bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The central hypothesis of this proposal is that a reduction in hepatic mitochondrial function
      is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non
      alcoholic steatohepatitis). The investigators further hypothesize that lifestyle
      modifications through aerobic exercise training without weight loss or diet-induced weight
      loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content
      and function in human subjects.

      The investigators propose a randomized, controlled human clinical trial to compare the
      effects of aerobic exercise training (without weight loss) versus diet-induced weight loss
      (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
    

Detailed description: 
      Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further
      hypothesize that lifestyle modifications through aerobic exercise training without weight
      loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving
      hepatic mitochondrial content and function in human subjects.

      The investigators propose a randomized, controlled human clinical trial to compare the
      effects of aerobic exercise training (without weight loss) versus diet-induced weight loss
      (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
    

Intervention name(s): Weight loss; Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Nutritional counseling; Under direct supervision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NAFLD; NASH; Weight loss; Exercise; NAS scores; Mitochondrial dysfunction
The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.
Condition: Respiratory Tract Infection; Children
MeSH terms: Bronchiolitis; Respiratory Tract Infections
Study type: Observational

Summary: 
      Sputum specimens will be obtained from children < 2 years of age and processed by different
      mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical
      and epidemiological data will also be obtained.
    

Detailed description: 
      The purpose of the study is to asses the various pathogens of bronchiolitis in children and
      its' clinical manifestations. Prospective study in 3 Medical centers in Northern Israel.
      Included will be about 200 infants and children < 2 years hospitalized with bronchiolitis.
      From each child sputum specimen will be obtained and processed for HUMP - PCR, Pertussis -
      PCR, RSV - ELISA, DFA, PCR, Influenza A, B, Parainfluenza 1,2,3 - DFA, PCR, Adenovirus - DFA.
      Epidemiological data will be obtained for every child by structured questioner. Clinical data
      will be daily obtained by scoring system.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 0-24 months hospitalized with acute bronchiolitis
      
Keywords: child, bronchiolitis,
The Effect of Leucine on Carnitine Transport to Skeletal Muscle
Condition: Muscle Loss
Study type: Interventional

Summary: 
      The primary aim of the current research project is to explore whether leucine stimulates
      carnitine transport, and thus affecting muscle carnitine content.

      A secondary aim of this project is to investigate the effect of carnitine with leucine
      supplementation on muscle strength and body composition.
    


Intervention name(s): L-carnitine; L-leucine
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): L-carnitine-L-tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Neuroanatomical and Functional Changes in Response to an Intensive Balance Training
Condition: Spatial Orientation; Balance
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether intensive slackline training improves
      spatial orientation abilities, balancing skills and causes neuroplasticity in related brain
      cortical regions.
    


Intervention name(s): Training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Repeated-measures, 2 groups * 2 timepoints
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MRI, Neuroplasticity, Balance, Spatial orientation, Hippocampus, Slacklining
Effect of Metformin on Lactate Metabolism
Condition: Hyperlactatemia
MeSH terms: Hyperlactatemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main objective of this study is to evaluate the influence of metformin on lactate
      metabolism.

      The main outcome is the lactate production following an exogenous lactate overload in healthy
      male subjects without metformin and one week later with metformin.
    

Detailed description: 
      Study design: Physiological study, controlled, open, non randomised

      Healthy male subjects, 18 to 30 years old

      Principal objective : To evaluate the influence of metformin on lactate metabolism
      (production) following exogenous lactate overload.

        -  Objective 2: To evaluate the influence of metformin on lactate metabolism (production)
           after muscular exercise.

        -  Objective 3: To evaluate the influence of metformin on lactate metabolism (elimination)
           after exogenous lactate overload.

        -  Objective 4: To evaluate the influence of metformin on lactate metabolism (elimination)
           after muscular exercise.

      Principal outcome : Lactate production following exogenous lactate overload.

        -  Outcome 2: Production of lactate following muscular exercise test.

        -  Outcome 3 and 3': Parameters modelizing elimination of lactate following exogenous
           lactate overload (bi-exponential model).

        -  Outcome 4 and 4': Parameters modelizing elimination of lactate following muscular
           exercise test (bi-exponential model).

      Inclusion criteria:

        -  Healthy male subjects, 18 to 30 years

        -  Body mass index (BMI) between 21 and 25 kg/m2 inclusive

        -  Informed consent

      Exclusion criteria :

        -  Ward of court or under guardianship (sheltered adults)

        -  Adult unable to express their consent

        -  Person deprived of freedom by judicial or administrative decision

        -  Person hospitalised without their consent

        -  Person under legal protection

        -  Existence of a previously diagnosed pathology

        -  Existence of a metabolic condition (obesity, diabetes) or a family history of such

        -  Ongoing medical treatment.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; metformin; hyperlactatemia
Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB
      symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of
      treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.

      Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment
      response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to
      1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be
      evaluated for changes in OAB symptoms and retreatment rate will be assessed.
    

Detailed description: 
      Primary Objective:

        -  To investigate the risk factors of OAB symptom relapse and retreatment in patients who
           showed therapeutic benefits after 1, 3 or 6 months of treatment with Tolterodine SR and
           who then discontinued these antimuscarinics for 3 month.

      Secondary Objective:

        -  To investigate the change of the patient perception and quality of life after
           antimuscarinic discontinuation

        -  To find the rate of patients who have OAB symptom relapse.

        -  To find the risk factors of patients who want retreatment.

        -  To find the rate of patients who want retreatment.
    

Intervention name(s): Tolterodine; Tolterodine; Tolterodine 6
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Extended release tolterodine tartrate 4 mg, once daily, for 1 months; Extended release tolterodine tartrate 4 mg, once daily, for 3 months; Extended release tolterodine tartrate 4 mg, once daily, for 6 months
Other intervention name(s): Detrusitol ER 4mg; Detrusitol ER 4mg; Detrusitol ER 4mg
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive bladder, Tolterodine,Symptoms Relapse, Predictor
Comparison of Orcinoside With Placebo in Treatment of MDD
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Orcinoside Capsule in different doses are
      effective in the treatment of Depression.

      And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in
      the Chinese Patients with Depression.
    


Intervention name(s): Orcinoside
Intervention type(s): Drug
Intervention description(s): oral, twice per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Chantix for Treating Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether varenicline (Chantix), is effective for the
      treatment of cocaine dependence.
    

Detailed description: 
      The purpose of study is to determine if Varenicline (Chantix™) promotes cocaine abstinence in
      cocaine dependent individuals. Varenicline (Chantix™) (2.0 mg/day) or placebo will be
      administered in a 9-week double-blind trial to patients meeting diagnostic criteria for
      cocaine dependence.
    

Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.0 mg BID for 8 weeks; placebo BID for 8 weeks
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine; crack cocaine; cocaine-related disorders; substance-related disorders; alpha4beta2 nicotinic acetylcholine receptor
Specific Autoantibody Testing in Patients With Interstitial Lung Disease
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the clinical utility of specific autoantibody
      testing in unmasking an underlying connective tissue disorder in patients who present with
      interstitial lung disease and found to have weak positive ANA (1:400 titre) with no overt
      connective tissue disease manifestations OR borderline/negative ANA with some clinical
      suggestion of connective tissue disease.
    

Detailed description: 
      It has been well established that patients with connective tissue disease associated
      interstitial lung disease respond better to immunosuppressive therapy, and have a better
      outcome compared to patients with idiopathic interstitial pneumonias. This makes it
      imperative to identify this group of patients for management and prognostication.
      Unfortunately some of these patients do not demonstrate overt clinical manifestations of
      connective tissue disease and our current available autoantibody screen does not detect all
      potential autoantibodies present. We would like to test for specific autoantibodies in this
      group of patients to evaluate its clinical utility in identifying covert connective tissue
      diseases associated with interstitial lung disease.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with weak positive ANA (1:400 titre) and no overt connective tissue disease
        manifestations OR borderline/negative ANA with some clinical suggestion of connective
        tissue disease.
      
Biospecimen description: 
      Blood
    
Keywords: interstitial lung disease; idiopathic pulmonary fibrosis
Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Respiratory Aspiration; Parkinson Disease
Study type: Interventional

Summary: 
      In this study investigators will examine the effects of inspiratory muscle training and
      balance training in patients with Parkinson's Disease
    

Detailed description: 
      Parkinson's Disease (PD) is the most common type of Parkinsonism and mainly due to
      degeneration of basal ganglions and substantia nigra occurs. Balance disorders are one of the
      common problems in patients with Parkinson's disease. These balance disorders; loss of
      postural reflexes, insufficiency in postural adjustments, rigidity in the trunk and
      extremities, and many disorders such as akinesia. Because of balance disorders in patients
      with PD, increase in addiction to daily life activities, causes physical disability. In the
      case of PD pulmonary problems may be the leading cause of mortality and mortality.
      Respiratory symptoms in these patients cause problems in weakness, swallowing, coughing,
      voice and speech functions. When the investigators look at the current literature, the effect
      of balance and respiration on Parkinson's patients is found to be seperately but their effect
      on each other is not sufficiently emphasized. For this reason, the researchers' aim to
      investigate balance and postural control in patients with Parkinson's disease and to increase
      the strength of respiratory muscles and to improve balance and postural control.
    

