bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Pioglitazone Hydrochloride When Given Together to Healthy Subjects
Condition: Healthy; Pharmacokinetics of ASP1941
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics and safety
      following the administration of ASP1941 and pioglitazone hydrochloride in multiple and single
      doses.
    

Detailed description: 
      All subjects will be enrolled at one center and confined to the unit for up to 23 days.
      Subjects will be dosed in the fasting state in one of the four groups.
    

Intervention name(s): ASP1941; pioglitazone hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; oral tablet
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone; Ipragliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1941; Actos; pioglitazone hydrochloride
Improving Prospective Memory Via Telehealth
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which
      can have a significant impact on several aspects of their daily lives. One cognitive domain
      that has been shown to impact daily functioning, but is understudied in MS, is prospective
      memory (PM). While there have been successful PM interventions in other clinical populations,
      to date there has not been a specific PM intervention for PwMS that has been tested in a
      clinical trial.

      The study will be a double-masked randomized feasibility trial, with 18 participants
      randomized to a PM intervention and 18 participants randomized to an active control
      (psychoeducation). Participants will meet with an interventionist twice a week for four
      weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2)
      adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment
      satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference
      using participants' performance on the Memory for Intentions Test, which will be given at
      baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of
      neuropsychological measures as part of their baseline and post-treatment assessments.
    


Intervention name(s): Prospective Memory Intervention; Educational
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive remediation focusing on prospective memory; Psychoeducation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prospective memory; cognitive dysfunction; multiple sclerosis
A Bioequivalence Study of Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) in Normal, Healthy, Adults Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate bioequivalence of single dose test formulation of Losartan potassium tablets
      (containing Losartan potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus with
      reference Cozaar® (containing Losartan potassium 100 mg) of "Merck Sharpe & Dohme B.V.",
      Haarlem, the Netherlands in normal, healthy, adult, human subjects under fasting
      conditions.To monitor adverse events and ensure the safety
    

Detailed description: 
      Total 66 normal healthy adult subjects will be enrolled in the study. Subjects will be
      administered either the Test or the Reference Product with 200 mL of water in each period as
      per the randomization schedule. Subjects will fast for at least 10 hours prior to
      administration of the study drugs and for four (4) hours after administration of the study
      drugs during each study period. Standardized meals will be provided in each study period.
      Water will not be accessible to the subjects 1 hour to administration of the study drugs and
      1 hour after administration of the study drugs in each period. A total of 29 blood samples
      will be withdrawn for pharmacokinetic profiling during each study period. The plasma
      concentrations of losartan and its carboxylic acid metabolite will be measured by a validated
      LC-MS/MS analytical method. ANOVA will be performed on log transformed pharmacokinetic
      parameters Cmax, AUC0-t, AUC0-∞, and 90% confidence interval will be constructed for the
      ratio of geometric least square mean of the Test and Reference products, obtained from the
      log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its
      90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for
      Cmax, AUC0-t.
    

Intervention name(s): Cozaar 100mg Tablet; Losartan potassium 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Cozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe & Dohme B.V. , Haarlem, the Netherlands); Losartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus)
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of multiple doses of LY2127399
      (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment
      period. All participants will be followed for up to 12 weeks after the last study drug
      administration.
    


Intervention name(s): LY2127399 (Tabalumab); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Other intervention name(s): LY2127399; Tabalumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance
Condition: Healthy Aging
Study type: Interventional

Summary: 
      The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination
      of both on markers of cardiovascular health and cognition.
    

Detailed description: 
      The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination
      of both on markers of cardiovascular health and cognition.

      Healthy volunteers are recruited to participate in a parallel study (n 30 per group) for 10
      to 12 weeks. Markers of cardiovascular health (FMD, markers of inflammation and fatty acid
      metabolism) and cognition (neuropsychological tests and plasma neurotrophins) are being
      measured before and after intervention.
    

