bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: BI 201335; Pegylated Interferon-alpha (IFN); Ribavirin (RBV); Placebo
Intervention description: BI 201335 once a day (QD) for 24 weeks; Pegylated Interferon-alpha for 48 weeks; Ribavirin (RBV) for 24 or 48 weeks; Placebo to BI201335 for 24 weeks
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 678.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or
      24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in
      chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
    

Eligibility criteria:

        Inclusion criteria:

          1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to
             screening

          2. Confirmed prior virological failure with an approved dose of PegIFN/RBV

          3. Age 18 to 70 years,

          4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

        Exclusion criteria:

          1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency
             Virus (HIV) co-infection

          2. Evidence of acute or chronic liver disease due to causes other than chronic HCV
             infection,

          3. Decompensated liver disease, or history of decompensated liver disease,

          4. Body weight < 40 or > 125 kg,

          5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary
             disease, history or evidence of retinopathy or clinically significant ophthalmological
             disorder

          6. Pre-existing psychiatric condition that could interfere with the subject's
             participation in and completion of the study

          7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD
             deficit)

          8. Hemoglobin < 12 g/dL for women and < 13 g/dL for men

          9. Patients who have been previously treated with at least one dose of any antiviral or
             immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV
             infection including and not restricted to protease or polymerase inhibitors,
Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec/insulin aspart; insulin detemir; insulin aspart; insulin aspart
Intervention description: Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.; Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.; Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.; Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 548.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe, Oceania, and the United States of America (USA).

      The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart
      (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes
      (main period) followed by the extension period comparing the long-term safety of NN5401 plus
      insulin aspart with insulin detemir plus insulin aspart.

      The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension
      period is registered as NN5401-3645.
    

Eligibility criteria:

        Inclusion Criteria:

          -  FOR THE MAIN TRIAL, NN5401-3594:

          -  Type 1 diabetes mellitus for at least 12 months

          -  Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin
             regimen, self mix regimen) for at least 12 months

          -  HbA1c 7.0-10.0% (both inclusive)

          -  BMI (Body Mass Index) below or equal to 35.0 kg/m^2

          -  FOR THE EXTENSION TRIAL, NN5401-3645:

          -  The subject must have completed the six-month treatment period in trial NN5401-3594

        Exclusion Criteria:

          -  FOR THE MAIN TRIAL, NN5401-3594:

          -  Treatment with other insulin regimens than insulin in a basal bolus regimen/premix
             insulin regimen/self mix regimen within 3 months

          -  Cardiovascular disease within the last 6 months

          -  Uncontrolled treated/untreated severe hypertension

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements

          -  Cancer and medical history of cancer

          -  FOR THE EXTENSION TRIAL, NN5401-3645:

          -  Anticipated significant lifestyle changes during the trial

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20vPnC; Saline; 13vPnC; PPSV23
Intervention description: 20vPnC; Saline; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1425.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a
      20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age
      and older in Japan, Korea, and Taiwan
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female participants 60 years of age and older at the time of consent.

          -  Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease, defined as disease not requiring significant change in therapy in the
             previous 6 weeks or hospitalization for worsening disease within 12 weeks before
             receipt of study intervention. (For adults 60 through 64 years of age to be enrolled
             at Japan sites: Participants must have a preexisting chronic stable disease with an
             elevated risk for pneumococcal disease.)

        Exclusion criteria:

          -  History of microbiologically proven invasive disease caused by S pneumoniae.

          -  Serious chronic disorder, including metastatic malignancy, severe COPD requiring
             supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of
             the liver, clinically unstable cardiac disease, or any other disorder that, in the
             investigator's opinion, excludes the participant from participating in the study.

          -  Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone; Olanzapine; Placebo comparator; Lurasidone 40 mg tablets
Intervention description: 120mg/day; 15mg/day; Placebor Comparator; Lurasidone 40 mg tablets
Intervention MeSH terms: Olanzapine; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Schizophrenia; Latuda; Lurasidone

Summary:

      Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical
      study is designed to test the hypothesis that lurasidone is more efficacious than placebo.
      The study will also evaluate the safety and tolerability of lurasidone as compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent and aged between 18 and 75 years of age.

          -  Meets DSM-IV criteria for a primary diagnosis of schizophrenia.

          -  Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate
             and reliable contraception for duration of study.

          -  Able and agrees to remain off prior antipsychotic medication for the duration of
             study.

          -  Good physical health on the basis of medical history, physical examination, and
             laboratory screening.

          -  Willing and able to comply with the protocol, including the inpatient requirements and
             outpatient visits.

        Exclusion Criteria:

          -  Considered by the investigator to be at imminent risk of suicide or injury to self,
             others or property.

          -  Any chronic organic disease of the CNS (other than schizophrenia).

          -  Used investigational compound within 30 days.

          -  Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence
             within the last 6 months
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
Condition: Contraception
Intervention: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300); Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300); Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
Intervention description: 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.; 3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.; 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
Intervention MeSH terms: Drospirenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1166.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine safety and efficacy of long-cycle regimens of an
      oral contraceptive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women who desire contraception

          -  smokers ≤ 30 Years old

        Exclusion Criteria:

          -  Contraindication against use of hormonal contraceptives
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 668.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese
      Infants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or female infants ≥2 months to ≤6 months at the time of consent.

