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
Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen
Condition: Pain
Intervention: Oral Acetaminophen; IV Acetaminophen; IV Morphine; Placebo Tablets; Saline
Intervention description: Acetaminophen for oral administration (2 tablets, 500 mg/tablet); Acetaminophen for intravenous (IV) administration (1,000 mg/100 mL); Morphine for IV administration (0.125 mg/kg); Placebo tablets matching oral acetaminophen; Saline placebo matching IV acetaminophen
Intervention MeSH terms: Acetaminophen; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post-surgical pain; Pharmacokinetics

Summary:

      Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can
      reduce the amount of opioids needed for this.

      The problem is that morphine slows down digestion. That can delay pain relief from APAP
      pills. It can even change what the body does to the drug [pharmacokinetics (PK)].

      Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills.

      This study will measure the PK of APAP pills and IV when used with morphine in healthy
      volunteers.

      IV APAP will likely be more effective and cause fewer side effects when used with morphine to
      treat pain after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must have a health status of "healthy" assessed by the investigator and
             defined as no clinically significant deviation from normal medical history, physical
             examination, vital signs, and clinical laboratory determinations.

          2. Subject must have a body mass index ≥ 19.0 and ≤ 32.0 kg/m² with a minimum weight of
             110 pounds (50 kg) at Screening.

        Exclusion Criteria:

          1. Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B
             (surface antigen), or hepatitis C virus antibody at screening.

          2. Subject has a history of any drug allergy, hypersensitivity, or intolerance to
             acetaminophen or morphine/opioids or to any of the excipients in the IV or oral
             formulations used.

          3. Subject has an oxygen saturation of less than 95% while awake at screening and
             check-in.

          4. Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates,
             cannabinoids, benzodiazepines, cocaine, amphetamine) or alcohol at the screening and
             check-in.

          5. Subject has donated or had significant loss of whole blood (480 mL or more) within 30
             days, or plasma within 14 days prior to dosing.

          6. Subject has any other medical, psychiatric and/or social reason for exclusion as
             determined by the investigator.
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Tenofovir DF; DEXA Scan
Intervention description: 300 mg tablet administered orally once daily for up to 96 weeks; Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
Intervention MeSH terms: Tenofovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to characterize the long term (ie, 96 weeks of follow
      up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment
      in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone
      mineral density (BMD) change between CHB-infected adolescents 12 to < 18 years of age treated
      with tenofovir DF in European treatment centers who are assigned to one of two schedules for
      renal and bone laboratory monitoring and BMD measurement.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. 12 to <16 years of age

          2. Documented chronic hepatitis B virus (HBV) infection

          3. Weight ≥ 35 kg

          4. Able to swallow oral tablets

          5. Negative pregnancy test for females of childbearing potential

          6. Adequate kidney (renal) function

          7. Parent or legal guardian of potential study subjects able to provide written informed
             consent

        Key Exclusion Criteria:

          1. Previously received tenofovir DF

          2. Sexually-active males or females of reproductive potential who are not willing to use
             an effective method of contraception during the study

          3. Females who are pregnant or breastfeeding, or females who wish to become pregnant
             during the course of the study

          4. Known hypersensitivity to tenofovir DF, the metabolites or formulation excipients

          5. Any condition (including alcohol or substance abuse) or prior therapy that, in the
             opinion of the Investigator, would make the subject unsuitable for the study or unable
             to comply with treatment requirements

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
RNS® System LTT Study
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: RNS® System
Intervention description: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epilepsy; Responsive neurostimulation; RNS System; NeuroPace; Brain stimulation; Seizures

Summary:

      The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the
      long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of
      seizures in individuals 18 years of age or older with partial onset seizures that are
      refractory to two or more antiepileptic medications. Candidates will continue to receive
      their epilepsy medications while participating in the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has completed either the RNS® System Pivotal or Feasibility study

          2. Subject has an implanted RNS® System

          3. Subject has elected to continue to receive responsive neurostimulation therapy after
             completion of the RNS® System Pivotal or Feasibility study

