bioihbjkbjnl/mcl2 huggingface dataset:
Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Brentuximab Vedotin; Adriamycin, vinblastine, and dacarbazine
Intervention description: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg; Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Brentuximab Vedotin; Dacarbazine; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-bulky; limited stage

Summary:

      Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a
      protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the
      antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy
      portion, which attempts to destroy the cell.

      The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you
      will receive in this research study are approved for use in people with Hodgkin Lymphoma. A
      drug called bleomycin is usually included with AVD, but since it appears to be a less
      effective drug with significant potential risks, it is being replaced in this study with the
      drug brentuximab.

      In this research study, the investigators are looking to see whether brentuximab in
      combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma

          -  Non-bulky disease defined as less than 10 cm in maximal diameter

          -  Measurable disease greater than or equal to 1.5 cm

          -  ECOG performance status of 0 or 2

          -  Willing to use 2 effective forms of birth control

        Exclusion Criteria:

          -  No prior chemotherapy or radiotherapy for Hodgkin lymphoma

          -  Not receiving any other investigational agents

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab

          -  No pre-existing grade 3 or greater neuropathy

          -  No uncontrolled intercurrent illness

          -  Not pregnant or breastfeeding

          -  No history of a different malignancy unless disease free for at least one year
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
Condition: Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: nilotinib
Intervention description: Nilotinib supplied in 50mg, 150mg, and 200mg capsules. It was administered orally at 230mg/m2, twice daily for up to 66 cycles (1 cycle = 28 days). Dose administration was rounded to the nearest 50mg dose (to a maximum dose of 400mg).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tasigna; nilotinib treatment; chronic phase; Ph+ CML; accelerated phase; newly diagnosed Ph+ CML; pediatric; leukemia; leukemia, pediatric; leukemia, myleiod; leukemia, mylegenous, chronic; leukemia, mylegenous, accelerated; BCR-ABL positive; myeloproliferative disorder; bone marrow disease; hematologic diseases; neoplastic processes; imatinib; dasatinib; enzyme inhibitor; protein kinase inhibitor

Summary:

      To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+
      chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant
             to either imatinib or dasatinib

          -  Karnofsky ≥ 50% for patients > 10 years of age and Lansky ≥ 50 for patients ≤ 10 years
             of age

          -  Adequate renal, hepatic and pancreatic function

          -  Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of
             normal)

          -  Written informed consent

        Key Exclusion Criteria:

          -  Treatment with strong CYP3A4 inhibitors or inducers

          -  Use or planned use of any medications that have a known risk or possible risk to
             prolong the QT interval

          -  Acute or chronic liver, pancreatic or severe renal disease

          -  History of pancreatitis or chronic pancreatitis.

          -  Impaired cardiac function

          -  No evidence of active graft vs host and <3mo since Stem Cell Transplant

          -  Total body irradiation (TBI) or craniospinal radiation therapy <6months

          -  Hypersensitivity to the active ingredient or any of the excipients including lactose.

          -  the criteria regarding pregnancy and contraception

          -  Active or systemic bacterial, fungal, or viral infection

          -  known Hepatitis B, Hepatitis C, or HIV infection
Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
Condition: Immune Mediated Necrotizing Myopathy
MeSH terms: Muscular Diseases
Intervention: zilucoplan; Placebo
Intervention description: Daily subcutaneous (SC) inection; Daily subcutaneous (SC) inection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients
      with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio
      to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of IMNM (Immune-Mediated Necrotizing Myopathy)

          -  Positive serology for anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMGCR) or
             anti-signal recognition particle (SRP) autoantibodies

          -  Clinical evidence of weakness (≤ grade 4 out of 5) on manual muscle testing in at
             least one proximal limb muscle group

          -  Creatine kinase (CK) of >1000 U/L at Screening

          -  No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated
             to occur during the first 8-weeks on study

          -  No changes in immunosuppressive therapy, including dose, for at least 30 days prior to
             Baseline or anticipated to occur during the first 8-weeks on study

        Exclusion Criteria:

          -  History of meningococcal disease

          -  Current or recent systemic infection within 2 weeks prior to Screening or infection
             requiring intravenous (IV) antibiotics within 4 weeks prior to Screening

          -  Recent initiation of intravenous immunoglobulin (IVIG) (i.e., first cycle administered
             less than 90 days prior to Baseline)

