linjc16/ctgov huggingface dataset:
Acceptability, Representations and Experiences of the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
The ARECOVID project is a comprehensive sociological study of what is being played out in organizational terms in the face of the COVID-19 pandemic. Through quantitative methods (questionnaires) and qualitative methods (semi-directive interviews), we would understand the essential views of the populations concerned by COVID-19, but also that of actors taking care of vulnerable elderly non-COVID. Special attention will be paid to the care pathway of elderly people with and without the virus, in a health system in full reorganization. We will try to understand the needs and experiences of all health actors (hospital/city) involved in COVID-19 and the experience of confinement and the Covid-19 of the elderly living at home, in order to reflect on a possible improvement in the health response of elderly people in the event of an epidemic health crisis.

Detailed Description
-----------------
understand the needs and experiences of all health actors (hospital/city) involved in COVID-19 and the experience of confinement and the Covid-19 of the elderly living at home

Official Title
-----------------
Acceptability, Representations and Experiences of the COVID-19 Pandemic : the ARECOVID Project

Conditions
-----------------
Aging

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For older people : minimum age : 65 years For caregivers : works in gerontology Exclusion Criteria: Person with a neurological disease Person under guardianship or curatorship
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 |
| --- | --- |
| Caregivers<br>Caregivers who work with older patients will be included. They will have a questionnaire | Other: Questionnaire<br>* Questions about the impact of COVID-19 in their works<br>|
| Older<br>Older 65 people who live alone in their house will be included. They will have Individual interviews. | Other: Individual interview<br>* Discussion between the searcher and the participant about representations of COVID-19 and experiences about confinement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis representations of COVID-19 and confinement of older people | Measure by individual interviews | Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis impacts of COVID-19 in works of caregivers | Measure by questionnaire | Day 20 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, caregivers, older, ageism, public health, hospital
Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .

Official Title
-----------------
A Multi-Center, Randomized, Open-Label Study To Evaluate Efficacy And Safety Of Dual Therapy With Atorvastatin Plus Amlodipine When Compared Amlodipine Therapy Alone In The Treatment Of Subjects With Concurrent Hyperlipidemia And Hypertension.

Conditions
-----------------
Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: atorvastatin
* Drug: amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a diagnosis of both hyperlipidemia and hypertension. Exclusion Criteria: Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus. Subjects with other atherosclerotic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: atorvastatin|nan|
|Drug: amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone. |  |  |
Effect of the Duration of Preoperative Fasting on Hypotension Induced by General Anesthesia in the Elderly Person

Study Overview
=================
Brief Summary
-----------------
This study aims to determine if prolonged fasting represents an independent risk factor for hypotension during induction of general anesthesia in the elderly.

Detailed Description
-----------------
Preoperative fasting aims to reduce the risk of adverse events (eg, inhalation), but may be responsible for dehydration whose consequence is a major hypotension. This problem of hypotension is important because it (MAP <55 mmHg) is directly correlated to the occurrence of pejorative events on the cardiac and renal level and even more so that the duration of the hypotension is long.

Official Title
-----------------
The Influence of Duration of Fluid Abstinence on Hypotension During General Anaesthesia Induction for Traumatic Hip Surgery in the Elderly

Conditions
-----------------
Preoperative Fasting and Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Risk Score anesthetic ASA I-III Patients ≥ 70 years Suffering from a femoral neck fracture to be treated surgically: either through prosthesis, either by intramedullary nailing (gamma nail) Exclusion Criteria: Risk Score anesthetic ASA IV Patient on Angiotensin Converting Enzyme (ACE) inhibitors or ARBs (ARA2) within 10 hours before surgery Obesity (BMI> 35) or weight <40kg Need to make a rapid sequence induction Inability to achieve the femoral block (standardization of induction) or patient refusal with respect to the technique.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Follow-up of the variation of the Mean arterial pressure |  | 8 months |
Potential Predictive Biomarkers in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Chemoresistance remains an obstacle in treating people with metastatic colorectal cancer (mCRC). Studying samples of blood and tumor tissue in the laboratory from patients with mCRC receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment. In this study, we aimed to evaluate biomarkers in chemotherapy regimens for first-line chemotherapy for mCRC.

