linjc16/ctgov huggingface dataset:
A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.

Official Title
-----------------
An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.

Conditions
-----------------
Von Willebrand Disease

Intervention / Treatment
-----------------
* Biological: Optivate® (Human Coagulation Factor VIII)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current Factor VIII<br>Optivate® (Human Coagulation Factor VIII) | Biological: Optivate® (Human Coagulation Factor VIII)<br> <br> |
| Experimental: Optivate®<br>Optivate® (Human Coagulation Factor VIII) | Biological: Optivate® (Human Coagulation Factor VIII)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters for FVIII:C |  | Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose |
Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance

Study Overview
=================
Brief Summary
-----------------
The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria

Official Title
-----------------
Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance

Conditions
-----------------
Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria

Intervention / Treatment
-----------------
* Other: Methodology of attachment of external foot prothesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral lower transtibial amputation Prosthetic user with socket type attachment (Cohort 1) or with direct skeletal attachment (Cohort 2) and be able to walk 50 meters independently, Between 18-60 years of age, Able to follow instructions, Able to provide consent. Exclusion Criteria: problems on the residuum, Non-prosthetic user, Bilateral amputation, Self-reported pain levels greater than 4 out of 10 at study outset, Experienced a fall within the last 8 weeks before assessment, Mental illness or intellectual impairment compromising participant's ability to give informed consent, Injuries involving contralateral (intact) limb, Major uncorrected visual deficit, History of epilepsy or recurrent dizziness,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C1<br>Subjects with socket-type attachment of their prostheses | Other: Methodology of attachment of external foot prothesis<br>* establishing the methodology of specific measurements of attachment of external foot prothesis<br>|
| C2<br>Subjects with direct skeletal attachment | Other: Methodology of attachment of external foot prothesis<br>* establishing the methodology of specific measurements of attachment of external foot prothesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stiffness and the index of anthropomorphicity IAm | Range of ankle stiffnesses, including three prostheses currently recommended to patients with direct skeletal attachment | 30 days | 
| IAb of the selected prosthetic feet | To establish IAb of the selected prosthetic feet via biomechanical gait testing | 30 days |
Cardiovascular Effects of Marathon Running

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the investigation of acute cardiovascular responses of marathon runners after the completion of a marathon race (42.2 km), as well as of the determinants of these changes.

Official Title
-----------------
FEIDIPIDIS Study: Cardiovascular Effects of Marathon Running

Conditions
-----------------
Athletes Heart

Intervention / Treatment
-----------------
* Diagnostic Test: Body fat measurement
* Diagnostic Test: Cardiopulmonary exercise testing
* Diagnostic Test: Echocardiography
* Diagnostic Test: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Marathon runner Exclusion Criteria: Chronic disease, Drugs
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Body fat measurement|Body fat measurement using skinfolds|
|Diagnostic Test: Cardiopulmonary exercise testing|Electrocardiographic exercise testing with ergospirometer on a treadmill|
|Diagnostic Test: Echocardiography|Transthoracic echocardiography|
|Diagnostic Test: Blood test|Blood test for measurement of haemoglobin, serum electrolytes, iron, ferritin and vitamins|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline left ventricular (LV) systolic function | Evaluation of LV ejection fraction | Evaluation of athletes within 3 weeks before the marathon running race. | 
| Baseline LV diastolic function | Evaluation of LV filling pressures | Evaluation of athletes within 3 weeks before the marathon running race. | 
| Baseline basal right ventricular (RV) function | Evaluation of tricuspid annular plane systolic excursion (TAPSE) | Evaluation of athletes within 3 weeks before the marathon running race. | 
| Baseline global RV function | Evaluation of RV fractional are change (RVFAC) | Evaluation of athletes within 3 weeks before the marathon running race. | 
| Post-exercise LV systolic function | Evaluation of LV ejection fraction | Evaluation of athletes immediately after the completion of the marathon running race. | 
| Post-exercise LV diastolic function | Evaluation of LV filling pressures | Evaluation of athletes immediately after the completion of the marathon running race. | 
| Post-exercise basal RV function | Evaluation of TAPSE | Evaluation of athletes immediately after the completion of the marathon running race. | 
| Post-exercise global RV function | Evaluation of RVFAC | Evaluation of athletes immediately after the completion of the marathon running race. |
Parental Knowledge and Beliefs About Infant Sleep Position

