linjc16/ctgov huggingface dataset:
Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

Study Overview
=================
Brief Summary
-----------------
To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: PEB
* Device: PES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intermittent claudication or critical limb ischemia de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis >70%) Exclusion Criteria: life expectancy <1 year contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel need for major amputation (MA) at the time of enrolment Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEB<br>PEB angioplasty plus provisional nitinol stent implantation | Device: PEB<br>* Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation<br>|
| Experimental: PES<br>Systematic PES angioplasty | Device: PES<br>* Systematic Paclitaxel eluting stent angioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic binary restenosis | incidence of binary restenosis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all cause mortality, major amputation and target lesion revascularization. | incidence of composite endpoint of all cause mortality, major amputation and target lesion revascularization. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femoropopliteal lesions
Effect of Immunophenotype on Prognosis of Sepsis

Study Overview
=================
Brief Summary
-----------------
The popuse of this study is to assess the inflammatory immunophenotypes of sepsis patients are significantly correlated with prognosis, which may provide theoretical basis for precise immune regulation of sepsis.

Detailed Description
-----------------
The clinical characteristics and inflammatory/immune markers of sepsis patients were analyzed dynamically and followed up to one year after diagnosis. Through latent category analysis, cluster analysis and other inflammatory immunophenotypes, the clinical characteristics of different inflammatory immunophenotypes and their relationship with the long-term prognosis of sepsis were clarified.

Official Title
-----------------
The Effect of Immunophenotype on Prognosis of Sepsis

Conditions
-----------------
Sepsis, Septic Shock, Sepsis Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with sepsis 3 diagnostic criteria were admitted to ICU; Aged 18 or above; Within 24 hours of diagnosis. - Exclusion Criteria:Malignant tumor; Autoimmune diseases; Diseases of the blood system; HIV infection; History of high-dose glucocorticoid use (hydrocortisone 200mg/d or other hormone with equivalent titer, more than one week); 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival or death in 28 days | observe wether the patients is survival or death in 28 days | From date of randomization until the date of out of ICU or date of death from any cause, whichever came first, assessed up to 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunophenotype
An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache

Official Title
-----------------
An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

Conditions
-----------------
Headache, Migraine

Intervention / Treatment
-----------------
* Device: Occipital nerve stimulation ON
* Device: Occipital nerve stimulation off


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with migraine patients 18 years aged or above Exclusion Criteria: patients which participated within the last 30 days or plan to participate during this study in another device or drug trial patients pregnant or planning on becoming pregnant during the study period

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occipital nerve stimulation ON<br> | Device: Occipital nerve stimulation ON<br>* Implant of an occipital nerve stimulator switched ON<br>|
| Other: Occipital nerve stimulation OFF<br> | Device: Occipital nerve stimulation off<br>* Implant of an occipital nerve stimulator switched OFF<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and the type of adverse events |  | Study period | 
| Reduction of headache frequency and intensity |  | Study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in drug intake |  | Study period | 
| Changes in QoL and interference in everyday activities |  | Study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache, Migraine
The Safety of Anesthesia Management for Traumatic Hip Surgery in Elderly

Study Overview
=================
Brief Summary
-----------------
Trauma for hip joint is common in old people. Anesthesia in these types of old patients carries more risk than the adult population. In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications.

Detailed Description
-----------------
Trauma for hip joint is common in old people; usually trauma for the hip joint is treated surgically under anesthesia. Anesthesia in these types of old patients carries more risk than the adult population, since these type of patients have a lot of chronic diseases which affect their general health. In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia between the years 2010 to 2015, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications like Deep Venous Thrombosis, Pulmonary complications, myocardial Infarction and others.

Official Title
-----------------
The Safety of Anesthesia Management for Traumatic Hip Surgery in Elderly: A Retrospective Study in a Tertiary Hospital

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Procedure: Hip fracture surgery and anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who sustained hip fracture. patients who underwent surgical correction under Regional or general anesthesia. Exclusion Criteria: Patients who sustained Hip fractures but treated conservatively.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hip fracture surgery and anesthesia|any operative fixation for hip fracture whether under General Anesthesia or Regional anesthesia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications | Complications like: Deep Venous Thrombosis, Pulmonary complications, Myocardial Infarction and others. | 30 days post-operative |
Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Study Overview
=================
Brief Summary
-----------------
This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.

Official Title
-----------------
An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Etanercept
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed the previous double-blind,randomized study. Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so. Exclusion Criteria: Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation. Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etanercept|nan|
|Drug: Methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis
Oral Mucosal Lesions Among Smokers in an Egyptian Population.

