bioihbjkbjnl/mcl2 huggingface dataset:
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
Condition: Surgical Skin Preparation
Intervention: ZuraPrep Clear Solution; ChloraPrep; ZuraPrep Vehicle
Intervention description: Apply topically.; Apply topically.; Apply topically.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex
      Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of
      human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good general health

          -  Minimum bacterial baseline requirements on abdomen and groin

          -  Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder
             near or on the applicable test area.

        Exclusion Criteria:

          -  Topical or systemic antimicrobial exposure within 14 days prior to screening and
             treatment days, including antibiotics.

          -  Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to
             screening and treatment days, excluding contraception or post-menopausal treatment.

          -  Subjects with allergies to study materials including isopropyl alcohol or
             chlorhexidine gluconate.

          -  Subjects with a history of skin sensitivity, skin allergies, or skin cancer.

          -  Subjects who are pregnant, attempting pregnancy or nursing.
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: 1% SPL7013 Gel; Placebo
Intervention description: Vaginal gel, daily for 7 days; Vaginal gel, daily for 7 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 251.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: SPL7013; VivaGel; bacterial vaginosis; BV

Summary:

      The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to
      placebo gel for the treatment of bacterial vaginosis (BV).

      After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or
      hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime
      for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and
      Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12)
      and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day
      21-30).
    

Eligibility criteria:

        Key eligibility criteria:

          -  Post-menarchal females, aged 12 years or more

          -  Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms:
             presence of white to grey homogeneous discharge; positive whiff test indicating an
             amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5;
             and presence at least 20% clue cells of total epithelial cells

          -  Nugent score of at least 4

          -  Otherwise healthy, as determined by medical history, physical examination

          -  normal Pap smear at or documented within 24 months of screening
Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Azithromycin microspheres; minocycline-placebo capsules; Azithromycin microspheres-placebo; Minocycline capsules,
Intervention description: Azithromycin microspheres, powder for oral suspension, 2 g a week, in unique administration PO, repeated weekly for 8 weeks and minocycline-placebo capsules daily for 8 weeks plus minocycline placebo; minocycline-placebo capsules daily for 8 weeks plus minocycline placebo; Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.; Capsules, PO, 100 mg daily for 8 weeks.
Intervention MeSH terms: Azithromycin; Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 118.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The primary objective is to evaluate the clinical efficacy of azithromycin microspheres
      treatment in outpatients with moderate to severe inflammatory acne compared with first line
      treatment minocycline after 8 weeks of therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and female, > 16 years of age, with diagnosis of acne papulo-pustular, moderate
             (19-30 GAGS score) to severe (31-33 GAGS score)

        Exclusion Criteria:

          -  pregnancy, gastrointestinal and endocrinological disease, specific systemic disease,
             hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)
Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging
Condition: Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases
Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention description: Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Central Nervous System Imaging; Diagnostic Imaging

Summary:

      This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called
      Gadavist. The purpose of this study is to look at the safety (what are the side effects) and
      efficacy (how well does it work) of Gadavist when used for taking images of the brain and
      spine. The results of the MRI will be compared to the results of images taken without
      Gadavist.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous
             procedures.

        Exclusion Criteria:

          -  Patients with acute renal insufficiency

          -  Patients with severe renal disease

          -  Patients with any contraindication to magnetic resonance imaging.
Study of the Effect of omega3 on Biomarkers of Cardiac Necrosis (CKMB and Troponin I) and Inflammation Marker (CRP) After Elective Percutaneous Coronary Intervention (PCI)
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Inflammation; Necrosis
Intervention: omega 3
Intervention description: 3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: elective percutaneous coronary intervention; hs-CRP; CKMB and troponin I

Summary:

      The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac
      necrosis(CKMB and troponin I) and inflammation marker CRP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  candidate of elective PCI

          -  treatment with aspirin at least 5 days before PCI

        Exclusion Criteria:

