bioihbjkbjnl/mcl2 huggingface dataset:
P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Condition: CNS Lesion; Blood Brain Barrier Defect
Intervention: P03277; Gadobenate dimeglumine; MRI
Intervention description: Single intravenous (IV) bolus injection at a rate of 2 mL/second; Single IV bolus injection at a rate of 2 mL/second
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine a safe and effective dose of a new
      gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when
      comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW).

      Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to
      contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise
      determination of P03277 clinical dose.

      This was a multi-center, international, prospective, double-blind, randomized, controlled,
      parallel dose groups, cross-over with comparator study in male and female subjects presenting
      with known or highly suspected focal areas of disruption of the Blood Brain Barrier including
      at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a
      routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male adult subjects, with known or highly suspected focal areas of disrupted
             Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm
             (long axis). This lesion had been detected on a previous imaging procedure
             (computerized Tomography [CT] or MRI).

          -  Subject scheduled for a routine contrast-enhanced MRI examination of Central Nervous
             System for clinical reasons and agreeing to have a second contrast-enhanced MRI
             examination for the purpose of the study.

        Exclusion Criteria:

          -  Subject presenting with acute or chronic Grade III (at least) renal insufficiency,
             defined as an estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m² based on
             one eGFR assessment performed the day of the MRI prior to the first contrast agent
             injection.
Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
Condition: Non-alcoholic Steatohepatitis NASH
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: LMB763; Placebo
Intervention description: Hard Gelatin Capsules; Hard Gelatin Capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-alcoholic Steatohepatitis; NASH; Fatty liver disease

Summary:

      The purpose of the present study is to assess the effects of LMB763 with respect to safety,
      tolerability, and on markers of liver inflammation in patients with NASH
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female patients, 18 years or older

          -  Written informed consent

          -  Presence of NASH by histologic evidence (liver biopsy) and elevated alanine
             aminotransferase (ALT), OR phenotypic diagnosis of NASH based on elevated ALT, BMI and
             diagnosis of Type 2 diabetes mellitus

        Exclusion Criteria:

          -  Current use of obeticholic acid (OCA)

          -  New initiation GLP-1 agonists such as liraglutide, exenatide , lixisenatide,
             albiglutide or dulaglutide within 3 months of screening

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, unless they are using highly effective methods of
             contraception during dosing and for 5 days after stopping study medication

          -  Current or history of significant alcohol consumption for a period of more than 3
             consecutive months within 1 year prior to screening

          -  Clinical evidence of hepatic decompensation or severe liver impairment

          -  Previous diagnosis of other forms of chronic liver disease

          -  Uncontrolled diabetes mellitus

          -  History or current diagnosis of ECG abnormalities

          -  Patients with contraindications to MRI imaging
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: omalizumab; placebo; H1 antihistamines; Diphenhydramine
Intervention description: Administered by subcutaneous injection; Participants received a single subcutaneous placebo injection on Day 0 of the study.; Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD; Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)
Intervention MeSH terms: Omalizumab; Diphenhydramine; Promethazine; Histamine H1 Antagonists; Histamine Antagonists
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Xolair; CIU

Summary:

      The study is a Phase II, dose-ranging, multicenter, randomized, double-blind,
      placebo-controlled, parallel-group study of the efficacy and safety of a single
      subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent
      and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic
      despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll
      approximately 76 patients at approximately 45 study centers in the United States and Germany.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CIU diagnosis > 3 months (by history)

          -  No underlying etiology clearly defined for urticaria (main manifestation cannot be
             physical urticaria)

        Exclusion Criteria:

          -  Pregnant, breastfeeding, or women not taking contraception

          -  Patients < 40kg

          -  Treatment with any investigational agent within 30 days of screening

          -  Recent history of drug or alcohol abuse

          -  Atopic dermatitis or other skin disease associated with pruritus

          -  Clinically relevant major systemic disease (making interpretation of the study results
             difficult)

          -  Previously treated with omalizumab (< 12 months since last injection)

          -  Patients may not take during treatment period or have been taking within the past 3
             months any of the following medications/treatments: regular (daily/every other day)
             hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or
             plasmapheresis

