bioihbjkbjnl/mcl2 huggingface dataset:
Intra-arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke
Condition: Stroke; Cerebrovascular Accident
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      SYNTHESIS is a pragmatic multicenter randomized controlled trial (RCT), open-label, with
      blinded follow-up aiming to determine whether loco-regional intra-arterial (IA) with
      recombinant tissue-plasminogen activator (rt-PA) and/or mechanical devices, as compared with
      systemic intravenous (I.V.) infusion of rt-PA within 3 hours of ischemic stroke, increases
      the proportion of independent survivors at 3 months.
    

Detailed description: 
      Eligibility criteria:patients with symptomatic, CT verified, acute ischemic stroke, being
      able to initiate IV rt-PA within 3 hours and IA thrombolysis within 6 hours of stroke onset,
      when uncertainty about appropriateness the two approaches exists as established by the
      treating physician.

      Eligible patients are randomized to receive either 0.9 mg/kg (max 90 mg) IV rt-PA (control
      arm) or up to 0.9 mg/Kg IA rt-PA (max 90 mg) over 60 minutes into the thrombus, eventually
      associated with clot mechanical disaggregation/dislocation or retraction/aspiration.
      Mechanical thrombolysis is possible also without the use of rt-PA. The procedural choices of
      the interventional neuroradiologist depend on the type of occlusion, circumstances and
      experience.

      The study is designed to detect or disprove (alpha=5% and power probability=80%) a 15%
      absolute difference between the treatment groups in the percentage of patients with a
      favourable outcome (Modified Rankin Scale Score = 0-1).Enrollment will be completed with 350
      randomized patients.

      Neurological deficit will be scored with NIH Stroke Scale at day 7 or discharge, or transfer
      to another hospital, whichever occurs first.Patient's clinical condition will be again
      evaluated by a telephone call after 90 days.
    

Intervention name(s): Alteplase IA and/or mechanical thrombolysis; Alteplase IV
Intervention type(s): Other; Drug
Intervention description(s): loca intra-arterial recombinant tissue plasminogen activator and/or mechanical thrombolysis; intravenous recombinant tissue plasminogen activator
Intervention MeSH terms: Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute ischemic stroke; thrombolysis; intra-arterial thrombolysis
Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Observational

Summary: 
      The primary objective is to determine whether inflammatory markers, such as C-Reactive
      Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide
      (VIP), or Substance P (SP) are reduced in patients having a migraine headache when treated
      with Imitrex or Treximet.

      The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive
      Protein (CRP) in patients with active migraine headaches.
    

Detailed description: 
      Migraine is a neurovascular process involving the brain and related structures.
      Neuroinflammatory substances such as CRP, CGRP, VIP, SP, and prostaglandins are liberated
      during the migraine. Elevation of these markers may be associated with other conditions which
      contain an inflammatory component such as coronary artery disease. VIP is an inflammation and
      pain transmission, and thus are markers of sensory nociceptive neurons.

      During this study, the subjects will have the following inflammation markers analyzed:
      C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal
      Polypeptide (VIP), and Substance P (SP).
    

Intervention name(s): sumatriptan and Treximet
Intervention type(s): Drug
Intervention description(s): sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.
Other intervention name(s): Imitrex 100mg; Treximet 85/500mg
Intervention MeSH terms: Sumatriptan
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and female patients with migraine headaches.
      
Keywords: Migraine
Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a Pollen and Dust Mite Mixture.
Condition: Type I Allergy
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicenter Skin Prick Test
    


Intervention name(s): Skin Prick Test
Intervention type(s): Other
Intervention description(s): Skin Prick Test
Assessing the Stability of Transcranial Magnetic Stimulation Plasticity Responses
Condition: Healthy
Study type: Interventional

Summary: 
      The overall goal of this proposed study is to assess the reliability of plasticity measured
      by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst
      stimulation plasticity measures and to assess the influence of an acute bout of aerobic
      exercise on TMS plasticity measures.
    


