bioihbjkbjnl/mcl2 huggingface dataset:
Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective multicenter registry in real-world Japanese patients undergoing DAPT for three
      months after stenting. To assess the long-term safety of Endeavor Zotarolimus-eluting stent
      through noninferiority in the primary endpoint between two different continuous regimen
      (three and twelve months) groups of DAPT after stenting with Endeavor Zotarolimus-eluting
      stent in real-world Japanese patients and to examine the optimal duration of DAPT after
      stenting with Endeavor Zotarolimus-eluting stent. The long-term DAPT group in the present
      clinical study (to be appropriated from the post-marketing surveillance of Endeavor) should
      consist of consecutive patients undergoing DAPT for twelve months after stenting, while the
      short-term DAPT group (to be newly registered in the present clinical study) should consist
      of patients who are instructed to undergo DAPT for three months after stenting.
    


Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): DAPT using aspirin 81 mg/day (minimal dose) and clopidogrel 75 mg/day should be conducted for 3 months (+ 30 days) after stenting.
Intervention MeSH terms: Clopidogrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Disease; Cardiovascular Disease; Arteriosclerosis; Arterial Occlusive Disease; Vascular Disease; Clopidogrel; Platelet Aggregation Inhibitors
Effects of Pentazocine Versus Lorazepam on Manic Symptoms
Condition: Bipolar Disorder; Schizoaffective Disorder; Manic Disorder; Mania; Manic State
MeSH terms: Mania; Bipolar Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals.
      To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind
      study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases
      manic symptoms.
    

Detailed description: 
      Dysregulation of the opioid system may underlie the pathophysiology of mood disorders, such
      as bipolar disorder. Drugs that modulate the opioid system might be effective treatments for
      bipolar disorder. The profile and actions of the kappa-opioid system make drugs that target
      this system particularly promising as a treatment modality, with relatively low risk of
      addictive properties. Pentazocine is an approved drug for pain relief with a good side effect
      profile. It is predominantly a kappa opioid agonist with weaker side effects at mu opioid
      receptors, at which it is an antagonist. Data from our open-label pilot study of pentazocine
      had promising results. We will follow up on these findings with a double-blind,
      active-control study of individuals with bipolar disorder or schizoaffective disorder who are
      currently hospitalized with acute mania. The antimanic effects of pentazocine will be
      compared with an active control (ativan).
    

Intervention name(s): Pentazocine; Lorazepam
Intervention type(s): Drug; Drug
Intervention description(s): see arms description; see arms description
Other intervention name(s): Talwin Nx; Ativan
Intervention MeSH terms: Pentazocine; Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder; bipolar mania; schizoaffective disorder; schizoaffective mania; mania; kappa opiates; opiates
Genomic Medicine for Ill Neonates and Infants (The GEMINI Study)
Condition: Pediatric: Genetic Syndrome
Study type: Interventional

Summary: 
      The Genomic Medicine for Ill Neonates and Infants (The GEMINI Study) is a research study
      aimed at comparing the clinical and economic utility of performing rapid whole genomic
      sequencing versus a targeted genomic sequencing panel on neonates and infants suspected of
      having a genetic disorder. This study is funded by the National Institutes of Health.

      This multicenter, prospective clinical trial will enroll 400 subjects at the Floating
      Hospital for Children at Tufts Medical Center (Boston, MA), Cincinnati Children's Hospital
      Medical Center (Cincinnati, OH), Mount Sinai Kravis Children's Hospital (New York, NY), North
      Carolina Children's Hospital (Chapel Hill, NC), Children's Hospital of Pittsburgh
      (Pittsburgh, PA), and Rady Children's Hospital (San Diego, CA).
    

