bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability Study for New Atorvastatin Formulation
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Atorvastatin suspension; Lipitor
Intervention description: A single dose of 80 mg Atorvastatin suspension; A single dose of 80 mg Lipitor tablet
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cardiovascular Diseases

Summary:

      The purpose of this study is to estimate the relative bioavailability of the commercial
      tablet with one prototype extemporaneous preparation suspension formulation, to assist with
      internal decision making on formulation development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects

          -  Body Mass Index (BMI) of approximately 18 to 30 kg/m2

        Exclusion Criteria:

          -  Any condition possibly affecting drug absorption

          -  A positive urine drug screening
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Prednisolone Acetate 1%; Prednisolone Acetate 0.12%; Loteprednol Etabonate 0.2%; Placebo
Intervention description: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.; One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.; One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.; One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Intervention MeSH terms: Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Lubricant Eye Drops; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Allergic conjunctivitis

Summary:

      To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to
      prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic
      suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of
      allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID)
      dosing and 1 week of four times daily (QID) dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age & either sex, any race

          -  Willing and able to follow all instructions

          -  Positive history of ocular allergies

          -  Reproducible positive ocular allergic reaction induced by conjunctival allergen
             challenge

        Exclusion Criteria:

          -  Have planned surgery during trial period

          -  Female currently pregnant, planning a pregnancy or lactating

          -  Use of disallowed medications

          -  Have ocular infections, or ocular conditions that could affect study parameters

          -  Have moderate to severe dry eye

          -  Have used an investigational drug or device within 30 days of start of study

          -  Female that is currently pregnant, planning a pregnancy or lactating
Cutivate Lotion HPA Axis Pediatric Study
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Fluticasone propionate 0.05% lotion
Intervention description: Daily applications
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 3 Months
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate,
      0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic
      dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are 3-12 months of age

          -  Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area

          -  Subjects meet protocol specific AD signs and symptom severity score

        Exclusion Criteria:

          -  Subjects with conditions effecting the HPA Axis

          -  Subjects with clinically significant systemic disease

          -  Subjects who require treatment with systemic or topical retinoids during the study

          -  Subjects who have been treated with various chronic therapies identified in the
             protocol

          -  Subjects who have received other investigational drug treatment within 30 days prior
             to study entry
Geriatric Ketamine for Pain Management Study
Condition: Pain
Intervention: Morphine; Ketamine
Intervention description: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.; Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.
Intervention MeSH terms: Ketamine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 65 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Geriatric, Pain, Ketamine, Emergency Medicine

Summary:

      This research project is geared towards geriatric analgesia in the Emergency Department (ED)
      with a goal of reducing the administration of opioid pain medications to elderly patients,
      thereby avoiding the commonly occurring, severe side effects associated with such
      medications, including hypotension, respiratory depression, altered mental status, delirium,
      as well as nausea/vomiting and constipation.

      The primary outcome of the study will be difference in pain score from baseline to 30 minutes
      post-medication administration.

      This project has the potential to change and modify the ED approach to geriatric analgesia by
      virtue of minimizing the use of opioid administration in elderly patients. T
    

Eligibility criteria:

        Inclusion Criteria:

          -  ED patients; 65 years of age and older; abdominal, flank, back, traumatic chest, neck
             or musculoskeletal pain; capacity to give verbal or written consent.

        Exclusion Criteria:

          -  ED patients <65 years old; altered mental status; presenting with headache,
             non-traumatic chest pain; allergy to morphine or ketamine; weight <40kg or >115kg,
             unstable vital signs (systolic blood pressure <90 or >180 mmHg; heart rate <5 or >150
             beats per minute; and respirations <8 or >30 per minute), and past medical history of
             severe renal or hepatic insufficiency, alcohol or drug abuse or psychiatric illness;
             Patients with BMI>40; severe COPD
Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
Condition: Neuromuscular Blockade; Anesthesia
Intervention: Neostigmine; Glycopyrrolate; Sugammadex
Intervention description: Neostigmine injection; Glycopyrrolate injection; Sugammadex injection
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sugammadex; Neostigmine; Reversal of neuromuscular block

Summary:

      The aim of this study is to evaluate whether the use of Sugammadex for reversing the
      neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed
      recovery of neuromuscular function. Half of participates will receive Neostigmine with
      glycopyrrolate, while the other half will receive Sugammadex.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years;

          -  American Society of Anesthesiologists (ASA) physical status 1-3;

          -  Scheduled for catheter-based neurointerventional procedures including coiling and
             stent insertion;

          -  General anesthesia.

