bioihbjkbjnl/mcl2 huggingface dataset:
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: BMS-986165; Placebo; Mycophenolate Mofetil
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Mycophenolic Acid; Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind Study
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared
      with placebo with regard to measures of kidney function in participants with lupus nephritis
      (LN).
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)
             criteria for Systemic Lupus Erythematosus (SLE)

          -  Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN)
             International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III,
             IV-S, or IV-G; or Class V

          -  Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a
             24-hour urine specimen

        Exclusion Criteria:

          -  Pure ISN/RPS Class V membranous LN

          -  Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m^2

          -  Dialysis within 12 months before screening or plans for dialysis within 6 months after
             enrollment in the study

          -  End-stage renal disease

        Other protocol-defined inclusion/exclusion criteria apply
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Intervention: CX516; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 175.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Mild Cognitive Impairment; Memory Loss; Alzheimer's Disease; Brain Aging; Ampalex®; CX516

Summary:

      Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild
      cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is
      evidence CX516 enhances brain activity by specifically targeting remaining glutamate
      receptors in the affected portions of the brain. This study will test the safety and efficacy
      of CX516 in the symptomatic treatment of participants with mild cognitive impairment.
    

Eligibility criteria:

        Inclusion criteria

          -  Clinical diagnosis of mild cognitive impairment

          -  Good general health with no additional diseases that would interfere with the study.

        Exclusion criteria

          -  Any significant neurologic disease (other than suspected incipient Alzheimer's
             disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia,
             Huntington's disease, head trauma, chronic CNS infection.

          -  History of major depression or another major psychiatric disorder within the past 6
             months.

          -  History of schizophrenia, mania or recurrent psychotic episodes.

          -  History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within
             the past year.

          -  History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the
             Investigator and considering the age of the participant.

          -  Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal
             or hematological illness or unstable medical condition which could interfere with drug
             safety, or absorption, distribution, metabolism and excretion, or lead to difficulty
             complying with the protocol.
Smell Changes & Efficacy of Nasal Theophylline
Condition: Olfactory Disorder; Anosmia; Viral Infection; Theophylline Causing Adverse Effects in Therapeutic Use; Smell Disorder
MeSH terms: Virus Diseases; Anosmia; Olfaction Disorders
Intervention: Theophylline; Saline Nasal
Intervention description: Theophylline delivered via high-volume, low-pressure nasal saline irrigation; Lactose delivered via high-volume, low-pressure nasal saline irrigation
Intervention MeSH terms: Theophylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two randomized arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Olfactory dysfunction; Anosmia; Hyposmia; Post-viral; Theophylline; Adverse effects; Smell

Summary:

      This study evaluates the efficacy and safety of nasal theophylline irrigation in treating
      smell loss related to a viral respiratory infection. Half the participants will undergo nasal
      theophylline irrigation treatment while the other half will undergo placebo nasal irrigation
      with saline alone. All participants will have their sense of smell tested before and after 6
      weeks of treatment. All participants will also be regularly asked about any potential side
      effects related to treatment. In addition, the first 10 participants will have their blood
      drawn to measure their theophylline level after 1 week of starting treatment to ensure it is
      not abnormally elevated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjective or clinically diagnosed olfactory dysfunction of 6 months to 36 months
             duration after a presumed viral upper respiratory infection

          -  Ability to read, write, and understand English

        Exclusion Criteria:

          -  Dependence on theophylline for comorbid conditions such as asthma and chronic
             obstructive pulmonary disease

          -  History of an allergic reaction to theophylline or other methylxanthines

          -  Prior sinonasal or anterior skull base surgery

          -  Nasal polyposis

          -  History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease,
             Lewy body dementia, frontotemporal dementia)

          -  Pregnant or breastfeeding mothers

          -  Current use of medications with significant (≥40%) interactions with theophylline,
             which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine,
             interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine,
             thiabendazole, ticlopidine, and troleandomycin
Phase II HDM-SPIRE Safety and Efficacy Study
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Intervention: HDM-SPIRE; Placebo
Intervention description: 1 dose every 4 weeks; 1 dose every 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 715.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cat allergy; Rhinoconjunctivitis

Summary:

      The purpose of this study is to compare the treatment effect of three treatment regimens of
      HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue
      medication usage, Quality of Life and Sleep Quality
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 18-65 years.