          -  Patients may not have been taking doxepin within the past 6 weeks regular (daily/every
             other day).
Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Condition: Insulin; Exercise
Intervention: Placebo into the intranasal mucosa; 20 IU NovoLog Insulin aspart into the intranasal mucosa; 40 IU NovoLog Insulin aspart into the intranasal mucosa; 60 IU NovoLog Insulin aspart into the intranasal mucosa; 80 IU NovoLog Insulin aspart into the intranasal mucosa; 100 IU NovoLog Insulin aspart into the intranasal mucosa; 120 IU NovoLog Insulin aspart into the intranasal mucosa
Intervention description: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer; 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer; 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.
Masking: Double (Participant, Investigator)
Masking description: Double blind, placebo controlled trial
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intranasal Insulin; Cognition; Exercise; Physical Activity

Summary:

      To determine if physical activity engagement alters the dose-response profile and safety of
      administration of insulin into the intranasal mucosa.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must be over the age of 18..

          2. Participants must have normal or corrected-to-normal vision in order to complete the
             cognitive task.

        Exclusion Criteria:

          1. Lack of consent.

          2. Presence of any major neurological health issues, brain trauma, or concussion with
             loss of consciousness assessed through a health history and demographics
             questionnaire.

          3. Type I or Type II Diabetes

          4. Self-reported pregnancy

          5. Currently has any type of inflammation or blockage of the nasal passageways (i.e.
             allergies or a cold affecting the sinuses).
A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females
Condition: Bone Mineral Density
Intervention: 91-day Levonorgestrel Oral Contraceptive; 28-day Levonorgestrel Oral Contraceptive
Intervention description: Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.
Take 1 tablet daily; Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Contraceptive Agents; Contraceptives, Oral; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1361.0
Sex: Female
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adolescents; Bone Mineral Density; Oral Contraceptive

Summary:

      This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a
      28-day OC regimen on bone mineral density (BMD) in adolescent females.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy postmenarchal adolescent female 12-18 years old, non-pregnant, nonlactating

          -  Regular spontaneous menstrual cycles

          -  Body mass index (BMI): 18 kg/m² to <30 kg/m², weight < 200 lbs

          -  Others as dictated by the Food and Drug Administration (FDA)-approved protocol

        Exclusion Criteria:

          -  Any contraindication to the use of oral contraceptives

          -  History of previous clinically significant adverse event while taking hormonal
             contraceptives

          -  Use of any medication which could significantly interfere with study assessments

          -  Others as dictated by FDA-approved protocol
Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Formoterol; Salmeterol; Placebo
Intervention description: Formoterol Turbuhaler 9 μg and Placebo Diskus; Salmeterol Diskus 50 μg and Placebo Turbuhaler; Placebo Diskus and Placebo Turbuhaler
Intervention MeSH terms: Formoterol Fumarate; Salmeterol Xinafoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; Onset of effect; COPD; Oxis Turbuhaler

Summary:

      -  Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single
           dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced
           Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.

        -  Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the
           FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1
           curve from 0 to 120 minutes)
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms

          -  A current or previous smoking history equivalent to 10 or more packs per year (1 pack
             year = 20 cigarettes smoked per day for one year).

          -  Documented use of a short-acting inhaled bronchodilator (β2-agonist or
             anticholinergics) as reliever medication.

        Exclusion Criteria:

          -  A history and/or current diagnosis of asthma.

          -  Patients who have experienced COPD exacerbation requiring hospitalisation and/or a
             course of antibiotics and/or a course of systemic steroid within 30 days (from end of
             exacerbation treatment) prior to Visit 1 and/or during the run-in period.

          -  A history and/or current diagnosis of atopic diseases such as allergic rhinitis or
             eczema before the age of 40.
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Lebrikizumab; Placebo
Intervention description: Sterile liquid solution administered subcutaneously.; Solution administered subcutaneously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eczema

Summary:

      The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared
      with placebo in participants with moderate-to-severe atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years or older.

          -  Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year
             before the screening visit .

