linjc16/ctgov huggingface dataset:
(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Urine reflux (urine backing up into the kidneys) is common in the pediatric population and may be complicated by renal abnormalities, such as infection and scarring. Currently, urine reflux is detected using either voiding cystourethrogram or other procedures. A new technique called ultrasound-based Acoustic Radiation Force Impulse (ARFI), or shear wave velocity imaging SVI) is performed using standard approved ultrasound machines and transducers bu the sound waves/impulses are produced in a different pattern. We hope to evaluate the usefulness of ARFI in diagnosing possible kidney damage caused from urine reflux (urine backing up into the kidneys).

Official Title
-----------------
Ultrasound Based Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)of the Kidneys in Pediatric Patients With Vesicoureteral Reflux

Conditions
-----------------
Urine Reflux, Kidney Damage

Intervention / Treatment
-----------------
* Procedure: ARFI SVI Ultrasound Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and younger Are scheduled to have a clinically ordered kidney ultrasound and a voiding cystourethrogram (to evaluate urine reflux) on the same day. - Exclusion Criteria: None to list

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

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

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

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: ARFI SVI ultrasound imaging<br>Acoustic Radiation Force Impulse (ARFI) Shear Wave Velocity Imaging (SVI) ultrasound imaging | Procedure: ARFI SVI Ultrasound Imaging<br>* Following a clinical renal ultrasound scan, the research scan using the ultrasound based acoustic radiation force impulse, or shear wave velocity imaging will be performed using standard approved ultrasound machines and transducers. This imaging will take approximately 5 to 10 minutes to complete.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound-Based Acoustic Radiation Force Impulse(ARFI)Shear Wave Velocity Imaging (SVI) | To determine if this new ultrasound based imaging will effectively measure shear wave velocity in kidneys affected by urine reflux and be useful in determining the extent of kidney damage | 6 months |
Evaluation of Practices, Knowledge and Expectations of Medical Students for Intimate Protection

Study Overview
=================
Brief Summary
-----------------
Intimate protections, designed to absorb menstrual flow during menstruation, are classified into two categories: internal intimate protections (tampon, menstrual cup) and external intimate protections (disposable or washable sanitary pads, panty liner, menstrual panty). Recently, women's expectations have changed with a demand for transparency regarding intimate protection's composition and potential health risks. The choice and use of a type of intimate protection will depend on multiple factors specific to each woman. The cost of intimate protectioncould influence patient choice, as disposable sanitary pads are often less expensive.

Detailed Description
-----------------
The primary objective is to describe medical students 's intimate protection practices.

Official Title
-----------------
Evaluation of Practices, Knowledge and Expectations of Medical Students for Intimate Protection

Conditions
-----------------
Intimate Protections

Intervention / Treatment
-----------------
* Other: Questionnaire regarding intimate protections habit.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Medical student Aged more than 18 Presenting menstrual cycles Agreeing to participate in the study Exclusion Criteria: - Aged less than 18

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical student<br>Medical student aged more than 18, presenting menstrual cycles, and agreeing to participate in the study. | Other: Questionnaire regarding intimate protections habit.<br>* Questionnaire regarding intimate protections habit.<br>* Other names: Data collection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of internal intimate protections | Number of patients using tampon or menstrual cup as hygienic protection | Day 0 | 
| Use of external intimate protections | Number of patients using disposable sanitary pads, washable sanitary pads, panty liner or menstrual panty as hygienic protection | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intimate protections, Medical student
Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies

Study Overview
=================
Brief Summary
-----------------
This study will provide follow-up evaluations of breast cancer or multiple myeloma patients who received gene therapy (gene transfer) as part of their participation in an NIH protocol. Gene therapy is a new technology, which may involve a permanent change in the patient s genetic code. Therefore, although the risk of long-term harmful effects of this therapy is very small, the Food and Drug Administration requires prolonged monitoring of patients health status. Patients previously enrolled in NIH protocols 96-C-0007, 93-C-0208, 92-C-0161, or 92-H-0057 will be followed under the current protocol. No further gene therapy will be provided in this study. Patients health status will be evaluated for an indefinite period of time, or as long as they are willing to be monitored. They will provide a blood sample once a year and will be interviewed about their health status twice a year for the first 5 years after gene therapy and once a year thereafter. These procedures are done to look for the development of any diseases such as cancer, neurological disorders, autoimmune or blood disorders that may be related to side effects of the gene transfer.

