bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BFF; Symbicort Turbuhaler
Intervention description: Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler); Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      Study comparing the same drugs as a dual combination product (budesonide and formoterol)
      given via two different inhalers. To see which one results in the best effect on breathing.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF.

          2. Individuals who have a physician diagnosis of COPD as defined by the American Thoracic
             Society (ATS)/European Respiratory Society (ERS)

          3. Require COPD maintenance therapy: all subjects must be receiving 2 or more inhaled
             maintenance therapies, including at least 1 long-acting bronchodilator, for the
             management of their COPD for at least 4 weeks prior to Visit 1.

          4. A post-bronchodilator FEV1/FVC of <0.70 and post-bronchodilator FEV1 of <50% predicted
             normal value at Visit 2.

          5. A pre-bronchodilator PIF of <50 L/min using the InCheck Inspiratory Flow Measurement
             Device set to Turbuhaler S resistance at Visit 2.

          6. Current or former smokers with history of at least 10 pack-years of cigarette smoking.

        Key Exclusion Criteria:

          1. Current diagnosis of asthma, in the opinion of the Investigator.

          2. Other respiratory disorders including known active tuberculosis, lung cancer, cystic
             fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis
             that causes repeated acute exacerbations), immune deficiency disorders, severe
             neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic
             interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary
             thromboembolic disease.

          3. A moderate or severe exacerbation of COPD ending within 6 weeks prior to randomization
             (Visit 3).

          4. Need for mechanical ventilation within 3 months prior to Visit 1.
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
Condition: Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: isatuximab SAR650984; carfilzomib; dexamethasone
Intervention description: Pharmaceutical form: solution for infusion
Route of administration: intravenous; Pharmaceutical form: solution for infusion
Route of administration: intravenous; Pharmaceutical form: tablets or solution for infusion
Route of administration: oral or intravenous
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-CD38 monoclonal antibody

Summary:

      The purpose of this study it to compare the efficacity of isatuximab when combined to
      carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple
      myeloma already treated with 1 to 3 prior lines of therapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with MM previously treated with prior 1 to 3 lines and with measurable
             serum M-protein (>= 0.5 gram/deciliter) and/or urine M-protein (>= 200 milligram/24
             hours).

        Exclusion criteria:

          -  Participants previously pretreated with carfilzomib, who never achieved at least one
             minor response during previous therapies and/or last previous therapy completed within
             14 last days.

          -  Participants with serum free light chain (FLC) measurable disease only.

          -  Participants less than 18 years old, participants with Eastern Cooperative Oncology
             Group performance status more than 2.

          -  Participants with inadequate biological tests.

          -  Participants with myocardial infarction, severe/unstable angina pectoris,
             coronary/peripheral artery bypass graft, New York Heart Association class III or IV
             congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or
             transient ischemic attack within last 6 months, and/or left ventricular ejection
             fraction lower than 40%.

          -  Participants with previous cancer unless disease free for more than 5 years or in situ
             cancer curatively treated.

          -  Participants with known acquired immunodeficiency syndrome related illness or human
             immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C
             active infection.

          -  Women of childbearing potential or male participant with women of childbearing
             potential who do not agree to use highly effective method of birth control.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
Condition: Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
MeSH terms: COVID-19; Pneumonia; Syndrome; Cytokine Release Syndrome
Intervention: Canakinumab; Placebo
Intervention description: Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.; 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 454.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; cytokine release syndrome; SARS-CoV-2; canakinumab; COVID; coronavirus; CAN-COVID; pneumonia; CRS

Summary:

      This was a multicenter, randomized, double-blind, placebo-controlled study to assess the
      efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC
      in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).
    

Eligibility criteria:

        Key inclusion Criteria:

          -  Adults ≥ 18 years old (for US only: patients ≥ 12 years old, although no children ever
             enrolled. This was an adult trial.)

          -  Body weight ≥40 kg

          -  Informed consent must be obtained prior to participation in this study. For US
             patients 12 - < 18 years old; parent/guardian consent must be obtained and assent if
             applicable.

          -  Clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic
             methodology

          -  Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan with
             pulmonary infiltrates

          -  SpO2 ≤ 93% on room air or arterial oxygen partial pressure (PaO2)/ fraction of
             inspired oxygen (FiO2) < 300mmHg

          -  C-reactive protein ≥20 mg/L or ferritin level ≥600 µg/L

        Key exclusion Criteria:

          -  History of hypersensitivity to canakinumab or to biologic drugs

          -  Intubated and on mechanical ventilation (invasive) at time of randomization

          -  Treatment with immunomodulators or immunosuppressant drugs, including but not limited
             to tocilizumab, TNF inhibitors and anti-IL-17 agents within 5 half-lives or 30 days
             (whichever is longer) prior to randomization with the exception of anakinra which is
             excluded within 5 half-lives only. Note: Immunomodulators (topical or inhaled) for
             asthma and atopic dermatitis and corticosteroids (any route of administration) are
             permitted.

          -  Suspected or known untreated active bacterial, fungal, viral, or parasitic infection
             with the exception of COVID-19
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in
      combination with insulin glargine or insulin degludec, is safe and effective in participants
      with type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have T1D for at least 1 year prior to screening and continuously
             using insulin for at least 1 year.

          -  Participants must have HbA1c of ≥7.0 and ≤10.0%.

          -  Participants must have been treated for at least 90 days prior to screening with
             either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at
             least twice daily.

          -  Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter
             (kg/m2).

