linjc16/ctgov huggingface dataset:
Hearing Program in Primary Care

Study Overview
=================
Brief Summary
-----------------
During a primary care visit, investigators will screen and identify participants with hearing loss and then randomize to a) counseling on accessible assistive listening devices or b) referral to traditional audiology care pathway alone.

Official Title
-----------------
Feasibility of a Hearing Program in Primary Care for Underserved Older Adults

Conditions
-----------------
Deafness

Intervention / Treatment
-----------------
* Behavioral: Alternative rehabilitation strategies
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: speaks English or Spanish; capacity to consent to research Exclusion Criteria: • has or uses hearing aids or cochlear implants

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alternative Rehabilitation Strategies<br>Patients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm. | Behavioral: Alternative rehabilitation strategies<br>* Counseling intervention.<br>|
| Active Comparator: Usual Care<br>Patients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone. | Behavioral: Usual Care<br>* Usual care audiology pathway.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Potential Participants Approached |  | Up to Month 3 | 
| Number of Potential Participants Screened |  | Up to Month 3 | 
| Percentage of Screened Participants with Hearing Loss |  | Up to Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Intervention Arm Participants who Complete Counseling Session |  | Up to Month 3 | 
| Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours |  | Up to Month 3 | 
| Percentage of Participants who Respond to 3-Month Follow-Up |  | Month 3 |
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

Study Overview
=================
Brief Summary
-----------------
Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy (tolerant) and in those taking immunosuppressive therapy (non-tolerant).

Detailed Description
-----------------
A retrospective single-center study was conducted aiming to define the incidence of de novo Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group).

Official Title
-----------------
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

Conditions
-----------------
Single Transplant, 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS

Intervention / Treatment
-----------------
* Drug: Immunosuppressive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single LT recipients with an attempt of IS withdrawal minimum 5 years follow-up Exclusion Criteria: Liver transplant combined with other organs Presence of metabolic syndrome and/or NASH and/or NAFLD as an indication for liver transplantation Loss of patient to follow-up

Ages Eligible for Study
-----------------
Minimum Age: 49 Years
Maximum Age: 89 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 |
| --- | --- |
| tolerant<br>patients who withdraw IS drugs after LT | Drug: Immunosuppressive<br>* compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.<br>|
| non tolerant<br>patients who couldn't wean IS drugs | Drug: Immunosuppressive<br>* compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation between MS development and IS in LT recipients | Evaluate the de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy (tolerant) and in those who could not withdraw IS (non-tolerant). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IS withdrawal in LT recipients | Evaluate the clinical course of patients undergoing discontinuation of immunosuppressive therapy | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance
Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to assess non-invasive tools' efficacy in predicting portal hypertension-related complications in individuals with advanced chronic liver disease. The main question it aims to answer are: - what are the cut-off values for non-invasive tests (NITs) (including LSM, SSM) that predict the presence and occurrence of hepatic decompensation in individuals with advanced chronic liver disease? Participants will undergo regular study visits involving non-invasive tests (LSM, SSM) and assessments to monitor hepatic decompensation over the study period.

Official Title
-----------------
Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study

Conditions
-----------------
Advanced Chronic Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18years old Advanced chronic liver disease (defined as LSM ≥ 10kPa) Ability to provide informed consent Exclusion Criteria: Transjugular intrahepatic portosystemic shunt previous liver transplantation Abnormality of the porto-mesenteric system (portal vein thrombosis, splenic vein thrombosis, splenectomy, portal cavernomatous transformation, porto-caval shunts) Hematological malignancy

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 |
| --- | --- | --- |
| Number of patients diagnosed with portal hypertension using elastography techniques | We will assess the diagnostic accuracy of liver and spleen stiffness for portal hypertension | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying patients at high-risk of liver related events using elastography techniques | We will use liver and spleen stiffness to identify patients at risk of developing liver -related events | 5 years |
EKO SENSORA: Detecting Clinically Significant Murmurs

Study Overview
=================
Brief Summary
-----------------
The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023). The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction. The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.

Official Title
-----------------
EKO SENSORA: Detecting Clinically Significant Murmurs

Conditions
-----------------
Heart Murmurs

Intervention / Treatment
-----------------
* Device: Eko Sensora


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope. Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography Exclusion Criteria: Contact isolation patients Pediatric patients under the age of 18

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: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Use of the Eko device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eko Device<br>Patients with cardiac risk factors | Device: Eko Sensora<br>* The exam involves placing the stethoscope in the aortic, pulmonic, tricuspid, and mitral areas for 15-30 seconds until a green light is displayed indicating that useful sound has been recorded. The recording is then uploaded by the device using wi-fi to the AI program for analysis. It does not carry patient identifiers. The device then indicates whether a clinically significant heart murmur was heard, and if so in which recording.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new clinically significant heart murmurs detected |  | through study completion, an average of 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of echocardiograms ordered |  | through study completion, an average of 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eko, heart murmur, ai, machine learning, heart murmur detection
Proactive and Reactive Attention to Negative Templates

Study Overview
=================
Brief Summary
-----------------
EEG Measures during Visual Search Task. In this line of research, the researchers having participants receive a positive (target) template cue, negative (distractor) template cue, or neutral (non-informative) template cue. Note: This is a re-analysis of previously collected data.

Detailed Description
-----------------
When finding a search target, receiving a target cue or distractor cue can increase search efficiency compared to a neutral cue. The researchers are examining the neural basis of visual search when participants receive a positive (target) cue, negative (distractor) cue, or neutral (baseline) cue. Note: This is a re-analysis of previously collected data.

