bioihbjkbjnl/mcl2 huggingface dataset:
A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Adalimumab; Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Intervention description: Administered every other week by subcutaneous injection for up to 48 weeks, depending on participants' disease activity.; ASAS recommended NSAID doses to treat axial spondyloarthritis.
Intervention MeSH terms: Adalimumab; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Axial Spondyloarthritis; Humira

Summary:

      A study comparing a treat-to-target (T2T) intense treatment approach with routine treatment
      (Standard of Care [SOC]) in reducing disease activity in participants with axial
      spondyloarthritis (axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent before start of study-related assessments or
             procedures

          -  Diagnosis of axSpA (either ankylosing spondylitis or non-radiographic axSpA) and
             fulfilling the Assessment of Spondyloarthritis International Society (ASAS)
             classification criteria for axSpA

          -  Participants aged ≥ 18 years

          -  Disease duration < 5 years

          -  Participants must have a Baseline disease activity as defined by an ASDAS ≥ 2.1 or a
             Bath AS Disease Activity Index (BASDAI) ≥ 4

          -  NSAID-naive or not treated with the maximal recommended NSAID dose during the last 2
             weeks prior to the Baseline visit

          -  Participants must never have failed a NSAID taken at maximal recommended dose for 2
             weeks or more.

        Exclusion Criteria:

          -  Contraindications for NSAIDs or tumor necrosis factor (TNF) blocker according to local
             labeling

          -  If entering the study on concomitant NSAIDs, participants taking the maximal
             recommended dose during the last 2 weeks prior to the Baseline Visit or have failed or
             developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more
             at any time

          -  Prior exposure to any anti-TNF therapy; any biologic therapy with a potential
             therapeutic impact on SpA, or participant has been treated with any investigational
             drug of chemical or biologic nature within a minimum of 30 days or five half-lives
             (whichever is longer) of the drug prior to the Baseline visit.
The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block
Condition: Shoulder Surgery; Nerve Block
Intervention: Systemic Dexamethasone; Perineural dexamethasone
Intervention description: Intravenous infusion of dexamethasone (4mg); Perinerual administration of dexamethasone (4mg)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A standard interscalene nerve block is performed with long acting local anesthetic
      (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of
      this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to
      a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block
      compared to ropivacaine alone for interscalene block with systemic dexamethasone.

      Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a
      nerve block.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences
             Centre, Toronto Western Hospital and Women's College Hospital.

          2. ASA functional status class I to III

          3. Age 18 to 80 years

          4. BMI ≤ 35 kg/m2

        Exclusion Criteria:

          1. Lack of patient consent

          2. Allergy to dexamethasone or ropivacaine

          3. BMI > 35 kg/m2

          4. Contraindications to low dose dexamethasone including peptic ulcer disease, systemic
             infection, glaucoma, active varicella/herpetic infections, diabetes mellitus

          5. Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease
             (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic
             deficit in ipsilateral upper extremity, localized infection

          6. Pregnant or nursing females

          7. Chronic opioid use defined as > 30mg oral morphine or equivalent per day

          8. Unable to take acetaminophen or celecoxib
Improving Driving in Young People With Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Buspirone
Intervention description: Buspirone is an atypical anxiolytic medication.
Intervention MeSH terms: Buspirone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: Autism Spectrum Disorder; ASD; Anxiety

Summary:

      This study will examine the effects of treatment with the anti-anxiety medicine buspirone on
      driving performance (eye tracking) in individuals with high-functioning autism spectrum
      disorder (HF-ASD).

      The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as
      two Driving Simulation visits that will take place at Massachusetts Institute of Technology
      (MIT). Subjects will be given buspirone and asked to take the medication for the two days
      preceding the Driving Simulation Visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder

          -  Has a valid Driver's License

        Exclusion Criteria:

          -  Major sensorimotor handicaps (e.g. deafness, blindness)

          -  Individuals who have never held a valid driver's license

          -  Intellectual Deficiency (Verbal Comprehension Index < 80)

          -  Inadequate command of the English language

          -  Subjects with any clinically meaningful medical or psychiatric condition as determined
             by the investigator

          -  Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any
             reason

          -  Pregnant
Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
Condition: Cardiac Arrythmias
MeSH terms: Arrhythmias, Cardiac
Intervention: Carbetocin
Intervention description: 50 mcg or 100 mcg bolus of carbetocin
Intervention MeSH terms: Carbetocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Carbetocin; Myocardial repolarization

Summary:

      Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial
             anesthesia

          -  American Society of Anesthesiologists (ASA) class 2

          -  Patients ≥ 19 years of age

        Exclusion Criteria:

          -  Long QT syndrome

          -  Cardiac disease or rhythm abnormalities

          -  Family history of long QT syndrome or abnormal cardiac conduction

          -  Currently taking medication that is known to prolong the QT interval

          -  Women who are high risk for uterine atony as outlined in SOGC

          -  Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin
             homologue

          -  Patients who are unable to give informed consent because of a language barrier as the
             study team only speaks English and will be unable to complete consent process and
             study procedure appropriately.
Effect of Milnacipran on Pain in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Milnacipram
Intervention description: Titration to 200mg PO daily
Intervention MeSH terms: Milnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibromyalgia; pain

Summary:

      The investigators want to study the effects of milnacipran treatment on neurotransmitter
      release in fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female age 18 or older

          -  Written informed consent and written release of health and research study information

          -  Diagnosis of Fibromyalgia

          -  Participant has pain greater than 4 on the NRS of 0 to 10 on average over the last
             week prior to initial evaluation that interferes with function most days per week

          -  Pain duration greater than 6 months

          -  Negative urine pregnancy test on experimental day 1 and 2 and on first day of
             treatment prior to administration of study medication and fluoroscopy

          -  Ability to speak and understand English, to follow instructions, and fill out study
             questionnaires

          -  Likely to complete all required visits

          -  Must be ambulatory and able to lay prone for 30 minutes

        Exclusion Criteria:

          -  Any condition or situation that in the investigator's opinion may put the participant
             at significant risk, confound the study results, or interfere significantly with the
             participant's participation in the study

          -  Serious, unstable medical illness that could lead to hospitalization over the next
             three months; and/or a DSM-IV diagnosis(es) with active problems within the last six
             months, such as: schizophrenia, bipolar disorder, antisocial personality disorder, or
             substance use disorder

          -  Known, uncontrolled, serious systemic disease, including: hypertension and/or
             tachyarrythmia

          -  Females who are pregnant, breast feeding, or who plan to become pregnant, or who may
             potentially become pregnant

          -  Allergy or sensitivity to any component of the study medication or to contrast dye

          -  Patients on coumadin, heparin, or any other known increase risk of bleeding

          -  Signs of increased intracranial pressure

          -  Patients who are unable to continue current pain medication

          -  Allergy or contraindication to acetaminophen

          -  Use of monoamine oxidase inhibitors

          -  Uncontrolled narrow-angle glaucoma
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
Condition: Liver Transplantation
Intervention: Everolimus; Tacrolimus; Corticosteroids
Intervention description: tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg; capsule containing 0.5, 1.0, or 5.0mg; For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.
Intervention MeSH terms: Everolimus; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 339.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Liver transplantation; Everolimus; Tacrolimus; Renal function

Summary:

      This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus
      versus a standard immunosuppressive regimen concerning kidney function in liver transplant
      recipients.
    

Eligibility criteria:

        Inclusion criteria:

        Male or female recipients of a full-size liver allograft, aged 18 to 65 years.

        Exclusion criteria:

        Patients with thrombocytopenia (platelets <50,000/mm³), with an absolute neutrophil count
        of <1,000/mm³ or leucopenia (leucocytes <2000/mm³), with anemia with Hb < 6g/dl at time of
        randomization

        Patients with uncontrolled hypercholesterolemia (>350mg/dL; >9mmol/L) or
        hypertriglyceridemia (>750 mg/dL; >8.5 mmol/L) at time of randomization

        History of malignancy of any organ system within the past 5 years whether or not there is
        evidence of local recurrence or metastases, other than non-metastatic basal or squamous
        cell carcinoma of the skin or HCC
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Intervention: Elagolix; Placebo
Intervention description: Oral; Tablet; Oral; Tablet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Elagolix; ABT-620; Uterine Fibroids; Heavy Menstrual Bleeding (HMB)

Summary:

      The main objective of this study is to assess safety and efficacy of elagolix compared to
      placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in
      premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces
      HMB associated with uterine fibroids in premenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant at the time of screening has a diagnosis of uterine fibroids documented by
             a pelvic ultrasound [transabdominal ultrasound (TAU) and transvaginal ultrasound
             (TVU)].

          -  Participant has HMB associated with uterine fibroids as evidenced by menstrual blood
             loss (MBL) > 80 mL during 1 menses in screening as measured by the alkaline hematin
             method.