          -  Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.

          -  Mean TRSS ≥10

          -  Positive skin prick test to Der p and Der f.

          -  Dep p and Der f specific IgE ≥0.7 kU/L

        Exclusion Criteria:

          -  Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3
             (www.ginasthma.org)or higher treatment

          -  FEV1 <80% of predicted.

          -  Clinically significant confounding symptoms of allergy to seasonal allergens during
             the final evaluation period.

          -  Significant symptoms of another clinically relevant illness that is likely to affect
             scoring of rhinoconjunctivitis symptoms.

          -  Clinically relevant abnormalities detected on physical examination.

          -  History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Plasma Cell Myeloma
MeSH terms: Lymphoma; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Crizotinib
Intervention description: Given PO
Intervention MeSH terms: Crizotinib; Tyrosine Protein Kinase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crizotinib; ALK; NCI-MATCH; Tyrosine Kinase Inhibitor

Summary:

      This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose
      cancer has a genetic change called ALK rearrangement. Crizotinib may stop the growth of
      cancer cells by blocking the ALK protein which may be needed for cell growth. Researchers
      hope to learn if crizotinib will shrink this type of cancer or stop its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met applicable eligibility criteria in the Master MATCH Protocol
             prior to registration to treatment subprotocol

          -  Patients must have an ALK rearrangement as defined via the MATCH Master Protocol

          -  Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
             assignment and must have no clinically important abnormalities in rhythm, conduction
             or morphology of resting ECG (e.g. complete left bundle branch block, third degree
             heart block)

        Exclusion Criteria:

          -  Patients must not have non small cell lung cancer or anaplastic large cell lymphoma
             (ALCL)

          -  Patients with a history of interstitial lung disease or pneumonitis are excluded

          -  Patients must not have known hypersensitivity to crizotinib or compounds of similar
             chemical or biologic composition

          -  Patients must not have had prior ALK-targeted inhibitors, including crizotinib,
             ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922

          -  Patients must not have had brain metastases unless 1) treated and neurologically
             stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not
             indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior
             to study enrollment

          -  Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will
             be excluded
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
Condition: Central Neuropathic Pain; Allodynia; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Neuralgia; Hyperalgesia; Wounds and Injuries
Intervention: Dextromethorphan; Lidocaine; Placebo (Dextromethorphan); Placebo (Lidocaine)
Intervention description: Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); 0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose); 0mg Dextromethorphan; 0mg/kg LBM Lidocaine
Intervention MeSH terms: Lidocaine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic pain; central neuropathic pain; spinal cord injury; dextromethorphan; lidocaine; combination therapy; analgesia

Summary:

      This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a
      larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of
      chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain
      following spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female adults, age 18 to 70 with central neuropathic pain for a
             minimum of 3 months following SCI as confirmed by neurologic evaluation, with an
             average pain intensity score of at least moderate over at least 50% of the day for the
             7 days prior to the screening visit and over the 7 days prior to starting study
             medication.

          2. Subjects used no medication or a stabilized medication regimen for chronic and
             well-controlled medical conditions

          3. Serum laboratory examination obtained at study entry:

          4. Normal cognitive function.

          5. Signed informed consent.

        Exclusion Criteria:

          1. Pregnancy or breast-feeding.

          2. Renal or hepatic dysfunction.

          3. Significant cardiac disease (e.g. MI within 1 year).

          4. Signs or symptoms of central neurological disorder, excluding SCI.

          5. Severe psychological disorder requiring treatment.

          6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.

