bioihbjkbjnl/mcl2 huggingface dataset:
Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
Condition: Colonoscopy; Adjunct Anesthesia Medication
Intervention: Diphenhydramine; Placebo
Intervention MeSH terms: Diphenhydramine; Promethazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Fentanyl; Midazolam; Sedation; Patient tolerance; Duration of colonoscopy

Summary:

      To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce
      the amount of standard sedatives used during colonoscopy in patients on chronic opioids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-64 years undergoing screening, surveillance, diagnostic and
             therapeutic colonoscopy

          -  Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at
             least 3 days per week for more than 3 months

        Exclusion Criteria:

          -  Inability to execute informed consent

          -  Allergy to Diphenhydramine, fentanyl or midazolam

          -  Known or suspected pregnancy

          -  Endoscopic procedure without sedation

          -  Patient scheduled to have other endoscopic procedures on the same day

          -  Prior alimentary tract surgery

          -  Severe cardiopulmonary disease (ASA IV)

          -  Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM); Recombinant Factor VIII (rAHF)
Intervention description: Infusion of 50 +/- 5 IU/kg bodyweight; Infusion of 50 +/- 5 IU/kg bodyweight
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 15 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate
      rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe
      hemophilia A (factor VIII level < 1%).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent obtained from participant or legally authorized representative

          -  15-60 years old

          -  Factor VIII level < 1% as documented by previously measured factor VIII and genotyping

          -  Previously treated with factor VIII concentrate(s) for a minimum of at least 150
             exposure days (as documented by the study site investigator) prior to study entry

          -  Observed decrease of efficacy by subject and/or treating physician after being
             switched from Recombinate rAHF to Advate rAHF-PFM

        Exclusion Criteria:

          -  The participant has a detectable factor VIII inhibitor at screening, with a titer >=
             0.4 Bethesda Unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the
             local and the central laboratory

          -  The participant has a known hypersensitivity to mouse or hamster proteins

          -  The participant is participating in another investigational drug study within 30 days
             prior to screening

          -  The participant is identified by the investigator as being unable or unwilling to
             cooperate with study procedures
Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: alefacept
Intervention description: Alefacept 15 mg IM once a week were to be administered for 12 weeks, which is the FDA approved dosage, duration, and frequency. This study allowed an additional 8 doses if subject did not achieve a 'clear' response with the original 12 weeks of treatment. Each enrolled subject must have failed a response to anti-TNF therapy prior to entering this study.
Intervention MeSH terms: Alefacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Study Status:

      Duke University Health System Institutional Review Board has received notification of study
      termination; final IRB closure date is 12/12/2008. Study enrollment is now closed.

      Enrollment Update:

      Only one subject was entered into this study out of an expected enrollment of 15 patients in
      this single site clinical trial. With no recruitment interest, the financial sponsor and
      Sponsor-PI chose to close the clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women between ages of 18 and 80 years

          -  Subjects diagnosed with chronic plaque psoriasis who require systemic therapy.

          -  Must be receiving anti-TNF treatment without achieving response of 'almost clear' or
             'clear' according to PGA or has not responded with 75% reduction PASI score.

          -  Must be willing to receive up to 20 weeks of IM injections weekly

          -  CD4 counts must be above 250 cells/mm3 at screening

        Exclusion Criteria:

          -  Diagnosis of unstable erythroderma or pustular psoriasis or guttate psoriasis

          -  Serious local infection or systemic infection 3 months prior to receiving study drug.

          -  Subjects with CD4 lymphocyte count less than 250 cells/mm3 at study entry
The Montefiore Metoclopramide Study
Condition: Nausea; Extrapyramidal Symptoms
MeSH terms: Nausea
Intervention: metoclopramide 10 mg; Diphenhydramine 25 mg; Placebo; Metoclopramide 20 mg
Intervention description: an anti-emetic medication; used for prophylaxis against akathisia; placebo; Metoclopramide 20 mg
Intervention MeSH terms: Diphenhydramine; Promethazine; Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 289.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Metoclopramide; Nausea; Akathisia; Emergency department

Summary:

      Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea,
      vomiting, and migraine headaches in Emergency Departments. However, little research has
      focused on the optimal dose of metoclopramide for treatment of nausea in the emergency
      department. We propose a randomized, double-blind, placebo controlled trial to investigate
      the optimal dose of metoclopramide for treatment of nausea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary or secondary complaints of nausea/vomiting