Detailed Description
-----------------
This Protocol aims to provide long-term follow-up of breast cancer and multiple myeloma subjects previously receiving autologous primitive marrow and blood hematopoietic cells exposed to gene transfer retroviral vectors on the following protocols: MB 294 (92-C-0161; T-92-0018), MB 310 (93-C-0208; T-92-0192), MB 361 (96-C-0007; T-95-0096) or (92-H-0057; T-92-0139) at the National Cancer Institute and the National Heart, Lung, and Blood Institute. Subjects will undergo an annual health history and annual complete blood counts will be performed. Blood samples will also be collected annually (either locally or off-site by the subjects' personal physicians) for testing for presence of the gene transfer vector and vector integration sites.

Official Title
-----------------
Follow-Up Study of Breast Cancer and Multiple Myeloma Subjects Previously Enrolled in Retroviral Gene Transfer Studies

Conditions
-----------------
Gene Transfer

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Subjects who received gene transfer products on the following protocols: MB 361, 96-C-0007, T-95-0096; MB 294, 92-C-0161, T-92-0018; MB 310, 93-C 0208, T-92-0192; or 92-H-0057, T-92-0139. EXCLUSION CRITERIA: Patients unwilling to participate.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gene Transfer, Hematopoietic Stem Cells, Follow-Up
Trendelenburg Study

Study Overview
=================
Brief Summary
-----------------
1) Observe the hemodynamic and cardiovascular changes associated with the change from the supine to the steep Trendelenburg position, 2) Observe the hemodynamic and cardiovascular changes during intra-abdominal insufflation used during laparoscopic surgical procedures.

Detailed Description
-----------------
This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the hemodynamic and cardiovascular effects of the steep Trendelenburg position on non-invasive or minimally invasive monitors used in the operating room during surgical procedures requiring this patient position. SPECIFIC AIMS: 1) Observe the hemodynamic and cardiovascular changes associated with the change from the supine to the steep Trendelenburg position. 2) Observe the hemodynamic and cardiovascular changes during intra-abdominal insufflation used during laparoscopic surgical procedures. HYPOTHESIS: Hemodynamic and cardiovascular changes during alterations in position from supine to steep Trendelenburg and intra-abdominal insufflation measured by non-invasive and minimally invasive monitors will correlate with transthoracic echocardiographic measurements.

Official Title
-----------------
An Observational Study on the Effects of Steep Trendelenburg Position and Pneumoperitoneum on Hemodynamic Changes Observed With Non-invasive Cardiac Monitors

Conditions
-----------------
Comparison of Non-invasive Monitors of Cardiac Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for elective surgery requiring steep trendelenburg positioning. Exclusion Criteria: BMI >30. <18 years. Pregnancy. Prisoners.

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 |
| --- | --- | --- |
| An observational study on the effects of steep Trendelenburg position and pneumoperitoneum on hemodynamic changes observed with non-invasive cardiac monitors | Changes in cardiac output associated with patient position. | One year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nexfin, Flotrac, Esophageal, Cardiac output
Energy Expenditure Estimation in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Estimation of energy requirements is essential for adequate nutritional support in ICU. Indirect calorimetry being the golden standard of resting energy expenditure estimation is not available in most intensive care units. Different predictive equations have been developed, but not evaluated in cardiac population and have low accuracy in compare to the indirect calorimetry. The aim of present study is to develop cardio-specific equation for resting energy expenditure estimation.

Official Title
-----------------
Resting Energy Expenditure in Cardiac Patients Operated Under Cardiopulmonary Bypass

Conditions
-----------------
Cardiovascular Surgical Procedures, Intensive Care

Intervention / Treatment
-----------------
* Device: Indirect calorimetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of cardiothoracic ICU Exclusion Criteria: Shock patients on ECMO Hypoxemia <60 mmHg Active bleeding Ventilation with FiO2 >0.6

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

| Intervention/Treatment |
| --- |
|Device: Indirect calorimetry|Resting energy expenditure will be studied using indirect calorimeter CCM Express (Medgraphics Inc, USA).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting energy expenditure measured in kcal/day using indirect calorimetry |  | participants will be followed for the duration intensive care unit stay, an expected average 2 days |
Weight Change in PWS Over Six Months

Study Overview
=================
Brief Summary
-----------------
This is a completely text-messaging based study and all data will be collected via surveys administered on a mobile phone. For this study, we will gather and analyze data on changes in body weight over a 6-month interval in individuals aged 12 and over. This will help us learn more about the normal variation in weight, over time, in the PWS population.

Detailed Description
-----------------
The incidence and natural history of several PWS symptoms are poorly defined. In this text-messaging based study we will gather and analyze data on changes in body weight over a 6-month interval, in individuals aged 12 and over. We would like to learn about the normal weight variation in the PWS population. We anticipate that this study will inform future clinical trials for hyperphagia/obesity related therapies, and provide a basis for understanding how well potential therapies are working. For this study, there will be no intervention and the all data will be collected via texting.

