linjc16/ctgov huggingface dataset:
Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.

Official Title
-----------------
A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Seasonal Influenza Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, adult and elderly volunteers over 18 years Exclusion Criteria: Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit | Biological: Seasonal Influenza Vaccine<br>* This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly | To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. | 22 days including follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seasonal Influenza, vaccine
Examine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response

Study Overview
=================
Brief Summary
-----------------
To characterize the burden of disease in GERD patients of prescription therapy'

Official Title
-----------------
A Cluster-Randomized Study to Examine National Characteristics and Outcome Measures of GERD Patients Utilizing the PPI Acid Suppression Symptom (PASS) Test for Response [EncomPASS].

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, 18 years or older, diagnosis of GERD Exclusion Criteria: Peptic ulcer disease, upper gastrointestinal surgery, malignancy

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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the improvement in burden of overall GERD symptoms after 4 weeks of treatment with Esomeprazole verses maintenance of current therapy in subjects with persistent GERD symptoms. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the relationship of the severity and frequency of GERD symptoms to treatment, at national, and regional levels. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD
Meniscus Surgery Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a data registry of arthroscopic partial meniscectomies performed at our institution. This information will then be used to examine trends over time, predictive factors, and outcomes of arthroscopic partial meniscectomy.

Official Title
-----------------
Arthroscopic Partial Meniscectomy Registry

Conditions
-----------------
Meniscus Lesion

Intervention / Treatment
-----------------
* Procedure: Arthroscopic Partial Meniscectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo arthroscopic partial meniscectomy with one of the study investigators at University at Buffalo Medical Doctors Orthopaedics and Sports Medicine Exclusion Criteria: Non-english speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Arthroscopic Partial Meniscectomy|Surgical treatment for meniscus tear|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Pain Score | minimum of 0 (poor function), maximum of 100 (excellent function) | 20 years |
Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Study Overview
=================
Brief Summary
-----------------
Expanded access to DCA as continued treatment for congenital lactic acidosis.

Detailed Description
-----------------
Subjects who participated in a Phase 3 Randomized Controlled Trial of DCA for treatment of Congenital Lactic Acidosis (CLA) are eligible to continue treatment with investigational medication DCA at the same dose of 25mg/kg/day for expanded access. Study participants must travel to the study site for bi-annual evaluation by the study investigator. Bi-annual evaluation will include an interim medical history review, physical exam, blood collection for DCA trough level, and urine pregnancy testing (if indicated).

Official Title
-----------------
Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Conditions
-----------------
Mitochondrial Enzyme Deficiencies

Intervention / Treatment
-----------------
* Drug: Dichloroacetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of congenital lactic acidosis Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis Exclusion Criteria: Intolerance to DCA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dichloroacetate|Subjects are given DCA 25mg/kg in a divided dose twice a day.|

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
-----------------
Dichloroacetate (DCA), Congenital Lactic Acidosis (CLA), acidosis, orphan disease
Metabolic Determinants of Cardiac Function

Study Overview
=================
Brief Summary
-----------------
Assessment of cardiac energy metabolism in patients with impaired glucose tolerance

Detailed Description
-----------------
Insulin resistance, hepatocellular lipids (HCL) and plasma concentrations of free fatty acids (FFA) are predictors of heart failure, the leading cause of mortality in patients suffering from type 2 diabetes mellitus (T2DM). Epidemiological data suggest that diabetic cardiomyopathy (DC) presents as ventricular dysfunction in patients with T2DM independent of coronary artery disease. The underlying cellular mechanisms are poorly understood. Reduced mitochondrial activity and insulin resistance of skeletal muscle relates to liver steatosis, possibly due to higher substrate flux to the liver. High oxidation rates in the liver result in oxidative stress, damage of mitochondria and apoptosis. The investigators hypothesize that (i) HCL and impaired liver energy metabolism correlate with ventricular dysfunction, (ii) impaired glucose uptake and mitochondrial capacity in skeletal muscle relates to enhanced oxidative capacity, oxidative stress and lipid deposition in heart tissue (iii) reduced myocardial oxidative capacity limits recovery of myocardial function in patients with acute heart failure. The investigators aim to assess (i) liver energy metabolism and heart function, (ii) respiration and lipid metabolites in skeletal muscle and heart tissue in humans with advanced heart failure and (iii) the prognostic impact of these factors in humans with acute heart failure. This study will improve the understanding of mechanisms underlying the development of DC and the identification of patients at risk for poor outcome in heart failure.

