bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: single-use autoinjector with a prefilled liquid Avonex syringe; Avonex prefilled syringe via manual IM injection; BG9418 (interferon beta-1a)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to evaluate the safe and effective use of the
      single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex® (interferon
      beta-1a) in participants with multiple sclerosis (MS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ability to understand the purpose and risks of the study and provide signed and dated
             informed consent and authorization to use protected health information (PHI) in
             accordance with national and local subject privacy regulations.

          2. Must be 18 to 65 years old, inclusive, at the time of informed consent.

          3. Must currently be self-administering Avonex Prefilled Syringes to treat MS and must
             have been self-administering Avonex Prefilled Syringes for the 12 weeks prior to the
             Screening Visit.

          4. In the investigator's opinion, subjects must be willing and able to self-administer
             all injections required by the protocol.

          5. Must speak English.

          6. All male subjects and female subjects of child-bearing potential must practice
             effective contraception during the study.

        Exclusion Criteria:

          1. History of seizure disorder or unexplained blackouts OR history of a seizure within 3
             months prior to the Screening Visit.

          2. History of suicidal ideation within 3 months prior to Day 1 or an episode of severe
             depression within 3 months prior to Day 1. Severe depression is defined as any episode
             of depression that requires hospitalization, or the initiation of antidepressant
             therapy, or an increase in the dose of an existing regimen of antidepressant therapy.
             NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the
             study unless the dose has been increased within the 3 months prior to the Screening
             Visit.

          3. Clinically significant local infection (for example cellulitis, abscess) or systemic
             infection (pneumonia, septicemia), at the discretion of the Investigator.

          4. Known history of Human Immunodeficiency Virus (HIV).

          5. Known history of, or positive test result for hepatitis C virus (test for hepatitis C
             virus antibody [HCV Ab]) or Hepatitis B virus (test for Hepatitis B Surface Antigen
             [HBsAg] and/or Hepatitis B Core Antibody [HBcAb]).
A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: telaprevir; ribavirin; peginterferon alfa-2a
Intervention description: 750 mg every 8 hours (q8h) for 12 weeks; 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks; 180 mcg/week for either 24 or 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 540.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Genotype 1

Summary:

      This study is being conducted to learn more about the safety and effect of telaprevir in
      combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with
      hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is
      designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who
      respond quickly to a telaprevir-based treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has not received any previous treatment with any approved or investigational drug or
             drug regimen for the treatment of hepatitis C

          -  Male and female subjects, 18 to 70 years of age, inclusive

          -  Genotype 1, chronic hepatitis C with detectable HCV RNA.

          -  Screening laboratory values, tests, and physical exam within acceptable ranges

          -  Able and willing to follow contraception requirements

          -  Able to read and understand, and willing to sign the informed consent form and abide
             by the study restrictions.

        Exclusion Criteria:

          -  Subject has any contraindications to Pegasys® or Copegus® therapy

          -  Evidence of hepatic decompensation in cirrhotic subjects

          -  History of organ transplant

          -  History of, or any current medical condition which could impact the safety of the
             subject in participation in the study
Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer
Condition: Breast Cancer; Metastases
MeSH terms: Breast Neoplasms
Intervention: vinflunine; Alkylating agent of physician choice registered in cancer
Intervention description: 280 mg/m2 on day 1 of each cycle every 3 weeks; cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin
Intervention MeSH terms: Alkylating Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 594.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes,
      antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs,
      therapeutic options are very limited. Alkylating agents showed a modest activity in
      pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and
      the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients
      who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.
    

Eligibility criteria:

        Inclusion Criteria:(main conditions)

          -  Female patients 18 to 75 years of age with metastatic breast cancer
             histologically/cytologically confirmed not amenable to curative surgery or
             radiotherapy and who have received at least two prior chemotherapy regimens including
             anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate
             for these drugs,

          -  Karnofsky performance score of at least 70 %, adequate haematological, hepatic and
             renal functions and ECG without clinically relevant abnormality.

