bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia
Condition: Haemophilia A; Haemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Observational

Summary: 
      The Hemophilia Growth and Development Study (HGDS) nearly 25 years ago showed haemophilia and
      HIV impacted brain development, thinking, and behaviour in children and adolescents. The
      eTHINK study is designed to understand whether advances in hemophilia treatment have removed
      any impact of hemophilia. If there still is an impact of hemophilia, the eTHINK study will
      help to identify which children or adolescents are still at risk, and how to screen other
      children. Participants and their child will participate in a comprehensive assessment of
      child's brain development, thinking and behavior through completing tests and questionnaires.
      There is only one study visit of 1 to 1.5 hours with no follow-up required
    


Intervention name(s): No treatment given
Intervention type(s): Other
Intervention description(s): The participants will undergo a brief physical examination focused on neurologic function (muscle function, sensation, coordination, walking). Parents will be asked by the study team or the psychologist about their children and will complete several commonly used standard surveys about brain development, thinking, behavior, and decision making. The participants will also engage with the psychologist to evaluate development or thinking (IQ), and depending on their age they may be asked to complete one or more commonly used standard surveys about behavior and decision making.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and young adults with hemophilia A or B, all severities
Effect of Oxytocin on Masked Facial Expressions: an fMRI Study
Condition: Facial Expressions
MeSH terms: Facies
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose is to test whether oxytocin has an effect on masked facial expressions
    

Detailed description: 
      The neuropeptide oxytocin (OXT) has been shown to modulate several aspects of human social
      cognition. Although the exact mechanisms behind these effects remain unclear, recent research
      suggests that OXT modulates the perception of cues that are important for interpersonal
      processing, particularly emotional facial expressions. Using a backward masking procedure and
      functional magnetic resonance imaging, we investigated the modulatory effects of intranasal
      OXT on the processing of sub-liminally presented emotional faces. In a double-blind
      placebo-controlled between-subject pharmaco-fMRI experiment healthy volunteers received
      either 24IU of intranasal oxytocin or placebo 45mins before they were presented emotional
      (happy, angry, fearful, sad, disgusting) faces and mirror-reversed neutral faces masked by
      neutral faces of the same individual. To ensure attentional processing of the faces subjects
      were required to perform a simple gender decision task in the scanner and a recognition
      memory task afterwards. All subjects were additionally assessed for their state and trait
      anxiety and depression as well as empathy. For the analysis, we will use matlab, SPM and SPSS
      to conduct structural ROI analysis and two Sample t test.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: treatment; mask face exoressions; genier
Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block
Condition: Prostate CA
Study type: Interventional

Summary: 
      Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal
      surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to
      prolong the effective duration of analgesia in several different peripheral nerve blocks. The
      study will examine, in a blinded, prospective and randomized fashion, whether the addition of
      dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will
      compare local anesthetic with and without the addition of dexamethasone in the TAP block.
    

Detailed description: 
      The study will be done in two phases. In the first phase, patients will be randomized to
      receive either 20 cc of 0.125% bupivicaine with or without 2 mg of dexamethasone on each side
      of their abdomen (40 cc and 4 mg in total) and patients who receive the dexamethasone will be
      compared with patients who did not receive it. In the second phase, we will assess whether
      patients can serve as their own controls by adding dexamethasone only to one side of the
      block (one side of the abdomen) and comparing pain relief/efficacy with the contra-lateral
      plain local anesthetic effect. The study will assess pain relief, opioid consumption, level
      of blockade, and operator's prospective assessment of likely efficacy, based on the
      ultrasound visualization of the local anesthetic injection as compared with actual efficacy.
    

