measurement the sensor will be removed. Each measurement takes approximately 85 seconds and involves the finger cuff inflating (to over systolic pressure) and deflating several times in quick successions in order to measure and calculate the Hb values. The two non invasive measurements will be performed using the same finger. After the NBM system testing is complete and recorded, the subject will have a venous (venipuncture) blood sample collected in order to provide two blood tests performed on two different models of routine automated CBC or Hb blood analyzers.

Official Title
-----------------
Evaluate the Accuracy of the NBM200 for Noninvasive Hemoglobin Measurements on Obstetric/Gynecological Patients.

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female volunteers aged 18 years and over. Any patient subject to CBC testing according to OBGYN standard care and clinical judgment. Exclusion Criteria: Participants under the age of 18 years Significant deformity, degenerative changes or edema of the thumb or index fingers Localized infection, ulceration or skin breaks involving the fingers Low peripheral body temperature (tissue perfusion) <36.0˚C Vascular disease or Raynaud's phenomenon affecting the fingers Participants who are unable to give informed written consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Hb values from the NBM200 series against the Hb from the lab blood analyser on obstetric/gynecological patients. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Accurate, Hb, noninvasive measurement
Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors

Study Overview
=================
Brief Summary
-----------------
determine whether cataract surgery has a major effect on outcomes of trabeculectomy with MMC or not. Success rates of trabeculectomy with MMC in Queen Elizabeth hospital. recurrence rate of uveitis after glaucoma surgery

Detailed Description
-----------------
determine different success rates of trabeculectomy with MMC undergone in QE hospital, UK. determine different complications and effect of cataract surgery on the outcome of glaucoma surgery

Official Title
-----------------
Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors

Conditions
-----------------
Outcomes of Trabeculectomy With MMC

Intervention / Treatment
-----------------
* Procedure: Trabeculectomy with MMC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fesh trabeculectomy surgeries Exclusion Criteria: recurrent surgeries
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| uveitic/ POAG<br>Outcomes, success rates, complications of trabeculectomy with MMC in Uveitic glaucoma | Procedure: Trabeculectomy with MMC<br>* glaucoma surgeries<br>* Other names: I-STENT;|
| POAG<br>Outcomes, success rates, complications of trabeculectomy with MMC and I stent in this groups | Procedure: Trabeculectomy with MMC<br>* glaucoma surgeries<br>* Other names: I-STENT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rates | IOP less 21 mmHg | 5 year period |
3T MRI CIED Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

Official Title
-----------------
Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices

Conditions
-----------------
Cardiac Rhythm Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Subject is intended to be implanted or is within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system Exclusion Criteria: Subject who is, or will be inaccessible for follow-up at a study site Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only) Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
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 |
| --- | --- | --- |
| The proportion of patients implanted with an MR Conditional CIED System with a pre-MRI to post-MRI scan PCT measure change of >0.5 Volts following 3T MRI scan exposure. |  | Patients will be followed for approximately 5 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3T, Magnetic Resonance Imaging (MRI), Implantable Cardioverter Defibrillator (ICD), Implantable Pulse Generator (IPG), Cardiac Resynchronization Therapy (CRT), Cardiac Implantable Electronic Device (CIED)
Influence of Myocardial Shortening on Coronary Tortuosity

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective analysis where coronary arteriograms are being analyzed to determine whether the presence of tortuous coronary arteries correlate with any specific measures of left ventricular mass or left ventricular function on echocardiography.

Official Title
-----------------
Determinants of Coronary Tortuosity

Conditions
-----------------
Coronary Artery Vessels, Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: No intervention. Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects referred for angiography echocardiography performed within 3 months. Exclusion Criteria: connective tissue disease severe LV dysfunction prior coronary artery bypass surgery major adverse coronary event between angiogram and echo procedures moderate or greater valve disease acute coronary syndrome

