bioihbjkbjnl/mcl2 huggingface dataset:
B&O for TLH Post-operative Pain and Nausea
Condition: Hysterectomy; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Belladonna Opium; Glycerin Suppository
Intervention description: Belladonna Opium 16.2-60mg rectal suppository; Glycerine rectal suppository
Intervention MeSH terms: Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization to one-time intervention A (medicated suppository) or intervention B (placebo), allocation was sealed in consecutively numbered opaque envelopes generated by biostatistician using blocked randomized technique.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Opaque sealed envelopes generated by biostatistician used to determine intervention A or B. Drug dictionary entries created within the Pyxis system by the Mercy Medical Center Department of Pharmacy, as "Protocol Drug A" and "Protocol Drug B", recorded in medical record in this way. Identity of "Protocol Drug A" and "Protocol Drug B" revealed by pharmacist at conclusion of data analysis.
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A prospective, single-center, double-blind, randomized, placebo-controlled trial to assess
      the impact of immediate post-operative placement of a Belladonna and Opium (B&O) rectal
      suppository on postoperative pain and nausea following laparoscopic and robot-assisted
      hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between ages 18 and 75,

          -  undergoing level I total laparoscopic or robot-assisted hysterectomy with or without
             bilateral salpingo-oophorectomy, cystoscopy, lysis of adhesions, or surgical treatment
             of endometriosis

        Exclusion Criteria:

          -  contraindications to the use of B&O (i.e. glaucoma, severe hepatic or renal disease,
             bronchial asthma, history of narcotic idiosyncracies, respiratory depression,
             convulsive disorders, acute alcoholism or delirium tremens, or regular use of an
             anticholinergic medication (twice per week or more frequently)

          -  additional surgical procedures being performed
Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Dexmedetomidine; Propofol; Interscalene block
Intervention description: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol; Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine; Interscalene block is used for the main anesthetic for the case
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The standard hospital procedure calls for the patient to undergo Interscalene block under
      ultrasound with or without nerve stimulation guidance prior to going to operating room (OR).
      The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the
      patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The
      participant is then brought to the OR and prolonged sedation is initiated, randomly using
      either Dexmedetomidine or Propofol.

      The primary objective of the present study is to use Dexmedetomidine for sedation, and
      compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for
      this study.

      Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and
      reduced need for supplemental medication for sedation, compared to Propofol
    

Eligibility criteria:

        Inclusion Criteria:

        Participants scheduled for shoulder arthroscopies in the beach chair sitting position.

        Participants who received a successful interscalene block.

        Exclusion Criteria:

        Failed interscalene block. Refusal to participate in the study. Allergy to the study drugs.
        Participants that need a secure airway.
Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Mirtazapine; Sertraline; Sugar pill
Intervention description: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks; Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks; Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
Intervention MeSH terms: Mirtazapine; Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PTSD; trauma; anxiety disorder; medication; sertraline; mirtazapine; pharmacotherapy

Summary:

      The overall goal of this study is to examine the efficacy of the combination of mirtazapine
      and sertraline in the treatment of posttraumatic stress disorder (PTSD). Sertraline is
      FDA-approved for PTSD, but it is often not fully effective. The combination of mirtazapine
      and serotonin reuptake inhibitors like sertraline has appeared highly effective in a related
      disorder -- depression.

      In this study, sixty patients with chronic PTSD will be randomized to treatment with either
      sertraline + mirtazapine or sertraline + placebo for 12 weeks. Patients who show at least a
      minimal response after 12 weeks will continue for another 12 weeks on the same treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current primary diagnosis of chronic PTSD

          -  Fluent in English or Spanish

        Exclusion Criteria:

          -  Past or current schizophrenia, schizoaffective disorder, organic mental disorder,
             bipolar disorder, or antisocial personality disorder.

          -  Substance abuse of dependence diagnosis in past 3 months

          -  Suicidal ideation or behavior in past 6 months that poses a significant danger.

          -  Medical illness that could significant increase risk of sertraline and mirtazapine
             treatment or assessment of response

          -  History of traumatic brain injury of greater than mild severity

          -  History of seizure disorder (except febrile seizure in childhood)

          -  Currently taking medication which has been effective for patient's PTSD.

          -  Inability to tolerate or unwillingness to accept a drug-free period prior to beginning
             the study for certain psychiatric medications.

          -  History of inability to tolerate sertraline or mirtazapine or inadequate response to
             an adequate trial of combined treatment.

          -  Pregnancy, lactation; for women of childbearing potential, not using an effective
             birth control method.

