bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; R940343 1mg; R940343 2mg
Intervention description: 1 puff bid or 2 puffs bid; R343 1mg, 1 puff bid; R343 2mg, 2 puffs bid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in
      the treatment of mild to moderate asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical history of asthma

          -  Ability to perform spirometry

        Exclusion Criteria:

          -  Chronic obstructive pulmonary disease or bronchiectasis

          -  Upper or lower respiratory infection
Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)
Condition: Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy
MeSH terms: Rhinitis; Conjunctivitis; Hypersensitivity
Intervention: Placebo; SCH 39641; SCH 39641
Intervention description: Placebo sublingual tablet, once daily; Allergy immunotherapy tablet (sublingual); Allergy immunotherapy tablet (sublingual)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: immunotherapy

Summary:

      The purpose of this study was to assess the safety and tolerability of a ragweed allergy
      immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years
      of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.

          -  Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis
             with or without asthma.

          -  Subject must have a positive skin prick test response to Ambrosia artemisiifolia at
             the Screening Visit

          -  Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of
             predicted value at the Screening Visit and at Randomization.

          -  A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs
             conducted at the Screening Visit must be within normal limits or clinically acceptable
             to the investigator.

        Exclusion Criteria:

          -  Subject with asthma who requires inhaled corticosteroids for the treatment of their
             asthma during the study period.

          -  Subject requiring anti-allergy medications during the time period from randomization
             to study completion.

          -  Subject who has received an immunosuppressive treatment within 3 months prior to the
             Screening Visit (except steroids for allergic and asthma symptoms).

          -  Subject with a history of anaphylaxis with cardiorespiratory symptoms.

          -  Subject with a history of chronic urticaria or angioedema.

          -  Subject with current severe atopic dermatitis.

          -  Female subject who is breastfeeding, pregnant, or intending to become pregnant.

          -  Subject with a history of allergy, hypersensitivity or intolerance to the ingredients
             of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia),
             or self-injectable epinephrine.

          -  Subject with a history of self-injectable epinephrine use.
Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Condition: Refractory Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Zanubrutinib
Intervention description: Administered as specified in the treatment arm.
Intervention MeSH terms: Zanubrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to evaluate the efficacy of zanubrutinib in
      participants with centrally confirmed relapsed or refractory MCL.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Diagnostic report had to include evidence for morphological and cyclin D1 or t (11;
             14).

          2. Eastern Cooperative Oncology Group performance status of 0-2.

          3. Measurable disease by computed tomography/magnetic resonance imaging.

          4. Received prior regimens for MCL.

          5. Documented failure to achieve any response, (stable disease or progressive disease
             during treatment) or documented progressive disease after response to the most recent
             treatment regimen.

          6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal
             (ULN).

          7. Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).

          8. Life expectancy of > 4 months.

        Key Exclusion Criteria:

          1. Current or history of central nervous system lymphoma.

          2. Prior exposure to a BTK inhibitor before enrollment.

          3. Prior corticosteroids with anti-neoplastic intent within 7 days.

          4. Major surgery within 4 weeks of screening.

          5. Toxicity must have recovered from prior chemotherapy.

          6. History of other active malignancies within 2 years of study entry.

          7. Currently clinically significant active cardiovascular disease.

          8. QT interval corrected with Fridericia's formula > 450 microseconds or other
             significant electrocardiogram abnormalities.

          9. Uncontrolled systemic infection or infection requiring parenteral anti-microbial
             therapy.

         10. Known human immunodeficiency virus infection, or active hepatitis B or hepatitis C
             infection (detected positive by polymerase chain reaction).

        Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer Metastatic
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Gemcitabine
Intervention description: 150 mg po daily; 1000 mg/m^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in
      chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell
      lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination
      with gemcitabine 1000 mg/m^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The
      anticipated time on study treatment is until disease progression, and the target sample size
      is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;

          -  no previous systemic chemotherapy, radiation therapy or immunotherapy;

          -  Eastern Cooperative Oncology Group (ECOG) >=2.

