linjc16/ctgov huggingface dataset:
Diabetes Medication Choice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.

Official Title
-----------------
Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Diabetes Medication Choice decision aid
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Have a diagnosis of type 2 diabetes mellitus of any duration; c-peptide test not required Use 1 or 2 oral hypoglycemic agents; not using insulin therapy Are not pregnant Have stable but inadequate glycemic control: both A1C at the time of eligibility and previous A1c within 6 months between 7-9.5% Recognize their primary care provider as their main diabetes care provider Do not have major barriers (i.e., severe hearing impairment, dementia, cannot communicate in English) to participate in shared decision-making (per provider?s assessment) Have no plans to relocate out of town in the next 6 months Enrolment is open to males and females of diverse racial backgrounds

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Medication Choice decision aid<br>Patients in this arm will discuss diabetes medication for glucose control with the help of a decision aid that covers five commonly prescribed anti-hyperglycemic medications. | Behavioral: Diabetes Medication Choice decision aid<br>* The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.<br>|
| Other: Usual Care<br>Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner. | Behavioral: Usual Care<br>* Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding |  | Directly proceeding the clinical encounter | 
| Decisional Conflict |  | Directly proceeding the clinical visit | 
| Treatment Action, adherence |  | Directly proceeding the clinical encounter, 6 months after the clinical encounter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trust |  | Directly proceeding the clinical visit | 
| Acceptability |  | Directly proceeding the clinical encounter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decision aid, diabetes, primary care
TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

Study Overview
=================
Brief Summary
-----------------
Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited. This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.

Official Title
-----------------
TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

Conditions
-----------------
Hematopoietic Stem Cell Transplant (HSCT), Diffuse Alveolar Hemorrhage, Thrombotic Microangiopathies, Interstitial Pneumonitis, Bronchiolitis Obliterans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT. Exclusion Criteria: Subjects over 24 years of age.

Ages Eligible for Study
-----------------
Maximum Age: 24 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 |
| --- | --- |
| Pediatric and young adult HSCT recipients<br>Prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Lung Injury after HSCT | Participants will be assessed for lung injury at 24 months after HSCT | 24 months after HSCT |
Evaluation of the Cell Detachment Ratio on pH-responsive Chitosan as a Prognostic Factor in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Biomaterial-based cell culture models have been gaining increasing attention as potential therapeutic strategies. The purpose of this project is to evaluate whether the cell detachment ratio on pH-responsive chitosan could be correlated with the overall survival in lung cancer patients. Through controllable cell-material interaction, this project has the intention to develop an alternative tool for both early diagnosis and accurate prognosis in cancer therapeutics.

Official Title
-----------------
Evaluation of the Cell Detachment Ratio on pH-responsive Chitosan as a Prognostic Factor in Lung Cancer

Conditions
-----------------
Clinical Decision-Making, Early Detection of Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung cancer patient between 20-70 years old who need surgery for the resection of lung lesions. Willing to sign the consent form under the informed consent. Exclusion Criteria: Vulnerable subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| The correlation between the cell detachment ratio and the overall survival | The purpose of this project is to evaluate whether the cell detachment ratio on pH-responsive chitosan could be correlated with the overall survival in lung cancer patients, hence serve as a prognostic factor for therapeutic strategies. The patient's information required for meta-analysis will be retrieved from medical records, and the log-term follow-up will be conducted. | 5-year follow-up after tumor resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The analyses of the detached cells by specific markers | The isolated and purified patient-derived tumor cells will be characterized by the expression of surface markers using flow cytometry. | About one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pH-responsive chitosan, Cancer stem-like cell, Cell detachment ratio, Prognostic factor
Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease

Study Overview
=================
Brief Summary
-----------------
Celiac is a chronic autoimmune disease that is treated with a gluten-free diet. Adolescents with celiac disease were affected differently by the restrictions during the COVID-19 pandemic. The aim of this study was to determine the compliance with a gluten-free diet during in adolescents with celiac disease during the Covid-19 pandemic and identify the associated factors. The sample of this study consisted of 85 adolescents in the 10-19 age group diagnosed with celiac disease. Research data were collected by online questionnaires (Google Forms) between January and April 2022. Sociodemographic and disease-related data of adolescents who were compliant and those who were non-compliant with a gluten-free diet during the COVID-19 pandemic were compared.

Official Title
-----------------
Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease During the Covid-19 Pandemic

Conditions
-----------------
Celiac Disease in Adolescents, Gluten-Free Diet in the Covid-19 Process

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being in the 10-19 age group, Being diagnosed with celiac disease according to the revised ESPGHAN criteria, Following a gluten-free diet for at least 6 months before the COVID-19 lockdown, Consenting to participate in the study by the adolescents and their parents. Exclusion Criteria: -Having any cognitive or mental disorders.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 19 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 |
| --- | --- | --- |
| Adolescents with celiac disease adherence to their diet | In this study, dietary compliance of adolescents with celiac disease was examined using the Gluten-Free Diet Compliance Form. | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of the pandemic on the gluten-free diet | The Factors Affecting Gluten-Free Diet Compliance form was used to determine the factors affecting adolescents' adherence to a gluten-free diet during the Covid-19 pandemic period. | 4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac Disease, Adolescence, gluten free diet
Robot Assisted Upper Limb Neuro-Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Our long term objectives are to understand the mechanisms of motor impairment following neurologic injury and to develop interventions to improve motor recovery. A series of complementary, overlapping clinical trials and development activities will validate and optimize the use of robot-assisted upper limb therapy for neuro rehabilitation. We have developed a robotic system that assists or resists elbow and shoulder movements in three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode enables hemiparetic subjects to practice mirror image upper limb exercises.

