bioihbjkbjnl/mcl2 huggingface dataset:
Toward Zero Prescribed Opioids for Outpatient General Surgery
Condition: Opioid Misuse and Addiction; Pain
MeSH terms: Opioid-Related Disorders
Intervention: Oxycodone; Zero Opioid Protocol
Intervention description: Investigators provided set opioid prescriptions for 10 pills each patient.; Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group, opioid sparing arm, and zero opioid arm
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigators have created an opioid reduction "package" which includes patient education,
      non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions
      provided at discharge in an attempt to reduce the number of opioid consumption after
      outpatient general surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Opioid naïve patients

          -  Age > 18

          -  Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy

        Exclusion Criteria:

          -  Urgent/emergent status

          -  Previous cholecystostomy tube placement
Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy
Condition: Diabetic Neuropathic Pain; Chronic Low Back Pain
MeSH terms: Neuralgia; Diabetic Neuropathies; Back Pain; Low Back Pain
Intervention: donepezil; duloxetine; donepezil 2.5 mg and duloxetine 30mg; placebo; gabapentin
Intervention description: Group 1: Will receive donepezil 5mg once a day; Group 2: Will receive duloxetine 30 mg twice a day; Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg; Group 4: Will receive placebo pills; Week 8: all subjects will have open label gabapentin added to their randomized study medication
Intervention MeSH terms: Gabapentin; Duloxetine Hydrochloride; Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Asymmetric Diabetic Proximal Motor Neuropathy; Diabetic Autonomic Neuropathy; Diabetic Neuralgia; Diabetic Neuropathy, Painful; Neuralgia, Diabetic; Low back pain, chronic

Summary:

      The purpose of the study is to determine whether the combination of the the three drugs
      gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic
      neuropathy or patients with failed low back syndrome (chronic back pain).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of diabetic neuropathy

          -  Age 18-80

          -  Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon
             entry into the study

        Exclusion Criteria:

          -  Pregnancy

          -  Allergy to study medications

          -  Uncontrolled narrow-angle glaucoma

          -  Currently being treatment with thioridazine (Mellaril)

          -  Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases

          -  Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization
Impact of LDL-cholesterol Lowering on Platelet Activation
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Evolocumab
Intervention description: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
Intervention MeSH terms: Evolocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperlipidemia, Hypercholesterolemia, atherothrombosis

Summary:

      The primary goal is to assess the impact of Evolocumab therapy on platelet function of
      familial hypercholesterolemia (FH) patients in a randomized, double blind study. Evolocumab
      is a humanized monoclonal antibody that targets circulating PCSK9, increases hepatic LDL
      receptor, decreases plasma LDL cholesterol and reduces risk of cardiovascular events.
      Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally
      tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel problems,
      who need additional lowering of LDL cholesterol.

      The secondary goal is to determine if platelet activation or the response to Evolocumab
      therapy is modified by rs3184504 polymorphism. The investigators believe that these
      investigations will complement ongoing studies to demonstrate that Evolocumab reduces
      athero-thrombotic risk and aid the decision-making as to whether Evolocumab can reduce the
      atherothrombotic risk in acute coronary syndrome (ACS) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have a clinical diagnosis of familial hypercholesterolemia (FH)

          -  Subjects who are referred to Dr. Ginsberg's Lipid Practice for treatment with PCSK9
             inhibitor

          -  Subjects with LDL cholesterol levels >100 mg/dl on baseline treatment with statins
             and/or ezetimibe

        Exclusion Criteria:

          -  Children under 18 years of age
Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD
Condition: COPD
MeSH terms: Respiratory Aspiration
Intervention: Trelegy Ellipta 100/62.5/25Mcg Inh 30D; Ventolin 90Mcg/Actuation Inhalation Aerosol
Intervention description: Administration of Trelegy in all patients; 2 hours after the administration of Trelegy, administer Ventolin in all patients
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label comparative design
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: DPI; PIF; FEV1

Summary:

      The purpose of the study is to determine whether PIF is clinically important when using the
      Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate
      way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF
      maneuver and to relate this PIF measurement to meaningful clinical outcomes in COPD patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoking history >10 pack years

          -  pre-bronchodilator FEV1 <60% predicted

          -  post-bronchodilator FEV1/FVC <70%

          -  female participants are eligible to participate if they are not pregnant, not
             breastfeeding, and at least one of the following conditions applies:

          -  not a woman of childbearing potential OR

          -  agree to follow the contraceptive guidance during the treatment period and until the
             safety follow-up contact after the last dose of study treatment

