louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05935930: Postoperative Effects of Propofol Versus Sevoflurane Anesthesia
Official title: Postoperative Effects of Propofol Versus Sevoflurane Anesthesia During Elective Non-Cardiac Surgeries. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Anesthetic Drug Adverse Reaction
Keywords: Cognitive function
General anesthesia
Inflammatory response
Oxidative stress
Propofol
Sevoflurane
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-07
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: The choice of appropriate anesthetics is essential to protect brain function, decrease perioperative complications, and provide high-quality care, and better quality of life.

Objectives: To compare the efficacy and safety of propofol versus sevoflurane in patients undergoing elective, non-cardiac operations under general anesthesia.

Methods: This was a randomized (1:1), parallel, phase four clinical trial; carried out on 44 patients, who were candidates for elective, non-cardiac operations under general anesthesia at our hospital. Patients were randomly allocated into two equal groups in which anesthesia was maintained with propofol infusion in group P and sevoflurane inhalation in group S.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 years
* Body Mass Index (BMI) 25-35 kg/m2

Exclusion Criteria:

* ASA physical status \> II
* Age \< 21 years
* Patients with Montreal Objective Cognitive Assessment (MoCA-B) score \< 24 points
* Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases
* Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia
* Patients on long-term use of sedatives or steroids, alcohol or drug abuse
* Allergy to any of the study drugs

Primary outcomes:
measure: Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
timeFrame: 24 hours after the end of operation
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05184530: In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction
Official title: In-hospital Initiation of PCSK9 Inhibitor and Short-term Lipid Profile Alteration, as Well as In-hospital Mortality and Readmission Rate in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 7556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 7556 consecutive patients admitted to the cardiology department of the First Affiliated Hospital of Xi'an Jiaotong University for AMI between January 2016 and December 2020 were enrolled.

Brief summary: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy. This study aims to investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitor among patients with acute myocardial infarction(AMI) based on real-world experience.

A total of 7556 AMI patients from the biobank database between January 2016 and December 2020 were screened for eligibility. After excluding those without revascularization or Statin based therapy, the remaining 5802 Statin users, 801 Statin plus Ezetimibe users and 170 Statin plus Evolocumab users (including 95 users without and 75 users with Ezetimibe), were selected for this study. Then, 1st and 3rd-month follow-up data were collected and analysed, including in-hospital mortality, readmission rate and lipid profiles


Eligibility criteria: Inclusion Criteria:

* confirmed admission diagnosis of AMI and were defined based on the universal definition criteria by the American Cardiology College

Exclusion Criteria:

* (1) severe noncardiac disease with an expected survival of less than 1 year and unwillingness to participate; (2) patients over the age of 80 years or living far away from the hospital's catchment area.

Primary outcomes:
measure: Readmission rate
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lou B, Liu H, Luo Y, Jiang GT, Wu H, Wang C, Wu Y, Zhou B, Yuan Z, She J, Liu J. In-hospital initiation of PCSK9 inhibitor and short-term lipid control in patients with acute myocardial infarction. Lipids Health Dis. 2022 Oct 24;21(1):105. doi: 10.1186/s12944-022-01724-9.
Clinical trial NCT06413030: Slow Gait Speed as an Indicator of Overweight, Dynapenic Obesity and Sarcopenic Obesity in Elderly People in the Community
Official title: Slow Gait Speed as an Indicator of Overweight, Dynapenic Obesity and Sarcopenic Obesity in Elderly People in the Community
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Frailty
Obesity
Sarcopenia
Sarcopenic Obesity
Gait Speed
Keywords: aged
Aged, 80 and over
Lead sponsor: University of Americas
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 383
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older people who live in the community and attend primary health care centers in the Bio Bio Region of Chile.

Brief summary: The goal of this observational study is to evaluate the relationship of gait speed with dynapenic or sarcopenic obesity in community-dwelling older people. The main questions it aims to answer are:

* Is slow walking speed related to overweight in older people in the community?
* Is slow walking speed related to dynapenic obesity in older people in the community?
* Is gait speed related to sarcopenic obesity in older people in the community?

Participants will answer a clinical interview to obtain sociodemographic data and will perform the following clinical tests: (1) 10-meter walk test, (2) Anthropometric measurement; (3) Handgrip dynamometry test, (4) Standing dynamometry test and (5) Physical functionality questionnaires.


Eligibility criteria: Inclusion Criteria:

* Subjects over 60 years of age
* Female and male
* Self-sufficient in the instrumental activities of daily living
* Subjects with or without drug consumption, capable of carrying out the activity of walking independently or dependent on technical aids.

Exclusion Criteria:

* Subjects with acute musculoskeletal injuries of the lower extremity.

Primary outcomes:
measure: Gait Speed
timeFrame: Month 1
measure: Anthropometric measures
timeFrame: Month 1
measure: Handgrip dynamometry
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Concepción
country: Chile
facility: Universidad de las Américas
Study officials:
affiliation: Academic
name: Karen Córdova-León, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00274430: Prevention of High Altitude Pulmonary Edema
Official title: A Randomized Controlled Trial of the Effects of Tadalafil and Dexamethasone Versus Placebo on Pulmonary Edema Formation and Cerebral Blood Flow Autoregulation in High Altitude Newcomers With a Previous History of High Altitude Pulmonary Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: High Altitude Pulmonary Edema
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2006-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A double-blind placebo controlled study

* To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary edema formation in subjects susceptible to HAPE.
* To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by measurement of the nasal potential difference, and prevention of HAPE.
* To investigate the effect of the tadalafil and dexamethasone versus placebo on the dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible subjects.


Eligibility criteria: Inclusion Criteria:

* At least one previous episode of high altitude pulmonary edema

Exclusion Criteria:

* pulmonary arterial hypertension
* congenital heart disease
* any chronic lung disease

Primary outcomes:
measure: prevention of high altitude pulmonary edema
Secondary outcomes:
measure: incidence of acute mountain sickness
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: Marco Maggiorini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maggiorini M, Brunner-La Rocca HP, Peth S, Fischler M, Bohm T, Bernheim A, Kiencke S, Bloch KE, Dehnert C, Naeije R, Lehmann T, Bartsch P, Mairbaurl H. Both tadalafil and dexamethasone may reduce the incidence of high-altitude pulmonary edema: a randomized trial. Ann Intern Med. 2006 Oct 3;145(7):497-506. doi: 10.7326/0003-4819-145-7-200610030-00007.
citation: Clarenbach CF, Senn O, Christ AL, Fischler M, Maggiorini M, Bloch KE. Lung function and breathing pattern in subjects developing high altitude pulmonary edema. PLoS One. 2012;7(7):e41188. doi: 10.1371/journal.pone.0041188. Epub 2012 Jul 19.
Clinical trial NCT00885430: Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes
Official title: Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamics
Hyponatremia
Keywords: colonoscopy
preparation
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2009-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Twenty adult volunteers will be administered Pico-Salax in the usual fashion for colonoscopy with intense monitoring of serum and urine chemistry and hemodynamics.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers older than 45

Exclusion Criteria:

* impaired renal function
* congestive heart failure ascites known electrolyte abnormalities

Primary outcomes:
measure: serum electrolytes
timeFrame: 48 hours
measure: patient hemodynamics
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Lawrence Hookey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04118530: Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant
Official title: Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplant
Atrial Fibrillation
Atrial Flutter
Keywords: Atrial Fibrillation
Hematopoietic Stem Cell Transplant
Atrial Flutter
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-10-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with the diagnosis that requires them to undergo HSCT who develop incident AF/AFL in the first 30 days of transplant.

Brief summary: The purpose of this study is to better understand the following aims:

1. Aim 1: To evaluate the rate of recurrent Atrial Fibrillation (AF)/Atrial Flutter (AFL) in hematopoietic stem call transplant (HCST) patients with incident AF/AFL identified during the initial 30 days of the transplant
2. Aim 2: To evaluate incident episodes of 1) stroke/TIA; 2) other thromboembolic events (not stroke/TIA); 3) Heart failure events; 4) Ischemic heart events
3. Aim 3: To evaluate overall implantation safety in this population

Detailed description: We propose a registry study in hematopoietic stem cell transplant (HSCT) patients with incident atrial fibrillation/atrial flutter (AF/AFL) during the initial 30 days of transplant who will be implanted with the Medtronic Reveal Linq Implantable Cardiac Monitor (ICM) within 90 days of HSCT. We will evaluate the rate of recurrent AF/AFL as well as incident episodes of major cardiovascular events and the safety of ICM implantation in this population.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18
2. CHADS-VASc ≥ 2
3. Recovery of platelets to \>50,000 within 90 days of incident atrial fibrillation (AF) diagnosis
4. Discharge from the incident stem cell transplant (SCT) hospitalization
5. Normal sinus rhythm at the time of consent

Exclusion Criteria:

1. Prior history of atrial fibrillation (AF) or atrial flutter
2. CHADS-VASc \<2
3. Platelets \<50,000 after 90 days post transplantation
4. Continued SCT hospitalization at 90 days
5. Inability to receive anticoagulation
6. AF or other arrhythmia at the time of consent
7. Current use of a class IC or III antiarrhythmic medication
8. Inability to provide informed consent/significant cognitive impairment
9. Expected survival less than one year.