          -  Rituximab use within 90 days prior to Baseline or anticipated to occur during study

          -  Statin use within 30 days prior to Baseline or anticipated to occur during study

          -  Plasma exchange within 4 weeks prior to Baseline or expected to occur during the
             8-week Treatment Period
Lactoferrin Treatment in HIV Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Recombinant Lactoferrin; Placebo
Intervention MeSH terms: Lactoferrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin
      (1500mg bid) for reducing inflammation among HIV positive participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year

          2. HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values)

          3. Age >40 years

        Exclusion Criteria:

          1. Prior cardiovascular disease or stroke

          2. Diabetes

          3. Rheumatologic Diseases

          4. Pregnancy

          5. Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2)

          6. Cirrhosis or end-stage liver disease
Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia
Condition: Relapsed Pediatric ALL; Relapsed Pediatric AML; Refractory Acute Myeloid Leukemia; Refractory Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intervention: Daunorubicin
Intervention description: Eligible patients with relapsed and/or refractory acute leukemia will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.
Intervention MeSH terms: Daunorubicin
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: 1 Year
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      In this pilot study, eligible pediatric patients will be treated with 5 consecutive days of
      low dose daunorubicin. All patients who receive low dose daunorubicin will be evaluated daily
      for potential toxicity during those 5 days. Once the patient has received 5 doses of
      daunorubicin, subsequent therapy will be at the discretion of the primary oncology team.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pathologically confirmed ALL or AML, whose disease is refractory to two
             induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in
             1st relapse or refractory to a single therapeutic attempt but are unable to receive
             intensive therapy at the time of consent.

          -  All prior upfront therapies including bone marrow transplant are acceptable. Pulse
             steroids (of 5 days duration or less in the prior month) administered as part of a
             routine maintenance therapy are acceptable.

          -  Age 1 to 21 years of age, inclusive

          -  Established central catheter IV access

        Exclusion Criteria:

          -  Females who are known to be pregnant or lactating

          -  Any Grade 3 or higher Cardiac Disorder per CTCAE version 5

          -  Patients with echocardiographic evidence of cardiomyopathy (shortening fraction <27%
             or ejection fraction <50%)

          -  Uncontrolled sepsis

          -  Absolute Blast Count >50 x10(3)/mcL at enrollment or on day 1 of study

          -  Direct hyperbilirubinemia >5mg/dL

          -  Grade 3 or higher anaphylaxis to daunorubicin

          -  Non-English speaking

          -  Patients, who in the opinion of the PI, are unable to tolerate any study-specific
             procedures

          -  Patients who have received cyclosporine, tacrolimus or other agents to prevent or
             treat graft-vs-host disease post bone marrow transplant in the last 14 days

          -  Concurrent investigational drugs or other chemotherapeutic agents (excluding
             hydroxyurea), immunotherapies or biosimilars during the 5 days of daunorubicin.

          -  Prior cumulative doses of anthracyclines will not be an exclusion regardless of the
             total cumulative dose previously received.
Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: Macitentan; Placebo
Intervention description: oral tablet, 10 mg once daily; matching placebo
Intervention MeSH terms: Macitentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pre- and post-capillary pulmonary hypertension; CpcPH

Summary:

      Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of
      subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left
      ventricular dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and Females >=18 years of age

          2. Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to
             left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)

          3. Optimized diuretic therapy

        Exclusion Criteria:

          1. Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice
             classification)

          2. Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs),
             Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
Condition: Triple Negative Breast Cancer; TNBC - Triple-Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Paclitaxel; CB-839
Intervention description: standard weekly paclitaxel in 28-day cycles; CB-839 administered as oral tablets twice daily (BID)
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to one of 4 arms depending on the number of prior lines of therapy they have received and whether or not they have African ancestry
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: African ancestry; African American; CB-839; Glutaminase Inhibitor; Glutaminase; TNBC; Tumor Metabolism; Glutamine

Summary:

      CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in
      participants of African ancestry and non-African ancestry with advanced triple negative
      breast cancer. Multiple single-arm cohorts will be enrolled in which 800 mg twice daily (BID)
      CB-839 will be administered in combination with the full approved dose of paclitaxel.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Meets criteria for 1 of the 4 defined study cohorts

          -  TNBC, defined as estrogen receptor (ER) and progesterone receptor (PR) negative (< 1%
             by immunohistochemistry) and human epidermal growth factor receptor 2 (HER2)-negative
             (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization [FISH] negative)

