bioihbjkbjnl/mcl2 huggingface dataset:
Bevacizumab Against Recurrent Retinal Detachment
Condition: Retinal Detachment; Proliferative Vitreoretinopathy
MeSH terms: Retinal Detachment; Vitreoretinopathy, Proliferative; Dissociative Disorders
Intervention: Bevacizumab
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Retinal detachment; Proliferative vitreoretinopathy

Summary:

      The investigators hypothesize that bevacizumab instilled into the vitreous after primary
      retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and
      subsequent retinal re-detachment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Eyes with rhegmatogenous retinal detachment

        Exclusion Criteria:

          -  Presence of PVR

          -  Need for a procedure other than primary PPV such as a scleral buckle with or without
             PPV, laser retinopexy, or pneumatic retinopexy.

          -  Recent intravitreal injection of an anti-VEGF agent less than 3 months prior

          -  Secondary retinal detachment repair

          -  Use of silicone oil as tamponade agent

          -  Patients less than 18 years of age

          -  Pregnancy

          -  Known allergy or contraindication to intravitreal bevacizumab
Combination Therapy With Carfilzomib for the Antibody-Mediated Rejection Diagnosis in Lung Transplantation
Condition: Lung Transplant Rejection
Intervention: Carfilzomib
Intervention description: Carfilzomib will be used in combination with the conventional therapy (plasma exchange and intravenous immunoglobulins)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: antibody-mediated rejection; lung transplant; Carfilzomib

Summary:

      The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safety
      and efficacy of combination therapy with carfilzomib, plasma exchange and intravenous
      immunoglobulins for AMR after lung transplantation and elucidate important clinical and
      immunologic phenotypes and mechanisms associated with these outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult lung transplant recipients ≥ 18 years of age who meet the diagnostic criteria
             for AMR and who have underwent PFT testing unless intubated and transbronchial biopsy
             prior to enrollment.

        Exclusion Criteria:

          -  Direct contraindications or previous intolerances to any component of the standard of
             care regimen including PLEX, 5% human albumin, 5% gammagard S/D or 10% gammagard
             liquid

          -  Leukopenia

          -  Neutropenia

          -  Thrombocytopenia

          -  Known Child-Pugh B/C cirrhosis

          -  Total bilirubin > 4

          -  ALT > 90

          -  Known systolic heart failure with LVEF < 40%

          -  Known pulmonary hypertension

          -  Any uncontrolled comorbid condition

          -  Pregnant women

          -  Breastfeeding women

          -  Ongoing bacterial or fungal or viral infection that is life-threatening

          -  Active cytomegalovirus disease

          -  Active varicella zoster infection

          -  Previous intolerance to carfilzomib

          -  Concurrent use of another proteasome inhibitor (e.g., bortezomib)
Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Tenalisib
Intervention description: Tenalisib 800 mg BID, Orally
Intervention MeSH terms: Tenalisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.
Masking: None (Open Label)
Masking description: None (open label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phosphoinositide 3-kinase; Pi3k Delta and gamma inhibitor; Tenalisib; Leukemia, Lymphocytic, Chronic, B-Cell

Summary:

      The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy
      and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at
      least one prior therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with diagnosis of B-cell CLL

          2. Disease status defined as refractory to or relapsed after at least one prior therapy.

          3. Presence of measurable lymphadenopathy presence of > 1 nodal lesion

          4. ECOG performance status ≤ 2.

          5. Adequate bone marrow, liver, and renal function

        Exclusion Criteria:

          1. Richter's (large cell) transformation, or PLL transformation.

          2. Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5
             half-lives (whichever is shorter).

          3. Prior exposure to drug that inhibits PI3K

          4. Patient with ASCT/Allo-SCT receiving treatment for active GVHD.

          5. Ongoing severe systemic bacterial, fungal or viral infection.

          6. Central nervous system (CNS) involvement of leukemia or lymphoma.

          7. Ongoing immunosuppressive therapy including systemic corticosteroids.

          8. Known history of severe liver injury as judge by investigator.

          9. Any severe and/or uncontrolled medical conditions or other conditions that could
             affect patient participation

         10. Women who are pregnant or lactating.

         11. Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus
             (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV)
             infection iv. active CMV infection

             -
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Aggression
Intervention: ELND005; Placebo
Intervention MeSH terms: Inositol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 50 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Agitation; Aggression; patients

Summary:

      The primary purpose of this study is to determine whether ELND005 is effective in treating
      symptoms of agitation and aggression in patients with Alzheimer's disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's
             Association (NIA-AA) guidelines (McKhann et al 2011).

          -  MMSE score of 5 to 24 (inclusive) at the Screening Visit.

          -  Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory
             (NPI)-agitation/aggression subscore of ≥4.

          -  No response or suboptimal response to standard nonpharmacological interventions.

        Exclusion Criteria:

          -  The agitation/aggression is attributable to concomitant medications, environmental
             conditions, or active medical or psychiatric condition.

          -  Current diagnosis of major depressive disorder according to the criteria of the
             Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision
             (DSM IV TR).

          -  Has persistent and distressing psychotic symptoms (delusion and/or hallucinations)
             that require psychiatric hospitalization.
Bortezomib to Treat Significant Complication of HSCT
Condition: Allogeneic Stem Cell Transplantation; Refractory Autoimmune Cytopenia(s)
MeSH terms: Anemia; Leukopenia; Thrombocytopenia
Intervention: Bortezomib
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 4 Months
Maximum age: 29 Years
Healthy volunteers: No
Keywords: HSCT; cytopenia; immune suppression; proteasome inhibitor

Summary:

      The purpose of this trial is to study the safety and effectiveness of a drug called
      Bortezomib for the treatment of low blood cell counts after bone marrow transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients, having undergone allogeneic stem cell transplantation at our center.

          -  Should have failed at least 2 standard treatments for autoimmune cytopenias. Standard
             treatments include corticosteroids, rituximab, IVIG, plasmapheresis, withdrawal of
             cyclosporine, cyclophosphamide and MMF. Definition of "failed" treatment will be no
             response of cytopenia after 2 weeks of continued treatment OR requirement of daily
             GCSF at 10 mcgs/kg/day for autoimmune neutropenia despite 2 weeks of treatment,
             transfusions of packed red blood cells or platelets 3 times weekly for 2weeks despite
             continued treatment OR 5days/week plasmapheresis for 2 weeks and inability to wean the
             duration.

          -  Definition of autoimmune hemolytic anemia- development of anemia, where there is a
             hemoglobin drop of >2 g/dL/48 hours or an absolute value of hemoglobin < 8 g/dL, and
             evidence of hemolysis by positive direct Coombs test with compatible peripheral blood
             cell morphology, reticulocyte count and bilirubin level.

          -  Definition of autoimmune neutropenia - absolute neutrophil counts < 500 for 2 weeks
             and presence of anti-neutrophil antibodies.

          -  Definition of autoimmune thrombocytopenia- Platelet counts < 20,000 cells/uL for 2
             weeks and presence of anti-platelet antibodies.

        Exclusion Criteria:

          -  Ongoing life threatening infections

          -  Documented anaphylaxis to bortezomib

          -  Failed engraftment

          -  Relapse of primary malignancy

          -  ≥6/8 matched or haploidentical transplants
Safety and Effect of Doxycycline in Patients With Amyloidosis
Condition: Amyloidosis
MeSH terms: Amyloidosis
Intervention: Doxycycline 100 mg po bid x 12 months
Intervention description: 100mg by mouth twice daily for 1 year.
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AL Amyloidosis; Primary Amyloidosis; Hereditary Amyloidosis; Familial Amyloidosis; SSA Amyloidosis; Senile Systemic Amyloidosis; AA Amyloidosis; Secondary Amyloidosis; Localized Amyloidosis; Systemic Amyloidosis

Summary:

      The tetracycline antibiotic doxycycline disrupts A beta amyloid fibrils (AB) in Alzheimer's
      disease, transthyretin (ATTR) amyloid fibrils in familial amyloidotic polyneuropathy, and
      immunoglobulin light chain (AL) amyloid fibrils in transgenic mouse models of disease. If
      untreated, amyloid deposits impair organ function, affecting the morbidity and mortality of
      patients.

      This single-center, twelve-month, open-label, prospective, pilot phase II study aims to
      determine whether doxycycline reduces amyloid deposits and improves organ function in
      patients with systemic or localized amyloidosis.

      The investigators plan to enroll patients with measurable amyloid disease according to
      internationally-accepted diagnostic criteria. Patients must have stable organ function at
      enrollment. Eligible subjects not receiving active treatments for amyloidosis affecting their
      kidneys, heart, aerodigestive tracts, peripheral or autonomic nervous system(s), lungs, eyes,
      skin, bladder, or breasts will undergo evaluations at baseline, 6 months, and 12 months - or
      more frequently as clinically indicated.

      Over 45 years experience indicates doxycycline is a safe, well tolerated antibiotic. The
      investigators will use standard grading systems to assess doxycycline response following
      twelve months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Biopsy-proven amyloidosis

          -  Biochemical or clinical evidence of amyloid induced end-organ dysfunction

        Exclusion Criteria:

          -  Concurrent use of other tetracyclines

          -  Ongoing active treatment for amyloidosis

          -  Pregnancy or unwillingness to use contraception by women of childbearing age

          -  Doxycycline drug allergy/hypersensitivity

          -  ECOG performance status > 3

          -  NYHA class > 3

          -  Renal insufficiency (estimated creatinine clearance < 25 ml/min)

          -  Transaminitis (AST or ALT > 5 times upper limit of normal)