        Exclusion Criteria:

          -  Participants must not have used other anti-hyperglycemic medications or therapies
             (inhaled, oral or injectable) except for metformin within 90-days prior to screening.

          -  Participants must not have had more than 1 severe hypoglycemic episode within 6 months
             prior to screening.

          -  Participants must not have had more than 1 hospitalization related to hyperglycemia or
             diabetic ketoacidosis within 6 months prior to screening.
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Condition: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Liprotamase; porcine (pig) PERT
Intervention description: oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement; oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No

Summary:

      Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes
      including lipase, protease, and amylase. The purpose of the present study is to provide
      additional efficacy and safety data compared to approved, porcine-derived, enterically-coated
      and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the
      study will be comparative efficacy measured as the change in the coefficient of fat
      absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

      Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of
      convenient formulations and with a number of foods without enteric coating.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride

          -  Fecal elastase <100 mcg/g stool

          -  Minimum Coefficient of Fat (CFA) at screening while on stable PERT therapy

          -  Good nutritional status

        Exclusion Criteria:

          -  History or diagnosis of fibrosing colonopathy

          -  Distal intestinal obstruction syndrome in 6 months prior to screening

          -  Receiving enteral tube feedings

          -  Chronic diarrheal illness unrelated to pancreatic insufficiency

          -  Liver abnormalities, or liver or lung transplant, or significant bowel resection

          -  Forced expiratory volume in 1 second (FEV1) <30%
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-Small-Cell Lung; Non-small Cell Lung Cancer; NSCLC
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib (tarceva); Placebo
Intervention description: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.; Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erlotinib; Tarceva; Web based; Stage III NSCLC

Summary:

      This is a national, randomized, web-based, double-blind study to determine whether erlotinib
      (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with
      inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic
      radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated
      agent following concurrent chemoradiation and prior to the emergence of drug resistance will
      prolong the progression-free survival by 40% (10 months → 14 months).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)

          -  No evidence of metastatic disease

          -  No prior treatment

          -  Adequate organ function

          -  Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)

        Exclusion Criteria:

          -  Metastasis

          -  Prior treatment

          -  Malignant pleural or pericardial effusion

          -  Peripheral neuropathy >= grade 2
A Study of SI-6603 in Patients With Lumbar Disc Herniation
Condition: Intervertebral Disc Disease; Lumbar Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Displacement
Intervention: Condoliase
Intervention description: 1.25 U, intradiscal injection, one time
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1011.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in
      patients with lumbar disc herniation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, L4-L5 or L5-S1) as assessed
             by MRI and clinical symptoms corresponding to position of the impaired nerve root.

          -  Patients assessed as positive in the Femoral Nerve Stretching (FNS) test for L1-L2,
             L2-L3, or L3-L4 and Straight Leg Raising (SLR) test.

          -  Patients with sciatica in either leg.

          -  Patients with no improvement from conservative treatment

        Exclusion Criteria:

          -  Patients who have 2 or more lumbar disc herniations as assessed by MRI.

          -  Patients in whom a rupture into the posterior longitudinal ligament is identified by
             MRI.

          -  Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or
             lumbar intradiscal therapies
Phase 3 Study of Dexpramipexole in ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Dexpramipexole; Placebo
Intervention description: Oral tablet 150mg twice daily for up to 18 months.; Oral tablet twice daily for up to 18 months.
Intervention MeSH terms: Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 942.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Amyotrophic Lateral Sclerosis; ALS; Motor Neurone Disease; Motor Neuron Disease; Lou Gehrig's disease

Summary:

      The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe
      and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 to 80 years old, inclusive, on Day 1.

          -  Diagnosis of sporadic or familial ALS.

          -  Onset of first ALS symptoms within 24 months prior to Day 1.

          -  World Federation of Neurology El Escorial criteria are met for a possible,
             laboratory-supported probable, probable, or definite ALS diagnosis.

          -  Upright slow vital capacity (SVC) of 65% or more at screening.

          -  Patients taking or not taking Riluzole are eligible for this study: if a patient has
             never taken Riluzole, he or she is eligible; if a patient is currently taking
             Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient
             has discontinued Riluzole, he or she must have stopped taking it for at least 30 days.

          -  Must be able to swallow tablets at the time of study entry.

        Exclusion Criteria:

          -  Other medically significant illness.

          -  Clinically significant abnormal laboratory values.

          -  Pregnant women or women breastfeeding.

          -  Prior exposure to dexpramipexole.

          -  Currently taking pramipexole or other dopamine agonists.

        Other protocol-defined inclusion/exclusion criteria may apply.
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: GSP 301 NS; GSP 301 Placebo NS pH 3.7; GSP 301 Placebo NS pH 7.0
Intervention description: FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks; 2 spray in each nostril twice daily for 52 weeks; 2 spray in each nostril twice daily for 52 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 601.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS
      formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and
      older)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged ≥12 years and older inclusive of either sex.

          2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit
             [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at
             least 3 mm greater than negative diluent control wheal) to at least 1 allergen known
             to induce PAR. Documentation of a positive result within 12 months prior to the
             Screening Visit (Visit 1) is acceptable.

        Exclusion Criteria:

          1. Pregnant or lactating women.

          2. History of anaphylaxis and/or other severe local reaction(s) to skin testing.

          3. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

          4. Documented evidence of acute or significant chronic sinusitis or chronic purulent
             postnasal drip.

          5. Subjects with an active pulmonary disorder or infection.

          6. Subjects with posterior subcapsular cataracts or glaucoma