bioihbjkbjnl/mcl2 huggingface dataset:
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
Condition: Relapsed/Refractory Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: brexucabtagene autoleucel; Cyclophosphamide; Fludarabine; Axicabtagene Ciloleucel
Intervention description: A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells; Administered intravenously; Administered intravenously; A single infusion of axicabtagene ciloleucel anti-CD 19 CAR T cells
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Axicabtagene ciloleucel; Brexucabtagene autoleucel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel
      (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
    

Eligibility criteria:

        Key Inclusion Criteria:

        Up to 5 prior regimens for MCL. Prior therapy must have included:

          -  Anthracycline or bendamustine-containing chemotherapy and

          -  Anti-CD20 monoclonal antibody therapy and

          -  Ibrutinib or acalabrutinib

        At least 1 measurable lesion

        Platelet count ≥ 75,000/uL

        Creatinine clearance (as estimated by Cockcroft Gault) > or = to 60 mL/min

        Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an
        echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings

        Baseline oxygen saturation >92% on room air.

        Key Exclusion Criteria:

          -  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B
             (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or
             hepatitis C is permitted if the viral load is undetectable per standard serological
             and genetic testing

          -  History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,
             cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or
             any autoimmune disease with central nervous system (CNS) involvement

          -  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
             requiring IV antimicrobials for management.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Colesevelam Hcl
Intervention description: 3.75 gm/day (six 675 mg tablets)
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NASH; NAFLD; Steatohepatitis; Nonalcoholic; Fatty Liver Disease

Summary:

      The purpose of the study is to see if the drug colesevelam is a potential treatment for
      Nonalcoholic Steatohepatitis(NASH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age at entry at least 18 years.

          2. Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the
             upper limits of normal. 19 or more in women and 30 or more in men.

          3. Evidence of hepatic steatosis or liver fat (>5%) by MRI.

          4. Evidence of definite or suspected NASH

          5. Written informed consent.

        Exclusion criteria:

          1. Evidence of another form of liver disease.

          2. History of excess alcohol ingestion.

          3. Contraindications to liver biopsy.

          4. Decompensated liver disease.

          5. History of gastrointestinal bypass surgery or ingestion of drugs known to produce
             hepatic steatosis.

          6. Recent initiation or change of anti-diabetic drugs.

          7. Use of colesevelam or other agents in the same class.

          8. Significant systemic or major illnesses other than liver disease that, in the opinion
             of the investigator would preclude treatment with colesevelam and adequate follow up.

          9. Positive test for anti-HIV.

         10. Active substance abuse, such as alcohol, inhaled or injection drugs within the
             previous one year.

         11. Pregnancy or inability to practice adequate contraception in women of childbearing
             potential.

         12. Evidence of hepatocellular carcinoma
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
Condition: Macular Edema; Diabetes Mellitus
MeSH terms: Macular Edema; Diabetes Mellitus
Intervention: Dexamethasone intravitreal implant; Steroid plus NSAID eye drop combination therapy
Intervention MeSH terms: Dexamethasone; Prednisolone acetate; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      There is a need to find an effective therapy for diabetic patients who develop macular edema
      after cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has diagnosis of Diabetes Mellitus, Type I or II.

          -  Patient has experienced the development of macular edema following cataract surgery in
             at least one eye.

          -  Patient has had cataract surgery within 90 days prior to the screening visit.

        Exclusion Criteria:

          -  Patient has other significant ocular disease in study eye, including glaucoma.

          -  Patient has any active infection in the study eye.

          -  Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure,
             uncontrolled diabetes mellitus).

          -  Patient has experienced a significant increase in intraocular pressure following a
             prior treatment with topical or intravitreal steroidal medication.

          -  Patient has received the OZURDEX® implant before in the study eye.
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Condition: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolus
MeSH terms: Pulmonary Embolism; Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Enoxaparin
Intervention description: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment of Enoxaparin using a clinical protocol developed with our inpatient pharmacists.
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60%
      without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an
      anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's
      inactivation of coagulation factor Xa (FXa), thus decreasing the likelihood of clot
      formation. Despite standard dosing enoxaparin prophylaxis, VTE rates in post-operative
      orthopedic trauma patients remain as high as 12.2%.The investigators will examine enoxaparin
      pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose
      adjustment can favorably alter the proportion of patients with in-range anti-Factor Xa (aFXa)
      levels. Outcomes will include peak and trough steady-state aFXa levels in response to
      standard and escalated doses of enoxaparin and the incidence of venous thromboembolism and
      bleeding events post-surgery. In the trauma and orthopaedic populations, patients with low
      initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus,
      this study has important implications for appropriate enoxaparin dose magnitude and
      frequency, and may ultimately help to decrease the substantial morbidity and mortality
      associated with post-operative VTE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving orthopedic trauma surgery

          -  Able to have enoxaparin initiated within 36 hours after procedure

        Exclusion Criteria:

          -  Intracranial bleeding/stroke

          -  bleeding disorder

          -  heparin-induced thrombocytopenia

          -  creatinine clearance < 30 mL/minute

          -  epidural catheter

          -  serum creatinine > 1.6 mg/dL
Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: Axitinib; Radiation Therapy
Intervention description: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity; 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: GBM; brain tumor

Summary:

      The purpose of this study is to determine whether the addition of an investigational
      medication, axitinib, to radiation therapy will improve the outcome of treatment in patients,
      above the age of 70.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed patients with histologically proven glioblastoma multiforme

          -  Age above 70 years

          -  Karnofsky score of 50-80

          -  Adequate organ function as defined by laboratory values

          -  Life expectancy of >12 weeks

          -  No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood
             pressure readings taken at least 1 hour apart. The baseline systolic blood pressure
             readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be
             90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are
             eligible.

