bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)
Condition: Meningococcal Disease; Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate persistence of bactericidal antibodies for N.
      meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years
      after primary vaccination in subjects who previously received a 2-dose series of
      MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune
      response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30
      days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a
      2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune
      response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated
      subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after
      an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive
      subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive
      subjects and subjects who previously received one dose of MenACWY
    

Detailed description: 
      Subjects will be randomised into two different blood draw schedules according to a 1:1 ratio
    

Intervention name(s): MenABCWY+OMV vaccine
Intervention type(s): Biological
Intervention description(s): Intramuscular injection of a single dose at Day 1 to subjects in the MenABCWY+OMV Group or as a 2 doses at Day 1 and Day 31, one month apart, to subjects in the MenACWY and Naive Groups.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antibody persistence; Young Adults; Healthy Adolescents; MenABCWY vaccine; Booster response; MenABCWY+OMV
Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for
      participants taking saxagliptin in combination with metformin immediate release (IR) versus
      metformin IR alone.
    


Intervention name(s): Saxagliptin plus metformin IR; Placebo plus metformin IR
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 2.5 mg, Twice daily, 12 weeks; Tablets, Oral, Placebo, Twice daily, 12 weeks
Other intervention name(s): BMS-477118; Onglyza
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity
      Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have
      an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the
      baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel
      groups trial. During this trial, dosing will be flexibly adjusted according to patient
      response or presence of side effects. The dosage will range from 1-4 mg. At the end of the
      four week trial, a follow up ERP study will be obtained.
    

Detailed description: 
      All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity
      Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have
      an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the
      baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel
      groups trial. During this trial, dosing will be flexibly adjusted according to patient
      response or presence of side effects. The dosage will range from 1-4 mg. At the end of the
      four week trial, a follow up ERP study will be obtained. Our hypotheses are: A) GXR will be
      superior to placebo at reducing symptoms of ADHD as measured by standardized clinical
      diagnostic tools by week 3 of treatment. B) Compared to placebo and pretreatment measures,
      GXR at week 4 of treatment will increase the amplitude of the right frontal N200 and
      frontal-central P300, and such changes will correlate with clinical response.
    

Intervention name(s): Guanfacine Extended Release; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.; Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.
Other intervention name(s): Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Disorder with Hyperactivity; Guanfacine; Event Related Potentials
To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol
Condition: Pharmacokinetics of Mirabegron; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy
      poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol
      change whilst being dosed at the same time with daily miragebron.
    

Detailed description: 
      The study is an open label, single center study. All subjects are genotyped for CYP2D6 before
      the study. Genotype expression is confirmed by dextromethorphan phenotyping.

      Part I: The pharmacokinetic profile of a single dose of YM178 is compared in 8 healthy male
      subjects genotyped and phenotyped as poor metaboliser (PM) for CYP2D6 and in 8 healthy male
      subjects genotyped and phenotyped as extensive metaboliser (EM) for CYP2D6.

      Part II: The effect of YM178 on the model substrate of CYP2D6 metoprolol is evaluated, using
      a cross-over design, in 12 healthy male subjects genotyped and phenotyped as EM for CYP2D6.
    

Intervention name(s): mirabegron; metoprolol
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): YM178
Intervention MeSH terms: Metoprolol; Mirabegron
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics,; Mirabegron; Metoprolol; CYP2D6; Phase 1
Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current
      stimulation (tDCS) has been used for the modulation of mild cognitive impairment (MCI)
      patients' cognitive function by altering the cortical excitability. Recently, more
      challenging approaches, such as stimulation of two or more sites or use of dual modality have
      been studied in MCI patients. In this study, simultaneous stimulation using both facilitatory
      rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral
      prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single
      facilitatory rTMS stimulation in mild cognitive impairment patients.
    


Intervention name(s): High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC; High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC; High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC
Intervention type(s): Device; Device; Device
Intervention description(s): 10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.; 10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.; 10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Noninvasive brain stimulation; Repetitive Transcranial Magnetic Stimulation; Transcranial Direct Current Stimulation
The Effect of Kinesiology Taping on Balance in Duchenne Muscular Dystrophy
Condition: Balance; Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      Investigators investigated that the effects of kinesilogy taping on balance in patients with
      Duchenne Muscular Dystrophy
    

Detailed description: 
      Forty-five patients from Level 1 and 2 according to the Brooke Lower Extremity Functional
      Classification were included in the study. Balance was assessed by Pediatric Berg Balance
      Test (PBBT), Timed and Go Test (TUGT), and standing on one leg test. Kinesiology taping (KT)
      with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles
      and the assessments were repeated 1 hour after application. The comparison between before and
      after taping was analyzed.
    

