bioihbjkbjnl/mcl2 huggingface dataset:
resVida and Fat Oxidation
Condition: Obesity
Study type: Interventional

Summary: 
      There is now a general consensus that the combination of excessive energy intake and a low
      capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is
      known for many years that physical exercise is the most powerful treatment to combat insulin
      resistance, but it is also known that it is difficult to get people to exercise. A major
      breakthrough has come from the nutrition field, with the finding that resveratrol, a natural
      polyphenolic compound, could serve as an "exercise mimetic" by protecting mice from many
      detrimental effects of diet-induced obesity. Therefore the researchers would like to
      investigate if resVida can increase skeletal muscle mitochondrial function and fat oxidative
      capacity in obese subjects. The researchers hypothesize that an increased mitochondrial
      function together with an increased intrinsic activity will lead to a better control of fatty
      acid handling in muscle, upon a high-fat challenge.
    


Intervention name(s): resVida; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.; resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.
Other intervention name(s): resveratrol
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: impaired fat oxidation; fat accumulation; mitochondrial dysfunction; mitochondrial biogenesis
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple ascending
      oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.

      During the course of the study, the amount of GLPG0634 present in the blood
      (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related
      parameters in the blood (pharmacodynamics) will be characterized.
    


Intervention name(s): GLPG0634; GLPG0634; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GLPG0634 300 mg oral capsules, qd, 10 days; GLPG0634 450 mg oral capsules, qd, 10 days; Placebo oral capsules, qd, 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Treadmill and Whole Body Vibration Training in Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      It is reported in the literature that children with attention deficit hyperactivity disorder
      (ADHD) may have executive function deficits, impaired social functions, emotional
      dysregulation, behavioral disorders and motor impairments. Furthermore, studies have shown
      that exercise, such as acute and chronic aerobic exercises and acute whole body vibration
      training, improves executive functions and motor abilities and so it is hypothesized that
      exercise may have a potential or additional treatment option for children with ADHD.
      Neurobiological researches have already proven the effects on brain changes during exercise
      and in the case of ADHD, increasing levels of serotonin, dopamine, and norepinephrine within
      the front striatal lobes of the brain were highlighted when discussing the effects on this
      neurodevelopmental disorder. The literature emphasizes the importance of physical activity in
      children with ADHD, but there is no clarity regarding the frequency, intensity or duration of
      the exercise. Thus, the aim of this study was to investigate and compare the effects of
      treadmill training as an aerobic exercise and whole body vibration training on executive
      functions and balance in children with ADHD.
    


Intervention name(s): Treadmill training; Whole body vibration training
Intervention type(s): Other; Other
Intervention description(s): Treadmill training Each season will be supervised and last 45 minutes. Treadmill speed will be adjusted to the child's maximal heart rate (MHR) (between 65 to 75 percent of the MHR).; Whole body vibration training whole body vibration frequence will be 50 Hertz and childrens will be standing position on vibration platform .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treadmill Training; Whole Body Vibration Training
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality
      and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.
    


Intervention name(s): Arotinolol Hydrochloride; Non arotinolol group
Intervention type(s): Drug; Drug
Intervention description(s): Antihypertensive medications plus arotinolol hydrochloride, dosage of arotinolol hydrochloride from 2.5mg bid, 2 days later increased to 5mg bid or 10mg bid, for 18 months; Antihypertensive medications without arotinolol for 18 months
Other intervention name(s): Almarl; Control group
Intervention MeSH terms: Arotinolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic kidney disease; hypertension
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid
      tumor for which there is no remaining standard curative therapy and no therapy with a
      demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.
      Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and
      efficacy. No formal interim analyses will be performed.

      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon
      enrollment, subjects will receive intravenous (IV) infusions of OMP-18R5 at a assigned dosing
      schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there
      is no evidence of disease progression or if the tumor is smaller, then subjects may continue
      to receive IV infusions of OMP-18R5 every week until disease progression.

      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose
      escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled
      in a cohort will not be treated on the same day. The dose may be administered at any time
      during the day. Three subjects will be treated at each dose level if no dose-limiting
      toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be
      expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be
      dosed at that level and 3 additional subjects will be added to the preceding dose cohort
      unless 6 subjects have already been treated at that dose level. Subjects will be assessed for
      DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled
      subjects, if appropriate, will occur after all subjects in a cohort have completed their Day
      28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to
      continue to receive weekly doses of OMP-18R5 until disease progression. An additional 14
      subjects will be enrolled at the highest dose level that result in < 2 of the 6 subjects
      experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours)
      or 4 adverse event (DLT).
    


