linjc16/ctgov huggingface dataset:
A Safety Study of ARRY-371797 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 study, involving both 1-day and 8-day dosing periods, designed to test the safety of investigational study drug ARRY-371797 in healthy subjects. Approximately 48 healthy subjects from the US will be enrolled in this study.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Single Day And Multiple Day Ascending Dose Study To Evaluate The Safety And Pharmacokinetics Of Orally Administered ARRY-371797 In Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: ARRY-371797, p38 inhibitor; oral
* Drug: Placebo; oral


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy male or female between the ages of 18 and 60 years. Females must be of nonchildbearing potential. Body weight > 50 kg (110 lbs) and < 113 kg (250 lbs). Additional criteria exist. Key Exclusion Criteria: A positive test for drugs or alcohol. Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug. Additional criteria exist.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARRY-371797<br> | Drug: ARRY-371797, p38 inhibitor; oral<br>* single dose and multiple dose, escalating<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo; oral<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. |  | Duration of study | 
| Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. |  | Duration of study |
Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Official Title
-----------------
Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood glucose criteria must be met Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 22-45 Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of serious diabetic complications Evidence of serious cardiovascular conditions Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose at 24 weeks |  |  | 
| Adverse event profile after 24 weeks of treatment |  |  | 
| Patients with endpoint HbA1c <7% at 24 weeks |  |  | 
| Patients with reduction in HbA1c >/= 0.7% after 24 weeks |  |  | 
| Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Clinical Evaluation of Total-Etch and Self-Etch Dental Adhesives - 6 Year Recall

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the performance of several dental adhesives used for bonding tooth-colored fillings to teeth 6 years after the fillings have been placed. Participants: Subjects which had participated in the study entitled Clinical Evaluation of New Total-Etch and Self-Etch Dental Adhesives (IRB Study #07-0673). Procedures (methods): Fillings that had been placed 6 years ago will be evaluated by a direct, visual examination. Close-up intra-oral clinical photographs of each filling will be made. An impression of the filling may be obtained. The specific study aim of this 6-year recall of the patients treated in IRB Study #07-0673 is to evaluate the fillings placed according to the following characteristics: Retention; Color match; Cavosurface margin discoloration; Secondary caries; Anatomic form; Marginal adaptation and/or integrity; Post-operative sensitivity.

Official Title
-----------------
Clinical Evaluation of Total-Etch and Self-Etch Dental Adhesives - 6 Year Recall

Conditions
-----------------
Dental Bonding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who participated in a 2007 study entitled Clinical Evaluation of New Total-Etch and Self-Etch Dental Adhesives (UNC IRB Study #07-0673). Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 82 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 |
| --- | --- | --- |
| Change from baseline to 6-year follow-up in retention. | Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study. | sole visit (6 years post participation in related study). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 6-year follow-up in color match. | Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study. | sole visit (6 years post participation in related study). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental bonding
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin

Detailed Description
-----------------
When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.

Official Title
-----------------
A Study to Evaluate Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction and Control Healthy Volunteers

Conditions
-----------------
Liver Dysfunction

Intervention / Treatment
-----------------
* Drug: Evogliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <Hepatic Dysfunction> At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction) Child-Pugh A or B <Healthy Control> Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject Exclusion Criteria: <Hepatic Dysfunction> Child-Pugh C History of Liver transplant <Healthy Control> History of chronic liver disorders Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 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: Evogliptin<br>Hepatic dysfunction, Healthy control | Drug: Evogliptin<br>* DPP4-inhibitor, Evogliptin<br>* Other names: DA-1229;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic(Cmax of Evogliptin) |  | Day1, Day2, Day3, Day4, Day5, Day6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type II
Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients

Study Overview
=================
Brief Summary
-----------------
Educating patients on visual performance with presbyopic correcting intraocular lenses is crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic crystalline lens will provide eye care provides useful information to better educate patients on visual performance expectations after cataract surgery with a presbyopic correcting intraocular lens. Our objective will be to assess the subjective range of clear vision of a pre-presbyopic and emerging presbyopic patient population utilizing a defocus curve. A comparison of the pre-presbyopic and emerging presbyopic defocus curve to all FDA-approved presbyopic intraocular lenses will be discussed in the manuscript.

Official Title
-----------------
Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Diagnostic Test: There is not an intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to provide written informed consent on the IRB approved Informed Consent Form 37-48 years of age Phakic Exclusion Criteria: Previous cataract surgery Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA Subjects that are unable to obtain 20/20 BCVA (i.e. amblyopia, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 37 Years
Maximum Age: 48 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: There is not an intervention|There is not an intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LogMar visual acuity during vision testing on ETDRS with loose lenses |  | Screening/enrollment visit |
Pilot Study of cNEP for the Treatment of Snoring

Study Overview
=================
Brief Summary
-----------------
This pilot study will examine the efficacy and safety of continuous negative external pressure (cNEP) for the treatment of chronic snoring in people without obstructive sleep apnea.

