bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: FKB238 (bevacizumab); Avastin (bevacizumab); Paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 731.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Bevacizumab; Carboplatin; Paclitaxel

Summary:

      The purpose of this research study is to compare the effectiveness and safety of FKB238
      against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18 years or older

          -  Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had
             not received any systemic anti-cancer therapy for metastatic disease

          -  Histologically or cytologically confirmed diagnosis of predominantly non-squamous
             NSCLC

          -  Existence of at least 1 measurable lesion by RECIST v1.1

          -  Adequate hematological, renal and liver function

          -  Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1

          -  Life expectancy longer than 6 months

        Exclusion Criteria:

          -  Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and
             mixed adenosquamous carcinomas of predominantly squamous nature

          -  Any unresolved toxicities from prior systemic therapy

          -  Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm
             microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK)
             translocation positive mutations

          -  Previous dosing with vascular endothelial growth factor (VEGF) inhibitor

          -  Known hypersensitivity to any excipients of the Investigational Products (IPs) and
             combination chemotherapy

          -  Use of prohibited concomitant medication

          -  Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection

          -  Fertile men or women of childbearing potential not using adequate contraception.

        Other inclusion/exclusion criteria may apply.
Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Tralokinumab; Placebo
Intervention description: Tralokinumab dose; Placebo dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Reactive Airways; Repiratory Tract Disease; Obstructive Lung Disease; Lung Diseases

Summary:

      A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to
      Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent
      Asthma.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Age 12-75 2) Documented physician-diagnosed asthma. 3) Documented treatment with ICS at
        a total daily dose corresponding to ≥500µg fluticasone propionate dry powder formulation
        and a LABA. 4) Subjects must have received OCS for the treatment of asthma for 6 months
        prior to Visit 1 and on a stable OCS dose between ≥7.5 to ≤30mg daily or daily equivalent
        for at least one month prior to enrolment (Visit 1) . 5) Pre-BD FEV1 value <80% (<90% for
        patients 12-17 yrs of age) of their PNV. 6) Post-BD reversibility of ≥12% in FEV1.

        Exclusion Criteria:

        1) Clinically important pulmonary disease other than asthma. 2) History of anaphylaxis
        following any biologic therapy. 3) Hepatitis B, C or HIV. 4) Pregnant or breastfeeding. 5)
        History of cancer. 6) Current tobacco smoking or a history of tobacco smoking for ≥10
        pack-years. 7) Previous receipt of tralokinumab.
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Intervention: GWP42003-P
Intervention description: Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open-label
Enrollment: 9.0
Sex: All
Minimum age: 1 Month
Maximum age: 24 Months
Healthy volunteers: No
Keywords: GWP42003-P; Cannabidiol

Summary:

      This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,
      and an open-label extension phase. The pilot phase only will be described in this record. 2
      cohorts of 5 participants will be enrolled sequentially. All participants will receive
      GWP42003-P.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant is aged 6- 24 months (inclusive) in the first cohort or aged 1-24 months
             (inclusive) in the second cohort, at the time of consent.

          -  Participant is diagnosed with IS and has failed to respond adequately following
             treatment with 1 or more approved IS therapies.

          -  To be considered hypsarrhythmia, as defined for use in the study, the
             electroencephalography (EEG) background must be slowed and have multifocal spikes. In
             addition, it must be either high voltage (above 300 µV) or have
             electrodecrement/discontinuity.

        Key Exclusion Criteria:

          -  Participant is currently taking or has taken clobazam or any mammalian target of
             rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit.

          -  Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB),
             of 460 msec or greater on ECG.

          -  Participant's caregiver is currently giving or has given recreational or medicinal
             cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the
             screening visit.

          -  Participant's caregiver is unwilling to abstain from giving the participant (including
             the participant's mother abstaining themselves, if breastfeeding)recreational or
             medicinal cannabis, or synthetic cannabinoid-based medications (other than the study
             drug) during the trial.

          -  Participant has any known or suspected hypersensitivity to cannabinoids or any of the
             excipients of the study drug, such as sesame oil.

          -  Participant has significantly impaired hepatic function at the screening visit.

