bioihbjkbjnl/mcl2 huggingface dataset:
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: VIVITROL 380mg
Intervention description: 380 mg IM injection given once monthly
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid dependence; VIVITROL; criminal justice

Summary:

      This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison
      and continuing VIVITROL upon release into the community.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Not currently addicted to opioids, but has a diagnosis of pre-incarceration opioid
             dependence

          -  Inmate at the Metropolitan Transition Center (Baltimore, MD), Maryland Correctional
             Institute for Women (Jessup, MD), Baltimore Pre-Release Unit (Baltimore, MD), or
             Jessup Pre-Release Unit (Jessup, MD) and eligible for release within 30 days of
             screening

          -  Expressing a goal of opiate-free treatment upon release

          -  Currently opioid free

          -  Planning to live in the Baltimore, MD area for at least 8 months following prison
             release

        Exclusion Criteria:

          -  Pregnancy and/or breastfeeding

          -  Clinically significant active medical condition

          -  Active hepatitis

          -  Past or present history of an AIDS-indicator disease in subjects who are infected with
             HIV

          -  Any untreated or unstable psychiatric disorder(eg, bipolar with mania)

          -  Recent suicidal ideation

          -  Current chronic pain diagnosis for which opioids are prescribed

          -  Positive drug test for opioids

          -  History of drug overdose within the past 3 years requiring inpatient hospitalization
Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
Condition: Depression
MeSH terms: Depression
Intervention: Duloxetine
Intervention description: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors
      (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia
      who are being treated with an SSRI and experiencing treatment-related sexual dysfunction will
      experience less sexual dysfunction if they are switched to duloxetine, and 2. they will
      experience either improved antidepressant response or no loss of antidepressant response.
    

Eligibility criteria:

        Inclusion Criteria::

          -  age 18 - 65 inclusive

          -  able to read and understand informed consent

          -  informed consent given

          -  currently being treated with an SSRI for depression or dysthymia

          -  currently suffering from treatment-emergent sexual dysfunction attributable to the
             SSRI

          -  have normal safety lab values at screen

          -  if currently taking medication to improve sexual performance, willing to discontinue
             the drug for the duration of the study

          -  female subjects of child bearing age need to use an acceptable form of birth control
             throughout the study Exclusion Criteria:- being pregnant, breastfeeding, or planning
             to become pregnant within 4 months

          -  suffering from psychotic, substance abuse, bipolar, or organic mental disorder, OCD,
             panic disorder, or personality disorder severe enough to interfere with study
             participation

          -  suffer from an unstable or serious medical disorder

          -  having a medical disorder that could be the cause of the sexual dysfunction

          -  taking a medication that is metabolized by hepatic enzyme CYP2D6

          -  having used a MAOI within 15 days of proposed start of duloxetine treatment

          -  having a known hypersensitivity to duloxetine or any of its ingredients

          -  having taken viagra or related drug within 3 months prior to starting SSRI treatment

          -  requiring ongoing treatment with a mood stabilizer (anticonvulsant) or antipsychotic
             medication
Spinal Cord Stimulation for Low Back Pain
Condition: Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Intervention: Precision Spinal Cord Stimulation System
Intervention description: Stimulation on throughout study
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Back Pain; Low Back Pain; Chronic Pain; Spinal Cord Stimulation

Summary:

      The purpose of this study is to assess the acute and chronic effectiveness of the Advanced
      Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery
      syndrome and associated low back axial pain.

      Subjects will undergo a temporary or permanent trial to assess their candidacy for placement
      of an implantable pulse generator. Those who demonstrate a significant clinical reduction in
      pain will be enrolled in the chronic study. Subjects will be followed for 12 months post
      implantation to assess the long-term effectiveness of the therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Eligible for spinal cord stimulation as labeled in the FDA approval for the
             Precision(R) Spinal Cord Stimulator by Advanced Bionics;

          2. Age ≥18 years;

          3. Have pain of neuropathic origin;

          4. Have chronic pain secondary to surgical spine procedure or intractable low back pain
             with or without leg pain for at least 3 months and not responding to less invasive
             clinical procedures.

