linjc16/ctgov huggingface dataset:
Epidemiology of Impaired Coagulant Balance in Diabetes

Study Overview
=================
Brief Summary
-----------------
To determine the nature, extent and molecular mechanisms responsible for impaired fibrinolysis in White, Black, Hispanic and American Indian populations with respect to the presence or absence of diabetes. The overall objective is to determine whether impairments of fibrinolysis underlie subclinical and clinical vascular disease in diabetes in specific populations with and without accelerated microvascular disease.

Detailed Description
-----------------
BACKGROUND: The results of this project should clarify the extent to which results obtained in experimental animals pertain directly to diabetes in human subjects. The study will also assist in the interpretation of results from clinical studies and from platelet activation experiments. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Blood Coagulation Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)

Study Overview
=================
Brief Summary
-----------------
Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.

Official Title
-----------------
A Randomized-Withdrawal Phase 3 Study Evaluation the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)

Conditions
-----------------
Uremic Pruritus

Intervention / Treatment
-----------------
* Drug: Nalfurafine HCl 2.5 µg
* Drug: Nalfurafine HCl 5.0 µg
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 yrs old or older moderate to severe pruritus end stage renal disease 3x weekly hemodialysis Exclusion Criteria: pruritus not due to renal disease abnormal liver function Ca-P > 80 mg/dl or HgB <8.5 g/dl or PTH > pg/mL Within four months spKt/V < 1.05

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients will be randomized into Placebo group | Other: Placebo<br>* Placebo daily dose<br>|
| Active Comparator: 2<br>2.5 µg group randomized | Drug: Nalfurafine HCl 2.5 µg<br>* Daily dose of 2.5 µg<br>|
| Active Comparator: 3<br>5.0 µg group randomized | Drug: Nalfurafine HCl 5.0 µg<br>* Daily dose of 5.0 µg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period. |  | 11 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uremic pruritus
QuantiFERON Access Clinical Performance Study Protocol

Study Overview
=================
Brief Summary
-----------------
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.

Official Title
-----------------
A Non-interventional, Prospective Clinical Performance Study of the QuantiFERON Access Kit to Demonstrate Clinical Accuracy Compared to a CE-marked In-Vitro Diagnostic Medical Device, in Participants With Varying Risk Factors for TB Infection and Disease.

Conditions
-----------------
Tuberculosis (TB)

Intervention / Treatment
-----------------
* Device: QFT Access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Be ≥ 18 years of age, 2. Have received no TB treatment or received treatment for less than 14 consecutive days. 3. Provide Informed Consent. Exclusion Criteria: 1. They do not meet the inclusion criteria, 2. Blood handling was not completed using QFT-Plus 3. Incubation was <16 and >24 hours 4. Improperly collected and/or stored samples per Instructions For Use

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects<br>Those with TB and those without TB. | Device: QFT Access<br>* Measure of Interferon Gamma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TB Result | QFT Access result compared to the QFT-Plus result (positive, negative) | At time of enrollment |
Indoor Temperature and Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether different indoor temperature affect the frequency of sleep apnea.

Official Title
-----------------
Indoor Temperature and Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: 16
* Other: indoor temperature of 20 degrees celcius
* Other: indoor temperature of 24 degrees celcius


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstructive sleep apnea Exclusion Criteria: Central sleep apnea
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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16<br>indoor temperature of 16 degrees celcius | Other: 16<br>* indoor temperature of 16 degrees celcius<br>|
| Experimental: 20<br>indoor temperature 20 degrees celcius | Other: indoor temperature of 20 degrees celcius<br>* indoor temperature of 20 degrees celcius<br>|
| Experimental: 24<br>indoor temperature of 24 degrees celcius | Other: indoor temperature of 24 degrees celcius<br>* indoor temperature of 24 degrees celcius<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea hypopnea index, karolinska sleepiness scale |  | one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep stages, sleep efficiency |  | One night | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep apnea syndromes, ambient indoor temperature
Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence

Study Overview
=================
Brief Summary
-----------------
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the device's 8-17 g/dL specification range. The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.

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

Intervention / Treatment
-----------------
* Device: R1-25 and R2-25 Pulse Oximeter Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years old Healthy Exclusion criteria: Do not understand the study and the risks involved Deemed ineligible by study test personnel

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: Other
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors | Device: R1-25 and R2-25 Pulse Oximeter Sensor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation | Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. | 1-5 hours |
Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With CPB

Study Overview
=================
Brief Summary
-----------------
Surgical site infection (SSI) is a serious operative complication that may be associated with any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery with cardiopulmonary bypass including its correlation with the incidence of postoperative SSI.