        Exclusion Criteria:

          -  Concurrent serious uncontrolled medical disorder,

          -  known or clinical evidence of brain metastases or leptomeningeal involvement,

          -  pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,

          -  history of second primary malignancy,

          -  HIV infection, preexisting neuropathy,

          -  pregnancy or breast feeding.
Rollover Study of VX-770 in Cystic Fibrosis Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to evaluate the safety of long-term VX-770 treatment
      in participants with cystic fibrosis (CF). The secondary objective of the study was to
      evaluate the efficacy of long-term VX-770 treatment in subjects with CF.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants who have completed the assigned study treatment in Study 102 or Study 103

          2. Participants who are females of childbearing potential must have a negative urine
             pregnancy test on Day 1 (first dose of VX-770)

          3. Participants who are able to understand and comply with protocol requirements,
             restrictions, and instructions and likely to complete the study as planned, as judged
             by the investigator

          4. Participants of child bearing potential and who are sexually active must meet the
             contraception requirements

          5. Participants must sign the informed consent form (ICF), and where appropriate, assent
             must be obtained

        Exclusion Criteria:

          1. Participants with a history of any illness or condition that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject

          2. Participants with a history of study treatment intolerance as observed in their
             previous VX-770 study that, in the opinion of the investigator, might pose an
             additional risk in administering study drug to the subject

          3. Participants who are pregnant, planning a pregnancy, breast-feeding, or not willing to
             follow contraception requirements

          4. Participants taking any inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4),
             including certain herbal medications (for example, St. John's Wort) and
             grapefruit/grapefruit juice
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Bardoxolone methyl
Intervention description: Capsules of Bardoxolone methyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; Pulmonary Hypertension; PH; PAH; Bardoxolone methyl; 6-minute walk distance; CDDO-ME; RTA 402; LARIAT; CATALYST; RANGER

Summary:

      This extended access study will assess the long-term safety and tolerability of bardoxolone
      methyl in qualified patients with pulmonary hypertension (PH) who previously participated in
      controlled clinical studies with bardoxolone methyl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment-compliant patients who are participating in qualifying ongoing studies and
             have completed required End-of-Treatment and/or Follow-up visits in a prior clinical
             study with bardoxolone methyl

        Exclusion Criteria:

          -  Participation in other investigational clinical studies involving interventional
             products being tested or used in a way different from the approved form or when used
             for an unapproved indication;

          -  Patients who have an ongoing SAE from a clinical study that is assessed by the
             investigator as related to bardoxolone methyl;

          -  Unwilling to practice acceptable methods of birth control (both males who have
             partners of childbearing potential and females of childbearing potential) while taking
             study drug;

          -  Women who are pregnant or breastfeeding;

          -  Patient is, in the opinion of the investigator, unable to comply with the requirements
             of the study protocol or is unsuitable for the study for any reason;

          -  Known hypersensitivity to any component of the study drug
Home-based Exercise Via a Telecommunications System
Condition: Functional Limitation
Intervention: Telecommunications system; attention control
Intervention description: health education
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Activities of daily living; Aging; Exercise; Weight lifting

Summary:

      This study is investigating the effects of a home-based resistance exercise program,
      administered via an interactive telecommunications system, in functionally limited older
      veterans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 65 years

          -  Ability to use a telephone without assistance

        Exclusion Criteria:

          -  Angina pectoris

          -  Myocardial infarction

          -  Ventricular dysrhythmia currently receiving therapy

          -  Systolic blood pressure 165 mm Hg or diastolic blood pressure 100 mm Hg
LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 90100 aerosol foam; Aerosol foam vehicle; Calcipotriol BDP gel; Gel vehicle
Intervention MeSH terms: Calcipotriene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 504.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of
      calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis
      vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or above

          -  Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and
             skin folds) involving 2-30% of the Body Surface Area (BSA)

          -  A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk
             and limbs

          -  A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and
             limbs.

        Exclusion Criteria:

          -  Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

          -  Systemic treatment with biological therapies, whether marketed or not, with a possible
             effect on psoriasis vulgaris within the following time periods prior to randomisation:

               -  etanercept - within 4 weeks prior to randomisation

               -  adalimumab, infliximab - within 8 weeks prior to randomisation

               -  ustekinumab - within 16 weeks prior to randomisation

               -  other products - within 4 weeks/5 half-lives prior to randomisation (whichever is
                  longer)

          -  Systemic treatment with all other therapies with a possible effect on psoriasis
             vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other
             immunosuppressants within 4 weeks prior to randomisation)

          -  Subjects who have received treatment with any non-marketed drug substance (i.e. a drug
             which has not yet been made available for clinical use following registration) within
             4 weeks/5 half-lives (whichever is longer) prior to randomisation.

