bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: MEDI-545; MEDI-545; MEDI-545; MEDI-545; MEDI-545; MEDI-545 600
Intervention description: Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses; Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses; Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Intervention MeSH terms: Sifalimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus; Japanese; phase 2; safety; tolerability; MEDI-545; Autoimmune Disease; Immune System Diseases

Summary:

      The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese
      adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1
      cohort of SC doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have previously met ≥4 of the 11 revised ACR criteria

          -  Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at
             screening

          -  Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG
             index at screening, or have a SELENA-SLEDAI score ≥6

        Exclusion Criteria:

          -  Have received prednisone >20 mg/day (or an equivalent dose of another oral
             corticosteroid) within 14 days before Visit 2 (Day 1)

          -  Have received the following medications within 28 days before Visit 2 (Day 1):

               -  Systemic cyclophosphamide at any dose

               -  Cyclosporine at any dose

               -  Tacrolimus at any dose

               -  Thalidomide at any dose

               -  Mycophenolate mofetil >2 g/day

               -  Methotrexate >15 mg/week

               -  Azathioprine >2 mg/kg/day

          -  Women who have a positive pregnancy test (serum hCG) at Visit 1
Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elotuzumab; Lenalidomide; Dexamethasone
Intervention MeSH terms: Dexamethasone; Lenalidomide; Elotuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible
      and safe.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2

          -  Documented evidence of active multiple myeloma:

               -  Newly diagnosed, not candidate for transplant

               -  Relapsed/refractory who have received up to 3 prior lines of therapy

          -  Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:

               -  Not refractory to prior Lenalidomide which is defined as no progression while
                  receiving Lenalidomide or within 60 days of last dose of Lenalidomide

               -  Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event
                  (AE)

        Exclusion Criteria:

          -  Target Disease Exceptions

               -  Plasma cell leukemia

               -  Monoclonal gammopathy of undetermined significance (MGUS)

               -  Smoldering Myeloma

          -  Primary amyloidosis

          -  Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes
             (POEMS) syndrome
Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: AQX-1125; Placebo
Intervention description: Synthetic SHIP1 activator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic dermatitis; Eczema; AD; AQX-1125; SHIP1

Summary:

      The primary objective of this study is to evaluate the effect of 12 weeks of treatment with
      once daily administration of AQX-1125 compared to placebo on change from baseline in Total
      Lesion Symptom Score in subjects with mild to moderate atopic dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged from 18 to 65 years old

          2. Confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin
             and Rajka criteria

          3. At least a 6 months history of atopic dermatitis.

          4. Body Surface Area (BSA) covered with atopic dermatitis of 1% or more

          5. Mild or moderate atopic dermatitis (IGA score of 2 or 3).

          6. TLSS of 5 or more at Day 0.

          7. Subject must use a non-medicated emollient daily for at least (≥) 7 days prior to Day
             0 and should continue using that same emollient, at the same frequency, throughout the
             study.

        Exclusion Criteria:

          1. Female subject who is pregnant or breast-feeding

          2. Unstable or clinically infected atopic dermatitis
Stimulant Oxytocin Study
Condition: Stimulant Use & Co-occuring Opioid Use Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Intranasal oxytocin; Intranasal placebo
Intervention description: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40 International Units (IU) to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.; Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oxytocin; substance-related disorders; Opioid Replacement Therapy; Psychophysiology; Stress Biomarkers

Summary:

      This study will investigate the effects of intranasal administration of oxytocin, a social
      neuropeptide, on reducing stimulant use, enhancing therapeutic engagement, and susceptibility
      to stress-induced relapse in Veterans with stimulant use disorders and enrolled in opioid
      replacement therapy (ORT) program for co-occurring opioid use disorder (OUD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years old

          2. Enrolled as a patient who at the SFVAMC Opioid Treatment Program or the Oakland
             Behavioral Health Clinic Opioid Treatment Program

          3. Stable dose of opioid replacement therapy for at least 2 consecutive weeks

          4. Veteran

          5. One documented urine toxicology screen positive for stimulants in the past 12 months.

        Exclusion Criteria:

          1. Severe neuropsychological disorder

          2. Suicidal or homicidal ideation within the past 90 days or a suicide attempt in the
             past 6 months

          3. Hemodialysis, unless participant can produce urine samples weekly

          4. Sensitivity to methylparaben or propylparaben

          5. Positive urine pregnancy test or women of childbearing age not practicing effective
             means of non-hormonal birth control

          6. Chronic nasal obstruction, discharge, or bleeding
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Condition: Covid19
MeSH terms: COVID-19
Intervention: BGB-DXP593; Placebo
Intervention description: Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm; Placebo to match BGB-DXP593 administered as specified in the treatment arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered
      intravenously as a single dose in participants with mild to moderate COVID-19
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Laboratory-confirmed severe acute respiratory syndrome (SARS)-CoV-2 infection
             (positive reverse transcription-polymerase chain reaction [RT-PCR] test or other
             authorized antigen testing methods) in any samples following local practice ≤ 72 hours
             prior to screening.

