bioihbjkbjnl/mcl2 huggingface dataset:
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: placebo; Elagolix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 815.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Non-Menstrual Pelvic Pain (NMPP); Dysmenorrhea (DYS); Elagolix; Endometriosis Associated Pain; Gonadotropin-Releasing Hormone Antagonist

Summary:

      A randomized study evaluating the safety and efficacy of elagolix in the management of
      moderate to severe endometriosis-associated pain in adult premenopausal female subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of
             signing consent.

          2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10
             years of entry into the Washout Period.

          3. Agrees to use required birth control methods during the entire length of participation
             in the study.

          4. Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 or greater at
             Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual
             pelvic pain.

          5. Subjects must have at least two regular menstrual cycles with an interval of 24-38
             days within the Screening Period, prior to Day 1.

        Exclusion Criteria:

          1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24
             months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the
             time of entry into the Screening Period.

          2. Subject has a history of previous non-response to gonadotropin-releasing hormone
             (GnRH) agonists, GnRH antagonists, Depot medroxyprogesterone acetate, or aromatase
             inhibitors as assessed by subject report of no improvement in dysmenorrhea or
             non-menstrual pelvic pain.

          3. Subject has chronic pelvic pain that is not caused by endometriosis that requires
             chronic analgesic or other chronic therapy, or that would interfere with the
             assessment of endometriosis related pain.

          4. Clinically significant gynecologic condition identified on Screening transvaginal
             ultrasound or endometrial biopsy.

          5. Subject has a history of osteoporosis or other metabolic bone disease.

          6. Subject has a current history of undiagnosed abnormal uterine bleeding.
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
Intervention: Blood sampling; Cervico-vaginal secretion (CVS) samples
Intervention description: Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.; CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 525.0
Sex: Female
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cervical cancer; HPV vaccine

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. This study is designed to evaluate the long-term immunogenicity and
      safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the
      first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals
      with objectives & outcome measures of the extension phase from Year 5 to Year 10. The
      objectives & outcome measures of the primary phase and extension phase up to year 4 are
      presented in a separate protocol posting (NCT00196937).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believed that they could and would comply with the
             requirements of the protocol.

          -  A female who had been enrolled in NCT00196937 study and received three doses of
             HPV-16/18 vaccine.

          -  Written informed consent obtained from the subject.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) or planned use
             during the study period.

          -  Chronic administration (defined as more than 14 consecutive days) of
             immunosuppressants or other immune-modifying drugs occurring less than three months
             prior to blood sampling.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device).

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding blood sampling.

          -  Administration or planned administration of any HPV vaccine, other than the three
             doses of HPV-16/18 vaccine administered in NCT00196937 study.
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: BIBW 2992; trastuzumab; vinorelbine; vinorelbine
Intervention description: patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management; patients receive trastuzumab 2mg/kg intravenously every week; patients receive vinorelbine 25mg/m² intravenously every week; patients receive vinorelbine 25mg/m² intravenously every week
Intervention MeSH terms: Trastuzumab; Vinorelbine; Afatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 508.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v.
      chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who
      failed one prior trastuzumab (Herceptin®) treatment
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed diagnosis of HER2-overexpression breast cancer

          -  Stage IV metastatic disease

          -  Must have progressed on one prior trastuzumab treatment

          -  no more than one prior trastuzumab based therapy regimen (either adjuvant or
             first-line)

          -  Must have received anthracycline and/or taxane based chemotherapy for adjuvant
             treatment of breast cancer or first-line treatment of metastatic breast cancer

          -  Must have (archived) tumour tissue sample available for central re-assessment of
             HER2-status

          -  At least one measurable lesion according to RECIST 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .

        Exclusion criteria:

          -  Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor
             Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab

          -  Prior treatment with vinorelbine

          -  Known pre-existing interstitial lung disease

          -  Active brain metastases

          -  History or presence of clinically relevant cardiovascular abnormalities such as
             uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable
             angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to
             randomisation.

          -  Cardiac left ventricular function with resting ejection fraction of less than 50%.