Intervention name(s): Short-term aerobic exercise
Intervention type(s): Behavioral
Intervention description(s): One bout of moderate intensity exercise (75% of maximal predicated heart rate).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Gamma-delta Tocotrienol as Potential Maintenance Treatment in Women With Metastatic Breast Cancer
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written
      informed consent to participate in the trial will be recruited to compare the rate and extent
      of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.
    

Detailed description: 
      Twelve healthy subjects will be admitted to a clinical study ward on the Day 0. Physical
      check up and the health status will be confirmed during check in. After fasting for a minimum
      of 10 hours overnight, each subject will be administered a single dose of TRF or Gamma-Delta
      after taking a standardized high-fat meal breakfast on Day 1. Thereafter, standard meals will
      be provided at 4 and 12 hours after dosing. Blood samples (5mL will be taken using an
      in-dwelling canula placed in the antecubital vein immediately before and at 0.5, 1, 2, 3, 4,
      5, 6, 7, 8, 10, 14, and 24 hours after dosing. Subjects will be admitted for 24 hours and
      discharged after the last blood sampling. During the study, blood pressure and the heart rate
      will be monitored regularly for safety profile.

      After a one week wash out period, subject will return to the ward and be given the other
      formulation (TRF or GDT) and the same procedures will be repeated. Any adverse events that
      arise during the treatment will be recorded and followed up till resolution.
    

Intervention name(s): Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction
Intervention type(s): Dietary Supplement
Intervention description(s): Single oral TRF or Gamma-Delta Tocotrienol dosage
Intervention MeSH terms: Tocotrienols; Vitamin E; Tocopherols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Biomarker for Duchenne Muscular Dystrophy
Condition: Increased Lordosis/Scoliosis; Hyporeflexia; Duchenne Muscular Dystrophy; Red-Green Color Blindness; Lordosis; Scoliosis; Muscular Atrophy; Muscular Weakness
MeSH terms: Muscular Dystrophies; Scoliosis; Muscular Dystrophy, Duchenne; Lordosis; Muscle Weakness; Muscular Atrophy; Blindness; Color Vision Defects; Reflex, Abnormal; Swayback
Study type: Observational

Summary: 
      International, multicenter, observational, longitudinal study to identify biomarker/s for
      Duchenne Muscular Dystropy (DMD) and to explore the clinical robustness, specificity, and
      long-term variability of these biomarker/s.
    

Detailed description: 
      Duchenne Muscular Dystrophy (DMD) is a devastating inherited neuromuscular disorder that
      affects 1 in 3300 live male births (females can be mildly affected carriers). DMD causes
      progressive weakness and loss of muscle mass, with symptoms usually appearing in early
      childhood. DMD arises from mutations in the DMD gene that codes for dystrophin.

      The DMD gene is located on the short arm of chromosome X (locus Xp21) and codes for
      dystrophin, containing 3685 amino acid residues. 60-65% of DMD mutations are large
      dele-tions, 10-30% are nonsense and frame-shift mutations, 5-15% are duplications, and 2% are
      intronic or 5'- and 3'-UTR alterations.Dystrophin aggregates as a homotetramer in the
      skeletal muscles or associates with actin and Dystrophin-Associated Glycoproteins (DAGs),
      forming a stable complex that interacts with laminin in the extracellular matrix. Dystrophin
      is considered a key structural element in the muscle fiber, whose primary function is to
      stabilize plasma mem-brane, while the DAGs maintain the sarcolemmal stability by mediating
      the complex interactions of the muscle membrane and extracellular environment. The low levels
      of dystrophin lead to cellular instability and progressive leakage of intracellular
      components, explaining the characteristically high levels of creatine phosphokinase (CPK) in
      the blood of DMD patients.

      Biomarkers serve as measurable indicators of normal biological or pathological processes.
      They are typically directly linked to genetic variants in specific genes and can predict,
      diagnose, monitor, and assess the severity of a disease. It is the goal of this study to
      identify, validate, and monitor biochemical markers from DMD affected participants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with Duchenne Muscular Dystrophy (DMD)
      
Biospecimen description: 
      Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)
    
Keywords: Duchenne Disease; Biomarker
A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune
      responses to tetanus and meningococcal vaccination in adult and adolescent participants with
      moderate-to-severe atopic dermatitis (AD).
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in
      adult and adolescent subjects (≥ 12 to 54 years) with moderate-to-severe AD. Eligible
      subjects must have a documented history of inadequate response to topical AD medication(s).
      Approximately 200 subjects will be randomized 1:1 to receive either 30 mg nemolizumab (with a
      60 mg loading dose) or placebo, stratified by baseline disease severity (IGA = 3, moderate;
      IGA = 4, severe). The study consists of a 2- to 4-week screening period, a 16-week treatment
      period, and an 8-week follow-up period (12 weeks after the last study drug injection).
    

