linjc16/ctgov huggingface dataset:
Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay Higher Among Those Aged Over 75 Years

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization.

Official Title
-----------------
Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay (Xaban) Higher Among Those Aged Over 75 Years, as AOD for Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 75 years Entering SAU or MPG (Nantes University Hospital) as part of an unscheduled hospitalization for acute or subacute disease (About MPG, will be included patients admitted to the department within 48 hours of calling the doctor) In xaban to entry (dabigatran, rivaroxaban, Apixaban) for non-valvular atrial fibrillation In whom hemostasis tests will be prescribed as part of usual care Patient has given its verbal agreement Exclusion criteria Patients with the following criteria may not be included: Patients refusing to participate in the study Patients under guardianship Inability to obtain the date and time of the last dose of xaban

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood test|bioassay xaban|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioassay direct oral anticoagulants |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, oral anticoagulant, bioassay, elderly subject
Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to collect information on problems that patients with the novel H1N1 influenza and/or the seasonal influenza experience. Novel H1N1 flu is also called the swine flu. Seasonal influenza is also called the regular flu. The purpose of this study is to collect information from patients who are infected with either the novel H1N1 or the seasonal flu and to determine what makes patients critically ill with these infections. The goal is to develop a registry that will aid investigators in determining specific markers that lead to development of severe illness in these infections.

Detailed Description
-----------------
Patients admitted to the medical intensive care unit with either novel H1N1 infection or seasonal influenza infection may be eligible for participation.

Official Title
-----------------
Human Subjects Registry of Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza

Conditions
-----------------
H1N1 Influenza, Seasonal Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the medical intensive care unit with a diagnosis of novel H1N1 influenza infection or with a diagnosis of seasonal influenza infection. Exclusion Criteria: Prisoners Refusal of study participation.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Novel H1N1 influenza<br> | |
| Seasonal influenza<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is to contrast patients infected with novel H1N1 influenza to those infected with seasonal influenza. |  | Patients will be evaluated until May 31, 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To evaluate biomarkers that cause critical illness in patients with novel H1N1 influenza and with seasonal influenza.
Electromagnetic Field Protection Device Use Impact in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single group, self-controlled study to evaluate the clinical and molecular impact of continuous in-home resonance-based electromagnetic field (EMF) protection device usage in healthy individuals.

Official Title
-----------------
Clinical and Molecular Impact of In-home Resonance-based Electromagnetic Field Protection Device Usage in Healthy Individuals

Conditions
-----------------
Aging, Aging Well

Intervention / Treatment
-----------------
* Device: In-home resonance-based electromagnetic field protection device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any sex, gender orientation, and ethnicity Between ages 30 and 70 Must be willing and able to participate in venipuncture, health history and clinical assessments, passive monitoring (Oura ring), and continuous in-home Blushield device usage Exclusion Criteria: Significant change in diagnosis and/or treatment of major illness or injury within 2 years prior to screening, e.g., diabetes, cancer, cardiovascular disease, psychiatric condition 2. Any ongoing immune system concerns or immunodeficiency disease History of any viral illness in preceding year Body mass index (BMI) > 35 kg/m2 Presence of active infection Any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable Unable or unwilling to provide required biological sample Unable or unwilling to avoid pregnancy during study period

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-home EMF protection device<br> | Device: In-home resonance-based electromagnetic field protection device<br>* Participants will have an in-home EMF protection device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic Testing |  | Change from baseline to 12 weeks |
Tissue Biomarker for Pegvisomant Action

Study Overview
=================
Brief Summary
-----------------
Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I levels in the blood. However, no studies have evaluated the effects of blocking GH receptors in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.

Official Title
-----------------
Tissue Biomarker for Pegvisomant Action

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Pegvisomant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acromegaly established on the basis of symptoms and signs at presentation, evidence of a pituitary adenoma on MRI, elevated serum concentrations of IGF1 (>1.3 X ULN), and inadequate GH suppression (>0.4 ng/mL) following OGTT Candidates to receive pegvisomant therapy following pituitary adenoma surgery, or intolerant of other medical treatments or had not undergone previous therapy Normal LFTs before treatment Dynamic testing of the pituitary axis and, if applicable, appropriate hormone replacement Exclusion Criteria: Treatment with a long-acting SRL within 12 weeks before enrollment Presence of a macroadenoma with visual field defects as a result of chiasmatic compression Clinically significant hepatic abnormalities and/or AST or ALT >3 X ULN on screening Known hypersensitivity to any of the test materials or related compounds History of, or known current, problems with alcohol or drug abuse Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegvisomant<br> | Drug: Pegvisomant<br>* Pegvisomant used as indicated<br>* Other names: Somavert;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Pegvisomant on Colon Tissue p53 Expression | Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromegaly
Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.