          -  Patients unable to comply with the protocol.

          -  Any contraindications for therapy with vinorelbine or trastuzumab.

          -  Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.

          -  Use of any investigational drug within 4 weeks of randomisation.

          -  Inadequate hepatic, renal and haematologic organ function
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Intervention: 13-valent Pneumococcal Conjugate Vaccine
Intervention description: 1 dose 13vPnC
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further
      evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate
      vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC,
      and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This
      study will determine if a subsequent dose of 13vPnC one year later results in similar or
      greater immune response (body's ability to protect against disease) than that measured after
      the initial dose of 13vPnC.
    

Eligibility criteria:

        -  Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS

          -  Generally healthy male or female adults 65 years of age or older

          -  Available for the duration of the trial - approximately 1 month

          -  No history of severe adverse reaction associated with a vaccine

               -  MMSE score less than or equal to 21 was an exclusion criteria.
Montelukast Back to School Asthma Study (0476-340)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast; Comparator: Placebo
Intervention description: montelukast 5 mg tablet Once a day (QD) for 8 weeks; Placebo to montelukast QD for 8 weeks
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1162.0
Sex: All
Minimum age: 6 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      This study, in children with chronic asthma, evaluates the number of days of worsening asthma
      during 8 weeks of treatment with montelukast after treatment is started for the first day of
      school.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma,
             history of at least one asthma exacerbation associated with a cold within the past
             year and a documented history of asthma that required treatment with any asthma
             medication within 6 months prior to Visit 1

        Exclusion Criteria:

          -  Participant cannot have any other acute or chronic pulmonary disorder, or
             hospitalization for asthma more than three times within one year prior to signing
             informed consent
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
Condition: Growth Disorders; Insulin-Like Growth Factor-1 Deficiency
MeSH terms: Growth Disorders; Failure to Thrive
Intervention: rhIGF-1 (mecasermin, Tercica, Inc.)
Intervention description: Twice Daily Injection
Intervention MeSH terms: Mecasermin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Primary IGF-1 Deficiency

Summary:

      This study is intended to determine whether twice daily weight based dosing with recombinant
      human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of
      prepubertal children with short stature associated with low IGF-1 levels but who produce
      sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or
      to active treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronological age ≥ 3 and chronological or bone age less than or equal to 11 years
             inclusive in girls;

          -  Chronological age ≥ 3 and chronological or bone age less than or equal to 12 years
             inclusive for boys

          -  Prepubertal

          -  Height SD score of < -2

          -  IGF-1 SD score of < -2

        Exclusion Criteria:

          -  Prior treatment with rhGH, rhIGF-1, or other growth-influencing medications

          -  Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal
             abnormality)

          -  Chronic illness such as diabetes, cystic fibrosis, etc.
Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Intervention: Butenafine HCl 1% (BAY1896425)
Intervention description: Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.
Intervention MeSH terms: Butenafine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this study researcher want to learn more about possible skin reactions such after repeated
      application of an antifungal cream containing Trolamine. They are especially interested in
      skin irritations or allergic skin reactions. The study plans to enroll about 225 female or
      male participants with the age 18 - 79 years. The antifungal test cream will be applied on
      the back between the shoulder blades of the participants and covered by a special dressing
      patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the
      cream on the same area of the back. At each visit the skin will be investigated for redness,
      dryness and other reactions. After a rest period of two weeks the test cream will be applied
      on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the
      two skin areas will again be investigated for redness, dryness and other reactions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have been aged 18 to 79 years, inclusive;

          -  Female subjects must have produced a negative urine pregnancy test prior to the
             initiation and also at the completion of the trial;

          -  Subjects must have been capable of understanding and following directions.