Detailed description: 
      This multicenter, prospective clinical trial will examine the diagnostic yield and clinical
      utility of NewbornDx, a targeted genomic sequencing panel for use in the neonate, and rapid
      whole genomic sequencing (rWGS) testing in high-risk infants with signs/symptoms consistent
      with a possible genetic disorder. Infants will undergo NewbornDx and rWGS (proband) testing.
      The biological parent(s), when available, will undergo NewbornDx testing at the same time as
      the infant. For rWGS,the infant will undergo testing first. If a specific diagnosis that is
      consistent with the phenotype is not made with rWGS proband analysis alone, the parent(s)
      will undergo rWGS. The study will also evaluate the cost effectiveness of each test as well
      as standard of care (SOC) testing. A retrospective chart review of infants with suspected
      genetic disorders will be done to understand 1-year cost and health outcomes that would have
      been incurred in the absence of the advanced testing. The resulting data from the trial will
      be used in the economic evaluation comparing NewbornDx, rWGS, and SOC over a 1-year period
      and used as basis to simulate the lifetime cost-effectiveness of these testing strategies. A
      web-based clinical reference database to provide references, clinical management guidelines,
      opportunities for clinical trial participation, and support groups for each condition will be
      developed with separate interfaces for the parent/guardian(s) and medical provider. The
      clinical reference database will be qualitatively assessed by a survey of medical providers.
    

Intervention name(s): rapid whole genomic sequencing (rWGS)
Intervention type(s): Diagnostic Test
Intervention description(s): rWGS and NewbornDx are genomic sequencing platforms
Other intervention name(s): NewbornDx
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy
      remained unanswered.
    

Detailed description: 
      A 14-day hybrid therapy invented by our study group appears very promising in H. pylori
      eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol
      and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that
      the eradication rate of reverse hybrid therapy was higher than that of standard triple
      therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than
      bismuth quadruple therapy remained unanswered.
    

Intervention name(s): pantoprazole+bismuth+tetra+metro; (panto+amox+clar+metr)+(panto+amox)
Intervention type(s): Drug; Drug
Intervention description(s): pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days; a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
Other intervention name(s): pantoprazole 40 mg; bismuth subcitrate 120 mg; tetracycline 500 mg; metronidazole 250 mg; pantoprazole 40 mg; amoxicillin 1 g; clarithromycin 500 mg; metronidazole 500 mg
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Tetracycline; Bismuth tripotassium dicitrate; Pantoprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Eradication rate
Canadian Alliance for Healthy Hearts and Minds
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The Cardiac, Vascular and Cognitive Dysfunction (CVCD) Alliance will be a prospective,
      multi-ethnic cohort study in healthy Canadian individuals between 35 and 69, looking at
      contextual risk factors and novel predictors of hard events over a period of four years.

      The unique features of this initiative are:

        -  MRI as the sole imaging technique (including the use of a mobile MRI machine)

        -  Contextual factor analysis (including community environmental profile assessments)

        -  Record linkage follow-up of individuals to health services (administrative) databases
           for major morbidity and mortality events and health services utilization
    

Detailed description: 
      Cardiac, vascular, and cognitive dysfunction have a strong impact on the quality of life,
      longevity and health care costs, in Canada and globally. Cardiovascular risk factors account
      for up to half of the attributable risk for dementia, mediated in large part by difficult to
      detect microvascular disease of the brain. In this study the investigators will try to
      understand the role of the societal structure, nutrition, access to health services, and
      other socio-environmental and contextual factors on cardiovascular risk factors, subclinical
      disease and clinical cardiovascular events at the individual and population levels. We will
      try to identify markers for early subclinical dysfunction in the brain, vessels, heart and
      abdomen using magnetic resonance imaging and investigate the associations with contextual and
      individual determinants of these markers, as well as to assess the predictive value of novel
      markers of subclinical dysfunction on the development of clinical cardiovascular events.
    

