bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease; Mild to Moderate Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: GRF6019
Intervention description: GRF6019 for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study is evaluating the safety, tolerability, and feasibility of GRF6019, a
      plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild
      to moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable AD based upon the National Institute on Aging-Alzheimer's
             Association (NIA-AA) Criteria

          -  MMSE Score 12-24 inclusive

          -  Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4

          -  Provided a signed and dated informed consent form (either the subject and/or subject's
             legal representative as well as the trial partner)

        Exclusion Criteria:

          -  Evidence of clinically relevant neurological disorder(s) other than probable AD

          -  History of blood coagulation disorders or hypercoagulability; any concurrent use of an
             anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa
             inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.

          -  Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine,
             Axona, vitamin E supplementation or selegiline within 3 months prior to screening.

          -  Heart disease (or history thereof), as evidenced by myocardial infarction, unstable,
             new onset or severe angina, or congestive heart failure (New York Association Class
             II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure
             (systolic blood pressure of 160 mmHg or higher and/or diastolic blood

          -  Prior hypersensitivity reaction to any human blood product or intravenous infusion;
             any known clinically significant drug allergy.

          -  Treatment with any human blood product, including transfusions and intravenous
             immunoglobulin, during the 6 months prior to screening.

          -  History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke,
             anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.

          -  Hemoglobin <10 g/dL in women; and <11 g/dL in men.
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Condition: Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone
Intervention: Zandelisib (ME-401)
Intervention description: Zandelisib (ME-401) 60 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule
Masking: None (Open Label)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with
      relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2
      prior lines of systemic therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis as defined in the World Health Organization (WHO)
             classification scheme

               1. Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or

               2. Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL

          -  Subjects that have had progression of disease or had no response to therapy after at
             least 2 prior systemic therapies for FL or MZL

          -  Age ≥ 18

          -  At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter
             by computed tomography (CT) scan as defined by the Lugano Classification

          -  Adequate hematologic, renal and hepatic parameters at screening unless abnormal values
             are due to FL per Investigator assessment

          -  QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds
             (msec);

          -  Left ventricular ejection fraction (LVEF) ≥ 45%

        Exclusion Criteria:

          -  Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma

          -  Known lymphomatous involvement of the central nervous system

          -  Uncontrolled clinically significant illness

          -  Ongoing or history of drug-induced pneumonitis

          -  History of clinically significant cardiovascular abnormalities

          -  History of clinically significant GI conditions

          -  Known history of, or active HIV infection
Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)
Condition: MPN (Myeloproliferative Neoplasms)
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Myeloproliferative Disorders; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: Ruxolitinib
Intervention description: Ruxolitinib (INCB018424), 5 mg bid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PMF; PPV-MF; PET-MF

Summary:

      To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms
      and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet
      counts of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose
      optimization from the starting ruxolitinib level of 5 mg bid will be associated with
      reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy

          -  Discontinuation of all drugs used to treat underlying MF disease at least 14 days
             prior to baseline visit

          -  INR <= 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry

          -  Hemoglobin level at least 6.5 g/dL at Screening visit

          -  Willingness to be transfused to treat low hemoglobin levels

        Exclusion Criteria:

          -  Females who are pregnant, unable to comply with birth control use to avoid becoming
             pregnant or breastfeeding

          -  Males who cannot comply with birth control use to avoid fathering a child

          -  Platelet count < 50 x10^9/L or absolute neutrophil count (ANC) < 1 x10^9/L at the
             Screening visit

          -  Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over
             the previous 2 years - international normalized ratio (INR) laboratory values cannot
             be > 1.5 x upper limit of normal at study entry.
Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
Condition: Pseudoachondroplasia
MeSH terms: Achondroplasia
Intervention: resveratrol; Placebo
Intervention description: 125 mg/day or 5 ml once per day for 90 days; 5 ml once per day for 90 days
Intervention MeSH terms: Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: resveratrol; joint pain

Summary:

      The purpose of this study is to determine if self-administered oral resveratrol can dampen
      joint pain for individuals with pseudoachondroplasia compared to placebo. Another goal of
      this study is to evaluate side effects in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The diagnosis of pseudoachondroplasia is based on clinical assessment either in person
             or by photographic review by skeletal dysplasia specialist (JTH),

          -  Healthy beyond pseudoachondroplasia associated complications,

        Exclusion Criteria:

          -  Current use of resveratrol

          -  Current use of blood thinners, lovastatin, ketoconazole, itraconazole, fexofenadine
             and triazolam.