Intervention name(s): OMP-18R5
Intervention type(s): Biological
Intervention description(s): IV infusion. Subjects with stable disease or a response at Day 56 will be allowed to continue until disease progression.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; dose escalation; histologically confirmed; malignancy metastatic
A Study on the Possible Health Effects of Lean Fish and Fatty Fish Intake in Overweight or Obese Adults
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The potential health effects of high intake of lean or fatty fish will be investigated in
      overweight or obese adults. Participants consume 750g/week of fillets of fish for 8 weeks.

      Hypothesis:

      High intake of fatty or lean fish will beneficially affect glucose regulation and the immune
      system.
    


Intervention name(s): Lean fish; Fatty fish
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets
Condition: Gastroesophageal Reflux Disease; Erosive Esophagitis; Heartburn
MeSH terms: Gastroesophageal Reflux; Esophagitis; Heartburn
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the in-vivo disintegration time of a single
      dexlansoprazole delayed-release orally disintegrating (OD) tablet.
    

Detailed description: 
      The drug being tested in this study is called dexlansoprazole. An orally disintegrating (OD)
      form of dexlansoprazole is being tested to look at the average time that it takes for one
      tablet to disintegrate in the mouth of healthy volunteers. At the point at which the panelist
      would normally swallow the granules, they will record the time and expectorate the
      disintegrated tablet mass and not actually swallow the tablet or granules.

      The study will enroll approximately 8 healthy volunteers. All participants will take one
      dexlansoprazole 30 mg OD tablet on up to three separate study days. No more than 60 mg of
      dexlansoprazole will be tested in any one day.

      This single-centre trial will be conducted in the United States. The overall time to
      participate in this study is approximately 2 weeks. Participants will make up to 4 visits to
      the clinic, and will be contacted by telephone approximately 1 week after last dose of study
      drug for a follow-up assessment.
    

Intervention name(s): Dexlansoprazole
Intervention type(s): Drug
Intervention description(s): Dexlansoprazole delayed-release orally disintegrating tablets
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparison of the pharmacokinetics/Pharmacodynamics of the HSK3486 in Patients With Mild and
      Moderate Hepatic Impairment Compared with Healthy Volunteers
    

Detailed description: 
      This is a single-center, open-label, non-randomized, parallel-controlled Phase I clinical
      study carried out in patients with compensated chronic liver disease (Child-Pugh A), patients
      with decompensated chronic liver disease (Child-Pugh B), and age-, weight-, and
      gender-matched subjects with normal liver functions.
    

Intervention name(s): HSK3486
Intervention type(s): Drug
Intervention description(s): HSK3486，Initially 0.4 mg/kg was administered as a 1 minute bolus, followed immediately by a constant infusion dose of 0.4 mg/kg/h administered as a 30 minute infusion via infusion pump.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis
Condition: Moderate to Severe Palmar Plantar Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the short and long term safety and effectiveness of
      ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.
    


Intervention name(s): Ustekinumab
Intervention type(s): Drug
Intervention description(s): Dosing will consist of a 45mg subcutaneous injection for patients weighing less than 100 kg and a 90 mg subcutaneous injection for patients whose weight is greater than 100 kg. Dosing will begin on week 0 followed by subsequent dosing on week 4 and week 16.
Other intervention name(s): Stelara
Intervention MeSH terms: Ustekinumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Palmar Plantar Psoriasis
Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine
Condition: Diphtheria; Tetanus; Pertussis; Polio
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      An open clinical trial to study the immune response and safety after giving a booster dose
      (5th Dose) of a combination vaccine against Diphteria-Tetanus-Pertussis-Polio to healthy
      adolescents 15-16 Years of age. The first three doses were given during the first year of
      life, according to the Norwegian child immunization program. The fourth dose was given in a
      previous clinical trial performed in 1998 when the children were 6-7 years old.

      In 2006 there was a change in the child immunization program in Norway: a fourth dose of a
      Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio is given to children 6-7 years
      old.

      This study will give us information if there is need for an additional dose (5th dose) of a
      combination vaccine, containing the pertussis components, before the adolescents are leaving
      secondary school.
    


Intervention name(s): Boostrix polio
Intervention type(s): Drug
Intervention description(s): 1 dose (0.5 ml) i.m.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphteria-tetanus-pertussis-polio vaccine; Booster immunization; Vaccine effect (Diphtheria-tetanus-acellular pertussis-polio); Immunity; Safety
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram
      per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of
      participants presenting with their first clinical episode consistent with multiple sclerosis
      (MS) to clinically definite multiple sclerosis (CDMS).

