bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity
Intervention: Farletuzumab; Carboplatin; Taxane; Farletuzumab-matched placebo
Intervention description: Farletuzumab IV infusion.; Carboplatin IV infusion.; Taxane (Paclitaxel or Docetaxel) IV infusion.; Farletuzumab-matched placebo IV infusion.
Intervention MeSH terms: Carboplatin; Taxane; Farletuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; relapsed ovarian cancer; Platinum-sensitive Ovarian Cancer

Summary:

      This research is being done to find out if Carboplatin and Taxane works better alone or when
      given with an experimental drug called MORAb-003(farletuzumab) in subjects with first
      platinum sensitive relapsed ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A histologically or cytologically confirmed diagnosis of non-mucinous epithelial
             ovarian cancer including primary peritoneal or fallopian tube malignancies

          -  Must have measurable disease by CT or MRI scan

          -  Must have relapsed radiologically with a randomization date within ≥6 and < 24 months
             of completion of first-line platinum chemotherapy

          -  Have been treated with debulking surgery and first-line platinum and taxane based
             chemotherapy.

          -  Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been
             at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or
             cancer vaccine therapy is allowed.

          -  Must be a candidate for carboplatin and taxane therapy

          -  Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

        Exclusion Criteria:

          -  Subjects who never responded to first-line platinum-based therapy or whose first
             relapse occurs <6 months or >24 months from the last platinum therapy

          -  Subjects who have received other therapy to treat their ovarian cancer since relapse

          -  Known central nervous system (CNS) tumor involvement

          -  Evidence of other active invasive malignancy requiring treatment in the past 5 years

          -  Known allergic reaction to a prior monoclonal antibody therapy or have any documented
             HAHA

          -  Previous treatment with MORAb-003 (farletuzumab)

          -  Clinical contraindications to use of a taxane
Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Condition: Vitreomacular Adhesion Including Macular Hole
MeSH terms: Retinal Perforations; Tissue Adhesions
Intervention: Ocriplasmin; Sham injection
Intervention description: 0.125 mg single intravitreal injection; Sham injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion
      / (VMT) including macular hole with ocriplasmin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 years of age or older and of either gender

          -  Presence of vitreomacular adhesion

          -  Best corrected visual acuity (BCVA) of 20/32 or worse in study eye

          -  BCVA of 20/800 or better in the non-study eye

        Exclusion Criteria:

          -  History or current evidence of proliferative retinopathy, exudative age-related
             macular degeneration (AMD) or retinal vein occlusion in the study eye

          -  Any vitreous hemorrhage or any other vitreous opacification which precludes the
             visualization of the posterior pole by visual inspection OR adequate assessment of the
             macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye

          -  Macular hole of > 400 µm diameter in the study eye

          -  Presence of epiretinal membrane (ERM)

          -  Aphakia in the study eye

          -  High myopia (more than 8D) in study eye

          -  History of rhegmatogenous retinal detachment in either eye

          -  History of vitrectomy in the study eye

          -  Previous participation in this trial or prior administration of ocriplasmin in the
             study eye
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Condition: Vaccines, Pneumococcal
Intervention: 13-valent Pneumococcal Conjugate Vaccine; 7-valent Pneumococcal Conjugate Vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 619.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal; Pediatric; Vaccine

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine pediatric vaccinations in Spain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month-old infants

          -  Available for the entire study period

        Exclusion criteria:

          -  Previous vaccination with any vaccine before the start of the study

          -  Known contraindication to vaccination
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
Condition: Anemia
MeSH terms: Anemia
Intervention: Darbepoetin alfa; methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: As prescribed; 120, 200 or 360 micrograms sc 4-weekly (starting dose)
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This two arm study will compare the efficacy and safety of subcutaneous Mircera versus
      darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients
      with chronic renal anemia. Patients currently receiving maintenance treatment with
      darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a
      starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of
      darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on
      2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months,
      and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, > or = 18 years of age;

