linjc16/ctgov huggingface dataset:
Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection

Study Overview
=================
Brief Summary
-----------------
Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this proposed test is to collect overnight at-home fetal ECG recordings on women during the second half of pregnancy using the pregnancy monitor.

Official Title
-----------------
Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal

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

Intervention / Treatment
-----------------
* Other: Data Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman, 18 years of age and up. Singleton or twin pregnancy. Exclusion Criteria: Self-reported substance abuse problems. Anyone unable or unwilling to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Pregnant women, at least 24 weeks gestation<br> | Other: Data Collection<br>* Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to collect observational fetal ECG readings with a novel wearable device |  | Up to 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy Tracker, Owlet Band, Owlet, Wearable Tech
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.

Official Title
-----------------
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.

Conditions
-----------------
Von Willebrand Disease, Blood Coagulation Disorders, Blood Platelet Disorders, Hematologic Disease

Intervention / Treatment
-----------------
* Drug: Blood coagulation Factor VIII and vWF, human


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subjects of any age Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP Require substitution with vWF/FVIII complex due to a surgery Key Exclusion Criteria: Known significant hemostatic disorder other than vWD Acquired vWD Known antibodies to FVIII or vWF Known platelet type vWD Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol History of allergic reaction to Humate-P® Treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-HIV agents) Progressive fatal disease/life expectancy of less than 6 months Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or vWF within 5 days of the pre-surgical pharmacokinetic assessment Pediatric patients of insufficient body weight to permit PK sampling Woman in the first 20 weeks of pregnancy
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

| Intervention/Treatment |
| --- |
|Drug: Blood coagulation Factor VIII and vWF, human|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
von Willebrand Factor, Blood Coagulation Disorders, Factor VIII
MigALastat Therapy Adherence Among FABRY Patients: A Prospective Multicentral Observational Study

Study Overview
=================
Brief Summary
-----------------
This study evaluates adherence to the oral chaperone therapy migalastat in patients with Fabry disease.

Detailed Description
-----------------
Fabry disease is a rare disease and part of the group of lysosomal storage disorders. Since 2016, chaperone therapy as a new therapeutic approach is available. This study is a prospective cohort study and observes patients under therapy with migalastat. This study is suggested to help estimating the adherence of the oral therapy. All patients in treatment with migalastat in the Fabry Center Wuerzburg (FAZiT) and selected patients of other cooperating Fabry Centers are included in this study if informed consent is provided.

Official Title
-----------------
A Structured Survey Among Fabry Patients With a Focus on Adherence to Therapy, Quality of Life and Pain Control

Conditions
-----------------
Rare Diseases, Fabry Disease, Adherence, Medication, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fabry disease (genetically confirmed) Signed informed consent 18 years and older Exclusion Criteria: No informed consent Withdrawal of informed consent

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to oral therapy with migalastat according to Medication Assessment Questionnaire | Pharmacological adherence according to adapted and translated 'Medication Assessment Questionnaire'. | From date of inclusion up to104 weeks (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life according to SF-36 and Wuerzburg pain questionnaire | Change of quality of life under migalastat therapy according to SF-36 and Wuerzburg pain questionnaire. Short Form (36), abbreviated SF-36, is a disease-specific measurement tool for increasing the health-related quality of life. The SF-36 is composed of eight scale-valued domains that correspond to the weighted sums of answers in each section. The range of values of each scale is 0-100 under the assumption that each question has the same weight. A score of 0 is the worst outcome (maximum disability) and a score of 100 is the best outcome (no disability). The eight domains of the SF-36 are vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. | From date of inclusion up to104 weeks (2 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fabry, Chaperone therapy, Migalastat, Pharmacological adherence
An Observational Study Evaluating Efficacy, Safety and Convenience of NovoNorm® in Treatment of Type 2 Diabetes in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy, safety and convenience of using repaglinide (NovoNorm®) in type 2 diabetes management in routine clinical practice.