        Exclusion Criteria:

        1. Enrollment in any research that would conflict with study requirements.
Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
Condition: Healthy
Intervention: Pregabalin; Placebo
Intervention description: pregabalin 600 mg given twice a day; Placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 222.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy males Human volunteers pregabalin or placebo sperm quality and quantity

Summary:

      This study is being performed as a Phase IV FDA commitment study and is being powered
      adequately to assess changes in sperm concentration, FSH and testosterone in healthy male
      subjects treated with pregabalin as compared to placebo, in addition to confirming lack of
      effects on sperm motility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 18 to 55 years old males

        Exclusion Criteria:

          -  Screening sperm count <20 x 106/mL; screening sperm motility <50% motile (a+b) or <25%
             Class "a" motile or screening sperm morphology <30% normal or semen volume <1.5 mL or
             white blood cell count >1 x 106 /mL on any screening visit sample
A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Ezetimibe; Placebo
Intervention description: 10 mg oral dose once daily for 24 weeks; Placebo to match ezetimibe orally once daily for 24 weeks.
Intervention MeSH terms: Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 152.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will examine the effect of ezetimibe on glucose metabolism in participants with
      Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated
      hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the
      placebo control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have hypercholesterolemia (high cholesterol) and have been diagnosed with type 2
             diabetes that is being treated with oral anti-diabetic drugs or insulin or both.

          -  No change in the medication (drugs, dose and administration) for the treatment of
             diabetes within previous 12 weeks with exception of small changes in insulin dosing

          -  No change in diet and exercise therapy within previous 4 weeks

        Exclusion Criteria:

          -  Coexisting disease (hemoglobinopathy, hemolytic anemia, etc.) that may affect HbA1c
             measurement

          -  Homozygous or heterozygous familial hypercholesterolemia

          -  Previously received ezetimibe

          -  Hypercholesterolemia associated with: hypothyroidism, obstructive gall bladder or
             biliary disease, chronic renal failure or pancreatitis

          -  Hyperlipidemia caused by medication
Once-Daily Asenapine for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Asenapine 10 mg daily in the evening; Asenapine 5 mg twice daily
Intervention description: The total daily dose of Asenapine will be given once daily in the evening; Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
Intervention MeSH terms: Asenapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; asenapine; Once daily; twice daily

Summary:

      The investigators propose to explore: 1. the acceptance by patients of once versus twice
      daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing
      with asenapine, and 3. the changes in psychopathology associated with these two dosing
      strategies, in 30 patients with schizophrenia or schizoaffective disorder.

      The investigators hypothesize that patient and staff acceptance will be better with once
      daily dosing and that improvements in psychopathology will be similar across once daily and
      twice daily dosing
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female individuals,

          -  18-65 years of age,

          -  who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder,

          -  who are newly admitted to Central Regional Hospital for treatment of an acute
             psychotic exacerbation,

          -  who provide signed informed consent to participate, will be included.

        Exclusion Criteria:

          -  Females who are lactating or pregnant,

          -  individuals with a prior history of poor therapeutic response or sensitivity to
             asenapine, will be excluded
Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic acid; Placebo
Intervention description: Zoledronic acid per protocol; Placebo
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In a randomized, double-blind trial, BMD of the operated proximal femur after total hip
      replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two
      years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n =
      24) at two weeks and one year after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing primary elective total hip replacement

        Exclusion Criteria:

          -  Osteoporosis (BMD ≤-2.5)

          -  Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric
             osteotomy, inflammatory arthritis

          -  Severe renal impairment

          -  Use of any medications affecting BMD

          -  Known sensitivity to bisphosphonates

          -  Severe dental problems, and pregnancy or being able to conceive and not using reliable
             birth control methods
Loss of Resistance, w/wo Stimulation, For Epidural Placement
Condition: Anesthesia
Intervention: Thoracic epidural block; Electrical Nerve stimulation; Solution For Thoracic epidural block
Intervention description: Thoracic epidural block with epidural placed with a loss of resistance technique alone.; In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters(19 Ga. x 90 cm StimuCath® Continuous Nerve Block Catheter with SnapLock™ Adapter (Arrow by Teleflex Medical, Morrisville, NC), and stimulation will be achieved using a B Braun Stimuplex HNS12 Nerve Stimulator product id 4892098.; Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
Intervention MeSH terms: Lidocaine; Epinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: As the patient will be sedated during epidural catheter placement, they will be blinded to their treatment arm. The investigator that determines if the epidural was successful placed will also be blinded to the patient's treatment arm.
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: epidural catheter placement

Summary:

      The purpose of this randomized, observer-blinded, investigative trial is to determine if the
      use of electrical stimulation, compared to the traditional loss of resistance technique
      alone, improves the success rate of epidural catheter placement at an academic teaching
      institution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults undergoing intra-thoracic or intra-abdominal procedures that normally would
             receive thoracic epidurals for post-operative analgesia will be eligible.

