bioihbjkbjnl/mcl2 huggingface dataset:
MT10109L in the Treatment of Lateral Canthal Lines
Condition: Lateral Canthal Lines
Intervention: MT10109L; Placebo
Intervention description: MT10109L will be injected into the LCL.; Placebo will be injected into the LCL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines
      (LCL) in participants with moderate to severe LCL.
    

Eligibility criteria:

        Inclusion Criteria

        • Female participants must not be pregnant or planning to get pregnant and willing to
        minimize the risk of inducing pregnancy for the duration of the clinical study and
        follow-up period.

        Exclusion Criteria

          -  Known immunization or hypersensitivity to any botulinum toxin serotype.

          -  Any medical condition that may put the participant at increased risk with exposure to
             MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function.

          -  History of facial nerve palsy.

          -  Any uncontrolled systemic disease.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study intervention).

          -  Anticipated need for surgery or overnight hospitalization during the study.

          -  Prior exposure to botulinum toxin of any serotype for any reason.

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study.

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.

          -  Participants who plan for an extended absence away from the immediate area of the
             study site that would preclude them from returning for all protocol-specified study
             visits.
MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC
Condition: NSCLC Stage IV
Intervention: Bevacizumab as MYL-1402O; Bevacizumab as Avastin
Intervention description: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV; Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, Double-Blind, Randomized, Parallel-Group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind
Enrollment: 671.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Assess the Efficacy and Safety of MYL-1402O Compared with Avastin®, in the First-line
      Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Written and signed informed consent

          2. Male or female at least 18 years of age with documented imaging diagnosis of Stage IV
             unresectable, recurrent or metastatic nsNSCLC with at least one measurable lesion as
             defined by RECIST 1.1

          3. Documented histologic or cytologic diagnosis of advanced nsNSCLC with negative or
             unknown sensitizing epidermal growth factor receptor (EGFR) mutation, and negative or
             unknown echinoderm microtubule-associated protein like 4 anaplastic lymphoma kinase
             (EML4 ALK) rearrangement.

          4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          5. Has not received any prior systemic therapy for first-line treatment of advanced lung
             cancer, except adjuvant chemotherapy, and remained disease-free for at least 12 months
             from time of surgery, and at least 6 months from last dose of chemotherapy.

          6. Treated and stable brain metastasis.

        Key Exclusion Criteria:

          1. Documented squamous NSCLC or small cell type or large cell neuroendocrine histology

          2. History of significant hemoptysis, central tumors with proximity to large vessels and
             tumor with cavitation

          3. Received prior treatment with paclitaxel, bevacizumab or anthracycline or had known
             hypersensitivity to any of these components.

          4. Recent significant cardiac condition or vascular event or inadequately controlled
             hypertension.

          5. On anticoagulant therapy not considered stable

          6. Risk of hemorrhage in the central nervous system

          7. Recent history of surgery, nonhealing wound, active ulcer, or untreated bone fracture.

          8. History of gastrointestinal fistula, perforation, or abscess.
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Elagolix
Intervention description: Elagolix tablets administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 496.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Endometriosis-associated pain; Elagolix; Gonadotropin-releasing Hormone Antagonist; Dysmenorrhea (DYS); Non-menstrual Pelvic Pain (NMPP); Dyspareunia

Summary:

      A randomized study evaluating the continued safety and efficacy of elagolix in the management
      of moderate to severe endometriosis associated pain in adult pre-menopausal women who
      completed 6 months treatment in pivotal Study M12-671 (NCT01931670).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the 6-Month Treatment Period in pivotal study M12-671.

          -  Agrees to use required birth control methods during the study through Month 6 of the
             Post-treatment Follow-up period

        Exclusion Criteria:

          -  Clinically significant gynecological condition

          -  Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine,
             femoral neck or total hip

          -  Plans to become pregnant in the next 18 months
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: risankizumab; placebo for risankizumab; ustekinumab; placebo for ustekinumab
Intervention description: Risankizumab administered by subcutaneous (SC) injection; Placebo for risankizumab administered by subcutaneous (SC) injection; Ustekinumab administered by subcutaneous (SC) injection; Placebo for ustekinumab administered by subcutaneous (SC) injection
Intervention MeSH terms: Ustekinumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Skin Diseases; Skin Diseases, Papulosquamous; ustekinumab; Dermatologic Agents; ABBV-066; BI 655066; risankizumab

Summary:

      The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066
      (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult
      patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients with age ≥18 years at screening.

