linjc16/ctgov huggingface dataset:
Impact of Sleep Disordered Breathing in Older Adults

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression.

Detailed Description
-----------------
BACKGROUND: The health impact of disordered breathing during sleep among middle-aged and older men and women in the general population had not been well studied, and the need for treating relatively mild degrees of sleep-disordered breathing was unknown in 1994. The study was the first population study which examined the effect of sleep-disordered breathing on these health outcomes. The study sought to establish the prevalence of clinically important sleep-disordered breathing among middle-aged and older men and women and to provide quantitative data to serve as the basis for selecting patients for screening and deciding which patients might benefit from therapeutic intervention. DESIGN NARRATIVE: The study evaluated the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression. The study used the Veterans Administration Normative Aging Study (NAS) population, which consisted of approximately 1,700 community-dwelling-men who returned for examination every three years. Respiratory function was assessed during sleep among these men and their wives using a validated method for home sleep monitoring. Blood pressure, health-related quality of life, and depression score were also assessed in the home. The potential associations of sleep-disordered breathing with hypertension, impaired health-related quality of life, and depression were evaluated, and the possibility that these relationships differed between men and women was examined. 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
-----------------
Lung Diseases, Cardiovascular Diseases, Hypertension, Depression, Sleep Apnea Syndromes

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 |
| --- | --- | --- |
Survey of Diet and Health Beliefs

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to better understand people's health and diet knowledge, beliefs, attitudes, and practices. The researchers will use this information to implement better strategies to help Americans maintain more nutritious diets.

Detailed Description
-----------------
The overall goal of this study is to determine whether there are differences in perceptions of healthy nutrition messages depending on from whom the message is coming. More specifically, the researchers aim to examine whether there are differences in how people perceive and intend to follow nutrition information that is coming from a variety of sources.

Official Title
-----------------
Effect of Dietary Advice Source on Perceptions of Information Accuracy and Intended Compliance

Conditions
-----------------
Dietary Guidelines

Intervention / Treatment
-----------------
* Other: Perception of information source


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: US citizen have access to internet have an Amazon Mechanical Turk (MTurk) account Exclusion Criteria: under 18 years of age no access to internet

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Control<br>No source will be indicated on information provided for review | Other: Perception of information source<br>* Participants will see the same health advice, with no source or one of three other sources indicated<br>|
| Government source<br>A government logo will be shown on information provided for review | Other: Perception of information source<br>* Participants will see the same health advice, with no source or one of three other sources indicated<br>|
| Medical source<br>A medical logo will be shown on information provided for review | Other: Perception of information source<br>* Participants will see the same health advice, with no source or one of three other sources indicated<br>|
| Social media source<br>A social media logo will be shown on information provided for review | Other: Perception of information source<br>* Participants will see the same health advice, with no source or one of three other sources indicated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of health information | Participants will rate the extent to which they trust the source of health information (i.e., the makers of the flyer) on a 7-point Likert-type scale ranging from not at all (1) to completely (7). | Baseline |
A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo

Study Overview
=================
Brief Summary
-----------------
This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.

Detailed Description
-----------------
This post-marketing surveillance required by Korea MFDS regulation. The objectives of this study are to monitor adverse events and effectiveness of Besivo.

Official Title
-----------------
A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo

Conditions
-----------------
Chronic Hepatitis b

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient diagnosed with chronic hepatitis B. The patient who is first prescribed and administered Besivo. Exclusion Criteria: The patients who are overreacting to this drug or its components Medium to severe Renal function disorder The patient under 19 The Patient who are taboo with L-Carnitine

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Incidence of adverse event after this drug administration in general medical practice. | Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. | 48weeks | 
| Incidence of serious adverse event after this drug administration in general medical practice. | Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. | 48 weeks |
Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes

Study Overview
=================
Brief Summary
-----------------
Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When planning the optimal therapy in patients with upper gastrointestinal malignancies it is essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has been added to conventional EUS examination and may provide complementary information to distinguish benign for malignant lymph nodes. The N-stage relates to the treatment choice and the prognosis, and it is therefore of particular interest to know the interobserver agreement in operator dependent techniques. This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.

Official Title
-----------------
Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes

Conditions
-----------------
Lymph Nodes, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the presence of a lymph node more than 10mm in diameter (short axis) detected during the EUS examination Exclusion Criteria: inadequate ES images were obtained by one of the observers

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?
-----------------
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
-----------------
Endoscopy, Endoscopic Ultrasound, Endoscopic Sonoelastography, Cancer, Interobserver agreement
Point of Care Early Infant Diagnosis Patient Impact Study

Study Overview
=================
Brief Summary
-----------------
In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.

Official Title
-----------------
Evaluation of the Clinical Impact of Point-of-Care HIV Early Infant Diagnostic Technologies

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Device: POC EID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Younger than 12 months of age Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother Exclusion Criteria: Older than 12 months of age Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation Already initiated ART

Ages Eligible for Study
-----------------
Maximum Age: 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 |
| --- | --- |
| POC EID<br>Point of Care Early Infant Diagnosis qualitative technologies (Alere q) will be implemented. Sample collection and testing will happen in the same location within the health care facility. | Device: POC EID<br> <br> |
| Laboratory-based testing<br>Conventional laboratory-based testing using the Abbott m2000 technology will continue to be used per standard of care in Malawi. Dried blood spot samples will be collected at health care facilities and transported within the national network to centralized laboratories for testing. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ART initiation retention | Proportion of HIV-positive infants initiated on anti-retroviral therapy | 6-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test turnaround time | Number of days from testing to result being received by the health care facility | 6-9 months | 
| Tests received | Proportion of tests received by the health care facility | 6-9 months |
Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes

Study Overview
=================
Brief Summary
-----------------
Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.

