linjc16/ctgov huggingface dataset:
Dexmedetomidine for the Treatment of Delirium After Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the treatment of psychomotor confusion in patients who are recovering from heart surgery. Study design: Multi-centre, prospective, randomised, placebo-controlled double-blind study of dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery. Data will be analyzed in two steps: The primary comparison is between placebo and dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison between dexmedetomidine and haloperidol will follow.

Official Title
-----------------
A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery

Conditions
-----------------
Postoperative, Delirium, Psychomotor, Confusion

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Haloperidol
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 65 years Clinical need for treatment of psychomotor confusion unresponsive to standard analgesic medication (RASS +2 to +3) Heart surgery and extracorporeal circulation (ECC) within 7 days Written informed consent obtained before surgery Mentally competent at the time of written informed consent Exclusion Criteria: Ongoing neuroleptic, propofol and α2 agonist medication Intubated patient Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite volume, vasopressors and IABP) Severe bradycardia without pacemaker backup (heart rate < 50 beats/min) AV-conduction block II-III (without pacemaker backup) Severe hepatic impairment (Serum bilirubin > 101 µmol/l) Lithium therapy

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Bolus and continuous infusion<br>* Other names: Precedex;|
| Active Comparator: Haloperidol<br> | Drug: Haloperidol<br>* Bolus doses<br>* Other names: Haldol;|
| Placebo Comparator: Placebo<br> | Drug: Saline<br>* Bolus and continuous infusion<br>* Other names: Vehicle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for rescue medication |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine
Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease.

Detailed Description
-----------------
Children with Crohn's disease have altered intestinal permeability. A pilot study in children showed that probiotics may decrease intestinal permeability. In this double blind, randomized controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a double sugar absorption test. PCDAI was monitored, but not analyzed.

Official Title
-----------------
Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Dietary Supplement: VSL#3
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current diagnosis of small bowel or colonic Crohn's disease as defined by histological and endoscopic criteria. Males or females ages 11-17 years. Crohn's disease in remission as defined by a Pediatric Crohn's Disease Activity Index (PCDAI) < 10 Patients on maintenance doses of aminosalicylates, 6-MP and/or Azathioprine for at least 2 months. Procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent. Exclusion Criteria: Patients with documented intestinal stricture. Patients with signs of symptoms of systemic or intestinal infection. Antibiotic use the previous 1 month. Probiotic use in the previous 2 months (excluding yogurt). Use of the following medications; Methotrexate, Cyclosporine, Tacrolimus and Infliximab. Patients with diagnosis of other co-morbid diseases such as heart disease, renal disease, immunodeficiency, diabetes, or thyroid disease. Patients with indwelling catheters. Patients with short bowel syndrome Positive urine pregnancy test for female subjects

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 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 |
| --- | --- |
| Active Comparator: VSL#3<br> | Dietary Supplement: VSL#3<br>* 1 packet BID<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 1 inactive packet BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Permeability - measured by Sugar Absorption Test |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VSL#3, Crohn's Disease, Pediatric, Permeability, Probiotic, Zonulin
Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass.

Detailed Description
-----------------
Hypothesis : RIPC using tourniquet might be a simple technique with the benefit to provide renal protection without disturbing operating procedure and prolongation of total operating time.

Conditions
-----------------
Heart Valve Disease

Intervention / Treatment
-----------------
* Procedure: Automated cuff-inflator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing complex valve surgery. Exclusion Criteria: older than 80 years those with left main disease >50%, or hepatic or pulmonary disease active infective endocarditis left ventricular ejection fraction <30% myocardial infarction (MI) within 3 weeks pre-existing renal dysfunction (serum creatinine (Cr) level >1.4 mg/dl), and those with peripheral vascular disease affecting the lower limbs.

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

Design Details

Primary Purpose: Prevention
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated cuff-inflator<br> | Procedure: Automated cuff-inflator<br>* RIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Gerontological Telemonitoring of Older Adults Living in Nursing Homes With COVID-19 Disease

Study Overview
=================
Brief Summary
-----------------
Since the last 3 months the world copes with the novel coronavirus disease : Covid-19 emerged in China in the end of 2019. WHO declared the pandemic situation as a Public Health Emergency around the world on January 2020. Firsts studies emphasized on higher risk to older adults to experience serious health consequences : hospitalizations and mortality, due to multimorbidity and multimedication. Nursing home resident are particulary frailer and vulnerable.

Official Title
-----------------
Gerontological Telemonitoring of Older Adults Living in Nursing Homes With Symptoms of Confirmed or Probable COVID-19 Disease

Conditions
-----------------
Coronavirus Infection

Intervention / Treatment
-----------------
* Other: telehealth applications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nursing home resident with Covid disease RT-PCR or Chest CT or rapid test Nursing home resident with Covid-19 disease symptoms : fever cough dyspnea SPO2<95% in ambient air (or <91% in COPD patient) Diarrhea Fall or balance disorder Confusion Exclusion Criteria: Age < 75 years Patient in respiratory distress No consent

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective cohort study (here and elsewhere)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gerontological telemonitoring action<br>Nurses answer a daily resident-reported questionnaire (e.g. temperature, dyspnea, pain), edited by French health authorities. From D0 to D20, data are transmitted to the NHSP. Warning algorithms specially developed for older persons identify signs that are monitored by the NHSP geriatrician coordinator. A feedback is provided to the general physician for specific actions required and appropriate support. A last questionnaire is completed at D30 by the nurse in order to stop monitoring and know event occurred between D20 to D30. | Other: telehealth applications<br>* telehealth applications during 30 days/patient<br>|
| No Intervention: routine care without gerontological telemonitoring<br>routine care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Gerontological telemonitoring on healthcare management for older adults living in Nursing Homes with symptoms of confirmed or probable COVID-19 disease (Death within 30 days). |  | day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, early gerontologic healthcare
Mucormycosis in COVID-19