          -  Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for
             at least 6 months before the first administration of study drug.

          -  Have stable moderate to severe chronic plaque psoriasis with or without psoriatic
             arthritis at both Screening and Baseline (Randomisation):

               1. Have an involved body surface area (BSA) ≥10% and

               2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and

               3. Have a static Physician Global Assessment (sPGA) score of ≥3.

          -  Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as
             assessed by the investigator.

          -  Must be a candidate for treatment with Stelara® (ustekinumab) according to local
             label.

        Exclusion criteria:

          -  Patients with:

               1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)

               2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta
                  blockers, calcium channel blockers, or lithium)

               3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis
                  that might confound trial evaluations according to investigator's judgment

          -  Previous exposure to BI 655066.

          -  Previous exposure to ustekinumab (Stelara®).
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Intervention: OAV101
Intervention description: Gene Therapy - 1.1e14 vector genome (vg)/kg as a one-time IV infusion was administered over approximately 60 minutes.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will receive a single administration of OAV101
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Zolgensma; OAV101; AVXS 101; gene therapy; Muscle atrophy; SBMA; spinal and bulbar muscular atrophy; spinal muscular atrophy; bulbar muscular atrophy; muscle function; myopathy; muscle wasting; atrophied muscle; loss of muscle strength

Summary:

      To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101
      (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the
      survival motor neuron 1 (SMN1) gene weighing ≥ 8.5 kg and ≤ 21 kg, over a 12 month period.
    

Eligibility criteria:

        Inclusion

          -  Symptomatic SMA diagnosis based on gene mutation analysis with bi-allelic survival
             motor neuron 1 (SMN1) mutations (deletion or point mutations) and any copy of the
             survival motor neuron 2 (SMN2) gene.

          -  Weight ≥ 8.5 kg and ≤ 21 kg at the time of Screening Visit 2

          -  Naive to treatment or have discontinued an approved drug/therapy

        Exclusion:

          -  Previous OAV101 use or previous use of any adeno-associated virus serotype 9 (AAV9)
             gene therapy

          -  BMI < 3rd percentile

          -  Participant with history of aspiration pneumonia or signs of aspiration

          -  Elevated anti-AAV9 antibody

          -  History of gene therapy, hematopoietic transplantation, or solid organ transplantation

          -  Inability to take corticosteroids

          -  Concomitant use of immunosuppressive therapy

          -  Requiring invasive ventilation, tracheostomy or awake non-invasive ventilation 9.
             Administration of vaccines 2 weeks prior to infusion of OAV101

          -  Awake hypoxemia or awake oxygen saturation level decrease

          -  Hepatic dysfunction

          -  Presence of a confirmed or suspected infection

          -  If previously treated with disease modifying therapy, specified washout times apply

          -  Documented any parental consanguinity.
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
Condition: Relapsing Multiple Scelrosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ofatumumab subcutaneous injection; Teriflunomide-matching placebo capsules; Teriflunomide capsule; Matching placebo of ofatumumab subcutaneous injections
Intervention description: Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter; Placebo capsule, matching in appearance to teriflunomide, taken orally once daily; Teriflunomide 14 mg oral capsule taken once daily; Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
Intervention MeSH terms: Teriflunomide; Ofatumumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 955.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; Ofatumumab; adult; OMB157; multiple sclerosis; T1 lesions; T2 lesions; relapse; GD-enhancing MRI; McDonald criteria; RRMS; SPMS

Summary:

      To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4
      weeks versus teriflunomide administered orally once daily in patients with relapsing multiple
      sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged 18 to 55 years at Screening

          -  Diagnosis of multiple sclerosis (MS)

          -  Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with
             disease activity

          -  Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during
             the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior
             to randomization

          -  Disability status at Screening with an Expanded Disability Status Scale (EDSS) score
             of 0 to 5.5

          -  Neurologically stable within 1 month prior to randomization

        Exclusion Criteria:

          -  Patients with primary progressive MS or SPMS without disease activity

          -  Disease duration of more than 10 years in patients with an EDSS score of 2 or less

          -  Patients with an active chronic disease of the immune system other than MS

          -  Patients at risk of developing or having reactivation of hepatitis

          -  Patients with active systemic infections or with neurological findings consistent with
             PML
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: GSP 301 NS; Olopatadine HCl NS; Mometasone furoate NS; GSP 301 Placebo NS
Intervention description: FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days; 2 sprays in each nostril twice daily for 14 days; 2 sprays in each nostril twice daily for 14 days; 2 sprays in each nostril twice daily for 14 days
Intervention MeSH terms: Mometasone Furoate; Olopatadine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1180.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Seasonal Allergic Rhinitis

Summary:

      Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to
      individual monotherapies (comparators) as well as the efficacy of these monotherapies
      (comparators) versus placebo NS over 14 days of study treatment
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 12 years and older inclusive of either sex.

