bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to study the comparison between the effects of supplementation with
      25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and
      Th1/Th2 balance in patients with Multiple Sclerosis.
    

Detailed description: 
      Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from
      myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFN-g, are believed to play a
      major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction
      in MS are believed to become activated outside the central nervous system (CNS) in lymphoid
      tissue and when they cross the blood brain barrier they will re-encounter their antigen.
      Immune deviation is the redirection of the immune response from most often Th1 like responses
      to Th2 like responses, even though the opposite can also occur. Vitamin A (VA) or VA-like
      analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a
      definitive description of their mechanism(s) of action is lacking. High level dietary vitamin
      A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine
      production. Retinoic acid inhibits IL 12 production in activated macrophages, and RA
      pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen
      primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases
      IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the
      immune response in a Th1 direction, whereas high level dietary vitamin A may bias the
      response in a Th2 direction.
    

Intervention name(s): Vitamin A; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 25000 IU/day (one capsule per day) Vitamin A for 6 months; 1 capsule per day for six months
Other intervention name(s): Retinyl palmitate
Intervention MeSH terms: Vitamin A; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Vitamin A; CD4-Positive T-Lymphocytes; Th1 Cells; Th2 Cells
Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study
Condition: Arthritis; Rheumatic Diseases; Autoimmune Diseases
MeSH terms: Spondylitis; Spondylitis, Ankylosing; Rheumatic Diseases; Collagen Diseases; Autoimmune Diseases
Study type: Interventional

Summary: 
      Axial spondyloarthritis (axSpA) is a chronic inflammatory immune disorder with a global
      prevalence that ranges from 20 to 160 cases per 10000 individuals. axSpA has two forms of
      clinical presentation (radiographic and non-radiographic) based on the presence or absence of
      radiographic sacroiliitis. This condition mostly affects the vertebral spine, and is
      characterized by joint pain and stiffness, fatigue, and restricted function, which leads to a
      substantial physical, psychological, and socioeconomic burden. The clinical management of
      axSpA needs to combine pharmacological and non-pharmacological approaches to reduce
      inflammation and improve health-related quality of life.

      The aim of the study will be to determine if a 12-week probiotic supplementation will be more
      effective than an online-delivered strength training program at improving functional capacity
      in adults with non-radiographic axSpA. As a secondary aim, we will compare the impact of both
      interventions on disease activity, spinal mobility, quality of life and biochemical measures.
      This will be the first randomized controlled trial where probiotics are compared with an
      active intervention.
    


Intervention name(s): Probiotic group; Exercise group
Intervention type(s): Dietary Supplement; Other
Intervention description(s): During the first 4 weeks, patients will be instructed to take two capsules of Enterelle plus (Bromatech lab, Manno, Switzerland) during morning time, before or after breakfast. Enterelle plus contains specific strains, i.e., S boulardi, E faecium, and acidophilus, that contribute to reduce the mycotic flora and modulate the gastrointestinal transit. For the next 8 weeks, participants will be told to ingest two capsules of Adomelle (Bromatech lab, Manno, Switzerland) at night, during or right after dinner. Adomelle contains several strains, including Bifidobacterium breve, that help to reduce abdominal fat, pain, and gas, and control the frequency of deposition; This type of intervention has shown to benefit patients with several chronic conditions 23, including axSpA 13. Exercises combined high knees, lunges, basic burpees, plank, skipping, mountain climbers, and squats with jumps. The training routine will be conducted three times per week, and each session will last around 8 minutes (2 sets of 4 minutes, with a 10 second rest between them). All sessions will be individually tailored and supervised by a senior professional with a degree in Physiotherapy and Sciences of Physical Activity and Sport. Overall, participants will be told to continue exercising if low to moderate bearable pain appeared during training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Semi-replicate Crossover Bioequivalence Study of Dirithromycin in Healthy Subjects Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of the investigational TEST product
      with the marketed REFERENCE products by measurement of Plasma concentrations of
      Erythromycylamine in plasma and calculation of the bioequivalence parameters from those
      measurements followed by ANOVA and 90% confidence interval statistical evaluation.
    

Detailed description: 
      An open-label, randomized, two-treatments, three-periods, three-sequences, semi-replicate
      crossover bioequivalence study with a washout period of at least 14 days between doses.
      Healthy, mixed skin Arab & Mediterranean Subjects ages between 18 and 50 years, body-mass
      index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers
      (smokers of not more than 10 cigarettes per day).
    

