bioihbjkbjnl/mcl2 huggingface dataset:
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Condition: Bipolar I Disorder
Intervention: SM-13496
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 495.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I
      disorder.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who completed the D1002001 study

        ・Patients who completed the D1002001 study and who are considered by the investigator to be
        eligible and without safety concerns.

        Patients who did not participate in the D1002001 study

          -  Patients who were fully informed of and understand the objectives, procedures, and
             possible benefits and risks of the study and who provided written voluntary consent to
             participate in the study.

          -  Outpatients aged 18 through 74 years at the time of consent

          -  Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode manic,
             hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood
             disturbance, but < 8 episodes in the previous 12 months prior to screening).

        Exclusion Criteria:

          -  Patients with imminent risk of suicide or injury to self, others, or property.

          -  Patients who are otherwise considered ineligible for the study by the investigator.
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: TAS-102; Placebo
Intervention description: 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.; Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 800.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Refractory, metastatic colorectal cancer

Summary:

      The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in
      patients with refractory metastatic colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has provided written informed consent

          2. Has adenocarcinoma of the colon or rectum

          3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic
             colorectal cancer

          4. ECOG performance status of 0 or 1

          5. Is able to take medications orally

          6. Has adequate organ function (bone marrow, kidney and liver)

          7. Women of childbearing potential must have a negative pregnancy test and must agree to
             adequate birth control if conception is possible. Males must agree to adequate birth
             control.

        Exclusion Criteria:

          1. Certain serious illnesses or medical condition(s)

          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,
             extended field radiation, received investigational agent, within the specified time
             frames prior to study drug administration

          3. Has received TAS-102

          4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any
             prior therapies

          5. Is a pregnant or lactating female
Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Eprosartan; Eprosartan Mesylate; Placebo Eprosartan mesylate; Placebo Eprosartan
Intervention description: Eprosartan 450 mg; Eprosartan mesylate 600 mg; Placebo Eprosartan mesylate; Placebo Eprosartan
Intervention MeSH terms: Eprosartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Aim of this study is to compare the blood pressure lowering effect of a new drug formulation
      of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide
      since years with proven efficacy. The new formulation is compared to the currently marketed
      eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be
      demonstrated.
    

Eligibility criteria:

        Inclusion Criteria

          -  Males or females with essential hypertension, blood pressure values between 140 mmHg
             and 179 mmHg systolic and between 90 mmHg and 109 mmHg diastolic

          -  Given written informed consent prior to starting the study

        Exclusion Criteria

          -  Women with childbearing potential, breast feeding or pregnant;

          -  Inability to discontinue all prior antihypertensive medication;

          -  Secondary hypertension

          -  Severe hypertension

          -  Severe diabetes mellitus (HbA1c greater 8.5%)
Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Intervention: Gardasil™; Placebo
Intervention description: Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6); Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 176.0
Sex: Female
Minimum age: 9 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Papilloma Virus

Summary:

      This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age
      in Korea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Girls ages 9 to 15 years (must not yet have had coitarche)

          -  Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3
             male or female sexual partners)

        Exclusion Criteria:

        All Subjects:

          -  History of known prior vaccination with an HPV vaccine.

        Women Ages 16 to 23 Only:

          -  Individuals with any prior history of genital warts or treatment for genital warts.

          -  Individuals with > 3 lifetime male or female sexual partners.
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: PF-05280586; MabThera®
Intervention description: PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22; MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rituximab; follicular lymphoma; Non-Hodgkin lymphoma; Non-Hodgkin's lymphoma

Summary:

      This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in
      patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to
      be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall
      Response Rate, is similar to that of rituximab-EU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma

          -  Ann Arbor Stage II, III, or IV

        Exclusion Criteria:

          -  Not a candidate for treatment with rituximab as a single-agent

          -  Evidence of transformation to a high grade or diffuse large B-cell lymphoma

          -  Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy,
             or steroids

          -  Any prior treatment with rituximab

          -  Active, uncontrolled infection
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ponesimod; Placebo
Intervention description: One tablet of ponesimod 20 mg administered orally once daily in the morning from Day 15 to EOT. To reduce the first-dose effect of ponesimod, an uptitration scheme will be implemented from Day 1 to Day 14 (with dose strength increasing from 2 mg to 20 mg).; One tablet of matching placebo administered orally once daily in the morning
Intervention MeSH terms: Ponesimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod
      vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to initiation of any study-mandated procedure.

          -  Women of childbearing potential must have a negative pregnancy test and use reliable
             methods of contraception

          -  Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic
             Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple
             sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed
             relapses).

          -  Ongoing treatment with DMF for at least 6 months prior to screening

          -  Active disease after at least 3 months of DMF treatment

          -  Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).

        Exclusion Criteria:

          -  Lactating or pregnant women and women intending to become pregnant during the study.

          -  Presenting with a diagnosis of MS with progressive course from onset (i.e., primary
             progressive MS or progressive relapsing MS).

