linjc16/ctgov huggingface dataset:
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.

Detailed Description
-----------------
RD047-26, a device, may be tolerable and effective for the treatment of mild to moderate atopic dermatitis with associated pruritus in adults. The treatment effect will be evaluated by the subject and investigator.

Official Title
-----------------
An Open-Label Pilot Study to Determine the Efficacy and Tolerability of a Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis With Associated Pruritus in Adults

Conditions
-----------------
Atopic Dermatitis, Pruritus

Intervention / Treatment
-----------------
* Device: RD047-26


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Female or male, 18 to 65 years of age and in good general health Clinical diagnosis of stable mild to moderate atopic dermatitis Willing and able to follow study instructions and likely to complete all study requirements Exclusion Criteria: Severe or uncontrolled asthma Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of birth control Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RD047-26<br>Study Device | Device: RD047-26<br>* RD047-26 emollient gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment | Investigator Global Assessment of Atopic Dermatitis Severity | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Pruritus Assessment | Investigator Pruritus Severity Assessment | 2 weeks | 
| Subject Itch Assessment | Subject assessment of itch severity | 2 weeks | 
| Adverse Events | Number of subjects with related adverse events | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis, Pruritus
Novel Evaluation of Aspirated Follicular Fluid

Study Overview
=================
Brief Summary
-----------------
A molecular study of follicular fluid aspirated from ovarian follicles during routine in vitro fertilization treatment, after the eggs were identified and separated.

Detailed Description
-----------------
Ovarian stimulation is a routine part of in vitro fertilization treatment: this process involves an inflammatory response in the developing follicles. We still do not completely understand the complex interactions leading to the maturation of the egg and the multiple interactions of the egg with its supporting cells. In this study we will assess follicular fluid, letf over after the eggs were identified and separated, for the presence of inflammatory mediators, dendritic cells , vasorin and soluble Flt1. The presence and quantification of these factors, as well as their correlation with the size of the aspirated follicle is the focus of this study.

Official Title
-----------------
Presence and Quantification of Inflammatory Cytokines, Dendritic Cells, Vasorin and Soluble Flt1 in Aspirated Follicular Fluid

Conditions
-----------------
Ovary Inflammation

Intervention / Treatment
-----------------
* Procedure: Ovum pickup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women going through a fertility/ fertility preservation indicated egg retrieval in the in vitro fertilization (IVF) unit in 'Meir medical center', Patients' informed consent Exclusion Criteria: Patients refusing to take part in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: Aspirated follicular fluid<br>Follicular fluid aspirated by follicle size and tested for the novel markers after eggs were identified and separated for the purpose of fertilization | Procedure: Ovum pickup<br>* Ovum pickup or Egg retrieval, that is performed not for the purpose of the study, but for the purpose of well known in vitro fertilization indications<br>* Other names: Egg retrieval;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soluble Vasorin levels |  | 24 hours post egg retrieval | 
| Soluble Flt 1 levels |  | 24 hours post egg retrieval | 
| Dendritic cells quantification |  | 24 hours post egg retrieval |
Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Hemodialysis remains associated with a high mortality (approximately 22% per year) and many complications despite improvements over the last twenty years. Several nephrologists have suggested that increasing the frequency and amount of dialysis will result in improved outcomes. In fact, various forms of daily dialysis have been performed in over 300 patients in the last 30 years with improvements in blood pressure, quality-of-life, bone disease, and other complications of renal failure. Whether this form of treatment can be expanded to the 220,000 Americans on hemodialysis is unknown. The primary outcome of this study is to determine the effectiveness of nocturnal dialysis in hemodialysis patients in St. Louis. If the pilot study is effective, then participation in a larger, multicenter trial is expected. The endpoints measured are use of antihypertensive medications, improvement in secondary hyperparathyroidism and use of phosphorus binders, quality-of-life measured by SF-36 surveys, and improvement in physical function as measured by maximal oxygen uptake.

Official Title
-----------------
Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Procedure: hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hemodialysis|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
-----------------
Renal Dialysis
Ondansetron Reduce Vomiting Associated With Ketamine PSA

Study Overview
=================
Brief Summary
-----------------
Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.

Official Title
-----------------
Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department

Conditions
-----------------
Conscious Sedation

Intervention / Treatment
-----------------
* Drug: Ondansetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 1-21 years, ASA I or II, fracture of dislocation reduction Exclusion Criteria: age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 21 Years

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine + Ondansetron<br>ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg) | Drug: Ondansetron<br>* ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)<br>* Other names: Zofran;|
| Placebo Comparator: Ketamine + Placebo<br>ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo | Drug: Ondansetron<br>* ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)<br>* Other names: Zofran;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of vomiting | The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up | Duration of ED stay and after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ED stay | Secondary outcome measures were length of ED stay | Duration of ED stay | 
| Satisfaction with Sedation | patient or parent satisfaction with their sedation | Length of ED stay. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketamine, children, emesis
Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that accuracy of CO measurement by IGR does not differ from classical CO measurement methods such as thermodilution or direct Fick method. This is why the study aims to determine whether non invasive cardiac output (CO) measurement using inert gas rebreathing (IGR)is a suitable method in patients with pulmonary hypertension. In order to examine this, the IGR method will be used in patients undergoing diagnostic or follow-up right heart catheterization.