Intervention name(s): DIRITHROMYCIN 500 MG ENTERIC COATED TABLET; DYNABAC 250 MG ENTERIC COATED TABLET
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dirithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fed Conditions
Continuous Saphenous Nerve Block for Total Knee Arthroplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Our study will compare the use of continuous saphenous nerve block performed at the adductor
      canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to
      LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block
      performed at the level of the adductor canal in addition to LIA provides better pain relief
      than the LIA alone without significantly compromising muscle strength and physiotherapy,
      enabling patients to mobilize early with reduced opioid consumption and les side effects.

      The investigators will enroll a total of 40 patients (20 patients will receive continuous
      saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until
      discharge, the investigators will record patients' pain scores, opioid consumption, side
      effects and physical therapy progress.

      If our study proves that the continuous saphenous nerve block in addition to LIA can
      effectively reduce postoperative pain scores to an acceptable level with better physical
      therapy progress and less opioid consumption, it could be seen as a more attractive
      alternative to LIA alone or other traditionally used methods of postoperative pain control
      that compromises muscle strength and physiotherapy.
    


Intervention name(s): continuous saphenous nerve block; Saline boluses in nerve catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days; A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Beta Blocker Effects in Traumatic Brain Injury
Condition: Trauma, Brain
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will be conducted on polytrauma patient who are admitted from emergency room or
      postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.
    

Detailed description: 
      The study will be conducted on polytrauma patient who are admitted from emergency room or
      postoperative with head trauma . Patients will be randomly assigned into two groups by sealed
      envelope technique into two equal groups.

      Parameters assessment:

        -  Length of ICU stay

        -  Length of total hospital stay

        -  CT scan to exclude another intracranial hemorrhage or increase in hemorrhage

        -  Functional status will be assessed using the GCS

        -  Hemodynamic data ( bl.p / hr )

        -  Crystalloid volume that patient need in 24h

        -  Mortality rate
    

Intervention name(s): Propranolol; Saline
Intervention type(s): Drug; Drug
Intervention description(s): intravenous propranolol for case patients; intravenous saline for placebo
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children
Condition: Beta Thalassemia Major Anemia; Iron Overload
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is looking at the effects of giving early treatment of deferiprone to young
      children with beta thalassemia who have started receiving regular blood transfusions but have
      not yet reached the criteria for starting on iron chelation therapy. Half the patients in the
      study will receive deferiprone, and the other half will receive placebo, for up to 12 months.
    

Detailed description: 
      This study will give deferiprone to infants and young children with thalassemia who have
      started receiving regular blood transfusions but whose iron load is not yet at the level
      where chelation treatment would normally begin. The purpose is to see if doing this will
      postpone the build-up of iron without causing serious side effects. Half the children in the
      study will be given deferiprone at a dose that is lower than what is normally prescribed, and
      the other half will be given placebo. All patients will receive the assigned product three
      times a day for up to 12 months. Tests for signs of iron overload will be done monthly, and a
      patient whose iron load reaches the level where chelation therapy would normally begin will
      be immediately taken out of the study and started on standard chelation therapy.
    

Intervention name(s): Deferiprone oral solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liquid formulation of deferiprone, with a concentration of 80 mg/mL; Liquid solution that matches deferiprone oral solution in appearance and taste
Other intervention name(s): Ferriprox; Placebo for deferiprone oral solution
Intervention MeSH terms: Pharmaceutical Solutions; Deferiprone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thalassemia; iron overload; chelation; deferiprone; Ferriprox
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional

Summary: 
      A non inferiority trial to determine the capability of optical coherence tomography (OCT)
      imaging to show vessel morphology in comparison to imaging provided by intravascular
      ultrasound imaging (IVUS).
    

Detailed description: 
      Patients requiring diagnostic imaging of peripheral vessels to determine vessel condition and
      planning treatment strategy will have vessel segments imaged by both OCT and IVUS imaging
      catheters. The images will be collected into a library and independent readers will rank each
      image on the quality of vessel morphology and disease.
    

Intervention name(s): IVUS and OCT Imaging
Intervention type(s): Device
Intervention description(s): Use of an imaging catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the long-term effects and tolerability of ABT-089
      in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
    


Intervention name(s): ABT-089
Intervention type(s): Drug
Intervention description(s): Subjects will take up to 80 mg daily for 24 months
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention-Deficit/Hyperactivity Disorder
Daily Self-weighing and Holiday-associated Weight Gain in Adults
Condition: Obesity
MeSH terms: Weight Gain; Body Weight
Study type: Interventional

Summary: 
      Background: Previous studies report 0.4-1.5kg of weight gain during the holiday season, which
      may contribute to annual weight gain.

      Purpose: To test whether daily self-weighing (DSW) can prevent holiday weight gain.

      Hypothesis: We hypothesized that daily self-weighing would effectively prevent weight and fat
      gain, and that individuals with overweight and obesity would respond most favorably to DSW.
    