          2. Have experienced COVID-19 symptoms for ≤ 7 days prior to treatment assignment, such as
             fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia

          3. Agree to the collection of nasopharyngeal swabs, saliva, and venous blood

        Key Exclusion Criteria:

          1. Severe COVID-19 having oxygen saturation (SpO2) ≤ 93 % on room air at sea level or
             ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to
             fractional inspired oxygen (FiO2) < 300, respiratory rate ≥ 30/min, heart rate ≥
             125/min

          2. Requires mechanical ventilation or anticipated impending need for mechanical
             ventilation

          3. Known allergies to any of the components used in the formulation of the interventions

          4. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30
             days before dosing

          5. Have received treatment with a SARS-CoV-2 specific monoclonal antibody

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Condition: Urinary Tract Infections; Catheter Infection; Catheter-Related Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Catheter-Related Infections
Intervention: Catheter insertion with Povidone Iodine; Standard of care catheter insertion
Intervention description: The catheter will be treated with Povidone Iodine prior to insertion.; Catheter inserted right out of package.
Intervention MeSH terms: Iodine; Povidone-Iodine; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery:
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or
Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Masking: None (Open Label)
Enrollment: 99.0
Sex: Female
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      Urinary Tract Infection (UTI) complications following catheter use in surgical patients
      remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by
      50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use
      associated with this complication and improve cost-effectiveness of care. The investigators
      hypothesize that they can reduce the incidence of UTIs after catheter placement with the
      implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the
      environment exposure of the catheter before, during and after insertion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. women 18-89 years of age

          2. admitted for surgery lasting >1 hour and requiring urinary catheter,

          3. have normal urine analysis within 24 hours pre-surgery, and

          4. able to provide informed consent.

        Exclusion Criteria:

          1. currently on dialysis,

          2. chronic urinary infection,

          3. hyperthyroidism,

          4. current infection,

          5. a history of allergy or sensitivity to iodine.

          6. women who are pregnant or breast feeding

          7. men due to their lower incidence of UTIs compared to the female population.
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551; Vehicle
Intervention description: Applied twice daily for two weeks; Applied twice daily for two weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; plaque psoriasis; 122-0551; steroid

Summary:

      Corticosteroids are one of the mainstays of treatment for subjects with
      corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to
      determine and compare the efficacy and safety of a formulation of 122-0551 versus the
      corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for
      14 consecutive days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a clinical diagnosis of stable plaque psoriasis

          -  Subject has an ODS score for the Treatment Area of 3 or 4 at study start

        Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

          -  Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid
             therapy within 30 days prior to study start

          -  Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous
             products within 90 days prior to study start

          -  Subject has used any systemic biologic therapy for the treatment of psoriasis within 5
             half-lives of the biologic prior to study start

          -  Subject had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to study start

          -  Subject has used topical body (excluding the scalp) psoriasis therapy including coal
             tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days
             prior to study start

          -  Subject has used emollients/moisturizers on areas to be treated within four hours
             prior to clinical evaluation at study start

          -  Subject is currently using lithium or Plaquenil (hydroxychloroquine)

          -  Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE
             (e.g., lisinopril) inhibitor at a dose that has not been stabilized

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study

          -  Subject is currently enrolled in an investigational drug or device study

          -  Subject has used an investigational drug or investigational device treatment within 30
             days prior to study start

          -  Subject has been previously enrolled in this study and treated with a test article
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: MSTT1041A; Placebo
Intervention description: MSTT1041A will be administered as subcutaneous injections.; Placebo matched with MSTT1041A.
Intervention MeSH terms: Astegolimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm
      study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with
      placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving
      medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following
      additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier
      (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The
      total duration of this study for each participant is approximately 70 weeks including
      screening, run-in, treatment, and follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of 18 to 38 kilogram/square meter (kg/m^2) and weight >= 40 kg
             at screening

          -  Documented physician-diagnosed asthma

          -  On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed
             controller medication

          -  Forced expiratory volume in 1 second (FEV1) of 40% to 80% of predicted

          -  Evidence of uncontrolled asthma

          -  Use of contraceptive measures

        Exclusion Criteria:

          -  Diagnosis of mimics of asthma

          -  Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma chronic obstructive
             pulmonary disease overlap syndrome, or bronchiolitis, as determined by the
             investigator

          -  Pregnant or lactating, or intending to become pregnant during the study or within 20
             weeks after the last dose of MSTT1041A

          -  Recent history of smoking

          -  History or evidence of substance abuse that would pose a risk to participants safety,
             interfere with the conduct of the study, have an impact on the study results

          -  Asthma exacerbation within 4 weeks prior to screening

          -  Intubation for respiratory failure due to asthma within 12 months prior to screening

          -  Comorbid conditions that may interfere with evaluation of investigational medicinal
             product

          -  Known sensitivity to any of the active substances or their excipients to be
             administered during dosing

          -  Positive pregnancy test