Study Overview
=================
Brief Summary
-----------------
The purpose is to allow phsyician reporters to contribute to MUNCO registry. Mucormycosis in COVID-19 is a rapidly escalating medical emergency reported in high numbers in India during the ongoing coronavirus surge. There is very little known about the risk factors, patterns and complications of mucormycosis as it occurs either during the infection or treatment phase of the novel coronavirus (COVID-19). In light of this emerging epidemic within a pandemic, it is of time sensitive importance to obtain a better understanding of the risk factors and outcomes of this fatal complication

Official Title
-----------------
Mucormycosis in COVID-19

Conditions
-----------------
Covid19, Mucormycosis, Aspergillosis, Candida Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed case of Mycotic Infection in COVID-19 Exclusion Criteria: None
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 |
| --- | --- | --- |
| Vision loss |  | 60 days |
Ankle Equinus Contracture Treated With Dynamic Splinting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus.

Official Title
-----------------
Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial

Conditions
-----------------
Ankle Equinus, Ankle Contracture, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Standard of care
* Device: Dynasplint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous Diagnosis Diabetes Mellitus Reduced flexibility in AROM of extension in the ankle Less than 10º Maximal, Active Dorsiflexion, while upright Impaired gait pattern Exclusion Criteria: Previous surgical treatment for this pathology Previous surgery of the Achilles tendon or triceps surae Current treatment with corticosteroids Current treatment with Botulinium Toxin-A (Botox), lower extremity Current treatment Fluoroquinolones (antibiotic medication) Current use of muscle relaxant medications Fibromyalgia Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity Current participation in manual, physical therapy Treatment with electrical stimulation assisting ambulation (i.e. Bioness, WalkAide, Parastep, etc.) Preexisting open sores on foot or leg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: Control<br>Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises. | Other: Standard of care<br>* shoe modification home stretching exercises<br>|
| Experimental: Experimental<br>Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint. | Device: Dynasplint<br>* shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | The primary outcome is change in ankle range of motion | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | The secondary outcome will be change in pain scale rating as reported by patient | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle Equinus, Ankle contracture, Diabetes Mellitus, Dynasplint, AFD
Lorraine Registry of Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events.

Detailed Description
-----------------
As every patient registry in France, the RelSEP is periodically (every four years) evaluated by an independent committee. The RelSEP interrogate multiple sources to insure its exhaustiveness : every neurologists of Lorraine MS patient network in Lorraine health insurance data PMSI (administrative French national database for hospitals) biological and imagery services in Lorraine Procedures (automatic and manual) are used to eliminate duplicates Once a patient has been identified its medical file are checked by investigators in order to retrieve the relevant information. New MS cases are confirmed by neurologists. Automatics (implemented in EDMUS software)and manual checks are implemented in the registry database, looking for inconsistencies. The following data are registered : Name, birthname Sex Date of birth Location (town) Birth location (town) Profession Number of siblings Marital status Number of children Date of onset Date and nature of clinical manifestations MRI reports CSF analysis reports Event-related potential reports Impairment and disability evolution Treatments (start and change of drug treatment) Drugs related events Cause of treatment discontinuation Disease progression Every case has a follow up at least every two years. The quality of data is evaluated by periodically auditing cases at random from our database. An annual report on the main data (incidence and prevalence) of MS in Lorraine is produced. Data are also used for observational studies on prognostic factors.

Official Title
-----------------
Lorraine Registry of Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Observational registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a confirmed multiple sclerosis diagnosis Living in Lorraine (French region) Exclusion Criteria: Refusal to be registered
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational registry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| case occurence of multiple sclerosis |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EDSS score |  | 30 years |
Unplanned-extubation in the ICU; Incidence, Characteristics and Prognosis. Success And Failure of Self-Extubation in the ICU

Study Overview
=================
Brief Summary
-----------------
Our study consists of a national observational study assessing quantitatively (incidence) and qualitatively unscheduled extubation in intensive care unit. In addition, we will compare the outcome of patients with success or failure in the self-extubation subgroup.

Official Title
-----------------
Unplanned-extubation in the Intensive Care Unit; Incidence, Characteristics and Prognosis.

Conditions
-----------------
Unplanned Extubation, Self Extubation

Intervention / Treatment
-----------------
* Other: NO INTERVENTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Mechanically ventilated with oral or nasotracheal intubation Occurrence of an unscheduled extubation (auto-extubation or accidental extubation) Extubation is defined as the removal of the orotracheal or nasotracheal tube with the impossibility of reinsertion of the same device. Exclusion Criteria: Opposition to the use of personal data Pregnant women Person under protective custody or guardianship

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 |
| --- | --- |
| Unplanned-extubation in the ICU<br>Patients with unplanned extubation in the ICU | Other: NO INTERVENTION<br>* NO INTERVENTION<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative description | Quantitative description of unscheduled extubation episodes in intensive care unit | During stay in the ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative description | Qualitative description of unscheduled extubation episodes in intensive care unit | During stay in the ICU | 
| re-intubation | To assess factors associated with re-intubation | During stay in the ICU | 
| Severe hemodynamic and respiratory events | To assess the incidence of severe hemodynamic and respiratory events of immediate onset | One hour after extubation | 
| Length of stay in intensive care unit, the duration of mechanical ventilation and mortality | Compare the length of stay in intensive care unit, the duration of mechanical ventilation as well as the mortality in intensive care of subjects with successful self-extubation (defined as no re-intubation on D7) compared to those in failure of self-extubation . | During stay in the ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self extubation, Unplanned extubation, intensive care unit