bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Golimumab in Participants With Active Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo; Golimumab
Intervention description: Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.; Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.
Intervention MeSH terms: Golimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 480.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic arthritis; Golimumab; Simponi

Summary:

      The purpose of this study is to evaluate the efficacy of intravenously (administration of a
      fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants
      with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with
      psoriasis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had psoriatic arthritis (PsA) for at least 6 months prior to the first
             administration of study agent

          -  Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more
             tender joints at Screening and at Baseline and C-reactive protein >=0.6 milligram per
             deciliter (mg/dL) at Screening

          -  Have active plaque psoriasis or a documented history of plaque psoriasis

          -  Have active PsA despite current or previous disease-modifying antirheumatic drugs
             (DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is
             defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance.
             NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID
             intolerance

        Exclusion Criteria:

          -  Have other inflammatory diseases that might confound the evaluations of benefit of
             Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing
             spondylitis, systemic lupus erythematosus, or Lyme disease

          -  Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
             the study or within 4 months after receiving the last administration of study agent

          -  Have used any biologic agents that are targeted for reducing tumor necrosis factors
             (TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab,
             Golimumab, and Certolizumab Pegol

          -  Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen
             mustard, or other Alkylating agents
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
Condition: Urge Urinary Incontinence; Urinary Frequency
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Intervention: Oxybutynin; Placebo
Intervention description: Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment.
Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo; Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment.
Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo
Intervention MeSH terms: Mandelic Acids; Oxybutynin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 626.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the double-blind phase of the study is to compare the effects of two
      doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to
      evaluate the extended safety and skin-irritation profile of topically administered oxybutynin
      gel.

      The hypothesis is that topically administered oxybutynin gel will decrease (compared to
      placebo) the number of incontinence episodes per week, average daily urinary frequency, and
      urinary urgency; increase average urinary void volume; and improve patient quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge
             incontinence for at least 3 months

          -  Have a history of at least 1 - 2 urge episodes and 8 or more voids per day

        Exclusion Criteria:

          -  Incontinence that is predominantly stress, insensate, or overflow in nature, or
             incontinence related to chronic illness, anatomical weakness/abnormalities or
             concomitant medications

          -  PVR volume > 200 mL or relative PVR > 50% of pre-void volume as determined by bladder
             ultrasound

          -  History of urinary retention, gastric retention, or uncontrollable narrow-angle
             glaucoma, or patients who are at risk for these conditions
A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Xyrem®; Placebo
Intervention description: two doses; Oral Solution
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 548.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FMS; Fibro; pain; Body pain; tenderness; joint pain; stiffness; muscular pain

Summary:

      The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to
      placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled,
      parallel group trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, 18 years or older who meet the American College of
             Rheumatology (ACR) diagnostic criteria for fibromyalgia.

        Exclusion Criteria:

          -  Subjects will be excluded if they have a history of rheumatic disease or other
             disorders that may compromise reliable representation of subjective symptoms.

          -  Any other condition that will cause a risk to subjects if they participate in the
             trial is also a reason for exclusion.
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ZD4054; Palcebo
Intervention description: 10 mg once daily oral dose; Matching Plcebo oral tablet once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2577.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone Resistant Prostate Cancer; Endothelin A Receptor Antagonist; Endothelin A; Endothelin A antagonist

Summary:

      Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan)
      in hormone resistant prostate cancer (HRPC).

      This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can
      improve progression-free survival and overall survival against a background of existing
      prostate cancer treatments.

      ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread
      by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054
      (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA
      after surgical or medical castration but have no evidence of metastases.

      All patients participating in this clinical trial will receive existing prostate cancer
      treatments in addition to trial therapy.

      Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive
      placebo in addition to standard prostate cancer therapy. By participating in this trial there
      is a 50% chance that patients will receive an agent that may slow the progression of the
      tumour.

      No patients will be deprived of standard prostate cancer therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who answer TRUE to the following criteria may be eligible to participate in this
        study.