Study Overview
=================
Brief Summary
-----------------
In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although a number of risk factors have been identified. Sleeping on the stomach has been identified as a major risk for SIDS. The rates of SIDS have dropped substantially in countries in which the usual sleep position has changed from the stomach to the side or back. Back sleep has been shown to be the most stable and safest position. The American Academy of Pediatrics now recommends the back sleeping position for all healthy infants. Since the American Academy of Pediatrics began advocating the back sleep position, the incidence of SIDS has decreased by more than 40% in this country. However, the decrease has not been uniform across segments of the population. Black infants continue to have a higher rate of SIDS compared with other groups. This discrepancy could be related to infant sleep position practices. Several studies have shown that infants born to low income, minority, inner-city families were more likely to be placed on the stomach to sleep. Education appears to influence choice of sleep position and may explain, at least to some degree, the difference in choice of sleep position among certain groups. We believe that uniform education of parents will influence the sleep position that parents choose for their baby. We will undertake this initial study to document what parents choose to do with their infants regarding sleep position and why they make these choices so that we can improve our educational approach.

Conditions
-----------------
Sudden Infant Death Syndrome

Intervention / Treatment
-----------------
* Behavioral: Parental knowledge and beliefs about infant sleep position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent of a two-week old infant born in the Well Newborn Nursery at Yale-New Haven Hospital. Infant is brought for well child care at Yale-New Haven Hospital Primary Care Center

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 2 Weeks

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Parental knowledge and beliefs about infant sleep position|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff

Study Overview
=================
Brief Summary
-----------------
A preliminary clinical usability study to assess design, comfort, wearability, and acceptance of Recovery Force's Deep vein thrombosis (DVT) cuff

Detailed Description
-----------------
A single site, observational study will be conducted at the University of Southern California (USC) with participants who have and/or have had previous experience with DVT pneumatic cuffs. Study staff will examine participants overall experience, product functionality and perceived adherence to Recovery Force's DVT II cuff.

Official Title
-----------------
A Preliminary Clinical Usability Study to Assess Design, Comfort, Wearability, and Acceptance of Recovery Force's Deep Vein Thrombosis (DVT) Cuff

Conditions
-----------------
Deep Vein Thrombosis, Venous Thrombosis

Intervention / Treatment
-----------------
* Device: Deep Vein Thrombosis (DVT) Cuff


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Age 18-65 who have had exposure with a DVT cuff on the calf within the last 6 months from a previous or current clinical condition Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DVT Cuff users<br>Current or previous DVT cuff users | Device: Deep Vein Thrombosis (DVT) Cuff<br>* Recovery Force's DVT II Cuff<br>* Other names: RF1400;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort and Patient Acceptance | FULL SCALE NAME: Wearability, comfort, and acceptance of the DVT cuff Scale. Created a likert-type scale in RedCAP with values from 0 to 10, with higher score equaling better outcome. TIME FRAME: Each participant wore the DVT cuff under study for 20 minutes, and evaluated their experience using the scale above. Evaluated through User Questionnaire: Recovery Force DVT Cuff - Post-Demonstration Patient Questionnaire; and subject interview | 1 day |
Study Evaluating Workload, Clinical and Therapeutic Management of Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
In Spain, there is little data available concerning the evolution and treatment of Psoriatic Arthritis by rheumatologists and dermatologists. This study is designed to obtain more data about the clinical and therapeutic management of Psoriatic Arthritis in Dermatology and Rheumatology Medical centers.

Official Title
-----------------
Workload, Clinical and Therapeutic Management of Psoriatic Arthritis

Conditions
-----------------
Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients older than 18 years with a psoriatic arthritis diagnosis that go to dermatologic and/or rheumatologic centers or primary care centers. patients that receive pharmacologic treatment for their condition patients that give their written consent to participate

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Determine diagnosis and evolution time of patients |  | 12 months |
Study of a Vestibular Biomarker of Phase in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania (maniac phase). Vestibular tests have been shown high sensibility and specificity as a biological marker for major depression. This exploratory investigation will measure and compare the vestibular activity of bipolar disorder patients during different phases ( 6 depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).