          -  Metastatic disease or locally-advanced disease not amenable to curative intent
             treatment

          -  Adequate hepatic, renal, cardiac, and hematologic function

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Recovery to baseline or ≤ Grade 1 Common Terminology Criteria for Adverse Events
             (CTCAE) version.4.0

        Key Exclusion Criteria:

          -  Known brain metastases or central nervous system (CNS) cancer unless adequately
             treated with radiotherapy and/or surgery and stable for ≥ 2 mo

          -  Unable to receive oral medications

          -  Known hypersensitivity to Cremophor®-based agents

          -  Major surgery within 28 days of Cycle 1 Day 1
Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis
Condition: Hepatic Sarcoidosis, Elevated Alkaline Phosphatase
MeSH terms: Sarcoidosis
Intervention: Ursodeoxycholic Acid
Intervention description: weight-based dosing
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will act as their own controls by undergoing a six-month initial observational period prior to initiating the six-month UDCA intervention
Masking: None (Open Label)
Masking description: All subjects will receive appropriately dosed UDCA after six months of observation
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatic sarcoidosis; elevated alp

Summary:

      This study aims to (1) evaluate efficacy of UDCA in improving liver function and quality of
      life; (2) monitor safety, tolerability of UDCA, as well as progression of hepatic sarcoidosis
      and liver disease, in patients diagnosed with hepatic sarcoidosis. A minimum of 10 subjects
      will be followed for 12 months. For all subjects, initial 6 months will be observational; in
      subsequent 6 months, UDCA will be administered. Visits will occur every 3 months and involve
      routine blood collection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Systemic sarcoidosis with evidence of liver involvement as denoted by any of the
             following:

               -  Elevated liver-specific alkaline phosphatase

               -  Granulomas on liver biopsy

               -  Hepatomegaly on imaging

               -  Portal Hypertension (via imaging or endoscopy)

          2. Stable dose of immunosuppressant, if taking (no dose variation for 6 months)

          3. If cirrhotic, absence of hepatocellular carcinoma as indicated by imaging within 6
             months of screening

        Exclusion Criteria:

          1. Female who is pregnant, planning to become pregnant during the study, or breastfeeding

          2. Clinically significant abnormalities, co-morbidities, or recent alcohol/drug abuse
             that make the subject an unsuitable candidate

          3. Concurrent liver disease including hepatitis B, hepatitis C, alcohol-related liver
             disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing
             cholangitis

          4. Currently on UDCA

          5. Prior intolerance to UDCA

          6. Receipt of any investigational product within a time period equal to 10 half-lives of
             the product, or 6 weeks (whichever is longer), to study drug administration

          7. Current evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy,
             or ascites). In the event potential participant is post-transplant, no evidence of
             hepatic decompensation since transplantation
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
Condition: Staphylococcal Vaccine
Intervention: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine; Placebo
Intervention description: SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery; Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 3450.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Staphylococcal Vaccine; Post-operative Surgical Site Infection; Spinal Surgery; MRSA; Staphylococcus aureus

Summary:

      The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent
      postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal
      fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective
      spinal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be scheduled to undergo an elective open posterior spinal fusion
             procedures with multilevel instrumentation, 10 to 60 days after study vaccination.

          -  Subject must be available for the entire duration of the study, and able to comply
             with scheduled visits, treatment plan, laboratory tests, and other study procedures
             including completion of the electronic diary for 10 days after study vaccination.

          -  Aged 18 to <86 years old

        Exclusion Criteria:

          -  Planned spinal fusion procedure requiring separate operations performed on separate
             days (ie, staged procedure).

          -  Surgical indication of malignancy, infection or acute or emergency trauma.

          -  History of major surgery within 3 months prior to enrollment, or anticipated major
             surgery other than the Index Surgical Procedure between study enrollment and
             completion of study participation.

          -  History of any spinal surgery performed within 6 months prior to study enrollment.

          -  History of any previous spinal surgery resulting in postoperative BSI or SSI.

          -  Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other
             illness requiring chronic treatment with known immunosuppressant medications,
             including monoclonal antibodies within a year of enrollment or the use of systemic
             corticosteroids for > 14 days within 30 days prior to enrollment.

          -  History of leukemia, lymphoma, underlying bone marrow disorder or history of bone
             marrow transplant.