          7. Participation in a study of an investigational drug or device within 30 days prior to
             screening for this study.
MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elranatamab (PF-06863135)
Intervention description: BCMA-CD3 bispecific antibody
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myeloma; Multiple Myeloma; relapsed Multiple Myeloma; refractory Multiple Myeloma; PF-06863135; BCMA; bispecific; bispecific antibody; BCMA-CD3 bispecific; Elranatamab; MagnetisMM-3

Summary:

      The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can
      provide clinical benefit in participants with relapsed/refractory multiple myeloma.
      Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and
      BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

          -  Measurable disease, as defined by at least 1 of the following:

               1. Serum M-protein >0.5 g/dL by SPEP

               2. Urinary M-protein excretion >200 mg/24 hours by UPEP

               3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin
                  kappa to lambda FLC ratio

          -  Refractory to at least one IMiD

          -  Refractory to at least one PI

          -  Refractory to at least one anti-CD38 antibody

          -  Relapsed/refractory to last anti-myeloma regimen

          -  Cohort A: has not received prior BCMA-directed therapy

          -  Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)

          -  ECOG performance status ≤2

          -  Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

          -  Not pregnant and willing to use contraception

        Exclusion Criteria:

          -  Smoldering multiple myeloma

          -  Active Plasma cell leukemia

          -  Amyloidosis

          -  POEMS syndrome

          -  Stem cell transplant within 12 weeks prior to enrollment

          -  Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or
             viral infection

          -  Any other active malignancy within 3 years prior to enrollment, except for adequately
             treated basal cell or squamous cell skin cancer, or carcinoma in situ.

          -  Previous administration with an investigational drug within 30 days or 5 half-lives
             preceding the first dose of study intervention used in this study (whichever is
             longer)
A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Intervention: Basmisanil; Placebo
Intervention description: Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.; Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition
      and functioning of stable schizophrenia participants treated with antipsychotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia of any type utilizing the Mini International
             Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders,
             fifth edition (DSM-5) direct clinical assessments, family informants and past medical
             records

          -  Evidence of stability of symptoms for 3 months at screening, that is, without
             hospitalizations for schizophrenia or increase in level of psychiatric care due to
             worsening of symptoms of schizophrenia

          -  Participants with schizophrenia clinical symptom severity defined by the following:
             hallucinatory behavior item score less than or equal to (</=) 5 and a delusion item
             score </= 5 of the PANSS

          -  Participants on a stable regimen of antipsychotic therapy for at least 3 months at
             screening and receiving no more than two antipsychotics

        Exclusion Criteria:

          -  Participants with current DSM-5 diagnosis other than schizophrenia including bipolar
             disorder, schizoaffective disorder and major depressive disorder

          -  Clinically significant neurological illness or significant head trauma that affects
             cognitive function, in the judgment of the principal investigator

          -  Full scale intelligence quotient </=65 on the Wechsler Abbreviated Scale of
             Intelligence at screening

          -  Positive result at screening for hepatitis B, hepatitis C, or human immunodeficiency
             virus-1 and 2

          -  Moderate to severe substance use disorder (other than nicotine or caffeine), as
             defined by the DSM-5, within the last 12 months

          -  Suicide attempt within 1 year or currently at risk of suicide in the opinion of the
             Investigator
Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Condition: Smoking
Intervention: Doxazosin 4mg/day; Placebo; Doxazosin 8mg/day
Intervention description: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.; Placebo; 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Intervention MeSH terms: Doxazosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking lapse behavior; smoking cessation; doxazosin; medication effect on smoking lapse behavior; medication effect on smoking cessation; stress

Summary:

      The purpose of this study is to examine whether doxazosin will attenuate the ability of
      stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants
      will participate in a smoking cessation attempt after the laboratory sessions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-60

          -  Able to read and write English

          -  Smoker

          -  Motivated to Quit Smoking

        Exclusion Criteria:

          -  Any significant current medical conditions that would contraindicate smoking

          -  Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or
             dependence of other substances, other than nicotine dependence or alcohol abuse

          -  Positive test results at intake appointment on urine drug screens for illicit drugs

          -  Past 30 day use of psychoactive drugs including anxiolytics and antidepressants

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal or evidence of current severe mental illness such as
             schizophrenia, bipolar disorder or major depression, or anxiety disorders

          -  Participants who have donated blood within the past 6 weeks

          -  Individuals who are currently taking other medications prescribed for smoking
             cessation

          -  Specific exclusions for administration of doxazosin or any alpha blocker