linjc16/ctgov huggingface dataset:
Physical Therapy Management Of The Patient With Central Sensitization

Study Overview
=================
Brief Summary
-----------------
In the literature there is still debate about the concept of central sensitization, as a pain mechanism that can support a neuromusculoskeletal pathology and which for Woolf corresponds to an amplification of neural signaling within the Central Nervous System causing hypersensitivity to pain. This mechanism is often confused with the concept of chronic pain, as in many conditions such as fibromyalgia, traumatic neck pain, low back pain or osteoarthritis, central sensitization supports its maintenance beyond 6 months. We believe it is important to investigate among Italian physiotherapists the management of the patient in which the presence of a central pain sensitization phenomenon is suspected, in order to provide consistent data to direct the education of health professionals towards more effective management of this problem. To achieve this goal we aim to: Conduct a Delphi study in order to reach consensus, into a panel of experts, on the methods useful for the management, in each phase of the physiotherapy process, of the patient with neuromusculoskeletal problems with pain underlying central sensitization mechanism Investigate, through a survey among Italian physiotherapists, their clinical approach to the patient in question Develop a free online course available to clinical professionals and/or students who wish to deepen this issue.

Official Title
-----------------
Physical Therapy Management Of The Patient With Central Sensitization: An Observational Study Among Italian Physiotherapists

Conditions
-----------------
Pain, Central Sensitisation, Musculoskeletal Diseases

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Italian physiotherapists who will decide to fill in the questionnaire Exclusion Criteria: No exclusion criteria

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

| Intervention/Treatment |
| --- |
|Other: Survey|It will be created a questionnaire to investigate, among Italian physiotherapists, their clinical approach to the patient with Central Sensitisation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical therapists' patient management | Exploring Italian physiotherapists' clinical approach to the patient in question through an online survey | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Management, Central Sensitisation, Muscoloskeletal Disease, Pain
COVID-19 Seroprevalence Study in French Guiana

Study Overview
=================
Brief Summary
-----------------
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.

Detailed Description
-----------------
Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana. This study is a interventional study that present minimal risks and constraints. The results of the study will allow estimation of COVID-19 virus infection, severity and attack rates, as well as inform public health responses and policy decisions in the French Guiana territory.

Official Title
-----------------
COVID-19 Seroprevalence Study in French Guiana

Conditions
-----------------
Coronavirus Infection, Severe Acute Respiratory Syndrome, SARS-CoV Infection, Covid19

Intervention / Treatment
-----------------
* Procedure: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person going to a prevention and care center or medical biology analysis laboratory as part of the care, regardless age, regardless of an acute or previous infection with COVID-19; State of health compatible with a blood sample as defined in the protocol Exclusion Criteria: Inability to consent Person under guardianship or curatorship Known pathology or a health problem contraindicated with the collect of blood sample.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Blood sample | Procedure: Blood sample<br>* Blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the COVID-19 immunity of the population | The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the level of asymptomatic and pauci-symptomatic infections | The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, COVID-19, Serology, French Guiana
Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care

Study Overview
=================
Brief Summary
-----------------
Women generally report discomfort and a delay in GI motility after CS. The Paula method, circular exercises of ring muscles has been shown to increase GI motility. This method had not been studied in women post CS. The current study is comparing the resumption of bowel sounds after CS in women utilizing the Paula exercises to standard care (no exercises).

Official Title
-----------------
Women's First Gastrointestinal Activation Post-elective Cesarean Birth During Post-partum Hospitalization:A Comparison of Paula Method (the Circular Exercises Method) to Standard Care

Conditions
-----------------
Bowel Dysfunction

Intervention / Treatment
-----------------
* Other: Paula exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective, singleton, term CS, with spinal or epidural anesthesia Exclusion Criteria: GI/ absorption disorders (Chron's, IBS) general anesthesia urgent CS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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: Paula Method<br> | Other: Paula exercises<br>* structured exercises aimed to stimulate ring muscles<br>|
| No Intervention: Standard of Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the Resumption of Bowel Functioning as Assessed by Flatus Passage | flatus passage | 72 hours |
A Study of IBI306 in Participants With Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: IBI306
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Males and females ≥ 18 to ≤ 75 years of age Diagnosis of hypercholesterolemia LDL cholesterol ≥ 70 mg/dl (1.8mmol/L) Very high or high cardiovascular risk TG≤500 mg/dL(5.64 mmol/L) Exclusion criteria Uncontrolled hypertension Uncontrolled hyperthyroidism or hypothyroidism Severe renal dysfunction Known sensitivity to any of the products to be administered during dosing

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI306<br>IBI306 administered subcutaneously (SC) | Drug: IBI306<br>* Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24<br>|
| Placebo Comparator: Placebo<br>administered subcutaneously (SC) | Drug: Placebo<br>* Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12 |  | Baseline to week12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent of subjects with LDL-C reduction no less than 50% from baseline |  | Baseline to week24 | 
| The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L) |  | Baseline to week24 | 
| The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline |  | Baseline to week24 |
Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study

Study Overview
=================
Brief Summary
-----------------
Children are admitted in intermediate units when the severity requires continuous monitoring. In France, Resources allocated to intermediate units are determined from lists of diagnoses and associated acts to additional budget. A score to assess the severity of illness may be associated with acts to develop an activity indicator easy to use. The investigators have chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not been validated. The correlation between the severity of children and the associated diagnoses and acts has not been studied. The main objective of this study is to validate these 2 scores. The secondary objective is to determine a simplified activity indicator.

