bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
Condition: Encephalitis, Japanese B
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia
      including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the
      total number of clinical cases is about 50,000. Of these cases, about 50% result in permanent
      neuropsychiatric sequelae. The disease occurs mostly among children aged <10 years. There is
      no specific antiviral treatment for JE. Vaccination is the single most important control
      measure. This study aims to evaluate the immunogenicity and safety of inactivated Vero cell
      derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da Biotechnology Co., Ltd,
      China "JEVAC" in Thai children.

      152 healthy Thai children aged between 1-3 years will be vaccinated with "JEVAC" in a dose of
      0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year
      (totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at one
      year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13 months
      study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing P3
      strain. Adverse events will be observed for 28 days after each vaccination. Serious adverse
      events will be observed throughout the study period.
    


Intervention name(s): JEVAC
Intervention type(s): Biological
Intervention description(s): Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: inactivated Japanese encephalitis vaccine; vero cell; children; immunogenicity; safety
Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Post Fibrinolysis
Condition: ST Elevation Myocardial Infarction; Fibrinolysis; P2Y12 Inhibitor
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a two-center, prospective, randomized, single-blind, investigator initiated,
      pharmacodynamic study of parallel design, carried out in 2 PCI-capable cardiology centers
      (Patras University Hospital and Konstantopoulio General Hospital of Athens).

      Patients with ST elevation myocardial infarction, having undergone fibrinolysis in the
      previous 3 to 48 hours, who present high residual PR (defined as PRU ≥208 ) on admission, pre
      coronary angiography, will be randomized after written informed consent, in a 1:1 ratio to
      either:

      Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6
      hours post LD, until discharge.

      Or

      Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD)
      starting 12±6 hours post LD, until discharge.

      Platelet reactivity assessment will be performed at randomization (Hour 0) and at 2, 24 hours
      after randomization, as well as pre-discharge, using the VerifyNow assay, in platelet
      reactivity units (PRU).

      Documentation of major adverse cardiac events (death, myocardial infarction, stroke, ischemia
      driven revascularization procedure with PCI or CABG) and bleeding (according to BARC
      criteria) will be performed until patient's discharge.
    


Intervention name(s): Ticagrelor 180mg loading dose and 90mg bid maintenance dose; Clopidogrel 600mg loading dose and 150mg maintenance dose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ST elevation myocardial infarction; Fibrinolysis; Ticagrelor; Clopidogrel; Platelet reactivity
Study of Itch Control by VLY-686 in Healthy Volunteers After Intradermal Injections of Substance P
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test whether VLY-686 can prevent or reduce the itch and
      dermatological reaction observed after healthy volunteers are injected with Substance P in
      comparison with placebo.
    

Detailed description: 
      This is a double-blind, randomized, 4-way crossover, pharmacokinetic and pharmacodynamic
      (PK/PD) study to compare the cutaneous vasoreactive intensity to intradermal injections of
      Substance P in healthy volunteers receiving oral doses of 20 mg, 50 mg or 100 mg VLY-686 or a
      matching placebo. Twelve healthy male subjects satisfying the selection criteria for the
      study will be enrolled. Each subject will participate in a screening period (up to 21 days
      prior to dosing), four one-day treatment periods each separated by a 7 (±2 days) day washout
      period, and an end-of-study evaluation prior to discharge from the study. This protocol also
      includes an option of subjects administered daily doses of study medication between Periods 3
      and 4. The treatment periods will be in a randomized sequence consisting of 1) 20 mg VLY-686,
      2) 50 mg VLY-686, 100 mg VLY-686 and 4) placebo. In each of the study periods, Substance P
      will be injected 5 times: pre-dose (the night before), 2, 4, 8 and 12 hours (± 10 minutes)
      after study medication administration. A dose of 100 μL of a 2.5 nmol/mL sterile solution of
      Substance P will be injected each time. Overall, subjects will be administered 1.25 nmol of
      Substance P in around 24 hours (5 doses). Substance P injections will be given in the volar
      of the forearm, alternating right and left and avoiding injections in an area adjacent to the
      area previously injected. The subject's forearm will be covered during and after each
      injection to avoid potential biases in the scoring of the Verbal Rating Scale (VRS) and
      Visual Analog Scale (VAS). Additionally, blood samples for VLY-686 pharmacokinetic (PK)
      analysis will be collected each period at pre-dose, 1, 3, 6, 10, and 24 hours after study
      medication administration.
    