          -  Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to
             randomisation

          -  Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation

          -  Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within
             2 weeks prior to randomisation

          -  Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D
             analogues or prescription shampoos within 2 weeks prior to randomisation

          -  Females who are pregnant, wishing to become pregnant during the trial or are
             breastfeeding
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20vPnC; 20vPnC; 20vPnC; 13vPnC
Intervention description: 20vPnC; 20vPnC; 20vPnC; Pneumococcal conjugate vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1710.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18
      through 49 years of age with no history of pneumococcal vaccination will be randomized in a
      2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or
      13vPnC.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults ≥18 and <50 years of age.

          2. 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 investigational product.

          3. Female subject of childbearing potential or male subject who is able to father
             children, and willing to use a highly effective method of contraception as outlined in
             this protocol for at least 28 days after the dose of investigational product; or
             female subject not of childbearing potential or male subject not able to father
             children.

        Exclusion Criteria:

          1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.

          2. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
             pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
             or without dialysis, clinically unstable cardiac disease, or any other disorder that,
             in the investigator's opinion, excludes the subject from participating in the study.

          3. History of microbiologically proven invasive disease caused by S pneumoniae.

          4. Pregnant female subjects or breastfeeding female subjects (known or suspected).
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: Cimzia
Intervention description: Active substance: Certolizumab Pegol
Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe
Concentration: 200 mg/ml
Route of Administration: Subcutaneous use
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CDP 870; Certolizumab Pegol; CIMZIA; Crohn's Disease; Crohn Disease; CD Induction; Induction; Clinical response; Clinical remission

Summary:

      The primary objective of the study is to assess the safety of long term therapy with
      Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject participated in study C87085 [NCT00552058] in which the subject completed the
             study at Week 6

          -  Subject is capable of providing informed consent, which must be obtained prior to any
             study related procedures

          -  Have a chest X-ray taken at Visit 1 that is read by a qualified radiologist or
             pulmonary physician, with no evidence of current active Tuberculosis (TB) or old
             inactive TB

          -  Subject has taken a TB survey and is committed to comply with TB prophylaxis if
             applicable

        Exclusion Criteria:

          -  Subject is experiencing an ongoing serious adverse event assessed as being related to
             study medication or is experiencing a serious adverse event that is still not
             assessable

          -  Subject has an intercurrent illness that requires termination of treatment, such as a
             serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess)

          -  Subject is non-compliant with TB prophylactic treatment (if applicable)

          -  Subject has had a chest X-ray at Visit 1 that shows an abnormality suggestive of a
             malignancy or active infection, including TB

          -  Female who is pregnant or breast feeding

          -  Female of child bearing age or post puberty males not practicing effective birth
             control

          -  Subject is expecting to receive any live virus or bacterial vaccination within 3
             months of first Study Medication administration, during the trial or 3 months after
             last dose of study drug
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Intervention: Ospemifene 60Mg Oral Tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Menopausal symptoms; Vulvar and vaginal atrophy in menopausal women; Vaginal atrophy; Urogenital atrophy

Summary:

      The objective of the study was to assess the long-term safety of daily doses of ospemifene 60
      mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a
      uterus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal
             atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and
             self-reported symptoms at Baseline for Protocol 15-50310

          -  Did not have a uterus

          -  Met the inclusion and exclusion criteria for Protocol 15-50310

          -  Had completed Protocol 15-50310 without any clinically significant abnormal findings
             at the end-of-study visit for Protocol 15-50310

          -  Provided written informed consent to participate in the study and agreed to follow
             dosing instructions and complete all required study visits

        Exclusion Criteria:

          -  Had clinically significant abnormal findings at the Week 12 End of Study visit for
             Protocol 15-50310

          -  Had any physical or mental condition which, in the opinion of the investigator, may
             have interfered with the subject's ability to comply with the study procedures