        Exclusion Criteria:

          -  Suspected difficult intubation;

          -  Neuromuscular disorder;

          -  Renal impairment creatinine ≥ 2 mg /dl;

          -  Hepatic dysfunction;

          -  History of malignant hyperthermia;

          -  Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;

          -  Perioperative respiratory infections and/or pneumonia;

          -  Intubated or unresponsive;

          -  Pregnancy or breastfeeding.
Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
Condition: Attention Deficit Hyperactivity Disorder; Dyslexia
MeSH terms: Hyperkinesis; Dyslexia; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Placebo
Intervention description: Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks; oral, daily, for 16 weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 10 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effects of atomoxetine on brain activation during attention and
      reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16
      years old with ADHD and comorbid dyslexia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria for
             ADHD

          -  Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteria
             for dyslexia

          -  Participants must achieve a score of 80 or more on the Full Scale Intelligence
             Quotient

          -  Child or adolescent participants must be 10 to 16 years old

          -  Must be able to communicate in English

          -  Must be able to swallow capsules

          -  Be reliable to keep appointments for clinic visits & all related tests

          -  Participants for healthy control group do not meet DSM-IV-TR criteria for ADHD and/or
             dyslexia

          -  Participants for healthy control group must achieve a score of at least 80 but not
             >120 on the Full Scale Intelligence Quotient

        Exclusion Criteria:

          -  Participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg.

          -  Participants with severe allergies to more than 1 class of medications or who have had
             multiple adverse drug reactions

          -  Participants with prior diagnosis of bipolar I or bipolar II disorder or psychosis

          -  Participants with documented history of autism, Asperger's syndrome, or pervasive
             developmental disorder

          -  Females who are pregnant or breastfeeding

          -  Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at
             least 4 to 6 weeks
Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
Condition: HIV Infections; Fatigue
MeSH terms: Fatigue
Intervention: Modafinil; Placebo
Intervention description: 50 mg per day, increasing to 200 mg per day as clinically indicated; 50 mg per day, increasing to 200 mg per day as clinically indicated
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HIV; AIDS; Modafinil; Depression

Summary:

      This study will determine whether modafinil (Provigil®), a medication approved for the
      treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 18-75

          2. HIV+

          3. Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus
             impairment on 1+ categories of Role Function Scale)

          4. Fatigue duration for 3+ months

          5. English-speaking

          6. Able to give informed consent

          7. Fecund women uses barrier method of contraception

        Exclusion Criteria:

          1. Primary care doctor does not approve of study participation

          2. Unstable medical condition (e.g. liver failure;cirrhosis, new onset opportunistic
             infection [O.I.] in past month)

          3. Untreated hypogonadism, except for men for whom testosterone replacement is medically
             contraindicated (serum testosterone below the reference range)

          4. Untreated hypothyroidism (thyroid stimulating hormone [TSH] over 5 IUI/mL)

          5. Untreated and uncontrolled hypertension

          6. Clinically significant anemia (hematocrit <30%)

          7. Started testosterone or nandrolone in past 6 weeks

          8. Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the
             change; otherwise, started or changed regimen in past 2 months

