bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; DMARD
Intervention description: 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate); Non-biologic DMARDs (including methotrexate) according to current best practice
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label, parallel-group study will assess the effect on disease remission
      of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs
      (DMARDs) versus current best practice non-biologic DMARD therapy in patients with
      moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the
      RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every
      4 weeks. The anticipated time on study treatment is 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, over the age of 18 years

          -  Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2
             years duration

          -  DAS28 >3.2

          -  Swollen joint count (SJC) >/=6 (66 joint count), and tender joint count (TJC) >/=6 (68
             joint count)

          -  Patients who have received DMARDs (including methotrexate) for 3-7 months

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months after baseline

          -  Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens
             syndrome or nodulosis with RA is permitted)

          -  Functional class III or IV as defined by ACR Classification of Functional Status in
             Rheumatoid Arthritis

          -  Prior history of or current inflammatory joint disease other than RA
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
Condition: Anemia, Sickle Cell; Pain
MeSH terms: Anemia, Sickle Cell
Intervention: Fentanyl Citrate; Normal Saline
Intervention description: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device; A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: fentanyl; intranasal; sickle cell; vasoocclusive crisis; pain crisis; pediatrics

Summary:

      The purpose of this study is to determine if intranasal fentanyl can decrease the pain of
      patients with sickle cell disease who present to the pediatric emergency department with a
      vaso-occlusive crisis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sickle Cell Disease

          -  Ages 3 years - 21 years

        Exclusion Criteria for Enrollment:

          -  Pregnancy

          -  Known allergy to Fentanyl

          -  Usage of daily home opiates

        Exclusion Criteria at presentation in ED with a painful crisis:

          -  Wong Baker FACES Pain Score <6

          -  Systolic blood pressure < 5 percentile for age

          -  Oxygen saturation <92% on room air

          -  Temperature > 102°F

          -  Respiratory distress

          -  Priapism

          -  Isolated abdominal pain

          -  Isolated headache

          -  New neurological symptoms

          -  Severe rhinorrhea or epistaxis

          -  History of trauma

          -  Pregnancy
Diphenhydramine for Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: metoclopramide; diphenhydramine; placebo
Intervention description: 10 milligrams, administered intravenously over 15 minutes; 50 milligrams, administered intravenously over 15 minutes
Intervention MeSH terms: Diphenhydramine; Promethazine; Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 208.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: migraine; headache; metoclopramide; diphenhydramine

Summary:

      Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite
      the fact that data supporting this practice do not exist. The investigators propose a
      randomized double blind study to test the hypothesis that 50mg of intravenous
      diphenhydramine, when added to standard migraine therapy, will result in a greater rate of
      sustained headache relief than standard migraine therapy alone. For this study, standard
      migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is
      defined as achieving a headache level of "mild" or "none" within two hours and maintaining a
      level of "mild" or "none" for 48 hours. Patients who present to the Montefiore emergency room
      (Bronx, NY) with an acute migraine will be approached for participation. They will be
      screened for medication contra-indications and non-migraine etiologies of headache. The study
      will be randomized. Assignment will be concealed. Participants and researchers will be
      blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours
      in the Emergency Department and by telephone 48 hours after medication administration. A
      sample size calculation, based on pilot data, revealed the need for 374 participants. An
      interim analysis will be performed after 200 participants have been enrolled with the goal of
      assessing for lack of conditional power.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute migraine headache

          -  Present to our emergency room in the Bronx, NY for treatment of migraine headache

        Exclusion Criteria:

          -  Temperature > 100.3 F

          -  Pheochromocytoma

          -  Seizure disorder

          -  Parkinson's disease

          -  Use of monoamine oxidase (MAO) inhibitors

          -  Use of anti-rejection transplant medications

          -  Use of potassium supplements

          -  Use of pramlintide
A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Condition: Labor; Forced or Induced, Affecting Fetus or Newborn; Pregnancy
Intervention: Misoprostol
Intervention description: Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: misoprostol; cytotec; cervical ripening; labor, induced; active labor

Summary:

      The purpose of this study is to study if misoprostol administered orally is at least as
      effective as misoprostol administered vaginally for cervical ripening and the induction of
      labor. The main purpose is to show that oral misoprostol administration is non-inferior to
      vaginal misoprostol administration with respect to the time interval from misoprostol
      administration to onset of active phase of labor. The study is a non-inferiority, prospective
      randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus
      vaginal misoprostol given as 25 mcg every 4 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pregnant Female Patients greater than or equal to 18 years of age

          2. Induction of labor for a single live intrauterine pregnancy

          3. Greater than or equal to 37 weeks gestational age

          4. Cephalic presentation

          5. 20 minute reassuring fetal heart rate (reactive nonstress test (NST))

          6. Bishop score based on sterile vaginal exam of less than or equal to 6, for which the
             cervical dilation is less than or equal to 2 cm.

