bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Condition: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, Non-Hodgkin
Intervention: asparaginase Erwinia chrysanthemi
Intervention MeSH terms: Asparaginase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Erwinaze; asparaginase; Eusa Pharma; Pharmacokinetic study; NSAA

Summary:

      This study will utilize Erwinaze via intravenous administration in patients between the ages
      of 1 and 30 who have experienced an allergy to their frontline therapy. The study will
      determine the proportion of patients with 2 day nadir serum asparaginase activity levels that
      are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,

          -  Ages >/= 1 and </= to 30 years at the time of initial diagnosis

          -  Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma

          -  Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli
             asparaginase or Calaspargase pegol

          -  Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining
             dose of either Pegaspargase or Calaspargase pegol

          -  Direct bilirubin less than or equal to Grade 2

          -  Amylase and lipase within normal limits (per institutional standards)

          -  Signed informed consent by the patient is greater than or equal to 18 years or by the
             parent if the patient is younger than 18 years old.

        Exclusion Criteria:

        -
An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: M281
Intervention description: M281 injection administered as intravenous infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: M281; Generalized Myasthenia Gravis

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of M281 in
      participants with generalized myasthenia gravis (gMG)
    

Eligibility criteria:

        Participants must be ≥18 years of age with a documented history of Generalized Myasthenia
        Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, previously
        participated in the MOM-281-004 study, had no major eligibility deviations or other major
        protocol deviations or not met any of the stopping criteria or discontinued study drug in
        the MOM-M281-004 study for any reason other than the need for rescue therapy as specified
        in the MOM-M281-004 study.

        Additional, more specific criteria are defined in the protocol.
Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial
Condition: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Intervention: No treatment given
Intervention description: For patient convenience, genetic material will be collected in the form of saliva samples.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study is conducted globally. This study describes pharmacogenetic testing of saliva
      samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The
      objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the
      FVII gene in patients previously exposed to rFVIIa analogue.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before collection of saliva samples

          -  Previous participation in adept™2 trial with 5 or more exposure days to rFVIIa
             analogue
A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tezacaftor/Ivacaftor; Ivacaftor; Placebo; Placebo
Intervention description: TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.; IVA 150 mg tablet.; Placebo matched to TEZ/IVA fixed-dose combination tablet.; Placebo matched to IVA tablet.
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination
      with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT)
      at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del CFTR mutation

          -  Confirmed diagnosis of CF

          -  Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age,
             sex, and height during screening.

          -  Stable CF disease as judged by the investigator

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             subject.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
             (first dose of study drug)

          -  Pregnant or nursing females.

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements.

          -  Any contraindication to undergoing chest imaging, as per the site's institutional
             guidelines
Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Tapinarof cream, 1%
Intervention description: Tapinarof cream, 1% applied topically once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single arm study
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an open-label, multicenter study to evaluate the systemic exposure and safety of
      topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque
             psoriasis and stable disease for at least 6 months prior to the study

          -  BSA involvement ≥ 20%

          -  PGA score of ≥ 3 at screening

          -  Females of child bearing potential and male subjects who are engaging in sexual
             activity that could lead to pregnancy agree to follow the specified contraceptive
             guidance throughout the study

          -  Capable of giving written informed consent

        Exclusion Criteria:

          -  Psoriasis other than plaque variant

          -  Any sign of infection of any of the psoriatic lesions

          -  Evidence of significant hepatic, renal, respiratory, endocrine, hematologic,
             neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory
             abnormality that will affect the health of the subject or interfere with the
             interpretation of the results

          -  Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources
             of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such
             exposures during the study which could potentially impact the subject's psoriasis

          -  Use of any prohibited medication within the indicated period before the first dose of
             study drug

          -  Pregnant females or lactating females

          -  The subject has received an investigational product within 30 days, 5 half-lives, or
             twice the duration of the biological effect of the study drug (whichever is longer)
             prior to first dose of study drug

          -  Current or a history of cancer within 5 years except for fully excised skin basal cell
             carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix

          -  Previous known participation in a clinical study with tapinarof
Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Antidepressants through Texas Medication Algorithm (TMA); Brief Interpersonal Psychotherapy (IPT-B)
Intervention description: Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.; IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
Intervention MeSH terms: Antidepressive Agents; Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Mood Disorders; Hispanic

Summary:

      This study will determine whether combination treatment driven by patient choice is better
      than standardized medication treatment at retaining and improving Hispanic patients with
      major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hispanic males and females

          -  DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate
             severity (HAM-D-17> 18)

          -  18- 79

          -  Patients with stable dosage of Benzodiazepines to treat anxiety disorders

        Exclusion Criteria:

          -  At risk of attempting suicide

          -  Unstable medical illness

          -  History of bipolar disorder, schizophrenia, or other psychotic disorder

          -  Pregnant or lactating

          -  Alcohol or substance use disorder that requires acute detoxification
Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome; Inflammation
Intervention: VIA-2291; Placebo
Intervention description: 100 mg, oral dosing, 1 time daily for 24 weeks; oral dosing, 1 time daily for 24 weeks
Intervention MeSH terms: Atreleuton
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Atherosclerosis

Summary:

      The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on
      vascular inflammation following 24 weeks of dosing.
    

Eligibility criteria:

        Inclusion Criteria

          -  Female patients must be of non-childbearing potential

          -  Recent acute coronary syndrome [(ACS) ST elevation myocardial infarction (STEMI),
             non-STEMI or unstable angina) event documented by ECG, cardiac enzymes or angiogram] 1
             - 3 months prior to randomization

          -  Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR)
             ≥ 1.6

          -  Receiving concomitant statin therapy following the qualifying ACS event for a minimum
             of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.