          -  Other non-pseudoachondroplasia related health conditions, e.g. cancers.

          -  Pregnancy or breastfeeding. Women must use adequate contraception during the study.

          -  Participation in another clinical study and/or using investigational agents.

          -  Use of Non-steroid anti-inflammatory (NSAIDs) or aspirin.

          -  Current use of Alfentanil, Cyclosporine, Dihydroergotamine, Dofetilide, Ergotamine,
             Fentanyl, Flibanserin, Oxycodone, Pimavanserin, Pimozide, Quinidine, Saquinavir,
             Sirolimus, Tacrolimus, Temsirolimus, Theophylline, Tizanidine, Thioridazine,
             Fosphenytoin, Phenytoin or Warfarin.

          -  Baseline level of pain of 2 or higher on 10 point scale.

          -  Platelet count below 50,000 per ul on baseline complete blood count (CBC).
Pilot Study of Pyridostigmine Upon Immune Activation in HIV-1 Patients Who Have an Inadequate Immune Response
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Pyridostigmine tablets
Intervention description: Patients will take 30mg tid PO for 12 weeks
Intervention MeSH terms: Pyridostigmine Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIDS; Immunological non-responders; Neuroimmune modulation; Pyridostigmine; Treatment Experienced

Summary:

      The purpose of this study is to determine whether the addition of Pyridostigmine to Highly
      Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant
      patients in which viral load diminishes, but T-cell levels remain low after the initiation of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected subjects 18 years of age or older

          -  Receiving HAART for at least two years

          -  At least a viral load determination per year since HAART initiation, all undetectable

          -  Patient's status is Immunological Non Responder (InR), that is, his or her viral load
             is reduced, but CD4+ cell count has not raised accordingly

          -  Current viral load: undetectable

          -  Patient agrees and signs informed consent

        Exclusion Criteria:

          -  Concomitant active infectious or neoplastic disease

          -  History of new AIDS-defining events during HAART

          -  Pregnancy or breast-feeding

          -  Patients who have been subjects of an investigational agent, chemotherapy or
             radiotherapy within the previous 28 days

          -  Subjects requiring treatment for Tuberculosis

          -  Subjects unable to follow, or comply with the protocol interventions

          -  Subjects receiving immunosuppressive treatment, including corticosteroids
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
Condition: Tumor; Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: NKTR-102; NKTR-102
Intervention description: NKTR-102 given on a q14 day schedule; NKTR-102 given on a q21 day schedule
Intervention MeSH terms: Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients
      with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based
      treatment in the metastatic setting.

      Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered
      at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d
      schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may
      be evaluated in this study with approximately 35 patients enrolled in each treatment arm.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Inoperable metastatic or locally advanced breast cancer

          2. No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced
             setting and prior treatment in the metastatic setting must have included a taxane

        Exclusion Criteria:

          1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1

          2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or
             minor surgery within 2 weeks prior to Day 1 of Cycle 1
A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
Condition: ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: MEDI6012; Placebo
Intervention description: MEDI6012; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: In this study, the participant and sponsor staff will be blinded. Sites will be trained to keep the investigator blinded. However, due to the acute nature of the study, members of the research team and, possibly, the investigator may be unblinded.
Enrollment: 593.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy,
      safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult
      participants presenting with acute STEMI (ST segment elevation myocardial infarction).

      The study will enrol participants presenting with acute STEMI who are planned for primary
      percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be
      performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also
      undergo an index and an end of study CTA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation

          -  Planned for primary PCI (percutaneous coronary intervention)

          -  Men and women without child-bearing potential aged 30-80 years of age

          -  Capable and willing to provide informed consent.

          -  Capable of completing study visits

        Exclusion Criteria:

          -  Fibrinolytic administration for index event

          -  Known prior MI or prior coronary artery bypass graft (CABG) surgery

          -  Known pre-existing cardiomyopathy

          -  History of anaphylaxis

          -  Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo
             cardiomyopathy)
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)
Condition: Hypothalamic Injury-induced Obesity (HIO)
MeSH terms: Obesity; Wounds and Injuries
Intervention: Tesofensine/Metoprolol; Placebo
Intervention description: During Part 1 subjects will be randomized to treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol (active medication); During Part 1 subjects will be randomized to matching placebo tesofensine and placebo metoprolol
Intervention MeSH terms: Metoprolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Double-blind, randomized, placebo-controlled, single- center study followed by an open-label
      extension period.