          4. Subject is able to attend scheduled appointments for the RNS® System LTT study

        Exclusion Criteria:

          1. Subject has active psychiatric or medical illness that makes it inadvisable for the
             subject to continue to receive responsive neurostimulation therapy with the RNS®
             System

          2. Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily
             generalized seizures during the RNS® System Pivotal or Feasibility study

          3. Subject has been noncompliant with scheduled appointments during the RNS® System
             Pivotal or Feasibility study

          4. Subject has been noncompliant with maintaining seizure diaries during the RNS® System
             Pivotal or Feasibility study

          5. Informed consent cannot be obtained from subject or caregiver
Sedative-Anxiolytic Effects on Simulated Driving Performance
Condition: Psychomotor Impairment
MeSH terms: Psychomotor Disorders
Intervention: Alprazolam 2mg (2ALP/PLC); Alprazolam 1mg (1ALP/PLC); Alprazolam 0.5mg (0.5ALP/PLC); Zolpidem 10mg (ZOL/PLC); Placebo (PLC/PLC); Alprazolam 1mg (PLC/ALC)
Intervention description: 2mg alprazolam administered at night, placebo administered in the morning.; 1mg alprazolam administered at night, placebo administered in the morning.; 0.5mg alprazolam administered at night, placebo administered in the morning.; 10mg alprazolam administered at night, placebo administered in the morning.; Placebo administered at night, placebo administered in the morning.; Placebo administered at night, 1mg alprazolam administered in the morning.
Intervention MeSH terms: Zolpidem; Alprazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Participants and outcomes assessors were masked with respect to each individual intervention.
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car
      the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed
      or in the morning before using a driving simulator to assess impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  valid driver's license

          -  english-speaking and literate

        Exclusion Criteria:

          -  using daily medication for chronic condition

          -  acute narrow angle glaucoma

          -  previous adverse experience with study drugs

          -  experiences motion sickness in response to driving simulator

          -  BMI > 30

          -  women who are pregnant, lactating, or planning on becoming pregnant

          -  regular use of tobacco products

          -  current substance use disorder

          -  clinically significant ECG

          -  current ongoing psychiatric disorder
CNS Study of Patients Switching From Tacrolimus to Envarsus
Condition: Renal Transplant Patients
Intervention: Envarsus XR
Intervention description: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study documenting the neurotoxic side effects including tremors in patients
      with a stable graft who are receiving Tacrolimus following kidney transplantation. A
      standardized questionnaire will be used to document these symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant recipients with stable graft function.

          -  More than 1 months post-transplant.

          -  18+ years of age with some CNS problems secondary to Prograf (tacrolimus).

        Exclusion Criteria:

          -  Multi-organ patients (kidney/pancreas, kidney/liver).

          -  Evidence of graft rejection or treatment of acute rejection within 14 days prior to
             baseline visit.

          -  Inability to self-administer the QOL questionnaires.
An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses
Condition: Seborrheic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
Intervention: A-101 Topical Solution
Intervention description: A-101 Topical Solution applied Day 1, Day 15 and Day 29
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is an open-label study designed to evaluate subject's satisfaction after treatment
      of seborrheic keratoses with A-101 40%.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject can comprehend and is willing to sign an informed consent for participation in
             this study.

          2. Male or female between the ages of 30 and 75 years old.

          3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the
             additional 1 target SK must be on the neck or decolletage.

          4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior
             to first treatment with A-101 Topical Solution.

          5. Target and non-target SKs must not have been previously treated.

          6. Subject is in good general health and free of any known disease state or physical
             condition which, in the investigator's opinion, might impair the evaluation of any
             target or non-target SK or which exposes the subject to an unacceptable risk by study
             participation

        Exclusion Criteria:

          1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.

          2. Subject has current systemic malignancy.

          3. Subject would require the use of any topical treatment (e.g., moisturizers,
             sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.

