bioihbjkbjnl/mcl2 huggingface dataset:
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: oral cromolyn sodium; Placebo
Intervention description: Oral cromolyn sodium; Saline
Intervention MeSH terms: Cromolyn Sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when
      made into a viscous preparation for the treatment of eosinophilic esophagitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of eosinophilic esophagitis

        Exclusion Criteria:

          -  Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed
             corticosteroids will require a 4 week washout period.

          -  Pregnancy (all females of child bearing potential will have urine pregnancy test done
             at baseline).

          -  Evidence of pathologic eosinophilia in other locations in the GI tract.

          -  Participation in another research protocol

          -  Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and
             liver function panel drawn)
Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication
Condition: Elective Orthopedic Surgery
Intervention: Midazolam; Propofol; Saline
Intervention description: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication; Propofol (20mg) 2 ml IV, in the pre-op area as a premedication; Saline 2 ml IV, in the pre-op area as a premedication
Intervention MeSH terms: Midazolam; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: propofol; midazolam; sedative; anxiolytic; amnesic; recall; Memory; Perioperative outcomes

Summary:

      The purpose of this research is:

      To evaluate the sedative (reduces irritability or agitation), anxiolytic (reduces anxiety),
      and amnesic (produces temporary lack of recall) effects of propofol or midazolam when
      administered for preoperative medication (before administration of drugs that will put
      patient to sleep) in comparison to placebo. This study is to test whether the use of the
      pre-anesthesia medication measurably reduces anxiety in comparison to receiving no
      pre-anesthesia medication prior to orthopedic procedures.

      To assess the effect of propofol in comparison to placebo and midazolam on the ability to
      recall (memory of):

        -  when the doctor places the mask on patient's face prior to going to sleep

        -  recall of 2 pictures

        -  on your satisfaction with the anesthesia as well as postoperative side effects in
           post-anesthesia care unit (PACU) e.g., nausea ,vomiting and sedation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willingness and ability to sign an informed consent document

          -  No allergies to midazolam or propofol

          -  18 - 70 years of age

          -  American Society of Anesthesiologists (ASA) Class I-III adults of either sex

        Exclusion Criteria:

          -  Patients with known allergy, hypersensitivity or contraindications to midazolam,
             propofol, anesthetic or analgesic medications

          -  Patients with clinically-significant medical conditions, such as brain, heart, kidney,
             endocrine, or liver diseases

          -  Pregnant or lactating women

          -  Subjects with a history of alcohol or drug abuse within the past 3 months

          -  Patients chronically using sedative, anxiolytic drugs prior to the surgery

          -  Morbid obesity (BMI >40 kg/m2)

          -  Patients who are agitated or confused prior to receiving the drug ( verbal rating
             scale [VRS] greater then 6)
Perioperative Administration of Pregabalin for Pain After Mastectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Pregabalin; Vitamin Complex (placebo)
Intervention description: Pregabalin 75 mg orally; Vitamin Complex orally
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: Female
Minimum age: 21 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: mastectomy; pain, postoperative; pregabalin

Summary:

      The investigators hypothesize that pregabalin will decrease post-operative pain scores and
      analgesic use following total mastectomy compared to placebo. The primary outcome will be
      acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total
      analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1
      week and 1 month after operation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. American Society of Anesthesia physical status class I & II

          2. Age > 20 and < 70 years

          3. Robot- assisted endoscopic thyroidectomy

        Exclusion Criteria:

          1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of
             the standardized medications

          2. Body mass index ≥ 40 kg/m2

          3. History of seizure disorder

          4. Current therapy with pregabalin, gabapentin, or any opioid

          5. Any other physical or psychiatric condition which may impair their ability to
             cooperate with post-operative study data collection

          6. Insulin-dependent diabetes mellitus

          7. Renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2)
Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI
Condition: Spinal Cord Injuries; Neuropathic Pain
MeSH terms: Spinal Cord Injuries; Neuralgia
Intervention: Gabapentin; No gabapentin
Intervention description: Timing of gabapentin initiation; No gabapentin
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: neuropathic pain; spinal cord injury

Summary:

      Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a
      significant negative effect on quality of life. Efficacy of various treatments, however,
      remains controversial. There is evidence to support that gabapentin and pregabalin have some
      benefit in reducing neuropathic pain. Gabapentin is effective in the management of symptoms
      and concerns related to SCI including motor recovery, spasticity, and mood among others. This
      makes gabapentin an important pharmacologic intervention, which compels providers to define
      treatment guidelines related to its use. One aspect of which should relate to the timing of
      initiation of therapy. The goal of this study is to determine whether timing of initiation of
      treatment with gabapentin will decrease prevalence and intensity of neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of acute spinal cord injury

          2. Admission to acute inpatient rehabilitation

        Exclusion Criteria:

          1. Unable to communicate verbally or by writing, unable to follow basic instructions, or
             unable to answer questions regarding their symptoms
Chronic Pain Risk Associated With Menstrual Period Pain
Condition: Cystitis, Interstitial; Dysmenorrhea; Migraine Disorders; Pelvic Pain; Endometriosis; Visceral Pain; Chronic Pain
MeSH terms: Migraine Disorders; Endometriosis; Cystitis; Cystitis, Interstitial; Chronic Pain; Pelvic Pain; Dysmenorrhea; Visceral Pain
Intervention: cyclic microgestin 1/20; continuous microgestin 1/20
Intervention description: Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat; Continuous OC use - Pills containing hormones will be taken every day for 1 year
Intervention MeSH terms: Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl; Mestranol; Norethindrone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 353.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cystitis, Interstitial; Dysmenorrhea; Migraine Disorders; Cross Organ Sensitization; Pelvic Pain; Endometriosis; Contraceptives, Oral; Birth Control Pills; Painful Bladder Syndrome; Visceral Pain; Chronic Pain

Summary:

      The purpose of this study is to determine if some women with dysmenorrhea (painful periods)
      are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives
      (OC) can be used to reverse this chronic pain risk.

      Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ
      sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected
      to reduce COS and decrease the risk of developing CPP.
    

Eligibility criteria:

        Inclusion Criteria:

        All

          -  Reproductive age women (18-45)

        For dysmenorrhea and D+COS group only:

          -  Participants must have had regular (22-45 day) menstrual cycles over at least a two
             month period preceding testing

        Exclusion Criteria:

        All

          -  presence of active pelvic or abdominal malignancies (primary or metastatic)

          -  active genitourinary infection in the last four weeks

          -  unable to read or comprehend the informed consent in English

          -  unwilling to undergo pelvic examination/testing

          -  presence of hypertension or risk for developing hypertension, and

        For dysmenorrhea and D+COS group only:

          -  absence of regular menses (including current pregnancy, recent pregnancy, or active
             breast feeding) unwilling to take either cyclic or combined OCs

          -  unwilling to withdraw from OCs for two months prior to the sensory testing study
             visit.
Suvorexant in Insomnia Co-morbid With Fibromyalgia
Condition: Insomnia; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Initiation and Maintenance Disorders
Intervention: suvorexant; placebo
Intervention description: suvorexant 20 mg taken before sleep; placebo taken before sleep
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Female
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; fibromyalgia; polysomnography; pain management

Summary:

      This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia
      co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet Diagnostic and Statistical Manual 5th ed criteria for insomnia

          -  meet American College of Rheumatology criteria for fibromyalgia

          -  otherwise good psychiatric and stable physical health

        Exclusion Criteria:

          -  other primary sleep disorders

          -  pain symptoms unrelated to fibromyalgia

          -  current pregnancy or breast-feeding
Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus
Condition: Schizophrenia
MeSH terms: Diabetes Mellitus; Schizophrenia
Intervention: Ziprasidone
Intervention MeSH terms: Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizophrenia; Ziprasidone; Diabetes; Insulin Resistance

Summary:

      This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone,
      added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients
      with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective
      disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During
      weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Schizophrenia, any subtype or schizoaffective disorder

          -  Ages 18-65 years

          -  Capable of providing informed consent

          -  Antipsychotic Agents -associated diabetes mellitus, impaired fasting glucose or
             insulin resistance

          -  Stable dose of clozapine or olanzapine for at least 1 month

          -  Optimal dose of clozapine or olanzapine, or a maximal dose if limited by significant
             side effects

        Exclusion Criteria:

          -  Serious medical or neurological illness (unstable cardiac disease including recent
             myocardial infarction or heart failure, seizure disorder, malignancy, liver or renal
             impairment, etc.)