Intervention name(s): VLY-686; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules containing either 10 mg or 50 mg VLY-686; Sugar capsule to mimic either VLY-686 10 mg capsule or 50 mg capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: itch
Effect of resVida on Liver Fat Content
Condition: Elevated Liver Fat Content and Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of the antioxidant "resveratrol" on
      liver fat content, body-composition and insulin sensitivity

      Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have
      health benefits such as improving fat metabolism, insulin action, and possibly extending
      lifespan. resVida™ is the name for the dietary supplement containing the natural antioxidant
      "resveratrol". resVida™ will be supplied by DSM Nutritional Products, Ltd.

      resVida™ is considered a dietary supplement, and therefore it is not an approved drug by
      German Authority. It is regulated like a food. The makers of resVida™ make no claim that this
      supplement is meant to treat any ailment.

      This study is designed to investigate the health benefits of resveratrol.
    


Intervention name(s): resveratrol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 150 mg resVida per day for 12 weeks; Placebo for 12 weeks
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Mitochondrial Dysfunction in Phelan-McDermid Syndrome
Condition: Phelan-McDermid Syndrome
MeSH terms: Chromosome Disorders; Syndrome; Chromosome Deletion
Study type: Observational

Summary: 
      The purpose of this study is to determine whether a relationship exists between gene
      deletion(s) specific to the mitochondrial electron transport chain and presentation of
      clinical characteristics in patients with Phelan-McDermid Syndrome (PMS).
    

Detailed description: 
      Phelan-McDermid Syndrome (PMS) results from a deletion within the 22q13 chromosome region.
      Most children have specific physical morphology and developmental delays with many displaying
      characteristics of autism spectrum disorder (ASD) including abnormalities in social
      development. The behavioral aspect of PMS that parallels ASD has raised particular interest
      as the SHANK3 gene, which lies in the 22q13 region, is important for synaptic development,
      and animal SHANK3 knockout models demonstrate ASD characteristics thereby confirming the
      importance of this gene in PMS. However, despite the importance of the SHANK3 gene,
      individuals with PMS have variations in their development, behavior and medical
      characteristics that cannot be fully explained by the SHANK3 deletion.

      Recently, Frye (2012) has noted the existence of 6 mitochondrial genes that lie slightly
      proximal to the SHANK3 gene within the 22q13 region. These include genes important electron
      transport change function (SCO2, NDUFA6), mitochondrial DNA (TYMP) and RNA (TRMU) metabolism,
      fatty acid metabolism (CPT1B) and tricarboxylic acid cycle function (ACO2). Since most
      Individuals with PMS have deletions that include chromosomal deletion outside of the SHANK3
      region, it is very likely that many, if not most, of children with PMS may have deletions in
      these mitochondrial genes. Many of these genes have been linked to mitochondrial disease,
      even in the heterozygous state. Even if recognized, mitochondrial disease is only linked to a
      homozygous abnormal state (autosomal recessive), the loss of one gene (heterozygous state)
      could result in symptomatology when associated with deletions in other mitochondrial or
      non-mitochondrial genes. Abnormalities in mitochondrial pathways can result in neurologic and
      non-neurologic symptoms including those sometimes seen in children with PMS. Added with the
      SHANK3 deletion, abnormalities in these mitochondrial genes could explain variations in
      patterns of development and the eventual cognitive potential.

      References: Frye RE. Mitochondrial disease in 22q13 duplication syndrome. J Child Neurol.
      2012; 27(7):942-9.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be identified through the registry for this specific aim. PMS patients in the
        registry will be offered to be entered the study.
      