Official Title
-----------------
Pilot Study to Assess the Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Reducing Respiratory Sounds in Individuals With Chronic Snoring

Conditions
-----------------
Snoring

Intervention / Treatment
-----------------
* Device: continuous negative external pressure (cNEP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sleep test within the previous six months that shows snoring of at least 30 dB for at least 30% of total sleep time AHI < 10/hr Exclusion Criteria: previous neck surgery or radiation carotid artery disease serious medical or psychiatric illness pregnancy silicone allergy excessive use of alcohol or sedating drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: treatment<br>continuous negative external pressure (cNEP) at various negative pressures | Device: continuous negative external pressure (cNEP)<br>* soft silicone collar placed on the anterior neck, to which a negative pressure is introduced<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | snoring decreased by <50% from baseline | one night | 
| Adverse Events | all adverse events | one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response | snoring for < 5% of total sleep tim | one night |
Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.

Official Title
-----------------
Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial

Conditions
-----------------
The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization

Intervention / Treatment
-----------------
* Other: Advanced Care at Home (ACH)
* Other: Traditional Brick-and-Mortar Hospitalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18 years of age and older. Present to one of the participating hospitals. Have a chief complaint of one of the target diagnoses. Are within a certain geographical area (based on zip codes). Have a health insurance plan that covers ACH services. Have the capacity to consent or could assent with the consent of a health care proxy who is physically present. Exclusion Criteria: The patient is not suitable for ACH or inpatient hospital care based on: being a nursing home patient; on or requiring dialysis; positive for COVID-19; having discharge order; requiring intensive care unit (ICU) level of care; history of drug abuse. Patients will also need to meet the clinical stability criteria. Do not have the capacity to consent or assent with the assistance of a health care proxy.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Care at Home (ACH)<br>Patients will receive inpatient hospitalization at home. | Other: Advanced Care at Home (ACH)<br>* Inpatient hospitalization offered in the home setting.<br>|
| Active Comparator: Traditional Inpatient (Brick-and-Mortar) Hospital Care<br>Patients will receive inpatient hospitalization at the hospital. | Other: Traditional Brick-and-Mortar Hospitalization<br>* Inpatient hospitalization offered in the hospital setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is a composite outcome of all-cause mortality | The rate of death | 30 days post-discharge | 
| 30-day readmission. | readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge. | 30 days post-discharge |
Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults

Study Overview
=================
Brief Summary
-----------------
This 5-year prospective, observational study will: (1) determine the individual, social, and environmental predictors of sleep duration, quality, latency, efficiency, timing and regularity in African American smokers, (2) quantify the prospective relationship between multiple metrics of sleep with tobacco use, such that a sleep phenotype of risk for smoking is defined, and (3) examine the extent to which short sleep (<7 hrs) and other unhealthy sleep metrics, predicts lung function through smoking behaviors and inflammation, in 480 African Americans at risk for advancing COPD (GOLD Stage 0-2 and current smoker). Study subjects will be recruited via Temple Health System sites. Following eligibility screening, initially eligible subjects will provide written study consent and complete an in-home sleep assessment to rule out the exclusionary moderate-severe sleep apnea and other sleep disorders. Consenting and eligible subjects will be entered into the study and across the 60-month data collection period, complete 8 assessments: 4 annual clinical based assessments, interspersed by 4 mid-year, phone-based, self-report assessments.

Official Title
-----------------
Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults

Conditions
-----------------
Sleep, Lung Diseases, Smoking

Intervention / Treatment
-----------------
* Other: Cohort Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-reported African American, White, or mixed ethnicity. 40 - 67 years. GOLD stage 0-3 as assessed by spirometry. No moderate-severe sleep disorders or use of sleep medication. Self-reported current cigarette smoker as defined by smoking one or more cigarettes in the last month. Able to communicate in English and provide written informed consent. Exclusion Criteria: Self-reported ethnicity (in full or part) other than Black/African American or White. < 40 years of age. Not a current cigarette smoker (< 1 cigarette in last month). GOLD stage >3. Presents with a diagnosed moderate-severe sleep disorder Use of any sleep medication. -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 67 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cohort Observational study|Cohort Observational study - there is no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1/FVC ratio | Lung function as defined as the ratio of Forced Expiration Volume in one second (FEV1) to the Forced Vital Capacity (FVC; FEV1/FVC ratio) will be computed | 365 days |
An Observational Study on The Impact of Insulin Resistance on Sustained Virological Response in Patients With Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated with Pegasys and Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and for 24 weeks of treatment-free follow-up.

Official Title
-----------------
Prospective Observational Study to Asses the Insulin Resistance (IR) and Its Impact on Sustained Virological Response in a Cohort of HCV-infected Patients Treated With Pegasys and Copegus

Conditions
-----------------
Hepatitis C, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Chronic hepatitis C (detectable HCV RNA) Initiation of treatment with Pegasys and Copegus Exclusion Criteria: Participation in a clinical trial during the study

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay) |  | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Host-, virus- and treatment-related factors influencing virological response and sustained virological response |  | 42 months | 
| Parameters of metabolic syndrome |  | 42 months | 
| Management of insulin resistance |  | 42 months | 
| Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ) |  | 42 months | 
| Safety: Incidence of adverse events |  | 42 months | 
| Patient characteristics |  | 42 months |