linjc16/ctgov huggingface dataset:
Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women.

Detailed Description
-----------------
Project development relied on principles of community based participatory research. Participants were recruited from faith institutions in four distressed Appalachian Kentucky counties. Investigators at the University of Kentucky worked closely with local staff who implemented study procedures in the field.

Official Title
-----------------
An Appalachian Cervical Cancer Prevention Project

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Behavioral: Lay health advisor visits and newsletter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outside of cervical cancer screening guidelines at the time of study initiation Able to provide informed consent Exclusion Criteria: History of cervical cancer History of hysterectomy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention<br>This group served as the treatment group for analysis of the primary outcome. | Behavioral: Lay health advisor visits and newsletter<br>* The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.<br>|
| No Intervention: Delayed Intervention<br>This group served as a wait-list control group, eventually receiving the intervention after the treatment group completed the intervention and the primary outcomes were assessed for both groups. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants self-reporting receipt of Pap test | This measure is obtained at multiple timepoints during the study, but as the primary outcome it will be analyzed at the timepoint one month following the Early Intervention group's completion of the intervention. | One month post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Papanicolaou test, Cervical cancer screening, Randomized controlled trial, Faith-placed, Appalachia
Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Study Overview
=================
Brief Summary
-----------------
The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years. The purpose of this study is to examine whether treatment of insomnia with cognitive behavioral therapy (CBT-I) is associated with a decrease in dementia biomarkers found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia will undergo overnight polysomnography and CSF sampling in the morning. This will be followed by 8 weeks of treatment with CBT-I and then repeat CSF sampling.

Official Title
-----------------
Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Conditions
-----------------
Insomnia Chronic

Intervention / Treatment
-----------------
* Behavioral: cognitive behavioral treatment of insomnia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 30-50 Men and women Meet DSM5 Diagnostic Criteria for insomnia disorder Exclusion Criteria: Diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history Women who have been pregnant or lactating within the past six months Non-fluency in spoken or written English Current or past month shiftwork defined as working during the evening or night shift Current use of medications or OTC products that impact sleep Evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, Chiari malformation).

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 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: Cognitive behavioral treatment of insomnia (CBT-I)<br>Eight weeks of cognitive behavioral treatment of insomnia. | Behavioral: cognitive behavioral treatment of insomnia<br>* A behavioral modification program consisting of 8 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF markers related to dementia | CSF levels of the proteins tau and beta amyloid | 8 weeks |
Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

Study Overview
=================
Brief Summary
-----------------
Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.

Conditions
-----------------
Parkinson's Disease With Deep Brain Stimulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic Parkinson's disease Age > 21 Underwent DBS surgery targeting the subthalamic nucleus (STN) Bilateral or midline involvement when off DBS/medication state Clinical history of gait impairment or freezing of gait Exclusion Criteria: Parkinson's plus syndrome, secondary, or atypical Parkinson's disease Underwent DBS surgery targeting the ventral intermediate (VIM) Unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study) Dementia (determined by a neuropsychological assessment).

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Parkinson's Disease with DBS<br>Individuals with Parkinson's disease and deep brain stimulation will be recruited. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of DBS cessation on motor function over time | Motor function evaluations (movement speed and magnitude) will be collected at various time points after DBS cessation. The effects over time will be examined. | All data will be collected within a single session not to exceed 4 hours. All data will be analyzed within one month of study completion. |
Pain in Different Office Hysteroscopy Diameter

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigators'study was To compare 2 different diameter rigid hysteroscopy in vaginoscopic approach regarding pain during and after the procedure. And to evaluate patient acceptability and tolerability in order to determine the best way to perform hysteroscopy in an outpatient setting.

Detailed Description
-----------------
Office hysteroscopy is used as diagnostic tool to investigate abnormal uterine bleeding and other diseases involving the uterine cavity one of The main limitation to its widespread use is feared from pain and low patient tolerability Narrower diameter hysteroscopy and endometrial biopsy devices are being developed to improve the acceptability of office hysteroscopy. Miniature optical systems allow performance of most diagnostic and operative hysteroscopy (after proper patient selection) in an outpatient or office setting .Flexible hysteroscopy seem to be less painful at the beginning and during the procedure ,but the optical qualities are poor Hysteroscopy is safe, feasible and accurate procedure for diagnosing intrauterine pathology. Provision of outpatient based diagnostic and operative services are gaining prominence as a standard of cure but the experience of pain can be off-putting for patients having outpatient diagnostic hysteroscopy. saline solution is an excellent alternative to carbon dioxide in women undergoing outpatient hysteroscopy, and there are fewer complications

Official Title
-----------------
Comparison of Pain Accompanying the Use of 3.7 mm and 4 mm Office Hysteroscopy in Nullipara: A Randomized Clinical Trial

Conditions
-----------------
Pain Associated Office Hysteroscopy

Intervention / Treatment
-----------------
* Procedure: office hysteroscopy 3.7
* Procedure: office hysteroscopy 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman with nulliparous cervix Exclusion Criteria: Pregnancy. female genital cancer Active pelvic infection Multipara patient not receiving misoprostol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group(A)<br>2.7 mm rigid hysteroscopy. | Procedure: office hysteroscopy 3.7<br>* office hysteroscopy with a 3.7 -mm outer sheath<br>|
| Group(B)<br>2.9 mm rigid hysteroscopy. | Procedure: office hysteroscopy 4<br>* office hysteroscopy with a4-mm outer sheath<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain more than 4 (according visual analogue scale |  | 5 minute |
Control Study of Nautilus BrainPulse for the Detection of Concussion

Study Overview
=================
Brief Summary
-----------------
To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.

