bioihbjkbjnl/mcl2 huggingface dataset:
A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to
      determine a maximum tolerated dose
    

Detailed description: 
      This study was designed as a randomized, double-blind, placebo-controlled, sequential
      multiple ascending dose study to assess the safety and pharmacokinetics of supratherapeutic
      doses of eslicarbazepine acetate in 32 healthy adult male and female subjects, with 8
      subjects per treatment group. In each study group, subjects were to receive single doses of
      eslicarbazepine acetate or placebo once daily for 5 days.

      A series of screening evaluations was performed within a 21-day period prior to the first
      dose of study medication in order to determine the eligibility of prospective study
      participants for the trial. Eligible subjects reported to the clinic on Day -1 prior to study
      medication administration and remained in the clinic until clinic discharge on Day 7. Plasma
      and urine samples were collected throughout the study to determine the pharmacokinetics of
      eslicarbazepine acetate and its metabolites.
    

Intervention name(s): Placebo; BIA 2-093 3000 mg once daily; BIA 2-093 3600 mg once daily
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching placebo tablets for oral administration; Eslicarbazepine acetate 600 mg tablets for oral administration; Eslicarbazepine acetate 600 mg tablets for oral administration
Other intervention name(s): sugar pills; eslicarbazepine acetate; Eslicarbazepine acetate
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anticonvulsant
The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in
      healthy male subjects.
    

Detailed description: 
      tPA treatment should be used within 3 hours after stroke onset for treating efficacy, but
      JPI-289 treatment(PARP-1 inhibitor) showed treating efficacy more than 10 hours after stroke
      onset. PARP-1 inhibitor add-on therapy of tPA will be very useful to prevent social, economic
      loss from physical, and mental disable by stroke.

      This clinical trial progresses to explore safety, tolerability,
      pharmacokinetic/pharmacodynamic properties of JPI-289 by single dose escalation(7cohort).
      Investigational product medication of each level within 4 weeks evaluate safety and
      tolerability of patient through Data Safety Monitoring Board(DSMB) which is composed of more
      than 3 experts except principal investigator until the last visit. In each level 6 patients
      for investigational product and 2 patients for placebo will be allocated respectively in
      double blind manner.
    

Intervention name(s): JPI-289; Placebo
Intervention type(s): Drug; Other
Intervention description(s): PARP-1 inhibitor; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: PARP-1 inhibitor
Improving Motor Stroke Recovery Using Patient-tailored Non-invasive Brain Stimulation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Many individuals are often left with problems moving their arm and hand, months to even years
      after a stroke. Recent progress in research suggests the application of non-invasive brain
      stimulation, such as transcranial direct current stimulation (TDCS), in conjunction with
      rehabilitation exercises can further improve a person's ability to move after stroke.
      However, the problem is that this doesn't work for everyone, and researchers do not know why.
      One reason may be that TDCS is currently applied using a one-size-fits-all approach.
      Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in
      the same way. But, researchers know this is not the case. For example, each person will
      likely have different amounts of damage to brain regions that control movements. A better
      understanding of how the stroke uniquely affects a person's brain will help us to know which
      is the correct type of TDCS to apply for that person. Therefore, the objective of this
      research is to determine whether the amount of damage to brain regions that control movements
      can predict which type of TDCS will be more effective to help a person improve their ability
      to move. Participants will undergo 1 session of magnetic resonance imaging, and three
      sessions of TDCS.
    


Intervention name(s): Sham TDCS; Anodal TDCS; Cathodal TDCS; Magnetic Resonance Imaging (MRI)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Placebo stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity; Excitatory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity; Inhibitory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity; Participants will receive a MRI of their brain to allow the research investigators to determine how the stroke has affected regions of the brain processing movements.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor; rehabilitation; transcranial direct current stimulation
Strength-enhancing Effect of Whey Protein Supplementation Following Resistance Exercise in Adolescent Males
Condition: Healthy
Study type: Observational

Summary: 
      This study investigates the strength gains associated with resistance training in a group of
      18 male high school athletes consuming either a whey protein supplement or chocolate milk
      following their exercise.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male high school athletes
      
Keywords: Adolescent; supplements; strength; whey protein; bench press strength; squat strength
Vitamin D Status and Dose Response in Infants
Condition: Vitamin D; Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and
      greater gestation who are fed infant formula to markers of inflammation and bone metabolism.
    

Detailed description: 
      It is hypothesized that serum 25(OH)D levels in infants 32 weeks and greater gestation are
      not maintained at optimal levels of greater than 32 ng/Ml with currently available infant
      formulas, and that this will have an inverse relationship with markers of inflammation and
      bone metabolism.
    