Intervention name(s): Dexamethasone; TAP block
Intervention type(s): Drug; Procedure
Intervention description(s): 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.; Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-Mannosidosis
Condition: Alpha-Mannosidosis
MeSH terms: Mannosidase Deficiency Diseases; alpha-Mannosidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective is to evaluate the long-term efficacy, safety and tolerability of
      repeated Lamazym i.v. treatment in patients 5-21 years of age with alpha-Mannosidosis
    


Intervention name(s): Lamazym
Intervention type(s): Drug
Intervention description(s): ERT, i.v. infusions weekly
Other intervention name(s): rhLAMAN; recombinant human alpha-mannosidase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Breakthrough Pain Computer Integrated Patient Controlled Epidural Analgesia
Condition: Pain
MeSH terms: Breakthrough Pain
Study type: Observational

Summary: 
      The computer-integrated patient controlled epidural analgesia (CIPCEA) system can
      automatically adjust the background infusion rate during combined spinal-epidural (CSE)
      analgesia based on the parturient's need as labour progresses. Analysis of parturients
      experiencing breakthrough pain may identify associated factors that can also be related to
      obstetric or foetal outcomes
    

Detailed description: 
      Computer integrated patient controlled epidural analgesia (CIPCEA) is a novel epidural
      analgesic delivery system that is currently used in daily practice in KK Women's and
      Children's Hospital. It has enabled us to monitor the infusion pumps through wireless
      connection to a central monitoring system and hence, collect pump utilisation data
      electronically. The CIPCEA system is programmed to analyse the LA usage across the last hour
      and adjust the background infusion rate according to a preset algorithm.

      Breakthrough pain is defined as maternal complaint of pain or pressure that required and was
      successfully treated with supplemental epidural medications. we investigated the potential
      factors associated with breakthrough pain in patients who receive CSE epidural analgesia with
      CIPCEA, with the aim of elucidating the important associated factors.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who had nulliparous requested for labour epidural analgesia
      
Keywords: Epidural Analgesia; Pain
Consequences of Marijuana Use in HIV-infected Youth
Condition: Youth With HIV
MeSH terms: Marijuana Use
Study type: Observational

Summary: 
      Proposed study focuses on Youth With HIV (YWH) recruited from the University of North
      Carolina using a cross sectional assessment of blood samples, clinical, demographic,
      behavioral, [including substance use and frequency], and neurocognitive data will be
      evaluated from YWH treated before CD4 T cell decline.
    

Detailed description: 
      The long-term goal for the proposed research is to apply a systems biology approach to
      discover evidence that provides the basis for understanding the complex and at times
      conflicting roles for marijuana in chronic inflammation in HIV-infected youth. To achieve the
      goal, a systems biology approach with two aims is designed:

      Aim 1. To identify inflammatory immune pathways perturbed by recreational marijuana with or
      without concomitant use of tobacco products by applying a deep sequencing approach to define
      global transcriptome of peripheral blood cells from HIV-infected virally suppressed youth.

      Aim 2. To develop biomarker profiles associated with pro- or anti-inflammatory pathways
      perturbed by marijuana and to discover biomarker profiles linked to neurocognitive impairment
      that are impacted by marijuana and tobacco use by YWH
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Enrollment will consist of approximately 61 HIV-infected youth meeting the below entry
        criteria who are receiving antiretroviral therapy with undetectable viral levels at the
        time of entry (based on viral load assay within 1 year of enrollment) Recruitment will
        include Youth Age 21-28

          -  Youth who use marijuana only [targeted number 20 participants]

          -  Youth who use tobacco products only [targeted number 24 participants]

          -  Youth who use marijuana and tobacco [targeted number 7 participants]

          -  Youth who do not use substances [targeted number 10 participants]
      
Biospecimen description: 
      plasma biomarker measurements, toxicology measurements, proteomics studies, transcriptome
      analyses, flow cytometric analysis and storage. Cryopreserved peripheral blood cells, serum
      and plasma .
    
Keywords: substance use
Open-Label Trial of the Use of Minocycline in the Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The tetracycline minocycline has, in addition to its anti-infective properties,
      anti-inflammatory properties which may be of use in the treatment of asthma. This study
      evaluates the benefit of minocycline as add-on therapy for adults with asthma.
    