          -  Participant has received an investigational medicinal product as part of a clinical
             trial within a minimum of 5 half-lives prior to the screening visit.
Fluticasone Nasal Spray Patient Preference Study
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: fluticasone propionate (FP); fluticasone furoate (FF)
Intervention description: 200 micrograms (mcg); an aqueous suspension of microfine FP; 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: taste; questionnaire; preference; attributes; odor; after taste; scent

Summary:

      The objectives of this study are to evaluate and compare patient preference for FF
      (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of
      allergic rhinitis following single-dose administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  allergic rhinitis

          -  literate

        Exclusion Criteria:

          -  clinical significant uncontrolled disease

          -  Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week
             exposure to FF, <4 weeks use of other INS)

          -  Use of intranasal medications <1 week

          -  Use of meds that significantly inhibit CYP4503A4

          -  Use of perfume or oral rinse on study day

          -  Allergy/intolerance to INS, antihistamines, or excipients

          -  Positive pregnancy test or female who is breastfeeding

          -  Affiliation with investigational site
Local Anesthetic Treatments for Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: alkalinized xylocaine; placebo
Intervention description: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks; normal saline
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Administration, Intravesical; Anesthetics, Local

Summary:

      The purpose of this study is to determine whether alkalized lidocaine instilled into the
      bladder is effective in the treatment of overactive bladder (OAB).
    

Eligibility criteria:

        Inclusion criteria:

          -  Female patient, 18 years of age and older

          -  Overactive bladder defined as:

               -  Urinary frequency defined as eight or more voids in a 24 hour period > 50% of
                  days of the week

               -  Symptoms of urgency

               -  Symptoms of at least three months duration

        Exclusion criteria:

          -  Positive urine culture in the past month, or more than 3 episodes of bladder infection
             in the last 2 months

          -  Stress or overflow urinary incontinence (determined by clinician) if more than 14
             episodes of urinary incontinence per week; also insensate incontinence

          -  Pregnancy

          -  Seizure disorder or clinically significant renal disease, allergy to lidocaine,
             uninvestigated hematuria, or history of urinary/reproductive tract malignancy

          -  Post-void residual more than 200 cc
Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Antimicrobial Barrier Dressing; Negative Pressure Wound Therapy (NPWT)
Intervention description: Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.; PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing
      or portable negative pressure wound dressing is superior in preventing wound complications
      and infection rates in obese patients undergoing total joint arthroplasty (TJA).
      Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip
      arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated
      dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and
      analyze the cost benefit of each.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Those identified at pre-operative testing to have an elevated BMI (> 35)

        Exclusion Criteria:

          -  Active infection

          -  previous scar or wound healing complication

          -  post traumatic degenerative joint disease (DJD) with hardware

          -  revision surgery

          -  inflammatory arthritis

          -  anticoagulation outside of the standard of care.
A Study of Actonel for the Prevention of Bone Loss
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia
Intervention: Actonel (Risedronate); Calcium; Vitamin D
Intervention description: 35 mg (pill) by mouth weekly; 500 mg by mouth twice a day for a total of 24 months.; 400 IU by mouth twice a day for a total of 24 months.
Intervention MeSH terms: Vitamin D; Risedronic Acid; Etidronic Acid; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Lymphoma; Acute Lymphocytic Leukemia; Lymphoblastic Lymphoma; Actonel; Risedronate; Bone Loss; Osteoporosis

Summary:

      The goal of this clinical research study is to learn if Actonel (risedronate) can help to
      prevent the development of osteoporosis (brittle and weak bones) caused by the steroid
      medication used to treat leukemia. The safety of this treatment in patients with ALL or LL
      will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than or equal to 18 years

          2. Newly diagnosed ALL or LL receiving chemotherapy with augmented BFM, Hyper-CVAD or any
             variant of hyper-CVAD.

          3. Female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for
             12 consecutive months), must be willing to use contraception.

          4. Negative pregnancy test in female patients.

          5. Patients must be enrolled within 6 weeks of starting induction chemotherapy.

        Exclusion Criteria:

          1. Hypocalcemia of less than 8.4 (corrected to account for the albumin level, [see
             Appendix E for formula])

          2. Hypersensitivity to risedronate or other bisphosphonates

          3. Inability to sit or stand upright for at least 30 minutes

          4. Bone density T-score of -2.5 S.D or less.

          5. Renal insufficiency (calculated creatinine clearance <30cc/min,[see Appendix F for
             formula])

          6. Patients with a 25-hydroxyvitamin D concentration of less than 20 ng/ml and evidence
             of osteomalacia (low ionized calcium and high intact PTH).