          -  high CKMB and troponin I level

          -  cardiac bypass in recent 3 months

          -  platelet count < 70×10 9/L

          -  sever chronic renal failure

          -  active bleeding

          -  treatment with glycoprotein IIb/IIIa inhibitors during PCI

          -  treatment with bivalirudin during PCI

          -  sensitivity to aspirin and clopidogrel
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Condition: Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone
Intervention: Zandelisib; Rituximab; Bendamustine; CHOP
Intervention description: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3; Rituximab IV 375 mg/m2 for 6 cycles; Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles; Cyclophosphamide, Vindcristine IV, and Prednisone daily orally
Intervention MeSH terms: Prednisone; Cyclophosphamide; Bendamustine Hydrochloride; Rituximab; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1: Rituximab plus Zandelisib
Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with
      rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or
      Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for
             subjects in Japan and Taiwan

          -  Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype
             limited to:

               1. FL Gr 1, Gr 2, or Gr 3a

               2. MZL (splenic, nodal, or extra-nodal)

          -  Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy

          -  Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm

          -  Adequate hematologic parameters at screening unless abnormal values are due to disease

          -  Adequate renal and hepatic function

          -  Adequate cardiac function based on ECG and LVEF assessments

        Exclusion Criteria:

          -  Histologically confirmed diagnosis of FL Gr 3b or transformed disease

          -  Prior therapy with PI3K inhibitors

          -  Ongoing or history of drug-induced pneumonitis

          -  Known lymphomatous involvement of the central nervous system

          -  Tested positive for or active viral infection with hepatitis B or C virus

          -  Tested positive or active infection with human immunodeficiency virus

          -  Tested positive, or active infection with human T-cell leukemia virus type 1

          -  Any uncontrolled clinically significant illness

          -  History of clinically significant cardiovascular abnormalities such as congestive
             heart failure

          -  History of clinically significant gastrointestinal (GI) conditions

          -  Females who are pregnant
A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: SM-13496 40mg; SM-13496 80mg; Placebo
Intervention description: once daily orally; once daily orally; once daily orally
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 457.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
      with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets DSM-IV-TR criteria for schizophrenia.

          -  Patient is aged 18 through 74 years at informed consent.

          -  Patient understands the objectives, procedures, and possible benefits and risks of the
             study and who provide written voluntarily consent to participate in the study

        Exclusion Criteria:

          -  Patient has a history of neuroleptic malignant syndrome, water intoxication, or
             paralytic ileus.

          -  Patient has Parkinson's disease.

          -  Patient has a history or complication of malignancy.
TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; placebo; tocilizumab [RoActemra/Actemra]
Intervention description: single iv infusion 8 mg/kg; single iv infusion; iv infusion 8mg/kg every 4 weeks for 11 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the onset and maintenance of effect of tocilizumab on relief in
      patients with active moderate or severe rheumatoid arthritis who have had an inadequate
      response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will
      be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4
      weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every
      4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target
      sample size is >100.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >/= 18 years of age

          -  active moderate or severe rheumatoid arthritis of <10 years duration with inadequate
             response to methotrexate or anti-TNF

          -  on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose

          -  patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4
             weeks

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA

          -  functional class IV by ACR classification

          -  history of inflammatory joint disease other than RA

          -  previous treatment with cell-depleting therapies, abatacept or rituximab

          -  active current or history of recurrent infection, or any major episode of infection
             requiring hospitalization or treatment with iv antibiotics <4 weeks or oral
             antibiotics <2 weeks prior to screening
Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
Condition: Influenza; Fever
MeSH terms: Influenza, Human
Intervention: Mammalian cell based flu vaccine; Egg based flu vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2055.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; children and adolescents; trivalent vaccine; cell culture; embryonated chicken eggs

Summary:

      Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents
      4 to 17 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

        - Healthy subjects 4-17 years of age

        Exclusion Criteria:

          -  Subjects who are not healthy,

          -  Subjects who are pregnant or breast feeding,

          -  Subjects with a history of severe allergic reaction or allergic to any of the vaccine
             components.
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Teriflunomide; Placebo (for teriflunomide)
Intervention description: Film-coated tablet
Oral administration; Film-coated tablet
Oral administration
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1088.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing Remitting; Secondary Progressive; Progressive Relapsing

Summary:

      The primary objective was to determine the effect of teriflunomide on the frequency of
      relapses in patients with relapsing multiple sclerosis (MS).

