bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 465.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared
      to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive
      disorder (MDD) who have a partial response to ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Visit 1

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study

               5. Dissociative disorder

               6. Posttraumatic stess disorder

               7. MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: maribavir; ganciclovir
Intervention description: 100mg twice a day for 14 weeks.; 1000mg three times per day for 14 weeks.
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate; Maribavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cytomegalovirus; CMV; prophylaxis; liver; liver transplant

Summary:

      The purpose of this research study is to investigate whether or not oral maribavir is safe
      and effective compared to oral ganciclovir for preventing CMV disease when administered for
      up to 14 weeks in patients who have had a liver transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Orthotopic liver transplant recipient

          -  Donor CMV seropositive / Recipient CMV seronegative

          -  Enrolled within 10 days after liver transplant

          -  Able to swallow tablets

        Exclusion Criteria:

          -  Multiple organ transplant

          -  HIV infection

          -  CMV disease

          -  Use of other anti-CMV therapy at time of enrollment
Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Intervention: OPC-34712 + ADT; Placebo + ADT; Placebo + ADT
Intervention description: Tablet, Oral, 2 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT); Placebo + FDA Approved Antidepressant (ADT); Placebo + FDA Approved Antidepressant (ADT)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 826.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment

Summary:

      To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive
      substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in
      patients with Major Depressive Disorder who demonstrate an incomplete response to a
      prospective trial of the same assigned FDA approved ADT
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 and 65 years of age, with diagnosis of major
             depressive disorder, as defined by DSM-IV-TR criteria

          -  The current depressive episode must be equal to or greater than 8 weeks in duration

          -  Subjects must report a history for the current depressive episode of an inadequate
             response to no more than three adequate antidepressant treatments

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug

          -  Subjects who report an inadequate response to more than three adequate trials of
             antidepressant treatments during current depressive episode at a therapeutic dose for
             an adequate duration.

          -  Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic
             or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other
             psychotic disorder, Bipolar I or II disorder

          -  Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of
             borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality
             disorder
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Condition: Choroidal Neovascularization; Macular Edema; Glaucoma, Neovascular; Diabetic Retinopathy
MeSH terms: Macular Edema; Diabetic Retinopathy; Choroidal Neovascularization; Glaucoma, Neovascular; Neovascularization, Pathologic
Intervention: ranibizumab
Intervention description: One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare
      VEGF driven ocular diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active choroidal neovascularization (CNV)

          -  Active macular edema (ME)

          -  Rubeosis iridis/neovascular glaucoma.

          -  Proliferative diabetic retinopathy requiring vitrectomy.

        Exclusion Criteria:

          -  wet Age-related macular degeneration

          -  pathologic myopia

          -  pseudoxanthoma elasticum

          -  diabetic macular edema

          -  retinal vein occlusion

          -  < 18 years of age

          -  History of hypersensitivity to ranibizumab

          -  Use of any systemic anti-angiogenic drugs 3 months before inclusion

          -  Women of child-bearing potential and Pregnant or nursing (lactating) women.

          -  Active or suspected ocular infection
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Fumaderm; risankizumab
Intervention description: Fumaderm tablet administered orally; Risankizumab administered by subcutaneous (SC) injection
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: ABBV-0066; BI 655066; risankizumab

Summary:

      The purpose of this study is to compare the efficacy and safety of subcutaneous (SC)
      risankizumab and oral FUMADERM provided as study medication in participants with moderate to
      severe plaque psoriasis who are naïve to and candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first
             administration of study drug. Duration since diagnosis may be reported by the
             participant

          -  Participant has stable moderate to severe plaque psoriasis (body surface area [BSA]
             >10, Psoriasis Area and Severity Index [PASI] >10, and Dermatology Quality of Life
             Index [DLQI] >10) with or without psoriatic arthritis at Baseline

          -  Must be naïve to and candidate for systemic therapy, as assessed by the investigator

          -  Participant has an inadequate response, intolerance or contraindication to topical
             psoriasis treatment

        Exclusion Criteria:

          -  Participants with non-plaque forms of psoriasis

          -  Participant has previously received systemic therapy for psoriasis, whether biologic
             or non-biologic or photochemotherapy

          -  Active systemic infection during the last 2 weeks (exception: common cold) prior to
             screening.

          -  Any documented active or suspected malignancy or history of malignancy within 5 years
             prior to screening, except appropriately treated basal or squamous cell carcinoma of
             the skin or in situ carcinoma of uterine cervix

          -  Participant has any condition or contraindication to Fumaderm that would preclude the
             patient's participation in the present study
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept; CHS-0214
Intervention description: Head-to-head comparison
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 521.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PsO

Summary:

      This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who
      have not yet received any biologic therapy for any indication (other than insulin or
      hormones).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults

          -  PsO diagnosis for 6 months

          -  Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment
             (PSGA) score greater than or equal to 3 (based on a scale or 0-5),

          -  Body Surface Area (BSA) involved with PsO greater than or equal to 10%

          -  Dermatology Life Quality Index (DQLI) greater than or equal to 10

          -  Previously received phototherapy or systemic non-biologic therapy for PsO

        Exclusion Criteria:

          -  Forms of Psoriasis other than PsO

          -  Drug induced Psoriasis

          -  Positive QuantiFERON-tuberculosis (TB) Gold Test

          -  Presence of significant comorbid conditions

          -  Chemistry and hematology values outside protocol specified range

          -  Major systemic infections
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
Condition: Coronary Artery Disease; General Anesthetic Drug Allergy; Coronary Artery Bypass Graft Surgery
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Drug Hypersensitivity
Intervention: Xenon; Sevoflurane; Propofol
Intervention description: Inhaled xenon, maximal inspired concentration of 65%.; Inhaled sevoflurane, maximal inspired concentration of 1.8%.; Hourly dose of 2-4 mg/kg
Intervention MeSH terms: Propofol; Sevoflurane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 509.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Xenon; Sevoflurane; Propofol; Total intravenous anaesthesia; Anaesthesia; Coronary artery disease; Coronary artery bypass graft

Summary:

      Xenon is a gaseous anaesthetic agent registered in several European countries. It has been
      administered safely during cardiac surgery in pilot studies. In animal studies, xenon
      decreases the size of experimental myocardial infarction.

