linjc16/ctgov huggingface dataset:
Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity

Study Overview
=================
Brief Summary
-----------------
There are few data on elderly people concerning mechanisms involved in the in vivo release and perception of aromatic compounds. Any knowledge on this point would be of great interest to the scientific community. Concerning the dimensions of sensory perception and in-mouth comfort, there is, to our knowledge, no methodology to describe them. These dimensions are truly original and innovative, and investigating them will lead to the development of foods adapted to elderly populations with chewing and salivation disorders. The expected results are: to obtain two groups of subjects with differences in chewing abilities and saliva production the characterization of flavour release profiles in elderly subjects with regard to oral physiology (mastication and salivation) and saliva composition a sensory profile describing in-mouth comfort when food is eaten

Official Title
-----------------
Creation et Characterization of Two Groups of Elderly Subjects so as to Evaluate the Link Between the Characteristics of Oral Physiology, Sensory Sensitivity, the Release in Vivo Aromatic Compounds, and In-mouth Comfort During the Consumption of Foods

Conditions
-----------------
Sensitivity

Intervention / Treatment
-----------------
* Dietary Supplement: Oral physiology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons who have provided written consent Age >= 65 years Persons living at home or in an old-people's home (Etablissement Hébergement Personnes Agées Dépendantes : EHPAD) Persons able to move around independently Exclusion Criteria: Persons without national health insurance cover Persons in hospital Persons whose MMSE (Mini-Mental State Examination) is < 24 Persons requiring enteral or parenteral feeding Persons who in the last 12 months have received € 4500 by participating in clinical studies, including the present study Persons in a period of exclusion following a previous study Food allergies Adults under guardianship

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: main study<br> | Dietary Supplement: Oral physiology<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index |  | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI) |  | At inclusion |
Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.

Official Title
-----------------
Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized in Resuscitation, Emergency or Intensive Care Units at the Roger Salengro Hospital at Lille University Hospital. With acute respiratory distress syndrome of intermediate or severe severity (1) for less than 24 hours. Mechanical ventilation with tracheal intubation or tracheostomy, in controlled assisted ventilation (VAC) mode. Patient adapted to mechanical ventilation (no triggering of spontaneous ventilation cycle in VAC mode verified by the equality between the respiratory rate prescribed on the ventilator and the actual respiratory rate of the patient). Exclusion Criteria: Patient under extracorporeal respiratory assistance at the time of inclusion. Anomalies or pathologies that make it dangerous or impossible to introduce an ETO probe: Fistula, perforation, stenosis, varicose vein or diverticulum of the esophagus and / or stomach History of esophageal and / or gastric surgery Caustic lesions of the esophagus and / stomach Tumor or history of oropharyngeal surgery Unstable lesions of the cervical spine Coagulopathy (thrombocytopenia <50 109 / L and / or TP <50%). Impossibility of measuring the diameter of the superior vena cava and cVCS in ETO due to poor echogenicity. Pregnant woman. Therapeutic limitation measures limiting the treatment of organ failure.

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 days lived without mechanical ventilation | This variable will be defined as follows:duration = 28 -x -y. where x is the number of days living under mechanical ventilation during the first 28 days and the number of days in the first 28 days. | at 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patient of death |  | At 28 days, at 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory variations,, superior vena cava, prognosis.
Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study

Study Overview
=================
Brief Summary
-----------------
In december 2019, SARS-CoV2 and its clinical manifestations, COVID-19, appeared in China and caused a pandemic. It led decision makers to prioritize emergency and intensive care dedicated to infection management. Other conditions, such as cancer screening, diagnosis, and treatment, may have been delayed during the containment period. Consequences of this distraction effect are being.

Detailed Description
-----------------
Quantitative monthly data were analyzed from January 1, 2019 to May 31, 2020 in two French tertiary care center (University Hospital and Godinot Cancer Institute in Reims) and in a third center in the French epicenter (Colmar hospital). Oncologic activity indicators were extracted using oncologic electronic file, International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) and nation-wide procedure codes (CCAM). The monthly number of different steps of oncology care pathway (screening, diagnosis and treatment) were collected: faecal immunochemical testing (FIT), mammography, histopathological and biomolecular/genetics analysis, nuclear medicine imaging, oncogeriatric evaluations, multidisciplinary tumor board meetings and files reviewed by meeting including first presentations, given personalized care program, medical announcement and reformulation nursing consultations, inserted central venous catheters, chemotherapy prepared and administered in chemotherapy day care, carcinologic surgeries and radiotherapy courses.

Official Title
-----------------
Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: data record


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every adult patient entering an oncology care pathway between 01/01/2019 and 31/12/2020 Exclusion Criteria: <18 yo

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: data record|Data record on registers without medical files|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| data record | faecal immunochemical testing (FIT), mammography, histopathological and biomolecular/genetics analysis, nuclear medicine imaging, oncogeriatric evaluations, multidisciplinary tumor board meetings and files reviewed by meeting including first presentations, given personalized care program, medical announcement and reformulation nursing consultations, inserted central venous catheters, chemotherapy prepared and administered in chemotherapy day care, carcinologic surgeries and radiotherapy courses. | from 01/01/2019 to 31/12/2020 |
Feasability and Interest of Screening for Infantile Pompe's Diseases at Birth

Study Overview
=================
Brief Summary
-----------------
Given the 100 fold increase of the incidence of Pompe's disease in Western French Guiana, the objective of the present study is to implement systematic screening in newborns in French Guiana in order to start treatment before the muscular and cardiac symptoms appear.