Intervention name(s): Nemolizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nemolizumab will be administered by 2 SC injections as 60-mg loading dose at baseline and a single 30-mg dose at Weeks 4, 8, and 12.; Placebo will be administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Eczema; AD; Vaccine; Nemolizumab; Pruritis; Itchy
Weighted Pacifier Vs. Non-Weighted Pacifier
Condition: Non-nutritive Sucking
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      This study will determine if it is beneficial to use a weighted pacifier in neonates.
    

Detailed description: 
      RCI-Pacifiers have been utilized for decades in the NICU to provide benifical Non-Nutritive
      Suck. They have been instrumental in transitioning premature infants from gavage to breast
      feeding Yiallouerou, S, et al, studied the effects of dummy/pacifier on autonomic activity
      during sleep and found pacifier use to be protective during sleep. Risks and Benefits of
      Pacifiers have cleary been identified Sexton, S and Natsale, R have identified that
      nonnutritive suck is a natural reflex for a fetus and newborn. Traditionally, the pacifier
      has been used as a method for fulfilling an infants innate desire to suckle. Study subjects
      will be introduced to either a standard/traditional pacifier (without stabilizing/weighted
      attachment) or a stabilizing/weighted pacifier. Standard/traditional pacifiers will be issued
      to patients that have been assigned an odd number study identifier and , stabilzing/weighted
      pacifiers will be issued to patients that have been assigned an even number study identifier.
      All eligible infants born at 30 weeks to 37.6 weeks who meet study criteria will be included.
      All staff/caregivers will be trained in proper placement of a stabilizing pacifier prior to
      use. Stabilizing pacifiers will not be placed on the infants chest. Traditional pacifiers
      will be used as standard of care at EH. The Neonatal Infant Pain Score (NIPS) scale and a
      caregiver survey will be used to determine efficacy.
    

Intervention name(s): Weighted Pacifier; Non-Weighted Pacifier
Intervention type(s): Other; Other
Intervention description(s): The weighted pacifier is a standard of care pacifier with a weighted, breathable star attachment to help keep the pacifier from popping out of the neonates mouth during non-nutritive suck.; The non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness
Condition: Pain; Osteoarthritis
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of the study is to identify non-invasive strategies that will optimize the
      neurobiological environment and improve learning and memory in the treatment of chronic pain.
      The overall aims of the current proposal are to determine if food restriction and/or glucose
      administration in conjunction with a relaxation/guided imagery exercise will result in
      neurophysiological changes and functional improvements compared to the relaxation/guided
      imagery exercise alone.
    

Detailed description: 
      Up to sixty adults with chronic knee pain with or/at risk of knee osteoarthritis will be
      randomized to one of three groups: food restriction (20 participants), glucose administration
      (20 participants), or control (20 participants). Participants will attend four sessions over
      a two to three week period.
    

Intervention name(s): Glucose Administration; Intermittent Fasting; Control
Intervention type(s): Other; Other; Other
Intervention description(s): For sessions 2 through 4, participants will fast for two hours prior to each session and consume 25-30 g of glucose at the start of each session.; For sessions 2 through 4, participants will fast for 16 hours prior to the session (no food or beverages other than non-caloric beverages or coffee after 6 or 7 pm the evening prior).; Normal food intake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Neuroplasticity
A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients
Condition: Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This is a prospective study in a cohort of about 500 patients with Idiopathic Parkinson's
      disease, examined routinely in the neurological outpatient clinic.