        Exclusion Criteria:

          -  Prior treatment with chemotherapy or radiation for glioblastoma multiforme

          -  Patients with extensive tumor hemorrhage

          -  Any of the following within the 12 months prior to study drug administration:
             myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft,
             symptomatic congestive heart failure, cerebrovascular accident or transient ischemic
             attack and 6 months for deep vein thrombosis or pulmonary embolism
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: BIBF 1120; sunitinib
Intervention description: VEGF inhibitor; VEGF inhibitor
Intervention MeSH terms: Sunitinib; Nintedanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and
      to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no
             previous systemic anti-cancer treatment.

          2. Histological-confirmed diagnosis of renal cell cancer with clear cell component.

          3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow
             sunitinib/BIBF 1120 treatment.

        Exclusion criteria:

          1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment

          2. Treatment with other investigational drugs or participation in another clinical study
             within the past 4 weeks before start of therapy or concomitantly with this study.

          3. Patients unable to comply with the 1199.26 protocol.

          4. Pregnancy or breast feeding.

          5. Active alcohol or drug abuse.

          6. Women of child bearing potential, or men who are able to father a child, unwilling to
             use a medically acceptable form of contraception during the study period.
A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
Condition: BRAF or NRAS Mutant Metastatic Melanoma
MeSH terms: Melanoma
Intervention: MEK162
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic melanoma,; BRAF-mutant,; NRAS-mutant

Summary:

      The study will assess the safety and efficacy of single-agent MEK162 in adult patients with
      locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring
      BRAFV600E or NRAS mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not
             potentially curable with surgery

          -  BRAF or NRAS mutation in tumor tissue

          -  All patients enrolled should provide sufficient fresh or archival tumor sample at
             baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses
             described in the protocol

          -  Evidence of measurable tumor disease as per RECIST

          -  WHO performance status of 0-2

          -  Adequate organ function and laboratory parameters

        Exclusion Criteria:

          -  History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO)
             or any eye condition that would be considered a risk factor for CSR or RVO

          -  Patients with unstable CNS metastasis

          -  Prior treatment with a MEK- inhibitor

          -  Impaired cardiovascular function

          -  HIV, active Hepatitis B, and/or active Hepatitis C infection

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential UNLESS they comply with protocol contraceptive
             requirements

        Other protocol-defined inclusion/exclusion criteria may apply.
An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Opdivo; Yervoy
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate safety and efficacy of different administration
      regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Advanced Renal Cell Carcinoma

          -  Must have full activity or, if limited, must be able to walk and carry out light
             activities such as light house work or office work

          -  Must have at least 1 lesion with measurable disease

        Exclusion Criteria:

          -  Subjects with active central nervous system metastases

          -  Subjects who received prior therapy with checkpoint inhibitor

          -  Subjects with active, known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive; Diabetes Mellitus
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Continuous positive airway pressure; Sham continuous positive airway pressure
Intervention description: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).; CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators will examine the possible synergistic effects of obstructive sleep apnea
      (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part
      investigation:

        -  A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy
           controls.

        -  A three-month randomized placebo-controlled trial of continuous positive airway pressure
           (CPAP) in subjects with OSA+DM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  OSA subjects: apnea-hypopnea index >=10 and <100

          -  DM subjects: clinical diagnosis of DM and glycated hemoglobin < 8.0%

        Exclusion Criteria:

          -  Hematocrit < 32

          -  Pregnancy

          -  Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Condition: Dry Eye Syndromes; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Intervention: KPI-121; Placebo
Intervention description: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.; Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Corticosteroid; Dry Eye; Hyperemia; Ocular Discomfort

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%
      ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented
      clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2
      drops instilled in each eye four times daily (QID).
    

Eligibility criteria:

        Inclusion Criteria:

        • Have a documented clinical diagnosis of dry eye disease in both eyes

        Exclusion Criteria:

          -  Known hypersensitivity/contraindication to study product(s) or components.

          -  History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being
             treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of
             Investigator could confound study assessments or limit compliance; or have been
             exposed to an investigational drug within the 30 days prior to screening.

          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply
             with study protocol or unable to successfully instill eye drops.
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Intervention: Active comparator: Modafinil + placebo; THN102 300/3; THN102 300/27
Intervention MeSH terms: Flecainide; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way
      cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102
      (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).
    

Eligibility criteria:

        Main inclusion Criteria:

          -  Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2
             (without cataplexy) according to the International Classification of Sleep Disorders
             (ICSD-3) criteria.

          -  Body mass index >18 kg/m2 and <35 kg/m2.

          -  Patients treated with modafinil at stable dosage for at least 2 months and still
             complaining of excessive daily somnolence (EDS) despite the treatment

          -  Epworth Sleepiness Scale (ESS) score should be ≥ 14/24 during the baseline period.

        Main exclusion Criteria:

          -  Patients with an untreated sleep apnea syndrome (respiratory disorder index > 30/h) or
             who have any other cause of daytime sleepiness as assessed on patient history.

          -  Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as
             Parkinson's disease, Alzheimer's disease, Huntington's Chorea, multiple sclerosis,
             moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical
             anxiety or depression, Beck Depression Inventory ≥ 21 or with suicidal risk (if item >
             0), or other problem that in the investigator's opinion would preclude the patient's
             participation and completion of this trial or comprise reliable representation of
             subjective symptoms.

          -  Contraindication to flecainide