Official Title
-----------------
A Study to Characterize and Evaluate Biomarkers of Chemotherapy in Patients With Metastatic Colorectal Cancer In The First-line Setting

Conditions
-----------------
Metastatic Colorectal Cancer, Chemotherapy Effect, Biomarker

Intervention / Treatment
-----------------
* Drug: fluorouracil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Histologically confirmed metastatic colorectal cancer Unresectable metastatic disease must be confirmed histologically if > 2 years since primary diagnosis Measurable metastatic disease > 1 cm by spiral CT scan or > 2 cm by other methods Scheduled to receive first-line chemotherapy for metastatic disease Chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin Exclusion Criteria Inadequate or unusable tissue as the only tissue available Brain metastases or meningeal disease Contraindication to chemotherapy Pregnant or nursing Other severe pathology that is likely to worsen during therapy Dementia or severely impaired mental condition Geographical or psychological reasons that would preclude treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Chemotherapy<br>FOLFOX/XELOX/FOLFIRI | Drug: fluorouracil<br>* chemotherapy treated patients<br>* Other names: laboratory biomarker analysis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | objective response rate | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | overall survival | 6 months | 
| Progression Free Survival (PFS) | progression free survival | 6 months |
Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.

Study Overview
=================
Brief Summary
-----------------
To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.

Official Title
-----------------
Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Device: Percutaneous PDA closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who are candidate for transcatheter PDA closure Exclusion Criteria: Patients with PDA dependent pulmonary circulation. Patients with small sized PDA which is silent by auscultation Patients with large sized PDA which is unsuitable for Trans-catheter closure Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7). Patients with active infection or active infective endarteritis. Patients refusing the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Percutaneous PDA closure|transcatheter patent ductus arteriosus closure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural safety | studying the occurrence of catheter related complications including Occurrence of vascular access hematoma(Yes/No ) Occurrence of contrast induced nephropathy (Yes/No) PDA closure Device embolization (Yes/No) Cardiac tamponade (Yes/No) | one month | 
| Procedural efficacy | timing of complete closure of the PDA with no residual shunts Residual left to right shunt (Yes/No) Degree of the residual shunt (Trace, Mild , Moderate, severe) Timing of closure of the shunt( immediately postprocedural, 24 hours post procedural , 1 month post procedural ) | one month | 
| Procedural outcomes | comparison of echocardiography data that will be done pre catheter closure, one day post procedure and one month later ( left ventricular and atrial dimensions-left ventricular ejection fraction-pulmonary artery systolic pressure- degree of tricuspid regurge) | one month |
Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil

Study Overview
=================
Brief Summary
-----------------
For reduction of dislocated shoulder, sedation with propofol and remifentanil should give satisfactory operating conditions and pain relief, and significantly reduce the time to full recovery, compared with morphine and midazolam

Detailed Description
-----------------
Propofol is a recognised agent for sedation and remifentanil is a short acting opioid analgesic. We intend to provide sedation with propofol, 0.5 mg/Kg, and analgesia with remifentanil 0.5 microgram/Kg for reduction of dislocated shoulders. This will be a randomised sex-stratified comparison with current therapy which is midazolam incrementally up to a maximum of 0.15 mg/Kg, and morphine incrementally up to 0.15 mg/Kg. The primary outcome measure is time to full recovery. Secondary aspects are pain or discomfort during the procedure and operating conditions.

Official Title
-----------------
Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil

Conditions
-----------------
Shoulder Dislocation

Intervention / Treatment
-----------------
* Drug: Sedation with propofol and remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Anterior dislocation of the shoulder suitable for manual reduction Exclusion Criteria: significant other illness body weight 25% greater than expected fear of oxygen masks alcohol intoxication

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sedation with propofol and remifentanil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to full recovery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating conditions |  |  | 
| Pain or discomfort |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, Propofol, Remifentanil, recovery
Use of Mobile-based Technologies to Improve Diabetes Self-management and Postprandial Glucose Control

Study Overview
=================
Brief Summary
-----------------
The project involve evaluation of a web-based nutrition education program and pilot-testing of a new smartphone app for real-time data logging to identify factors causing glycemic variability.

Detailed Description
-----------------
The intervention will be three (3) months in duration and will entail use of a smart phone app for real-time data logging to identify factors causing glycemic variability, as well as use of a web-based nutrition education program. The investigators postulate that the interactive nutrition education curriculum - which will provide feedback to patients about the inter-relationship between their food intake and postprandial glucose profiles, as well as practical guidance for improvements - will lead to a change in food choices and improved post-prandial glucose control.