          -  Current cognitive-behavioral therapy. Any psychotherapy initiated within 3 months of
             beginning this study.
Inpatient Diabetes on Corticosteroids
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: NPH; Correction Factor
Intervention description: NPH given per study table based on steroid dose and patient weight in kg.; Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: corticosteroid; diabetes; insulin

Summary:

      Despite a significant problem with out-of-control glucose levels in patients with diabetes
      receiving corticosteroids for a variety of illnesses, there are no published protocols
      addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators
      propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin
      for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed
      to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's
      usual insulin regimen and timed to correspond to the corticosteroid dosing regimen.
      Investigators will prospectively enroll eligible consented patients with diabetes who are
      receiving corticosteroids as part of their treatment in a large county hospital, will
      randomize them to intervention or control groups, and will monitor their glucose levels
      during their inpatient stay. The protocol will demonstrate improved control of glucose levels
      with minimal risk of hypoglycemia, and will provide a practical and readily implementable
      protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior history of diabetes

          -  Able to provide informed consent

          -  Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the
             equivalent of dexamethasone or methylprednisolone

          -  Expect to be hospitalized for 48 hours

        Exclusion Criteria:

          -  Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2

          -  ALT (alanine aminotransferase) > 2 times upper normal for laboratory
Topical Antibiotics and Intravitreous Injections
Condition: Intravitreous; Injections
Intervention: gatifloxacin
Intervention MeSH terms: Gatifloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluation of efficacy of topical preoperative antibiotics in patients undergoing
      intravitreous injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  intravitreous injection

        Exclusion Criteria:

          -  antibiotic use
Kaletra Sex/Gender Pharmacokinetics (PK) Study
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: LPV/r
Intervention description: LPV/r 800/200 mg once daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sex differences; Pharmacokinetic; Lopinavir/ritonavir; Treatment Experienced; HIV-infection

Summary:

      The levels of lopinavir achieved in the blood following oral ingestion of standard doses of
      Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in
      HIV-infected women receiving the same dose of the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater or equal to 18 years

          -  Diagnosis of HIV infection as previously established by HIV Enzyme-Linked
             Immunosorbent Assay (ELISA) test and confirmed by Western blot analysis.

          -  Must have been taking LPV/r as part of an antiretroviral regimen at a dose of 400/100
             mg orally twice per day for at least 3 months.

          -  Recent (within last 90 days) HIV-RNA copies must be less than 400 copies/ml

        Exclusion Criteria:

          -  Hepatic abnormality: alanine-aminotransferase (ALT), aspartate-aminotransferase (AST)
             or total bilirubin (TBR) ≥ 3 x upper limit of normal

          -  Renal insufficiency: serum creatinine ≥ 2 mg/dl

          -  Co-infection with hepatitis B and/or C viruses

          -  Pregnant or breastfeeding

          -  Use of concurrent medications known to affect lopinavir or ritonavir concentrations
             significantly.
A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram
Intervention description: Escitalopram will be administered as oral tablets 10 mg per day and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depressive Disorder, Major; Depressive Disorder; Depression; Anxiety; Escitalopram; Quality of life; Social functionality

Summary:

      The purpose of this study is to evaluate the impact of escitalopram on quality of life and
      social functionality in patients with major depressive disorder with anxiety symptom.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of major depressive disorder according to the American Psychiatric
             Association's Diagnostic and Statistical Manual-IV, Text Revision (DSM-IV-TR)
             diagnostic criteria

          -  Minimum scores of 9 on Sheehan Disability Scale

          -  Minimum scores of 14 on Hamilton Anxiety Scale

        Exclusion Criteria:

          -  History of primary or comorbid diagnoses of schizophrenia, schizoaffective disorder,
             bipolar disorder, or dementia

          -  Presence of unstable serious illness and/or has a clinically significant renal or
             hepatic impairment, seizure disorders or any other disease which may be detrimental to
             the participant or the study

          -  Participant who have continuously taken psychoactive substances, antidepressants,
             anxiolytics, Monoamine oxidase inhibitors, psychoactive herbal remedies, lithium,
             electroconvulsive therapy, carbamazepine in the past 2 weeks before the baseline visit

          -  Diagnosis of major depressive disorder who currently require treatment systematically
             within past 2 months from baseline

          -  Receiving pharmacological treatment, which is disallowed in the current approved
             Chinese summary of product characteristics for escitalopram
A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin, 100 mg; Canagliflozin, 300 mg; Placebo
Intervention description: One 100 mg capsule taken orally (by mouth) once daily.; One 300 mg capsule taken orally (by mouth) once daily.; One placebo capsule taken orally (by mouth) once daily.
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Canagliflozin; Hemoglobin A1c; Metformin; Sitagliptin; T2DM; JNJ-28431754

Summary:

      The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to
      placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have
      inadequate glycemic control on maximally or near-maximally effective doses of metformin and
      sitagliptin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of type 2 diabetes mellitus

