bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab (Herceptin®); anastrazole (Arimidex®)
Intervention description: 4mg/kg iv loading dose, followed by 2mg/kg iv weekly; 1 mg tablet taken orally daily
Intervention MeSH terms: Trastuzumab; Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab
      (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line
      treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2)
      overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to
      receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading
      dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg
      iv. The anticipated time on study treatment was until disease progression, and the target
      sample size was 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal women;

          -  metastatic breast cancer suitable for endocrine therapy;

          -  positive hormone receptor status;

          -  Human epidermal growth factor receptor 2 (HER2) overexpression.

        Exclusion Criteria:

          -  patients on hormone replacement therapy;

          -  previous chemotherapy for metastatic disease;

          -  uncontrolled cardiac disease and history of cardiac failure.
A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Fluoxetine
Intervention description: Administered orally
Intervention MeSH terms: Fluoxetine
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: 20 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the
      treatment of MDD in adult Japanese participants.

      Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#:
      NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an
      additional 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612)

          -  Agree to abstain from sexual activity or to use a reliable method of birth control

        Exclusion Criteria:

          -  Significant suicidal risk

          -  Have a current or previous diagnosis of bipolar disorder, psychotic depression,
             schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive
             disorder, or post-traumatic stress disorder

          -  Have a history of substance abuse or dependence within the past 6 months, excluding
             caffeine and nicotine

          -  Need to use thioridazine or pimozide during the study

          -  Have a positive urine drug screen for drugs with abuse potential

          -  Female participants who are either pregnant, nursing, or have recently given birth, or
             male participants who are planning for their partners to be or become pregnant

          -  Have frequent or severe allergic reactions to multiple medications

          -  Have a serious or unstable medical illness or condition, or psychological condition

          -  Participants deemed ineligible by the investigator or sub-investigator for other
             reasons
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Beclomethasone dipropionate; Flunisolide
Intervention description: Beclomethasone dipropionate; Flunisolide
Intervention MeSH terms: Beclomethasone; Flunisolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: questionnaire; nasal spray; Seasonal allergic rhinitis; nasal spray questionnaire; allergic rhinitis

Summary:

      The Protocol section needs to be updated using the following text "The main goal of the study
      was to validate the Preference Module of the EARNS-Q and to test the reliability using
      Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for
      determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an
      Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen
      attribute rating items followed by fourteen importance weighing questions. The Preference
      Module includes the same items along with preference questions related to each item as well
      as a global preference question.
    

Eligibility criteria:

        Inclusion criteria:

          -  Seasonal allergic rhinitis.

          -  Nasal allergy symptoms during the spring allergy season.

        Exclusion Criteria:

          -  Prior use of beclomethasone dipropionate or flunisolide.

          -  Significant concomitant medical conditions.

          -  Use of corticosteroids.

          -  Use of allergy and other identified medications during the study.

          -  Current tobacco use or tobacco use within the past year.
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome With Constipation (IBS-C)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Placebo; Linaclotide
Intervention description: matching Placebo Capsules, Oral, once daily; Linaclotide 290 ug Capsules, Oral, once daily
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1722.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial is an international, multicenter, randomized, double-blind,
      placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo.
      Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be
      randomized at up to 60 trial centers in China, Australia, and New Zealand.

      The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12
      weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment
      Period, patients meeting the entry criteria for this trial will be randomized to one of two
      double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient has signed an Informed Consent Form(ICF).

          2. Patient Must not be pregnant or breastfeeding and agree to use birth control

          3. Patient meets the colonoscopy requirements defined by the American Gastroenterological
             Association guidelines and no clinically-significant laboratory or physical
             examination findings;

          4. Patient meets protocol-defined criteria for Irritable Bowel Syndrome with
             Constipation(IBS-C), including stool frequency, straining, stool consistency,
             abdominal pain, and abdominal discomfort criteria

          5. Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from
             making any new, major life-style changes that may affect IBS-C symptoms

        Exclusion Criteria:

          1. Recent history of mushy or watery stools

          2. Various medical conditions, medical histories, or family medical histories that would
             not make the patient a good candidate for the study

          3. Patient currently has both unexplained and clinically significant alarm symptoms or
             systemic signs of infection or colitis.

          4. Surgery to the gastrointestinal tract

          5. Usage of prohibited medications
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin phosphate; Metformin
Intervention description: Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.; Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This study will assess, over a 4-week treatment period, the safety and efficacy of the
      addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who
      failed to achieve glycemic control on metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with T2DM failing metformin monotherapy

          -  Between the ages of 18 and 79

        Exclusion Criteria:

          -  Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Intervention: Bremelanotide; Placebo
Intervention description: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 714.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HSDD Female; Sexual Desire Disorder; decreased desire; female sexual dysfunction

Summary:

      A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an
      optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered
      subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without
      decreased arousal) in premenopausal females.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Has met diagnostic criteria for HSDD for at least 6 months

          -  Is willing and able to understand and comply with all study requirements

          -  Has a normal pelvic examination at screening

        Main Exclusion Criteria:

          -  Subjects should be generally healthy premenopausal females with no psychological,
             gynecological or urological conditions which might contribute to the sexual
             dysfunction, compromise study participation, or confound interpretation of the study
             results

          -  Not currently under treatment for the sexual dysfunction and willing to forego other
             treatments through the course of the clinical trial
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
Condition: Bipolar I Disorder
Intervention: Lurasidone
Intervention description: Lurasidone 20-80 mg taken orally once daily
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 377.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lurasidone; Latuda; Bipolar Disorder

Summary:

      This is an open-label, multi-center,12 week extension study designed to evaluate the longer
      term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to
      lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either
      completed the core study D1050296 or experienced a protocol defined recurrence of a mood
      event in the double-blind phase of the core study D1050296
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has agreed to participate by providing written informed consent.

