bioihbjkbjnl/mcl2 huggingface dataset:
A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Secukinumab
Intervention description: Matching placebo to secukinumab I.V.; In part 1 (blinded period), participants randomized to secukinumab received 10 mg/kg I.V.. Participants, enrolled in part 2 (open label), received secukinumab 300 mg subcutaneous.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; IgG1K monoclonal antibody; Interleukin-17A neutralizing

Summary:

      This study aims to confirm if patients with a specific biomarker might have a better response
      to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done.
      The goals of these exploratory studies are to (1) find biomarkers that will identify persons
      with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to
      identify persons who will have fewer side effects in order to maximize their benefit from
      secukinumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis

          -  Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX,
             leflunamide or sulfasalazine)

          -  Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or
             hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating
             study treatment

          -  Disease activity at screening defined by ≥6 out of 28 tender joints and ≥6 out of 28
             swollen joints and hsCRP >10mg/L

        Exclusion Criteria:

          -  Patients with severe rheumatoid arthritis (functional status class IV according to the
             ACR 1991 revised criteria)

          -  Previous exposure to secukinumab or any other biologic, including TNF inhibitors.

          -  Use of high potency opioid analgesics

          -  Pregnant or nursing (lactating) women

          -  Use of any investigational drug other than RA therapy and/or devices at the time of
             randomization or within 30 days or 5 half-lives of randomization, whichever is longer.

        Other protocol-defined inclusion/exclusion criteria may apply
Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Ipilimumab; Platinum Doublet Chemotherapy
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 324.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of part 1 of this study is to determine the objective response rate (ORR) in
      stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line
      therapy.

      The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab
      and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and Women ≥ 18 years of age

          -  Diagnosed with stage IV Non-Small Cell Lung Cancer

          -  Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous
             concurrent chemoradiation with no further curative options.

        Exclusion Criteria:

          -  Subjects with untreated CNS metastases are excluded.

          -  Subjects with carcinomatous meningitis

          -  Subjects with an active, known or suspected autoimmune disease.

          -  Subjects with a condition requiring systemic treatment with either corticosteroids ( >
             10 mg daily prednisone equivalent) or other immunosuppressive medications within 14
             days of first treatment.

          -  Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.

        Other protocol defined inclusion/exclusion criteria apply
MEK162 for Patients With RAS/RAF/MEK Activated Tumors
Condition: Solid Tumor and Hematologic Malignancies
MeSH terms: Hematologic Neoplasms
Intervention: MEK162
Intervention description: MEK162 will be dosed on a flat scale of 45 mg twice daily on a continuous dosing schedule.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RAS, RAF, MEK, NF1, MEK162, signature, papillary thyroid, small intestine, bladder, esophagus, lung cancer, NSCLC, acute myelogenous leukemia, AML

Summary:

      The purpose of this signal seeking study is to determine whether treatment with MEK162
      demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic
      malignancies to warrant further study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a confirmed diagnosis of a select solid tumor (except for primary
             diagnosis of pancreatic cancer, biliary cancer, colorectal cancer, low grade serous
             ovarian cancer, melanoma) or hematologic malignancy (except for primary diagnosis of
             chronic myelomonocytic leukemia).

          -  Patients must be pre-identified as having a tumor with a mutation in RAF, RAS, NF1 or
             MEK at a CLIA certified laboratory

          -  Patient must have received at least one prior treatment for recurrent, metastatic and
             /or locally advanced disease and for whom no standard therapy options are anticipated
             to result in a durable remission.

          -  Patient must have progressive and measurable disease as per RECIST 1.1. or other
             appropriate hematological guidelines.

          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

          -  Patient has received prior treatment with MEK162.

          -  Patients with primary CNS tumor or CNS tumor involvement

          -  History of retinal degenerative disease

          -  History or current evidence of central serous retinopathy (CSR) or retinal vein
             occlusion (RVO)

          -  Any ophthalmopathy visible at screening that would be considered a risk factor for CSR
             or RVO by the ophthalmologist

          -  Patients who have neuromuscular disorders that are associated with elevated CK
Trial II of Lung Protection With Azithromycin in the Preterm Infant
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Intervention: Azithromycin; Placebo
Intervention description: Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.; vehicle dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: premature infant; respiratory distress syndrome; mechanical ventilation

Summary:

      The hypothesis of this study is that administration of azithromycin to ventilated premature
      infants will decrease the incidence and severity of BPD.

      The purpose of this study is to determine if Azithromycin treatment is beneficial for
      prevention of bronchopulmonary dysplasia in preterm infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  birthweight less than 1250 grams admitted to UK NICU

          -  mechanical ventilation within the first 72 hours of life

        Exclusion Criteria:

          -  confirmed sepsis by blood culture

          -  multiple congenital anomalies or known syndromes

          -  intrauterine growth retardation with birthweight less than 10%ile for gestational age

          -  ROM for >7 days
A Study for Patients With Non-Hodgkin's Lymphomas
Condition: T-Cell Lymphoma; B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: enzastaurin
Intervention description: 1125 mg loading dose then 500 mg, oral, daily until progressive disease
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this study, all patients will get investigational drug. There will be no comparator drug.
      This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and
      Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:

        -  T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL)

        -  Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2)
           and marginal zone lymphoma

        -  Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and
           aggressive lymphoma with prior clinical history of indolent lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have measurable lesions

          -  Have recovered from prior chemotherapies

          -  Have an estimated life expectancy of at least 12 weeks

          -  Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal to
             2.0 x ULN (less than 5x if liver metastases are present)

          -  Renal: serum creatinine less than or equal to 1.5XULN

          -  Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /Liter (L)
             Criteria:

          -  Have a second primary malignancy (except adequately treated nonmelanomatous skin
             cancer, or other cancer that is considered cured by surgical resection or radiation).