        Exclusion Criteria:

          -  Subjects who were in ill health or taking medication, other than birth control, which
             could influence the purpose, integrity or outcome of the trial;

          -  Subjects who had any visible skin disease that might be confused with a skin reaction
             to the test material;

          -  Subjects who were participating in another clinical trial at this facility or any
             other facility;

          -  Subjects who used topical or systemic steroids or antihistamines for at least 7 days
             prior to trial initiation and during the duration of the trial;

          -  Subjects who had a history of adverse reactions to adhesive tape, cosmetics, OTC drugs
             or other personal care products;

          -  Subjects judged by the PI to be inappropriate for the trial;

          -  Female subjects who were pregnant as evidenced by a urine pregnancy test, planning to
             become pregnant, or nursing during the course of the trial.
Study of Antidepressants in Parkinson's Disease
Condition: Parkinson Disease; Depression
MeSH terms: Parkinson Disease; Depression
Intervention: paroxetine; venlafaxine; placebo
Intervention description: Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.; Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.; an inactive substance
Intervention MeSH terms: Paroxetine; Venlafaxine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 115.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson disease; depression; Parkinson's disease; paroxetine; venlafaxine; antidepressant

Summary:

      The purpose of this study is to find out if two antidepressant medications, paroxetine and
      venlafaxine, can help control depression in Parkinson's disease, and if these medications
      affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and
      balance.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible you must be:

          -  30 years old or older

          -  diagnosed with Parkinson's disease

          -  experiencing symptoms of depression such as sadness, decreased energy, or problems
             sleeping
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: Duloxetine Hydrochloride; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus
      placebo in the treatment of Japanese children and adolescents with depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with Major Depressive Disorder or persistent depressive
             disorder and completely meet the criteria of major depressive episode as defined by
             the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with
             the Mini International Neuropsychiatric Interview for Children and Adolescents
             (MINI-KID) ver.7.0.2.

          -  Participants whose incipient age of depression was ≥7 years old.

          -  Total score of CDRS-R is ≥40 and CGI-S score is ≥4 at both screening and baseline.

        Exclusion Criteria:

          -  Have remarkable response to psycho-education (defined as >30% decrease in the total
             score of CDRS-R between screening and baseline).

          -  Have a current or previous diagnosis (DSM-5) of the following as judged by the
             investigator:

               -  Neurodevelopmental disorders

               -  Schizophrenia spectrum and other psychotic disorders

               -  Bipolar and related disorders

               -  Trauma and stressor-related disorders

               -  Disruptive · Impulse Control · and Conduct disorders

          -  Have a current diagnosis (DSM-5) of the following as judged by the investigator:

               -  Obsessive-compulsive and related disorders

               -  Anorexia nervosa, Bulimia nervosa, Binge-eating disorder

               -  Sleep-wake disorders

               -  Neurocognitive disorders

               -  Disruptive mood dysregulation disorder

          -  Have personality disorders, in the judgement of the investigator.
Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
Condition: Pharyngitis
MeSH terms: Pharyngitis
Intervention: Celecoxib; Celecoxib; celecoxib; placebo
Intervention description: dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg; dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo; dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg; dose 1 placebo followed 6-12 hours later by dose 2 placebo
Intervention MeSH terms: Celecoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: sore throat; acute pain

Summary:

      We are proposing a study in which we utilize and augment the sore throat pain model to assess
      the analgesic effectiveness of celecoxib compared to placebo in patients with painful
      pharyngitis under randomized, double-blind, placebo-controlled conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient must have a diagnosis of pharyngitis with objective findings of
             tonsillo-pharyngitis.

          -  The patient is willing to take "nothing by mouth" including inhaled treatments except
             trial medication during the two hours while at the site and following trial drug
             administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The
             patient will be allowed food and drink between hours 2 and 24, but no other oral or
             inhaled treatments such as smoking, lozenges, chewing gum. After the two hour
             assessment, the patients will be allowed food and drink within one half-hour following
             any hourly evaluations sore throat.

        Exclusion Criteria:

          -  The patient has used any analgesic/antipyretic within 1 dosing interval preceding
             administration of the first dose of trial medication.

          -  The patient anticipates using any inhaled therapy including beta-agonists (e.g.,
             ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy
             on an intermittent basis in the week prior to the screening visit.