Intervention name(s): Kinesiology tape
Intervention type(s): Device
Intervention description(s): Kinesiology taping (KT) was developed by Kenzo Kase in the 1970s. KT has similar thickness and flexibility to the skin. These tapes are used in orthopedic and sports injuries as well as neurological and rheumatic diseases, pediatric patients, lymph edema and painful conditions. These tapes are used for correcting muscle function, increasing circulation, increasing proprioception, reducing pain, and repositioning the sublease joint according to the usage method
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: kinesiology taping; balance; Duchenne Muscular Dystrophy
IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing CABG
Condition: Myocardial Infarct; Heart Failure
MeSH terms: Myocardial Infarction
Study type: Interventional

Summary: 
      Following myocardial infarct, cellular therapy is a potential approach to repopulate the
      injured myocardium, to treat heart failure and restore cardiac function. The purpose of this
      study is to assess the safety, feasibility and efficacy of intramyocardial delivery of
      selected autologous CD133+ bone marrow stem cells at time of coronary artery bypass grafting
      in patients with chronic ischemic cardiomyopathy.
    

Detailed description: 
      CD133+ are well-characterized distinct early progenitor group of stem cells that possess high
      engraftment, pluripotent and angiogenic capacity and proved to be valuable for cardiac repair
      by promoting neovascularization, inhibition of apoptosis and cardiomyogenesis.

      Our proposed research protocol involves patients with chronic ischemic heart disease and left
      ventricular dysfunction undergoing coronary artery bypass grafting (CABG). In this phase II
      clinical trial, prospective, randomized, 2 arm, double-blind, placebo-controlled study, we
      will assess the safety, feasibility and functional effect of intra-myocardial injection of
      highly selected autologous CD133+ bone marrow stem cells to placebo.
    

Intervention name(s): Injection of stem cells at time of coronary artery bypass grafting
Intervention type(s): Procedure
Intervention description(s): Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells,or placebo solution containing plasma and indistinguishable will be injected in the myocardium. A total of 2.0 ml with 10-15 injections will be injected.
Other intervention name(s): CD133+ autologous stem cells OR placebo solution containing autologous plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stem cell or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stem cells; Cellular therapy; Myocardial repair
The Impact of WeChat Group Patient Education on the Eradication Rate of Helicobacter Pylori
Condition: Helicobacter Pylori Infection; Helicobacter Pylori Eradication; Patient Education
Study type: Interventional

Summary: 
      In this study, effects of oral and written education, WeChat education plus oral and written
      education on Helicobacter pylori eradication will be compared in a randomized way.
    

Detailed description: 
      There are two randomized parallel groups in this study, control group and Wechat group.All of
      the patients will be treated with Amoxicillin + Clarithromycin + Bismuth + Vonoprazan
      fumarate. In control group,the patients will be educated by oral and written way about the
      regimen. In Wechat group, the patients will be educated by Wechat oral and written way. Then,
      the eradication rates, compliance, adverse events, patients' satisfaction and experience will
      be evaluated.
    

Intervention name(s): oral and written education; Wechat group
Intervention type(s): Other; Other
Intervention description(s): oral and written education; Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two randomized parallel groups in this study, control group and Wechat group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: helicobacter pylori; eradication; patient education; Wechat group
Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants
Condition: Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is comprised of two discrete Parts. Part A is a 3-period cross over evaluating
      relative bioavailability. Part B is a 2-period cross over evaluating bioequivalence. There
      will be a minimum of a 7-day washout period between treatment periods. Participants will
      participate in Part A or Part B, but not both. Approximately 200 participants will be
      included in the study.
    


Intervention name(s): Daprodustat
Intervention type(s): Drug
Intervention description(s): Daprodustat will be available as oral tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Daprodustat; Pharmacokinetic; Bioequivalence; Bioavailability
Enhanced Perioperative Mobilization (EPM) Trial
Condition: Pancreatic Resection; Liver Resection; Gastric Resection; Colorectal Resection
Study type: Interventional

Summary: 
      Randomized Controlled Trial to monitor and increase the postoperative mobilization of the
      patients undergoing major visceral surgery by giving a continuous autofeedback of the step
      count using activity tracking wristbands.
    

Detailed description: 
      Patients undergoing elective open and laparoscopic surgery of colon, rectum, stomach,
      pancreas and liver for any indication will be included. Further inclusion criteria are: age
      between 18-75 years, ASA score < 4, and a signed informed consent. Patients are stratified
      into two subgroups (laparoscopic and open surgery) and will be randomized 1:1 for an
      autofeedback of their step-count using an activity tracker wristband or for the control group
      without autofeedback. Sample size (n = 29 patients in each of the four groups, overall n =
      119) is calculated on an assumed difference in step-count of 250 steps daily (intervention
      versus control group). The primary study endpoint is the step-count during the first five
      postoperative days; secondary endpoints are the percentage of patients in the two groups, who
      master the predefined mobilization (step-count) targets, the assessment of additional
      activity data from the devices, the assessment of the preoperative mobility, length of
      hospital and intensive care unit stay, number of patients who receive physiotherapy, 30-day
      mortality, and the overall 30-day morbidity.
    