      This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous
      anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery
      conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before
      and after extracorporeal circulation. Propofol will be administered during extracorporeal
      circulation in the three groups of patients.

      The study will compare the postoperative myocardial damage observed 24 hours after surgery
      from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The
      main hypothesis is that the myocardial damage observed after xenon administration will not be
      superior to the damage observed after sevoflurane administration (non-inferiority). The
      second hypothesis is that the myocardial damage observed after xenon administration will be
      inferior to the damage observed after total intravenous anaesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  coronary artery disease

          -  elective surgery, planned coronary artery bypass graft

          -  moderate hypothermia or normothermia

          -  cardiac arrest cold and warm cardioplegia

          -  normal of moderately impaired left ventricular systolic function

          -  written informed consent

        Exclusion Criteria:

          -  pregnancy or child bearing potential

          -  ongoing treatment with nicorandil or sulfonylurea medication

          -  severe renal or hepatic dysfunction

          -  ongoing myocardial infarction or unstable angina
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
Condition: Normal Pressure Hydrocephalus
MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure
Intervention: [18F] Flutemetamol
Intervention description: All subjects will receive an intravenous (IV) dose of [18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels (MBq).
Intervention MeSH terms: Flutemetamol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Amyloid; NPH Normal pressure hydrocephalus; PET Positron Emission Tomography; SUVR Standard uptake value ratios

Summary:

      This study will determine the level of association between the quantitative estimates of
      brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of
      amyloid levels in biopsy samples previously obtained during shunt placement in patients who
      have normal pressure hydrocephalus (NPH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is 50 years old or older.

          -  The subject has had a frontal lobe cortical biopsy adequate for the detection and
             quantitation of amyloid.

          -  Informed consent has been signed and dated by the subject/and/or subjects' legally
             acceptable representative, if applicable, in accordance with local regulations.

        Exclusion Criteria:

          -  The subject has a contraindication for MRI or PET.

          -  The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol.

          -  The subject has participated in any clinical study using an investigational agent
             within 30 days of dosing.
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Placebo; GP2017 (adalimumab biosimilar); AIN457 150 mg
Intervention description: Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes; 40 mg in pre-filled syringes was administered subcutaneously; 150 mg in pre-filled syringes was administered subcutaneously
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study was partially blinded. Subjects, investigators, site personnel, persons performing the assessments, monitors and the Sponsor remained blinded to the dose group of secukinumab (150 mg versus 300 mg)
Masking: Single (Outcomes Assessor)
Masking description: The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
Enrollment: 859.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ankylosing spondylitis; AS; secukinumab; GP2017; adalimumab biosimilar; mSASSS; ASAS20; ASAS40; adult; r-axSpA; AIN457; radiographic; SURPASS

Summary:

      The purpose of this study is to demonstrate the impact of secukinumab on the progression of
      structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis
      Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-nursing female patients at least 18 years of age

          -  Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence
             (centrally read X-ray) fulfilling the Modified New York criteria for AS despite
             previous or current NSAID/ nonbiologic DMARD therapy

          -  Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10

          -  Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)

          -  Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)

          -  hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

        Exclusion Criteria:

          -  Patients with total ankylosis of the spine

          -  Pregnant or nursing (lactating) women

          -  Evidence of ongoing infectious or malignant process

          -  Previous exposure to any biologic immunomodulating agent, including those targeting
             IL-17, IL-17 receptor or TNFα

          -  Subjects taking high potency opioid analgesics

          -  Previous treatment with any cell-depleting therapies including but not limited to
             anti-CD20, investigational agents

        Other protocol-defined inclusion/exclusion criteria may apply
Smoking-Cessation and Stimulant Treatment (S-CAST)
Condition: Cocaine Dependence; Methamphetamine Dependence; Nicotine Dependence
MeSH terms: Tobacco Use Disorder; Cocaine-Related Disorders
Intervention: Smoking-cessation treatment
Intervention description: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 538.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stimulant treatment; Smoking Cessation

Summary:

      The primary objective of this study is to evaluate the impact of substance-abuse treatment as
      usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as
      usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether
      concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use
      outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or
      methamphetamine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of cocaine/methamphetamine dependence

          -  Smoked cigarettes for at least 3 months

          -  Currently smoking > 6 cigarettes/day

          -  Have an interest in quitting smoking

          -  Enrolled in outpatient treatment at a participating site

        Exclusion Criteria:

          -  Clinical diagnosis of current alcohol or sedative dependence, bipolar disorder; or a
             life-time diagnosis of anorexia nervosa or bulimia

          -  Seeking/receiving treatment for opiate-agonist replacement therapy

          -  Medical conditions that could compromise participant safety

          -  Taking medications with known/potential interactions with bupropion

          -  Hypersensitivity to bupropion, nicotine, or menthol

          -  Pregnant or breastfeeding

          -  Abnormal ECG

          -  Recent smoking cessation treatment

          -  Use of tobacco products other than cigarettes in the past week

          -  Likely to enter residential/inpatient treatment within 10 weeks

          -  Have all stimulant-positive urine drug screens during screening/baseline