          -  Subject has completed the 28 week Double-blind Phase of Study D1050296 and all
             required assessments on the final study visit (Week 28, Visit 28); OR

          -  Subject has experienced a protocol-defined recurrence of any mood event during the
             Double blind Phase of Study D1050296 and has completed all required assessments on the
             final study visit; OR

          -  Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor
             stopped the study and has completed all required assessments on the final study visit.

          -  Subject is judged by the Investigator to be suitable for participation in a 12 week
             clinical trial involving open-label lurasidone treatment and is able to comply with
             the protocol in the opinion of the Investigator.

        Exclusion Criteria:

          -  Subject is considered by the Investigator to be at imminent risk of suicide or injury
             to self, others, or property.

          -  Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with
             some intent to act, without specific plan) or item 5 (active suicidal ideation with
             specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at
             the extension baseline visit (final study visit in Study D1050296).
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Lispro Protamine Suspension; Insulin Glargine
Intervention description: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks; Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Protamines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 471.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; type 2

Summary:

      The purpose of this study is to examine the effectiveness and safety of insulin lispro
      protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in
      adults with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus for at least 1 year.

          -  Are greater than or equal to 18 years old.

          -  Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at
             least 3 months immediately prior to the study and have been on stable doses of at
             least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin-
             Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs)

          -  Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to
             10.0%, as measured by a central laboratory before Visit 2.

          -  Body mass index (BMI) greater than or equal to 25 and less than or equal to 45
             kg/meter squared.

        Exclusion Criteria:

          -  Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except
             for short-term treatment of acute conditions, and up to a maximum of 4 weeks.

          -  Have taken any glucose-lowering medications not included in Inclusion Criterion #3;
             (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide)
             in the past 3 months before Visit 1.

          -  Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry
             into the study, or is currently diagnosed as having hypoglycemia unawareness.

          -  Have had 2 or more emergency room visits or hospitalizations due to poor glucose
             control in the past 6 months.

          -  Are pregnant or intend to become pregnant during the course of the study or are
             sexually active women of childbearing potential not actively practicing birth control
             by a method determined by the investigator to be medically acceptable.
Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: ZOSTAVAX
Intervention description: 1 dose 0.65 mL
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 354.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      PRIMARY OBJECTIVES

      Two co-primary objectives are:

        -  To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route
           (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)

        -  To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of
           varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination

      SECONDARY OBJECTIVES

      Immunogenicity objectives

        -  To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following
           ZOSTAVAX administered by IM or SC route

        -  To evaluate the immune response as measured by a second assay, the VZV Interferon gamma
           Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or
           SC route

      Safety objective

      - To describe the safety profile of ZOSTAVAX administered by IM or SC route
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged >=50 years

          -  Varicella history-positive or residence for >30 years in a country with endemic VZV
             infection

        Exclusion Criteria:

          -  Febrile illness

          -  History of hypersensitivity or anaphylactoid reaction to any of the vaccine components

          -  Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes
             zoster within the 4 weeks prior to vaccination

          -  Prior receipt of varicella or zoster vaccine

          -  Active untreated tuberculosis

          -  Thrombocytopenia, any other coagulation disorder contraindicating intramuscular
             injection

          -  Receipt of medication / vaccine that may interfere with study assessments

          -  Known or suspected immune dysfunction

          -  User of recreational / illicit drugs or subject with alcohol abuse or dependence
             within the last year

          -  Any condition that might interfere with the interpretation of the study,
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
Condition: Resuscitation
Intervention: T-piece resuscitator Neopuff TM; Self Inflating Bag with PEEP; Self Inflating Bag without PEEP
Intervention description: Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.; Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.; Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1032.0
Sex: All
Maximum age: 2 Minutes
Healthy volunteers: No
Keywords: Bag and mask; Neopuff; Resuscitation; Newborn; Intubation; devices; PEEP

Summary:

      A multicenter cross-over cluster randomized controlled trial protocol study in newborn
      infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure
      ventilation [PPV]) for resuscitation in the delivery room comparing a T-piece resuscitator
      device versus resuscitation bag.
    

Eligibility criteria:

        Inclusion criteria:

        Live-born infants of ≥ 26 weeks' GA with HR < 100 bpm requiring resuscitation with positive
        pressure ventilation with mask in the delivery room according to the current AAP/AHA
        recommendations

        Exclusion Criteria:

        Infants requiring intubation from birth. Newborns of < 26 weeks´ GA. Newborns presenting
        major congenital malformations. Multiple births. Problems (difficulty or malfunctioning)
        with the device assigned.