Official Title
-----------------
A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoNorm® in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: repaglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Newly diagnosed or not adequately controlled with current therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Repaglinide<br> | Drug: repaglinide<br>* Prescription according to the product labelling at the physicians' discretion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose (FPG) |  |  | 
| Postprandial glucose values |  |  | 
| Incidence of hypoglycaemia |  |  | 
| Adverse drug reactions (ADR) |  |  |
Implementation of the Hospital to Home (H2H) Heart Failure Initiative

Study Overview
=================
Brief Summary
-----------------
This study determines if a community of practice of clinicians and quality improvement specialists can be used to implement a national quality initiative known as Hospital to Home (H2H). This quality initative is designed to reduced readmission rates for patients with heart failure or heart attack by improving the transition of care upon discharge.

Official Title
-----------------
Implementation of the Hospital to Home (H2H) Heart Failure Initiative

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Community of Practice Facilitation
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VA medical centers are the unit of randomization. A medical center will be included if had at least 20 patients discharged with a principal diagnosis of heart failure in 2008
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community of Practice Facilitation<br>Medical Centers assigned to this arm will recieive the communtiy of practice facilitation. In this process we will contact existing members of the community of practice (called the Heart Failure Network) at the facility as well as attempt to identify new providers and other staff at the facility with an interest in improving heart failure care. The facilitation includes: describing the national H2H program, providing talking points and strategies for local providers to obtain support from their local facility to initiate local projects related to H2H, providing a forum for successful sites to describe how they initiated projects to sites yet to initiate projects. | Other: Community of Practice Facilitation<br> <br> |
| Experimental: Usual Care<br>Medical centers in this arm will hear of H2H through usual routs (calls with facilty Directors and Chiefs of staff). | Other: Usual Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H2H enrollment | H2H enrollment by the facility as determined by the H2H program of the American College of Cardiology and Institute for Healthcare Improvement | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality improvement programs initiated due to H2H | A new quality improvement initiated that addressess one of the 3 areas of H2H focus. These include, medication reconcilliation, early follow-up after discharge, and symptom recognition. | 6 months |
Application of Digital Infrared Thermal Imaging (DITI) in Graves' Disease

Study Overview
=================
Brief Summary
-----------------
Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. Pathogenesis involves autoimmune process. The investigators think temperatures of the area involved in the inflammation may change. Thus the investigators plan to take temperature pictures of Graves' patients using digital infrared thermal imaging system and observe the change.

Detailed Description
-----------------
We will recruited patients of Graves' disease from out patient clinics. We will perform thyroid echo and soft tissue echo first. Then we let patients sit before the thermal camera and take thermal images of eyes necks and tibia. After data collection, we analyse the relation between temperature and laboratory data such as thyroid function and autoimmune profiles.

Official Title
-----------------
Application of Digital Infrared Thermal Imaging in Thyroid Disease and Associated Ophthalmopathy and Dermopathy

Conditions
-----------------
Graves' Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Graves' disease patients. Healthy people Exclusion Criteria: Pregnancy. <16 years old or > 60 years old

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

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 |
| --- | --- |
| Graves' disease<br> | |
| Healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Endometrial Flora in Women Undergoing IVF Treatments

Study Overview
=================
Brief Summary
-----------------
Characterization of the female genital tract microbiome in women undergoing IVF treatment

Detailed Description
-----------------
The primary goal With The purpose of our study is to examine the uterine microbiome by Next-generation sequencing of the bacteria specific regions . Vaginal and uterine swabs will be taken in different women undergoing IVF /PGD. Novel bacteria and results of taxonomy assignments will be examine to find correlation of uterine flora with IVF and obstetrical outcomes. The metagenomics approach will be used to seek previously unidentified bacterial species in the human upper genital tract.