        Exclusion Criteria:

          -  Subjects with contraindications to regional anesthesia:

          -  history of allergy to amide local anesthetics

          -  presence of a progressive neurological deficit

          -  patients that are on anticoagulant medications that prohibit placement of an epidural

          -  Systemic infection

          -  Infection at the site of placement
Efficacy and Safety Study of Transdermal Therapeutic System (TTS) Fentanyl in Participants With Osteoarthritis Knee Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: TTS-fentanyl
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis, Knee; Transdermal therapeutic system (TTS) fentanyl; Durogesic

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic
      system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so
      the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is
      seen mostly in older persons, in which the joints become painful and stiff) participants with
      moderate to severe pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic (lasting a long time) primary osteoarthritis knee pain, one or two side with
             stage II Kellgen-Lawrence, for more than 3 months with Visual Analogue Scale (VAS)
             more than 4

          -  Good knee deformity, no limit range of motion

          -  Participant who has signed the informed consent form

        Exclusion Criteria:

          -  Skin disease that prevents the use of the transdermal system or which could affect the
             absorption of fentanyl or local tolerability

          -  History or suspicion of alcohol or drug abuse within the past 5 years

          -  History of cardiac, nervous system or respiratory disease which in the investigator's
             judgment prevents participation in the study because of the potential for respiratory
             depression

          -  Confusion, reduced level of consciousness, or concomitant psychiatric disorder which,
             in the opinion of the investigator, could prevent participation in the trial

          -  Participants who do not understand or speak Thai
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Albuminuria
MeSH terms: Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Canagliflozin, 100 mg; Canagliflozin, 300 mg
Intervention description: One placebo capsule taken orally (by mouth) once daily for 156 weeks; One 100 mg capsule taken orally (by mouth) once daily; One 300 mg 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: 5813.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Albuminuria; Canagliflozin; Cardiovascular outcomes; Type 2 Diabetes Mellitus; T2DM; JNJ-28431754; Antihyperglycemic Agent

Summary:

      The purpose of this study is to assess the effect of canagliflozin compared to placebo on
      progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard
      care but with inadequate glycemic control and at elevated risk of cardiovascular events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of type 2 diabetes mellitus

          -  Must have inadequate diabetes control (as defined by glycosylated hemoglobin level
             >=7.0% to <=10.5% at screening)

          -  Greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or
             >= 50 yrs old with high risk of CV events

          -  Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy,
             or combination AHA therapy with any approved agent for the control of blood glucose
             levels.

        Exclusion Criteria

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell
             transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  History of one or more severe hypoglycemic episode within 6 months before screening

          -  History of hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Ongoing, inadequately controlled thyroid disorder

          -  Renal disease that required treatment with immunosuppressive therapy or a history of
             chronic dialysis or renal transplant

          -  Myocardial infarction, unstable angina, revascularization procedure, or
             cerebrovascular accident within 3 months before screening.
Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Condition: Chronic Stable Angina
MeSH terms: Angina, Stable
Intervention: Ranolazine; Aerobic Exercise; Placebo
Intervention description: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day; Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test); Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day
Intervention MeSH terms: Ranolazine
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
Healthy volunteers: No

Summary:

      The primary objective is to assess whether the increased angina threshold on ranolazine and
      subsequent higher training intensity will result in improved exercise tolerance and oxygen
      consumption; and greater than that observed with exercise training on placebo. The study team
      anticipates the chronic exercise improvements with ranolazine will be incrementally higher
      than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key
      secondary objectives include the acute ranolazine and chronic exercise plus ranolazine
      effects on total daily energy expenditure (TDEE) and angina-related quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented CAD diagnosis

          -  Stable angina ≥ 3 months

        Exclusion Criteria:

          -  Class III or IV heart failure

          -  Myocardial Infarction or coronary revascularization procedure within 2 months

          -  QT interval > 500ms or prescribed medication known to prolong the QTc interval

          -  Contraindicated Medications

          -  Metformin dose > 1700mg/day

          -  Class Ia, Ic and III anti-arrhythmics

          -  CYP3A inhibitors

          -  Simvastatin >20mg/day

          -  Severe renal disease (< 30ml/min creatinine clearance)

          -  Currently on dialysis

          -  Lack of transportation to the exercise and testing facilities

          -  Implanted pacemaker that is not rate responsive