        Exclusion Criteria:

          -  prior systemic anti-tumor therapy with human epidermal growth factor receptor 1
             (HER1/EGFR) inhibitors;

          -  active, non-controlled systemic disease;

          -  any other malignancies within 5 years (except for adequately treated cancer in situ of
             cervix, or basal or squamous cell skin cancer).
Cognitive Remediation for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: levodopa/carbidopa; Ropinirole 2 mg/d; Placebo; Ropinirole 4 mg/d
Intervention description: 800/200 mg/d; 2 mg/d; sugar pill; 4 mg/d
Intervention MeSH terms: Levodopa; Carbidopa; Ropinirole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: cocaine; cognition; medication; treatment

Summary:

      The purpose of this study is to evaluate treatments designed to improve cocaine treatment
      success by combining medications that target cocaine-related cognitive impairments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet criteria for cocaine dependence

          -  seeking treatment for cocaine dependence

          -  be in acceptable health based on medical history and physical exam

        Exclusion Criteria:

          -  dependent on drugs other than cocaine, nicotine, marijuana

          -  have a medical condition contraindicating treatment with study medications

          -  having conditions of probation or parole requiring reports of drug use to officers of
             the court
Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Intervention: Buzzy; Topical Lidocaine 4% Cream
Intervention description: Cold, Vibrational Device; Applied to anticipated IV site at least 30 minutes prior to cannulation.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 4 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain; Anxiety; IV Cannulation; Topical Lidocaine; Buzzy; Face, Legs, Activity, Crying, Consolability (FLACC) scale; Faces Pain Scale Revised (FPS-R); Child Rating of Anxiety Scale

Summary:

      The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable
      device that provides cold and vibration, in reducing the pain associated with intravenous
      (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical
      lidocaine cream in reducing the pain associated with IV cannulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is aged 4 to 18 years of age

          -  Subjects will be having a peripheral IV line placed at the discretion of the treating
             physician for usual care of presenting complaints.

          -  Physician in charge of the subject is willing to wait the 30 minutes needed for the
             study preparation

          -  Subject/caregiver understands English

          -  Parent or legal guardian has signed Institutional Review Board (IRB) approved informed
             consent and subject (if age 7 years or older) has given assent

        Exclusion Criteria:

          -  Subject is critically ill with a triage category of 1

          -  Subject has a condition that precludes the use of the self-report pain scale

          -  Subject has an abrasion, infection or break in skin in the area where Buzzy® would be
             placed

          -  Nerve damage is present in the extremity for planned IV placement
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Oxycodone; Buprenorphine; Placebo Film; Placebo Capsule
Intervention description: Single-dose of over-encapsulated oral 5-mg oxycodone capsule; Single-dose of buprenorphine HCl buccal film; Single-dose of placebo buccal film; Single-dose of oral placebo capsule
Intervention MeSH terms: Oxycodone; Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl)
      buccal film in the treatment of dental pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  extraction of 2 or more third molars, at least 1 of which must be fully or partially
             impacted in mandibular bone

          -  males or non-pregnant females, aged 18 to 45 years

          -  good general health and capable of providing informed consent

        Exclusion Criteria:

          -  history of substance abuse or dependence

          -  positive urine toxicology screen or alcohol breath test

          -  history of hypersensitivity to or allergy to any study drug

          -  donation of blood within prior 30 days

          -  use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet
             agents within 24 hours
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
Condition: SARS-CoV-2 Infection; Acute Kidney Injury
MeSH terms: COVID-19; Acute Kidney Injury
Intervention: Placebo; Nicotinamide riboside
Intervention description: Placebo capsule containing inert ingredient; 250 mg Nicotinamide riboside capsules
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double-blind, placebo-controlled clinical interventional trial
Masking: Double (Participant, Investigator)
Masking description: The study drug (NR or placebo) packaging and labeling will be designed to maintain the blinding of the investigator's team and the participants.
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An interventional clinical trial using oral nicotinamide riboside (NR) in hospitalized
      patients with COVID-19 infection and acute kidney injury to determine the effect of NR on
      whole blood nicotinamide adenine dinucleotide (NAD+) levels and to evaluate safety of the use
      of NR.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of signed and dated informed consent form from a participant or legally
             authorized representative (LAR);

          2. Male or female, >18 years old;

          3. Hospitalized participants with a laboratory diagnosis of COVID-19 infection

          4. Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes
             (KDIGO) guidelines (Table 3);