Detailed description: 
      A single-blinded randomized control trial:

      Adults (age 18-75y, BMI ≥ 18.5kg/m2) were randomized to either a control or daily
      self-weighing (DSW) group. There were 3 testing visits: pre-holiday (v1: within 7d before
      Thanksgiving), post-holiday (v2: within 7d after New Year's Day), and a follow-up (v3: 14
      weeks after v2). The DSW group were given Wi-Fi scales that provide graphical feedback of
      daily weight. They were instructed to perform DSW during the holidays and to try not to gain
      weight above baseline weights. Anthropometrics were measured at each visit.
    

Intervention name(s): Daily self-weighing (DSW)
Intervention type(s): Device
Intervention description(s): DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.
Other intervention name(s): DSW
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Holiday weight gain; Daily self-weighing; Weight maintenance; Caloric titration method; Obesity; Overweight; Holiday season
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were to evaluate the safety and tolerability of lucerastat and
      to determine its pharmacokinetic profile after multiple dosing. Also, the potential effect of
      food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.
    

Detailed description: 
      The subjects were to be enrolled sequentially to three dose groups, starting with the lowest
      dose level. Subjects could participate in only one Group. Progression to an increased dose of
      lucerastat was permitted only after review of all data from the previous cohort suggested
      that it was safe to do so.
    

Intervention name(s): Lucerastat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule for oral administration containing lucerastat; Placebo capsules matching lucerastat capsules
Other intervention name(s): OGT-923; ACT-434964; CDP923
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Pharmacokinetics; Safety
Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million
      individuals in the United States, resulting in an annual cost of care of $305 billion. AD is
      functionally characterized by progressive degeneration of large-scale brain networks (LSBNs),
      including the default mode network (DMN) presumably from the deposition of amyloid plaques
      and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and
      memantine offer limited benefit and modest impact on quality of life. In combination with
      resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with
      intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to
      pharmacotherapy in persons with AD. We propose a pilot trial using rs-fMRI to target
      dysfunctional LSBNs in early stage AD.
    


Intervention name(s): Intermittent theta burst stimulation
Intervention type(s): Device
Intervention description(s): MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz
Other intervention name(s): Transmagnetic stimulation; MagVenture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transmagnetic stimulation; functional MRI guided Theta Burst Stimulation; Early Stage
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
Condition: Hepatitis C Infection
MeSH terms: Infections; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well
      tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the
      treatment of hepatitis C virus genotype 1 in chronically infected patients who are
      treatment-naïve and nonresponsive to the standard of care
    


Intervention name(s): BMS-790052; BMS-790052; Placebo; Peginterferon alfa-2b; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 10 mg, daily, 24-48 weeks; Tablets, Oral, 60 mg, daily, 24-48 weeks; Tablets, Oral, 0 mg, daily, 48 weeks; Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks; Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other intervention name(s): PegIntron®; Rebetol®
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Green Tea Extract and Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to see if a green tea extract can beneficially alter several
      markers of cancer risk and progression.
    

Detailed description: 
      To evaluate the short-term effects of a daily dose of Polyphenon E administered during the
      interval between prostate biopsy and radical prostatectomy in men with recently diagnosed
      prostate cancer. Endpoints will be changes in serum and tissue biomarkers related to
      progression of cancer.

      The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary
      objective. Secondary objectives include the effects on the other tissue and serum biomarkers.
      Evaluation of the safety and tolerability of Polyphenon E in this subject population is
      another objective.

      1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation
      levels in patients with prostate cancer 1.2 Determine the effects of Polyphenon E on PI-3K
      activation in patients with prostate cancer 1.3 Determine the effects of Polyphenon E on MAPK
      activation in patients with prostate cancer 1.4 Determine the effects of Polyphenon E on
      expression levels of other proteins involved in motility and invasion such as Rho GTPases and
      extracellular proteinases in patients with prostate cancer 1.5 Determine the effects of
      Polyphenon E on markers of angiogenesis in patients with prostate cancer 1.6 Determine the
      effects of Polyphenon E on serum Prostate Specific Antigen (PSA) in patients with prostate
      cancer 1.7 Determine the effects of Polyphenon E on other serum markers: C-reactive protein
      (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3
      (IGFBP-3), Hepatocyte Growth Factor HGF 1.8 Evaluate the safety and tolerability of
      Polyphenon E in this subject population
    

Intervention name(s): Polyphenon E (EGCG)
Intervention type(s): Drug
Intervention description(s): 4 capsules daily with a meal for the duration of the study
Other intervention name(s): Polyphenon E
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: EGCG; polyphenols; biomarkers; prostate specific antigen