      The secondary objectives were:

        -  To demonstrate the effect of teriflunomide, in comparison to placebo, on:

             -  Reducing conversion to definite multiple sclerosis (DMS)

             -  Reducing annualized relapse rate (ARR)

             -  Reducing disease activity/progression as measured by Magnetic Resonance Imaging
                (MRI)

             -  Reducing accumulation of disability for at least 12 weeks as measured by the
                Expanded Disability Status Scale (EDSS)

             -  Proportion of disability-free participants as assessed by the EDSS

             -  Reducing participant-reported fatigue

        -  To evaluate the safety and tolerability of teriflunomide

        -  To evaluate the pharmacokinetics (PK) of teriflunomide

        -  Optional pharmacogenomic testing aimed at assessing the association between the main
           enzyme systems of teriflunomide metabolism and hepatic safety, and other potential
           associations between gene variations and clinical outcomes
    

Detailed description: 
      The study consisted of 4 periods:

        -  Screening period: up to 4 weeks,

        -  Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants
           who experienced conversion to CDMS),

        -  Extension treatment period (without placebo-control): the extension period continued
           until teriflunomide was commercially available in participant's country of residence.

        -  Post-treatment washout period: 4 weeks after last treatment intake.

      The maximal duration of the study period per participant was expected to be 116 weeks if
      he/she did not continue in the extension treatment period.
    

Intervention name(s): Teriflunomide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet Oral administration; Film-coated tablet Oral administration
Other intervention name(s): HMR1726; Aubagio
Intervention MeSH terms: Teriflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MS; Clinically Isolated Syndrome; CIS; CDMS; relapses
Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco
      smokers and nonsmokers.
    

Detailed description: 
      Aim 1:

      To determine sex differences in amphetamine-induced dopamine (DA) release in healthy tobacco
      smokers and nonsmokers.

      FLB-457 has been used in several PET centers and has recently been approved for use at the
      Yale University PET Center. We would like to determine whether there are sex differences in
      amphetamine induced DA release in healthy tobacco smokers and nonsmokers. Specifically, 40
      healthy tobacco smokers and 40 healthy nonsmokers will have an magnetic resonance imaging
      (MRI) scan followed on another day by two FLB scans (ideally, the two PET scans will be
      carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine
      (0.4mg/kg, PO) will be administered.

      Aim 2:

      To determine sex differences in amphetamine-induced dopamine release in tobacco smokers from
      Aim 1 after treatment with guanfacine. Guanfacine will be given under a different protocol.
      We plan to determine whether guanfacine treatment differentially inhibits amphetamine-induced
      DA release in men and smokers from Aim 1. After their first scan, the same 40 healthy tobacco
      smokers from Aim 1 will take guanfacine for 3 weeks under and then will have another set of
      FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3
      hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered, as before.
      The sets of scans will be separated by at least 21 days, but due to scheduling and technical
      difficulties the second set may be scheduled up to 6 weeks after the first set.
    

Intervention name(s): Amphetamine
Intervention type(s): Drug
Intervention description(s): Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
Other intervention name(s): dextroamphetamine
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Smokers and non smokers
      
Biospecimen description: 
      Samples will be obtained for hormones and amphetamine drug levels
    
Keywords: amphetamine; cigarette smokers
Computerized Cardiotocography and Maternal Coffee Habits
Condition: Prenatal Care
Study type: Observational [Patient Registry]

Summary: 
      The study includes pregnant women referred for foetal antepartum computerized
      cardiotocography (cCTG) monitoring as outpatients. Pregnant women were divided into two
      groups based on their coffee intake: the coffee group and the control group. Each pregnant
      woman had cCTG. Two doctors assessed and recorded the amount of coffee taken by pregnant
      women before the CTG.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        we included only term pregnant, who performed a computerized cardiotocography before the
        delivery.
      
Keywords: computerised cardiotocography; Fetal monitoring; nutrition in pregnancy; prenatal care; fetal heart rate
Young Plasma Transfusions for Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy
MeSH terms: Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, multi-center, open-label study of the safety, tolerability,
      pharmacodynamics, and preliminary efficacy of young (<30 years of age) healthy male donor
      plasma transfusions in patients with PSP. Up to 10 subjects will receive once monthly 4-unit
      transfusions of young healthy male donor plasma for 6 months.
    

Detailed description: 
      This is a phase 1, multi-center, open-label study of the safety, tolerability,
      pharmacodynamics, and preliminary efficacy of young (<30 years of age) healthy male donor
      plasma transfusions in patients with PSP. Up to 10 subjects will receive once monthly 4-unit
      transfusions of young healthy male donor plasma for 6 months.

      If ≥3 subjects experience drug limiting toxicity (DLT), as defined in Section 7.19, the study
      will be terminated. Any subject that experiences a DLT will be discontinued from further
      treatment with the study drug.

      An interim futility analysis will be performed after five subjects have completed 6 months of
      study drug treatment. If the criteria listed in Section 9.3 of this protocol are met, an
      additional 5 subjects will be enrolled in the trial. If not, the trial will be terminated.
    

Intervention name(s): Fresh Frozen Plasma
Intervention type(s): Biological
Intervention description(s): Fresh Frozen Plasma [young (<30 years of age) healthy male donors] Solution for intravenous infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PSP; Young Plasma