bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Cariprazine in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine; Placebo
Intervention description: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 446.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Acute Schizophrenia; Psychotropic Drugs; Antipsychotic Agents; Mental Disorders; Dopamine Agents; Central Nervous System Agents

Summary:

      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided informed consent prior to any study specific procedures

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,
             disorganized type, catatonic type or undifferentiated type), as confirmed by the
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (SCID)

          -  Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS)
             total score ≥ 80 and ≤ 120

          -  Diagnosis of schizophrenia for a minimum of 1 year before Visit 1

          -  Patients with normal physical examination, laboratory, vital signs,and/ or
             electrocardiogram (ECG)

        Exclusion Criteria:

          -  Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform
             disorder, other psychotic disorders other than schizophrenia, or bipolar I or II
             disorder

          -  Patients in their first episode of psychosis

          -  Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during
             the study

          -  Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and
             other cognitive disorders

          -  Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR
             axis II disorder of sufficient severity to interfere with participation in this study

          -  Substance abuse or dependence within the prior 3 months
An Efficacy and Safety Study of Ravulizumab in ALS Participants
Condition: Amyotrophic Lateral Sclerosis; ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Placebo; Ravulizumab
Intervention description: Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.; Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.
Intervention MeSH terms: Ravulizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ravulizumab; ALXN1210; Ultomiris; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; ALS

Summary:

      The purpose of the study is to assess the efficacy and safety of ravulizumab for the
      treatment of adult participants with ALS.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria
             (possible, laboratory-supported probable, probable, or definite ALS).

          2. ALS onset ≤ 36 months from Screening.

          3. Documented meningococcal vaccination not more than 3 years prior to, or at the time
             of, initiating study treatment.

          4. Upright slow vital capacity ≥ 65% predicted at Screening.

          5. If on riluzole, participant must be on a stable dose for 30 days; if on edaravone,
             participant must be on a stable dose for 60 days (2 cycles).

          6. Body weight ≥ 40 kilograms at Screening.

          7. Contraceptive use by men or women should be consistent with local regulations
             regarding the methods of contraception for those participating in clinical studies.

        Key Exclusion Criteria:

          1. History of Neisseria meningitidis infection.

          2. Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody
             titer).

          3. Dependence on invasive or non-invasive mechanical ventilation.

          4. Previously or currently treated with a complement inhibitor.

          5. Exposure to an investigational drug or device within 30 days of Screening or 5 half
             lives of the study drug, whichever is greater.
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
Condition: Antibody-mediated Rejection
Intervention: C1-esterase inhibitor; Placebo
Intervention description: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution; Excipients of C1-INH plus albumin
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized-withdrawal
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibody-mediated kidney transplant rejection; Renal

Summary:

      This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant
      patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase
      inhibitor as add-on to standard of care (IVIG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age;

          -  Evidence of at least one donor-specific antibody (DSA);

          -  Recipient of a kidney transplant;

          -  Achieved a steady-state, post-transplant eGFR ≥ 40 mL/min/1.73 m2 within 60 days of
             post-transplant OR a 50% increase in urine output with a 50% decrease in serum
             creatinine over the first 7 days post-transplant in subjects with slow or delayed
             graft function;

          -  Acute AMR.

        Exclusion Criteria:

          -  Recipient of an en bloc kidney transplant;

          -  Current active hepatitis C virus (HCV) infection;

          -  Active bacterial or fungal infection;

          -  Ongoing dialysis >2 weeks;

          -  Known congenital bleeding or coagulopathy disorder;

          -  Current cancer or a history of cancer;

          -  Female subjects who are pregnant or breast feeding;

          -  Male or female subjects who are unwilling to use contraception or who are not
             surgically sterile.
Long-term Study of DSP-5423P in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: DSP-5423P
Intervention description: 40-80mg/day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria

          -  Patients who are aged 18 years or older at informed consent

          -  Patient understands the objectives and procedures of the study and who provide written
             voluntarily consent to participate in the study, etc.

        Exclusion Criteria:

          -  Patients who fall under a contraindication listed in the LONASEN® package insert

          -  Patients with Parkinson disease, etc.
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy; Stroke
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: Botulinum Toxin Type A
Intervention description: Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the
      treatment of pediatric upper limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum weight of 10 Kilograms (kg) / 22 Pounds (lb)

          -  Upper limb spasticity due to cerebral palsy or stroke

        Exclusion Criteria:

          -  Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
             sclerosis, or mitochondrial disease

          -  Uncontrolled epilepsy

          -  Botulinum Toxin therapy of any serotype for any condition within the last 3 months

          -  History of surgical intervention of the upper limb within 1 year, or planned surgery
             of any limb during the study
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.
Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma
Condition: Severe Asthma
MeSH terms: Asthma
Intervention: Biological: Experimental: Tezepelumab
Intervention description: Tezepelumab subcutaneous injection every 4 weeks
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All subject will be dosed tezepelumab administered subcutaneously
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Asthma; Uncontrolled Asthma; Severe Uncontrolled Asthma

Summary:

      This is an open-label, single arm study designed to evaluate the safety of tezepelumab
      administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with
      inadequately controlled severe asthma.
    