          7. Equal to 3 or less uterine contractions over 10 minutes

        Exclusion Criteria:

          1. Previous uterine scar

          2. Contraindication to vaginal delivery

          3. Patients with preeclampsia

          4. Grand multiparty - greater than or equal to 5 live births or stillbirths

          5. Premature rupture of membranes

          6. Suspected intrauterine growth restriction

          7. Fetal anomalies

          8. Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)
Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study
Condition: Glaucoma; Drugs; Normal Tension Glaucoma; Primary Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma
Intervention: Timolol Maleate; Brimonidine Tartrate
Intervention description: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.; Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
Intervention MeSH terms: Timolol; Brimonidine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study evaluates the possible acute changes in peripapillary blood flow after
      instillation of antiglaucoma medications in patients with primary open angle glaucoma (POAG),
      normal tension glaucoma (NTG), or ocular hypertension (OHTN) using Optical Coherence
      Tomography (OCT) angiography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ocular hypertension, primary open angle glaucoma, or normal tension
             glaucoma in the study eye(s)

          -  Age 18-90

          -  Best corrected visual acuity of 20/60 or better

        Exclusion Criteria:

          -  Current use of either brimonidine or timolol

          -  Other disease, ophthalmic or systemic, that is likely to significantly affect the OCT
             test in the study eye(s) including:

               -  More than moderate grade cataract that significantly reducing OCTA scan signal
                  level

               -  Macular degeneration other than mild drusen or pigmentary changes

               -  Diabetic retinopathy other than mild background non proliferative retinopathy

               -  Prior or current macular edema

               -  Prior laser treatment to the retina

               -  Prior retinal detachment

               -  Prior central serous retinopathy

               -  Prior retinal vein or artery occlusion

               -  Prior inflammatory retinopathy or choroidopathy

               -  Keratoconus or other corneal ectasia

               -  Corneal scarring in central 4 mm

               -  Prior penetrating keratoplasty

               -  Ischemic optic neuropathy

               -  Dementia beyond early/mild memory loss

               -  History of cerebrovascular accident

               -  History of severe carotid stenosis

               -  History of previous ocular surgery other than non-complicated cataract extraction
Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Condition: Opiate Addiction
MeSH terms: Chronic Pain; Opioid-Related Disorders; Behavior, Addictive
Intervention: Methadone; Buprenorphine/naloxone
Intervention description: Oral, 10-60 mg per day, 2-4 times per day, 6 months; Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
Intervention MeSH terms: Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opiate Addiction; Narcotic Addiction; Drug Addiction; Pain

Summary:

      The purpose of this study is to determine if buprenorphine or methadone is better for the
      treatment of chronic pain among patients who have become addicted to prescription narcotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic back pain

          -  opioid addiction

          -  not successful with abstinence

          -  at least 18 years old

          -  able to understand spoken English

          -  live in Western New York State (Erie or Niagara county)

          -  have health insurance or ability to pay for health care

          -  no methadone or buprenorphine treatment within past year

          -  not member of a vulnerable population (e.g., pregnancy, prisoner)

        Exclusion Criteria:

          -  homelessness

          -  unable to give consent (e.g., dementia, psychosis)

          -  serious heart or lung disease

          -  taking a medication that could interact with methadone or buprenorphine

          -  pregnancy
CBT as an Adjunct to SRIs in the Treatment of BDD
Condition: Body Dysmorphic Disorder
MeSH terms: Body Dysmorphic Disorders
Intervention: Cognitive Behavioral Therapy; Venlafaxine
Intervention description: standard psychiatric evaluation; start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Body Dysmorphic Disorder; SRIs; Cognitive Behavioral Therapy

Summary:

      The research project is a controlled pilot study of the efficacy of cognitive-behavioral
      therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body
      dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to
      relaxation and stress management training (RSMT), an active control treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 16-65

          -  A diagnosis of DSM-IV BDD or its delusional variant (delusional disorder, somatic
             type)

          -  Ability to communicate meaningfully with the investigators

          -  Competent to provide written consent, if over 18 years old, or competent to provide
             written assent, if 16-17 years, 11 months

          -  Parental consent, if under 18 years old

          -  For phase two: must be on a stable therapeutic dose of one of the following SRI
             medications for at least 8 weeks: fluoxetine, fluvoxamine, venlafaxine, clomipramine,
             paroxetine, citalopram, or sertraline.