          -  Anti-lymphoma therapy within the past 3 weeks

          -  Unable to swallow tablets

          -  Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14
             days prior to study enrollment
Deposition of Inhaled Prolastin in Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Alpha1-Proteinase Inhibitor (Human)
Intervention description: 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks.
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to determine the optimal region of the lung for depositing
      Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF).
      The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either
      the deep lung or to the upper airways in a one to one randomization. The study will measure
      how much of the activity of the enzyme elastase is inhibited by AAT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with diagnosis of CF

          -  Age >= 8 years

          -  Forced expiratory volume at one second (FEV1) > 25 % of predicted value

          -  Free elastase activity checked at visit 1 must be positive (free elastolytic activity
             in the sample, 2 standard deviations above of the negative blank samples in the
             assay.) .

          -  Patient must be positive at least 3 times for pseudomonas in the last 2 years

          -  Patient must be positive for pseudomonas at Visit 1

          -  Patient must be able to perform reliable spirometry

          -  Patient must be on stable concomitant therapy at least 2 weeks prior to visit 1 and
             during the study

          -  Written informed consent of the patient or legal representative(s)

        Exclusion Criteria:

          -  FEV1 < 25% of predicted value post-bronchodilator

          -  History of lung transplant

          -  Any lung surgery within the past 2 years

          -  On any thoracic surgery waiting list

          -  Severe concomitant disease (serious malignant disease, congestive heart failure New
             York Heart Association (NYHA) III/IV, cor pulmonale with the need of oxygen therapy)

          -  Severe liver cirrhosis with ascites, hypersplenism or grade III/IV esophageal varices.

          -  Known selective immunoglobulin A (IgA) deficiency with known antibody against IgA
             (anti-IgA antibody)

          -  Active pulmonary exacerbation within the 4 weeks prior to screening

          -  Current Smoking

          -  Pregnancy or lactation

          -  Women of child-bearing age without adequate contraception

          -  Any medical condition which the investigator feels will prohibit the patient from
             completing the trial

          -  Participation in another clinical trial within 30 days prior to inclusion at visit 1
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
Condition: Pain; Postoperative Pain; Pain, Acute
MeSH terms: Toothache; Acute Pain
Intervention: MR-107A-01; Placebo
Intervention description: Oral tablet; Oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after
      dental surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ≥18 years of age.

          2. Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of
             which involves partial or complete mandibular bony impaction.

          3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours
             following the end of surgery.

          4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e.,
             none, mild, moderate, severe) during the 5 hours following the end of surgery.

        Exclusion Criteria:

          1. Previously dosed with MR-107A-01.

          2. Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).

          3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel
             disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may
             affect coagulation.

          4. Use of any investigational drug within 28 days, or 5 half-lives, prior to screening
             whichever is longer.

          5. Use of medications with the potential to interact with MR-107A-01.

          6. Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the subject inappropriate for entry into this
             study.
A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms; Disease Progression
Intervention: Trastuzumab
Intervention description: 4 mg/kg initial dose, followed by 2 mg/kg
Intervention MeSH terms: Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or
      advanced gastric cancer with disease progression during platinum-based or
      5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until
      disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-75 years of age;

          -  metastatic or advanced gastric cancer;

          -  disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based
             chemotherapy for metastatic disease;

          -  >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;

          -  >=1 measurable lesion;

          -  HER2 overexpression (IHC [2+] or [3+]).

        Exclusion Criteria:

          -  concurrent chemotherapy or immunotherapy;

          -  brain or meningeal metastases;

          -  clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;

          -  co-existing malignancies or malignancies diagnosed within last 5 years, except basal
             cell cancer or cervical cancer in situ;

          -  women who are pregnant or breastfeeding.
AXS-05 Phase II Trial on Smoking Behavior
Condition: Smoking Cessation; Smoking, Cigarette; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: AXS-05; Bupropion SR
Intervention description: Dextromethorphan Immediate Release + Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.; Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.
Intervention MeSH terms: Dextromethorphan; Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to either take AXS-05 or BUP SR in parallel for the duration of the study.
Masking: Double (Participant, Care Provider)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking cessation; Nicotine dependence; Bupropion; DXM; Nicotine addiction; Cigarette smoking; Dextromethorphan

Summary:

      This research study is designed with the purpose of evaluating a new drug, combination
      Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age 18 years or above

          2. Daily smoker using 10 or more cigarettes per day

          3. Willing to be smoke-free for 7 days

          4. Is able to provide written informed consent (in English) to participate in the study
             and able to understand the procedures and study requirements.

          5. Is willing to voluntarily sign and date an informed consent form that is approved by
             an institutional review board before the conduct of any study procedure.

        Key Exclusion Criteria:

          1. Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline,
             bupropion)

          2. Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless
             tobacco)

          3. Not pregnant or breastfeeding

          4. Contraindication to the use of bupropion.

          5. Additional criteria may apply.
G-Pen™ for Hypoglycemia Rescue in T1D Patients
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: Glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is an open-label, exploratory pilot study in patients with T1D. The study will involve
      two daytime clinical research center visits 7-14 days apart. Subjects will receive a single
      injection of G-Pen™ (glucagon injection) at each visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes mellitus for at least 24 months

        Exclusion Criteria:

          -  Pregnant or Lactating

          -  HbA1c >10.5% at screening

          -  Use of > 2.0 U/kg total insulin dose per day

          -  Inadequate bilateral venous access in both arms

          -  Renal insufficiency

          -  Congestive heart failure, NYHA class II, III or IV

          -  Active malignancy within 5 years from screening

          -  Major surgical operation within 30 days prior to screening

          -  Seizure or bleeding disorder

          -  Glycogen storage disease

          -  Active substance or alchohol abuse