          -  Must have a screening HbA1c of >=7.5% to <=10.5%

          -  Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed
             dose combination) at a stable dose for at least 12 weeks before screening

        Exclusion Criteria:

          -  History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption
             or primary renal glycosuria

          -  A myocardial infarction, unstable angina, revascularization procedure or
             cerebrovascular accident within 12 weeks before screening

          -  eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for
             women

          -  Known significant liver disease (eg, acute hepatitis, chronic active hepatitis,
             cirrhosis)

          -  Major surgery (ie, requiring general anesthesia) within 12 weeks before screening
Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia
Condition: Pneumonia, Ventilator-Associated
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Intervention: Aerosolized Tobramycin or Vancomycin; Aerosolized Placebo
Intervention description: Tobramycin: 300 mg diluted in 5 mL of 0.9% normal saline q.12h. Vancomycin: 125 mg diluted in 5 mL 0.9% normal saline q.8h.; Placebo tobramycin: 5 ml 0.9% normal saline q. 12h. Placebo vancomycin: 5m 0.9% normal saline q. 8 hr.
Intervention MeSH terms: Vancomycin; Tobramycin
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: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if administering inhaled antibiotics directly into
      the lungs in conjunction with intravenous (IV) antibiotics leads to better outcomes and
      decreased recurrence of ventilator associated pneumonia (VAP) when compared to IV antibiotics
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical Pulmonary Infection Score (CPIS) greater than or equal to 6

          2. Intubated greater than or equal to 48 hours

          3. Screened for possible eligibility

          4. Bronchoscopy and bronchoalveolar lavage (BAL) or combicath performed

          5. Started on empiric intravenous (IV) and inhaled antibiotics after BAL for suspected
             ventilator associated pneumonia (VAP)

          6. > 104 Colony Forming Units (CFU) on BAL

        Exclusion Criteria:

          1. <18 years of age

          2. Pregnant

          3. Human Immunodeficiency Virus (HIV) or on chronic immunosuppressants

          4. Absolute Neutrophil Count <1,000

          5. Allergy to vancomycin or tobramycin

          6. Anaphylaxis to penicillin

          7. Cystic Fibrosis

          8. Previous enrollment

          9. Creatinine >2 mg/dl or doubled within the previous 72 hours
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone; Placebo
Intervention description: 2 puffs in each nostril once daily of nasal spray; 2 puffs in each nostril once daily of nasal spray
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      People with allergies frequently complain of a loss or reduction in the sense of smell.

      In this study, the investigators propose to perform a randomized, double blind, placebo
      controlled parallel study of subjects with nasal allergies and decreased smell to determine
      the effect of a treatment for allergies on the sense of smell.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between 18 and 59 years of age.

          2. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.

          3. Positive skin or RAST test to allergen.

          4. Symptoms of olfactory dysfunction.

          5. No significant history of chronic sinusitis.

        Exclusion Criteria:

          1. Women of childbearing potential not using the contraception method(s) (Birth control
             pills, depo Provera, double barrier) as well as women who are breastfeeding.

          2. Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study (heart, lung, kidney, neurological, oncologic or
             liver disease).

          3. Use of any other investigational agent in the last 30 days.

          4. Absence of olfactory or nasal symptoms.

          5. Use of medications that may affect olfaction.

          6. Medical conditions that may affect olfaction.

          7. Smoking.

          8. URI at the time of screening.
Acceptability of the NuvaRing Among Students
Condition: Birth Control Compliance
Intervention: Ortho Tri-cyclen Lo; NuvaRing
Intervention description: Low dose oral contraceptive; Contraceptive vaginal ring
Intervention MeSH terms: Moxifloxacin; NuvaRing; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 273.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception, Compliance, Acceptability

Summary:

      The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing®
      vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side
      effects, overall acceptability and intent to continue use of the method. The study is focused
      on the acceptability of the vaginal ring among female undergraduate or graduate students.
    

Eligibility criteria:

        Inclusion Criteria:

          -  over 18

          -  student enrolled in college or graduate program

          -  Not have used the contraceptive patch or oral contraceptives within the last month

          -  Never have used a contraceptive vaginal ring

          -  Interested in using hormonal contraceptives, specifically NuvaRing and oral
             contraceptive pills for next 3 months

          -  In general good health

          -  Premenopausal with the ability to menstruate

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  Pregnancy within 2 months of trial medication

          -  Past use of any contraceptive vaginal ring

          -  Hypersensitivity or allergy to NuvaRing or Oral Contraceptives

          -  Use of investigational drug within 2 months of start of trial medication

          -  Use of the contraceptive patch or oral contraceptives within past month

          -  Use of any injectable contraception within 6 months of trial medication

          -  Planning pregnancy in next 6 months