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 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 |
| --- | --- |
| Normal coronary arteries<br>Patients in whom coronary arteriography has demonstrated no significant tortuosity. | Other: No intervention. Observational study<br>* No intervention<br>|
| Tortuous coronary arteries<br>Patients in whom coronary arteriography has demonstrated tortuous coronary arteries defined as >1 major bend of >45 degrees in a major coronary artery | Other: No intervention. Observational study<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of longitudinal shortening | Measurement of longitudinal shortening of the left ventricle measured on an echocardiography (retrospectively) that was performed within 3 months of the angiogram | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV mass | Measurement of longitudinal shortening of the left ventricle measured on an echocardiography (retrospectively) that was performed within 3 months of the angiogram | 3 months |
Fit Plus: Assessing the Impact of a School-based Intervention on Toilet Quality

Study Overview
=================
Brief Summary
-----------------
This study will assess the impact of a school-based water, sanitation, and hygiene management intervention on toilet use and pupil handwashing in the Philippines.

Official Title
-----------------
A Randomised Control Trial of a Sanitation Operation and Management Intervention in Elementary Schools in the Philippines (Fit for School Plus)

Conditions
-----------------
Hand Hygiene

Intervention / Treatment
-----------------
* Other: FIT Plus
* Other: Comparator arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending study school on day of observation Exclusion Criteria: No predefined exclusion criteria since individual-level data is not recorded.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fit Plus<br>The experimental arm will receive the Fit For School expanded intervention, which addresses pupil handwashing, toothbrushing, and school sanitation maintenance. Interventions will begin in July 2017. | Other: FIT Plus<br>* Group handwashing facilities Daily group handwashing and toothbrushing activities Sanitation operation and maintenance manuals for school officials Toilet cleaning consumable Toilet and handwashing station maintenance kits Soap, toothbrushes, and toothpaste<br>|
| Active Comparator: Comparator<br>This group will receive the Fit Plus intervention after the trial is complete (January 2017) | Other: Comparator arm<br>* This is the same intervention as FIT Plus, but will be delivered to schools following endline data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toilet Usability Index | The Toilet Usability Index is a composite score based on toilet availability, accessibility, and privacy collected through direct observation of facilities. | 5 months after intervention delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soap Use Ratio | The secondary outcome measure is the soap-use ratio per toilet, which will be calculated based on the weight of soap used in one day divided by the number of toileting events in the same day. | 5 months after intervention delivery |
National Survey on Asthma

Study Overview
=================
Brief Summary
-----------------
To evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms, according to the patient's level of asthma control.

Official Title
-----------------
A Mirror Assessment of the Words Used By Patients and Physicians to Express Asthma Symptoms, According To the Patient's Level of Asthma Control In General Medicine

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of persistent asthma treated with an inhaled corticosteroid based maintenance treatment for more than 3 months Given his/her consent to participate to the study and who is able to answer the questionnaire in french by him/her-self. Exclusion Criteria: Patient with a cardiac disease (congestive heart failure, coronary artery disease) Patient with a respiratory disease other than asthma (COPD, sleep apnea syndrome).

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concordance of the most frequently used words by the patients and the physicians to express asthma symptoms, according to the patient's level of asthma control. |  | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma symptoms, words used by patients and physicians, express asthma symptoms
OCT Image Quality Performance Evaluation

Study Overview
=================
Brief Summary
-----------------
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.

Detailed Description
-----------------
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources with equivalent specifications: the micro-electro-mechanical short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface emitting laser.

Official Title
-----------------
OCT Image Quality Performance Evaluation

Conditions
-----------------
Healthy Eyes

Intervention / Treatment
-----------------
* Device: DRI OCT Triton
* Device: DRI OCT Triton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Participants must be at least 18 years of age They must be able to complete all testing (all OCT scans) They must volunteer to be in the study and sign the consent form Exclusion Criteria Subject with history of ocular disease or ocular pathology Subjects unable to complete all OCT imaging modes

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects Presenting With Normal Eyes<br>Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton | Device: DRI OCT Triton<br>* DRI OCT Triton using micro-electro-mechanical short cavity tunable laser<br>Device: DRI OCT Triton<br>* DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT image quality |  | 5 minutes | 
| OCT angiography image quality |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full Retinal Thickness |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
no known ocular pathology