Study Overview
=================
Brief Summary
-----------------
This cross-sectional study will assess the prevalence of oral changes among smokers in an Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo University), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in Egypt

Detailed Description
-----------------
The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Official Title
-----------------
Prevalence of Oral Mucosal Lesions Among Smokers in an Egyptian Cohort: A Hospital-based Cross-Sectional Study (II)

Conditions
-----------------
Smokers

Intervention / Treatment
-----------------
* Other: printed questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: males and females. Age: all age groups. Smokers. Individuals who agreed to sign the informed consent. Exclusion Criteria: Individuals suffering from any systemic disease. Individuals on medications. Non-Egyptians.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: printed questionnaire|For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral mucosal lesions | Identifying and recording oral mucosal lesions | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health-related quality of life (OH-QoL) evaluation | using Oral Health Impact Profile (OHIP) | one year | 
| histopathological evaluation | light microscope | one year |
Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics. Despite cognitive and motor difficulties, there is a possibility of intervention based on the knowledge of motor learning. However, it is important to study the motor learning process in individuals with DS during a virtual reality task to justify the use of virtual reality to organize intervention programs. The aim of this study was to analyze the motor learning process in individuals with DS during a virtual reality task. Methods: A total of 40 individuals participated in this study, 20 of which were with DS (24 males and 8 females, ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and gender to the individuals with DS. To examine this issue, we used software that uses 3D images and reproduced a coincidence timing task.

Official Title
-----------------
Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Behavioral: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical diagnosis of DS and the ability to understand the task. Exclusion Criteria: disorders in cognitive function that would prevent comprehension of the experimental instruction

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 28 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Down Syndrome Group<br>Group with Down Syndrome | Behavioral: Virtual reality<br>* Evaluation of observational motor learning using virtual reality<br>|
| Active Comparator: Typical Development Group<br>Control group with typical development | Behavioral: Virtual reality<br>* Evaluation of observational motor learning using virtual reality<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Learning test by using a timing coincident task in virtual reality | Improvement on their performance, by reaching the task with precision | four months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality
Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)

Study Overview
=================
Brief Summary
-----------------
The study seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in a Doppler mode is placed on the chest wall and the unique software the investigators have developed analyzes the signals reflected from within the lung. On the basis of of pilot studies performed previously the investigators expect to receive different signals from different diseases that will enable diagnosis of different lung diseases.

Official Title
-----------------
Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)

Conditions
-----------------
Lung Disease, Chronic Obstructive, Lung Disease, Interstitial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to provide informed consent Age 18 years or older Clinic and hospital records including additional background medical data such as results of echocardiograms, cardiac catheterization pathology reports etc., available and accessible. Evaluation by a physician who determines that a High Resolution Computed Tomography (HRCT) of the Thorax and pulmonary function tests, including spirometry, lung volumes and diffusion capacity, are indicated as part of the standard clinical care. If full lung function tests are normal imaging with a regular chest x-ray is sufficient. Study Population - subjects will be grouped based on the following criteria after obtaining pulmonary function tests and HRCT of the thorax - COPD based on clinical assessment and spirometry showing airflow limitation i.e., (FEV1/FVC < 0.70). Interstitial lung disease (ILD) diagnosed by HRCT. Control subjects presenting with pulmonary complaints evaluated by full PFTs (spirometry, lung volume and DLCO) and a chest x-ray and/or HRCT , all found to be within normal limits, . Exclusion Criteria: Primary or metastatic lung cancer. Acute pneumonia. Concomitant or previous diagnosis of Bronchial Asthma. Patients with severe chest wall deformity Decompensated heart failure or volume overload. Significant right-sided pleural effusion.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of Lung Doppler signals obtained from different lung diseases. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic obstructive lung disease;, Interstitial lung disease;, Ultrasound Doppler;, Lung disease diagnosis;
Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of the GET2HOME Intervention bundle.

Official Title
-----------------
Garnering Effective Telehealth 2 Help Optimize Multidisciplinary Team Engagement

Conditions
-----------------
Children With Complex Chronic Conditions

Intervention / Treatment
-----------------
* Behavioral: GET2HOME Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with complex chronic disease based on a Pediatric Medical Complexity Algorithm (PMCA) score of 3 and their families and their primary care providers Discharged from pediatric hospital medicine service at our hospital Exclusion Criteria: Patients who live independently without a parent or guardian in the home, including those that live at skilled nursing facilities Patients admitted for end of life care Patients admitted for suicidal or homicidal ideation Patients who previously enrolled in the study Patients in county custody
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Hospital-Based Care Coordination<br>Patients and families randomized to this arm will receive best practice standard of care hospital-based transition planning in the hospital with routine outpatient care team follow-up post-discharge. | |
| Experimental: GET2HOME Intervention<br>The GET2HOME intervention includes: 1) a pre-discharge telehealth huddle with the family, inpatient team, primary care team, and home care nursing; 2) a visual discharge task tracker (DTT) to monitor progress across care management tasks; and if desired by family and primary care 3) a post-discharge telehealth huddle 2-7 days after discharge with the family, inpatient team, primary care team, and home care nursing | Behavioral: GET2HOME Intervention<br>* Intervention bundle designed to improve discharge effectiveness<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urgent healthcare reutilization | Yes/no to any: unplanned hospital readmission, ED revisit, or urgent care visit | 30-days post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Quality of Life Scale | Quality of Life assessment for child, caregiver and family; minimum score 0, maximum score 100; higher score means a better outcome | 7-, 30-, 60-, and 90-days post-discharge | 
| Return to baseline | Capturing the time it takes to return to a normal routine (family designed measure) | 7-, 30-, 60-, and 90-days post-discharge |