Detailed description: 
      Adult asthmatic (ages 18 to 75 years) with a history of moderate to severe persistent asthma
      are given minocycline capsules as add-on therapy for treatment of asthma. Treatment is for
      one year. Dosing begins at 150 mg twice daily and can increase every eight weeks by 50mg BID
      to a maximum of 250 mg twice daily. This is as per patient tolerance as minocycline can cause
      dizziness and stomach upset, as well as effects of liver enzymes.Patients undergo routine
      blood toxicity screens every two months, at which time spirometry is performed Exclusion
      criteria: pregnant women (adequate contraception in mandated) previous history of
      hypersensitivity to tetracyclines, chronic liver disease Outcome measures: improvement in
      FEV1 and other spirometric parameters, decrease in oral steroid requirements, change in total
      serum IgE, improvement in quality of life
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): addition of 150 mg to 250 mg po bid to standard asthma care regiment
Other intervention name(s): Minocin
Intervention MeSH terms: Minocycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: minocycline; asthma; oral steroids; IgE
Cardiovascular Effects of Incremental Diesel Exhaust Inhalation in Middle-Aged Healthy GSTM1 Null Human Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular
      events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as
      a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of
      the glutathione-s-transferases (GSTs) have been shown to participate in the antioxidant
      defenses to air pollutants. This study examined the dose effects of diesel exhaust exposure
      on the cardiovascular system in healthy middle-aged subjects.

      Participants: Six healthy 50-75 year-old male and female subjects with GSTM1 null genotype
      had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3,
      200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy 50-75 year-old male and female subjects with GSTM1 null genotype.
      
Keywords: risk of cardiovascular events
Use of Hypoallergenic (H.A.) Cereals in Children With Diagnosed Allergy to Wheat
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      The investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in
      order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for
      children with allergy to wheat. The study has the potential to offer a desensitization
      treatment option for children allergic to wheat.

      The investigators hypothesize that H.A. wheat cereals have similar efficacy with less side
      effects than native wheat cereals.
    

Detailed description: 
      In this pilot study, the investigators aim to assess the feasibility of a SOTI (Specific Oral
      Tolerance Induction) with hypoallergenic (H.A.) cereals in children with diagnosed
      IgE-Mediated allergy to wheat.

      This is a multi centre, open, pilot study testing 1 product.10 children of any ethnicity aged
      from 1 to 12 years old with diagnosed allergy to wheat will be eligible to participate in the
      study. The duration of the treatment will be 6 months with a minimum of 1 month of daily
      consumption of the hydrolyzed wheat cereals.

      Each subject will feed with a quantity of the assigned study product according to the SOTI.
      The SOTI will be performed at the hospital under the control of qualified doctors and nurses.

      The study product is administered starting with very low dosages, which are increased
      stepwise every 30 minutes up to an amount equivalent to the usual daily oral intake.
      Thereafter, the study product corresponding to the maximum dose tolerated is given in a
      maintenance dose in one serve every day until the final visit during which a challenge test
      with wheat will be performed to assess the tolerance of whole wheat.
    

Intervention name(s): HA wheat cereals
Intervention type(s): Other
Intervention description(s): HA wheat cereals used in SOTI test and as part of desensitization plan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SOTI; tolerance; desensitization; challenge test; HA wheat cereals
An fMRI Study of SYN115 in Cocaine Dependent Subjects
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The dopamine system is critical in modulation of reward and has been implicated in the
      initiation and maintenance of addiction (Volkow et al 2004). Medications that increase
      dopamine either directly or indirectly have been shown to have preliminary efficacy at
      reducing cocaine use in cocaine dependent subjects (Grabowski et al 2004a; Schmitz et al
      2008). A novel class of medications that has recently been shown to indirectly modulate
      dopamine function is adenosine A2A receptor antagonists (Fuxe et al 2007). Based on their
      effect on dopamine function it has been suggested that these compounds may be efficacious in
      the treatment of drug addiction (Ferre et al 2007c). Before clinical efficacy studies are
      undertaken, more basic research on the effects of adenosine A2A antagonists on brain function
      and behavior are warranted. The aim of this study is to examine the acute effects of a single
      dose of the selective adenosine A2A antagonist (SYN115, Synosia Therapeutics, Chemical name:
      4-Hydroxy-4-methyl-piperidine-1-carboxylic
      acid-(4-methoxy-7-morpholin-4-yl-benzothiazol-2-yl)-amide) on brain function and behavior in
      cocaine dependent individuals using functional magnetic resonance imaging (fMRI). To examine
      the effect of a single dose of SYN115 on brain function and behavior in cocaine dependent
      subjects.

