bioihbjkbjnl/mcl2 huggingface dataset:
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
Condition: TTR-mediated Amyloidosis; Amyloidosis, Hereditary; Amyloid Neuropathies, Familial; Familial Amyloid Polyneuropathies; Amyloid Neuropathies; Amyloidosis, Hereditary, Transthyretin-Related
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis, Familial; Amyloidosis
Intervention: patisiran (ALN-TTR02); Sterile Normal Saline (0.9% NaCl)
Intervention description: administered by intravenous (IV) infusion; administered by intravenous (IV) infusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic; FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis

Summary:

      The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in
      patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term
      follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants
      who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of 18 to 85 years of age (inclusive);

          -  Have a diagnosis of FAP

          -  Neuropathy Impairment Score requirement of 5-130

          -  Meet Karnofsky performance status requirements

          -  Have adequate complete blood counts and liver function tests

          -  Have adequate cardiac function

          -  Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV)

        Exclusion Criteria:

          -  Had a prior liver transplant or is planned to undergo liver transplant during the
             study period;

          -  Has untreated hypo- or hyperthyroidism;

          -  Has known human immunodeficiency virus (HIV) infection;

          -  Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the
             skin or carcinoma in situ of the cervix that has been successfully treated;

          -  Recently received an investigational agent or device

          -  Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid
Multi-Center Study of New Medications to Treat Vaginal Infections
Condition: Vaginal Infection
MeSH terms: Infections
Intervention: Terconazole; Placebo
Intervention MeSH terms: Terconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the
      treatment of vaginal infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:

          -  Capable of providing written informed consent or assent

          -  Currently not menstruating and not anticipating menses during treatment

          -  If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically
             sterile, or practicing an acceptable form of birth control

          -  Negative pregnancy test

          -  Other criteria as identified in the protocol

        Exclusion Criteria:

          -  Other infectious causes of vulvovaginitis

          -  Subject has recently used, or is expected to require the concomitant use of prohibited
             medications/products

          -  Nursing mother

          -  Use of any investigational drug within 30 days of enrollment

          -  History of hypersensitivity to any ingredient/component of the formulations

          -  Other criteria as identified in the protocol
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
Confirmatory Study of OPC-12759 Ophthalmic Solution
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: OPC-12759; Placebo
Intervention description: Instillation, 4 times/day for 4 weeks
Intervention MeSH terms: Rebamipide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 209.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective
      compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a
      reference drug.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Out patient

          2. Subjective complaint of dry eye that has been present for minimum 20 months

          3. Ocular discomfort severity is moderate to severe

          4. Corneal - conjunctival damage is moderate to severe

          5. Unanesthetized Schirmer's test score of 5mm/5minutes or less

          6. Best corrected visual acuity of 0.2 or better in both eyes

        Exclusion Criteria:

          1. Presence of anterior segment disease or disorder other than that associated with dry
             eye

          2. Ocular hypertension patient or glaucoma patient with ophthalmic solution

          3. Anticipated use of any topically-instilled ocular medications or patients who cannot
             discontinue the use during the study

          4. Anticipated use of contact lens during the study

          5. Patient with punctal plug

          6. Any history of ocular surgery within 12 months

          7. Female patients who are pregnant,possibly pregnant or breast feeding

          8. Known hypersensitivity to any component of the study drug or procedural medications

          9. Receipt of any investigational product within 4 months.
Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation
Condition: Tachycardia, Ventricular; Catheter Ablation
MeSH terms: Tachycardia; Tachycardia, Ventricular
Intervention: Antiarrhythmic drug
Intervention description: Continuation of amiodarone or sotalol.
Intervention MeSH terms: Amiodarone; Sotalol; Anti-Arrhythmia Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients that meet inclusion criteria and agree to participate will be randomized and allocated to continue class III AADs or discontinuation using block randomization, stratified by type of AADs and type of cardiomyopathy (ischemic vs nonischemic) used until goal enrollment is achieved. The randomization sequence was created using STATA 14.2 (StataCorp, College Station, TX, USA) statistical software.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventricular Tachycardia; Catheter Ablation; Antiarrhythmic drugs

Summary:

      The investigators aim to study if patients that undergo catheter ablation for ventricular
      tachycardia benefit from continuation of Vaughan-Williams class III antiarrhythmic drugs for
      3 months after their ablation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18 years.