Official Title
-----------------
Exploratory Study of a Vestibular Biomarker of Phase in Bipolar Disorder

Conditions
-----------------
Bipolar Disorder, Depression, Bipolar

Intervention / Treatment
-----------------
* Device: Vestibular test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar disorder I or II depressive phase of bipolar disorder maniac phase of bipolar disorder euthimic phase of bipolar disorder Exclusion Criteria: drugs addiction alcohol addiction neurologic condition, disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Depressive phase<br>Vestibular test | Device: Vestibular test<br> <br> |
| Maniac phase<br>Vestibular test | Device: Vestibular test<br> <br> |
| Euthimic phase<br>Vestibular test | Device: Vestibular test<br> <br> |
| Healthy subject<br>Vestibular test | Device: Vestibular test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vestibular test |  | December 2017 |
Use of Technology and Telemedicine to Improve Quality of Care in COVID 19 Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the use of technology including remote vital sign monitoring in improving quality of patient care, decreasing hospital admissions and re-admissions, decreasing hospital length of stay and decreasing use of personal protective equipment.

Official Title
-----------------
Use of Technology and Telemedicine to Improve Quality of Care in COVID 19 Patients

Conditions
-----------------
Diagnoses Disease, Covid19

Intervention / Treatment
-----------------
* Behavioral: Doctorgram Patient Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patient with COVID 19 or outpatient under investigation for or diagnosed with COVID 19 Clinically stable (on 4L O2 or less, non ICU) Demonstrates ability to be trained in use of digital stethoscope technology Exclusion Criteria: Pregnancy Delirium

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 Patients<br>Patients that are admitted to the hospital with COVID 19. | Behavioral: Doctorgram Patient Kit<br>* Participants will use the Doctorgram Patient Kit for remote monitoring and remote use stethoscope.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient provider experience survey score | Five questions related to satisfaction with experience using home pulse oximetry, each on a scale of 1 (poor) to 5 (excellent) summed and averaged for an overall range of 1 to 5 (higher scores = better experience). | Once after completion of device use (up to 15 minutes to complete the survey) | 
| Provider experience survey score | Four questions related to satisfaction with experience using home pulse oximetry, each on a scale of 1 (poor) to 5 (excellent) summed and averaged for an overall range of 1 to 4 (higher scores = better experience). | Once after completion of device use (up to 15 minutes to complete the survey) | 
| Use of personal protective improvement | Level of personal protective improvement in an in-patient setting. | 6 months | 
| Number of in-patient encounters with COVID patients as a measure of provider exposure to high risk illness |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine
RenalGuard System for Prevention of Contrast Induced Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.

Official Title
-----------------
RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial

Conditions
-----------------
Radiographic Contrast Agent Nephropathy

Intervention / Treatment
-----------------
* Device: RenalGuard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: serum creatinine >1.2mg/dl glomerular filtration rate (GFR) < 60ml/min Exclusion Criteria: acute renal failure use of radiological contrast in the latest 7 days Current use of N-acetylcysteine or hydration of sodium bicarbonate Patients in dialysis Emergency procedures

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RenalGuard<br>Hydration with the device renalguard | Device: RenalGuard<br>* Intravenous saline hydration matched with urine output, using the device Renalguard<br>|
| No Intervention: Saline<br>Hydration with saline 1ml/Kg/h for 12h | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of contrast-induced nephropathy | Contrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast Nephropathy, Prevention, Renalguard
Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure

Study Overview
=================
Brief Summary
-----------------
Current prospective cohort study is to evaluate the association between fasting lipid profiles (including total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, triglycerides, apolipoprotein A, apolipoprotein B and lipoprotein(a)) and fasting plasma glucose at admission with cardiovascular disease outcomes (including fatal and non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, or cardiovascular mortality) and all-cause mortality.in patients with ischemic heart failure and left ventricular ejection fraction < 45 % evaluated by echocardiography during 12 months follow-up.

Official Title
-----------------
Fasting Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure

Conditions
-----------------
Ischemic Heart Failure, Lipids, Fasting Plasma Glucose, Cardiovascular Outcomes, All-cause Mortality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Diagnosed as coronary artery disease by coronary angiography; 2. Left ventricular ejection fraction < 45% evaluated by echocardiography during index hospitalization. - Exclusion Criteria: Coexistent malignant diseases; stage 3 or more of chronic kidney disease; liver dysfunction with ALT or AST higher than 3 times of normal limit range; do not want to participant in current study -
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 |
| --- | --- | --- |
| Cardiovascular diseases outcomes | Fatal or non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, and cardiovascular mortality | 12 months after discharge from index hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality | 12 months after discharge from index hospitalization |