Official Title
-----------------
Endometrial Flora Sampling in Women Undergoing IVF/PGD Treatments

Conditions
-----------------
Endometrial Flora Characterization in Infertile Women

Intervention / Treatment
-----------------
* Diagnostic Test: Endometrial sampling of a Typical Embryo transfer catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All undergoning IVF treatment Embryo transfer of one Blastocyst Exclusion Criteria: More then one Embryo Transfer Recent antibacterial treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Endometrial sampling of a Typical Embryo transfer catheter|no intervention no additional change from unit protocol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess endometrial caracteristicas in fertile and infertile women using next generation sequencing of bacterial identification | Type of flora identified by next generation sequencing of bacterial identification | 2017-2020 | 
| To identify specific endometrial flora in association to faliure of IVF treatment | Type of flora identified by NGS | 2017-2020 | 
| to assess the feasibility of endometrial sampling in women undergoing embryo transfer by a standart transfer cateteher | Mode of endometrial sampling | 2017-2020 |
Aviation Portable Oxygen Delivery System

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate dose based oxygen delivery vs. continuous flow of oxygen during simulated altitude conditions as would be experienced after a loss of pressure during commercial aircraft flight. Testing will be performed at rest and during light exercise at a simulated altitude of 15,000 feet in a hypobaric chamber. Performance of the two oxygen delivery systems will be compared using oxygen saturation determined by pulse oximetry.

Official Title
-----------------
Aviation Portable Oxygen Delivery System Based on Pneumatic Pulse Technology

Conditions
-----------------
Oxygen Delivery Systems at Altitude

Intervention / Treatment
-----------------
* Device: Integra Pulse Portable- Continuous flow
* Device: Integra Pulse Portable- Pneumatic pulsed flow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: smoking pregnancy sickle cell trait cardiovascular or pulmonary disease significant ear or sinus problems that would prevent equalization during pressure change estimated VO2peak <35 mL/kg per minute (males) or <30 mL/kg per minute (females)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous Flow<br>Oxygen delivery at 4 liters per minute is the standard method | Device: Integra Pulse Portable- Continuous flow<br>* 4 liters per minute oxygen flow<br>|
| Other: Pneumatic Pulsed Flow<br>Oxygen delivery using test method | Device: Integra Pulse Portable- Pneumatic pulsed flow<br>* Oxygen flow determined by test device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device performance, as measured by SpO2 | The same subject must complete both oxygen delivery system exposures for the data to be used in system performance analysis. Equivalence of the two oxygen delivery systems will be defined as the lack of statistically significant difference (N=20) in SpO2 during the last minute of exercise between the pulse and continuous flow oxygen delivery systems. Average minimum SpO2 over the last minute of the test period will be reported. | one minute |
Active Clearance Technology (ACT) Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.

Official Title
-----------------
Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry

Conditions
-----------------
Retained Blood Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery. Patient undergoing cardiac surgery via sternotomy Exclusion Criteria: Robotic surgery Any access via thoracotomy Any condition deemed inappropriate for inclusion by the investigators. Intolerance to implantable silicone materials.

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 |
| --- | --- |
| Retrospective cohort<br> | |
| Prospective PleuralFlow cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of interventions to Treat Retained Blood Syndrome | Retained Blood Syndrome (RBS) is defined by a composite endpoint of specific reoperation for bleeding, pericardial effusion, and hemothorax. | Discharge from operating room for index-surgery through hospital discharge - approximate 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of new on set of post operative atrial fibrillations (POAS) |  | 30 day | 
| Number of readmissions for any diagnosis of RBS or POAS re-occurrences |  | 30 day |
A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds

Study Overview
=================
Brief Summary
-----------------
As this is a proof-of-concept study, the primary objective is to provide preliminary data on the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds left to heal by secondary intent.

Official Title
-----------------
A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds

Conditions
-----------------
Pilonidal Sinus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over 18 years, willing and able to provide written informed consent. Subjects who have an excised pilonidal sinus wound left to heal by secondary intent. Subjects who are willing to commit to having two biopsies being taken during the study. Exclusion Criteria: Subjects with a history of skin sensitivity to any of the components of the study product Subjects whose wound is infected Subjects who have participated in a previous clinical study within the past 3 months Subjects' with a known history of poor compliance with medical treatments Subjects who are pregnant (where pregnancy is a possibility, a pregnancy testing kit will be provided) Necrotic/sloughy wounds unless surgically debrided prior to enrolment Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study Subjects with impaired renal function

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 |
| --- | --- | --- |