Intervention name(s): Respiratory Muscle Strength; Balance Training; Inspiratory Muscle Training
Intervention type(s): Diagnostic Test; Device; Device
Intervention description(s): Respiratory muscle strengths will evalueted with inspiratory and expiratory mouth pressure devices.; Balance training will provide with Biodex® Balance Training System; 15 minutes twice a day, 5 times a week for 8 week with Threshold IMT device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Inspiratory Muscle Training; Balance Training
Effect of a Probiotic Water on Oral Health in Adults
Condition: Oral Bacteria; Halitosis
MeSH terms: Halitosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of consuming a probiotic on salivary,
      plaque, and tongue bacteria, as well as oral malodor (bad breath). Healthy volunteers will
      consume a probiotic powder, or a placebo powder, that is dissolved in water for 4 weeks.
    

Detailed description: 
      The oral cavity houses one of the most diverse microbiota in the human body. There are nearly
      800 unique oral bacterial species identified with more species expected to be added with
      further sampling and identification. As with microbiota of other sites in the body, a
      balanced oral microbiota is essential to maintaining the health of the human host.
      Streptococcus salivarius is a pioneer species that colonizes the human oral cavity from
      birth, and remains a predominant member of the commensal microbiota throughout life. The
      commensal microbiota provides protection against pathogenic species associated with
      conditions such as dental caries, periodontal disease, and oral malodor (halitosis). This
      randomized, double-blind, placebo-controlled study is conducted to investigate the effect of
      a Streptococcus salivarius DB-B5 strain on oral bacteria levels and halitosis. Doses of 2
      billion and 10 billion colony forming units (CFU) per day are tested.
    

Intervention name(s): Streptococcus salivarius DB-B5 - 2 billion CFU/day; Streptococcus salivarius DB-B5 - 10 billion CFU/day; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 1 billion CFU/sachet) dissolved in water twice daily for 4 weeks.; The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 5 billion CFU/sachet) dissolved in water twice daily for 4 weeks.; The participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Probiotic; Oral microbiome
Endotracheal Tube Securement Study
Condition: Mechanical Ventilation Complication
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic,
      randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube
      fastener on complications including lip ulcers, facial skin tears, endotracheal tube
      dislodgement, and ventilator associated pneumonia among critically ill adults requiring
      intubation and mechanical ventilation for at least 24 hours.
    

Detailed description: 
      Background: The optimal securement method of endotracheal tubes is unknown, but should
      provide adequate security while minimizing complications. This study tests the hypothesis
      that use of an endotracheal tube fastener would reduce complications among critically ill
      adults undergoing endotracheal intubation. This hypothesis will be tested in a pragmatic,
      single center, randomized trial comparing the effect of adhesive tape versus endotracheal
      tube fastener (Hollister) among critically ill adults requiring intubation and mechanical
      ventilation for at least 24 hours.
    

Intervention name(s): Tube Fastener; Adhesive Tape
Intervention type(s): Device; Device
Intervention description(s): Endotrachel tube secured with tube fastener; Endotracheal tube secured with adhesive tape.
Other intervention name(s): Hollister AnchorFast
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The endotracheal tube securement study was a pragmatic, single center, open-label, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister AnchorFast Guard) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: endotracheal tube; tube fastener; facial skin tear; lip ulcer; endotracheal tube dislodgement
A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin
      lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both
      state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin
      efficacy after injection into these different areas is still unclear. The results from this
      study may expand the knowledge on the severity of this issue and may provide evidence for
      future treatment recommendations regarding injection sites for insulin administration.
    


Intervention name(s): Insulin LISPRO
Intervention type(s): Drug
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital
Condition: Interventional Vascular Conditions
Study type: Observational

Summary: 
      The purpose of this study is to collect feedback on imaging guidance adequacy from physicians
      who use the OEC™ Elite CFD Mobile Fluoroscopy System-Motorized Configuration to perform
      surgical procedures for which the use of mobile fluoroscopy is prescribed per standard of
      care.

      Up to 40 eligible subjects will be enrolled and have their clinically indicated procedure
      completed using the investigational device.

      Following completion of each subject's procedure, the investigators will complete a User
      Survey specific to the workflow and guidance adequacy of the OEC Elite device. The survey
      will consist of a series of questions on the use of the system as well as anonymized image
      data.

      After all subjects' procedures are completed at a given site, the site investigator will
      review survey data from the study subjects enrolled at the site and document his/her
      assessment of the overall acceptability of the system for use in a clinical environment.

      There is no statistical hypothesis being tested in this study. Results will be summarized
      using descriptive statistics.
    


Intervention name(s): Fluoroscopic imaging with the OEC Elite Device
Intervention type(s): Device
Intervention description(s): Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be adults undergoing vascular, gastrointestinal (GI), urology or
        pain management procedures for which use of the OEC Elite system in the vascular
        configuration would be prescribed.
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers
Condition: Muscle Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      Single center, randomized, single dose study to evaluate the safety, tolerability,
      pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers
    


Intervention name(s): ACE-031
Intervention type(s): Biological
Intervention description(s): single subcutaneous dose of ACE-031
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment