bioihbjkbjnl/mcl2 huggingface dataset:
Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: Abatacept; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus disease 2019 (COVID-19); Coronavirus; Coronavirus infections; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Summary:

      The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept
      administered to hospitalized COVID-19 participants with respiratory compromise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2
             (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).

          -  Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)

          -  Respiratory compromise as defined by requirement of oxygen supplementation to maintain
             oxygen saturation ≥ 93% but not requiring mechanical ventilation

          -  Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical
             condition that would serve as an exclusionary criteria

          -  Women and men must agree to follow specific methods of contraception, if applicable

        Exclusion Criteria:

          -  Women who are breastfeeding

          -  Recent acute infection defined as:

             i) Any acute infection within 60 days prior to randomization that required
             hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii)
             Any acute infection within 30 days prior to randomization that required oral
             antimicrobial or antiviral therapy

          -  History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,
             osteomyelitis, bronchiectasis)

          -  Prior exposure to BMS-188667 (abatacept)

        Other protocol-defined inclusion/exclusion criteria apply
Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Fludarabine; Cyclophosphamide; Rituximab
Intervention description: 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.; 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.; 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 289.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Leukemia; FCR; Fludarabine; Cyclophosphamide; Rituximab

Summary:

      The goal of this clinical research study is to learn more about the characteristics of CLL,
      including genes and chromosome abnormalities and proteins expressed by the leukemia cells,
      which may help doctors predict if patients who receive standard treatment (fludarabine,
      cyclophosphamide, and rituximab) for the first time will experience a complete remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients will have a diagnosis of CLL, Small Lymphocytic Lymphoma (SLL), or CD20
             positive low-grade lymphoproliferative disorder.

          2. All patients with untreated Rai stage III-IV are eligible for this protocol. Prior
             treatment with single-agent rituximab permitted. OR Patients with untreated Rai stage
             0-II who meet one or more criteria for active disease as defined by the International
             Working Group for CLL (IWCLL). Prior treatment with single-agent rituximab permitted.

          3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0-3.

          4. Patients must have adequate renal and hepatic function (creatinine <2mg%, bilirubin
             <2mg%). Patients with renal or liver dysfunction due to organ infiltration by
             lymphocytes may be eligible after discussion with the study chairman.

          5. Patients may not receive other concurrent chemotherapy, radiotherapy, or
             immunotherapy. Localized radiotherapy to an area not compromising bone marrow function
             does not apply.

          6. Patients must be 16 years of age or older.

          7. Patients must sign informed consent indicating that they are aware of the
             investigational nature of this study according to the policies of the MD Anderson
             Cancer Center Institutional Review Board (MDACC IRB).

        Exclusion Criteria:

        N/A
Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis
Condition: Herpes Zoster Keratitis
MeSH terms: Herpes Simplex; Herpes Zoster; Herpes Zoster Ophthalmicus; Keratitis
Intervention: gancyclovir gel; Hypromellose gel
Intervention description: 0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.; 0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.
Intervention MeSH terms: Ganciclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the
      treatment of herpes zoster keratitis. Half the patients will receive the study drug while the
      other half of the patients will receive the placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 and above

          -  have not been on gancyclovir gel or any other form of topical antiviral therapy for
             the past month

          -  able and willing to attend subsequent follow-up visits

        Exclusion Criteria:

          -  Associated retinitis

          -  patients who are allergic to gancyclovir

          -  patients who will require systemic or intra-vitreal gancyclovir therapy

          -  patients who are pregnant or breastfeeding
Modulation of Lung Injury Complicating Lung Resection
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries
Intervention: N-acetylcysteine; 0.9% saline
Intervention description: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively; 0.9% saline 1 litre intravenous over 12 hours pre-operatively
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute lung injury; Lung resection

Summary:

      The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day
      pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on
      blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective lung resection for cancer

        Exclusion Criteria:

