bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.
Condition: Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      In this trial, the investigators aim to assess the effectiveness of a multispecies probiotic
      consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of
      Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L.
      rhamnosus W71, and L. salivarius W24) in reducing the risk of antibiotic-associated diarrhoea
      in a group of children undergoing antibiotic therapy for common infections.
    

Detailed description: 
      Certain individual probiotic strains have been proven to be effective in reducing the risk of
      antibiotic-associated diarrhoea (AAD). However, the effects of using multispecies probiotics
      remain unclear. The investigators aim to assess the effectiveness of a specific multispecies
      probiotic preparation (Ecologic AAD Kids) in reducing the incidence of AAD in children.

      In this trial, a total of 350 children aged 3 months to 18 years, undergoing antibiotic
      treatment, will be randomly allocated to receive either a multispecies probiotic consisting
      of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of
      Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L.
      rhamnosus W71, and L. salivarius W24) at a total dose of 10^10 colony-forming units daily, or
      a placebo, from the first day of antibiotic treatment until 7 days after antibiotic
      cessation. The primary outcome measure will be the incidence of AAD, defined as ≥3 loose or
      watery stools (a score of A on the Amsterdam Infant Stool Scale for children younger than 1
      year and a score of 5-7 on the Bristol Stool Form scale for children older than 1 year) in 24
      hours, caused either by Clostridium difficile or of otherwise unexplained aetiology (after
      testing for common diarrhoeal pathogens), occurring during and/or up to 7 days after the end
      of the antibiotic therapy.
    

Intervention name(s): Multispecies probiotic; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Multispecies probiotic consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71 and Lactobacillus salivarius W24 at a dose of 5x10^9 Colony Forming Units (CFU), twice daily, orally.; Placebo identical in taste, smell and color to the multispecies probiotic.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: antibiotic-associated diarrhea; probiotics
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of BMS-986325 in healthy Japanese participants
    


Intervention name(s): BMS-986325; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced
      by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with
      recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.
    


Intervention name(s): Sugammadex; Succinylcholine; Rocuronium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex; Single bolus IV dose of 1.0 mg/kg succinylcholine; Single bolus IV dose of 1.2 mg/kg rocuronium
Other intervention name(s): Org 25969; MK-8616; Zemuron®
Intervention MeSH terms: Rocuronium; Succinylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevent Inability To Control Urination
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the capacity of self-efficacy to predict
      maintaining a behavior change at four years post urinary control intervention.
    

Detailed description: 
      This is a study that will monitor and compare attitudes and strategies that women use to
      maintain behavior changes that prevent urination problems. Women will complete
      questionnaires, do muscle strength exercises, and bladder training at 3 months, one year, and
      4 years post intervention.
    

Intervention name(s): Bladder Health Class
Intervention type(s): Behavioral
Intervention description(s): A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Self Care; Behavior Modification
The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
Condition: Traumatic Brain Injury; Alexithymia
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Affective Symptoms
Study type: Interventional

Summary: 
      The purpose of this study is to examine a web-based training program for treating emotional
      problems in people who have suffered a traumatic brain injury (TBI).
    

Detailed description: 
      This is a pilot study to examine how subjects with TBI feel about the virtual reality program
      as a treatment and to assess the effectiveness of the virtual reality program at increasing
      subjects' awareness and understanding of emotions.
    

Intervention name(s): Emotion Builder
Intervention type(s): Behavioral
Intervention description(s): Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Alexithymia; Emotions
Vytorin on Carotid Intima-media Thickness and Overall Rigidity
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of the effect on the progression of the carotid intima-media interphase thickness
      (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct
      measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients
      with established cardiovascular disease (myocardial infarct, atherosclerotic coronary
      disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density
      lipoprotein level > 100 mg/dL, treated with simvastatin, pravastatin or the combination of
      simvastatin-ezetimibe during a period of at least one year.
    


Intervention name(s): ezetimibe (+) simvastatin; simvastatin; pravastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive the combination of ezetimibe/simvastatin 10/20 mg o.d. with the possibility to increase the dose to 10/40 mg o.d. for 1 year. Tablets; Patients will receive 40mg od. With the possibility to escalate the dose to 80 mg o.d. if therapeutic goals not attained; for 1 year. Tablets; Patients will receive pravastatin 40 mg o.d. with the possibility to add up 10mg of ezetimibe daily if LDL-C goal is not achieved; for 1 year. Tablets
Other intervention name(s): MK0653A; Vytorin; Zocor
Intervention MeSH terms: Simvastatin; Ezetimibe; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect in artery stiffness of enalapril maleate in Rheumatoid
      Arthritis women patients. Half of participants will receive 5 mg enalapril maleate every 12
      hrs, while the other half will receive a placebo.
    