Eligibility criteria:

        Inclusion Criteria:

        Age. 12-80 Documented physician-diagnosed asthma for at least 12 months Subjects who have
        received a physician-prescribed asthma controller medication with medium or high dose ICS
        for at least 12 months.

        Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg
        fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3
        months.

        At least one additional maintenance asthma controller medication is required according to
        standard practice of care and must be documented for at least 3 months.

        Documented history of at least 1 asthma exacerbation events within 12 months. ACQ-6 score
        ≥1.5 at screening or on day of registration.

        Exclusion Criteria:

        Pulmonary disease other than asthma. History of cancer. History of a clinically significant
        infection. Current smokers or subjects with smoking history ≥10 pack-yrs. History of
        chronic alcohol or drug abuse within 12 months. Hepatitis B, C or HIV. Pregnant or
        breastfeeding. History of anaphylaxis following any biologic therapy. Subject randomized in
        the current study or previous tezepelumab studies
Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
Condition: Fatigue
MeSH terms: Fatigue
Intervention: armodafinil 150 mg; Placebo; armodafinil 250 mg
Intervention description: given orally; given orally; given orally
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies armodafinil to see how well it works in reducing
      cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve
      fatigue in patients with high grade glioma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma,
             glioblastoma with oligo features, glioblastoma with primitive neuroectodermal
             tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic
             oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have
             completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24
             months prior to enrollment; NOTE: clinical stability will be defined as a stable or
             improved Karnofsky performance status (KPS) compared to the prior month

          -  >= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question
             3); it is not required for the patient to complete the entire BFI to meet this
             criterion

          -  Undergone surgery (gross total or subtotal resection) or biopsy and will have been
             treated with concurrent radiation therapy and chemotherapy as standard of care for
             glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with
             oligo features, glioblastoma with primitive neuroectodermal tumor-like components
             (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or
             anaplastic oligoastrocytoma patients; Note: radiation must be completed, but
             chemotherapy is allowed; patients who are currently using Optune device will be
             eligible to participate in this trial

          -  Negative serum pregnancy test done =< 7 days prior to registration only for women
             determined to be of childbearing potential by their treating physician

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3

          -  Provide informed written consent

          -  Willing to return to enrolling institution for follow-up (during the Active Monitoring
             Phase of the study)

          -  Stable dose of corticosteroid >= 14 days prior to registration
A 6-Month Extension Study of OTO-104 in Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Intervention: OTO-104
Intervention description: Single intratympanic injection of 12 mg OTO-104
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label extension study of a single intratympanic injection of OTO-104 given
      every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study
      104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to
      be eligible for this open-label extension study.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506)
             clinical study.

          -  Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS
             criteria

        Exclusion Criteria includes, but is not limited to:

          -  Subject is pregnant or lactating.

          -  Subject has a history of immunodeficiency disease.

          -  Subject has experienced an adverse reaction to intratympanic injection of steroids.
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
Condition: Sjogrens Disease
MeSH terms: Sjogren's Syndrome
Intervention: Abatacept; Placebo
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in
      patients with Sjögren's Syndrome.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5

          -  Positive anti-SS-A/Ro antibody at screening

          -  meet the 2016 American College of Rheumatology (ACR) / European League Against
             Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)

        Exclusion Criteria:

          -  Secondary Sjögrens syndrome

          -  Active life-threatening or organ-threatening complications of Sjögren's-syndrome

          -  Other medical condition associated with sicca syndrome

        Other protocol defined inclusion/exclusion criteria could apply
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Intervention: turoctocog alfa; turoctocog alfa
Intervention description: The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.; Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Male
Healthy volunteers: No

Summary:

      This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy
      of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe
      haemophilia A (FVIII≤1%).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients

          -  Age from 0 years

          -  With the diagnosis of severe congenital haemophilia A (FVIII≤1%)

          -  History of exposure days (ED) to any FVIII products fulfilling the criteria of
             previously treated patients:

          -  Patients of 12 years or above: 100 exposures days (ED) or more

          -  Patients below 12 years: 50 exposure days (ED) or more

        Exclusion Criteria:

          -  Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory

          -  Known history of FVIII inhibitors