bioihbjkbjnl/mcl2 huggingface dataset:
Pregabalin Versus Levetiracetam In Partial Seizures
Condition: Partial Seizures
MeSH terms: Seizures
Intervention: pregabalin; levetiracetam
Intervention description: 300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects; 1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
Intervention MeSH terms: Pregabalin; Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 509.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epilepsies partial; Partial Seizure Disorder; Complex Partial Seizure Disorder; Epilepsy

Summary:

      This study will compare pregabalin and levetiracetam in patients with partial seizures. It
      will also evaluate the safety and tolerability of pregabalin and levetiracetam in these
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with
             partial seizures, as defined in the International League Against Epilepsy (ILAE)
             classification of seizures.

          -  Partial seizures may be simple or complex, with or without secondary tonic-clonic
             generalization.

          -  Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have
             been unresponsive to treatment with at least two but no more than five prior
             antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages
             of 1 or 2 standard AEDs.

        Exclusion Criteria:

          -  Females who are pregnant, breastfeeding, or intend to become pregnant during the
             course of the trial will be excluded

          -  Subjects with other neurologic illness that could impair endpoint assessment, or
             subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the
             12 months prior to trial entry, or with seizures due to an underlying medical illness
             or metabolic syndrome, will be excluded.
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Voclosporin; Placebo Oral Capsule
Intervention description: Calcineurin inhibitor, oral, 23.7 mg twice daily (BID); Voclosporin placebo, oral, 3 capsules twice daily (BID)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: lupus nephritis; calcineurin inhibitors; voclosporin

Summary:

      The purpose of this study is assess the long-term safety and tolerability of voclosporin
      compared with placebo for up to an additional 24 months following completion of treatment in
      the AURORA 1 study in subjects with lupus nephritis (LN).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1
             study. Subjects who had a temporary interruption and successfully restarted study drug
             during the AURORA 1 study will be allowed with Medical Monitor approval.

          2. Written informed consent before any study-specific procedures were performed.

          3. In the opinion of the investigator, subject required continued immunosuppressive
             therapy.

          4. Women of childbearing potential must continue to use effective contraception and have
             a negative urine pregnancy test at Month 12.

          5. Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the
             duration of the study.

        Exclusion Criteria:

          1. Currently taking or known need for any of the medications or food items listed in
             Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.

          2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or
             expected to require dialysis during the study period.

          3. A planned kidney transplant within study treatment period.

          4. Subjects with any medical condition which, in the Investigator's judgment, may be
             associated with increased risk to the subject or may interfere with study assessments
             or outcomes.

          5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using
             adequate contraceptive precautions.

          6. Vaccines using live organisms, virus or bacterial, while taking the study treatment.
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Thalidomide; Dexamethasone; DOXIL
Intervention description: Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.; Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.; DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.
Intervention MeSH terms: Thalidomide; Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma; Newly diagnosed multiple myeloma; Thalidomide; Dexamethasone; DOXIL; Pegylated liposomal hydrochloride doxorubicin injection

Summary:

      The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL
      (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in
      treating newly diagnosed patients with multiple myeloma. The number of patients whose
      multiple myeloma disappears for a period of time (complete Response) will be studied to make
      the determination of which treatment is more effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated, histologically confirmed multiple myeloma (per International
             Myeloma Working Group [IMWG] criteria

          -  Eastern Cooperative Oncology Group (ECOG) status 0-2

          -  Adequate absolute neutrophil count (ANC), platelet count and hemoglobin

          -  Adequate serum calcium

          -  Enrollment in System for Thalidomide Education and Prescribing Safety Program
             (S.T.E.P.S.)

        Exclusion Criteria:

          -  No treatment with dexamethasone for multiple myeloma

          -  No peripheral neuropathy of Grade 2 or higher

          -  No Left Ventricular Ejection Fraction (LVEF) of less than 45 percentage

          -  No history of life-threatening thromboembolic events of any kind (ie, myocardial
             infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in
             the study

          -  No deep vein thrombosis (DVT) within 1 year of enrollment

          -  No current anticoagulation for DVT
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: aprepitant; Comparator: ondansetron; Comparator: dexamethasone; Comparator: fosaprepitant dimeglumine; Comparator; Placebo (unspecified); Comparator; Placebo (unspecified)
Intervention description: aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.; Ondansetron 8 mg capsule Three day treatment period.; dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.; fosaprepitant dimeglumine 115 mg; dexamethasone 12mg Pbo tablets.; Aprepitant 80 mg & 125 mg Pbo capsules.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; Fosaprepitant; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 848.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will test aprepitant for the prevention of CINV in patients receiving their initial
      cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of
      chemotherapy may opt to participate in an optional second cycle during which the patient will
      receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant
      will be given in place of the oral formulation on study day one. Study drug administration on
      subsequent days will be given orally as in cycle 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be naive to emetogenic chemotherapy with histologically or cytologically
             confirmed malignant disease scheduled to receive a single dose of moderately
             emetogenic chemotherapy on study day 1

          -  Karnofsky score of 60 or greater

        Exclusion Criteria:

          -  Patient is scheduled to receive any dose of cisplatin

          -  Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after
             initiation of chemotherapy

          -  Any allergies to study drug or antiemetics

          -  Taking CYP3A4 substrates/prohibited medication

          -  Significant medical or mental conditions

          -  Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or
             creatinine).
Protocolized vs Discretionary Use of Opioids in Acute Pain
Condition: Pain
MeSH terms: Acute Pain
Intervention: Hydromorphone; IV opioid
Intervention description: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later; Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 350.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hydromorphone; acute pain; Protocolized; Efficacy; Safety

Summary:

      We are testing whether patients who received protocolized pain management (1 mg of IV
      hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later
      if the patients wants more) will have better pain relief and no more adverse events than
      patients receiving discretionary care, in which the patients receives whatever IV opioid the
      treating physician wants to give, in whatever dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 21 to 64 years.