          -  Diabetes mellitus or hemoglobin A1C > 6.2%
Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
Condition: Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
MeSH terms: Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine; Decitabine; Decitabine
Intervention description: 10 mg/m^2 by vein over 1 hour daily for 10 days; 20 mg/m2 by vein (IV) over 1 hour daily x 5 days; 20 mg/m2 subcutaneous (SQ) daily x 5 days
Intervention MeSH terms: Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; MDS; Decitabine; Dacogen; Methylation

Summary:

      The goal of this clinical research study is to learn if decitabine (given at 3 different
      doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments
      will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or
             chronic myelomonocytic leukemia

          2. Performance status 0-2 (Eastern Cooperative Oncology Group (ECOG) scale); adequate
             hepatic (bilirubin < 2 mg/dl) and renal functions (creatinine <2mg/dl); New York Heart
             Association (NYHA) cardiac status III-IV excluded.

          3. Signed informed consent

          4. No prior intensive combination chemotherapy or high-dose ara-C (>/= 1g/m2 per dose).
             Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.

          5. Patients must have been off chemotherapy for 2 weeks prior to entering this study and
             recovered from the toxic effects of that therapy, unless there is evidence of rapidly
             progressive disease. Use of Hydroxyurea for patients with rapidly proliferative
             disease is allowed for the first two weeks on therapy.

        Exclusion Criteria:

          1. Nursing and pregnant females are excluded. Patients of childbearing potential should
             practice effective methods of contraception. Should a woman become pregnant or suspect
             she is pregnant while participating in this study, she should inform her treating
             physician immediately.

          2. Patients with active and uncontrolled infections

          3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or
             psychiatric illness/social situations that would limit compliance with study
             requirements
A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Intervention: PF-04217329; latanoprost vehicle; PF-04217329; latanoprost
Intervention description: Topical ocular solution, once-daily for 14 days; Topical ocular solution, once-daily for 14 days; Topical ocular solution, once-daily for 14 days; Topical ocular solution, once-daily for 14 days
Intervention MeSH terms: Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This study will characterize the effect of PF-04217329, alone and in combination with
      latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood
      samples will be collected to measure the amount of active metabolite of PF-04217329 in the
      plasma following dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes

          -  Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye
             at 8 AM after discontinuing previous glaucoma treatment

          -  Visual acuity correctable to 20/100 or better in each eye.

        Exclusion Criteria:

          -  Closed/barely open anterior chamber angle or a history of acute angle closure in
             either eye.

          -  Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic
             retinopathy, macular degeneration) in either eye.

          -  Advanced glaucoma or a history of severe central visual field loss in either eye.

          -  History of ocular surgery or trauma in either eye within 6 months of the screening
             visit.

          -  History of ocular infection, ocular inflammation, or laser surgery in either eye
             within 3 months of the screening visit.
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab
Intervention description: Bimekizumab will be administered subcutaneously in 2 different doses.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis; Chronic Plaque Psoriasis; Bimekizumab

Summary:

      This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have completed all dosing requirements in PS0016 without meeting any
             withdrawal criteria

          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
             potential, must be willing to use a highly effective method of contraception up till
             20 weeks after last administration of study drug, and have a negative pregnancy test
             at Visit 1 (Screening) and immediately prior to first dose

          -  Male subjects with a partner of childbearing potential must be willing to use a condom
             when sexually active, up till 20 weeks after the last administration of study
             medication (anticipated 5 half-lives)

        Exclusion Criteria:

          -  Subjects previously participating in this study

          -  Subject has any medical or psychiatric condition that, in the opinion of the
             Investigator, could jeopardize or would compromise the subject's ability to
             participate in this study. Note: For any subject with an ongoing serious adverse event
             (SAE), or a history of serious infections (including herpes zoster or
             hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the
             subject's entry into PS0018

          -  Subject has any current sign or symptom that may indicate a medically significant
             infection

          -  Subject has current clinically active infection with Histoplasma, Coccidiodes,
             Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria
             (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with
             Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces,
             Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if
             treatment has been completed.

          -  Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded
             from participating in the open-label extension study (PS0018)
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: QBX258; Placebo
Intervention description: QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.; The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma; Interleukin; QBX258; QAX576; VAK694

Summary:

      This study is designed to investigate the efficacy and safety of QBX258 in subjects with
      moderate to severe asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with atopic asthma >1 year duration diagnosed according to the GINA
             guidelines.

          -  Subjects must weigh at least 50 kg to participate in the study, and must have a body
             mass index (BMI) within the range of 18 - 39 kg/m2.

          -  Asthma which is not adequately controlled on current treatment, as demonstrated by an
             Asthma Control Questionnaire (ACQ) score of > 1.5.

          -  FEV1 40 to 90% of predicted.

        Exclusion Criteria:

          -  Diagnosed with COPD as defined by the GOLD guidelines

          -  Subjects who have had a respiratory tract infection within 4 weeks prior to screening.

          -  Women of child-bearing potential must use highly effective methods of contraception
             during dosing and for at least 18 weeks after last study drug administration