linjc16/ctgov huggingface dataset:
Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.

Official Title
-----------------
Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Conditions
-----------------
Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility Exclusion Criteria: A positive (reactive) HIV and/or HCV and/or HBV test

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Human Blood Donor Plasma Specimens<br> | Device: Blood test<br>* Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity |  | 01 August 2007 to 31 December 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nucleic acid test, HIV-1, hepatitis, HBV, HCV, TMA, HIV Seronegativity
Individual Patient Expanded Access to CA102N

Study Overview
=================
Brief Summary
-----------------
This study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.

Detailed Description
-----------------
In the individual patient expanded access, the subject who was enrolled in Phase 1 trial (Study Number: HS-CA102N-101) Part 2 (dose expansion) and had completed at least 12 treatment cycles with CA102N combined with trifluridine /tipiracil (LONSURF) will be provided access to treatment with CA102N (0.72 mg/kg Nimesulide Equivalent of CA102N).

Official Title
-----------------
Expanded Access to CA102N in One Patient Who Completed at Least 12 Cycles of Combination Therapy of CA102N Plus Lonsurf in Clinical Study Number of HS-CA102N-101

Conditions
-----------------
Advanced or Metastatic Colorectal Cancer (mCRC)

Intervention / Treatment
-----------------
* Drug: CA102N


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CA102N|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Stair Instead of Elevator Use at Work: Cardiovascular Primary Preventive Effects on Hospital Employees.

Study Overview
=================
Brief Summary
-----------------
This is an intervention study which evaluates the cardiovascular primary preventive effects of using stairs instead of elevators at the worksite during a 12-weeks period. We hypothesize that stair-climbing during working hours can meet the daily amount of physical activity recommended by current public health guidelines.

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years No or little stair-use at work (< 5 stories/day) Sedentary lifestyle Exclusion Criteria: Positive answers to the health screening physical activity readiness questionnaire (PAR-Q) Part-time employment < 80% Absence of more than 2 weeks during the intervention period Intention to begin a weight control program Medication changes which may influence blood pressure, lipid or glucose metabolism

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Physical activity|Climbing stairs instead of taking elevators at worksite during 12 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
320 Multidetector Computed Tomography Prior to Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
Recent advances in technology have resulted in the development of scanners that can n image the heart arteries within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. This means that coronary heart disease may be more readily identified (or ruled out) and allow better diagnosis and treatment of patients with symptoms suggesting coronary heart disease. Here, we propose to assess the latest and most powerful scanners to see if it can accurately diagnose the extent of coronary artery disease and facilitate the planning of heart surgery.

Official Title
-----------------
320 Multidetector Computed Tomography in the Preoperative Assessment for Coronary Artery Bypass Graft Surgery

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Radiation: Computed tomography scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have undergone conventional coronary angiography and have been referred for coronary artery bypass surgery or valve replacement Exclusion Criteria: age less than 18 pregnancy or breast feeding inability to undergo computed tomography scanning inability to give informed consent severe renal failure (serum creatinine >250umol/l or estimated glomerular filtration rate <15ml/min) known allergy to iodinated contrast

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 |
| --- | --- |
| Patients awaiting cardiac surgery<br> | Radiation: Computed tomography scan<br>* Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and myocardial perfusion scanning.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary disease, Coronary artery bypass, Cardiac surgery, Computed tomography, Coronary angiography
Within-subject Variability of Insulin Detemir in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

Official Title
-----------------
A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese men or women Holding a Japanese pass-port and Japanese-born parents Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator Body Mass Index (BMI) between 18 and 30 kg/m^2, incl. Fasting blood glucose maximum 6 mmol/L Exclusion Criteria: Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator Subject with history of alcohol or drug dependence

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin detemir<br> | Drug: insulin detemir<br>* On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)<br>|
| Active Comparator: Insulin glargine<br> | Drug: insulin glargine<br>* On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum glucose infusion rate (GIRmax) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve (AUCGIR) |  |  | 
| Time to maximum glucose infusion rate (tGIRmax) |  |  | 
| Area under the insulin concentration curve (AUC) |  |  | 
| Maximum insulin concentration (Cmax) |  |  | 
| Adverse events |  |  |
A School Health Center Intervention to Increase Adolescent Vaccination

Study Overview
=================
Brief Summary
-----------------
The study will evaluate a health services intervention to increase uptake of adolescent vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five school health centers by improving the consent process for parents.