Primary outcomes:
measure: Recurrent AF/AFL episodes
timeFrame: 1 year
Secondary outcomes:
measure: Incident Episodes of Interest
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael Fradley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04438330: The Immunological Profile of Nickel Dermatitis
Official title: The Immunological Profile of Nickel Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nickel; Eczema
Nickel Sensitivity
Allergy
Inflammatory Response
Keywords: Patch test
metal allergy
Lead sponsor: National Allergy Research Center, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2020-06-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.

Detailed description: Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital, test participants will be exposed to nickel sulfate in a patch test on their back, which will create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after which the same areas are again exposed to nickel sulfate at different concentrations in a patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed trough Nanostring RNA technologies of around 600 immunerelated genes.

Eligibility criteria: inclusion criteria

* Must be able to understand the written and oral participant information in Danish.
* Previously proven nick allergy by patch testing within the last 5 years, for the nickel allergic test participants.

exclusion criteria

* Pregnancy and / or breastfeeding.
* Systemic immunomodulatory treatments within the last 14 days.
* Local treatments of selected skin areas, such as applying hormone cream within the last two weeks or applying cream / lotion within 24 hours up to sample collection.
* Allergy to local anesthesia.
* Exposed to solar or sunlight on the back within 21 days.
* History of inflammatory skin diseases, asthma, Diabetes Mellitus, hives or arthritis (exclusion criteria only for participation in the healthy control group).
* Participation in another scientific experiment within the last 4 weeks. risks,

Primary outcomes:
measure: mRNA Nanostring screening
timeFrame: 1 month
Secondary outcomes:
measure: Protein verification
timeFrame: 2 month
Other outcomes:
measure: Allergic response
timeFrame: 1 day
Locations:
city: Hellerup
country: Denmark
facility: National Allergy Research Center
state: Danmark
Study officials:
affiliation: National Allergy Research Center, Denmark
name: Jeanne D Johansen, Proff.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00795730: Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789
Official title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects and Subjects With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Healthy Subjects
Keywords: Alzheimer's Disease
schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease


Eligibility criteria: Inclusion Criteria

* Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
* Women must be surgically sterile or postmenopausal
* Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.

Exclusion Criteria

* Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
* Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.

Primary outcomes:
measure: Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetic and pharmcodynamic parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03800225: Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.
Official title: Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study Comparing Internal Brace Repair and a Patella Tendon Autograft Reconstruction.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ligament; Laxity, Knee
Anterior Cruciate Ligament Injury
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.


Eligibility criteria: Inclusion Criteria:

* Anterior cruciate ligament rupture

Exclusion Criteria:

* Current malignant disease
* Rheumatoid arthritis
* Other knee ligament instability
* Obesity BMI \>30
* Morbus Bechterew

Primary outcomes:
measure: Knee Laxity
timeFrame: 12 Months
Secondary outcomes:
measure: Patient reported outcome scores
timeFrame: 12 Months
measure: Patient reported outcome scores
timeFrame: 12 Months
measure: Pain measurement
timeFrame: 12 Months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Study officials:
References:
Clinical trial NCT01650025: Effects of VSL#3 on Metabolic, Endocrine, Lipidomic and Inflammatory Parameters of Pediatric Patients With BMI>90°
Official title: Effects of the Probiotic Preparation VSL#3 on the Metabolic, Endocrine, Lipidomic and Inflammatory Parameters as Well as Variation of the Microbiota in Pediatric Patients With Body Mass Index >90°
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: probiotic, obesity, BMI, metabolic profile, metabolomics
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obesity in children has become a significant social problem considering that nowadays 4 to 5 % of all children are obese in the industrialized countries with increased incidence in Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome in 30% of the children and is considered as a state of chronic inflammation inducing the production of pro-inflammatory cytokines which determine metabolic and endocrine alterations on the organism. It has been observed that obesity is also linked to a change in the intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the metabolites may provide us with a characterization of the existing phenotypes and variations in relation to the changes of the physiological state, in particular when supplemented or not with a probiotic preparation.


Eligibility criteria: Inclusion Criteria:

* age 6-12
* parents or tutors able to give the written consent and follow the study procedures Value of BMI\>90°

Exclusion Criteria:

* - Any severe or concomitant clinical or psychiatric condition that, in the investigator's opinion, could affect the treatment, the evaluations and the inclusion in the protocol;
* Evidence of active liver disease due to other causes;
* Steroid treatment; immuno suppressive therapies, chemotherapy agents within 2 month from screening;
* Pregnancy or breastfeeding;
* Abuse of alcohol and drugs clinically relevant;
* Diabetes.

Primary outcomes:
measure: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90°
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Children Hospital
Study officials:
affiliation: Bambino Gesù Children Hospital
name: Valerio Nobili, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alisi A, Bedogni G, Baviera G, Giorgio V, Porro E, Paris C, Giammaria P, Reali L, Anania F, Nobili V. Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2014 Jun;39(11):1276-85. doi: 10.1111/apt.12758. Epub 2014 Apr 16.