          -  kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;

          -  functioning graft of > 6 months and < 10 years after kidney transplantation, with no
             signs of acute rejection;

          -  stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months;

          -  poorly controlled hypertension;

          -  significant acute or chronic bleeding;

          -  need for dialysis therapy expected in next 6 months.
ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
Condition: Acute Hepatic Porphyria; Acute Intermittent Porphyria; Porphyria, Acute Intermittent; Acute Porphyria; Hereditary Coproporphyria (HCP); Variegate Porphyria (VP); ALA Dehydratase Deficient Porphyria (ADP)
MeSH terms: Porphyria, Acute Intermittent; Porphyrias, Hepatic; Coproporphyria, Hereditary; Porphyria, Variegate; Porphyria, Erythropoietic; Porphyrias
Intervention: Givosiran; Placebo
Intervention description: Givosiran by SC; Matching placebo (normal saline [0.9% NaCl]) by SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 94.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acute Intermittent Porphyria (AIP); Acute Hepatic Porphyria (AHP); Hereditary Coproporphyria (HCP); Variegate Porphyria (VP); ALA dehydratase deficient porphyria (ADP) (ALAD); RNAi therapeutic; Porphyria

Summary:

      The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1),
      compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic
      Porphyrias (AHP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 12 years of age

          -  Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary
             Corproporhyria, Variegate Porphyria, aminolevulinic acid (ALA) dehydratase deficient
             porphyria)

          -  Elevated urinary or plasma porphobilinogen (PBG) or ALA values within the past year,

          -  Have active disease, with at least 2 documented porphyria attacks within the last 6
             months

          -  Willing to discontinue or not initiate the use of prophylactic hemin throughout the
             study.

          -  Women of child bearing potential must have a negative serum pregnancy test, not be
             nursing, and use acceptable contraception

        Exclusion Criteria:

          -  Clinically significant abnormal laboratory results

          -  Anticipated liver transplantation

          -  History of multiple drug allergies or intolerance to subcutaneous injections

          -  Active HIV, hepatitis C virus, or hepatitis B virus infection(s)

          -  History of recurrent pancreatitis
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry
Condition: Platelet Inhibition; Coronary Stent Implantation
Intervention: prasugrel or ticagrelor; Clopidogrel
Intervention description: prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month; clopidogrel 75mg od for 12 month
Intervention MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1008.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: clopidogrel-nonresponder; stent thrombosis

Summary:

      The purpose of this study is to determine the efficacy and safety of a routine individualized
      antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet
      reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).
    

Eligibility criteria:

        Inclusion Criteria:

          -  all consecutive PCI patients with stent implantation of our institution

        Exclusion Criteria:

          -  pregnancy
Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
Condition: Stress Disorders, Posttraumatic
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: stepped preventive care
Intervention description: 2 targeted assessments (T1: in hospital within a few days of injury; T2: two weeks post-discharge) are administered by nurse or social worker, and determine need for additional assistance modules. Additional modules include case management, care coordination, assistance with child and family coping with injury/distress, and trauma-focused Cognitive Behavior Therapy (CBT) beginning at 4-6 weeks post-injury if needed.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 290.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the impact of a brief psychosocial intervention delivered to
      children or adolescents who are hospitalized for an unintentional injury. The intervention is
      designed to promote psychological recovery and enhance functional outcomes after injury. The
      study will also provide preliminary data concerning cost-effectiveness of the intervention.