Detailed Description
-----------------
This study is a non-blinded study in high school athletes who will be presumed to no be suffering from a concussion. Healthy controls will be recruited from high school sports that are not associated with physical contact, which could generate concussions. The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical will perform analysis.

Official Title
-----------------
Non Blinded Control Study of High School Athletes in Non Contact Sports

Conditions
-----------------
Brain Concussion

Intervention / Treatment
-----------------
* Device: Nautilus BrainPulse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female between 14 and 19 years of age Participating in non-contact sport at the Freshman, JV, and varsity level in a Bay Area High School Able to provide signed informed consent or have a legally authorized representative willing to provide informed consent on the subject's behalf Exclusion Criteria: History, if any, of concussion or stroke History, if any, of alcohol or drug abuse History, if any, of mental disorder or cerebrovascular disorder Pregnant women Failure to comply with recording schedule Not suitable for participation in the study in the opinion of the PI Have suffered a concussion during the study Plays a contact sport (ex- football, lacrosse, basketball, soccer, ice hockey, cross-country) Related to a Jan Medical employee

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 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>Nautilus BrainPulse | Device: Nautilus BrainPulse<br>* A noninvasive device to detect concussion utilizing headset and sensors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport | BrainPulse recordings collected in this study will be used as an age-matched control cohort for comparison with already collected concussion data that is under development for identifying a concussion algorithm. The device recordings will be visually compared for similarities and differences using data mining practices looking for features that are consistent between the concussion subjects and healthy normals. | 4 months |
Healthcare Decisions on Dietary and Environmental Allergen Exposure

Study Overview
=================
Brief Summary
-----------------
Design of this study is to collect data and review Principal Investigators standard operating procedures on allergy testing and changes made to their specific SOP.

Detailed Description
-----------------
The purpose of this minimal risk observational study is to increase surveillance for dietary and environmental allergens exposure and to also determine targeted risk reducing and preventative strategies.

Official Title
-----------------
Medical Provider Experience and Assessment on Healthcare Decisions Regarding Dietary and Environmental Allergen Exposure

Conditions
-----------------
Dietary Allergy, Environmental Allergy

Intervention / Treatment
-----------------
* Other: Standard Operating Procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a medical practitioner Medical Doctor (MD) Doctor of Osteopathic (DO) Physician Assistant (PA) Advanced Practice Registered Nurse (APRN) Nurse Practioner (NP) Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history. Exclusion Criteria: Government funded insurance data cannot be included in the study
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Standard Operating Procedures|Observational on Standard Operating Procedures|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Structures and Processes | Plan of Care Changes due to Allergy testing. Provider based observational survey system on the health and well being of patients and populations. | 36 months |
Non Attendance at Scheduled Appointments as a Marker of Mortality and Hospital Admission

Study Overview
=================
Brief Summary
-----------------
To evaluate the association of non attendance at scheduled appointments with visits in the emergency department, hospitalizations and mortality during one year follow up.

Detailed Description
-----------------
Nonattendance at scheduled appointments at outpatient clinics is a common problem in general medical practice, representing a significant cost to the health care system, and resulting in disruption of daily work planning.Nonattendance at medical appointments has consequences not only for doctors (as it requires a greater use of resources and time), but also for patients, because there may be deterioration in the quality of care, and dissatisfaction associated with delays in obtaining a new appointment

Official Title
-----------------
Non Attendance at Scheduled Appointments as a Marker of Visits in the Emergency Department, Hospitalization and Mortality

Conditions
-----------------
Appointments and Schedules, Outpatient Clinics, Hospital/Economics, Emergency Department, Hospitalization, Mortality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 17 years. Adults who attended, did not attend a scheduled appointment at the Outpatient care system at the Italian Hospital of Buenos Aires (HIBA) Exclusion Criteria: - The refusal to register or to the informed consent process.

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 |
| --- | --- |
| Retrospective Cohort<br>Retrospective Cohort of scheduled outpatient appointment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Mortality of all causes retrospective assesment from secondary data bases | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause unprogrammed consult to the emergency department | First emergency department consults from secondary data base in 1 year retrospective | 1 year | 
| All cause unprogrammed admissions to hospital | First all cause unprogrammed admissions to hospital | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appointments and Schedules, Outpatient Clinics, Hospital/Economics, Emergency Department, Hospitalization, Mortality
A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150 mg SR Tablets under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.
* Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bupropion HCI ER Tablets, 150 mg | Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.<br> <br> |
| Active Comparator: 2<br>WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg | Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA timelines |  | 29 days |
A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

Official Title
-----------------
A Phase II, Randomised, Dose-Ranging, Open-Label, Multi-Centre Study to Evaluate the Safety and Efficacy of Celgosivir for 12 Weeks in Patients With Chronic Hepatitis C Infection

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

Intervention / Treatment
-----------------
* Drug: Celgosivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be 18 to 65 years of age, inclusive. Primary diagnosis of chronic HCV infection. Exclusion Criteria: Patients who did not respond or relapsed following therapy with interferon.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Celgosivir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analysis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C viral load |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Celgosivir, HCV, Genotype 1