Detailed Description
-----------------
Randomized controlled clinical trial of the Mirror Image Movement Enabler (MIME) robotic device for shoulder and elbow neurorehabilitation in subacute stroke patients. MIME incorporates a PUMA 560 robot that applies forces to the paretic limb during unilateral and bilateral movements in three dimensions. Robot-assisted treatment (bilateral, unilateral, and combined bilateral and unilateral) was compared with conventional therapy.

Official Title
-----------------
Robot Assisted Upper Limb Neuro-Rehabilitation

Conditions
-----------------
Acute Stroke

Intervention / Treatment
-----------------
* Device: Robot-assisted therapy
* Device: Traditional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke patients Exclusion Criteria: Unable to follow instructions; medically unstable.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1 hour/day of mechanically-assisted upper limb therapy | Device: Robot-assisted therapy<br>* 1 hour/day of mechanically-assisted upper limb therapy<br>|
| Active Comparator: 2<br>1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot | Device: Traditional therapy<br>* 1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer score |  | end of training, 6-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebrovascular, Hemiplegia, Robotics
The Effects of TMS on Memory-consolidation in Human Primary Visual Cortex

Study Overview
=================
Brief Summary
-----------------
Rapid Transcranial Magnetic Stimulation will be used in order to examine whether the human primary visual cortex is essential to visual memory consolidation.

Official Title
-----------------
The Effects of Transcranial Magnetic Stimulation of the Brain on Memory-consolidation in Human Primary Visual Cortex

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

Intervention / Treatment
-----------------
* Device: rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Right handed Exclusion Criteria: Active/past neurological/psychiatric disorder Personal/first-degree history of seizures Cardio-vascular disorder or disease including hypertension chronic use of medication Metal/electronic device implant Pregnancy

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: rTMS|repetitive transcranial meagnetic stimulation of the brain|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI).

Official Title
-----------------
Advanced MRI and EEG to Predict Recovery of Consciousness After Severe Traumatic Brain Injury

Conditions
-----------------
Consciousness Disorder, Coma, Brain Injuries, Traumatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients: Inclusion Criteria: Traumatic Brain Injury Glasgow Coma Scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness Clinical evidence of disorder of consciousness defined as coma, VS, or MCS Exclusion Criteria: History of prior severe brain injury or dementia Emergence from MCS at time of initial CRS-R assessment Healthy Subjects: Exclusion Criteria: History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease

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 |
| --- | --- |
| Patient (n=50)<br>Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post injury. | |
| Healthy (n=25)<br>Healthy adults with no neurological, psychiatric, or medical disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability Rating Scale total score | The Disability Rating Scale (DRS) provides quantitative information regarding functional disability in patients recovering from severe brain injury. The total score on the DRS ranges from 0 to 29 with higher scores indicating a greater degree of disability. DRS subscale scores include eye opening [score range 0-3], communication [score range 0-4], motor response [score range 0-5], cognitive ability for feeding [score range 0-3], cognitive ability for toileting [score range 0-3], cognitive ability for grooming [score range 0-3], level of function [score range 0-5], and employability [score range 0-3]. Subscale scores are summed to produce the total score. | 6 months post injury |
Hospitalizations During Pandemia in the Italian Coronary Care Unit Network

Study Overview
=================
Brief Summary
-----------------
Multicentre, national, observational, retrospective and prospective study. The BLITZ-COVID19 study aims at describing the epidemiology of admissions to Italian Cardiology Intensive Care Units in the COVID-19 infection pandemia, the main aspects of the clinical management of inpatients, their short-term outcome, the absorption of resources related to their admission.

Detailed Description
-----------------
The BLITZ-COVID19 study, aims at describing the epidemiology of admissions to Italian Cardiology Intensive Care Units . The study is observational, multicentre, national and involves the collection of clinical data, both retrospectively and prospectively, using a web-based system. In conducting the study, no drugs are tested, nor are diagnostic tests or non-pharmacological therapies performed other than those that each participating cardiologist decides to perform following the rules of normal clinical practice. Diagnostic procedures and pharmacological and non-pharmacological therapies habitually prescribed for cardiovascular pathologies, which are the object of hospitalization, and those used in the event of a COVID-19 infection, will be recorded in the database.

Official Title
-----------------
Epidemiology of the Hospitalizations in the Italian Coronary Care Unit Network at the Time of Covid19

Conditions
-----------------
Management and Epidemiology of Patients Admitted in ICU

Intervention / Treatment
-----------------
* Other: Epidemiology of admissions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients aged ≥18 years admitted with any diagnosis to one of the participating ICU Exclusion Criteria: - Refuse to signe consent

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 |
| --- |
|Other: Epidemiology of admissions|Cardiology Intensive Care Unit admission|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact that COVID-19 infection may have had on the in-hospital mortality | Impact that COVID-19 infection may have had on the in-hospital mortality of the various clinical conditions admitted to ICU | Enrollment | 
| Epidemiology and management of patients admitted to ICU | The different diagnoses of discharge from the ICU and their frequency will be described. All hospitalized cardiac and non-cardiac pathologies will be listed, with particular reference to any COVID-19 infection. | Enrollment | 
| Management of patients admitted to ICU | Description of the main therapeutic decision in patients hospitalized for the most relevant pathologies | Enrollment |