          -  Current substance abuse

          -  Pregnancy, nursing, or unwilling to use appropriate birth control measures during
             participation if female and fertile

          -  History of serious blood dyscrasia requiring discontinuation of clozapine

          -  Serious suicidal or homicidal risk within the past six months

          -  History of diabetes mellitus prior to treatment with clozapine or olanzapine

          -  H/o prolongation of QTc interval (>450) on EKG or clinically significant EKG
             abnormalities.

          -  Treatment with medications that significantly prolong QTc interval such as dofetilde,
             sotalol, quinidine, class Ia and III antiarrhythmics, mesoridazine, thioridazine,
             chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacine,
             halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyul acetate,
             dolasetron myselate, probucol, or tacrolimus.
Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: budesonide/formoterol Turbuhaler 320/9µg; formoterol Turbuhaler 9µg; Placebo
Intervention description: Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms; Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily; Placebo, 1 inhalation twice daily
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to investigate the effect on exercise tolerance, lung function
      and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic
      obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >=40 years of age

          -  diagnosed COPD with symptoms >= 2 years

          -  pre-bronchodilatory FEV1 <=50% of PN

        Exclusion Criteria:

          -  Current respiratory tract disorder other than COPD

          -  history of asthma or rhinitis

          -  significant or unstable cardiovascular disorder
Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol
Condition: Pain
Intervention: Zaldiar; Paracetamol-Tramadol
Intervention description: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol); Postoperative analgesia with intravenous Paracetamol and Tramadol
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a
      classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with
      Zaldiar (combination of paracetamol and tramadol).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients incoming for inguinal hernia repair

        Exclusion Criteria:

          -  Preoperative abuse of analgesics
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Guanfacine Extended Release; Placebo
Intervention description: Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.; Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.
Intervention MeSH terms: Guanfacine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Attention Deficit Disorder with Hyperactivity; Guanfacine; Event Related Potentials

Summary:

      All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity
      Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have
      an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the
      baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel
      groups trial. During this trial, dosing will be flexibly adjusted according to patient
      response or presence of side effects. The dosage will range from 1-4 mg. At the end of the
      four week trial, a follow up ERP study will be obtained.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 6-12 years

          -  Meet criteria for Attention Deficit Hyperactivity Disorder

        Exclusion Criteria:

          -  Do not meet criteria for Major Depression, Bipolar, Autism

          -  Talking any psychotropic medication for a condition other than ADHD

          -  History of epilepsy, severe head injury or loss of consciousness

          -  History of Intolerance to guanfacine
Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System
Condition: Brain Neoplasms, Malignant, Primary
MeSH terms: Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms
Intervention: Temozolomide; Temozolomide
Intervention MeSH terms: Temozolomide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: brain neoplasm; bioequivalence; temozolomide

Summary:

      The purpose of this crossover, single-dose, bioequivalence study is to compare the rate and
      extent of absorption of Temozolomide after the administration of the study product
      (Dralitem®, Monte Verde S.A.) and the reference product (Temodal®, Schering Plough) in
      primary Central Nervous System patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients with primary malignant tumors of the central nervous system
             (CNS) excluding subjects with primary CNS lymphoma.

          2. Age> 21 years.

          3. There should be a gap of two weeks between the last surgery and/or radiotherapy
             procedure and the day of randomization. If the procedure were intrabdominal, the gap
             should be of four weeks.

          4. Patients with neutrophils> 1.5 x 109 / L and platelets> 100 x 109 / L.

          5. Signed written informed consent for participation in the trial.

        Exclusion Criteria:

          1. Known hypersensitivity to Temozolomide or any other ingredient of the pharmaceutical
             formulation.

          2. Any situation (eg. vomiting) that may interfere with the absorption of the product
             under study.

          3. Chemotherapy or biological therapy within four weeks prior to administering the
             products under study.

          4. Patients who experience any symptoms of toxicity to prior antineoplastic therapies
             upon administration of the products under study.

          5. Participation in other clinical research studies during the 90 days before the start
             of this study.

          6. History of alcohol or drugs abuse.

          7. History of severe allergic reactions to any type of antigen.

          8. History of gastrointestinal surgery (except uncomplicated appendectomy, of at least
             three months old).

          9. Patients whose clinical status would affect the safety of the products under study or
             interfere with the pharmacokinetic evaluation, at the discretion of the investigator.

         10. Pregnant women or women planning to become pregnant during the study.