          5. Willing to adhere to the study intervention regimen;

        Exclusion Criteria:

          1. Hypersensitivity to nicotinamide riboside (NR);

          2. Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per
             local requirements;

          3. eGFR <15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration
             equation at admission lab;

          4. Maintenance renal replacement therapy or initiation of renal replacement therapy
             before randomization

          5. Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins
             are allowed);

          6. Concomitant cirrhosis of liver or acute liver failure;

          7. Any medical history or condition that might, in the opinion of the attending
             physician, put the participant at significant risk if he/she were to participate in
             the trial;

          8. Individuals with kidney transplant;

          9. Individuals with blood platelet count <100,000/microL
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
Condition: Tumor; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: NKTR-102 q14d; NKTR-102 q21d
Intervention description: NKTR-102 given on a q14 day schedule; NKTR-102 given on a q21 day schedule
Intervention MeSH terms: Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients
      with metastatic or locally advanced platinum-resistant ovarian cancer.

      Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102
      will be administered at a dose level of 145 mg/m^2 in both arms. In Arm A, NKTR-102 will be
      given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the
      initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer,
             primary peritoneal cancer or fallopian tube cancer

          2. Inoperable metastatic or locally advanced ovarian cancer

          3. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of
             last dose of most recent platinum drug

          4. Platinum-resistant patients who have progressed after receiving PLD
             (Doxil/Caelyx)therapy in a platinum-resistant setting or who otherwise unable to
             receive PLD therapy.

          5. Diseases must be measurable as defined by RECIST in at least 1 lesion not previously
             irradiated.

          6. ECOG performance score of 0 or 1.

          7. Adequate organ and bone marrow functions at Screening.

        Exclusion Criteria:

          1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) and have not recovered to NCI-CTCAE grade 1 toxicity
             prior to Day 1 of Cycle 1

          2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or
             minor surgery within 2 weeks prior to Day 1 of Cycle 1

          3. Patients who have received CYP3A4 inducers or inhibitors.

          4. Patients who have received any treatment with a camptothecin derivative (eg.
             irinotecan, topotecan, SN38 investigational agents, etc.).

          5. Patients with CNS metastases.
A Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Samidorphan (Low Dose); Samidorphan (Medium Dose); Samidorphan (High Dose); Placebo; Olanzapine
Intervention description: Tablets taken once daily; Tablets taken once daily; Tablets taken once daily; Tablets taken once daily; Tablets taken once daily
Intervention MeSH terms: Naltrexone; Olanzapine; ALKS-33
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 347.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Schizophrenia; Olanzapine; Samidorphan; Alkermes

Summary:

      This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted
      in 2 parts. The study duration for each subject will be approximately 33 weeks and will
      include 25 study visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 50 years, inclusive

          -  Body mass index (BMI) of 17-30 kg/m2, inclusive

          -  Diagnosis of schizophrenia that is clinically stable

        Exclusion Criteria:

          -  Initiated 1st antipsychotic treatment within the past 12 months and/or has had
             symptoms lasting <2 years

          -  Current diagnosis of alcohol or drug use disorder, moderate or severe

          -  Clinically significant or unstable medical illness, condition, or disorder

          -  Pregnant or breastfeeding

          -  Significant changes in diet or exercise regimen or plans to join a weight management
             program during the study

          -  Opioid medications taken within 14 days and/or need to take opioid medication during
             the study period

          -  History of hypersensitivity to or intolerance of olanzapine

          -  Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more
             than 1 week during the past year
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
Condition: BK Virus Infection
MeSH terms: Viremia
Intervention: MAU868; Placebo
Intervention description: MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells; 250 mL D5W placebo IV to be labeled to match that of MAU868
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical research study will test the safety and efficacy of the investigational
      medication MAU868, compared to a placebo, in patients who have had a kidney transplant who
      have active BK virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a male or female 18 years of age or older.

          -  Recipient of a kidney (or kidney-pancreas) transplant within the year prior to
             enrollment

          -  Documented BKV viremia based on local or central laboratory testing within 10 days

        Exclusion Criteria:

          -  A BKV plasma viral load which has exceeded 10^3 copies/mL for >4 months.

          -  A BKV plasma viral load of ≥ 10^7 copies/mL.