      Hypotheses:

        1. SYN115 100 mg will increase brain activation in the dorsolateral prefrontal cortex
           compared to placebo in cocaine dependent subjects performing a working memory task.

        2. SYN115 100 mg will increase brain activation in the ventral striatum compared to placebo
           in cocaine dependent subjects performing a reversal learning task.

        3. SYN115 100 mg will reduce brain activation in the anterior cingulate gyrus and amygdala
           compared to placebo in cocaine dependent subjects performing a cocaine-word Stroop task.
    


Intervention name(s): SYN115; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg single dose; PLACEBO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease and Allied Conditions
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory
      process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and
      mortality in COPD. Early changes of vascular integrity can be detected via markers of
      subclinical atherosclerosis.

      Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option
      in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an
      anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data.

      The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor
      Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of
      systemic inflammation in the peripheral circulation of patients with stable chronic
      obstructive pulmonary disease.
    


Intervention name(s): Roflumilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Roflumilast coated tablet, 500µg oral application, once daily in the morning; Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning
Other intervention name(s): Daxas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; comorbidity; arterial stiffness; roflumilast
Tanglewood Trail Walking Program in Rural Kentucky 2019
Condition: Dietary Habits
Study type: Interventional

Summary: 
      The Tanglewood Trail Walking Program is a well established community health initiative that
      encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market
      each Saturday. The study aims to determine if walking to the market with a community health
      coach results in healthier options being selected at the market when compared to the driving
      group.
    

Detailed description: 
      In the summer of 2017, community members of Whitesburg, KY were recruited to join the
      Tanglewood Trail Walking Program to the Whitesburg farmers market. Each Saturday,
      participants reported whether or not they walked the 1 mile trail to the farmers market and
      they reported which fruits and vegetables they purchased. Participants completed
      questionnaires about fruit and vegetable consumption and physical activity. Participants also
      provided physical and biological measurements. The ClinicalTrials.gov record for the original
      trial in 2017 is NCT03495648.
    

Intervention name(s): walking group led by a community organizer
Intervention type(s): Behavioral
Intervention description(s): Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: farmers market; Appalachia; physical activity; fruit and vegetable voucher program
Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      To assess the effect of risperidone 2 mg daily (QD) on the differential sensitivity of 2
      spatial working memory tests (the GMLT and MDR) in non-agitated, drug-naive patients
      suffering from first-episode schizophrenia/schizophreniform disorder.
    


Intervention name(s): Risperidone 2 mg
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Coffee Polyphenols Antioxidants
Condition: Healthy
Study type: Interventional

Summary: 
      Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic
      acids) and bioavailability of these bioactive compounds is now somewhat well understood. In
      addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence
      remains to be observed in vivo. The objective of this trial is to understand if regular (10d)
      coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and
      plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as
      beneficial as the whole beverage in reducing oxidative stress compared to placebo
    

Detailed description: 
      This is an interventional study with a crossover randomized placebo-controlled double-blind
      design to assess the effect of regular consumption of coffee on oxidative stress compared to
      placebo.
    

Intervention name(s): coffee; coffee polyphenols mixed with placebo; maltodextrin enriched with caffeine
Intervention type(s): Other; Other; Other
Intervention description(s): coffee, placebo enriched with polyphenols and placebo with caffeine; coffee polyphenols mixed with placebo; maltodextrin enriched with caffeine
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)