Official Title
-----------------
Proactive and Reactive Attention to Negative Templates

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

Intervention / Treatment
-----------------
* Behavioral: Attentional Cue Type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal or corrected to normal visual acuity, normal color vision, no history of neurological disorders Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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
Intervention Model: Single Group Assignment
Interventional Model Description: Within-Subjects Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Within-Subjects Attentional Information<br>All Participants receive all levels of the attentional cue (target, distractor, or neutral cue). | Behavioral: Attentional Cue Type<br>* Positive cue (target), negative cue (distractor), or neutral cue (baseline)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Button Press Reaction Time | Speed to respond correctly to the target- after participant finds the target shape on a computer screen, they press a button to indicate what shape they see | During Testing (single day) | 
| Button Press Accuracy | Accuracy of responses to target item- we will measure whether the participants presses the correct button which corresponds to the target shape presented on the computer screen or the incorrect button | During Testing (single day) | 
| Proactive EEG Activity | Proactive (pre-search) Measures of EEG Theta Activity | During Testing (single day) | 
| Reactive EEG Activity | Reactive (post-search) Measures of EEG Alpha Activity | During Testing (single day) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attention, visual search, electroencephalogram (EEG)
Accuracy of Evie Ring Pulse Oximeter in Profound Hypoxia

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.

Official Title
-----------------
Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Device: Pulse oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good general health with no evidence of any medical problems. Subject is fluent in both written and spoken English. Subject provided written informed consent and is willing to comply with the study procedures. Subject is willing to have their skin color assessed. Exclusion Criteria: Subject is obese with a BMI over 30. Subject has a known history of heart disease, lung disease, kidney or liver disease. Subject has asthma, sleep apnea, or uses a CPAP. Subject has diabetes. Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation. Subject has any other serious system illness. Subject is a current smoker. Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly. Subject has a history of fainting or vasovagal response. Subject has a sensitivity to local anesthesia. Subject has Raynaud's disease. Subject has unacceptable collateral circulation based on an exam by the investigator. Subject is pregnant, lactating, or trying to get pregnant. Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures. Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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 |
| --- | --- |
| Healthy Adult Volunteers<br>Minimum of ten (10) subjects meeting the eligibility criteria. | Device: Pulse oximeter<br>* Devices (2) were placed on the finger and the fingertip. Blood samples were taken at each stable level of oxygenation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RMSE compared to arterial blood SaO2 | Root Mean Squared Error between Movano Ring SpO2 measurement and the arterial blood SaO2 calibrated using arterial blood gas. | 2 days |
Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population

Study Overview
=================
Brief Summary
-----------------
Frailty is becoming an increasingly established risk factor for adverse postoperative outcomes. Given the high incidence of complications after total joint arthroplasty and the propensity for comorbidities in older patients, it would be necessary to evaluate frailty status of patients by using a 5-factor modified frailty index (mFI-5) as a predictor of adverse events.

Official Title
-----------------
Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population: a Retrospective Cohort Study

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Other: Frailty Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) participants ≥ 65 years of age; Exclusion Criteria: lacked any covariate indicator or missing data for any confounder (such as demographic information, intraoperative surgery or anesthesia information); ASA physical status Ⅴ; Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia; Surgery time ≤ 60 min.

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 |
| --- | --- |
| no frailty<br> | Other: Frailty Index<br>* The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database<br>|
| low frailty<br> | Other: Frailty Index<br>* The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database<br>|
| medium frailty<br> | Other: Frailty Index<br>* The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database<br>|
| high frailty<br> | Other: Frailty Index<br>* The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-year all-cause mortality |  | postoperative 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-month readmission rates |  | postoperative 1 month | 
| major complications |  | From the moment of living operation room to the moment of discharge from hospital,up to 7 day |
Changes in Function of the Upper Limb With Physiotherapy

Study Overview
=================
Brief Summary
-----------------
This paper describes a pilot clinical study designed to compare changes in ROM, muscle strength and functional recovery of the upper limb during the inpatient treatment period of burn injury.

Detailed Description
-----------------
Patients with burns can face challenges throughout their recovery, including contractures and a reduced range of motion (ROM) in the upper limb (UL), upper and lower limb impairment. Restoring range of motion, muscle strength, and mobility is essential to reduce scarring formation and contractures. The study included 17 patients with unilateral or bilateral superficial, deep partial and full thickness burns to the upper limbs, with or without burns to the upper body, covering 10% or more of the total body surface area

Official Title
-----------------
Changes in Function of the Upper Limb With Physiotherapy for Acute Burns: a Pilot Study

Conditions
-----------------
Burn of Upper Limb, Except Wrist and Hand

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18-69 years had burns on the upper limb(s) with or without burns on the upper body burns involving ≥ 10% total body surface area (TBSA) with the presence of deep partial thickness or full thickness burns who agreed to take part in the study Exclusion Criteria: inability to perform or understand tests other injuries (fractures, brain injury) central and peripheral nervous system disorders amputation with burns on the head, hands, feet, and genital area

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb range of motion | A range of motion assessment evaluates the mobility of the injured joint and assesses the limitations of the range of motion. | Day 0, 7,14,21, 28, 35, more 35 days | 
| Upper limb muscle strength | Assessing muscle strength helps determine how much muscle strength will be lost as a patient heals from a burn injury. | Day 0,14,35, more than 35 days | 
| Pain intensity | The pain rate scale assesses the intensity of pain. A higher score indicates a higher level of pain. | Day 0, 7,14,21, 28, 35, more than 35 days | 
| Activities of daily living | Assessment of daily activity assesses the limitations of your daily activities. Higher scores associated with greater independence in daily activities. | Day 0,14,35, more than 35 days | 
| Functional recovery of the upper limbs | Assesses impairment and activity limitation, as well as a restriction of leisure and work activities due to upper limb dysfunction. A higher score indicates a higher degree of disability. | Day 0,14,35, more than 35 days |