Detailed description: 
      Rheumatoid Arthritis (RA) is a chronic inflammatory systemic disease considered as an
      independent cardiovascular risk factor that is associated with cumulative inflammatory load
      with an elevation of circulating levels of cytokines, which mediate the mechanism of
      endothelial cells activation by increasing the angiotensin converting enzyme (ACE) function
      and generation of vasoconstriction. Enalapril maleate is a prodrug that is hydrolyzed by
      hepatic esterases in enalaprilat, which is a potent inhibitor of ACE. ACE inhibition
      decreases vascular systemic resistance and mean, diastolic and systolic blood pressures in
      several hypertensive states, independently of the mechanism, ACE inhibitors have a widespread
      clinic use for cardiovascular diseases. Therefore, the researchers considered that there
      could be an association between the use of enalapril and the decrease in arterial stiffness.
    

Intervention name(s): Enalapril Maleate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.; Placebo 5 mg tablet, every 12 hrs for 90 days.
Other intervention name(s): Angiotensin converting enzyme inhibitor.; Inactive drug
Intervention MeSH terms: Enalapril; Enalaprilat; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind, controlled, parallel groups clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: arterial stiffness; enalapril maleate
RSA RCT: Attune RP TKA Versus LCS RP TKA
Condition: Osteoarthritis Arthritis; Joint Disease; Musculoskeletal Disease
MeSH terms: Osteoarthritis; Joint Diseases; Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement
      with a good clinical track record and good survival rates.

      The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has
      been designed to provide better range of motion and address the unstable feeling some
      patients experience during everyday activities, such as stair descent and bending. It is
      expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval
      early 2016. Patient inclusion will start after regular approval has been obtained.

      The objective of this study is to accurately assess and compare migration, clinical and
      radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the
      Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete
      Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy
      Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32
      patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included.

      The study population will consist of patients with symptomatic osteoarthritis of the knee
      scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The
      Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95%
      is Osteo Arthritis (OA). The investigator anticipates that inclusion can be accomplished
      within a 1 year period and that the total study duration is 3 years.

      Main study parameters/endpoints are:

        -  Migration, measured by means of RSA.

        -  Patient Reported Outcome Measures by means of questionnaires.
    


Intervention name(s): ATTUNE Knee Prosthesis by DePuy; LCS Knee Prosthesis by DePuy
Intervention type(s): Device; Device
Intervention description(s): Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy; Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Comparative study; Knee Prosthesis; Prosthesis Design; Treatment Outcome; Follow-up studies; Arthroplast, Replacement, Knee/methods
Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Condition: Pain
Study type: Observational

Summary: 
      Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in
      infants. Despite the short- and long-term adverse effects of pain, there are no guidelines
      for the reduction of such pain. Previous studies evaluated different treatment modalities;
      however, in most of them, pain response was assessed by subjective measures.

      Aims of study: 1. To characterize the pain response of infants by using a computerized
      analysis of the ECG. 2. To compare six different methods of pain reduction during heel
      lancing in newborns.

      Methods: The time, geometric and frequency domains of the infants' ECG will be computed
      during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups:
      breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying
      with a pacifier and lying while getting a glucose solution. The differences in pain response
      to these six treatment modalities will be assessed and compared to the infants' length of
      cry, and scoring of the infants' behavioral response.
    


Time perspective: Prospective
Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade
Condition: Macular Holes; Optical Coherence Tomography
MeSH terms: Retinal Perforations
Study type: Interventional

Summary: 
      State of the art treatment for idiopathic macular holes consists of pars plana vitrectomy,
      internal limiting membrane staining with a blue colouring dye, internal limiting membrane
      peeling and filling of the vitrectomized space with a specific tamponade such as air and SF6.
      Air and SF6 have previously shown similar closure rates, although there was a trend towards
      lower closure rates in large diameter IMH (Idiopathic Macular Holes) using air. IMH with
      diameters < 600 μm are currently believed to have similar closure rates with air and SF6. The
      investigators want to assess possible effects of the used tamponade (air or SF6) on closure
      rates and perfusion parameters represented by OCTA (Optical coherence tomography
      angiography). IMH eyes with a minimum diameter > 600 μm will be excluded. Two idiopathic
      macular hole patient groups will therefore be formed: The first group (group 1) will receive
      air after vitrectomy and membrane peeling, the second group (group 2) will receive 10% SF6
      (and 90% air) after vitrectomy and membrane peeling. After recruitment, patients will
      therefore be electronically randomized to one of the two groups. The groups will then be
      compared by the means of OCT (Optical coherence tomography) and OCTA.

      Note: The trial was registered retrospectively on Clinicaltrials.gov after start of
      recruitment.
    


