bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
Condition: Anemia
MeSH terms: Anemia
Intervention: Darbepoetin alfa; methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: As prescribed, iv.; 120, 200 or 360 micrograms iv / month, starting dose
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 490.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa,
      administered at extended dosing intervals, in the maintenance treatment of anemia in patients
      with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving
      once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to
      receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360
      micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study)
      or intravenous darbepoetin alfa every 2 weeks before switching to once monthly
      administration. The anticipated time on study treatment is 3-12 months, and the target sample
      size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia;

          -  hemodialysis 3 times weekly for >=12 weeks before screening, and during
             screening/baseline period;

          -  receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and
             during screening/baseline period.

        Exclusion Criteria:

          -  overt gastrointestinal bleeding within 8 weeks before screening or during
             screening/baseline period;

          -  transfusion of red blood cells within 8 weeks before screening or during
             screening/baseline period;

          -  active malignancy;
An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Dimebon
Intervention description: Tablet for oral administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 649.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in
      patients with Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of previous Phase 3 Dimebon study (B1451027).

        Exclusion Criteria:

          -  Have any severe 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 patient
             inappropriate for entry into this study.
Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
Condition: Varicella
MeSH terms: Chickenpox
Intervention: VARIVAX™ New Seed Process; VARIVAX™ 2007 process; M-M-R II™
Intervention description: Varicella virus vaccine live manufactured with a new seed process; Varicella virus vaccine live manufactured with the 2007 process; Measles, Mumps, and Rubella virus vaccine live
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 611.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella
      Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™
      2007 process. The primary hypotheses being tested are that antibody response rate and mean
      antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior
      to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by
      VARIVAX™ NSP is acceptable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella

        Exclusion Criteria:

          -  Received any measles, mumps, rubella, or varicella vaccine at any time prior to the
             study, or is anticipated to receive any of these vaccines outside the study

          -  Any congenital or acquired immune deficiency, neoplastic disease, or depressed
             immunity

          -  Received systemic immunomodulatory steroids within 3 months prior to entering the
             study or is expected to receive them during the course of the study

          -  History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg
             proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™

          -  Received salicylates within 14 days prior to study vaccination

          -  Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior
             to study vaccination

          -  Received immune globulin, a blood transfusion, or blood-derived products within 5
             months prior to study vaccination

          -  History of seizure disorder, including febrile seizure

          -  Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination

          -  History of thrombocytopenia

          -  Born to a human immunodeficiency virus (HIV)-infected mother

          -  Participated in any other clinical trial (other than a surveillance study) within 30
             days prior to study enrollment.
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine (Lu AA21004); Agomelatine
Intervention description: encapsulated tablets, daily, orally; encapsulated tablets, daily, orally
Intervention MeSH terms: Vortioxetine; Agomelatine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 495.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression; Multimodal antidepressant

Summary:

      The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is
      at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms
      that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant
             (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR
             criteria)

          -  The response to the current SRI treatment is inadequate and patient agrees to
             discontinue the current SRI at the baseline

          -  Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the Screening
             Visit and Baseline

          -  The patient, if a woman, must: agree not to try to become pregnant during the study,
             AND use adequate, highly effective contraception

        Exclusion Criteria:

          -  The patient has any current Axis I disorders (DSM-IV criteria) other than Major
             Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder
             (SAD)

          -  The patient is at significant risk of suicide

          -  The patient is currently receiving formal psychotherapy or other psychoactive
             medications

        Other protocol-defined inclusion and exclusion criteria may apply.
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Condition: Cholera
MeSH terms: Cholera
Intervention: PXVX0200; placebo
Intervention description: Single dose; liquid suspension after reconstitution with buffer; 5x10^8
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine if PXVX0200 is safe and effective in preventing
      cholera infection
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy men or women,

          -  age 18 to 45 years inclusive;

          -  normal medical history and physical examination; and

          -  no clinically significant abnormalities from:

          -  urine dipstick for glucose, protein, and blood

          -  complete blood count,

          -  serum hepatic transaminases,

          -  total bilirubin (direct if abnormal),

          -  creatinine,

          -  electrolytes,

          -  albumin, or

          -  electrocardiogram.