Official Title
-----------------
Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Conditions
-----------------
Surgical Site Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 7 years old undergoing elective cardiac surgery with cardiopulmonary bypass receive cefazolin as prophylactic antibiotic Exclusion Criteria: Known or family history of penicillin or cephalosporins allergy Coexisting liver or renal disease Previous infection or received any antibiotics within 4 weeks Previous surgery with median sternotomy Predicted cardiopulmonary bypass time of less than 30 minutes or more than 150 minutes Severe hemodynamic instability during the operation, requiring mechanical circulatory support

Ages Eligible for Study
-----------------
Maximum Age: 7 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 |
| --- | --- | --- |
| plasma concentration of cefazolin in pediatric cardiopulmonary bypass | plasma concentration of cefazolin | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of surgical site infection after elective pediatric cardiac surgery | surgical site infection | 30 days |
Visual Outcome After Vitrectomy With Subretinal tPA Injection

Study Overview
=================
Brief Summary
-----------------
evaluate the safety of Eva surgical system

Detailed Description
-----------------
The purpose of this retrospective study is to evaluate the safety and clinical results using this surgical technique when performed using the EVA surgical system and associated instrumentation and disposable surgical equipment

Official Title
-----------------
Visual Outcome After Vitrectomy With Subretinal tPA Injection to Treat Submacular Hemorrhage Secondary to Age-related Macular Degeneration or Macroaneurysm

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Other: retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with VTX subretinal tPA ( + phaco) patients with submacular bleeding Exclusion Criteria: none

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: retrospective study|vitrectomy performed in case of submacular bleeding|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-operative best corrected visual acuity | • The pre-operative BCVA will be taken from the visit when the indication for the surgery was set | pre surgery | 
| Surgical adverse events | Surgical adverse events or issues that were recorded in the surgical report | postoperative visit on day 1 | 
| post-operative best corrected visual acuity | The post-operative BCVA will be taken from the latest visit after the surgical procedure | 6 weeks after surgery |
Omegaven Expanded Access Protocol

Study Overview
=================
Brief Summary
-----------------
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

Official Title
-----------------
Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375

Conditions
-----------------
Parenteral Nutrition Associated Liver Disease

Intervention / Treatment
-----------------
* Drug: Omegaven


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment. Failed standard/conventional therapies to prevent progression of PNALD. Age newborn to 17 years of age Signed informed consent. Exclusion Criteria: Allergy to eggs and/or shellfish Female who is pregnant or lactating Severe hemorrhagic disorder Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,) 18 years of age or older Parent/legally authorized representative is unwilling to consent.

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Omegaven|10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.|

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
-----------------
cholestasis, short bowel syndrome
Regulatory Hycamtin(Oral) PMS

Study Overview
=================
Brief Summary
-----------------
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information

Detailed Description
-----------------
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information Topotecan will be administered as described the prescribing information or by physician's decision.

Official Title
-----------------
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of HYCAMTIN Administered in Korean Patients According to the Prescribing Information

Conditions
-----------------
Lung Cancer, Small Cell

Intervention / Treatment
-----------------
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
All subjects must satisfy the following criteria. Subject who is under the indication to the prescribing information of oral Hycamtin. Subject who is treated with oral Hycamtin according to the judgement of her or his investigator. All subjects must not satisfy the following criteria. • Subject who is under the contraindication to the prescribing information of oral Hycamtin. As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe oral Hycamtin according to prescribing information which approved in Korea.
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 administrated Topotecan<br>There is only one group. This group includes patients administrated Topotecan | Drug: Topotecan<br>* patients administrated Topotecan according to the prescribing information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events after Topotecan administration |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of unexpected adverse event or adverse drug reaction |  | 9 months | 
| Occurrence of serious adverse event or adverse drug reation |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PMS (post-marketing surveillance), Topotecan
Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift.

Detailed Description
-----------------
Night shift increases physical and psychological pressure, and even affects their sleep quality. This study aims to evaluate the effects of aroma massage to sleep quality of the nurses during night shift after life-style modification and/or aroma massage. The investigators adopt a Randomized Controlled Trial (RCT) in this study. The investigators expect aroma massage would improve the sleep quality during night shift.

Official Title
-----------------
Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors

Conditions
-----------------
Shift-Work Sleep Disorder

Intervention / Treatment
-----------------
* Behavioral: massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shift-Work Nurses and Staff Exclusion Criteria: Diabetes mellitus, cardiovascular disease and psychological disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: massage<br>massage for 30 min, once a week for 4 weeks | Behavioral: massage<br>* massage<br>|
| No Intervention: control<br>Rest as control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain-derived neurotrophic factor |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index (PSQI) | Psychological questionnaire | 4 weeks | 
| Depression score ( Zung's Self-Reported Depression Scale) | Psychological questionnaire- Zung's Self-Reported Depression Scale | 4 weeks | 
| Anxiety score (Beck Anxiety Inventory) | Psychological questionnaire- Beck Anxiety Inventory | 4 weeks | 
| Heart rate variability | Cardiopulmonary functions | 4 weeks | 
| Metabolic syndrome (NCEP) | Third Report of the National Cholesterol Education Program (NCEP) criteria | 4 weeks | 
| VCAM-1 | Cardiovascular risk and Inflammatory markers | 4 weeks | 
| Irisin | Cardiovascular risk and Inflammatory markers | 4 weeks | 
| circadian rhythm | orexin | 4 weeks |