Official Title
-----------------
Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study.

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children admitted to the paediatric inpatient unit Exclusion Criteria: parental refusal

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 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 |
| --- | --- |
| intermediate units<br>Children admitted to the paediatric inpatient unit in 7 regional hospitals French | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changed inPaediatric Advanced Warning Score (PAWS) | Temperature, Capillary Refill Time (CRT), respiratory rate, heart rate,neurological status, oxygen saturation, respiratory distress measure at admission, each 8 hours and if deteriorations | at admission and each 8 hours, up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changed in Pediatric Early Warning System score (PEWS) | heart rate, systolic blood pressure, Capillary Refill Time (CRT), respiratory rate, respiratory effort,transcutaneous oxygen saturation and oxygen therapy are measured at admission, each 8 hours and if deteriorations | at admission and each 8 hours, up to 5 days | 
| Transfer in pediatric intensive care (YES/NO) | this secondary outcome is evaluated when the bedPEWS and PAWS scores are collected : at admission, each 8 hours and if deterioration | at each 8 hours, up to 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical illness, disease progression, severity of illness index, monitoring, child
Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Detailed Description
-----------------
Micafungin (a new class of antifungal drugs) is compared to fluconazole (current standard treatment) in the treatment of patients with serious fungal infections (invasive candidiasis and candidemia) to determine its efficacy and safety. Patients, both male and female, aged over 16 and with confirmed disease by the doctor could be recruited and evaluated.

Official Title
-----------------
A Single Center, Open, Parallel, Comparative, Randomized Study of Micafungin (FK463) vs Fluconazole (Diflucan) in the Treatment of Invasive Candidiasis and Candidaemia (Protocol No: MCFGCAN-0301F-TW)

Conditions
-----------------
Invasive Candidiasis, Candidemia

Intervention / Treatment
-----------------
* Drug: Micafungin
* Drug: fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a confirmed diagnosis of candidemia and invasive candidiasis Patients could be newly diagnosed with candidiasis who received no more than 48 hours of prior systemic antifungal therapy Inpatients aged 16 and above Exclusion Criteria: Patients with serious invasive candidiasis whose prognoses are considered to be poor (life expectancy judged to be less than 5 days). Patients with severe complications in the liver Pregnant or lactating women Patients who have received at least 5 days of prior systemic treatment of fluconazole or echinocandin with no response. Patients who have prior antifungal infection requiring treatment with systemic antifungal agents for conditions other than candidemia and invasive candidiasis.

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Micafungin<br>* IV<br>* Other names: FK463;|
| Active Comparator: 2<br> | Drug: fluconazole<br>* IV<br>* Other names: Diflucan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 2-8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response, mycological response |  | 2-8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
micafungin, fluconazole, invasive candidiasis, candidemia
Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation

Study Overview
=================
Brief Summary
-----------------
The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.

Detailed Description
-----------------
Neuromuscular monitoring is a basic monitoring for all curarised patients. Acceleromiography is used to supervise neuromuscular blockade and allow measuring in an objective and quantitative manner the curarisation level during surgery and phase of recovery from neuromuscular blockade. Various parameters are usually measured during surgery: T4/T1 ratio: ratio between the 4th and 1st response to train of four stimulation (TOF, 4 stimulations of 0.2 ms in 2 s). Neuromuscular recovery is considered appropriate if T4/T1 ratio is > 0.9 Double burst stimulation (DBS): 2 short tetanic stimulations separated by an interval of 750 ms. It is known that when DBSs induce the same visual and/or tactile response, T4/T1 recovery time is > 0.6. However, for an optimal recovery, T4/T1 ratio must be > 0.9. This study will analyze the interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9, from anesthesia sheet of patients undergone surgery with tracheal intubation curarisation. Results will define a minimum time to have an optimal recovery after having visually identical DBS responses.

Official Title
-----------------
Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation

Conditions
-----------------
Anesthesia, Surgery

Intervention / Treatment
-----------------
* Procedure: Surgery with tracheal intubation curarisation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA score 1-3 Needing a surgery with tracheal intubation curarisation Exclusion Criteria: none

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Curarized patients<br> | Procedure: Surgery with tracheal intubation curarisation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9 | measured with TOF-Watch Sx | day 0 |
A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

Study Overview
=================
Brief Summary
-----------------
The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

Detailed Description
-----------------
he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

Official Title
-----------------
A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

Conditions
-----------------
Neuromuscular Disease

Intervention / Treatment
-----------------
* Device: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: man or female age18 years neuromuscular disease coughassist adaptation treatment peak cough flow<270liter/minute Exclusion Criteria: acute organ failure insufflation contrindication pregnant women/no affiliation to a social security scheme plan of legal protection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neuromuscular patients<br>Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) | Device: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)<br>* Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimal negative pressure treshold value | Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimal pressure treshold based on the best peak flow. |  | 10 minutes | 
| volume-flow curve aspect |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
efficient cough flow, cough help, in-exsufflation, neuromuscular disease, cough assistance optimization