      Secondary objectives were:

        -  to evaluate the effect of teriflunomide on the accumulation of disability as measured by
           Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic
           Resonance Imaging [MRI] and patient-reported fatigue;

        -  to evaluate the safety and tolerability of teriflunomide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Multiple sclerosis [MS] subject who was ambulatory (EDSS of ≤ 5.5)

          -  Exhibiting a relapsing clinical course, with or without progression (relapsing
             remitting, secondary progressive or progressive relapsing);

          -  Meeting McDonald's criteria for MS diagnosis;

          -  Experienced at least 1 relapse over the 1 year preceding the trial or at least 2
             relapses over the 2 years preceding the trial;

          -  No relapse onset in the preceding 60 days prior to randomization;

          -  Clinically stable during the 30 days prior to randomization, without
             adrenocorticotrophic hormone [ACTH] or systemic steroid treatment.

        Exclusion Criteria:

          -  Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
             systemic disease;

          -  Significantly impaired bone marrow function;

          -  Pregnant or nursing woman;

          -  Alcohol or drug abuse;

          -  Use of cladribine, mitoxantrone, or other immunosuppressant agents such as
             azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before
             enrollment;

          -  Any known condition or circumstance that would prevent in the investigator's opinion
             compliance or completion of the study;
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Condition: Healthy
Intervention: Gabapentin; Diphenhydramine citrate; Triazolam; Placebo
Intervention description: 250 mg, oral, prior to bedtime on the night before performance testing; 76 mg, oral, prior to bedtime on the night before performance testing; 0.5 mg, oral, prior to bedtime on the night before performance testing; Oral, prior to bedtime on the night before performance testing
Intervention MeSH terms: Diphenhydramine; Promethazine; Triazolam; Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 25 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sleeplessness

Summary:

      This study will examine the next-day residual effects of a nighttime dose of gabapentin 250
      mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on
      simulated driving performance in normal volunteer subjects. It will also examine other
      measures of next-day performance and next-day sleepiness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and females of non-childbearing potential, 25-55 years of age

          -  Valid driver's license

        Exclusion Criteria:

          -  Psychiatric disorder

          -  Recent history of clinically significant neurological disorder, such as seizures,
             stroke, multiple sclerosis, or head trauma

          -  Recent histroy or current treatment for sleep disorder
A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus 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: Brexpiprazole; Seroquel XR; Placebo
Intervention description: tablet/capsule; tablet/capsule; tablet/capsule
Intervention MeSH terms: Quetiapine Fumarate; Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2182.0
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 efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy
      to an assigned open label antidepressant therapy (ADT) in the proposed subject population
      with MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed
             consent.

          -  Subjects with both a diagnosis of MDD, and in a current major depressive episode, as
             defined by DSM-IV-TR criteria

          -  Subjects willing to discontinue all prohibited psychotropic medications to meet
             protocol-required washouts prior to and during the trial period.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result during
             screening prior to receiving trial medication

          -  Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia,
             Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder,
             Posttraumatic stress disorder

          -  Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the
             current major depressive episode.

          -  Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the
             past 180 days

          -  Subjects currently treated with insulin for diabetes.

          -  Subjects with uncontrolled hypertension

          -  Subjects with known ischemic heart disease or history of myocardial infarction,
             congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery

          -  Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs

          -  Inability to swallow tablets or tolerate oral medication

          -  Abnormal laboratory test results, vital signs and ECG results

          -  Subjects who previously participated in any prior brexpiprazole clinical trial.