Intervention name(s): MRI
Intervention type(s): Other
Intervention description(s): Magnetic Resonance Imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants of Canadian Partnership for Tomorrow Project (CPTP) cohorts (BC Generations,
        Alberta Tomorrow Project, Ontario Health Study, CARTaGENE, Atlantic PATH) or non--CPTP
        cohorts (Montreal Heart Institute Biobank or the Prospective Urban-Rural Epidemiology, PURE
        study, or aboriginal cohort participants).

        Multi-ethnic participants including reserve-based Aboriginal peoples.
      
Biospecimen description: 
      The study will precisely phenotype individuals with respect to cardiac, vascular and
      cognitive dysfunction and to identify novel targets for indicators of early disease.
    
Keywords: Cardiac Magnetic Resonance (CMR); Cardiovascular Diseases; socio-environmental factors; Contextual factors
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Condition: Influenza; Human; Virus Diseases
MeSH terms: Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3 clinical study is a randomized, observer-blind, comparator-controlled,
      multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47
      months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits
      an immune response that is noninferior to that of a US-licensed comparator QIV containing the
      same virus strains, in children 6 months through 47 months of age.
    


Intervention name(s): QIVc; Comparator QIV
Intervention type(s): Biological; Biological
Intervention description(s): Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29.; Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV.
Other intervention name(s): Flucelvax Quadrivalent; Afluria Quadrivalent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; RNA Virus; WHO Strains
The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery
Condition: Failed Moderate Sedation During Procedure
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to compare the efficiency of rectal midazolam addition after applying
      bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional
      analgesics, postoperative recovery, sedation, and to find out its adverse effects in children
      having lower abdominal surgery.
    

Detailed description: 
      Summary Background: This study aimed to compare the efficiency of rectal midazolam addition
      after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need
      for additional analgesics, postoperative recovery, sedation, and to find out its adverse
      effects in children having lower abdominal surgery.

      Methods: 40 children between 2 and 10 years of American Society of Anesthesiologist (ASA)
      I-II stages were randomized and applied caudal anesthesia under general anesthesia. Patients
      were applied caudal block in addition with saline and 1milliliter/kilograms (mL/kg)
      bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5 milliliter (mL)
      saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline.
      Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The
      patients were observed for their analgesic need, first analgesic time, and adverse effects
      for 24 hours.
    

Intervention name(s): 1 mL/kg bupivacaine 0.25%.
Intervention type(s): Drug
Intervention description(s): 40 children between 2 and 10 years of ASA I-II were randomized and they received caudal anesthesia under general anesthesia. Patients underwent the application of caudal block in addition with saline and 1 mL/kg bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5mL saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
Other intervention name(s): AstraZeneca Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bupivacaine, caudal, rectal midazolam, children
Effects of Urban Afforestation Activity on Pain Mechanisms
Condition: Healthy
Study type: Interventional

Summary: 
      This single-group pretest-posttest clinical trial aims to evaluate the effects of a
      single-session afforestation activity on pain thresholds.
    

Detailed description: 
      Participants will perform an afforestation activity for a single session of 90 minutes. The
      therapist will direct the participants' attention to the visual, auditory, olfactory, and
      tactile features of the surrounding environment. A battery of quantitative sensory tests pre-
      and post-intervention.
    

Intervention name(s): Urban Afforestation Intervention Program
Intervention type(s): Other
Intervention description(s): An afforestation intervention program based on land cultivation and transplantation of several plants for 90 minutes will be implemented.
Other intervention name(s): Nature-based activity; Afforestation activity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Green spaces; Nature-based activities; Horticultural therapy; Quantitative sensory testing; Pain mechanisms
A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to measure how many of the dopamine receptors
      lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective
      disorder and over what time period the occupancy occurs. This is research because lurasidone
      is an investigational medication that has not yet been approved by the Food and Drug
      Administration (FDA). Dopamine receptors have key roles in many processes, including the
      control of motivation, learning, and fine motor movement. The degree of occupancy and the
      transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent
      relapses is a controversial area that this study will address.