Detailed Description
-----------------
Inert Gas Rebreathing method enables non invasive measurement of cardiac output (CO) using the single rebreathing method. A mixture of blood soluble (N2O) and blood insoluble gas (SF6) and environmental air is inhaled and the amount of N2O, SF6, O2 and CO2 is measured by a photoacoustic analysator. The length of a measurement is about 1 minute. As the gold standard measurement of CO is performed invasively, there is an urgent need for the development of non-invasive tools like IGR.

Official Title
-----------------
Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing

Conditions
-----------------
Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Patients who undergo right heart catheterization Exclusion Criteria: Missing written informed consent

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 |
| --- | --- | --- |
| Cardiac output |  | at baseline |
Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software

Study Overview
=================
Brief Summary
-----------------
Collection of a panel of stool images from healthy infants/toddlers for the development of a software

Detailed Description
-----------------
To collect at least 200 images per Brussels Infant and Toddler Stool Scale (BITSS) score and at least 200 images of empty (no stool) disposable diapers from healthy infants/toddlers aged 0-24 months for the development of a software

Official Title
-----------------
Observational Study: Image Collection of Infant/Toddler Stools for Danone Software Development

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Stool pattern


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants/toddlers (0-24 months of age at time of enrollment) Informed consent from mother ≥21 years of age In-home access to reliable internet connections; a mobile device suitable for electronic communication; and a device suitable for capturing and transmitting high-quality electronic images as per the PI's discretion Infant/toddler consumes standard, age-appropriate food (breast milk; formula; commercial/homemade baby, table or finger food) Based on the number of stools already acquired per relevant strata at time of enrollment, infant/toddler may or may not be required to regularly produce stools scored as a Score 1, 2, 6 or 7 Exclusion Criteria: Mothers of Infants/Toddlers: The use of cloth diapers (mothers must commit to using disposable diapers for the duration of the study) Known to have a significant condition (including during pregnancy) that might interfere with the study compliance, as per PI's clinical judgment Deemed likely to be non-compliant with the study protocol, as per PI's clinical judgment

Ages Eligible for Study
-----------------
Maximum Age: 24 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Stool pattern|Collection of stool images|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Stool Images Collected | Creation of a database containing at least 1600 pictures of individual diapers: 200 images of diapers with stool per each score (BITSS types 1 to 7) 200 images of empty (no stool) disposable diapers | At least 30 days |
Epilepsy Birth Control Registry

Study Overview
=================
Brief Summary
-----------------
Despite the importance of birth control to women of reproductive age, there has been little formal investigation of the safety and effectiveness of birth control methods in women with epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have developed a website that offers a survey to help us gain more knowledge and some educational material that will be updated regularly to provide the latest information. The ultimate goal is to develop guidelines for the selection of safe and effective birth control methods and to make sure that the best forms of birth control become available to women with epilepsy in all communities of our society. Go to www.epilepsybirthcontrolregistry.com take our survey and then catch up on the latest information about birth control for women with epilepsy.

Official Title
-----------------
Epilepsy Birth Control Registry

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with Epilepsy between 18 and 47 Exclusion Criteria: Women without epilepsy Women under 18 Women over 47

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 47 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 |
| --- | --- |
| Epilepsy<br>Cohort is comprised of women with epilepsy between 18 and 47. | Other: Non-interventional<br>* This is an observational study conducted by anonymous survey. There is no intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Contraceptive, Birth Control, Seizure, This study is looking at the use of different birth control measures in women with epilepsy.
Step Up Versus Step Down in Controlled Ovarian Stimulation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate if the Step up protocol is equal or superior regarding efficacy and security than the step down protocol. In couple submitted two intrauterine insemination.

Official Title
-----------------
Step Up Versus Step Down in Controlled Ovarian Stimulation for Intrauterine Insemination. A Controlled Randomised Trial.

Conditions
-----------------
No Explained Sterility

Intervention / Treatment
-----------------
* Drug: FSH-r (Follicule stimulate hormone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with unexplained sterility with needs of intrauterine insemination. Exclusion Criteria: Contraindications to intrauterine insemination.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step Down<br>Step Down: We begin the COS (controlled ovarian stimulation) with 150 IU of FSH-r until 7th day of stimulation. This day we make an adjustment reducing the dose if necessary. | Drug: FSH-r (Follicule stimulate hormone)<br>* Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r<br>|
| Active Comparator: Step Up<br>Step up: We begin the COS (controlled ovarian stimulation) with 75 IU of FSH-r until 7th day of stimulation.This day we make an adjustment increasing the dose if necessary. | Drug: FSH-r (Follicule stimulate hormone)<br>* Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rate |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sterility, FSH-r, intrauterine insemination, unexplained sterility
Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent

Study Overview
=================
Brief Summary
-----------------
self-expandable metal stents for palliation of malignant biliary strictures

Detailed Description
-----------------
The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker axial force than other stents. Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.

Official Title
-----------------
PARTIALLY COVERED NITINOL ComVi STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION

Conditions
-----------------
Malignant Biliary Strictures

Intervention / Treatment
-----------------
* Device: Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable. Patients without liver metastases and 6 months life expectancy Patients at the first attempt of endoscopic biliary drainage. Negative history for biliary tract surgery. Exclusion Criteria: Patients with ampullary cancer. Patients with hilar and/or intra-hepatic ducts malignancy. Patients with haemobilia. Patients with acute cholangitis at the time of stenting. Patients with previous percutaneous, endoscopic or surgical biliary drainage.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ComVi biliary stent<br> | Device: Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)<br>* Metal stents placement in the main biliary duct during ERC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant strictures of the main biliary duct