Keywords: Electron Transport Chain; Mitochondrial Disease; Chromosomal Deletion
Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation
Condition: Endothelial Dysfunction
MeSH terms: Dilatation, Pathologic
Study type: Observational

Summary: 
      The investigators examined the effects on post-digestion brachial artery flow mediated
      dilation (FMD) and in vitro antioxidant capacity of 40% semolina flour replacement with
      sprouted chickpea flour.
    

Detailed description: 
      The purpose of the current study was to examine in-vitro and in-vivo effects of replacing 40%
      of semolina flour with sprouted chickpea flour for the use in pasta. Antioxidant capacity
      in-vitro was measured by Trolox Equivalent Antioxidant Capacity. Brachial artery
      flow-mediated dilation, a test of in-vivo endothelial function, was performed for assessment
      of effects on post-digestion endothelial function. The investigators hypothesized that FMD
      would be higher after consuming 40% of semolina flour with sprouted chickpea flour pasta vs.
      100% of semolina flour pasta.
    

Intervention name(s): Experimental: Sprouted Chickpea Flour; Control: Semolina Flour
Intervention type(s): Other; Other
Intervention description(s): 255g of pasta with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.; 255g of pasta with 100% semolina flour (SEM100) with butter.
Other intervention name(s): SCF40; SEM100
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adults
Foot Plantar Pressure Changes After Plantar Dry Needling
Condition: Myofascial Pain Syndrome; Foot Diseases
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Foot Diseases
Study type: Interventional

Summary: 
      The aim of this clinical trial is to check the effects of dry needling in the Flexor
      digitorum Brevis.

      Twenty healthy subjects wil be recruited for a quasi-experimental study. Participants will be
      from 18 to 40 years old, not obese. Participants will be measured before and after bilateral
      dry neddling in Flexor digitorum Brevis. The investigators will measure static footprint
      variables. The footprint variables will be divided in bilateral rear foot, bilateral midfoot,
      bilateral fore foot.
    


Intervention name(s): Static footprint
Intervention type(s): Other
Intervention description(s): The static footprint will measure the plantar pressures and surface area of the back of the foot, midfoot and forefoot. Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned 30 degrees from the midline.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supporting Children's School Readiness.
Condition: Language Development
Study type: Interventional

Summary: 
      The aim of this project is to test whether training parents to ask their children 'inference-
      eliciting' questions during book reading is effective in promoting story comprehension for
      4-year-olds from a range of socio-economic backgrounds.
    

Detailed description: 
      Language comprehension relies on the ability to make local and global inferences (e.g.,
      inferring what a pronoun refers to, or inferring why a protagonist in a story did something
      based on information distributed through the text). These skills develop in the preschool
      years and are demonstrated when children make sense of stories that are read to them. While
      important for later reading ability and academic success, relatively little is known about
      whether anything can be done to improve inference-making skills in the preschool years. One
      possibility is that parent-child book reading would help. During book reading, some parents
      naturally ask their children questions about the story that would require them to make
      inferences about the text. The current study is designed to test whether doing this promotes
      children's ability to make inferences. Half the parents in this study will be given books
      with inference eliciting questions added to them and will be provided with training about how
      to ask these questions and respond to their children's answers. The other half of the parents
      will be given a maths exercise book and asked to spend the same amount of time per day
      working through this.
    

Intervention name(s): Language comprehension intervention; Counting intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Language Development; Shared Picture Book reading; Preschoolers; Inference making
The Effect of Propofol or Sevoflurane on Renal Function
Condition: Acute Kidney Injury; Anesthesia
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the role of the anesthetic agents propofol and sevoflurane on renal
      function in otherwise healthy patients undergoing basic back surgery.
    

Detailed description: 
      Water-sodium homeostasis is central for anyone undergoing surgery, and can therefore affect
      surgical outcome, level of postoperative care and the length of hospital stay. Too much or
      too little fluid during surgery can affect the patients negatively. The kidneys play an
      imperative role in the regulation of water and sodium homeostasis, however there are lack of
      knowledge in how the anesthesia per se affects renal function. Previous studies have shown
      that volatile anesthetic agents such as sevoflurane can cause fluid retention. Why this
      happens is not completely known.