          9. Untreated or under-treated major depressive disorder

         10. Started antidepressant medication within past 6 weeks

         11. Substance abuse/dependence (past 4 months)

         12. Regular and frequent cannabis use (> twice/week regularly)

         13. Currently clinically significant suicidal ideation or Hamilton Depression Rating Scale
             (HAM-D) >24

         14. History or current psychosis or bipolar disorder

         15. Pregnant or breastfeeding

         16. Significant untreated insomnia (score >3 on HAM-D insomnia items)

         17. Currently taking psychostimulant medication or past nonresponse to modafinil

         18. Has no alternative viable antiretroviral regimen after the current one

         19. Left ventricular hypertrophy; mitral valve prolapse
A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients
Condition: Hypertension; Brain Tumor; Epilepsy
MeSH terms: Brain Neoplasms; Epilepsy; Hypertension
Intervention: Clevidipine
Intervention description: Clevidipine (0.5 mg/ml in 20 % lipid solution) will be administered via peripheral vein using syringe pump; drug infusion will be initiated at 5 mg/hr (10ml/h) and titrated to effect up to a maximum rate of 32 mg/hr when SBP exceeds 130 mm Hg. The anesthesiologist will be allowed to administer the alternative antihypertensive treatment (e.g. labetalol, hydralazine) after achieving a maximum clevidipine infusion rate.
Intervention MeSH terms: Clevidipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hypertension; Neurosurgery; bloodpressure control; brain tumor resection; epilepsy focus resection

Summary:

      This protocol describes a study to gain experience in the use of Clevidipine for
      perioperative blood pressure control in patients undergoing craniotomy for brain tumor or
      epilepsy focus resection. The purpose of this study is to establish the efficacy of
      Clevidipine for intraoperative blood pressure control in patients undergoing intracranial
      procedures, and gather information on the dosage and adverse effects of Clevidipine in
      neurosurgical patients. This initial pilot experience serves to familiarize the investigators
      with the use of this drug prior to initiating a planned randomized trial versus institutional
      standard-of-care therapy. The investigators will obtain greater familiarity with the dosing
      of clevidipine in this patient population and collect information on the incidence of adverse
      effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21 or older

          -  Able to give consent

          -  No significant laboratory abnormalities

          -  Undergoing elective surgery for tumor resection or epilepsy focus resection

        Exclusion Criteria:

          -  Patients with acute cardiac ischemia, renal or liver dysfunction, unstable
             hemodynamic, advanced heart block, or pregnancy defective lipid metabolism such as
             pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied
             by hyperlipidemia; and in patients with severe aortic stenosis will be excluded.

          -  Known or suspected allergy to study drug or study drug components,patients with
             allergies to soybeans, soy products, eggs, or egg products; Participation in other
             clinical research studies involving the evaluation of other investigational drugs or
             devices within 30 days of enrollment in this study.
Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
Condition: Pain
Intervention: EXPAREL
Intervention description: 133 mg EXPAREL in 10 mL.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single
      dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for
      prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of
      the adenoids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ≥18 years of age at the Screening Visit.

          -  Subjects undergoing tonsillectomy with or without removal of the adenoids.

          -  Able and willing to comply with all study visits and procedures.

          -  Willing and capable of providing written informed consent.

        Exclusion Criteria:

          -  History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.

          -  Received any investigational drug within 30 days prior to EXPAREL administration,
             and/or has planned administration of another investigational product or procedure
             while participating in this study.

          -  Currently pregnant, nursing, or planning to become pregnant during the study or within
             1 month after EXPAREL administration. Female subjects must be surgically sterile, at
             least 2 years postmenopausal, or using an acceptable method of birth control. If of
             childbearing potential, must have a documented negative pregnancy test within 24 hours
             before EXPAREL administration.

          -  Subjects with significant medical conditions or laboratory results that, in the
             opinion of the Investigator, indicate an increased vulnerability to EXPAREL and/or
             procedures, or cause inability to comply with the study requirements.
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
Condition: HIV Coinfection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Coinfection; HIV Infections; Hepatitis
Intervention: Maraviroc; Placebo
Intervention description: 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy; 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Intervention MeSH terms: Maraviroc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV coinfection; maraviroc; CCR5 blocker; entry inhibitor; liver disease; viral hepatitis

Summary:

      To describe liver enzyme elevations in patients who are coinfected with HIV and either
      Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with
      their current suppressive anti-HIV drug therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV coinfected with HCV and/or HBV.

          -  Undetectable HIV-1 RNA for at least 3 months prior to the screening visit

          -  Treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir)
             for at least 5 months.

        Exclusion Criteria:

          -  Currently receiving maraviroc.

          -  Active opportunistic infections.

          -  ALT and/or AST >5x upper limit of normal.

          -  Direct bilirubin >1.5x upper limit of normal.

          -  Severe or decompensated liver disease.

          -  Liver disease unrelated to viral hepatitis infection.