          4. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun
             damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the
             opinion of the investigator, might put the subject at undue risk by study
             participation or interfere with the study conduct or evaluations
Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
Condition: Atherogenic Dyslipidemia; Obesity Associated Disorder
MeSH terms: Dyslipidemias
Intervention: Therapeutic Lifestyle Changes; Placebo; Fenofibrate; Wax Matrix Extended Release Niacin (WMER Niacin)
Intervention description: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Intervention MeSH terms: Niacin; Fenofibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Enrollment: 161.0
Sex: Female
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Extended Release Niacin; Fenofibrate; treatment; Obesity; Atherogenic Dyslipidemia

Summary:

      Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a
      higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is
      characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and
      type 2 diabetes mellitus and has emerged as an important marker for the increased
      cardiovascular disease (CVD) risk observed in these populations.

      Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires
      integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent
      studies have focused on optimizing treatment for AD and compare the efficacy and tolerability
      of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach
      has not yet been established.

      The present study was intended to evaluate the restorative efficacy of Extended Release
      Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their
      safety and tolerability in females with obesity-induced AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI≥30 kg/m2.

          -  Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG
             more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.

        Exclusion Criteria:

          -  The use of any antilipidemic medication.

          -  Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).

          -  Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).

          -  Clinical or laboratory findings suggestive for thyroid dysfunction.

          -  Established diagnosis of Diabetes Mellitus.

          -  History of gout, hyperuricemia, or on hypouricemic agents.

          -  Active peptic ulcer.

          -  Pregnancy, or nursing mothers.

          -  Alcohol or tobacco consumption.
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection
Condition: Calcific Tendinitis
MeSH terms: Tendinopathy
Intervention: Barbotage; Dexamethasone
Intervention description: Administered as per standard of care; 4 mg of dexamethasone
Intervention MeSH terms: Dexamethasone; Cortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of barbotage therapy by comparing the
      clinical and sonographic changes in patients that solely receive barbotage to patients
      receiving the standard of care, barbotage with cortisone injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age and younger than 90 years of age

          -  Diagnosed with calcific tendonitis and ruled out other shoulder-related pathologies

          -  Failed 1st line therapy (physical therapy and cortisone injection)

               -  Intention to receive barbotage with cortisone as standard of care

               -  3 or more months of shoulder pain

               -  Finding of one or more calcifications ≥5 mm in size on either sonogram or
                  radiograph, located on the supraspinatus tendon

               -  Positive Hawkin's test or Neer's sign for impingement

        Exclusion Criteria:

          -  Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia,
             etc.)

          -  Osteoarthritis of the glenohumeral joint of the affected shoulder

          -  Previous surgery or barbotage to the affected shoulder

          -  History of prior allergic/hypersensitivity reactions related to the study medication

          -  Shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy,
             fibromyalgia, frozen shoulder or cervical radiculopathy

          -  Sub-acromial injection with a corticosteroid or treatment by ESWT during the last 3
             months before inclusion

          -  Younger than 18 years of age or older than 90

          -  Any patient considered a vulnerable subject
Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens
Condition: Post Partum
MeSH terms: Emergencies
Intervention: Plan B (Levonorgestrel)
Intervention description: PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 14 Years
Maximum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Teen; Plan B; Post Partum; Emergency Contraception

Summary:

      This is a pilot randomized controlled trial to assess the effects of advanced supply of
      emergency contraception versus routine care in a teen postpartum population. The goals are to
      assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the
      prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse
      exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to
      assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and
      unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female

          2. English speaking

          3. Aged 14-19 at enrollment

          4. Immediately postpartum of a live infant

          5. Planning to parent the baby

          6. Desiring to delay another pregnancy for at least one year

          7. General good health

          8. Willing and able to follow the study protocol

        Exclusion Criteria

          1. Allergy to levonorgestrel

          2. Current substance abuse

          3. Plans for relocation outside of Philadelphia