linjc16/ctgov huggingface dataset:
Impact of Disease on the Concept of End-of-life Decisions of the Elderly in the Community

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the priorities of the elderly in the community about end-of-life decisions. To check the perception of the disease in the elderly in the community.

Detailed Description
-----------------
This study is descriptive adapters which examines the relationship between illness perception and preferences of end of life decisions in the elderly in the community. Population and sample: The target population will be elderly and healthy community elderly population was accessible due to a special branch of the club together in the center of the country. Sample to be a sample of convenience. The study will include 88 seniors aged 65 and over to get the power of 0.80 and alfa 0.05, Tools: The study used three tools. The first tool is a questionnaire on demographic and clinical details The second tool questionnaire the Long term support program (LTSP) The third tool is a questionnaire perception of the disease Revised Illness Perceptions Questionnaire (IPQR) The research process: Investigator will present the proposal to the Commissioner Fund hospitals and request approval for the study. After receiving approval from the director Department of Health fund the hospital will make data collection phase HMO, days and hours of reception. Interrogator he is to partition the questionnaires and will be present when filling out the questionnaires to help, if and created a situation of lack of understanding of the questionnaires. Scholar, came to the population for the Disabled arriving at the clinic visit, and introduce himself and the subject of research. investigator will indicate questionnaire is anonymous.

Conditions
-----------------
Sick Elderly

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic illness Literate in Hebrew Treated in community HMO Exclusion Criteria: Someone hospitalized in previous year History of mental illness Cognitive problems

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Sick elderly in community<br> | Other: Questionnaire<br>* Questionnaire to be distributed among sick elderly in the community<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sick Elderly in the Community | Questionnaires regarding end-of-life decisions and perception of illness | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End of life decisions, Perception of illness
Same Day Discharge for Wedge Resection

Study Overview
=================
Brief Summary
-----------------
Monitoring carefully selected participants to determine if participants can be safely discharged the same day of pulmonary resection

Detailed Description
-----------------
Determination of the feasibility of implementing a same day discharge program after minor pulmonary surgery. This will be determined by evaluating the percentage of participants who have chest tubes removed successfully, as well as evaluating the percentage of participants who would be classified as discharged on the day of surgery. The investigators will also be evaluating morbidity associated with this protocol by capturing rates of pleural reintervention.

Official Title
-----------------
The Development of a Novel Same Day Discharge Program After Pulmonary Resection: A Safety and Feasibility Pilot Study

Conditions
-----------------
Surgery, Minor, Lung Cancer

Intervention / Treatment
-----------------
* Other: same day discharge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years of age and older who are scheduled to undergo an elective minimally invasive wedge resection of their lung. Exclusion Criteria: Pulmonary function tests demonstrating forced expiratory volume in 1 second (FEV1) <70% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide (DLCO) <70% predicted. Patients is an active smoker within 4 weeks of their surgery. Patient receives an intraoperative pleurodesis. Conversion to open thoracotomy or mini thoracotomy intraoperatively. Any history or suspicion of untreated obstructive sleep apnea. Active pregnancy. Thoracic Revised Cardiac Risk Index Score (ThRCRI)8 >2. Underlying cognitive disorder resulting in inability to complete activities of daily living.

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
Intervention Model: Sequential Assignment
Interventional Model Description: 2 phases
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Discharge<br>Phase 1-Patients will continue to be admitted after their surgery as is the current practice. Phase 2-Patients will have their chest tube removed once they meet chest tube removal criteria and will be discharged home once they meet discharge criteria. | Other: same day discharge<br>* same day discharge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful same day discharge | These patients will have their chest tube removed once they meet chest tube removal criteria and will be discharged home once they meet discharge criteria. | 2 years |
Effects of Lomitapide on Carotid and Aortic Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.

Detailed Description
-----------------
This is a multi-center long-term open-label non-comparative study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. Patients from countries in the EU, the US and Canada who are being treated with lomitapide and are enrolled in The Lomitapide Observational Worldwide Evaluation Registry (LOWER), will be invited by the LOWER enrolling physician to participate in this substudy.