          -  Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT
             spread to the other parts of the body (metastases). Patients with lymph node
             involvement may be eligible if specified criteria is met.

          -  Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment

          -  Currently receiving treatment with surgical or medical castration

        Exclusion Criteria:

        Patients who answer TRUE to the following may NOT be eligible to participate in this study.

          -  Currently using opiate based pain killers for cancer related pain

          -  Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior
             targeted cancer therapies are permitted if received during a previous clinical trial

          -  Suffering from heart failure or had a myocardial infarction within last 6 months

          -  A history of epilepsy or seizures
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
Condition: Cervical Ripening; Labor, Induced
Intervention: Misoprostol vaginal insert 100 mcg; Misoprostol vaginal insert 50 mcg; Dinoprostone vaginal insert (Cervidil)
Intervention description: Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.; Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.; Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Intervention MeSH terms: Misoprostol; Dinoprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1308.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cervical ripening; Induction of labor; Dinoprostone vaginal insert; Cervidil; Misoprostol vaginal insert; Modified Bishop's Score; PGE2; PGE1; Uterine Hyperstimulation; Cesarean section

Summary:

      The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and
      100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R)
      in women who need to have cervical ripneing and induction of labor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women at least 36 weeks gestation requiring cervical ripening and induction
             of labor

        Exclusion Criteria:

          -  No uterine scar (no previous delivery by cesarean section)

          -  No multiple gestation

          -  No condition that disallows use of prostaglandins for induction of labor

          -  No more than 3 previous vaginal births beyond 24 weeks gestation
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Condition: Vaginitis
MeSH terms: Vaginitis
Intervention: POLYGYNAX®; GYNODAKTARIN®; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 661.0
Sex: Female
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated
      for the local treatment of vaginitis due to sensitive germs and treatment of non specific
      vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.

      Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study
      supporting the interest of the combination of antifungal and antibiotics agents versus
      antifungal agent alone.

      The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole
      in the treatment of women experiencing symptoms of infectious vaginitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with an abnormal vaginal discharge associated with one (or more) functional
             vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation
             clinically evoking an infectious vaginitis:

               -  bacterial vaginitis

               -  non-specific vaginitis (atypical symptoms)

               -  mixed vaginitis (i.e. suprainfected fungal vaginitis) and able to receive an
                  empirical local treatment

        Exclusion Criteria:

          1. Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious
             vaginitis in the 12 months prior to inclusion

          2. Vaginal infection justifying systemic therapy

          3. History of atrophic vaginitis or suspected atrophic vaginitis at inclusion

          4. Patient presenting with signs of genital herpes or signs of non-infectious vulvar
             pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact
             dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))

          5. Patient with current Sexually Transmitted Infection (STI) and/or patients with
             clinical suspicion of STI

          6. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes
             mellitus, corticosteroids treatments)

          7. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to
             inclusion

          8. Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the
             time of inclusion

          9. Pregnant or lactating women or delivery within last 1 month
Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
Condition: Pneumonia, Pneumococcal
MeSH terms: Pneumonia, Pneumococcal
Intervention: Pneumosil; Synflorix
Intervention description: 10-Valent Pneumococcal Conjugate Vaccine; Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2250.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 8 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at
      the immune response in infants. In addition, the study will compare the immunogenicity of the
      Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.
    

Eligibility criteria:

        Inclusion Criteria:

          -  They are healthy infants based on medical history and clinical assessment.

          -  They are between 6 and 8 weeks (ie 42 to 56 days) old, inclusive.

          -  Subject's parent must provide voluntary written/thumb-printed informed consent and be
             willing to comply with study requirements and procedures.

        Exclusion Criteria:

          -  Use of any investigational medicinal product prior to randomization.

          -  Previous vaccination against or infection with S. pneumoniae.

          -  History of anaphylactic shock or an allergic reaction to any prior vaccination.

          -  Any fever, illness (including malaria).

          -  Receipt of another vaccine within 30 days of study start.