      In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3 ligand
      18F-fallypride (a radioactive, injectable substance) to help the researchers measure the use
      of these receptors. Researchers hope that quantifying the amount of receptors being occupied
      by the medication will help them to determine the best dose of study medication in terms of
      improvement and least side effects related to body size and gender as well as in preventing
      relapse that may be related to hypersensitivity. Magnetic Resonance Imaging (fMRI) will also
      be performed. MRI is a scanning method which makes pictures of parts of the brain using a
      large magnetic field. This study will use a particular kind of MRI called fMRI, or functional
      MRI. fMRI takes pictures of the brain while the person is thinking or doing a simple task.
      fMRI will allow the researchers to investigate patients regional brain activation during
      cognitive (mental) and emotional tasks.
    


Intervention name(s): Lurasidone 80 mg; Lurasidone 120 mg; Lurasidone 160 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients
Condition: Hemodynamic Monitoring
Study type: Observational

Summary: 
      Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are
      compatible with standard invasive monitoring using pulse contour analysis EV1000
    


Intervention name(s): Transthoracic Electrical Bioimpedance; Pulse Contour Analysis
Intervention type(s): Device; Device
Intervention description(s): Non-invasive hemodynamic monitor; Invasive hemodynamic monitor
Other intervention name(s): ICON; EV1000
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients planned to undergo elective kidney transplantation surgery as recipient
      
Keywords: Bio-impedance; Haemodynamic monitoring; Pulse contour analysis; kidney transplantation
UVB: Skin to Gut Study
Condition: Healthy
Study type: Interventional

Summary: 
      This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB)
      radiation on the intestinal microbiota composition and confirm a regulatory skin-to-gut axis
      during baseline conditions. Changes in the intestinal microbiota composition caused by NB-UVB
      phototherapy could be beneficial for patients with chronic/auto-inflammatory diseases like
      inflammatory bowel disease (IBD) by removing dangerous bacteria, increasing beneficial
      bacteria, and ultimately modulating immune responses.
    

Detailed description: 
      Purpose:

      To explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the
      intestinal microbiota composition in humans and confirm a regulatory skin-to-gut axis during
      baseline conditions.

      Hypothesis:

      Humans exposed to UVB-NB light will show changes in the intestinal microbiota composition
      with the selection of certain phyla of bacteria.

      Justification:

      To date, there is no data that describes a biological response to UVB light in the body that
      affects the intestinal microbiota. Changes in the intestinal microbiota composition caused by
      NB-UVB phototherapy could be beneficial for patients with chronic/auto-inflammatory diseases
      like IBD by removing dangerous bacteria, increasing beneficial bacteria, and ultimately
      modulating immune responses.

      Objectives:

        1. Establish if there is a skin regulatory response towards NB-UVB light in humans.

        2. Examine what changes in the microbiota composition can be observed on bacterial phyla
           and class level.

        3. Determine if this research is worth pursuing in a larger cohort.

      Research design:

      During the first visit, the skin type will be assessed by using the Fitzpatrick skin type
      questionnaire.

      Subsequently, subjects will be exposed three times within one week to full body NB-UVB light
      in The Skin Care Centre to a sub erythemic dose (cause slight redness of the skin but not
      burning). The exposures will happen during the winter months to prevent UVB exposure from the
      sun during daily activities to interfere with our observations. Stool samples will be
      collected before the first exposure (2x) and after the last exposure (2x) to analyze the
      microbiota composition. Also, serum vitamin D (25-hydroxy vitamin D) will be measured before
      and after the UVB exposure as a marker of previous UVB exposure before the experiment.
    

Intervention name(s): NB-UVB light exposure
Intervention type(s): Radiation
Intervention description(s): Participants are exposed to three low dose Narrow Band UVB light.
Intervention model: Single Group Assignment
Intervention model description: All participants are receiving the same treatment of which the UVB dose is adjusted for the participants Fitzpatrick skin type.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phototherapy; Microbiome; Vitamin D