Official Title
-----------------
Metabolic Determinants of Cardiac Function

Conditions
-----------------
Heart Failure, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 20 and ≤85 years myocardial biopsy for medical reason Exclusion Criteria: acute infection autoimmune disease pregnancy cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Control<br>Control | |
| Insulin Resistant<br>Insulin Resistant | |
| Type 2 Diabetes<br>Type 2 Diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mitochondrial oxygen flux | measured using high resolution respirometry. Unit: pmol/(s*mg) | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Diabetes Mellitus, Mitochondrial Respiration
Use of Erythromycin in Mustard-Induced Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans

Official Title
-----------------
Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans

Conditions
-----------------
Bronchiolitis Obliterans, Acute Obliterating Bronchiolitis

Intervention / Treatment
-----------------
* Drug: Erythromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented chemical exposure Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT) Non-responsiveness to high dose bronchodilator therapy Exclusion Criteria: Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic History of cigarette smoking and occupational exposure to toxic agents of hypersensitivity to macrolides History of treatment with a systemic antibiotic within 7 days before the start of the study Any investigational medicine within 4 weeks of the study History of antibiotic injection within 6 weeks before the study Concomitant Theophylline or Carbamazepine, unless their serum concentrations were regularly monitored Patients who were in the exacerbation phase of their respiratory complications Need to use medications interact with macrolides such as Digoxin, Theophylline and Carbamazepine Systemic antibiotics Systemic Corticosteroids Admission to the hospital Abnormal kidney or liver function
Sexes Eligible for Study
-----------------
Male

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure

Official Title
-----------------
Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure

Conditions
-----------------
Acute Respiratory Failure, Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged ≥ 19 years Written informed consent by the patient or legally authorized representative Critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation Exclusion Criteria: No informed consent A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability

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 |
| --- | --- | --- |
| Rate of respiratory viral infections | Rate of respiratory viral infections in patients with acute respiratory failure | within 24 hours after intensive care unit (ICU) admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality rate | Association between respiratory viral infections and death in ICU and risk factors of death in patients with ARF | Through study completion, an average of 1 year | 
| Hospital mortality rate | Association between respiratory viral infections and death in hospital and risk factors of death in patients with ARF | Through study completion, an average of 1 year |
Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers

Study Overview
=================
Brief Summary
-----------------
Human papilloma virus-related gynecologic malignancies affect over 20,000 women in the United States, and over half a million women globally each year. In addition, approximately 200,000 women are diagnosed with high-grade cervical dysplasia, a pre-cancerous tumor. There is no currently available serum biomarker for these tumors, and surveillance and diagnosis in these patients often requires invasive testing and procedures. The ability to diagnose and monitor for these cancers with a simple blood draw would have a significant impact both here in the US and abroad. In order to detect circulating tumor-specific HPV DNA, the investigators will collaborate with the molecular diagnostics company, Naveris. Naveris has designed a blood test that utilizes digital droplet polymerase chain reactions (PCR) in order to quantify fragments of tumor-specific DNA that the investigators believe is shed by HPV-associated cancer cells in the blood. In this pilot study, the investigators will first test whether the quantification of plasma cell-free HPV DNA can distinguish pre-invasive from invasive cervical cancers.