          -  Chronic administration of an immunosuppressant or administration of immunoglobulins

          -  History of blood disorder, primary immunodeficiency, or a sibling who has such a
             diagnosis or who died of suddenly without apparent cause.

          -  History of meningitis, seizures or any neurological disorder.
A Long-term Study for the Treatment of Painful Diabetic Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies
Intervention: Duloxetine hydrochloride; Duloxetine hydrochloride
Intervention description: Duloxetine 40 mg QD, PO, 1 year; Duloxetine 60 mg QD, PO, 1 year
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 258.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to investigate safety and efficacy of duloxetine for patients
      with painful diabetic neuropathy at long-term use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients who have completed the 13-week treatment in the preceding study (Protocol
             No. 0715N0831: NCT00552175).

          -  Patients who desire to receive continued treatment with LY248686 from the preceding
             study.

          -  Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.

          -  Patients who can provide written consent in person.

        Exclusion Criteria:

          -  Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or
             blood disease, or symptomatic peripheral vascular disease, and thus are considered
             inappropriate to be included in the study.

          -  Pregnant patients or women who desire to become pregnant during the study period, and
             breast feeding patients.

          -  Other patients judged by the investigator/subinvestigator to be inappropriate as a
             subject in this study.
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Condition: Heart Failure; Anemia; Cardiovascular Disease; Ventricular Dysfunction; Congestive Heart Failure
MeSH terms: Heart Failure; Cardiovascular Diseases; Ventricular Dysfunction; Anemia
Intervention: Darbepoetin alfa; Placebo
Intervention description: Administered by subcutaneous injection; Placebo subcutaneous injection
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2278.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Survival study; morbidity and mortality; heart failure hospitalization; all-cause death; patient-reported outcomes; Kansas City Cardiomyopathy questionnaire; anemia treatment

Summary:

      The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin
      alfa compared to placebo on the composite of time to death from any cause or first hospital
      admission for worsening heart failure in patients with symptomatic left ventricular systolic
      dysfunction and anemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart failure of at least 3 months duration and of New York Heart Association (NYHA)
             class II, III, or IV

          -  hemoglobin between 9.0 g/dL and 12.0 g/dL

          -  left ventricular ejection fraction equal to or less than 40%

        Exclusion Criteria:

          -  Transferrin saturation (Tsat) < 15%

          -  Blood pressure > 160/100 mm Hg

          -  Heart failure primarily due to valvular heart disease or clinically significant
             valvular heart disease that might lead to surgical correction within 12 months of
             randomization

          -  Recipient of a major organ transplant or receiving renal replacement therapy

          -  Serum creatinine > 3.0 mg/dL (> 265 µmol/L)
A Study in Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil; Placebo
Intervention description: Administered orally, once daily for 8 weeks; Administered orally, once daily for 8 weeks
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 97.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for
      8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of
      Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate
      transition zone.
    

Eligibility criteria:

        Inclusion Criteria

          -  Present with benign prostatic hyperplasia

          -  Provide signed informed consent at the screening

          -  Agree not to use other treatment for Benign Prostatic Hyperplasia, Erectile
             Dysfunction or Overactive Bladder (including herbal treatments) during the study

        Exclusion Criteria

          -  Have prostatic cancer or are being treated for cancer.

          -  Any condition that may negatively influence the transrectal ultrasound.

          -  Are being treated for heart disease with any drug that is called a nitrate (for
             example, nitroglycerin).

          -  Any evidence of moderate to severe cardiac disease

          -  Have had any of the following in the past 90 days: chest pain (called unstable angina
             or angina) that requires treatment, heart attack also known as myocardial infarction,
             heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to
             open up blood vessels in the heart know as angioplasty or stent placement
             (percutaneous coronary intervention), positive cardiac stress test without effective
             cardiac intervention.

          -  Have very high or very low blood pressure.

          -  Have uncontrolled diabetes.

          -  Have certain problems with your kidneys, liver, or nervous system.