Official Title
-----------------
Feasability and Interest of Screening for Infantile Pompe's Diseases at Birth

Conditions
-----------------
Pompe's Disease

Intervention / Treatment
-----------------
* Other: observational (no intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborn Exclusion Criteria: parent refusal

Ages Eligible for Study
-----------------
Maximum Age: 2 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational (no intervention)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acid maltase activity | The acid maltase enzyme activity is evaluated just after birth. If it is abnormal then PCR allows to identify signature mutations. | At birth | 
| Signature mutation for pompe's disease | The acid maltase enzyme activity is evaluated just after birth. If it is abnormal then PCR allows to identify signature mutations. | At birth |
Compassionate Use of Pozelimab

Study Overview
=================
Brief Summary
-----------------
Provide compassionate use of pozelimab

Detailed Description
-----------------
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

Intervention / Treatment
-----------------
* Drug: Pozelimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pozelimab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a randomized, controlled trial.

Official Title
-----------------
Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery

Conditions
-----------------
Non-thyroidal Illness Syndrome

Intervention / Treatment
-----------------
* Drug: liothyronine sodium
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are undergoing Off-pump coronary artery bypass graft Exclusion Criteria: No normal sinus rhythm, History of thyroid disease Abnormal thyroid hormone Renal dysfunction Hepatic dysfunction LVEF <30% Recent MI Active infection 1 15

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T3<br>triiodothyronine | Drug: liothyronine sodium<br>* liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)<br>|
| Active Comparator: cyanocobalamin<br>vitamin B12 | Drug: placebo<br>* vitamin B12<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the serum T3 concentrations and the number of patients with serum T3 concentrations below the normal range between the groups |  | until 36 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of hemodynamic performance and myocardial injury | difference of hemodynamic performance and myocardial injury between the groups | during surgery and 36 hr after surgery |
Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Stroke is the third common cause of adult disability in dveloped countries. Early identification of the potential for motor recovery is important to avoid 'learned disuse' and to initiate appropriate therapy with achievable goals. The current cohort study focuses on those patients with SAFE <8 and using motor evoked potentials (MEPs) to improve on prognostication of upper limb motor recovery among subacute stroke patients in a local stroke population.

Official Title
-----------------
Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients

Conditions
-----------------
Stroke, Subacute

Intervention / Treatment
-----------------
* Diagnostic Test: MEPs induced by TMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First stroke with hemiparesis or hemiplegia with SAFE <8 Exclusion Criteria: contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to understand the consent

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 |
| --- | --- |
| Presence of motor evoked potentials<br>Those patients with Shoulder Abduction and Finger Extension (SAFE) score <8/10 with the presence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex | Diagnostic Test: MEPs induced by TMS<br>* Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials<br>|
| absence of motor evoked potentials<br>Those patients with Shoulder Abduction and Finger Extension (SAFE) score <8/10 with the absence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex | Diagnostic Test: MEPs induced by TMS<br>* Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test | Upper limb functional test | Change of Baseline Action Research Arm Test at 12 weeks post-stroke |
Home Based Massage and Relaxation for Sickle Cell Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of in-home, family-administered massage and in-home relaxation training on measures of physical status and health care utilization in a sample of African American adolescents age 15 years and older and adults with chronic pain associated with sickle cell disease who have been randomly assigned to six sessions of either family-administered massage or progressive muscle relaxation training.

Official Title
-----------------
Home Based Massage and Relaxation for Sickle Cell Pain

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Procedure: massage
* Behavioral: relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Medically diagnosed with sickle cell disease, including hemoglobin SS disease, hemoglobin SD disease, hemoglobin SC disease, or sickle-thalassemia Self-report of having experienced chronic pain related to sickle cell disease during the past 30 days. Availability of a family member or friend who agrees to be trained to administer massages if the participant is randomized to the massage arm of the study. Exclusion Criteria: Sickle cell trait instead of sickle cell disease diagnosis. Diagnosis of disease in addition to sickle cell disease which requires regular use of pain medication. (Please note, regular use of pain medication for sickle cell pain is NOT an exclusion)

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- |
|Procedure: massage|nan|
|Behavioral: relaxation|nan|

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
-----------------
Chronic Pain, Sickle Cell Pain, Sickle Cell Disease, Alternative Medicine/Therapy, Complementary Medicine, Massage Therapy, Relaxation Technique, Home-based Therapy
Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

Study Overview
=================
Brief Summary
-----------------
Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.

Official Title
-----------------
Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury

Conditions
-----------------
Coronary Artery Disease, Valvular Heart Disease

Intervention / Treatment
-----------------
* Procedure: IRPC, Remote preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years Scheduled for coronary artery bypass grafting with or without valve replacement associated Use of blood cardioplegia EuroSCORE II greater than or equal to 1.0% Exclusion Criteria: History of cardiogenic shock Complications in the admission Pregnant patients Severe peripheral arterial disease affecting the upper limbs Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃) Significant pulmonary disease (˂ FEV1 40%) Renal failure with glomerular filtration rate ˂ ml/min/1,73 m² Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRPC, Remote preconditioning<br>This group will be submitted to ischemic preconditioning | Procedure: IRPC, Remote preconditioning<br>* The patients will be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion. This cycle will be repeated 4 times.<br>|
| Placebo Comparator: Control<br>This patients will be submitted to the standard surgery protocol in the institution. The patients will not be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular pathway activation |  | 2 days | 
| Inflammatory response |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause of mortality |  | 30 days | 
| All cause of mortality |  | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemia, reperfusion, myocardial ischemia, myocardial reperfusion