          2. Pain with onset within 7 days.

          3. Emergency Department attending physician's judgment that patient's pain warrants use
             of intravenous opioids.

          4. Normal mental status.

        Exclusion Criteria:

          1. Prior use of methadone.

          2. Use of other opioids, tramadol, or heroin in the past seven days.

          3. Prior adverse reaction to morphine, hydromorphone, or other opioids.

          4. Chronic pain syndrome.

          5. Alcohol intoxication.

          6. Systolic Blood Pressure < 90 mm Hg.

          7. Use of monoamine oxidase (MAO) inhibitors in past 30 days.

          8. Weight less than 100 pounds.

          9. Baseline room air oxygen saturation less than 95%.

         10. C02 measurement greater than 46: In accordance with a number of similar studies that
             we have performed, four subsets of patients will have their CO2 measured using a
             handheld capnometer prior to enrollment in the study. If the CO2 measurement is
             greater than 46, then the patient will be excluded from the study. The 4 subsets are
             as follows:

               1. All patients who have a history of chronic obstructive pulmonary disease (COPD)

               2. All patients who have a history of sleep apnea

               3. All patients who report a history of asthma together with greater than a 20
                  pack-year smoking history

               4. All patients reporting less than a 20 pack-year smoking history who are having an
                  asthma exacerbation
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Esmirtazapine; Placebo
Intervention description: Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name corn starch), magnesium stearate, and lactose monohydrate.; The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.
Intervention MeSH terms: Mirtazapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 419.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders

Summary:

      The purpose of this trial is to investigate the efficacy, safety and tolerability of
      esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of chronic primary insomnia

        Exclusion Criteria:

          -  Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy,
             sleep/wake rhythm disorders

          -  Has significant medical or psychiatric illness as causing the sleep disorder

          -  Diagnosed with major depressive disorder

          -  Substance abuse within the past year

          -  Night worker or work on rotating shifts

          -  Has had serious head injury, stroke, epilepsy

          -  Has a history of bipolar disorder or family (immediate family) history of suicide

          -  Smokes more than 15 cigarettes per day and cannot abstain from smoking during the
             night or in the sleep laboratory

          -  Drinks beverages containing more than 500 mg caffeine per day
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin glargine
Intervention description: Injected once daily subcutaneously (s.c., under the skin); Injected once daily subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7637.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to compare cardiovascular safety
      of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of
      cardiovascular events.
    

Eligibility criteria:

        Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined
        previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with
        predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to
        7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to
        20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s)
        Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days -
        Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure
        NYHA (New York Heart Association) class IV - Current or past (within the last 5 years)
        malignant neoplasms (except basal cell and squamous cell skin carcinoma)
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)
Condition: Alcohol Dependence
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Nalmefene hydrochloride; Placebo
Intervention description: As-needed; tablets, orally; As-needed; tablets, orally
Intervention MeSH terms: Nalmefene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 678.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in
      patients with alcohol dependence will be evaluated in a multicenter, randomized,
      double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of
      nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol
      consumption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese males and females aged 20 or above who have signed the informed consent form

          -  The patient has alcohol dependence, diagnosed according to Diagnostic and Statistical
             Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) and confirmed by
             Mini-international Neuropsychiatric Interview (M. I. N. I.)

          -  The patient has a drinking risk level of High or above (> 60 g for men and > 40 g for
             women) both at the Screening Visit and at the Randomization Visit .

        Exclusion Criteria:

          -  The patient with a current diagnosis or history of substance use disorders (except for
             alcohol, nicotine, and caffeine), according to DSM-IV-TR and confirmed by M. I. N. I.

          -  The patient has reported current use of, or has tested positive for, drugs of abuse
             (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test
Management of Etonogestrel Subdermal Implant-related Bleeding
Condition: ESI-related Bleeding
MeSH terms: Hemorrhage
Intervention: Doxycycline; Placebo
Intervention description: Doxycycline 100 mg oral capsules twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.; Placebo, one capsule orally twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.
Intervention MeSH terms: Doxycycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Implanon; Etonogestrel subdermal implant; Nexplanon; Contraception; Irregular Bleeding; Menometrorrhagia

Summary:

      This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be
      conducted within the Mayo Clinic and the Mayo Clinic Health System.

      The goal of the research study is to gather information to determine whether Doxycycline is
      effective for the treatment of unacceptable bleeding associated with the etonogestrel
      subdermal implant (ESI), as compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women, aged 18-51 years

          -  Expressed desire for compliance-independent contraception

          -  No current pregnancy or anticipated desire for childbearing within 3 years of study
             enrollment and Implanon insertion

          -  Agreement to participate in all study related procedures and evaluations as documented
             by a signed informed consent

        Exclusion Criteria:

          -  Current or prior use of Implanon

          -  Current long-term use of Doxycycline for other indications

          -  Known structural uterine abnormalities such as polyp, submucosal leiomyoma

          -  Prior permanent sterilization or endometrial ablation

          -  Pregnancy or desire for childbearing within 3 years

          -  Contraindications to or intolerance of etonogestrel

          -  Allergy to or intolerance of Doxycycline

          -  Inability or unwillingness to complete study related procedures and evaluations