Intervention name(s): Vitamin D3; vitamin D3 placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.; Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
Other intervention name(s): DVi-Sol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: vitamin d; prematurity; 25(OH)D; infant; CRP; PTH
Single and Multiple Dose Asian Bridging Study
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK),
      pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a
      selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.
    

Detailed description: 
      This study will evaluate the single-dose (SD) pharmacokinetics (PK), pharmacodynamics (PD),
      safety, and tolerability of oral doses of 10, 40, and 80 mg E5501 administered to 36 healthy
      male and female Japanese, Chinese, and Caucasian subjects. For the SD Treatment Period, 12
      subjects from each ethnic group will be randomized to receive single doses of 10, 40, or 80
      mg E5501 or matching placebo each treatment period. Each subject will be allocated to a
      treatment sequence to be dosed with either placebo for the three periods or dosed with each
      of the three different doses in the three periods. For the Multiple-Dose (MD) Treatment
      Period the 12 subjects in each ethnic group will be further randomized as active (dose level
      to be determined from the SD Treatment Period or placebo in a 3:1 ratio.
    

Intervention name(s): E5501; E5501; E5501; E5501
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment Group 1: 10mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 40mg E5501 in Treatment Period 2, followed by a single dose of 80mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose reatment Period.; Treatment Group 2: 40 mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 80mg E5501 in Treatment Period 2, followed by a single dose of 10mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose Treatment Period.; Treatment Group 3: 80mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 10mg E5501 in Treatment Period 2, followed by a single dose of 40mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose Treatment Period.; Treatment Group 4: A single dose of matching placebo in each of the three Single Dose Treatment Periods and in the Multiple Dose Treatment Period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      Multiple Sclerosis (MS) is a chronic autoimmune neurodegenerative disease of the central
      nervous system (CNS). The symptoms of MS are wide-ranging, but patients perceive loss of
      physical function (gait) and cognitive function as the most critical consequences of the
      disease. Moreover, recent studies have shown that already at early disease stages functional
      impairments are present.

      One of the more recent approved medical treatments for MS patients is Alemtuzumab (product
      name Lemtrada), a humanized monoclonal antibody targeting CD52 cells, that depletes and
      repopulates B lymphocytes and T lymphocytes, causing sustained changes in the adaptive
      immunity. In 2013 and 2014 Alemtuzumab was approved in EU and USA, respectively.

      With the exception of the MS Functional Composite z-score, the previous clinical studies
      investigating the effect of Alemtuzumab have exclusively focused on clinical parameters such
      as MRI indications of disease activity (accumulation of lesion, total and regional brain
      atrophy etc.), relapse-rates, changes in 'expanded disability status scale' (EDSS) and
      side-effects/adverse events. However, no previous studies have performed in depth monitoring
      on how physical or cognitive performance are affected following initiation of treatment with
      Alemtuzumab despite the paramount importance to patients.

      The primary purpose of this project is to monitor the changes in physical performance during
      the first two years of treatment with Alemtuzumab in a well characterised Danish cohort of
      people with relapsing-remitting MS. A secondary purpose is to monitor the impact of
      Alemtuzumab treatment on cognition during the first two years of treatment.
    


Intervention name(s): Alemtuzumab
Intervention type(s): Drug
Intervention description(s): Alemtuzumab will be given two times, separated by 1 year.
Other intervention name(s): Lemtrada
Intervention MeSH terms: Alemtuzumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple Sclerosis patients will be recruited from MS clinics all over Denmark.
A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This open-label, multi-center study will evaluate the effect on the quantitative HBsAg
      reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic
      hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of
      treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of
      treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS
      monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting
      from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.
    


Intervention name(s): Adefovir; peginterferon alfa-2a [PEGASYS]; peginterferon alfa-2a [PEGASYS]; peginterferon alfa-2a [PEGASYS]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Adefovir 10 mg po once daily for 36 weeks; Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks; Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks; Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha; Adefovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PD1-CD19-CART in Patients With r/r B-cell Lymphoma
Condition: B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional

Summary: 
      This is an open label, single-site, dose-escalation study in up to 25 participants with
      relapse/refractory B-NHL. This study aims to evaluate the safety and efficacy of the
      treatment with PD1-CD19-CART.
    

Detailed description: 
      PD1-CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene
      integration and also PD1 knockout by one-step gene-editing. After completion of study
      treatment, subject participation for this study will be followed up to 15 years post T cell
      infusion.
    