          -  Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline
             visit.

          -  Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and
             the baseline visit.

          -  ≥10% body surface area (BSA) of AD involvement at the screening and the baseline
             visit.

        Exclusion Criteria:

          -  Treatment with any of the following agents within 4 weeks prior to the baseline visit:

          -  Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
             cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine,
             methotrexate, etc.)

          -  Phototherapy and photochemotherapy (PUVA) for AD.

          -  Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)
             within 1 week prior to the baseline visit.

          -  Treatment with:

          -  An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is
             longer, prior to the baseline visit.

          -  Dupilumab within 3 months prior to baseline visit.

          -  Cell-depleting biologics, including rituximab, within 6 months prior to the baseline
             visit.

          -  Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit
             (whichever is longer).

          -  Use of prescription moisturizers within 7 days of the baseline visit.
Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Leuprorelin Acetate Depot; Elagolix; Placebo to Elagolix; Placebo to Leuprorelin Acetate
Intervention description: Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection; Elagolix tablets administered orally; Placebo tablet administered orally; Saline solution administered as an intramuscular injection
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: bone mineral density,endometriosis,pelvic pain

Summary:

      This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418)
      compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month
      period followed by an additional three months of treatment on elagolix.
    

Eligibility criteria:

        Inclusion Criteria

          -  Female, aged 18 to 45 years, inclusive

          -  Have moderate to severe pelvic pain due to endometriosis

          -  Have been surgically (laparoscopy) diagnosed with endometriosis within the last 5
             years and have recurrent or persistent endometriosis symptoms

          -  Have regular menstrual cycle (23-33 day)

          -  Agree to use two forms of non-hormonal contraception during the study

        Exclusion Criteria:

          -  Received a Gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or
             have received any of these agents within 6 months of the start of screening.

          -  Received subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular (i.m.)
             medroxyprogesterone acetate (DMPA-IM), or have received either of these agents within
             3 months of the start of screening.

          -  Are currently using hormonal contraception or other forms of hormonal therapy or
             received such treatment within the last month

          -  Have had surgery for endometriosis within the last month

          -  Are using systemic steroids on a chronic or regular basis within 3 months

          -  Have uterine fibroids or other pelvic lesions ≥ 3 cm in diameter

          -  Have had a hysterectomy or oophorectomy

          -  Have pelvic pain that is not caused by endometriosis

          -  Have unstable medical condition or chronic disease

          -  Have been pregnant within the last 6 months and is currently breast feeding
A Study of LY3127804 in Participants With COVID-19
Condition: COVID-19; Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: LY3127804; Placebo
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Zansecimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Corona Virus Disease 19 (COVID-19); 2019 Novel Coronavirus (2019 n-COV); Severe Acute Respiratory Syndrome (SARS); Pulmonary Disease; SARS-CoV-2

Summary:

      A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants
      who are hospitalized with pneumonia and presumed or confirmed COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are hospitalized with pneumonia, and presumed or confirmed COVID-19

          -  Are able and willing to give signed informed consent (legally authorized
             representative can provide informed consent if needed)

        Exclusion Criteria:

          -  Female participants must not be pregnant and/or lactating

          -  Have Acute Respiratory Distress Syndrome (ARDS) or will require immediate intermittent
             mandatory ventilation (IMV), or are ineligible for IMV

          -  Have any concurrent serious medical condition (for example dialysis) or concomitant
             medication that would preclude participation in the study

          -  Are moribund irrespective of the provision of treatments

          -  Have a known history or show evidence of human immunodeficiency virus (HIV) and/or
             hepatitis

          -  Have recently undergone major surgery or central venous access device placement

          -  Have a significant bleeding disorder or active vasculitis

          -  Have experienced a thromboembolic event

          -  Have symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac
             arrhythmia

          -  Have a serious, nonhealing wound, peptic ulcer, or bone fracture

          -  Have liver cirrhosis

          -  Have a known sensitivity to monoclonal antibodies (mAbs) or other therapeutic proteins

          -  Have a history of hypertensive crisis or hypertensive encephalopathy or current,
             poorly controlled hypertension