Official Title
-----------------
Use of Mobile-based Technologies to Improve Diabetes Self-management and Postprandial Glucose Control

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

Intervention / Treatment
-----------------
* Behavioral: Sugar Sleuth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Individuals that satisfy all of the following conditions will be considered for participation: Must be between the ages of 25 - 75 years of age (inclusive) Type 1 diabetes diagnosis at least 1 year, treated with multiple daily injections or insulin pump. A1c 7.5-9.0% Exclusion Criteria Current or past use of real-time CGM for more than 2 months. Pregnancy (self-reported) or planning conception in next 6 months. History of disordered eating, actively trying to lose weight or planning to do so, BMI > 30 kg/m2 (to limit participation by individuals who are actively trying to lose weight), Medical conditions or medications that would affect gastric emptying such as gastroparesis, bariatric surgery, medications such as pramlinitide, liraglutide or exenatide.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Educ Module and App<br>Participants in this arm to be given smartphone app (Sugar Sleuth) and educational module. | Behavioral: Sugar Sleuth<br>* Educational module and use of smart phone app (Sugar Sleuth)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under the curve (AUC) above target (> 180 mg/dL) | Amount of time spent above >180 mg/dL on CGM Freestyle Libre readings | 3 months |
Transcranial Direct Current Stimulation in Post-stroke Fatigue

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.

Official Title
-----------------
tDCS in Post-stroke Fatigue: a Double Blind, Sham-controlled, Bilateral Anodal Motor Cortical Stimulation Study

Conditions
-----------------
Fatigue, Stroke

Intervention / Treatment
-----------------
* Device: Anodal tDCS
* Device: sham tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with stroke at least 3 months post-stroke Exclusion Criteria: Other neurological conditions on Anti-depressants severe motor impairment (affected hand grip <60% unaffected hand) severe cognitive impairment (unable to follow instructions, or give informed consent) scored >11 in the depression sub-section of HADS questionnaire contraindications for TMS or tES

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anodal tDCS<br>40 minutes of 2mA intensity direct current stimulation | Device: Anodal tDCS<br>* 40 minutes of 2mA intensity direct current stimulation was delivered over both the right and left motor cortex simultaneously<br>|
| Sham Comparator: sham tDCS<br>40 minutes of 0mA intensity. the session starts with a ramp up to 2mA, but machine is switched off after 2 minutes of stimulation. | Device: sham tDCS<br>* The stimulator was switched off after 2 minutes of stimulation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale - 7 | a questionnaire based fatigue scale | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Motor Threshold | This is a measure of cortical excitability as measured by transcranial magnetic stimulation | 1 day | 
| Input-output curves | This is a measure of cortical recruitment as measured by transcranial magnetic stimulation | 1 day | 
| Perceived effort - Explicit | A VAS scale associated with a grip task | 1 day | 
| Perceived effort - Implicit | A novel line length estimation task | 1 day |
Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

Study Overview
=================
Brief Summary
-----------------
Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.

Detailed Description
-----------------
Hyperbilirubinaemia may interfere with oximetry values as measured by Near Infrared Spectroscopy devices. The number of wave lengths used by different devices can influence the oximetry values in adult patients. This has never been demonstrated in children with hyperbilirubinaemia scheduled for elective liver transplantation.The study will compare cerebral and somatic oximetry values measured by two different Near infrared spectroscopy devices (FORESIGHT and INVOS) and analyse the influence of bilirubin levels on these differences.

Official Title
-----------------
Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation

Conditions
-----------------
Liver Transplant; Complications

Intervention / Treatment
-----------------
* Device: Near infrared spectroscopy with INVOS device
* Device: Near infrared spectroscopy with Foresight device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution Free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure Exclusion Criteria: refusal of the patient or his parents to consent known brain or Neurological pathology

Ages Eligible for Study
-----------------
Maximum 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pediatric liver transplant patients<br>Using somatic and cerebral Near infrared spectroscopy devices | Device: Near infrared spectroscopy with INVOS device<br>* somatic and cerebral oximetry by INVOS in pediatric liver transplantation<br>Device: Near infrared spectroscopy with Foresight device<br>* somatic and cerebral oximetry with Foresight device in pediatric liver transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of chromophores such as bilirubin on oximetry values provided by two different devices | measure of oximetry values by two different devices at different time points in function of serum bilirubin levels | From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours) |