Intervention name(s): activity tracking for autofeedback
Intervention type(s): Device
Intervention description(s): The intervention group receives an unblinded wristband. The handling of the activity trackers is explained to the patients and a predefined mobilization end-point (step-count) for the first five PODs is targeted. The target step-count was set at the 85% quartile obtained from a previous pilot study. The patients are assessed and monitored two times daily between 9 and 11 o'clock AM and between 3 and 5 o'clock PM by a surgical fellow or a study nurse throughout their hospital stay for read-out of the step count, assurance of the proper use and functioning, and for communication of the autofeedback.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: activity tracking; postoperative recovery; ERAS; fast-track surgery
Optimalization of Nephroprotection Using N-Acetylcysteine
Condition: Chronic Kidney Disease; Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional

Summary: 
      The main purpose of the study is find whether the addition of N-acetylcysteine (antioxidant)
      to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme
      inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria,
      main prognostic marker of chronic kidney disease progression.
    

Detailed description: 
      The renin-angiotensin-aldosterone system (RAAS) plays an important role in the progression of
      chronic kidney diseases (CKD), and inhibition of the RAAS with angiotensin-converting enzyme
      inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB) may retard CKD
      progression. Dual pharmacological blockade of the RAAS with ACEI and ARB is recommended as a
      standard renoprotective management at least in patients with nondiabetic proteinuric CKD.
      However, neither ACEI nor ARB, even in high doses or in concomitant usage, abrogate the
      progression of CKD completely. Innovative approaches are needed to keep patients with CKD off
      dialysis. Additional antioxidant (N-acetylcysteine) may prove to be such beneficial
      therapeutic concept. To shed more light on this issue, we performed a randomised open
      controlled study to evaluate the influence of triple N-acetylcysteine and RAAS therapy on
      surrogate markers of kidney injury, i.e. proteinuria, markers of tubular involvement and
      kidney fibrosis.
    

Intervention name(s): ACC (N-acetylcysteine) 1200 mg
Intervention type(s): Drug
Intervention description(s): N-acetylcysteine (ACC) 1200 mg In the 8-weeks run-in period angiotensin converting enzyme inhibitors and/or angiotensin II subtype 1 receptor antagonists were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 1200 mg N-acetylcysteine in two active treatment periods lasting 8 weeks each
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proteinuria; Antioxidant; N-acetylcysteine
Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B
Condition: Botulism Vaccine
MeSH terms: Botulism
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter
      investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different
      three-dose dosing schedules.
    

Detailed description: 
      The study includes 18 months (547 days) of follow-up after the first vaccination for all
      randomized volunteers who receive at least one vaccination. Analysis of cumulative data
      collected through Day 547 ± 14 days will be reported in the final clinical study report.
    

Intervention name(s): Placebo (USP sterile saline for injection); rBV A/B-40 vaccine; Placebo (USP sterile saline for injection); rBV A/B-40 vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182; 0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182; 0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182; 0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182
Other intervention name(s): placebo; placebo; rBV A/B vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)
Condition: TOURETTE SYNDROME
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of
      SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the
      pharmacokinetic of SD-809 and its metabolites.
    


Intervention name(s): SD-809
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tourette Syndrome; adolescents
Mitochondrial Remodeling After Exercise
Condition: Overweight and Obesity; Insulin Resistance; Metabolic Disease; Mitochondrial Metabolism; Sedentary Lifestyle
MeSH terms: Overweight; Insulin Resistance; Metabolic Diseases
Study type: Interventional

Summary: 
      Regulation of mitochondrial health in overweight and obese individuals may be impaired. The
      purpose of this study is to identify impairments in regulation of mitochondrial health within
      skeletal muscle and to determine if short-term exercise training (2-weeks) can reverse such
      impairments. The investigator's hypothesis is that pathways that serve to degrade poorly
      functioning mitochondria in overweight and obese individuals are down-regulated, but that
      short-term exercise training can restore these pathways to improve skeletal muscle
      mitochondrial function.
    


Intervention name(s): Short-term Exercise Training
Intervention type(s): Behavioral
Intervention description(s): Participants will perform 2-weeks of supervised exercise training on a stationary bike.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be asked to complete 2 screening visits to determine eligibility. If participants remain eligible, they will be asked to complete 2 metabolic study visits, 1 before and 1 after 2 weeks of supervised exercise training on a stationary bike.
Masking: None (Open Label)
Primary purpose: Basic Science