bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Kombucha on Blood Sugar Levels in Humans
Condition: Glucose; Glucose Metabolism Disorders (Including Diabetes Mellitus); Blood Sugar; High
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia
Study type: Interventional

Summary: 
      As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in
      humans.
    

Detailed description: 
      Consumption of kombucha, a fermented tea beverage, has been promoted for a wide range of
      health benefits. However, a systematic literature review (Kapp & Sumner, 2019) revealed a
      lack of evidence for human health benefit. Despite the lack of evidence, U.S. retail sales of
      kombucha and other fermented beverages have increased 37.4% in 2017, and kombucha is the
      fastest growing product in the functional beverage market.

      As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in
      humans. We plan for 20 subjects to take part in this study.

      This is a randomized-controlled counter-balanced study design. Subjects will be asked to
      complete 4 in-person visits over 2 months time (twice per month). At the first visit,
      subjects will be randomized into one of four groups. At each subsequent visit, subjects will
      be randomized into one of the remaining groups until they have completed each arm.

      Arms (at least 5 subjects in each arm, minimum total=20 subjects)

        1. Intervention group 1: commercial kombucha: drink 8oz kombucha

        2. Intervention group 2: brewed kombucha: drink 8oz kombucha

        3. Control group: drink 8oz tea (the same type as used to brew the kombucha)

        4. Control group 2: drink 8oz tap water
    

Intervention name(s): Commercial kombucha tea; Brewed kombucha tea; Control: Tea; Control: Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): Commercially-available kombucha tea.; Kombucha tea brewed; Tea brewed in our lab.; Tap water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: kombucha; kombucha tea; tea; fermented food
Trial of HQK-1001 in Beta Thalassemia Intermedia in Lebanon
Condition: Beta Thalassemia Intermedia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Beta thalassemia intermedia syndromes are genetic anemias caused by mutations which reduce
      production of beta globin, a major component of adult hemoglobin A, the protein which
      delivers oxygen throughout the body. Patients suffer from poor growth, fatigue, heart
      failure, endocrine deficiencies, and eventually, many require chronic blood transfusions.
      There is no approved therapeutic for the deficiency of beta globin chains in beta
      thalassemia.

      This trial will study an oral therapeutic which stimulates production of fetal globin, an
      alternate type which is produced by all humans, but is normally switched off in infancy. This
      type of globin can compensate for the missing protein in beta thalassemia.
    

Detailed description: 
      This is a trial of an experimental oral medicine which stimulates production of fetal
      hemoglobin, an innate type of hemoglobin which is normally made but is suppressed in infancy.
      Fetal globin (HbF) can perform the function of the missing beta globin and reduce anemia in
      beta thalassemia, when it is produced in higher amounts than normal.

      In this trial, 10 patients with beta thalassemia intermedia in Lebanon will all receive the
      study drug for 6 months at a dose which has been previously shown to be safe in normal
      volunteers and in beta thalassemia and sickle cell patients and to stimulate fetal globin
      production in many, when given for brief periods. The purpose of this trial is the following:

        1. To determine if total hemoglobin levels increase above baseline in some subjects when
           the study drug is taken for 26 weeks.

        2. To determine if fetal globin is increased above baseline levels in a proportion of
           subjects when the study drug is taken for 26 weeks.

        3. To determine the number of adverse events which occur with 26 weeks of administration of
           the study drug in beta thalassemia intermedia subjects.

      After a screening period, the subjects will take the study drug at home once a day. They will
      be seen once every 4 weeks for examinations and laboratory tests during the dosing period and
      for 4 weeks afterwards.

      This trial will provide an important step in evaluating a potential treatment for patients
      with beta thalassemia intermedia, that can be used around the world, if it is effective and
      safe.
    

Intervention name(s): Sodium 2,2 dimethylbutyrate
Intervention type(s): Drug
Intervention description(s): Oral capsules, dose 20 mg/kg/day, once per day for 26 weeks
Other intervention name(s): ST20
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thalassemia intermedia; Fetal hemoglobin; Hemoglobin
rTMS and Botulinum Toxin in Benign Essential Blepharospasm
Condition: Benign Essential Blepharospasm
MeSH terms: Blepharospasm
Study type: Interventional

Summary: 
      Benign essential blepharospasm (BEB) is a functionally disabling focal dystonia. Botulinum
      neurotoxin (BoNT) therapy is suboptimal in many BEB patients. Repetitious transcranial
      magnetic stimulation (rTMS) therapy is a promising noninvasive therapy and has shown positive
      benefits in BEB. rTMS therapy can be easily combined with BoNT injections to enhance the
      effects of BoNT in BEB.
    