          -  Age less than 18 years

          -  Women of child-bearing age or potential

          -  Known allergy to N-acetylcysteine

          -  Oral steroid in the preceding 1 month

          -  N-acetylcysteine in the preceding 1 month

          -  Unable to receive standardised anaesthetic approach
Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)
Condition: Lymphoma. Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab is effective in the treatment of
      DLBCL in patients that have failed or are ineligible for ASCT
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1

          -  At least one lesion that measures >1.5 cm

          -  Prior therapy and screening lab criteria must be met

          -  Appropriate contraceptive measures must be taken

        Exclusion Criteria:

          -  Known central nervous system (CNS) lymphoma

          -  History of interstitial lung disease, prior malignancy, active autoimmune disease,
             positive test for hepatitis B or hepatitis C virus

          -  Prior allogeneic stem cell transplant (SCT), chest radiation ≤ 24 weeks from study
             drug, ≥1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of
             pre-transplant conditioning regimen, prior treatment with drug targeting T-cell
             costimulation or immune checkpoint pathways

          -  Women who are breastfeeding or pregnant
Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ofatumumab
Intervention description: Given IV
Intervention MeSH terms: Ofatumumab; Antibodies, Monoclonal
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: 66 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well ofatumumab works as front-line therapy in treating
      elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as
      ofatumumab, may interfere with the ability of cancer cells to grow and spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with chronic lymphocytic leukemia requiring treatment at the time of signing
             informed consent.

          -  Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
             status of 2-3 and a Cumulative Illness Rating Scale (CIRS) or Charlson co-morbidity
             score of 2 or higher.

          -  Creatinine < 2mg/dL.

          -  Estimated glomerular filtration rate (eGFR) more than 30cc/minute.

          -  Bilirubin < 2mg/dL.

          -  Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may
             be eligible after discussion with the study chairman.

          -  Patients with Gilbert's syndrome are eligible.

        Exclusion Criteria:

          -  Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the
             blood).

          -  Known positivity for human immunodeficiency virus (HIV).

          -  Hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg).
             In addition, if negative for HGsAg but hepatitis B core antibody (HBcAb) positive
             (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed
             and if positive the subject will be excluded.

          -  Prior treatment for chronic lymphocytic leukemia.

          -  Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal
             antibodies. Localized radiotherapy to an area not compromising bone marrow function
             does not apply. Patients with malignancies with indolent behavior such as prostate
             cancer treated with radiation or surgery can be enrolled in the study as long as they
             have a reasonable expectation to have been cured with the treatment modality received.

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             places the subject at unacceptable risk if he/she were to participate in the study.

          -  Any known hypersensitivity to ofatumumab or its components.
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GS-9876; Filgotinib; GS-9876 placebo; Filgotinib placebo; Methotrexate
Intervention description: One tablet administered orally once daily; Two tablets administered orally once daily; One tablet administered orally once daily; Two tablets administered orally once daily; Background therapy with methotrexate administered orally or parenterally once weekly
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for
      the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active
      RA as measured by change from baseline in Disease Activity Score for 28 joint count using
      C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a
             swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1

          -  Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25
             mg/week continuously for at least 12 weeks

          -  No evidence of active or latent tuberculosis

        Key Exclusion Criteria:

          -  Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6
             months prior to the first dose of study drug and documented return of CD19+ cells at
             screening

          -  Prior treatment with any commercially available or investigational spleen tyrosine
             kinase (SYK) inhibitor

          -  Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other than
             MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate
             wash out as defined in the protocol)

          -  Concurrent treatment with any biological disease modifying anti-rheumatic drug
             (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in the
             protocol). Prior failure to treatment with bDMARDs is not an exclusion criterion.