Intervention name(s): PD1 specific integrated anti-CD19 Chimeric Antigen Receptor T Cells
Intervention type(s): Biological
Intervention description(s): Gene editing autologous T cells with anti-CD19 ScFv expression and knockout of PD1
Other intervention name(s): PD1-CD19-CART
Intervention model: Sequential Assignment
Intervention model description: Patients will receive one of the three doses of 2*10^6/kg, 4*10^6/kg,6*10^6/kg.
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Condition: Vasoconstriction; Healthy; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic
      nervous system-mediated vasoconstriction in the human leg.
    


Intervention name(s): Insulin
Intervention type(s): Drug
Intervention description(s): Priming dose then a constant infusion at 40 mU•m-2•min-1
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Kinesio® Tape on Neck Pain and Disability
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study is a within-subjects design; therefore, the participant will serve as their own
      control. Participants will be included in the study if they have neck pain or disability
      defined by a score of more than 14 on the Neck Disability Index. They will be excluded if
      they have any diagnosed disc pathology. A mask-associated pain questionnaire will be
      completed by the participants prior to the study to determine their perceived effect of
      mask-wearing on neck pain. This questionnaire is adapted from the HAPPE study on
      mask-associated headache pain. A baseline pain rating will be recorded a numerical pain
      scale. Next, active cervical range of motion will be measured, three times in each direction
      to be averaged. A pain rating will be recorded for pain during cervical motion. Kinesio® Tape
      will be applied to activate the cervical extensor muscles. The participant will sit with the
      tape on for 20 minutes, then active cervical range of motion and pain will be recored again.
    


Intervention name(s): Kinesio® Tape
Intervention type(s): Device
Intervention description(s): In order to increase the activity of underactive muscles, the tape is applied from origin to insertion with a 15-25% tension. The Kinesio® Tape mechanical muscle correction will be performed with one Y-strip of Kinesio® Tape over the bilateral cervical multifidus and semispinalis cervicis muscles, while also including portions of other cervical extensor muscles (the semispinalis capitis, splenius cervicis, levator scapulae, upper trapezius, longus coli, and splenius capitis).
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MIG-HD: Multicentric Intracerebral Grafting in Huntington's Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to assess the clinical benefit of intrastriatal grafting of human
      cells from the foetal ganglionic eminence in patients with Huntington's disease. The duration
      of the study will be 52 months. A first group of patients will be grafted at M13-14 (early G
      group) and a second group of patients will be grafted at M33-34 (late G group). The principal
      criterion is the comparison of the progression between M12 and M32 of the motor score (TMS)
      of the UHDRS between grafted patients (early G group) and not yet grafted patients (late G
      group). An additional evaluation will be performed to compare the progression in individual
      patients over the 52-month study period. We will thus be able to compare the pre and
      post-graft TMS progression for all patients.
    

Detailed description: 
      The aim of this study is to show the existence of a clinical benefit rising from a
      substitution of the striatal neurons degenerated among a large cohort of Huntington's patient
      at early stage by homologous neurons coming from human foetuses, This effect will be
      estimated, compared with a group of patients not treated at first, on the results of the
      motor scale of the Unified Huntington Disease Rating Scale (UHDRS, Huntington study group, on
      1996).

      Transplants will be realized in two surgical times to avoid the risk of hurts per-operating,
      BI-CAUDES, if transplants were realized at single time. The minimal interval between both
      transplants will be of 2 weeks, so as to let the patient recover of the first general
      anaesthesia It's a multicentric study of phase II randomised and controlled, with direct
      individual benefit.
    

Intervention name(s): graft intracerebral of foetal neurons
Intervention type(s): Biological
Intervention description(s): graft intracerebral of foetal neurons
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Huntington; graft; cellular therapy; striatum
A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '1+2' Sequential Schedule With bOPV in Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of
      Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '1+2' sequential schedule with bivalent
      oral poliovirus vaccine in 2-month-old infants
    

Detailed description: 
      This study is a randomized, double-blind, active-controlled phrase III clinical trial. The
      purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by
      Sinovac Vaccine Technology Co., Ltd in a '1+2' sequential schedule with bOPV in 2-month-old
      infants. 240 infants aged between 60-90 days will be randomly assigned into experimental
      group or control group in the ratio 1:1. The experimental group received sIPV-bOPV-bOPV
      vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group
      received wIPV-bOPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1,
      2). The control wIPV was manufactured by SANOFI PASTEUR S.A.
    

Intervention name(s): sIPV-bOPV-bOPV vaccination schedule; wIPV-bOPV-bOPV vaccination schedule
Intervention type(s): Biological; Biological
Intervention description(s): Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I & type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.; Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Sabin strain; Inactivated poliovirus vaccine; poliomyelitis; safety; immunogenicity; infant; sequential schedule