Detailed description: 
      A two week course of rTMS therapy to achieve sustained benefits will be employed. With
      standard BoNT treatment, the peak-dose benefits are seen at about 4-6 weeks after the
      administration of injections. rTMS will be introduced during this peak-dose period (about 6
      weeks after BoNT or T1).The effects of combined therapy at about 10 weeks after BoNT
      injections (T2) and at about 12 weeks after BoNT injections (T3) will be examined along with
      the physiological effects at these time points.
    

Intervention name(s): Magstim RapidStim2; Sham Magstim RapidStim2
Intervention type(s): Device; Device
Intervention description(s): Application of repetitious transcranial magnetic stimulation (TMS) pulses using Magstim RapidStim2 to a specific brain target at predefined stimulation parameters.; Same procedure as real rTMS without stimulating the cerebral cortex.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      The study will enroll children and adolescents (0 - 17 years) suspected of having concussion
      or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the
      patients as well as from corresponding age- and gender-adjusted healthy controls.
    

Detailed description: 
      The collected samples will be alienated to the Sponsor who will perform biochemical studies
      to identify and measure from the samples relative level of the brain injury-specific
      biomarkers.
    

Intervention name(s): Sample collection
Intervention type(s): Diagnostic Test
Intervention description(s): Samples of urine and saliva will be collected from participants using customary sample collection means.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Effects of Smoking Environments on Brain Reactivity
Condition: Cigarette Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study is to evaluate correlations between brain reactivity (as assessed via
      functional magnetic resonance imaging (fMRI) following 24-h abstinence) and the amount of
      smoking in a specific location. The investigators will use ecological momentary assessment
      (EMA) to ask smokers to rate their exposure to, and smoking in, specific personal smoking
      environment cues (PSEs) over the course of 2 weeks before quitting smoking and 2 weeks after
      quitting smoking. The investigators propose to identify 48 regular cigarette smokers who will
      complete 8 visits (1 screening visit, 1 training visit, 1 camera turn-in visit, 1 fMRI
      session and 4 post-quit medication check sessions). Multiple methods will be used to test
      hypotheses about brain functioning during cue-reactivity (CR). The investigators will examine
      correlation between brain responses to smoking environments (minus non-smoking environments)
      and smoking cessation outcomes (i.e. days to lapse, days to relapse). Our EMA+Global
      Positioning System (GPS) analysis will primarily focus on locations where smokers smoke
      before and after quitting smoking. The investigators will evaluate whether EMA-assessed
      smoking intensity values are correlated with brain responses to these personal smoking
      environments.
    


Intervention name(s): Nicotine patch
Intervention type(s): Drug
Intervention description(s): Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The
      drug is administered via subcutaneous injection once six months and is approved for various
      indications, including the treatment of postmenopausal women with osteoporosis at
      increased/high risk of fracture. This phase 1 clincical study investigates the
      pharmacokinetics, safety and immnogenicity of CMAB807,compared to prolia®, in healthy Chinese
      male subjects.
    

Detailed description: 
      This is a phase 1 single center, randomized, double-masked, parallel-group clinical trial.
      The primary objective is to assess the pharmacokinetics similarity of single and subcutaneous
      injection of CMAB807 injection or Prolia® in health volunteers. The secondary objectives are
      to assess the clinical safety and immnogenicity similarity of single and subcutaneous
      injection of CMAB807 or Prolia® in healty volunteers. Meanwhile, exploring the
      pharmacodynamic similarities of CMAB807 and Prolia®.

      Subjects will receive a single 60mg of CMAB807 or Prolia® through subcutaneous injection.
    

Intervention name(s): Prolia®; CMAB807
Intervention type(s): Drug; Drug
Intervention description(s): mAb targeting RANKL. human monoclonal antibody targeting RANKL.; human monoclonal antibody targeting RANKL.
Other intervention name(s): Denosumab Injection; Denosumab Injection
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-masked, Parallel-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Hepatitis B; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and
      Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in
      a cohort of chronic kidney disease (CKD) patients over time.
    

