bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib
Condition: Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Verteporfin photodynamic therapy; Pegaptanib; Triamcinolone acetonide
Intervention description: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.; Pegaptanib sodium 0.3 mg administered by intravitreal injection.; Triamcinolone acetonide administered by intravitreal injection.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Verteporfin; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; age-related macular degeneration; choroidal neovascularization

Summary:

      To evaluate the safety and efficacy of the combination treatments in wet age-related macular
      degeneration. The combination treatment consists of verteporfin photodynamic therapy and
      either triamcinolone acetonide or pegaptanib added as an intravitreal injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age >50

          -  all types of untreated subfoveal choroidal neovascularization secondary to AMD

          -  lesion size <5400 microns in greater linear dimension (GLD)

        Exclusion Criteria:

          -  have a history of prior photodynamic therapy, external beam radiation, subfoveal focal
             laser photocoagulation, submacular surgery, or transpupillary thermotherapy

          -  known allergy to verteporfin, triamcinolone or pegaptanib

          -  have received prior treatment with Macugen, or other anti-angiogenic compound or any
             investigational treatment (e.g. Ruboxistaurin, Lucentis [ranibizumab], Retaane
             [anecortave acetate], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD

          -  have the presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (tip)
             of the retinal pigment epithelium or other hypoflourescent lesions obscuring greater
             than 50% of the CNV lesion

          -  have had previous pars plana vitrectomy in the study eye

        Other protocol-specified inclusion/exclusion criteria applied.
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Hexvix; Standard white light cystoscopy
Intervention description: Single installation, TURB
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrence of bladder cancer; Fluorescence cystoscopy

Summary:

      The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted
      Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with
      suspicion of non-invasive bladder cancer.

      The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix
      assisted TURB compared to standard white light TURB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral
             resection of the bladder

          -  Above 18 years

          -  Written informed consent obtained

        Exclusion Criteria:

          -  Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting
             in marked amounts of blood in the urine, which may interfere with fluorescence
             cystoscopy. Where the bleed is light, the patient should not be excluded if in the
             investigator's opinion, rinsing during cystoscopy will alleviate the possible
             interference with fluorescence cystoscopy).

          -  Patient with porphyria.

          -  Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.

          -  Participation in other clinical studies with investigational drugs either concurrently
             or within the last 30 days.

          -  Pregnant or breast-feeding (all women of child-bearing potential must document a
             negative serum or urine pregnancy test at screening and use the contraceptive pill or
             intrauterine device (IUD) during the treatments and for at least one month
             thereafter).

          -  Conditions associated with a risk of poor protocol compliance.
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Metabolic Syndrome; Hypercholesterolemia
Intervention: simvastatin (+) ezetimibe; Comparator: atorvastatin
Intervention description: simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks; atorvastatin 10 mg; tablet, once daily, 8 Weeks
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Metabolic Disorder

Summary:

      Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting
      on such increasing populations like metabolic syndrome patients with Vytorin® in korea.
      Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian
      population with metabolic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of the metabolic syndrome according to 2005 American Heart
             Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement

          -  No history of diabetes and 100 <=LDL-C <=250 mg/dl

        Exclusion Criteria:

          -  Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months

          -  Congestive heart failure defined by New York Heart Association (NYHA) class III or IV

          -  Uncontrolled endocrine or metabolic disease known to influence serum lipids or
             lipoproteins

          -  Uncontrolled hypertension

          -  Unstable angina
LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: Placebo; Afatinib
Intervention description: Once daily; Once daily
Intervention MeSH terms: Afatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 617.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomised, double-blind phase III trial will be performed in patients with head and
      neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy
      and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have
      received definitive chemo-radiotherapy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Histologically or cytologically confirmed loco-regionally advanced head and neck
             squamous cell carcinoma (HNSCC), stage III to IVb

          2. Unresected tumour prior to chemo-radiotherapy (CRT)

          3. Concomitant CRT completed prior to randomisation

          4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and
             radiographic examinations

          5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

        Exclusion criteria:

          1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules,
             EGFR-targeted antibodies, and/or any investigational agents for HNSCC

          2. Patients with smoking history of less than or equal to 10 pack years and with primary
             tumour site of base of tongue and/or tonsil

          3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated
             superficial basal cell skin cancer and surgically cured cervical cancer in situ)
             unless free of disease for at least five years

          4. Known pre-existing Interstitial Lung Disease (ILD)

          5. Pregnancy or breast feeding
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: 700 μg Dexamethasone; Sham
Intervention description: 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.; Sham administered in the study eye on Day 1.
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 262.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug
      Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month
      double-blind period versus sham followed by a 2 month open label period.
    