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Reduced Intensity Conditioning Using CD3+/CD19+ Depletion for Non Malignant Transplantable Diseases
Condition: Bone Marrow Failure Syndromes; Immunodeficiencies; Immune Dysregulation Syndromes
MeSH terms: Bone Marrow Failure Disorders; Pancytopenia; Syndrome
Intervention: CliniMACs device
Intervention description: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells.
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Maximum age: 22 Years
Healthy volunteers: No
Keywords: Transplant related mortality; Graft versus host disease; Bone marrow transplant

Summary:

      This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen
      to allow successful engraftment with CD3+ /CD19+ depleted peripheral stem cell grafts from
      mismatched donors. There are two conditioning regimens depending upon patient diagnosis and
      age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bone marrow failure syndromes for which SCT is indicated, including severe aplastic
             anemia refractory to non transplant therapies congenital neutropenia, congenital
             thrombocytopenia, congenital red cell aplasia

          -  Immunodeficiencies for which allogeneic hematopoietic stem cell transplant is
             indicated, including severe combined immunodeficiencies, Wiskott-Aldrich syndrome,
             IPEX syndrome, X-linked lymphoproliferative disease

          -  Immune dysregulation syndromes, including refractory or recurrent hemophagocytic
             lymphohistiocytosis, HLH with genetic mutations, refractory multisystemic Langerhans
             cell histiocytosis, other MAS refractory to standard therapy

          -  Organ function clearance

        Exclusion Criteria:

          -  Uncontrolled bacterial, viral or fungal infections

          -  HLA matched related or unrelated donor able to donate mobilized peripheral stem cells.

          -  Fanconi's syndrome, dyskeratosis congenita or other chromosomal fragility syndromes

          -  Pregnant Females
Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
Condition: Pulmonary Hypertension; Sickle Cell Disease; Thalassemia
MeSH terms: Hypertension, Pulmonary; Hypertension; Anemia, Sickle Cell; Thalassemia; Hemolysis
Intervention: L-Glutamine
Intervention description: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pulmonary Hypertension; Sickle Cell Disease; Thalassemia

Summary:

      The primary hypothesis of this study is that glutamine supplementation will improve the
      erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and
      pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with
      PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography >
      2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and
      subsequently alter sickle red cell endothelial interaction that can be identified using
      endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological
      markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will
      decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced
      arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine
      bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD
      and Thal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of SCD (Hb SS, SC or SBeta- thalassemia) or Thal

          -  PH documented by echocardiography, defined as at TRV greater than 2.5 m/s

          -  Age greater than or equal to 4 years

        Exclusion Criteria:

          -  Inability to take or tolerate oral medication

          -  Acute crisis or hospitalization within 1 month of enrollment

          -  Hepatic dysfunction (SGPT greater than 3X normal)

          -  Renal dysfunction (Creatinine greater than 2X normal)

          -  Allergy to glutamine

          -  Pregnancy or breastfeeding

          -  Patients on sildenafil (Viagra), calcium channel blockers, or amino acid/protein
             supplements (other therapies acceptable if stable more than 3 months)
Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy
Condition: Adrenoleukodystrophy
MeSH terms: Adrenoleukodystrophy
Intervention: glyceryl trierucate/glyceryl trioleate
Intervention description: Administration of glyceryl trierucate/glyceryl trioleate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: Male
Minimum age: 18 Months
Maximum age: 8 Years
Healthy volunteers: No
Keywords: adrenoleukodystrophy; inborn errors of metabolism; rare disease; sphingolipidoses

Summary:

      OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl
      trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.

      II. Compare the frequency and severity of neurological disability of study patients with
      untreated historical controls.
    

Eligibility criteria:

        Inclusion criteria.

          1. Boys between the age of 18 months and 8 years of age

          2. Biochemically proven asymptomatic X-linked adrenoleukodystrophy determined by
             elevation of very long chain fatty acids or DNA analysis.

          3. Platelet count in normal range

        Exclusion criteria.

          1. Abnormal MRI consistent with childhood cerebral disease

          2. Boys who have undergone bone marrow transplantation

          3. Other medical condition which in the opinion of the investigator prevents evaluation
             or treatment