          -  stratification requiring at least 1/3 of patients having a PIF of < 60L/min (AM
             pre-dose based on using the level 2 InCheck Dial resistance setting with a sharp
             maximal effort starting after exhaling fully)

        Exclusion Criteria:

          -  any subject with unstable disease, including

          -  COPD exacerbation in the last 6 weeks

          -  upper respiratory tract in in the last 4 weeks

          -  COPD or upper respiratory tract infection during run-in (subjects may be re-screened x
             1 when stable after an acute event)

          -  pulmonary disease other than COPD

          -  any lung resection

          -  unstable cardiac conditions (at the discretion of the investigator)

          -  other unstable medical conditions (at the discretion of the investigator)
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
Condition: Actinic Cheilitis
MeSH terms: Cheilitis
Intervention: aminolevulinic acid hydrochloride; Photodynamic therapy with blue light
Intervention MeSH terms: Aminolevulinic Acid
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
Healthy volunteers: No
Keywords: Actinic cheilitis; Photodynamic therapy; Levulan; Blue light

Summary:

      To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the
      treatment of actinic cheilitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be able to understand and voluntarily sign an informed consent form

          -  Must be male or female ≥ 18 years of age at the time of consent

          -  Must be able to adhere to the study visit schedule and other protocol requirements

          -  Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy
             specimen or clinical presentation

        Exclusion Criteria:

          -  Inability to provide voluntarily consent or mentally incompetent

          -  Active herpes labialis lesions

          -  Subjects with any condition which places the subject at unacceptable risk if he/she
             were to participate in the study, or confounds the ability to interpret data from the
             study

          -  Subjects with any other skin condition that might affect the evaluation of the study
             disease

          -  Pregnant or breastfeeding female subjects

          -  Subjects who have used any investigational medication within one month prior to study
             entry

          -  Subjects who have been previously exposed to PDT and/or topical Levulan therapy for
             the treatment of actinic cheilitis

          -  Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5%
             fluorouracil) within three months of study entry

          -  Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six
             months of study entry

          -  Subjects who are currently using photosensitizing agents (e.g. thiazides,
             tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk
             of augmented photosensitivity

          -  Subjects who are frequently exposed to ultraviolet radiation (e.g. lifeguards,
             construction workers, frequent sunbed users, etc.)

          -  Subjects with a history of cutaneous photosensitization, porphyria, hypersensitivity
             to porphyrins, or photodermatosis

          -  Subjects with a known hypersensitivity to Levulan

          -  Subjects who are immunocompromised
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
Condition: Heart Transplantation
Intervention: Everolimus (EVR); cyclosporine A (CyA); tacrolimus (TAC); Enteric coated mycophenolate sodium (EC-MPS); mycophenolate mofetil (MMF); Corticosteroids
Intervention description: Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL); 10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only; 0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only; 180 mg or 360 mg tablet dosed 1440-2280 mg per day; 250 mg or 500 mg tablets with a dose of 1500-3000 mg per day; according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Heart Transplantation; Cardiac Transplantation; CNI-sparing; renal function; CNI; Cyclosporine A; Everolimus; mycophenolic acid

Summary:

      This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and
      mycophenolic acid is associated with a better renal outcome as compared to the standard
      regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while
      both treatments are expected to be comparable with respect to efficacy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Heart transplantation, 3 months prior to enrollment

          -  Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral,
             Certican® and corticosteroids

          -  Sufficient graft function

          -  Sufficient renal function

          -  Females capable of becoming pregnant must have a negative serum pregnancy test within
             7 days prior to or at baseline, and are required to practice an approved method of
             birth control for the duration of the study and for a period of 6 weeks following
             discontinuation of study medication, even where there has been a history of
             infertility

        Exclusion criteria:

          -  Multi-organ recipients, re-transplantation, or previous transplant with any other
             organ.

          -  Patients who are recipients of A-B-O incompatible transplants

          -  Cold ischemia time >6 hours

          -  Historical or current peak PRA of > 25% at time of transplantation

          -  Already existing antibodies against the HLA-type of the receiving transplant Other
             protocol-defined inclusion/exclusion criteria may apply
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab
Intervention description: Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Idiopathic Urticaria; CIU; Urticaria; Chronic Hives; Xolair

Summary:

      This study looks at changes in cell proteins in people with chronic hives treated with
      omalizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic urticaria (hives) for more than 6 weeks.

          -  No improvement with standard doses of antihistamines (loratadine 10 mg daily,
             desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or
             levocetirizine 5 mg daily)

        Exclusion Criteria:

          -  Taken any oral steroids for 1 month prior to beginning the study.