Intervention name(s): Cocoa flavanols and berries anthocyanins
Intervention type(s): Other
Intervention description(s): Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
PREVENT Tool Study: Late Effects Clinic
Condition: Cardiovascular Disease; Childhood Obesity
MeSH terms: Cardiovascular Diseases; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to test the feasibility of a novel, Health Information
      Technology behavior change tool in a single clinic setting. The PREVENT tool is the first
      electronic health record (EHR)-compatible tool that both tailors evidence-based behavior
      change strategies and incorporates community-level data specific to each patient into routine
      care. The central hypothesis is that PREVENT will improve patient's attitudes towards
      behavior change recommendations, increase adherence to recommended behavior change and
      improve cardiovascular health. Fifty adolescents will be randomized to intervention or
      wait-list, routine care control to assess the preliminary effectiveness of PREVENT.
      Qualitative and quantitative methods will be used among patients, parents and providers to
      examine barriers to current and future implementation of the PREVENT tool to inform adoption
      and maintenance.
    


Intervention name(s): Wait-List Control; PREVENT Tool
Intervention type(s): Other; Other
Intervention description(s): -Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool; -PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese adolescent patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Irritable Bowel Syndrome (IBS) Functional Magnetic Resonance Imaging (fMRI) With Desipramine
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Individuals with irritable bowel syndrome (IBS) may experience abdominal pain as a result of
      pain signals in the bowel and how these signals are processed in the brain. Studies using
      brain imaging (pictures) have shown that IBS patients with more pain diagnoses (i.e.
      fibromyalgia, migraines, etc.) have greater activity in the regions of the brain responsible
      for the emotional and thought processing of pain signals. This could possibly make bowel
      sensations and bowel difficulties feel abnormal or more noticeable, in turn causing more
      severe IBS symptoms. The purpose of this protocol is to explore the role of pain diagnoses
      and their affect on brain activity in IBS patients. The investigators will also examine the
      use of a medication, desipramine, which is known to affect these brain regions, in IBS
      patients.
    


Intervention name(s): Desipramine
Intervention type(s): Drug
Intervention description(s): Desipramine 25 mg/day administered in the evening. Dosing may be increased dependent upon side-effects and clinical response to a maximum of 100 mg/day. Absent significant side-effects, all patients are increased at the one week visit to 50 mg/day at bedtime if they have not achieved a report of "Adequate relief". Thereafter, up to week 4, the daily desipramine dose may be increased weekly by 25 mg up to the 100 mg/d maximum.
Intervention MeSH terms: Desipramine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, approximately 16 subjects will receive raltegravir 400mg twice daily for 5
      days (Treatment A) followed by a washout period. In Period 2, subjects will receive
      GSK2248761 200mg once daily for 5 days (Treatment B). There will be no wash out between
      Period 2 and 3. Subjects will then be administered raltegravir 400mg twice daily in
      combination with GSK2248761 200mg once daily (Treatment C) for 5 days. Subjects will be
      housed in the unit for the duration of the study. Safety evaluations and serial PK samples
      will be collected during each treatment period. A follow-up visit will occur 7-14 days after
      the last dose of study drug.
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship.
    

Intervention name(s): Raltegravir; GSK2248761; GSK2248761 + Raltegravir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): raltegravir 400mg q12h x 5 days (Reference Treatment); GSK2248761 200mg q24h x 5 days (Reference Treatment); GSK2248761 200mg q24h + raltegravir 400mg q12h x 5 days (Test Treatment)
Intervention MeSH terms: Raltegravir Potassium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: GSK2248761, raltegravir, drug interaction, pharmacokinetics
Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar
      CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately
      to severe inflammatory bowel disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with moderate to severe inflammatory bowel disease who need to receive biosimilar
        CT-P13
      
Keywords: inflammatory bowel disease; biosimilar; anti-drug antibody; trough drug concentration
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
Condition: Respiratory Syncytial Virus Prevention
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate non-inferiority in terms of humoral immune
      responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine
      in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
    


Intervention name(s): Ad26.RSV.PreF-based Vaccine
Intervention type(s): Biological
Intervention description(s): Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Usability Comparison of a mHealth Application for Pre-anesthesia Evaluation Before and After Re-design of User Interface
Condition: Usability; Anesthesia
Study type: Observational

Summary: 
      Pre-anesthesia assessment is an important part of anesthesiologists daily routine. A thorough
      assessment leads to an impeccable anesthesia plan. In the past, the department of
      anesthesiologist in NTUH (National Taiwan University Hospital) utilizes paper assessment
      form. As government policy leans towards digitization, the department of anesthesiologist in
      NTUH collaborates with the information technology office to develop an electronic
      pre-anesthesia assessment system called EVAN, which is an iOS based application (App). EVAN
      includes an anesthesia patient list, patient EMR (electronic medical record) and
      pre-anesthesia assessment form. EVAN was online since March, 2018.