Official Title
-----------------
A Study to Assess Change in Weight Over Six Months in Prader-Willi Syndrome

Conditions
-----------------
Weight Change, Body

Intervention / Treatment
-----------------
* Other: weekly weight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with PWS are eligible for this study. Eligible PWS participants must be 12 years and older. Participant/legal representative of participant must have a text messaging enabled mobile phone in order to participate in the study Participants must reside in the U.S. or Canada - Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Individuals with Prader-Willi Syndrome<br>Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months | Other: weekly weight<br>* weekly weight data collection for six months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Change in Weight | weekly weight data will be collected via text for 6 months | baseline and 6 months | 
| Percent of Change in BMI | weekly weight and height data will be collected via text for 6 months | baseline and 6 months |
Recurrence of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation.

Official Title
-----------------
Risk Factors for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proved diagnosis of HCC according to AASLD practice guidelines (Bruix and Sherman, 2005). Patients underwent RFA for HCC with BCLC (The Barcelona-Clinic- Liver-Cancer staging system) stage A (Bruix and Sherman, 2005) with no eligibility or ability to do transplantation or resection. Patients should be followed-up for more than 12 months to exclude early recurrence i.e. recurrence within 1 year. Patients with INR < 1.5 or prothrombin concentration > 50%. Platelet count > 50000 cell/mm3. Exclusion Criteria: Presence of extra-hepatic metastasis or gross vascular invasion. Child class C patients. Follow up period of less than 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Patients with recurrence<br>Hepatocellular carcinoma patients with intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation | |
| Patients with no recurrence<br>Hepatocellular carcinoma with no intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of hepatocellular carcinoma |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular cacinoma, Radiofrequancy ablation, Intrahepatic recurrence
A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19.

Detailed Description
-----------------
Demonstrate that safety and suitability of the iZephyr Hood in patients receiving non-invasive ventilation (NIV) or high flow oxygen therapy (HFOT). Determine the user acceptability of the iZephyr Hood in patients receiving NIV and HFOT. Determine the reduction in aerosol spread of COVID-19 viral particles when using the Zephyr hood in patients using non-invasive ventilation or high flow oxygen.

Official Title
-----------------
A Safety Assessment of the iZephyr Hood for Non Invasive Ventilation in COVID-19 Patients

Conditions
-----------------
Aerosol Disease, Covid19, Noninvasive Ventilation

Intervention / Treatment
-----------------
* Device: iZephyr hood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult COVID-19 negative patients who are requiring non-invasive ventilation (phase II) Adult COVID-19 positive patients who are requiring non-invasive ventilation (Phase III) Exclusion Criteria: Patients under the age of 18 years or those lacking capacity

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Environmental contamination of SARS Co-V2 (air and surface) will be tested around COVID patients receiving Non-invasive ventilation or high flow oxygen therapy before using the iZephyr hood and then with the iZephyr hood in place, to determine if the hood changes the amount of environmental contamination
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: iZephyr hood|Assessment of an aerosol containment device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV | Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy. | 3 month | 
| Determine the background concentration of SARS-Co-V2 when the iZephyr hood is in use | Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy inside an iZephyr hood. | 12 months | 
| Impact of iZephyr hood on environmental SARS Co-V2 contamination | Determine if there is a change in the concentration of SARS-Co-V2 virus on the surfaces and in the air samples surrounding a COVID-19 positive patient whilst using the iZephyr compared to when not using the iZephyr. | 12 months |
OCS-01: A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.

Official Title
-----------------
OCS-01: A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Conditions
-----------------
Disorders of the Eye Following Cataract Surgery

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Vehicle Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye; Have a pin-hole visual acuity (VA) without any other correction > 20 letters (approximately 20/400) in the operative eye and > 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 [prior to surgery]). Exclusion Criteria: Have any intraocular inflammation (e.g. white blood cells or flare)present in either eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit lamp examination; Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment Arm<br>OCS-01 (Ophthalmic Suspension) - topical use | Drug: Dexamethasone<br>* Dexamethasone<br>* Other names: OCS-01;|
| Placebo Comparator: Vehicle Placebo Arm<br>Vehicle | Drug: Vehicle Placebo<br>* Placebo comparator<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Absence of Anterior Chamber Inflammation | Absence of cells (i.e., score of ´0´) in the anterior chamber of the study eye at Day 15 (Visit 6) | Day 15 | 
| Number of Participants With an Absence of Ocular Pain | Absence of pain (i.e., score of ´0´) in the study eye at Day 4 (Visit 4) | Day 4 |