          -  Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine,
             cyclosporine, methotrexate) for 1 month prior to beginning the study.

          -  Physical urticaria as a primary diagnosis.

          -  Known allergic precipitant of urticaria such as foods.

          -  Urticarial Vasculitis.

          -  Anemia.

          -  Asthma.

          -  Serum Immunoglobulin E (IgE) >700 IU/ml.

          -  Women of childbearing potential not using contraception method(s), as well as women
             who are pregnant and/or breastfeeding.

          -  Known sensitivity to omalizumab or this class of drug.

          -  Use of any other investigational agent in the last 1 month.

          -  Untreated intercurrent illness.
Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Ibandronate (SB743830HD)
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: Female
Healthy volunteers: No
Keywords: risedronate; Ibandronate; preference; Osteoporosis

Summary:

      This is a randomized open label, multi-centre study for Korean women with postmenopausal
      osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or
      the once-weekly dosing of risedronate.

      Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly
      regimen.

      Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with
      risedronate 35 mg or vice versa.

      After taking the first interventional medicine for 3 months or 12 weeks completely, a subject
      changes the treatment arm. There is no washout period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with postmenopausal osteoporosis diagnosed by DXA scanning, defined by T-score
             of -2.5 SD at spine or femur.

          -  Patients who have never received bisphosphonates therapy (bisphosphonates naive)

        Exclusion Criteria:

          -  Inability to stand or sit in the upright position for at least 60 minutes;

          -  Hypersensitivity to any component of risedronate and ibandronate;

          -  Administration of any investigational drug within 30 days preceding the first dose of
             the study drug;

          -  Patient has been on hormone (estrogen) replacement therapy or other osteoporosis
             medication (e.g. SERMS and calcitonin) within the previous 3 months.

          -  Patient has been on systemic corticosteroids therapy for more than 1 month within the
             past year.

          -  Other bone disease except osteoporosis

          -  Current medical history of uncontrolled major upper GI disease
Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
Condition: Osteoarthritis; Arthroplasty
MeSH terms: Osteoarthritis
Intervention: Ropivacaine with NaCl; Epinephrine; Morphine; Ketorolac Tromethamine; Ropivacaine
Intervention description: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment; 0.15 mg Epinephrine are injected as part of the drug "cocktail"; 4 mg Morphine are injected as part of the drug "cocktail"; 30 mg morphine are injected as part of the drug "cocktail"; 30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Epinephrine; Morphine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to examine whether there is a difference in the level
      of resting pain following total hip arthroplasty with an anterior approach with use of a
      psoas compartment block versus a local periarticular anesthetic infiltration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at
             Beaumont Hospital Royal Oak

          -  Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease)

          -  Surgical approach is anterior

        Exclusion Criteria:

          -  Minors (age less than 18 years)

          -  Pregnant (surgically sterile, post-menopausal, or negative blood test)

          -  Previous ipsilateral hip surgery

          -  Lumbar instrumentation

          -  Acute trauma

          -  Rheumatoid arthritis

          -  Avascular necrosis

          -  Hip dysplasia

          -  Known sensitivity, allergy, or contraindication to anesthetics being used in the study

          -  Narcotic sensitivity

          -  History of over 6 months of opioid dependency prior to surgery (excluding tramadol)

          -  Peripheral neuropathy

          -  Mental/cognitive impairment that would interfere with the patient's self-assessments
             of function, pain, or quality of life
Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor
Condition: Labor; Forced or Induced, Affecting Fetus or Newborn
Intervention: Oxytocin; Transcervical Foley catheter
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 323.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: induction; Foley catheter; oxytocin

Summary:

      The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for
      induction of labor will increase the rate of delivery within 24 hours stratified by parity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years

          -  Pregnant, singleton gestation, vertex presentation

          -  Admitted for induction of labor between gestational ages 24 - 42 weeks

          -  Bishop score <6

        Exclusion Criteria:

          -  Multiple gestation

          -  Non-vertex presentation

          -  Latex allergy or latex-free Foley catheter to be placed

          -  Fetal death

          -  Anomalous fetus

          -  Placenta/vasa previa

          -  Placental abruption (known or suspected)

          -  Intrapartum bleeding

          -  Non-reassuring fetal tracing with following criteria: category III tracing, OR minimal
             variability AND decelerations of any kind, OR late decelerations occurring >50% of
             contractions

          -  2 or more previous cesarean section, myomectomy, or classical cesarean

          -  Need to use ripening agents prior to Foley placement

          -  Spontaneous labor

          -  Active genital herpes

          -  Inability to consent

          -  Any contraindication to a vaginal delivery