Official Title
-----------------
A Lifestyle Program for Severe Comorbid Obstructive Sleep Apnea With Severe Obesity

Conditions
-----------------
Obstructive Sleep Apnea, Obesity

Intervention / Treatment
-----------------
* Behavioral: Home-based pulmonary rehabilitation (PR) system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18 years of age or older. Newly diagnosed with severe Obstructive Sleep Apnea (OSA) and severe obesity (BMI > 35). Exclusion Criteria: Individuals < 18 years of age. Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe Comorbid OSA<br>Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system | Behavioral: Home-based pulmonary rehabilitation (PR) system<br>* Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors upload the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches call patients regularly to celebrate progress, assist with any issues, and set new goals.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of proposed system in patients with OSA and Obesity | Qualitative Interview | Qualitative Interviews will be completed at the end of the two week trial |
Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1 receptor agonists are used for the treatment of T2DM. Insulin resistance is a pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1 secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared to healthy controls. The results of this study will expand the knowledge of the pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.

Detailed Description
-----------------
Primary endpoint: GLP-1 response to oral glucose Secondary endpoints: glucose and insulin responses to oral glucose challenge

Official Title
-----------------
Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls

Conditions
-----------------
Non Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Other: Oral glucose tolerance test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven NAFLD or NASH Exclusion Criteria: additional concomitants liver disease T2DM alcohol consumption >40g/d for male subjects and >20g/d for female subjects

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 |
| --- | --- |
| NAFLD<br>Patients with biopsy proven NAFLD | Other: Oral glucose tolerance test<br>* Oral intake of 75 g glucose after overnight fast<br>|
| Control<br>Matched healthy control subjects | Other: Oral glucose tolerance test<br>* Oral intake of 75 g glucose after overnight fast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT | The difference in GLP-1 secretion in response to oGTT as assessed by area under the curve (AUC) and peak plasma concentration (cmax) in patients with NAFLD compared to healthy controls. | 0, 15, 30, 60, 90, 120 min. after glucose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion and glucose curves in response to oGTT |  | 0, 15, 30, 60, 90, 120 min. after glucose administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAFLD, NASH, GLP-1
Self-monitoring Focus Groups With Vibrant Lives Pasadena Participants

Study Overview
=================
Brief Summary
-----------------
This study investigates how individuals feel about a dietary mobile application. Information collected from focus groups and interviews may help doctors and mobile application developers to determine preferences and participant feedback about the appeal and usefulness of a mobile application.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To gather qualitative data to assess appeal, preference, and usefulness of a food and beverage self-monitoring mobile application. OUTLINE: PHASE I: Participants attend 4 sessions of focus groups. PHASE II: Participants attend virtual Zoom interviews or one-on-one interviews.

Official Title
-----------------
Self-Monitoring Focus Groups With Vibrant Lives Pasadena Participants

Conditions
-----------------
Obesity-Related Malignant Neoplasm

Intervention / Treatment
-----------------
* Behavioral: Discussion
* Other: Interview
* Other: Survey Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pasadena Independent School District (ISD) employees who have completed the 6-month Vibrant Lives weight loss program or adults who have completed a weight loss program within the last 12 months
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 |
| --- | --- |
| Observational (focus group, interview)<br>PHASE I: Participants attend 4 sessions of focus groups. PHASE II: Participants attend virtual Zoom interviews or one-on-one interviews. | Behavioral: Discussion<br>* Attend focus groups<br>* Other names: Discuss;Other: Interview<br>* Attend interviews<br>Other: Survey Administration<br>* Ancillary studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preferences of food and beverage self-monitoring methodology and respective feedback messages | Thematic and narrative analyses will be conducted from the transcriptions to gain an understanding for the preferences of food and beverage self-monitoring methodology and respective feedback messages. | Up to 3 years |
A Study to Evaluate Vaccines Against COVID-19 in the Real World

Study Overview
=================
Brief Summary
-----------------
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have afflicted tens of millions of people in a worldwide pandemic. Considering its high mortality and rapid spread, an effective vaccine is urgently needed to control this pandemic. Recently, mass vaccination campaigns using newly approved vaccines, ranging from conventional viral and protein-based vaccines to those that are more cutting edge, including DNA- and mRNA-based vaccines are beginning in many parts of the world. Randomized clinical trials of different vaccines reported efficacies for preventing COVID-19 in the range of 50% to 95%. Although these randomized clinical trials are considered the gold standard for evaluating intervention effects, they have notable limitations of sample size and subgroup analysis, restrictive inclusion criteria, and a highly controlled setting that may not be replicated in a mass vaccine rollout. The aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of different vaccines against COVID-19 under real-world practice conditions.

Official Title
-----------------
A Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of Vaccines Against COVID-19 in the Real World

Conditions
-----------------
Chronic Liver Disease, Hepatic Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects received COVID-19 vaccines; Able to comprehend and provide written informed consent in accordance with institutional guidelines. Exclusion Criteria: Not received any COVID-19 vaccines; Not willing to participate and/or give their written informed consent.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity index-seroconversion rates of neutralizing antibody | Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline. | The 4 weeks after the second dose vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety index-incidence of adverse reactions | Incidence of adverse reactions after each dose vaccination | Day 0-28 after each dose vaccination | 
| Immunogenicity index-seropositive rates of neutralizing antibody | neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive. | The 4, 12, 24, and 48 weeks after the second dose vaccination |