          2. Able to give written, informed consent

          3. Structural heart disease.

          4. Implanted and normally functioning ICD or undergoing ICD implant at index admission.

          5. Undergoing initial radiofrequency ablation procedure for sustained monomorphic VT.

          6. Receiving a class III AADs prior to VT ablation.

          7. No VT inducible at the end of VT ablation.

          8. No VT inducible on non-invasive programmed stimulation following VT ablation.

        Exclusion Criteria:

          1. LV assist device in place

          2. Decompensated heart failure and/or requiring continuous inotropic therapy and/or
             awaiting cardiac transplantation

          3. Ongoing acute coronary syndrome.

          4. Mechanical prosthetic aortic and mitral valves.

          5. Pedunculated or mobile left ventricular thrombus.

          6. Persistent VT at the end of index catheter ablation.

          7. Absolute contraindications for class III AADs.

          8. Participation in other trial.

          9. VT induced on NIPS after VT ablation.

         10. Another reason for continuation of class III AADs (i.e., atrial fibrillation).
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
Condition: Ankylosing Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Apremilast tablet 20 mg; Apremilast tablet 30 mg BID; Placebo
Intervention description: Apremilast 20 mg was taken orally twice a day (BID); Apremilast 30 mg was taken orally twice a day; Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 490.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: spondylitis; spondyloarthritis; Spondyloarthropathy; Oral preparation

Summary:

      Apremilast is a new, orally available, small molecule drug that specifically inhibits
      phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical
      study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain
             and stiffness, which improves with exercise, but is not relieved by rest for more than
             3 months prior to screening. At the completion of screening procedures, a documented
             diagnosis of definite active AS, as defined by the modified New York criteria (1984)
             whereby both criteria, at least 1 radiographic criterion and at least 1 clinical
             criterion, must be met

          -  Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is ≥ 4

          -  Total back pain is ≥ 4

          -  On stable dose of AS medication (or lack of medication) prior to randomization and
             through week 24

        Exclusion Criteria:

        - Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for
        AS
Comparing Safety and Efficacy of Dexmedetomidine and Propofol
Condition: Safety and Efficacy of Sedation Medications
Intervention: Dexmedetomidine; Propofol
Intervention description: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete.; An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete.
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 3 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: dexmedetomidine; propofol; sedation; MRI; scanning; pediatric; children; Magnetic Resonance Imaging

Summary:

      This is a prospective, open label randomized study. The purpose of this study is to compare
      propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically
      identifying important patient demographics and looking at important outcomes including
      adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is 3 - 11 years

          -  Patient is scheduled for MRI at Children's Hospital Boston.

          -  Patient meets criteria to receive either dexmedetomidine or propofol sedation

          -  Patient's guardian provides written consent

        Exclusion Criteria:

          -  Patient does not meet established sedation criteria

          -  Patient has history of allergy, intolerance, or reaction to dexmedetomidine or
             propofol or hypersensitivity

          -  Patient has current, repaired, or risk for Moya-Moya disease

          -  Patient has had a stroke within the past six months

          -  Patient has uncontrolled hypertension

          -  Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker

          -  Known soy, Lecithin, or egg allergy
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Intervention: GWP42003-P
Intervention description: Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open-label
Enrollment: 9.0
Sex: All
Minimum age: 1 Month
Maximum age: 24 Months
Healthy volunteers: No
Keywords: GWP42003-P; Cannabidiol

Summary:

      This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,
      and an open-label extension phase. The open-label extension phase only will be described in
      this record. All participants will receive GWP42003-P.
    

Eligibility criteria:

        Only participants who completed the pilot or pivotal phases of the trial may proceed to
        take part in this open-label extension phase of the trial.

        Key eligibility criteria for the blinded phase were as follows:

        Key Inclusion Criteria:

          -  Participant is diagnosed with IS and has failed to respond adequately following
             treatment with 1 or more approved IS therapies.

        Key Exclusion Criteria:

          -  Participant is currently taking or has taken clobazam or any mammalian target of
             rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit.

          -  Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB),
             of 460 msec or greater on ECG.

          -  Participant's caregiver is currently giving or has given recreational or medicinal
             cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the
             screening visit.

          -  Participant's caregiver is unwilling to abstain from giving the participant (including
             the participant's mother abstaining themselves, if breastfeeding)recreational or
             medicinal cannabis, or synthetic cannabinoid-based medications (other than the study
             drug) during the trial.

          -  Participant has any known or suspected hypersensitivity to cannabinoids or any of the
             excipients of the study drug, such as sesame oil.

          -  Participant has significantly impaired hepatic function at the screening visit.

          -  Participant has received an investigational medicinal product as part of a clinical
             trial within a minimum of 5 half-lives prior to the screening visit.
A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 3831
Intervention description: Tablets were administered for daily dosing
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Safety

Summary:

      The primary objective of this study is to evaluate the long term safety and tolerability of
      ALKS 3831 in subjects with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the 4-week treatment period (all visits up to and including end
             of treatment visit) in the antecedent study ALK3831-A305 within 7 days.

          -  Agrees to use an acceptable method of contraception for the duration of the study.

          -  Additional criteria may apply.

        Exclusion Criteria:

          -  Subject is currently taking medications that are contraindicated with olanzapine use.

          -  Subject has a positive test for drugs of abuse at study entry.

          -  Subject is pregnant, planning to become pregnant, or breastfeeding during the study.

          -  Additional criteria may apply.
Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Sponsor is also masked.
Enrollment: 986.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as galcanezumab in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of migraine as defined by International Headache Society (IHS)
             International Classification of Headache Disorders (ICHD)-3 beta version (1.1 or 1.2)
             (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
             screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 MHD.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to galcanezumab or another Calcitonin Gene-Related
             Peptide (CGRP) antibody.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to galcanezumab.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.