          -  Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS
             assessment.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             full participation in the study or compliance with the protocol.
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Condition: Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction); Bronchopulmonary Dysplasia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Premature Birth
Intervention: Infasurf (ONY Inc.); Sham
Intervention description: Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.; Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
Intervention MeSH terms: Calfactant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 7 Days
Maximum age: 14 Days
Healthy volunteers: No
Keywords: nitric oxide; surfactant; bronchopulmonary dysplasia; prematurity; neonates; iNO; Infasurf; lung function; ventilated infants

Summary:

      The purpose of this study is to determine if the combination of late doses of Infasurf with
      inhaled nitric oxide will interact to improve the surfactant function and thus the
      respiratory status and outcome of treated infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Less than or equal to 1000 gm. birth weight

          -  Less than or equal to 30 weeks gestational age

          -  Day 7-14 of life

          -  Intubated and mechanically ventilated at any time days 7-14 of life

        Exclusion Criteria:

          -  Serious congenital malformations

          -  Life expectancy less than 7 days from enrollment

          -  Previous treatment with iNO

          -  Active pulmonary hemorrhage at time of enrollment

          -  Active air leak syndrome at time of enrollment

          -  Bilateral grade IV intracranial hemorrhage prior to enrollment

          -  Less than 48 hours from last clinical dose of early surfactant.
Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: 210 mg brodalumab; 140 mg brodalumab; Placebo
Intervention description: 210 mg brodalumab administered via subcutaneous injection; 140 mg brodalumab administered via subcutaneous injection; Placebo administered via subcutaneous injection until week 24.
Intervention MeSH terms: Brodalumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Brodalumab; AMG 827

Summary:

      The primary objective of this study is to evaluate the efficacy of brodalumab, compared to
      placebo, in subjects with psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic
             Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding the
             distal interphalangeal joints)).

          -  Subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on a
             centrally read radiograph or an elevated CRP.

        Exclusion Criteria:

          -  Subject has known history of active tuberculosis.

          -  Subject has a planned surgical intervention between baseline and the week 52
             evaluation.

          -  Subject has an active infection or history of infections.

          -  Subject has any systemic disease (eg, renal failure, heart failure, hypertension,
             liver disease, diabetes, anemia) considered by the Investigator to be clinically
             significant and uncontrolled.

          -  Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality
             that, in the opinion of the investigator, could cause this study to be detrimental to
             the subject.

          -  Subject has severe depression measured by Personal Health Questionnaire Depression
             Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide
             Severity Rating Scale (e-CSSRS)

          -  Subject has a history or evidence of psychiatric disorder or substance abuse
             considered by the Investigator to pose a risk to subject safety
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Darbepoetin alfa; Placebo
Intervention description: Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion.; Prefilled syringe placebo, to match active arm
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 51.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Quality of Life; Chronic Kidney Disease; Anemia

Summary:

      Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety
      follow up phase of 52 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 3-5 CKD not on dialysis

          -  Patients ≥ 70 years of age

          -  Haemoglobin < 110g/L at screening

          -  Transferrin saturation ≥ 15% at screening

        Exclusion Criteria:

          -  Clinical history of type 2 diabetes mellitus

          -  Anticipating or scheduled to go on renal replacement therapy in the next year,
             including renal transplant

          -  Uncontrolled hypertension on two separate measurements during screening

          -  Use of any erythropoietic protein within 12 weeks of screening
Convalescent Plasma in Outpatients With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: Convalescent Plasma; Saline
Intervention description: SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.; Saline with multivitamin administered via intravenous (IV) infusion..
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The overarching goal of this project is to confirm or refute the role of passive immunization
      as a safe and efficacious therapy in preventing the progression from mild to severe/critical
      COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies
      after passive immunization.The primary objective is to determine the efficacy and safety of a
      single dose of convalescent plasma (CP) for preventing the progression from mild to severe
      COVID-19 illness. The secondary objective is to characterize the immunologic response to CP
      administration.

      This study will enroll adults presenting to the emergency department (ED) with mild,
      symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to
      severe/critical illness, but who are clinically stable for outpatient management at
      randomization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection

          -  Has at least one study defined risk factor for severe COVID-19 illness

          -  Clinical team deems stable for outpatient management without supplemental oxygen

          -  CP available at the site at the time of enrollment

          -  Duration of symptoms ≤ 7 days at ED presentation

          -  Informed consent from subject

        Exclusion Criteria:

          -  Age less than 18 years

          -  Prisoner or ward of the state

          -  Presumed unable to complete follow-up assessments

          -  Prior adverse reaction(s) from blood product transfusion

          -  Receipt of any blood product within the past 120 days

          -  Treating clinical team unwilling to administer 300 ml fluid

          -  Enrollment in another interventional trial for COVID-19 illness
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Condition: Asthma
MeSH terms: Asthma
Intervention: QAW039; QAW039; Placebo
Intervention description: QAW039 150 mg once daily; QAW039 450 mg once daily; Placebo once daily
Intervention MeSH terms: Indoleacetic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 877.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; QAW039

Summary:

      This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to
      placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care
      (SoC) asthma therapy (GINA 2016) in the following two populations:

        -  patient with inadequately controlled severe asthma and high eosinophil counts
           (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)

        -  patients with inadequately controlled severe asthma (overall study population)
           Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent.

          -  Male and female patients aged ≥12 years.

          -  A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.

          -  Evidence of airway reversibility or airway hyper- reactivity.

          -  FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for
             patients aged 12 to <18 years

          -  An ACQ score ≥1.5

          -  A history of 2 or more asthma exacerbations within the 12 months prior to entering the
             study.

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of study entry, or within 30
             days, whichever is longer.

          -  Subjects who have participated in another trial of QAW039.

          -  A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).

          -  History of malignancy with the exception of local basal cell carcinoma of the skin.

          -  Pregnant or nursing (lactating) women.

          -  Serious co-morbidities.

          -  Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
             >2 mg of pitavastatin.
Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Human-cl rhFVIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Healthy volunteers: No

Summary:

      The purpose of the study is to collect long-term data on the inhibitor development rate of
      Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Patients who completed GENA-05 in accordance with the study protocol

        Exclusion Criteria:

          1. Severe liver or kidney disease

          2. Concomitant treatment with any systemic immunosuppressive drug;

          3. Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of
             GENA-05 and start of GENA-15 (except emergency cases).