        Exclusion Criteria:

          -  current or lifetime diagnosis of any DSM_IV psychotic disorder not attributable to
             delusional BDD, current or lifetime diagnosis of DSM-IV bipolar disorder,

          -  current or recent (within 2 months of study entry) DSM-IV alcohol or substance
             dependence or abuse,

          -  recent suicide attempt, or suicidal ideation that warrants consideration of
             hospitalization,

          -  need for inpatient or partial hospital treatment,

          -  use of any medication prescribed for the treatment of BDD other than SRIs, including
             tricyclic antidepressants, buspirone, or neuroleptics,

          -  presence of any significant and/or unstable medical condition,

          -  females who are pregnant or breast-feeding, or who are sexually active and not using
             adequate contraception.
Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
Condition: Healthy
Intervention: Omnipaque; Gastroview
Intervention description: Oral CT contrast; Oral CT contrast
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: CT scan; oral contrast

Summary:

      Patients who are scheduled by their health care provider for routine computed tomography (CT)
      scan will be asked to participate in this study. The primary purpose is to determine if there
      is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for
      abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference
      in bowel opacification for the two agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal
             pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with
             the patient's provider will be screened for eligibility.

        Exclusion Criteria:

          -  Not competent to give consent.

          -  Pregnant.

          -  Known allergy to either of the contrast agents.

          -  Loss of sense of taste or smell.

          -  Contraindication to oral administration such as aspiration risk.
Early Sodium Intake in Preterm Newborns
Condition: Hyponatremia; Premature
MeSH terms: Hyponatremia
Intervention: Sodium < 1mEq/kg/day; Sodium 5mEq/kg/day
Intervention description: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1; Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 52.0
Sex: All
Maximum age: 24 Hours
Healthy volunteers: No
Keywords: Preterm infant; Sodium; Hyponatremia

Summary:

      Hyponatremia is a common complication among preterm infants, renal losses of sodium
      contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact
      in newborns outcome. There is controversy about the time of initiation and the requirements
      of sodium in premature infants. Hypothesis: early (24 hours of life) sodium supplementation
      (5mEq/kg/day) prevents the develop of hyponatremia in preterm infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Preterm infants <35 Weeks gestation

        Exclusion Criteria:

          -  Urinary malformations

          -  Congenital abdominal wall defect

          -  Intestinal atresia / obstruction

          -  Congenital heart defect
Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery
Condition: Surgery
Intervention: Dexamethasone; Ropivacaine
Intervention description: IV dexamethasone; Ropivacaine only
Intervention MeSH terms: Dexamethasone; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 8.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Neuraxial; Caudal; Block; Anesthesia; Dexamethasone

Summary:

      Caudal injection of local anesthetic is a neuraxial technique routinely performed on young
      children for postoperative analgesia after lower abdominal and lower extremity surgical
      procedures. One of the major limitations of the use of single shot neuraxial injections for
      this purpose is the limited duration of action of the injected local anesthetic. Adjuvant
      medications, such as clonidine and epinephrine, have been added to the local anesthetic to
      prolong the duration of the neuraxial block, with varying results. Dexamethasone is a
      synthetic glucocorticoid steroid commonly used in the perioperative setting for a multitude
      of indications, including the prolongation of local anesthetic based analgesia. It has been
      shown that the administration of dexamethasone either intravenously or via perineural
      injection can significantly increase the duration of analgesia derived from a local
      anesthesia based peripheral nerve block. Literature also suggests that the effect of
      dexamethasone is equivalent whether given intravenously or perineurally. Interest in
      dexamethasone enhanced caudal analgesia exists and a previous study noted that caudal
      anesthesia can be prolonged by intravenous dexamethasone. The study was criticized for using
      a higher dose of dexamethasone (0.5 mg/kg) than is routinely used in the pediatric population
      outside of airway procedures, which may expose patients to dose related side effects of
      dexamethasone. A large meta-analysis has suggested that 0.1 mg/kg is effective for analgesic
      prolongation, but no direct study of low dose intravenous dexamethasone in combination with
      caudal anesthesia has been performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 2 to 10 years

          -  Scheduled for elective inpatient genitourinary surgical procedure

          -  Caudal anesthesia standard of care for surgical procedure

          -  have provided parental consent and assent in accordance with the institutional review
             board requirements

        Exclusion Criteria:

          -  Abnormal/difficult anatomy

          -  known allergy to ropivacaine or dexamethasone

          -  history of documented chronic pain

          -  existing infection at site of intended injection