Intervention name(s): Air; 10% SF6 and 90% air
Intervention type(s): Procedure; Procedure
Intervention description(s): Test if air is sufficient for macular hole closure.; Test if 10% SF6 and 90% air is sufficient for macular hole closure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the PK properties of lorcaserin in subjects with end
      stage renal disease (ESRD) who require dialysis and will be studied under dialysis and
      non-dialysis conditions.
    


Intervention name(s): Lorcaserin 10mg
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2; Nutrition Disorders; Obesity; Body Weight; Metabolic Syndrome x; Metabolic Diseases
MeSH terms: Metabolic Syndrome; Diabetes Mellitus, Type 2; Metabolic Diseases; Nutrition Disorders; Body Weight
Study type: Interventional

Summary: 
      This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes
      investigates the nutrition influence of animal protein in comparison to plant protein on the
      glucose metabolism.
    

Detailed description: 
      2x20 patients with Diabetes mellitus type 2 are randomise by a blind computer assist for an
      equal allocation in both groups (animal protein vs. plant protein). The food components for
      both groups are 40% carbohydrates, 30% fat and 30% protein. The carbohydrates are correspond
      with a high fiber content and a low blood sugar effectiveness of carbohydrates (glycemic
      index).
    

Intervention name(s): High animal protein diet group; High plant protein diet group
Intervention type(s): Other; Other
Intervention description(s): 25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks; 25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nutritional support; diet therapy; protein diet; isocaloric diet
Treatment of Severe Depressive Illness by Targeted Brain Surgery
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      This study will report on the outcome of a clinical program, operational since 1998, that has
      used surgery targeting an emotional pathway in the brain in the treatment of severe
      depressive illness that has failed to respond to all other available interventions. Benefit
      from surgery was anticipated on the basis that the lesion (bilateral anterior capsulotomy) is
      a well established surgical target for treating severe treatment resistant depression.
    

Detailed description: 
      Since 1998 bilateral anterior capsulotomy (BAC) has been available to patients in British
      Columbia Canada who have treatment refractory severe depressive illness. This study will
      report on the outcome of patients who have received this intervention. BAC is achieved by
      stereotactic radiofrequency lesioning. To date 8 patients have received BAC. For all patients
      there is follow-up data of at least 24 months. The purpose of this retrospective study is to
      report on the surgical protocol and to demonstrate the efficacy and safety of BAC in severe
      depression.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All subjects who received BAC for treatment resistant depression between 2000 and 2009
      
Keywords: Limbic surgery; Stereotactic surgery; Major Depressive Disorder: Treatment Refractory
Pediatric Induction Therapy in Kidney Transplantation
Condition: Kidney Transplant Rejection; Pediatric Kidney Disease
MeSH terms: Kidney Diseases
Study type: Observational

Summary: 
      The goal of this observational study is to compare the efficacy of two most commonly used
      induction therapy for the prevention of acute rejection (AR) after renal transplantation in
      children. The main question it aims to answer is:

      Is basiliximab (anti-CD25 monoclonal antibody) induction therapy effective and safe in
      preventing AR after kidney transplantation in children compared with anti-thymoglobulin
      polyclonal antibodies induction therapy?

      The transplant and follow-up data of participants will be retrospectively collected.

      Researchers will compare the rate of AR to see if basiliximab (anti-CD25 monoclonal antibody)
      induction therapy is a better option for certain pediatric kidney transplant recipients.
    


Intervention name(s): Basiliximab Injection; rabbit ATG
Intervention type(s): Drug; Drug
Intervention description(s): As an induction treatment for kidney transplantation; As an induction treatment for kidney transplantation
Other intervention name(s): Simulect; Thymoglobuline
Intervention MeSH terms: Thymoglobulin; Basiliximab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The cohort will be selected from five centers with the highest number of pediatric kidney
        transplant cases in China, including Tongji Hospital of Tongji Medical College of Huazhong
        University of Science and Technology, Changhai Hospital Affiliated to Naval Medical
        University, the First Affiliated Hospital of Zhengzhou University, the First Affiliated
        Hospital of Zhejiang University and the First Affiliated Hospital of Sun Yat-sen
        University.
Sulforaphane Supplementation in Atopic Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN)
      for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is
      possible with this supplementation regimen in individuals with allergic asthma.
    

Detailed description: 
      This pilot study will examine if oral SFN supplementation can induce NRF2 and NRF2-dependent
      phase II enzymes in nasal epithelial cells of allergic asthmatics. Subjects will receive both
      a SFN-rich broccosprout homogenate preparation and an alfalfa sprout homogenate (placebo) in
      a crossover fashion. mRNA levels of NRF2 and NRF2-dependent phase II enzymes will be compared
      between the active and placebo periods.
    

Intervention name(s): Alpha Sprout Homogenate; Sulforaphane Homogenate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Alpha Sprout Homogenate; Active
Other intervention name(s): Placebo
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; Asthmatics; allergic; allergies