Detailed description: 
      An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™
      compared with Engerix-B® in Adults with Chronic Kidney Disease who Have Previously Received
      At Least One Hepatitis B Vaccine Series
    

Intervention name(s): HEPLISAV; Engerix-B
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL administered intramuscularly (IM) at Week 0, Week 4 and Week 24.
HEPLISAV booster injection = one dose of 0.5 mL volume when needed.; 2.0 mL administered intramuscularly (IM) at Week 0, Week 4, Week 8 and Week 24.
Engerix-B booster injection = one dose of 2.0 mL volume when needed
Other intervention name(s): Hepatitis B vaccine (recombinant), adjuvanted; Hepatitis B vaccine (recombinant)
Intervention MeSH terms: Vaccines
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with Chronic Kidney Disease previously enrolled in the Dynavax clinical studies
        DV2-HBV-17 and DV2-HBV-18
      
Biospecimen description: 
      Serum retained during study duration for additional testing if indicated
    
Keywords: Prevention of Hepatitis B infection.; End Stage Renal Disease; Hepatitis B vaccination; Hepatitis B virus (HBV)
Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).
Condition: Temporomandibular Joint Disorders
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Acute Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objetive of this study is to explore the efficacy and safety of a triple combination of
      ibuprofen, magnesium and ascorbic acid for acute pain treatment in TMJD patients
    


Intervention name(s): Ibuprofen; Magnesium; Ascorbic Acid; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Ascorbic Acid; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: temporomandibular; joint; pain; ibuprofen; magnesium; vitamin C
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both
      children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.
    


Intervention name(s): Keppra XR
Intervention type(s): Drug
Intervention description(s): Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily. Duration: 4-7 days
Other intervention name(s): Levetiracetam XR
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levetiracetam; Epilepsy; Children; Adults
Treatment of Adults With Growth Hormone Deficiency
Condition: Pituitary Disorders; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Pituitary Diseases; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this rollover study is to evaluate the long term (1 year) safety of a new
      weekly administered growth hormone preparation in adults with growth hormone deficiency who
      were treated with the same experimental preparation in study BPLG-005. In addition, further
      change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional
      efficacy and safety data of the experimental preparation will be obtained from the
      switch-over patients.
    


Intervention name(s): Growth hormone - LB03002
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth hormone Deficiency
Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study
Condition: Hypercholesterolemia, Familial
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous
      evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in
      adults with heterozygous familial hypercholesterolemia (HeFH).
    


Intervention name(s): Evolocumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Administered by subcutaneous injection; d by subcutaneous injection
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heterozygous Familial Hypercholesterolemia; Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed
      thinking because of the hay fever will improve when treated with an effective anti-hay fever
      medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate
      better thinking.
    

Detailed description: 
      In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness
      as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and
      cognitive performance weekly as measured by a validated test of cognitive performance (TOVA).
      The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays
      in each nostril once daily will be compared to a placebo treated group of similar subjects
      with seasonal allergic rhinitis.
    

Intervention name(s): Fluticasone furoate Nasal Spray 110 mcg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations.; Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.
Other intervention name(s): Fluticasone Furoate Nasal Spray; Placebo Veramyst Nasal Spray
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Hay Fever; Daytime somnolence; Cognition
Functional Task Kinematic in Musculoskeletal Pathology.
Condition: Musculoskeletal Disease
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      The aim of this project is to create references values to patients with musculoskeletal
      pathology using functional tasks and measuring with a smartphone and video imaging (3D motion
      capture cameras).
    

Detailed description: 
      Musculoskeletal pathologies can affect bones, muscles, joints and other structures related to
      this system. These disorders are extremely common and can have an origin from autoimmune,
      inflammatory, traumatic, etc. The risk of developing this pathologies increases with age.

      The diagnosis could delayed by lack of information, expensive assessment or difficult
      execution.

      Currently, you can use a Smartphone to get the same information as sensors. In addition to
      Smartphone, 3D motion capture systems with a camera have been frequently used to analyse
      kinematics and are being integrated as a rehabilitation tool in patients. The use of
      Smartphones and 3D motion capture cameras would help to find fast and cheap assessment
      methods for professionals.
    

Intervention name(s): Standard Care
Intervention type(s): Procedure
Intervention description(s): The guidelines for the management according to the musculoskeletal disorder in primary care will be the treatment guidelines for the Standard Care.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients treat in general care or diagnosed by a specialist.
      
Keywords: musculoskeletal pathology; motion sensor; motion capture; functional task; biomarker
Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
Condition: TBI (Traumatic Brain Injury); Post Concussion Syndrome; Post Traumatic Stress Disorder; Chronic Post Traumatic Stress Disorder
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Syndrome; Wounds and Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric
      oxygen therapy can improve cognition and brain imaging in subjects with either chronic
      mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or
      chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
    


Intervention name(s): Low pressure hyperbaric oxygen therapy; Low pressure hyperbaric oxygen therapy
Intervention type(s): Drug; Drug
Intervention description(s): HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments; HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
Other intervention name(s): HBOT; HBOT
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic traumatic brain injury; Post concussion syndrome; Post traumatic stress disorder; Chronic post traumatic stress disorder