Official Title
-----------------
Implementation of Circulating HPV DNA for the Screening and Surveillance of HPV-related Gynecologic Cancers

Conditions
-----------------
Cervical Dysplasia, Cervical Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: NavDx(R)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients above age 18, with biopsy proven HPV-related high-grade cervical dysplasia or invasive cervical cancer will be included. Exclusion Criteria: Persons who do not meet the above inclusion criteria.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Circulating HPV DNA<br> | Diagnostic Test: NavDx(R)<br>* NavDx® is a blood test that utilizes digital droplet PCR in order to quantify fragments of tumor-specific DNA shed by HPV-associated cancer cells in the blood. The technology has the ability to distinguish tumor-tissue modified virus particles present in the plasma cell-free DNA from non-cancer associated sources of HPV DNA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Treatment Circulating HPV DNA | The presence or absence of ct-HPV DNA | Week 0 | 
| On-Treatment Circulating HPV DNA | The presence or absence of ct-HPV DNA | Up to 8 weeks | 
| Post-Treatment Circulating HPV DNA | The presence or absence of ct-HPV DNA | 8-12 weeks |
Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.

Detailed Description
-----------------
Clinical Investigation for a non-inferiority/equivalence study that aims to determine the acceptable performance of the Monica AN24 during the first and when possible the second stages of labor by determining whether the Monica AN24 fetal heart rate (FHR) and uterine contractions (UC) monitoring device is non-inferior/equivalent to Doppler FHR and tocodynamometer UC using direct fetal scalp electrode (FSE) FHR and intrauterine pressure catheter (IUPC) UC as a reference, either collected simultaneously with the Monica and Doppler FHR/tocodynamometer UC data, or from previous studies to define the expected accuracy and success rate when comparing Monica FHR and UC with Doppler FHR and tocodynamometer UC respectively

Official Title
-----------------
Study to Determine the Equivalence of the Monica AN24 Monitor to Predicate Devices for (FHR) and (UC) During Pre-term Labor and Multiples

Conditions
-----------------
Pre Term Labor, Multiple Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: She is >=24weeks 0days but less than 36 completed weeks, with a singleton pregnancy or >=34weeks 0days with a multiple pregnancy and has been admitted to the Labor and Delivery Unit She is in the latent phase of spontaneous labor, or has been admitted for induction of labor She has given her informed consent to participate as a subject She has none of the exclusion criteria Exclusion Criteria: Known major fetal malformation or chromosome abnormality Involvement in another clinical trial currently or previously in this pregnancy Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, sensitivity to adhesives) Significant medical or obstetric problem that in the investigator's opinion would make the woman incapable of taking part in the study

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| equivalence with predicate device |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTL, Multiples
GLOBAL Clinical Study

Study Overview
=================
Brief Summary
-----------------
The GLOBAL study is an international multi-center, prospective study designed to enroll up to 10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography for assessment of suspected coronary artery disease (CAD). The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in patients phenotyped using advanced imaging modalities of atherosclerosis.

Official Title
-----------------
Genetic Loci and the Burden of Atherosclerotic Lesions

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-90 Caucasian and of Non-Hispanic or Non-Latino origin Referral for coronary CT angiography to evaluate for presence of CAD The patient has signed the appropriate Institutional Review Board approved Informed Consent Form Exclusion Criteria: Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding 30 days (except if steroids are administered as pre-medication prior to contrast administration for CT scan within 24 hours). Chemotherapy in the preceding year Major surgery in the preceding 2 months Blood or blood product transfusion in the preceding 2 months Subjects for whom coronary CT angiography is contraindicated per institutional standard of care Subjects with previous coronary arterial revascularization (PCI or CABG) Subjects with atrial fibrillation/flutter or frequent irregular or rapid heart rhythms, which occurred within the past 3 months Subjects with a pacemaker or implantable cardioverter-defibrillator implant Active congestive heart failure or the presence of known non-ischemic cardiomyopathy Known genetic disorders of atherosclerosis, lipid or lipoprotein metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Subjects with CAD<br> | |
| Subjects without CAD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genome-Wide Association | The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease. | Baseline |