          -  Participant has negative urine and/or serum pregnancy test in Washout (if applicable)
             and/or Screening and just prior to first dose.

          -  Participant has an adequate endometrial biopsy performed during Screening, the results
             of which show no clinical significant endometrial pathology.

        Exclusion Criteria:

          -  Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS)
             or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a
             clinically significant gynecological disorder.

          -  Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.

          -  Participant has clinically significant abnormalities in clinical chemistry,
             hematology, or urinalysis.

          -  Participant has a history of major depression or post-traumatic stress disorder (PTSD)
             episode within 2 years of screening, OR a history of other major psychiatric disorder
             at any time (e.g., schizophrenia, bipolar disorder).

          -  Participant is using any systemic corticosteroids for over 14 days within 3 months
             prior to Screening or is likely to require treatment with systemic corticosteroids
             during the course of the study. Over the counter and prescription topical, inhaled,
             intranasal or intra-articular injectable (for occasional use) corticosteroids are
             allowed.
Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery
Condition: Chest Pain; Surgery
MeSH terms: Chest Pain; Pain, Postoperative
Intervention: Intercostal block Bupivacaine based
Intervention description: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post surgical pain

Summary:

      It is well known that chest surgery patients suffer from high level pain in the perioperative
      period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain
      control technique for thoracoscopic approaches is still under debate. One of the most popular
      methods for pain control is these procedures is the Intercostal block. The Intercostal block
      is usually based upon topical analgesic. In this study the investigators will try to examine
      the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The
      study is a prospective comparative study. The cohort will be divided into two groups. In the
      control group patients will have Intercostal block after surgery and in the study group the
      intercostal block will be given in the beginning of the surgical procedure. All other
      analgesic treatment during and post-surgery will be the same in both groups. The study will
      evaluate pain level in the days after the surgery, analgesic medication consumption and
      relevant morbidity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Thoracoscopic surgery candidate.

          -  Over 18 years old.

          -  No known allergy to Bupivacaine.

          -  Patient is able to read understand and singe an inform consent.

        Exclusion Criteria:

          -  Previous thoracic operation in the same side.
Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Intervention: Propofol; Methohexital
Intervention description: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved; Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
Intervention MeSH terms: Propofol; Methohexital
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardioversion; Propofol; Deep sedation; Intravenous anesthetics

Summary:

      A randomized, open-blinded, prospective study to evaluate the timeliness and safety of direct
      current cardioversion (DCCV) when using methohexital when compared to the more often used
      propofol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who present to Wake Forest Baptist Medical Center for a direct current
             cardioversion for treatment of paroxysmal or persistent atrial fibrillation as well as
             atrial flutter.

        Exclusion Criteria:

          -  Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV

          -  Hemodynamically compromised patients (as defined by hypotension <90/50 mmHg, altered
             mental status, shock, ischemic chest discomfort, or heart failure)
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin glulisine; insulin aspart
Intervention description: Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days; Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Type 1 diabetes mellitus in children; insulin glulisine; insulin aspart; post prandial

Summary:

      To determine whether insulin glulisine decreases the breakfast post prandial glycemic
      excursion in comparison to insulin aspart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current patient in the Helen DeVos Children's Hospital Diabetes Clinic;

          -  ages 4-11 years;

          -  prepubertal (Tanner Stage I);

          -  diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or
             presenting at time of diagnosis with positive serum or urine ketones and requiring
             insulin since diagnosis;

          -  at least six months from date of diagnosis of type 1 diabetes mellitus;

          -  TSH within reference range and negative transglutaminase IgA antibodies within nine
             months of study start;

          -  HbA1C between 6.9 and 10% within 30 days of study start; parent or guardian able and
             willing to provide written informed consent prior to enrollment;

          -  at time of study start, current insulin regimen includes multiple daily injections
             with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the
             pre-meal rapid acting insulin

        Exclusion Criteria:

          -  pubertal (Tanner stage 2 or greater);

          -  concurrent Addison's disease, celiac disease or untreated hypothyroidism; - receiving
             oral, injectable or inhaled steroids or immunosuppressant medications;

          -  receiving stimulants for treatment of attention deficit disorder or attention deficit
             hyperactivity disorder;

          -  intercurrent illnesses such as a fever > 101 degrees F, infection, or gastroenteritis;

          -  use of any medication to treat diabetes other than those listed under in inclusion
             criteria;

          -  potential for lack of compliance or any other issue which, in the opinion of the
             investigator, would compromise the subject's safety or successful participation in the
             study