Eligibility criteria:

        Inclusion Criteria:

        -Presence of macular edema defined as macular thickening involving the center of the macula
        due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

        Exclusion Criteria:

          -  History of glaucoma, ocular hypertension or optic nerve head change

          -  Any active bacterial, viral, parasitic, or fungal infections in either eye

          -  Eye surgery, including cataract surgery, and/or laser of any type in the study eye
             within 3 months prior to study start

          -  History of use of intravitreal steroids or any intravitreal injectable drug in the
             study eye within 3 months prior to study start

          -  Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal
             steroids within 1 month prior to study start

          -  Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents
             within 3 months prior to study start

          -  Use of topical ophthalmic corticosticosteroids within 2 weeks of study start
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
Condition: Neutropenic Complications; Breast Neoplasms; Chemotherapy-induced Neutropenia; Chemotherapeutic Toxicity
MeSH terms: Breast Neoplasms; Neutropenia
Intervention: LA-EP2006; Neulasta®
Intervention description: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.; Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 316.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: biosimilars; Pegfilgrastim,; G-CSF,; neutropenia,; breast cancer,; myelosuppressive chemotherapy,; supportive care; granulocyte-colony-stimulating factor

Summary:

      The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the
      mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in
      breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically proven breast cancer

          -  eligible for six cycles of neoadjuvant or adjuvant chemotherapy

        Exclusion Criteria:

          -  concurrent or prior chemotherapy for breast cancer

          -  concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy,
             immunotherapy, monoclonal antibodies, and/or biological therapy

          -  concurrent prophylactic antibiotics

          -  previous therapy with any G-CSF (granulocyte-colony stimulating factor) product

        Other protocol-defined inclusion/exclusion criteria may apply.
A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Bapineuzumab 0.5 mg/kg
Intervention description: I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 494.0
Sex: All
Minimum age: 51 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: antibody; immunotherapy

Summary:

      The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab
      in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over
      250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each
      subject's participation will last approximately 4 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging
             (MRI) scan consistent with the diagnosis of Alzheimer Disease

          -  Mini-Mental Status Examination (MMSE) >=10 at screening

          -  Caregiver able to attend all clinic visits with subject

        Exclusion Criteria:

          -  Any medical or psychiatric contraindication or clinically significant abnormality
             that, in the investigator's judgment, will substantially increase the risk associated
             with the subject's participation in and completion of the study or could preclude the
             evaluation of the subject's response.

          -  Any significant brain MRI abnormality.

          -  Use of any investigational drugs or devices, other than bapineuzumab within the last
             60 days prior to screening
Dry Eye Assessment and Management Study
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Omega-3 supplements; Placebo
Intervention description: 2000 mg EPA and 1000 mg DHA per day; Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 535.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the DREAM study is to evaluate the effectiveness and safety of
      supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry
      eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than or equal to 2 of the following 4 signs in the same eye at screening and
             baseline visits (Same signs must be present at Screening and Baseline visits):
             Conjunctival staining present greater than or equal to 1 (out of possible score of 6
             per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a
             possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7
             seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5
             minutes.

          -  Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.

          -  Symptoms of DED for greater than or equal to 6 months.

          -  Use of or desire to use artificial tears at least 2 times per day in preceding 2
             weeks.

          -  Ability to swallow large, soft gelcaps

        Exclusion Criteria:

          -  Allergic to ingredients in supplements or placebo

          -  Contact lens wear

          -  Pregnant, nursing, or lactating

          -  Current ocular infection, inflammation, or acute allergic conjunctivitis

          -  History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery,
             use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation,
             hemophilia or bleeding tendencies

          -  Currently on anticoagulation therapy

          -  Eyelid abnormalities or extensive ocular scarring

          -  Use of EPA/DHA supplements in excess of 1200 mg per dayi

          -  Current use, insufficient washout period, or intent to change specific treatments for
             dry eye disease
Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)
Condition: Anesthesia; Neuromuscular Blockade
Intervention: Sugammadex; 0.9% sodium chloride (NaCl)
Intervention description: At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of 4.0 mg.kg-1 sugammadex (volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion.; At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of placebo (0.9% NaCl, volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current trial was designed to demonstrate faster recovery in participants undergoing
      elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a
      fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of
      neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex
      compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the
      Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants

          -  American Society of Anesthesiologists (ASA) class 1, 2 or 3

          -  Age >=18 years

          -  Scheduled to undergo a surgery requiring profound NMB such as cardiovascular,
             gynaecologic, neurologic and thoracic surgical procedures under general anesthesia
             requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if
             applicable maintenance of NMB in a position allowing neuromuscular monitoring

          -  Given written informed consent

        Exclusion Criteria:

          -  Participants known or suspected to have neuromuscular disorders affecting NMB
Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets
Condition: Allergy
Intervention: 300 IR (4M); 300 IR (2M); Placebo
Intervention description: 300 IR grass pollen allergen extract tablet starting 4 months before the pollen season; 300 IR grass pollen allergen extract tablet starting 2 months before the pollen season; Placebo tablet
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 633.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Sublingual immunotherapy; Grass pollen tablet; Allergic rhinoconjunctivitis

Summary:

      A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR
      sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen
      rhinoconjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients aged 18 to 50 years

          -  Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen
             seasons

          -  Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens

          -  A score of greater than or equal to 12 out of a possible 18 on the Retrospective
             Rhinoconjunctivitis Total Symptom Score (RRTSS)

        Exclusion Criteria:

          -  Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to
             sensitisation to allergens other than grass pollen must not be included. Patients must
             be asymptomatic to all other allergens during the grass pollen season. Patients who
             have allergic rhinitis due to perennial allergen may not be included.

          -  Asthma requiring treatment other than beta-2 inhaled agonists.

          -  Patients who have received any desensitisation treatment for grass pollen or with any
             other allergen within the previous 5 years.