      We are now investigating the different affects of sevoflurane and propofol anesthesia on
      renal function in patients undergoing basic back surgery to elucidate if there is a
      difference in the risk of developing acute kidney injury.
    

Intervention name(s): Back Surgery; Propofol; Sevoflurane
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): All patients undergo basic back surgery.; Anesthesia on propofol alone.; Anesthesia on sevoflurane alone.
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized into one of two treatment groups which during surgery receives one of two different anesthetic agents. The two groups are then compared to each other.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: sevoflurane; propofol
Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      A study evaluating the safety and pharmacokinetics of multiple oral doses of an
      investigational oral diabetic agent when given to healthy Japanese male volunteers.
    


Intervention name(s): PPM-204
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Diagnostic
Effects of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support on Microcirculation
Condition: Circulatory Failure
MeSH terms: Shock
Study type: Observational

Summary: 
      Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and
      respiratory support to patients with heart and respiratory failure. It can save time for
      these patients to regain organ function or to receive transplantation. Both the
      investigators' team and Ince et al. from the Netherland found that the microcirculatory
      dysfunction is more severe in ECMO non-survivors. The next step of research is to find out
      the key factors that affect microcirculation in ECMO patients. Because the blood flow
      supplied by the venoarterial ECMO (VA-ECMO) is directly related to macrocirculation, this
      study aims to investigate the effect of adjustment of VA-ECMO blood flow on microcirculation.
      The investigators hope that the results of this study can help the medical team to improve
      the quality of ECMO care.
    

Detailed description: 
      After evaluation, explanation, and acquisition of agreement, the sublingual microcirculation
      will be examined within 24 h and at 48 h after placement of VA-ECMO. The VA-ECMO blood flow
      will be recorded, and the baseline microcirculation will be examined. After the ECMO
      technician adjusting the ECMO flow, sublingual microcirculation will be examined 2 minutes
      after each adjustment, and the change of ECMO blood flow will be recorded. When the ECMO team
      plans to weaning off the ECMO within 72 h, the sublingual microcirculation will be examined.
      The VA-ECMO blood flow will be reduced by ECMO technician, and sublingual microcirculation
      will be examined 2 minutes after each adjustment of the blood flow. The ECMO parameters,
      medications, and clinical data will be recorded, and the prognosis will be followed up on the
      28th day.
    

Intervention name(s): Extra-corporeal membrane oxygenation life support
Intervention type(s): Device
Intervention description(s): Adjustment of blood flow of extra-corporeal membrane oxygenation life support
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support
A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Condition: B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is the area under the curve (AUC) for GB241 and rituximab
      concentrations.
    


Intervention name(s): GB241; Rituximab
Intervention type(s): Biological; Biological
Intervention description(s): Single intravenous infusion (IV) 375 mg/m2; Single intravenous infusion (IV) 375 mg/m2
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GB241; Rituximab; B-cell Lymphoma
Discovering New Treatments for Asthma and COPD. A New Human Rhinvovirus for Human Challenge
Condition: Rhinovirus
Study type: Interventional

Summary: 
      A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers
      in the human viral challenge model.
    

Detailed description: 
      Human Rhinovirus infection is an important precursor to asthma and chronic obstructive
      pulmonary disease exacerbations and the Human Viral Challenge model may provide a powerful
      tool in studying these and other chronic respiratory diseases. In this study we have reported
      the production and human characterisation of a new HRV-16 challenge virus produced
      specifically for this purpose.

      An HRV-16 isolate from an 18 year old experimentally infected healthy female volunteer
      (University of Virginia Children's Hospital, USA) was obtained with appropriate medical
      history and consent. We manufactured a new HRV-16 stock by minimal passage in a WI-38 cell
      line under Good Manufacturing Practice conditions. Having first subjected the stock to
      rigorous adventitious agent testing and determining the virus suitability for human use, we
      conducted an initial safety and pathogenicity clinical study in adult volunteers in our
      dedicated clinical quarantine facility in London.
    

Intervention name(s): Titre 1; Titre 2; Titre 3
Intervention type(s): Other; Other; Other
Intervention description(s): Virus infection; Virus infection; Virus infection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science