          7. Concomitant use of bisphosphonates, calcitonin, anabolic steroids, or fluoride.

          8. Corrected calcium above 10.2, due to a cause not related to leukemia/lymphoma (i.e.
             hyperparathyroidism, multiple myeloma).
Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
Condition: Anesthesia, General
Intervention: Sugammadex; Rocurium
Intervention description: intravenous (IV) single bolus dose of 0.6 mg.kg-1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of
      sugammadex in participants 65 and over with participants under 65. There is no hypothesis
      defined for the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 to 3

          -  18 years of age or older

          -  Scheduled for elective surgical procedure under general anesthesia requiring
             neuromuscular block with the use of rocuronium

          -  Scheduled for surgery in supine position

          -  Given written informed consent

        Exclusion Criteria:

          -  Participants in whom a difficult intubation is expected due to anatomical
             malformations

          -  Participants known or suspected to have neuromuscular disorders impairing
             neuromuscular blockade and/or significant renal dysfunction

          -  Participants known or suspected to have a (family) history of malignant hyperthermia

          -  Participants known or suspected to have an allergy to narcotics, muscle relaxants or
             other medications used during surgery

          -  Participants receiving medication known to interfere with neuromuscular blocking
             agents such as anticonvulsants, antibiotics and magnesium

          -  Female participants who are pregnant or breast-feeding

          -  Females participants of childbearing potential not using an acceptable method of birth
             control [condom or diaphragm with spermicide, vasectomized partner (> 6 months),
             intrauterine device (IUD), abstinence]

          -  Participants who had already participated in a Org 25969 trial including Protocol
             19.4.305

          -  Participants who had participated in another clinical trial, not pre-approved by
             Organon, within 30 days of entering into Protocol 19.4.305
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Lacosamide
Intervention description: Pharmaceutical Form: Oral tablets
Concentration: 50 mg
Route of Administration: Oral administration
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No
Keywords: Lacosamide; Vimpat; Epilepsy; Partial onset seizures; Tonic-clonic seizures; Monotherapy; AED

Summary:

      Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in
      patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of
      additional monotherapy safety data, and will facilitate access to treatment until commercial
      availability for monotherapy use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An Institutional Review Board /Institutional Ethics Committee approved written
             Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or
             legal representative. The ICF or a specific Assent form, where required, will be
             signed and dated by minors

          -  Subject/legal representative is considered reliable and capable of adhering to the
             protocol, visit schedule, and medication intake according to the judgment of the
             investigator

          -  Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been
             treated with lacosamide monotherapy

        Exclusion Criteria:

          -  Subject is receiving any investigational drugs or using any experimental devices in
             addition to lacosamide (LCM)

          -  Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during
             SP0994

          -  Subject required another Anti Epileptic Drug (AED) for the treatment of seizures

          -  Subject meets a "must" withdrawal criteria for SP0994

          -  Subject is experiencing an ongoing Serious Adverse Event from SP0994

          -  Female subject who is pregnant or nursing, and/or a woman of childbearing potential
             who is not surgically sterile, 2 year postmenopausal or does not practice one highly
             effective method of contraception, unless sexually abstinent, for the duration of the
             study
A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: Pilocarpine HCl; Vehicle
Intervention description: Pilocarpine HCl ophthalmic solution 1.25% ocular drops.; Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.
Intervention MeSH terms: Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 230.0
Sex: All
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Presbyopia; AGN-190584; Pilocarpine HCl 1.25%; Old Eye; Aged Eye

Summary:

      Currently available treatments for presbyopia (old eye) include nonsurgical options
      (spectacles or contact lenses) and surgical options, however, each has its own risks and
      limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating
      presbyopia compared to vehicle (placebo).

      AGN-190584 is an investigational drug being developed for the treatment of presbyopia.
      Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a
      different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle.
      Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in
      the study in approximately 20 sites in the United States.

      Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days.

      There may be additional procedures for participants in this trial compared to their standard
      of care. Participants will attend regular visits during the study at a doctor's office. The
      effect of the treatment will be checked by medical assessments, vision/eye tests, checking
      for side effects and completing questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

        - Objective and subjective evidence of presbyopia.

        Exclusion Criteria:

          -  Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial
             dystrophy, guttata, or edema) in either eye that are likely to interfere with visual
             acuity.

          -  Narrow iridocorneal angles (Shaffer grade <=2 or lower on gonioscopy examination),
             history of angle-closure glaucoma, or previous iridotomy.

          -  Diagnosis of any type of glaucoma or ocular hypertension.

          -  History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery,
             radial keratotomy, or any intraocular surgery.

          -  Use of temporary or permanent punctal plugs or history of punctal cautery in one or
             both eyes.