bioihbjkbjnl/mcl2 huggingface dataset:
Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy
Condition: Total Laryngectomy
Intervention: Provox Xtra HME
Intervention description: Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: HME; Provox; voice prosthesis; laryngectomy

Summary:

      This study is a short term feasibility study that aims to investigate patient satisfaction
      with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are
      considered are for example performance for stoma occlusion, speaking, breathing, appearance,
      compliance, and short-term impact on pulmonary symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  total laryngectomy

          -  compliant Provox HME user (24/7 use)

        Exclusion Criteria:

          -  current medical problems that might influence HME use
Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Rozibafusp Alfa; Placebo
Intervention description: Administered by subcutaneous injection once every 2 weeks.; Administered by subcutaneous injection once every 2 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile
      of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis
      (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index: 18-35 kg/m^2

          -  Diagnosed with RA (disease duration of at least 6 months)

          -  Stable dose of methotrexate (5-25 mg weekly for ≥ 4 weeks)

          -  Immunizations up to date

          -  Willing to use highly effective contraception during treatment and through
             end-of-study

        Exclusion Criteria:

          -  Uncontrolled, clinically significant systemic disease other than RA (i.e., diabetes
             mellitus, liver disease, asthma, cardiovascular disease, hypertension)

          -  Malignancy within 5 years

          -  Presence of serious infection, recurrent/chronic infections

          -  Class IV RA according to American College of Rheumatology/ (ACR) revised response
             criteria

          -  Diagnosed with Felty's syndrome

          -  Known or suspected sensitivity to mammalian cell-derived products

          -  History of alcohol and/or substance abuse within the last 12 months

          -  Receipt of rituximab at any time in the past

          -  Evidence of renal disease
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Dasatinib; Nivolumab
Intervention MeSH terms: Nivolumab; Dasatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find a dose of Nivolumab that can be safely added to
      Dasatinib in patients with Chronic Myeloid Leukemia.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase
             :

               -  With historically documented Ph+ cells

               -  ≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML

               -  Currently progressing, resistance to or with a suboptimal response to their most
                  recent therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1

        Exclusion Criteria:

          -  Blast phase CML

          -  Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
Glutamate Reducing Interventions in Schizophrenia
Condition: Clinical High Risk for Psychosis
MeSH terms: Schizophrenia
Intervention: Pomaglumetad methionil
Intervention description: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized, phase 1b, multiple dose trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      Participants will be administered several doses of pomaglumetad (POMA) (low and high doses)
      over 14 days to individuals at clinical high risk for developing psychosis and use magnetic
      resonance imaging (MRI) brain imaging to determine whether these doses of POMA are affecting
      glutamate levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capacity to provide informed consent

          -  Currently using a reliable form of birth control

        Exclusion Criteria:

          -  Metal implants in body or a history of metal working

          -  Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity
             to contrast agents

          -  Lifetime diagnosis of renal failure/disease

          -  Acute neurological, neuroendocrine, or medical disorder including renal insufficiency
             (CrCl<40 mL/min/1.73m2)

          -  Lifetime diagnosis of hypertension or diabetes or seizure disorder

          -  IQ<70

          -  Acute risk for suicide and/or violence

          -  Pregnant lactating

          -  Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative
             hypnotics)

          -  Current use or anticipated need for antipsychotics or mood stabilizers (all
             antipsychotics, also depakote, lithium, lamotrogine, pregabalin or any med with a
             mechanism of action like gabapentin), probenecid, selective serotonin reuptake
             inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors

          -  More than one previous gadolinium scan
A Study of LY2835219 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY2835219; ¹³C₈-LY2835219
Intervention description: Administered orally; Administered IV
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to compare how much of the study drug gets into the blood stream
      when it is given as a single oral dose and as an intravenous infusion (given directly into a
      vein via a small needle).

      The study will also provide information on how well the study drug is tolerated when given as
      a capsule in combination with giving it intravenously, and information on any changes in
      heart function.

      The study will last about 10 days. Screening is required within 28 days before study drug is
      given.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy sterile males or surgically sterile females or postmenopausal females

          -  Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)

          -  Have given written informed consent approved by Lilly and the ethical review board
             (ERB) governing the site.

          -  Participants who are reliable and willing to make themselves available for the
             duration of the study and are willing to follow study procedures

        Exclusion Criteria:

          -  Have participated in a clinical trial involving investigational product within the
             last 90 days

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have an abnormal blood pressure

          -  Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C

          -  Have donated blood of more than 500 milliliters (mL) within the last month

          -  Have consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A
             inducer, herbal supplements, grapefruits or grapefruit containing products, Seville
             oranges or Seville orange containing products, star fruits or star fruit containing
             products within 2 weeks prior to dosing or intend to consume during the study

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening
Tobramycin Tear Concentrations
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Intervention: TOBRADEX Ophthalmic Suspension; Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension; TOBREX Ophthalmic Solution
Intervention description: TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline; Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline; TOBREX Ophthalmic Solution 1 drop each eye at baseline
Intervention MeSH terms: Tobramycin; Tobramycin, Dexamethasone Drug Combination; Dexamethasone; Ophthalmic Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: normal volunteers; anti-infective; tobramycin

Summary:

      To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension,
      Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic
      Solution in normal volunteers.
    

Eligibility criteria:

        Inclusion:

          -  Visual Acuity (VA) of 0.6 logMAR or better

          -  Tear meniscus height of ≥ 0.3mm at Visit 1.

          -  No concomitant topical ocular medications, including artificial tears, during the
             study period

        Exclusion

          -  ocular hypertension, iritis or uveitis, glaucoma

          -  ocular surgery, intraocular surgery or ocular laser procedures in either eye within
             the past six months

          -  epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella
             viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial
             infection of the eye; and / or fungal disease of the eye

          -  lacrimal duct obstruction, dry eye, ocular allergies.

          -  contact lens within 7 days of Visit 1.

          -  ocular medications within 14 days of Visit 1.