Official Title
-----------------
A School Health Center Intervention to Increase Adolescent Vaccination

Conditions
-----------------
Immunization Program, School Health Services, HPV Vaccines

Intervention / Treatment
-----------------
* Behavioral: Modified Vaccine Consent Form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All students enrolled at target schools Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Parents served by experimental school sites received intervention packets including modified vaccine consent form | Behavioral: Modified Vaccine Consent Form<br>* Packet of written immunization materials for parents and students which includes the following: Cover letter Vaccine promotional flyer Vaccine information sheets (one for adolescent vaccination and one for other vaccination) Improved consent form Note advertising a lottery for free movie tickets for returning the consent form Self-addressed stamped envelope<br>|
| No Intervention: Control<br>Did not receive intervention materials | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline In The Number of Adolescent Vaccines | Change in vaccination rates for HPV, Tdap, meningococcal conjugate and influenza between Fall 2011 (baseline) and Fall 2012. | 4 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Returned Consent Forms Authorizing Vaccination | Number of signed and returned consent forms for adolescent vaccines HPV, Tdap, meningococcal conjugate and influenza in the intervention arm. | 4 months post intervention |
A PHASE I, SINGLE-CENTER, MIXED METHODS STUDY ON THE HEALTH OUTCOMES OF VISUAL SELF EXPRESSION

Study Overview
=================
Brief Summary
-----------------
To gain understanding about the impact of visual art making on biomarkers, such as cortisol, alpha amylase, oxytocin, etc. to examine whether and to what extent there are changes in levels of stress and immune function in patients and caregivers adults (including family caregivers and medical professionals)

Official Title
-----------------
A PHASE I, SINGLE-CENTER, MIXED METHODS STUDY ON THE HEALTH OUTCOMES OF VISUAL SELF EXPRESSION

Conditions
-----------------
A Healthcare Professional, a Patient or Caregiver in the Radiation Oncology Department at the University of Pennsylvania

Intervention / Treatment
-----------------
* Behavioral: Art therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between the age of 18 - 70 A healthcare professional, a patient or caregiver in the Radiation Oncology Department at the University of Pennsylvania Subjects must be capable of giving informed consent Exclusion Criteria: Any healthcare professional or patient/caregiver not working in or being seen at Radiation Oncology Department at the University of Pennsylvania

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Art therapy|Art Therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NUmber of changes in levels of stress and immune function in patients and caregivers |  | 1 year |
Shanghai Pediatric Cataract Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of pediatric cataract participants, including congenital and traumatic cataract. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of pediatric cataract.

Official Title
-----------------
Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study

Conditions
-----------------
Pediatric Cataract, Congenital Cataract, Traumatic Cataract, Visual Outcome, Genetic Anticipation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of pediatric cataract Must be able to cooperate with the ophthalmic examination Exclusion Criteria: Clinical diagnosis of mental illness Mentally disabled

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 20 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 |
| --- | --- |
| Congenital cataract group<br>Cataract patients diagnosed with congenital cataract. | |
| Traumatic cataract group<br>Cataract patients diagnosed with traumatic cataract. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in the visual outcomes of pediatric cataract patients. | Visual outcomes are evaluated including visual acuity with or without correction, refractive changes, intraocular pressure, fundus function, fixation type, vision development, growth of axial length, contrast sensitivity and other visual outcome measurements. | Follow-up until ten years after surgery. | 
| Genetic diversity based on biospecimen samples of pediatric cataract patients. | Sequencing of genes (including exons, promoters, 5' UTR and 3' UTR sequences) on a large scale to intensively investigate into the sites and functions of single nucleotide polymorphism (SNP) correlated with clinical features of congenital cataract patients, compared to traumatic cataract patients.Samples of blood, aqueous humor, anterior capsular membranes and lens tissues were applied for the genetic analysis. | Analyzed within six months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in the clinical phenotypes of pediatric cataract patients. | Cataract type and severity of ametropic cataract patients are evaluated and images are captured before receiving the cataract surgery. | Evaluated before receiving the cataract surgery. |
Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The study is being conducted to explore the safety and tolerability of CoVaccine HT in healthy male and female volunteers. In this study volunteers will receive intramuscular injections of CoVaccine HT.

Official Title
-----------------
A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers

Conditions
-----------------
Vaccine

Intervention / Treatment
-----------------
* Biological: CoVaccine HT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (BMI) Generally healthy as determined by pre study medical history, physical examination, 12 lead ECG. Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening and rapid influenza diagnostic test at admission. Exclusion Criteria: History of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption. Fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoVaccine HT<br> | Biological: CoVaccine HT<br>* intramuscular injection, dose escalation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Events | Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event. | Duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccine, hypertension
Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect physiologic data streams with the Accuryn Monitoring System and validate the accuracy of these measurements against existing gold standards, and to track and analyze changes in these physiologic data streams to identify clinical signatures that may enable earlier diagnosis and intervention of critical conditions.

Official Title
-----------------
Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients

Conditions
-----------------
Critical Care, Intensive Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to the hospital with trauma (including burn) Anticipated ICU stay of at least 72 hours Anticipated transfusion of ≥1 unit blood products (pRBC's, platelets, and/or plasma) within the first 24 hours of hospitalization, and/or a current diagnosis of sepsis/septic shock, and/or ICU admission primarily for burn Anticipated requirement for a urinary bladder catheter for ≥ 72 hours Exclusion Criteria: Inability to receive a 16F urinary bladder catheter Significant bladder or urethral injury In the opinion of the investigator the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial Pregnancy known at the time of presentation

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 |
| --- | --- | --- |
| Comparison of physiologic signals as measured by the Accuryn Monitoring System compared to existing gold standard measurements. |  | During the ICU stay (approximately 2-4 weeks) |