        Exclusion Criteria

          -  Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)

          -  Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) >1.5 x ULN (i.e., above
             the normal range) or positive screening test for hepatitis B (hepatitis B surface
             antigen) or hepatitis C (by ELISA)

          -  Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) >
             9%

          -  Heart failure defined by New York Heart Association Class III or IV

          -  Coronary Artery Bypass Surgery (CABG) within 4 months of randomization

          -  Use of zileuton, montelukast, coumadin or steroids

          -  Acetaminophen use in any form in the 7 days before enrollment at Visit 1

          -  Allergy to contrast agents

          -  Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months

          -  Current atrial fibrillation, atrial flutter or frequent premature ventricular
             contractions
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: AKST4290; Placebo
Intervention description: Oral AKST4290; Oral Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CCR3 inhibition; Diabetic Retinopathy; Oral Treatment

Summary:

      A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in
      Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years.

          2. Type 1 or type 2 DM.

          3. BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.

          4. Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).

        Exclusion Criteria:

          1. Evidence of neovascularization (NV) (including active iris or angle NV) requiring
             treatment, per investigator discretion.

          2. PRP or grid laser within 1000 microns of the foveal center.

          3. Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is
             defined as DME within 1,000 microns of the foveal center).

          4. Prior Intraocular of periocular steroid Injection

          5. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and
             assignment to a randomized treatment.

          6. History of vitreoretinal surgery.

          7. History of major ocular surgery (including cataract extraction, scleral buckle, any
             intraocular surgery, etc.) within prior 4 months or anticipated within the next 6
             months following randomization.

          8. History of DME or DR treatment with laser or intraocular injections of medication.

          9. Medical history or condition that, in the opinion of the investigator would preclude
             participation in the study.

         10. Clinically relevant abnormal laboratory value at Screening, including hematology,
             blood chemistry, or urinalysis (laboratory testing may be repeated once during the
             Screening phase).

         11. Malignancy for which the participant has undergone resection, radiation, or
             chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured
             squamous cell carcinoma are allowed).

         12. Concurrent participation in another interventional clinical trial; prior clinical
             trial participants must have been off study agents for at least 30 days for small
             molecules, 4 months for disease modifying therapies, and 1 year for vaccine or
             immunotherapy trials prior to Screening.
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Brinzolamide ophthalmic suspension, 1%; Brimonidine tartrate ophthalmic solution, 0.2%
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions; Brinzolamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-Angle Glaucoma; Ocular Hypertension; Intraocular Pressure; Brinzolamide; Brimonidine

Summary:

      The purpose of this study was to describe the ocular discomfort immediately upon instillation
      of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1%
      Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with
      open-angle glaucoma and/or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign Informed Consent document.

          -  Diagnosis of open-angle glaucoma or ocular hypertension

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Females of childbearing potential if pregnant, lactating, or not using highly
             effective birth control measures.

          -  Severe central vision loss in either eye.

          -  Any chronic or recurrent inflammatory eye disease.

          -  Ocular trauma within the preceding 6 months.

          -  Ocular infection or ocular inflammation within the preceding 3 months.

          -  Best-corrected visual acuity score worse than 55 letters using the Early Treatment
             Diabetic Retinopathy Study chart.

          -  Any intraocular surgery within the preceding 6 months.

          -  Any ocular laser surgery within the preceding 3 months.

          -  History or current evidence of severe illness or any other conditions which would make
             the subject, in the opinion of the Investigator, unsuitable for the study.

          -  Other protocol-defined exclusion criteria may apply.
PD-1 Alone or With Dendritic Cell/Renal Cell Carcinoma Fusion Cell Vaccine
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: CT-011; DC/RCC fusion vaccine
Intervention description: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks; Vaccination once per cycle on Day 8 of treatment cycles 2-4
Intervention MeSH terms: Pidilizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney; Metastatic; Stage IV

Summary:

      CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug
      that are known to target specific cells (in this case, cells in the immune system) The DC RCC
      Vaccine is agent that tries to help the immune system to recognize and fight against cancer
      cells.

      The purpose of this research study is to determine the safety of CT-011 alone, and in
      combination with the Dendritic Cell Renal Cell Carcinoma (DC RCC) vaccine. The investigators
      are also trying to find out what effect the combination has on the disease, and on your
      immune system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IV renal cancer

          -  Measurable disease

          -  Life expectancy > 3 months

          -  Adequate organ and marrow function

        Exclusion Criteria:

          -  Clinical evidence of central nervous system (CNS) disease. Subjects with a history of
             treated brain metastasis must be stable with no evidence of disease for 3 months

          -  Clinically significant autoimmune disease

          -  HIV+

          -  Serious intercurrent illness such as infection requiring intravenous (IV) antibiotics,
             or significant cardiac disease characterized by significant arrhythmia, uncontrolled
             hypertension, unstable ischemic coronary disease or congestive heart failure

          -  Pregnant or lactating

          -  History of clinically significant venous thromboembolism (For Cohort 2)
An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product
Condition: Primary Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost
Intervention description: Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.
Intervention MeSH terms: Bimatoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in
      participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All
      participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then
      had the Insert removed and a new insert placed for another 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed FSV5-002 study.

          2. Written informed consent prior to any study procedure.

          3. Willingness to comply with the visit schedule.

        Exclusion Criteria:

          1. Participation in an investigational drug or device study other than FSV5-002 within
             the past 6 months or anticipated participation during the study period.

          2. Subjects who will require contact lens use during the study period.

          3. Any condition or situation (such as uncontrolled systemic disease) that, in the
             Investigator's opinion, might confound the results of the study, may put the subject
             at significant risk or might interfere with the subject's ability to participate in
             the study.