      This is an observational research to investigate the user experience and improve the user
      interface of EVAN.

      This research subjects include anesthesiologists from NTUH. This research has three parts:
      user tasks, questionnaires, and a semi-structured interview. First, the research assistant
      will record how the user use the App to complete the tasks, which includes video recording
      and App monitoring. After the tasks is completed, the subject will write a questionnaire.
      Then the principal investigator will give an interview for feedbacks from the users.
    


Intervention name(s): iOS application usability test
Intervention type(s): Other
Intervention description(s): user tasks, questionnaires, semi-structured interviews
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Enroll the anesthesiologists and anesthesiology residents in NTUH
Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      An urgent priority in the field of paediatric neurorehabilitation is the development of
      effective early motor interventions.

      Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the
      concepts of motor skill learning and intensive training to both the Upper Extremities (UE)
      and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE
      and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3
      levels of the International Classification of Functioning, Disability and Health (ICFDH). The
      principles and content of HABIT-ILE can be applied to pre-school children and this method is
      highly promising for early rehabilitation.
    

Detailed description: 
      The primary objective of this study is to evaluate the effect of two weeks of early HABIT-ILE
      on gross motor function in pre-school children with unilateral and and bilateral Cerebral
      Paralysy (CP), in comparison with two weeks of usual motor activity including usual
      rehabilitation (control group).
    

Intervention name(s): MRI; Electro-Encephalography-High Density (children with unilateral PC only); 3D and EMG analysis; care and classic activities; Accelerometers
Intervention type(s): Other; Other; Other; Other; Device
Intervention description(s): MRI at baseline and J90; Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90; 3D and EMG analysis at baseline and J90; physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.; During 5 days a sensor at each wrist to quantify their movement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Cerebral Palsy (CP); pre-school children with unilateral and bilateral CP
Oxytocin and Cognitive Control in Adult ADHD
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled crossover study of single-dose
      intranasal oxytocin (24 IU) in 18-55 year-old men with attention deficit/hyperactivity
      disorder (ADHD). Following a screening visit to determine eligibility, participants will
      return for two main study visits. During the main study visits, study participants will
      receive either oxytocin (Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) or
      placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy), followed by
      assessments of cognitive control over attention and behavior. Twenty-four participants will
      be randomized 1:1 to one of two drug orders, i.e., oxytocin - placebo or placebo - oxytocin.
      In an additional neuroimaging substudy, a subset of participants will undergo task-based and
      resting-state functional magnetic resonance imaging (fMRI) following oxytocin/placebo
      administration to investigate the effects of oxytocin on fMRI activation and functional
      connectivity within the cognitive control network.
    


Intervention name(s): Oxytocin nasal spray; Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland); Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Attention; Attention deficit/hyperactivity disorder; Cognitive control; Executive control; Executive functions; Impulse control; Impulsivity; Oxytocin
Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
Condition: Dysthymic Disorder
MeSH terms: Dysthymic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of
      dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.

      It is hypothesized that Escitalopram will be superior to placebo in improving depression, as
      well as psychosocial, temperamental, and cognitive functioning.
    

Detailed description: 
      This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of
      Dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.

      Flexible dosing to a maximum of 40 mg per day will be used. It is hypothesized that
      Escitalopram will be superior to placebo in improving depression, as well as psychosocial,
      temperamental, and cognitive functioning. Blood cytokine levels will also be measured at
      weeks 0, 12, and 24 to determine their relationship to depressive symptoms and improvement.
    

Intervention name(s): Lexapro (escitalopram)
Intervention type(s): Drug
Intervention description(s): antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Other intervention name(s): lexapro; escitalopram; s-citalopram; d-citalopram
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysthymic Disorder; Depression; Chronic Depression; Escitalopram