Official Title
-----------------
Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)

Conditions
-----------------
Homozygous Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Lomitapide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Adult patients (age ≥18 years) who are enrolled in LOWER Exclusion Criteria: Patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy Patients with a contraindication to MRI examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body) Patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment Patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality MRI scans Patients with an implanted insulin pump Patients with metal shrapnel or bullet wounds Patients with a body mass index (BMI) > 40 kg/m2 (since it may be difficult to position comfortably with the MRI scanner) Patients who work with metal lathes (unless an orbit x-ray performed prior to the enrollment MRI scan has been done to rule out metal fragments in the eye)

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 |
| --- |
|Drug: Lomitapide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline in cartoid vessel wall area at the two-year evaluation |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline to one and five years on therapy for carotid and aortic vessel wall area, and carotid and aortic vessel wall thickness. |  | 5 Years |
Computer Vision Syndrome Visual Sequelae

Study Overview
=================
Brief Summary
-----------------
the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations

Detailed Description
-----------------
CVS-F3 is a survey form consisted of up to 30 questions regarding Computer Vision Syndrome (CVS) complains, thereafter a randomized sample of students will be subjected to complete ophthalmic examination including visual acuity and refractive measurements, intraocular pressure measurements, Slitlamp and fungus examinations, mfERG examinations. the sudents will be requested to decrease their screen time and the examinations will be repeated one month later.

Official Title
-----------------
Visual and Ocular Sequelae of Computer Vision Syndrome: A Randomized Controlled Trial

Conditions
-----------------
Computer Vision Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: mfERG (multifocal-retinogram)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - University students Exclusion Criteria: Amblyopia Anisometropia strabismus Previous eye surgery
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-complaining group<br>the students in this group are not complaining of CVS symptoms but will be examined to diagnose CVS or exclude it | Diagnostic Test: mfERG (multifocal-retinogram)<br>* mfERG will be performed for the students to document the effect of CVS on retina<br>|
| Experimental: Complaining group<br>the students in this group are complaining of CVS symptoms but will be examined to document their complains and correlate to clinical findings | Diagnostic Test: mfERG (multifocal-retinogram)<br>* mfERG will be performed for the students to document the effect of CVS on retina<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | visual changes i.e. uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) using logMAR measurements following reduction of screen time | 1 month | 
| near vision | near vision changes following reduction of screen hours using card test, near visual acuity chart and near point test while the measurements will be diopters and lines of near chart | 1 month |
Genetics of Spina Bifida and Anencephaly

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to discover the genetic and environmental factors that contribute to the cause of neural tube defects such as spina bifida and anencephaly. Ultimately, this type of research may result in improved diagnosis, improved treatment and possibly prevention.

Official Title
-----------------
The Hereditary Basis of Neural Tube Defects

Conditions
-----------------
Anencephaly, Acrania

Participation Criteria
=================
Eligibility Criteria
-----------------
Not currently enrolling new participants.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anencephaly<br>Fetuses with anencephaly, parents and siblings | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genetic factors associated with neural tube defects | This study aims to discover genetic factors associated with neural tube defects such as anencephaly. | end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anencephaly, acrania
Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.