      • The study will have two parts:

        -  Part 1: 24 weeks double-blind treatment (DB), followed by

        -  Part 2: 24 weeks open-label extension (OLE) - all subjects still participating at the
           end of Part 1 will be given an option to continue for additional 24 weeks on the active
           drug if evaluated eligible by the Investigator
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities

          -  Males and females, aged 18-75

          -  Confirmed diagnosis of HIO

          -  BMI ≥27 kg/m2 (where overweight is related to the HIO)

        Exclusion Criteria:

          -  Blood Pressure (BP) ≥160/90 mmHg

          -  Heart rate (HR) ≥ 90, <50 bpm

          -  Type 1 diabetes, Cushings disease, acromegaly, hypophysitis, infiltrative diseases or
             Prader-Willi syndrome

          -  Heart failure New York Heart Association (NYHA) level II or greater, decompensated
             heart failure

          -  Previous myocardial infarction or stroke within the last 5 years
Tofacitinib for Inflammatory Eye Disease
Condition: Uveitis; Scleritis
MeSH terms: Eye Diseases; Uveitis; Scleritis
Intervention: tofacitinib
Intervention description: tofacitinib extended release, 11mg, daily, oral
Intervention MeSH terms: Tofacitinib
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

Summary:

      Non-infectious inflammatory eye disease, such as uveitis and scleritis, is a chronic,
      auto-immune process that leads to vision loss. While steroids are effective in the short
      term, the side-effect profile of chronic steroid use necessitates the identification of
      effective steroid-sparing therapies. Tofacitinib is a small molecule that inhibits the
      signaling pathways of multiple inflammatory cytokines. The investigators plan to evaluate
      whether tofacitinib may have efficacy for patients with uveitis and / or scleritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of uveitis

          -  a clinical response to steroids

          -  active disease requiring at least 10mg of prednisone daily (or steroid equivalent)

        Exclusion Criteria:

          -  suspected or confirmed ocular infection

          -  chronic or recurring infections, such as HIV

          -  renal insufficiency that would preclude safe administration of tofacitinib
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Condition: Leukemia; T-cell Prolymphocytic Leukemia (T-PLL); Cancer
MeSH terms: Leukemia; Leukemia, Prolymphocytic; Leukemia, Prolymphocytic, T-Cell
Intervention: Venetoclax; Ibrutinib
Intervention description: Venetoclax tablets taken orally once a day (QD). Initially, venetoclax was administered utilizing a 5-step dose ramp-up over 5 days. Subjects were hospitalized and closely monitored for 7 days. The venetoclax ramp-up was administered in a daily manner: 20 mg on Week 1 Day 1, 50 mg on Week 1 Day 2, 100 mg on Week 1 Day 3, 200 mg on Week 1 Day 4, and 400 mg on Week 1 Day 5 and thereafter, once daily, until the end-of-treatment. The dose of venetoclax may have been increased to 600 mg QD at Week 8 or thereafter.; Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.
Intervention MeSH terms: Venetoclax
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T-cell Prolymphocytic Leukemia (T-PLL); Cancer; Venetoclax; Venclexta; Venclyxto; Ibrutinib; Imbruvica; Relapsed or Refractory T-lymphoid malignancy

Summary:

      The main objective of this study is to evaluate the efficacy of the combination of venetoclax
      plus ibrutinib for treating adults with T-cell prolymphocytic leukemia (T-PLL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adequate liver, kidney and hematology function per laboratory values as described in
             the protocol.

          -  Diagnosis of T-cell prolymphocytic leukemia (T-PLL) that requires treatment.

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

          -  Received prior alemtuzumab (unless unsuitable or unavailable).

          -  Has no malignancies other than T-PLL that:

               -  currently require systemic therapies;

               -  were not previously treated with curative intention (unless the malignant disease
                  is in a stable remission due to the discretion of the treating physician); or

               -  developed signs of progression after curative treatment.

        Exclusion Criteria:

          -  History of or current decompensated cirrhosis including Child-Pugh class B or C,
             ascites, hepatic encephalopathy, or variceal bleeding.

          -  Has human T-cell lymphotropic virus, type 1.

          -  Prior allogeneic stem cell transplant within 6 months of study drug administration and
             requirement for graft versus host therapy.

          -  Has an uncontrolled or active infection including severe acute respiratory syndrome-
             coronavirus-2 (SARS-COV-2).

          -  Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.

          -  Received a prohibited therapy within the specified time frame as described in the
             protocol.