Detailed Description
-----------------
Many CGM systems use a surrogate for blood glucose--tissue glucose or interstitial glucose. Interstitial fluid (ISF) is the medium for these approaches. A physiological lag in ISF glucose relative to capillary blood glucose has been noted, probably due to relatively low blood perfusion at the sampling site. 9 This physiological lag can result in an accuracy error, manifesting as a significant bias between blood and tissue glucose, particularly during periods of rapid glucose change. This lag error might be particularly meaningful when glucose is rapidly dropping towards hypoglycemia.

Official Title
-----------------
Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult A1c >7.4 within last 4 months type 1 or 2 diabetes treated with basal/bolus insulin Exclusion Criteria: under 18 years of age unable to read/write english allergy to adhesives employee of CGM company

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 |
| --- | --- |
| Diabetes Insulin Treated<br>People with type 1 or type 2 diabetes on insulin. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect sufficient glucose data by means of continuous glucose monitoring for the purpose of detecting clinically relevant alterations in blood glucose throughout a typical or modal day. |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous glucose monitoring accuracy
Tissue Drug Levels of HIV Medications

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find out why HIV continues to make copies in people taking HIV drugs. The investigators want to know if the medications most people use to treat HIV get into the lymphatic tissue where HIV persists.

Official Title
-----------------
A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: Initiation of anti-retroviral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV+ Treatment naive or >30 days off ARV therapy Documented sensitivity to prescribed antiretrovirals Age ≥ 18 years Negative pregnancy test for eligible women of childbearing potential Ready to start ARV therapy Exclusion Criteria: Contraindications to surgical & endoscopy procedures (as judged by PI) Psychiatric or psychological illness that would make adherence to protocol procedures unlikely Pregnancy

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 |
| --- | --- |
| ART treated individuals<br> | Drug: Initiation of anti-retroviral therapy<br>* Subjects begin taking a preferred initial anti-retroviral regimens as determined by their primary care provider. Intracellular levels of those medications are measured.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracellular antiretroviral drug concentrations |  | Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months & 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of HIV replication in blood and lymphoid tissue |  | Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, & 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV 1, Pharmacokinetics, Drug levels, Treatment naive
Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is first, to determine whether baseline perfusion characteristics of pancreatic cancer, as characterized by CT perfusion studies, can predict tumor response to treatment by stereotactic body radiotherapy (SBRT). The second goal of this study is to determine whether baseline perfusion characteristics in those patients with resectable pancreatic cancer correlate with immunohistologic markers of angiogenesis such as microvessel density and vascular endothelial growth factor (VEGF) expression.

Official Title
-----------------
Prognostic Value of Baseline CT Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Stereotactic body radiotherapy
* Drug: Iodixanol
* Drug: Iohexol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected and/or biopsy-proven pancreatic adenocarcinoma, and referral to Radiology for pre-treatment baseline pancreatic protocol CT. Exclusion criteria: 1) are absolute contraindications to intravenous iodinated contrast or CT scan.

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

| Intervention/Treatment |
| --- |
|Procedure: Stereotactic body radiotherapy|Standard of Care|
|Drug: Iodixanol|IV, calculated per patient|
|Drug: Iohexol|IV, Calculated per patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological markers of tumor angiogenesis (microvessel density, EGF/VEGF expression level) |  | 1 day | 
| Tumor response to treatment in SBRT patients, based on WHO criteria (No Change/Progressive Disease vs. Partial/Complete Response) |  | 1 year |
Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients

Study Overview
=================
Brief Summary
-----------------
The investigators will collect plasma samples at baseline, during treatment, and at progression.

Detailed Description
-----------------
In this study, the investigators will collect plasma samples at baseline, during treatment, and at progression. This plasma bank will be used to study the potential value of some biomarkers to predict treatment activity or resistance to cetuximab or other targeted agents

Official Title
-----------------
Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck

Conditions
-----------------
Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
-----------------
* Other: Plasma samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated with radiation therapy and cetuximab according to Bonner et al patients treated with cetuximab in combination with chemotherapy according to Vermorken et al. patients treated with a molecular targeted agent as a part of a clinical study Exclusion Criteria: patients with another type of head and neck cancer patients non treated with targeted therapies

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 |
| --- | --- |
| No treatment<br>Patients with squamous cell carcinoma of the head and neck, targeted therapies, plasma samples: Group 1 = patients treated with radiation therapy and cetuximab according to Bonner et al [11] Group 2 = patients treated with cetuximab in combination with chemotherapy according to Vermorken et al. [10] Group 3 = patients treated with a molecular targeted agent as a part of a clinical study | Other: Plasma samples<br>* Plasma samples at baseline (and one whole blood sample) and at every radiological evaluations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective storage of plasma samples of patients treated with cetuximab or other targeted agents | All the analyses will be done when we have enough of collected samples | one year after the collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Targeted therapies, Plasma samples