Official Title
-----------------
Phase 1 Study of Mirtazapine in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: mirtazapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male sex Age 20-25 years Somatically and mentally healthy Normal body weight (body mass index (BMI)18.5-25) Exclusion Criteria: Smoking within the last 6 months Medication within last 6 months Current or former psychiatric illness Positive family history (first grade relatives) for metabolic diseases Alcohol abuse Current or former illicit drug abuse Current or former drug abuse Known intolerance to, or former prescription of study medication Participation in other clinical trials at the same time or participation in clinical trials associated with administration of a drug within the last 6 months Homelessness Shift work within last 12 months Known hypersensitivity to mirtazapine or other components of the drug given Known epilepsy; glaucoma; liver, kidney, or heart disease; urinary dysfunction; hypotonia; diabetes or any other metabolic disease Known hematologic disease, especially agranulocytosis or leukopenia Blood donation within last 6 months prior to the begin of the study Hemoglobin below 13.5 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mirtazapine<br> | Drug: mirtazapine<br>* 30 mg mirtazapine once daily for 7 days<br>* Other names: Remergil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mirtazapine, metabolism, depression, Healthy males
Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
=================
Brief Summary
-----------------
PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Pirfenidone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Select Inclusion Criteria: Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration Age 40 to 80 at randomization Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening Select Exclusion Criteria: Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of bronchodilator at Screening Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization Known explanation for interstitial lung disease History of asthma or chronic obstructive pulmonary disease Active infection Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Arm<br> | Drug: Pirfenidone<br>* Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.<br>|
| Placebo Comparator: Placebo Arm<br> | Drug: Placebo<br>* Placebo equivalent given as 3 divided doses 3 times per day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pirfenidone, ASCEND, IPF, FVC
Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed)

Study Overview
=================
Brief Summary
-----------------
The goals of this R21 exploratory pilot and feasibility study were to: 1) design an Internet-based self-management intervention for adolescents with type 1 diabetes; 2) test that intervention in a small randomized trial to establish technical feasibility, intervention acceptability, and competence in completing the necessary recruitment and research procedures. Although not powered to detect statistically significant changes, possible outcomes of this study include improvements in problem-solving, coping, and self-management behaviors.

Official Title
-----------------
Adolescent Self-Management of Type 1 Diabetes: an Intervention

Conditions
-----------------
Adolescent Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: YourWay Internet Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:diagnosed for at least 6 months, age 13-17; Internet access, parental consent - Exclusion Criteria: Any sensory deficits that would preclude seeing or hearing. -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Measurement Only<br> | Behavioral: YourWay Internet Intervention<br>* The intervention is an 11 week program that teaches problem solving of barriers to self-management.<br>|
| Experimental: Internet Intervention<br> | Behavioral: YourWay Internet Intervention<br>* The intervention is an 11 week program that teaches problem solving of barriers to self-management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management behaviors |  | End of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management Problem solving |  | end of study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, adolescent, self-management
Seal Pressure With Classical Laryngeal Mask and Cookgas Mask in Adult Patients

Study Overview
=================
Brief Summary
-----------------
The working hypothesis in this study is that the supraglottic device COOKGAS provides seal pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are sommeted to both interventions.

Official Title
-----------------
EFFECTIVENESS OF SEAL PRESSURE IN AIRWAY OF THE CLASSIC LARYNGEAL MASK AND THE COOKGAS LARYNGEAL MASK IN ADULT PATIENTS UNDERGOING SURGERY IN AMBULATORY SETTINGS

Conditions
-----------------
Seal Pressure

Intervention / Treatment
-----------------
* Device: cookgas mask
* Device: LMA mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years Patient ASA I, II and III Complete fast Ambulatory Surgery Time less than two hours surgically Supine Surgery Acceptance of informed consent Exclusion Criteria: No acceptance of informed consent Pregnancy or breastfeeding Hemostatic alterations Abdominal surgery History of gastrointestinal reflux BMI over 35 Mouth opening less than 1.5 cm Airway abnormalities Surgery in respiratory tract

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cookgas<br>This group will be assigned to use cookgas mask | Device: cookgas mask<br>* This group will be assigned to use cookgas mask<br>|
| Active Comparator: LMA mask<br>This group will be assigned to use LMA mask | Device: LMA mask<br>* LMA mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seal pressures | The primary objective is to determine the effectiveness of the seal pressure between the mask COOKGAS ™ and LMAc in patients undergoing outpatient surgeries in ambulatory-based IPS, University of Antioquia (institution services health clinic) located in the city of Medellin. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seal pressure, Cookgas, AirQ, LMA, supraglottic device