          -  age 21-65

        Exclusion Criteria:

          -  pregnancy

          -  use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours
             of presentation

          -  previous adverse reaction to study medications

          -  use of opioid medications prior to study start time within that ED visit
Gao Bipolar Spectrum Lithium/Quetiapine Study
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium; Quetiapine
Intervention description: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.; Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
Intervention MeSH terms: Quetiapine Fumarate; Lithium Carbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness
      trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who
      currently require a medication change for their illness. Stratified randomization will reduce
      bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment
      goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is
      the difference between lithium and quetiapine in the time to 'all cause' medication
      discontinuation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent before beginning any study-specific procedures

          -  Male and female patients at least 18 years of age

          -  Meets Diagnostic and Statistical Manual -IV criteria for BPI, BP II, or National
             Comorbidity Survey-R criteria for sub-threshold BP with or without symptoms, in need
             of medication adjustment(s)

          -  Willing to be randomized to either Lithium or Quetiapine

          -  If a sexually active female of childbearing potential, be using a reliable method of
             contraception, such as oral contraceptive or long-term injectable or implantable
             hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and
             foam, condom and sponge), intrauterine devices, and tubal ligation

          -  Women with reproductive potential must have a negative urine pregnancy test

        Exclusion Criteria:

          -  Unwilling to comply with study requirements

          -  Patients who have had severe adverse reaction to Lithium or Quetiapine

          -  Patients who require inpatient care

          -  Drug/alcohol dependence requiring immediate acute detoxification

          -  Pregnancy as determined by serum pregnancy test or breastfeeding

          -  History of nonresponse to Lithium at doses >900 mg ≥8 wks or to Quetiapine at doses of
             at least 300 mg/d ≥ 8 week for depression and at least 400-600 mg/d ≥ 4 wks for mania.
Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg; Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Intervention MeSH terms: Fluticasone; Budesonide; Formoterol Fumarate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 442.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Symbicort; Seretide

Summary:

      This study is to assess the effects with two different inhaled respiratory medications with
      regards to improvement of lung function, symptoms and morning activities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at
             least 2 years

          -  FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC <70%

          -  Pre-bronchodilator

        Exclusion Criteria:

          -  Current respiratory tract disorder other than COPD

          -  History of asthma or rhinitis

          -  Significant or unstable cardiovascular disorder
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
Condition: Analgesia, Obstetrical; Cesarean Section
Intervention: Morphine; Hydromorphone
Intervention description: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.; Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
Intervention MeSH terms: Morphine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cesarean Delivery; Intrathecal Morphine; Intrathecal Hydromorphone; Obstetrical Analgesia; Spinal Anesthesia

Summary:

      Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve
      pain control after cesarean delivery. In this study, the investigators are going to determine
      the doses of each of those medicines that provides optimal pain control to women undergoing
      cesarean delivery while limiting side effects related to those medicines. The investigators
      hypothesize that the doses of hydromorphone and morphine that provide optimal pain control
      without significant side effects will be 100 micrograms and 150 micrograms, respectively. The
      investigators further hypothesize that at each respective optimal dose, side effects will be
      less in the hydromorphone group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women presenting for elective cesarean delivery with no major co-morbidities,
             including pregnancy induced co-morbidities (e.g. pre-eclampsia)

          -  Singleton gestation at term (37-42 weeks)

          -  Desire to have a spinal anesthesia technique for cesarean delivery

        Exclusion Criteria:

          -  Current or historical evidence of clinically significant medical disease or condition

          -  Any contraindication to the administration of a spinal technique for anesthesia

          -  History of hypersensitivity or idiosyncratic reaction to opioid medications

          -  Chronic pain syndrome or current regular opioid use

          -  Evidence of anticipated fetal anomalies

          -  Allergy or intolerance to Tylenol, ketorolac, ibuprofen, or oxycodone

          -  BMI > 40
Modafinil Effects on Cognition in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: modafinil (M1, M2, M4)
Intervention description: modafinil 100, 200, and 400 mg oral dose
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 54 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cognition, pharmacology, memory, attention

Summary:

      Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This
      includes many types of cognitive dysfunction, such as in attention, memory and language.
      These problems may explain why patients with schizophrenia think and act in unusual ways, and
      often have problems managing aspects of their lives that healthy adults take for granted.
      Unfortunately, the biochemical aspects of these dysfunctions are presently unknown, and it is
      not clear whether current psychiatric medications can improve these functions. A recent
      FDA-approved medication that may improve this function is modafinil. Studies in animals and
      healthy adults show that this medication can improve many of these cognitive functions. We
      plan to study the effects of modafinil on these cognitive processes, by giving various doses
      of this medication to patients before they perform tasks of these cognitive processes. We
      predict that when patients receive modafinil, they will perform better on a cognitive test,
      and that these benefits will depend on the dose given.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults age 18-54

          -  diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or
             family history of mental illness

          -  able to provide informed consent

        Exclusion Criteria:

          -  history of significant head injury or other neurological illness

          -  active psychiatric illness requiring significant acute care

          -  significant intellectual impairment (e.g. standardized full-scale IQ < 70)

          -  history of medical illness or treatment that is associated with significant increase
             in risk from modafinil treatment (e.g. cardiac disease)

          -  significant active substance abuse

          -  active pregnancy

          -  active treatment with medications that have drug interactions with modafinil
Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
Condition: Anemia
Intervention: Ferumoxytol injection
Intervention description: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 19 Years
Maximum age: 110 Years
Healthy volunteers: No

Summary:

      Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is
      FDA-approved for treatment of iron deficiency anemia. Ferumoxytol injection achieves iron
      repletion in fewer doses (2) when compared with other available injectable iron formulations
      (5-6) available at NYU Langone Health, and thus may be useful to reduce travel burden and
      expedite full iron repletion in patients with iron deficiency. Iron-deficiency anemia is
      common in patients after placement of a ventricular assist device (VAD) for treatment of
      end-stage heart disease. This is a pilot study to test the feasibility of iron repletion with
      ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency
      after placement of a VAD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Status post placement of durable ventricular assist device with stable clinical status
             for >30days

          -  Hemoglobin >6 g/dL AND <13 g/dL (men) or <12 g/dL (women) within last 90 days

          -  Serum ferritin <100 ng/mL OR Serum ferritin 100-299 ng/mL with transferrin saturation
             <20% within last 90 days

          -  Able and willing to provide written informed consent

        Exclusion Criteria:

          -  Known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation

          -  History of anaphylaxis

          -  Treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months

          -  Renal failure on hemodialysis

          -  Respiratory failure on mechanical ventilation

          -  Disabling Stroke

          -  Ventricular assist device thrombosis

          -  Evidence of active gastrointestinal bleeding or other active blood loss

          -  Hospitalization <30 days

          -  Pregnant or breastfeeding women
Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: XEN® Gel Stent; Cataract Surgery
Intervention description: The XEN® Gel Stent (XEN45 implant) was placed in the study eye.; Participants diagnosed with a cataract elected to have cataract surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: XEN; Primary Open Angle Glaucoma; Filtration Device; Ab interno

Summary:

      The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45
      Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when
      medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by
      comparing medicated preoperative IOP to postoperative values. Additionally, the number of
      topical IOP-lowering medications at screening were compared to the number of IOP-lowering
      medications at 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary open angle glaucoma

          -  Participants are taking at least one and no more than four topical IOP-lowering
             medications.

        Exclusion Criteria:

          -  Angle Closure Glaucoma

          -  Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma
             associated with vascular disorders

          -  Clinically significant inflammation or infection in the study eye within 30 days prior
             to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis,
             herpes simplex infection)

          -  Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival
             pathologies (e.g., pterygium) in the target quadrant
Nicotine Replacement for Smoking Cessation During Pregnancy
Condition: Nicotine Dependence; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Intervention: Nicotrol Inhaler; Placebo Inhaler
Intervention description: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper; Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 154.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Pregnancy; Nicotrol Inhaler; Placebo Inhaler; Nicotine Inhaler

Summary:

      This is a clinical trial to determine if the nicotine inhaler in combination with counseling
      will help pregnant women quit smoking, and whether it is safe when compared to placebo (an
      inactive inhaler).
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoking at least 5 cigarettes per day for the preceding 7 days

          -  previous attempt to quit smoking during pregnancy by self report

          -  13-26 weeks gestation

          -  at least 16 years of age

          -  able to speak English or Spanish

          -  intent to carry pregnancy to term

          -  stable residence

        Exclusion Criteria:

          -  current drug or alcohol abuse or dependence (other than methadone maintenance)

          -  twins or other multiple gestation

          -  unstable psychiatric disorder

          -  unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis
             gravidarum)

          -  known congenital abnormality