          -  Healthy infants determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Major known congenital malformation or serious chronic disorder.

          -  History of microbiologically proven invasive disease caused by S pneumoniae.

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.
Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Intervention: 64Cu-DOTATATE
Intervention description: Detection of somatostatin positive lesions in NET
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE
      peptide, labelled with the 64Cu tracer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed or suspicion of NET based on histology/ biopsy report.

          -  Confirmed or suspicion of NET based on conventional imaging scans of affected area
             such as MRI and/or contrast enhanced CT and/or an FDG PET

          -  CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to
             study date.

        Exclusion Criteria:

          -  Pregnant, planning to be pregnant within the next two weeks

          -  Inability to provide written consent.

          -  Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and
             Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging.
             If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28
             days is required before the injection of the study drug.
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
Condition: Intraventricular Hemorrhage (IVH); Bleeding in the Brain; Prematurity; Very Low Birth Weight Infants
MeSH terms: Cerebral Hemorrhage; Premature Birth; Hemorrhage; Birth Weight
Intervention: indomethacin; placebo
Intervention description: an anti-inflammatory drug; saline
Intervention MeSH terms: Indomethacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 630.0
Sex: All
Maximum age: 6 Hours
Healthy volunteers: Accepts Healthy Volunteers
Keywords: intraventricular hemorrhage (IVH); bleeding in the brain; indomethacin; prematurity; very low birth weight infants

Summary:

      The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in
      the brain of very low birth weight preterm infants.
    

Eligibility criteria:

        -  Preterm infants < 1250 g birth weight

          -  Admitted to participating institution < 6 hrs of age

          -  No evidence for congenital malformations

          -  Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular
             hemorrhage
Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Eisenmenger Complex
Intervention: Macitentan 10 mg tablet, once daily.
Intervention description: Macitentan 10 mg tablet, once daily.
Intervention MeSH terms: Macitentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Eisenmenger Syndrome; exercise capacity

Summary:

      Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used
      for treatment of Eisenmenger syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with ES (including those with Down Syndrome) having completed the double-blind
        AC-055-305 / MAESTRO study as scheduled, i.e., who remained in the double-blind study up to
        Week 16 (whether or not they were still taking study drug at the end of this period).

        Exclusion Criteria:

        Subjects who prematurely discontinue double-blind study drug during the AC-055-305 /
        MAESTRO study due to:

          -  an AE assessed as related to the use of study drug,

          -  or elevated liver tests (related or unrelated to study drug).
Ketamine to Prevent PPD After Cesarean
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression
Intervention: Ketamine 50 MG/ML; Control
Intervention description: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).; Administration of 0.9% Sodium Chloride (N/S)
Intervention MeSH terms: Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised to one of three groups (two interventional and one control).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The ketamine and placebo study injectates (subcutaneous and intravenous) will be prepared, in way that does not allow differentiation, by pharmacy staff who are otherwise uninvolved in the study. Participants will be allocated to groups using a random sequence generator. The patients, investigators and outcome assessors will remain unaware of their group until data collection is complete for all participants.
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The investigators plan to randomise participants to receive ketamine or placebo control
      subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to
      assess the incidence of postpartum depression. This feasibility pilot study is designed to
      explore the adequacy of the study procedures and tolerability of the interventions.
    

Eligibility criteria:

        Inclusion criteria:

          -  Term pregnancy

          -  Age 18-45 years of age

          -  Scheduled cesarean delivery under neuraxial anesthesia

        Exclusion criteria:

          -  ASA classification IV or V

          -  History of psychotic episodes

          -  History of allergy to ketamine

          -  Inability to communicate in English or any other barrier to providing informed consent
Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Sci-B-Vac®; Engerix-B®
Intervention description: Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml; Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sci-B-Vac®; Prophylactic vaccine; HepB vaccines; Phase 3; pre-S1; pre-S2; Surface antigen

Summary:

      This study was a comparative, randomized, double-blind clinical study of the efficacy and
      safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel
      groups of hepatitis B-naive healthy adult subjects in Russia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Availability of written Informed Consent to participate in the study from the subject.

          2. Male or female between 18 and 45 years old without previous contact with hepatitis B
             virus (HBV).

          3. Good health condition based on full physical examination.

          4. Normal values of laboratory biochemical blood tests.

          5. Seronegative with respect to anti-HBs (surface) antibodies, anti-HBc (core)
             antibodies, and HBs Antigen (HBsAg) on screening.

          6. Not pregnant and not breast-feeding.

          7. For men and women of reproductive age: consent for use of an effective contraception
             method, for example, an intrauterine device, oral contraceptive, hypodermic implant or
             double barrier method (a condom with contraceptive sponge or contraceptive
             suppository) throughout the entire study.

        Exclusion Criteria:

          1. Congenital or inherited immunodeficiency disorder in family history.

          2. Information of a serious blood disorder, cardiac disorder, or tumour.

          3. Current use of any medication that could alter immune reactivity.

          4. Infection with HBV at the present time or in the past, confirmed by HBV markers test.

          5. Anaphylaxis or severe allergy, or atopy, history of alcoholism or drug abuse.

          6. Pregnancy and breast-feeding.