          2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit
             [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the spring
             allergy season (tree/grass pollen)

          3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for
             the AM assessment at the Screening Visit (Visit 1).

        Exclusion Criteria:

          1. Pregnant or lactating women.

          2. Plans to travel outside the known pollen area for the investigative site for > 24
             hours during the last 7 days of run in period.

          3. History of anaphylaxis and/or other severe local reaction(s) to skin testing.

          4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

          5. Documented evidence of acute or significant chronic sinusitis or chronic purulent
             postnasal drip.

          6. Subjects with an active pulmonary disorder or infection.

          7. Subjects with posterior subcapsular cataracts or glaucoma
Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
Condition: Blood Coagulation Disorders; Hemorrhage
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
Intervention: Fresh frozen plasma transfusion
Intervention description: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Fresh frozen plasma; Bleeding

Summary:

      The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in
      patients with moderately elevated international normalized ratios (INR) prior to undergoing
      an invasive procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. INR level between 1.50 and 2.50 inclusive

          2. undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology

        Exclusion Criteria:

          1. undergoing a surgical procedure in the operating room;

          2. active bleeding;

          3. undergoing a procedure involving or proximal to the central nervous system or spinal
             cord;

          4. cardiac catheterization,

          5. using 4 factor plasma concentrates

          6. using systemic heparin/heparinoid therapy, direct factor X inhibitors and other
             anticoagulants for which plasma will not correct prolonged INR;

          7. platelet count less than 50,000/ul,

          8. congenital coagulation disorders;

          9. acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the
             disorder;

         10. women who are pregnant and;

         11. unwillingness to consider blood transfusion.
The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans
Condition: Healthy
Intervention: 0.4mU Insulin followed by withdrawal period followed by 0.8mU study; 0.8mU Insulin followed by withdrawal period followed by 0.4mU study
Intervention description: Clamp study with insulin infused at 0.4 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.8 mU/Kg/min; Clamp study with insulin infused at 0.8 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.4 mU/Kg/min
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this research is to help understand the relative importance of changes in
      insulin secretion (which lowers glucose) and changes in glucagon (which raises glucose) to
      regulate metabolism and the body's ability to make glucose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  We will recruit 15 otherwise healthy subjects using intramural and local extramural
             advertising after approval from the Mayo Clinic Institutional Review Board.
             Individuals who express interest in participating will be invited for a screening
             visit. Individuals with a BMI < 19 or > 28 kg/m2 will be excluded from the study to
             avoid potential confounding effects that may result from extreme leanness or from
             obesity. Subjects will have no known systemic illness, taking any medication that
             could affect glucose metabolism and no history of upper gastrointestinal surgery.

        Exclusion Criteria:

          -  Subjects < 18 years of age or > 40 years of age will not be studied to minimize the
             potential confounding effects of age on glucagon and insulin action. The subjects will
             not be taking medications that affect glucose metabolism (to be determined by PI) and
             have no history of chronic illness or upper gastrointestinal surgery. We are seeking
             to recruit subjects who do not have diabetes (fasting glucose <100mg/dL).
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ublituximab; Teriflunomide; Oral Placebo; IV Placebo
Intervention description: Administered as an IV infusion.; Film-coated tablets administered orally.; Administered orally.; Administered as an IV infusion.
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, double-blinded, active-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded, active-controlled study
Enrollment: 549.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96
      weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral
      placebo compared to 14 mg oral teriflunomide/IV placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-55 age

          -  Diagnosis of RMS (McDonald criteria 2010)

          -  Active disease

          -  Expanded disability status scale (EDSS) 0-5.5 (inclusive) at screening

        Exclusion Criteria:

          -  Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed
             treatment

          -  Treatment with the following therapies at any time prior to randomization:
             alemtuzumab, natalizumab, teriflunomide, leflunomide and stem cell transplantation

          -  Diagnosed with Primary Progressive MS (PPMS)

          -  Pregnant or nursing