      The core study hypotheses are that children receiving the intervention will (1) have lower
      severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2)
      show greater adherence to discharge instructions and better health-related quality of life at
      follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and
      lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury,
      compared to those receiving usual care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 8 to 17

          -  Admitted to hospital for treatment of unintentional injury

          -  Sufficient English fluency to participate in an interview

          -  Family has access to a telephone (for telephone follow-up contacts)

        Exclusion criteria:

          -  Child's medical status or cognitive functioning precludes participating in an
             interview

          -  Child has moderate to severe head injury, defined as Glasgow Coma Score (GCS) <= 12

          -  Child's injury involved family violence or abuse (physical or sexual)

          -  No parent or guardian available to consent
Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia
Condition: Hyperlipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bococizumab 150mg; Bococizumab 75mg; Bococizumab 150mg placebo; Bococizumab 75mg placebo
Intervention description: Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.; Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.; Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.; Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 299.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mixed dyslipidemia

Summary:

      This study is a multicenter, randomized study in subjects with high cholesterol receiving
      statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of
      bococizumab and an autoinjector (pre-filled pen).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL

        Exclusion Criteria:

          -  Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or
             procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly
             controlled hypertension
Phase 3 Papulopustular Rosacea Study
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: CD5024; Azelaic acid 15% Gel
Intervention description: CD5024 1% Cream, once daily; Topical Gel applied twice daily
Intervention MeSH terms: Azelaic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 688.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PPR

Summary:

      The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its
      vehicle when applied once daily, at bed time, during a 12 week period in subjects with
      Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA)
             score rated 3 (moderate) or 4 (severe),

          2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and
             pustules) on the face.

        Exclusion Criteria:

          1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans,
             isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that
             may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial
             keratosis pilaris, seborrheic dermatitis, and acne,

          2. The subject has rosacea with more than two nodules on the face.
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Romozosumab; Teriparatide
Intervention description: Administered by subcutaneous injection once a month.; Administered by subcutaneous injection once a day.
Intervention MeSH terms: Teriparatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 436.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Postmenopausal Osteoporosis

Summary:

      The primary objective of the study was to evaluate the effect of 12 months of treatment with
      romosozumab compared with teriparatide on total hip bone mineral density (BMD) in
      postmenopausal women with osteoporosis who were previously treated with bisphosphonate
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women, aged ≥ 55 to ≤ 90.

          -  Received oral bisphosphonate therapy for at least 3 years immediately prior to
             screening

          -  BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck

          -  History of nonvertebral fracture after age 50, or vertebral fracture.

        Exclusion Criteria:

          -  Use of other agents affecting bone metabolism including Strontium ranelate, fluoride
             (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV
             bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH)
             analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators
             (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic
             glucocorticosteroids:

          -  History of metabolic or bone disease (except osteoporosis) that may interfere with the
             interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid
             arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing
             spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.

          -  Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined
             by the central laboratory.

          -  Current hyper- or hypocalcemia

          -  Current, uncontrolled hyper- or hypothyroidism
Metoclopramide for Post Traumatic Headache
Condition: Post-Traumatic Headache
MeSH terms: Post-Traumatic Headache; Headache
Intervention: Metoclopramide; Diphenhydramine; Normal saline
Intervention description: Metoclopramide 20mg; Diphenhydramine 25mg; 100ml normal saline
Intervention MeSH terms: Diphenhydramine; Promethazine; Metoclopramide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Nearly 1.5 million patients present to US emergency departments annually following head
      trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study
      is to see if an intravenous medication called metoclopramide can improve the symptoms of
      patients with acute post-traumatic headache.
    

Eligibility criteria:

        Inclusion Criteria:

        Included patients will be adults who meet International Classification of Headache
        Disorders criteria for acute post-traumatic headache. These are as follows:

          -  Traumatic injury to the head has occurred

          -  Headache has developed within 7 days of injury to the head

          -  Headache is not better accounted for by another diagnosis (eg, previous history of
             migraine or tension-type headache)

        The headache must be rated as moderate or severe in intensity at the time of initial
        evaluation.

        Exclusion Criteria:

        Patients will be excluded if more than ten days have elapsed since the head trauma, if the
        headache has already been treated with an anti-dopaminergic medication, or for medication
        contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use
        of MAO inhibitors, and use of anti-rejection transplant medications.