          -  Women must have a negative pregnancy test.

        Exclusion Criteria:

          -  travel to a cholera endemic area in the previous 5 years;

          -  abnormal stool pattern or regular use of laxatives;

          -  history of eating disorders (such as bulimia), anal or rectal disorders, allergy to
             tetracycline and/or ciprofloxacin;

          -  history of cholera or enterotoxigenic E. coli challenge or infection;

          -  current or recent antibiotic use;

          -  pregnancy or nursing;

          -  positive serology for HIV, hepatitis B antigen, or hepatitis C;

          -  any immunosuppressive medical condition;

          -  history of hospitalization for psychiatric illness or use of specific psychiatric
             drugs.
Mirena Extension Trial
Condition: Contraception
MeSH terms: Menorrhagia
Intervention: Levonorgestrel IUS (Mirena, BAY86-5028)
Intervention description: Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.
Intervention MeSH terms: Levonorgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 364.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Birth Control; Heavy menstrual bleeding

Summary:

      The study is performed to assess if Mirena is effective and safe as a birth control method
      beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted
      for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Women, 18 to 35 years of age at the time of screening (visit 1) who are currently
             using Mirena for contraception or for contraception and heavy menstrual bleeding. The
             duration of use of the current Mirena has to be at least 4 years 6 months at the start
             of screening phase but not more than 5 years at visit 2 and the woman is willing to
             continue with its use and has a continuing need for contraception.

          -  Normal or clinically insignificant cervical smear not requiring further follow up

        Exclusion Criteria:

          -  Menopausal symptoms with Follicle-stimulating hormone>30 mIU/ml

          -  Pregnancy or suspicion of pregnancy

          -  Uterine bleeding of unknown etiology

          -  Untreated acute cervicitis or vaginitis or other lower genital tract infections

          -  Increased susceptibility to pelvic infection

          -  Acute pelvic inflammatory disease (PID) or a history of PID unless successfully
             treated and which, in the investigator's opinion, has not negatively affected
             subject's fertility

          -  Congenital or acquired uterine anomaly if it distorts the uterine cavity

          -  History of, diagnosed or suspected genital or other malignancy and untreated cervical
             dysplasia

          -  Any active acute liver disease or liver tumor (benign or malignant)

          -  Clinically significant endometrial polyp(s)
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Inhaled Insulin; Subcutaneous insulin
Intervention description: Inhaled insulin with dose adjusted according to premeal blood glucose; Subcutaneous insulin with dose adjusted according to premeal blood glucose
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 635.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is being done to find out the good and bad effects of inhaled insulin that is used
      by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name
      for this inhaled insulin is Exubera®.

      This study included a 2-year comparative treatment period followed by a 6-month follow-up
      period during which inhaled insulin-treated subjects were switched back to subcutaneous
      short-acting insulin. After this follow-up period, all eligible subjects entered a
      comparative extension period that was to last for 5 years. When the comparative portion of
      the study was terminated, all subjects were requested to return for a final extension
      follow-up month 3 visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

        Exclusion Criteria:

          -  COPD

          -  Asthma

          -  Smoking Pregnancy
A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab
Intervention description: Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque
      psoriasis and to document the same using sequential photographic images.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a
             dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to
             baseline

          -  Active psoriatic skin lesions of plaque psoriasis (Ps)

          -  Are a candidate for phototherapy and/or systemic therapy

          -  Men must agree to use a reliable method of birth control or remain abstinent during
             the study and for at least 12 weeks after stopping treatment

          -  Women must agree to use reliable birth control or remain abstinent during the study
             and for at least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  Are unable to commit to the photography schedule for the duration of the study

          -  Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists,
             including ixekizumab