      This study aims to evaluate the correlation between oculometric measures and clinical
      endpoints. Subjects will be evaluated following a physician examination.The evaluations will
      include MDS-UPDRS examination, as well as an oculometric evaluation for eye movements. In
      addition, 500 healthy subjects will be evaluated.
    

Detailed description: 
      This is a prospective study in a cohort of patients with idiopathic PD who are visiting the
      Parkinson's outpatient clinic. The aim of the study is to evaluate the correlation between
      oculometric measures and MDS-UPDRS score in subjects who meet the inclusion criteria and who
      provide a signed Informed Consent.

      This study is designed to evaluate the correlation between oculometric measures and the
      Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
      (MDS-UPDRS). Subjects will be evaluated at their visit to the clinic. The evaluations will
      include an MDS-UPDRS examination by a certified neurologist and other tests. In addition, all
      patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking
      recordings. All assessments will be performed during a clinic visit unless authorized to be
      conducted remotely. In addition, 500 healthy subjects will be evaluated, undergoing a
      NeuraLight session for oculometric evaluation along with eye-tracking recordings.
    

Intervention name(s): NeuraLight software-based platform
Intervention type(s): Other
Intervention description(s): NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Laboratory Model for Heroin Abuse Medications - 8
Condition: Heroin Dependence; Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of treatment medications (methadone,
      buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and
      smoked heroin self-administration."
    

Detailed description: 
      Abuse of prescription opioid medications has increased dramatically in the U.S. during the
      past decade, as indicated by a variety of epidemiological sources. However, few studies have
      systematically examined the relative reinforcing effects of commonly abused opioid
      medications. The current inpatient study was designed to compare the effects of intravenously
      delivered fentanyl , oxycodone, morphine, buprenorphine and heroin in morphine-maintained
      heroin abusers. All of the participants received all of the drugs tested; drugs and doses
      were administered in non-systematic order.
    

Intervention name(s): opiates
Intervention type(s): Drug
Intervention description(s): prescription opioids
Other intervention name(s): morphine; fentanyl; buprenorphine; oxycodone; methadone
Intervention MeSH terms: Fentanyl; Morphine; Oxycodone; Buprenorphine; Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heroin, opioid disorders, substance related disorders
High Protein Breakfast on Weight Management and Glycemic Control in 'Breakfast-skipping' Teens
Condition: Breakfast; Appetitive Behavior
Study type: Interventional

Summary: 
      75 overweight, habitual 'breakfast-skipping' adolescents will complete the following
      long-term, randomized controlled trial. Participants will be randomly assigned to the
      following breakfast treatments: 350 kcal high protein breakfasts containing 30 g protein
      (primarily from lean beef), 35 g carbohydrates, and 10 g fat; 350 kcal normal protein
      breakfasts containing 10 g protein, 55 g carbohydrates, and 10 g fat; or will continue to
      skip breakfast. The following outcomes will be assessed during baseline and 4-month
      (post-intervention): body weight & body composition; waist circumference; daily food intake;
      24-h free-living glycemic control; and pre and post-prandial satiety. In addition, body
      weight and free-living breakfast intake (quantity, quality, and type) will also be assessed
      at 2-month follow-up
    

Detailed description: 
      The NP and HP groups will be provided with their respective breakfast meals to consume, at
      home, between 6:00-8:00 am each day over the 4-mo intervention. The energy content of the NP
      and HP breakfast meals will be standardized to 350 kcal. The energy content of the breakfast
      meals is ~18% of daily energy intake estimated from the energy expenditure equations specific
      for adolescents ages 13-16 y. The NP breakfasts will be 11% protein (10 g protein), 63% CHO,
      and 26% fat, whereas the HP breakfasts will be 34% protein (30 g protein), 40% CHO, and 26%
      fat. The types of protein incorporated within the NP and HP meals will include a combination
      of beef (40%), dairy (20%), eggs (20%), and plant-based (20%) proteins. The NP and HP meals
      will include the same types of breakfasts but will vary in protein and CHO content. An 8-d
      breakfast rotation will occur throughout the study.
    

Intervention name(s): Breakfast
Intervention type(s): Dietary Supplement
Intervention description(s): If randomized to a breakfast consuming group, participants will be given breakfasts to consume between 6:00-8:00 am.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other