          -  Serious disorder or illness other than psoriasis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women
A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects
Condition: Healthy
Intervention: placebo; raxibacumab; placebo; raxibacumab
Intervention description: 40 mg/kg intravenously, double dose (day 0 and 14), Group 3; 40 mg/kg intravenously, double dose (day 0 and 14), Group 1; 40 mg/kg placebo, single dose (day 0), Group 4; 40 mg/kg intravenously, single dose, day 0, Group 2
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 322.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy volunteers

Summary:

      To evaluate the safety and tolerability of raxibacumab in healthy subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, 18 years of age or older

          -  Normal laboratory (blood test) results

          -  Subjects are eligible to enter the study if they are not pregnant or nursing, are
             sterile or of non-childbearing potential, or are willing to practice abstinence or use
             appropriate birth control methods during the study (about 2 months)

        Key Exclusion Criteria:

          -  History of significant, acute or chronic diseases (ie, heart, lung, gastrointestinal,
             liver, kidney, neurological or infectious diseases).

          -  Prior immunization with anthrax vaccine adsorbed (AVA), prior treatment with
             investigational anthrax therapies, prior treatment for anthrax exposure, or prior
             anthrax infection.

          -  History of Type I hypersensitivity reaction to food or drugs, IV contrast agents,
             antihistamines, or history of hives.

          -  A current drug or alcohol addiction.

          -  Positive for human immunodeficiency virus (HIV-1), Hepatitis B surface antigen, or
             Hepatitis C antibody.

          -  Cancer within the last 5 years (with the exception of adequately treated basal cell
             carcinoma of the skin or in situ carcinoma of the cervix).

          -  Participation within 60 days of intiating study or refusal to refrain from
             participation during the study in any other clinical trials of an investigational
             compound.

          -  Previous exposure to raxibacumab.
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Condition: Complicated Skin and Soft Tissue Infection
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections
Intervention: Ceftaroline fosamil; Vancomycin; Aztreonam
Intervention description: IV ceftaroline 600mg every 8 hours; IV vancomycin 15mg/kg every 12 hours; IV aztreonam 1 g every 8 hours
Intervention MeSH terms: Vancomycin; Ceftaroline fosamil; Aztreonam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 802.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: complicated skin and soft tissue infections (cSSTI); skin infection; ceftaroline; wound infection; cellulitis; burn infection; bacterial infection; vancomycin

Summary:

      The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin
      plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue
      infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 18 years or older

          -  Complicated skin and skin structure infection (cSSTI)

          -  Infection of sufficient severity to warrant hospitalization

          -  Infection of sufficient severity such that it is expected to require at least 5 days
             of intravenous antibiotic therapy

        Exclusion Criteria:

          -  Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior
             to first dose of study drug

          -  Uncomplicated skin and skin structure infections, skin infections suspected to be
             caused by viral or fungal pathogens

          -  Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease

          -  Infection caused by human or animal bites, sternal wound infections, bone infection or
             arthritis due to an infection, critical limb ischemia of the affected limb

          -  Chronic liver disease or severe impaired renal function, severe low white blood cell
             count, burns on greater than 15% of total body surface area, necrotizing skin
             infection, amputation required of primary site of infection, sustained shock
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Telaprevir; Peg-IFN-alfa-2a; Ribavirin; Placebo
Intervention description: Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.; Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.; Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.; Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
Intervention MeSH terms: Ribavirin; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 663.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Telaprevir; Peg-IFN-alfa-2a; Ribavirin

Summary:

      The purpose of this study is to determine the safety, efficacy and tolerability of using two
      regimens of telaprevir (with and without delayed start) with standard treatment compared to
      standard treatment alone in participants with chronic, genotype 1, hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >=
             1000 IU/mL

          -  Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard
             treatment)

          -  Patient must be willing to use 2 effective methods of birth control for up to 7 months
             after last dose of study medication

        Exclusion Criteria:

          -  Patient is a previous non-responder that is classified as a viral breakthrough case

          -  Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one
             subtype

          -  Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other
             genotype

          -  Evidence of decompensated liver disease

          -  Patient has condition that requires use of systemic corticosteroids