bioihbjkbjnl/mcl2 huggingface dataset:
Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.
Condition: Wet Macular Degeneration; Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Wet Macular Degeneration; Edema
Intervention: Dorzolamide-timolol
Intervention description: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
Intervention MeSH terms: Timolol; Dorzolamide
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: dorzolamide-timolol; topical aqueous suppression; neovascular age-related macular degeneration; macular edema; intravitreal injection; anti-vascular endothelial growth factor

Summary:

      This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and
      functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections
      in non-responders with wet age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina.

          2. Volunteer patients age 18 years and older.

          3. Healthy enough to participate in the study.

          4. Willing and able to consent to participation in the study.

          5. Diagnosis of wet age-related macular degeneration

          6. Prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months
             and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during
             this period

          7. Injection of the same anti-VEGF agent for at least two visits prior to study
             enrollment

          8. Fixed interval between at least two visits prior to study enrollment

        Exclusion Criteria:

          1. History of uveitis

          2. Any ophthalmic surgery within previous 6 months, including cataract extraction.

          3. Any history of vitrectomy

          4. History of any glaucoma drop usage or prior glaucoma surgery

          5. Systemic diuretic or corticosteroid usage

          6. Any contraindication (bradycardia, decompensated heart failure, or reactive

          7. airway disease) for topical use of a beta-blocker

          8. Any history of sulfonamide allergy

             -
Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: ZD6474 (vandetanib)
Intervention description: oral once daily tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Caprelsa (vandetanib); ZD6474

Summary:

      The purpose of this open label, two stage, phase II study is to evaluate the efficacy and
      tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary
      thyroid carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or hereditary medullary thyroid cancer

          -  Signed informed consent

          -  One or more measurable lesions

        Exclusion Criteria:

          -  Brain metastases or spinal cord compression

          -  Specific laboratory ranges

          -  Specific heart problems

          -  Prior chemotherapy and/or radiation therapy

          -  Participation in other trials within 30 days
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma (MCL)
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: ACP-196 (acalabrutinib)
Intervention MeSH terms: Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Bruton tyrosine kinase inhibitor; Btk; Mantle Cell Lymphoma; MCL; ACP-196; Acalabrutinib; ACE-LY-004; Calquence

Summary:

      The purpose of this study is to characterize the safety and efficacy profile of ACP-196
      (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
    

Eligibility criteria:

        Inclusion criteria:

          -  Men and women ≥ 18 years of age.

          -  Pathologically confirmed MCL, with documentation of monoclonal B cells that have a
             chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

          -  Agreement to use contraception during the study and for 30 days after the last dose of
             study drugs if sexually active and able to bear or beget children.

        Exclusion criteria:

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at
             undue risk

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening, or
             any Class 3 or 4 cardiac disease as defined by the New York Heart Association
             Functional Classification, or corrected QT interval (QTc) > 480 msec.

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel or ulcerative colitis, symptomatic
             inflammatory bowel disease, or partial or complete bowel obstruction.

          -  Breast feeding or pregnant
Safety Study of Zimura™in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Zimura; Avastin; Lucentis; Eylea
Intervention description: Zimura 2 mg, administered by intravitreal injection; Avastin 1.25 mg, administered by intravitreal injection; Lucentis 0.5 mg, administered by intravitreal injection; Eylea 2 mg, administered by intravitreal injection
Intervention MeSH terms: Bevacizumab; Ranibizumab; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Neovascular age-related macular degeneration (NVAMD)

Summary:

      The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in
      combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment
      experienced subjects with neovascular age-related macular degeneration (AMD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment experienced subjects defined as subjects with 1 prior dose of same
             intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular
             age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters
             of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start
             of anti-VEGF treatment.

          -  Presence of subfoveal active choroidal neovascularization (CNV)

        Exclusion Criteria:

          -  Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of
             indication, with the exception of the 1 prior anti-VEGF injections.

          -  Presence of other causes of choroidal neovascularization, including pathologic myopia,
             ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal
             choroiditis.

          -  Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months
             of trial entry.

          -  Prior thermal laser in the macular region, regardless of indication.

          -  Ocular or periocular infection in the past twelve weeks.

          -  History of any of the following conditions or procedures in the study eye:
             rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma
             drainage device, or corneal transplant.

          -  Previous therapeutic radiation in the region of the study eye.

          -  Evidence of diabetic retinopathy
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Condition: Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Hypersensitivity
Intervention: Oral rucaparib
Intervention description: 600 mg BID
Intervention MeSH terms: Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 491.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; fallopian tube cancer; primary peritoneal cancer; peritoneal cancer; platinum sensitive; relapsed disease; PARP Inhibitor; rucaparib; homologous recombination; homologous recombination deficiency; genomic scarring; loss of heterozygosity; CO-338; PF 01367338; AG 14699; platinum sensitive ovarian cancer; platinum sensitive fallopian tube cancer; platinum sensitive primary peritoneal cancer; platinum sensitive peritoneal cancer; gynecological cancer; Clovis; Clovis Oncology; ARIEL2; ARIEL 2; ARIEL3; ARIEL 3

Summary:

      The purpose of this study is to determine which patients with ovarian, fallopian tube, and
      primary peritoneal cancer will best respond to treatment with rucaparib.
    

Eligibility criteria:

        The following eligibility criteria pertain to patients enrolling into PART 2 of the study:

        Inclusion:

          -  Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3
             endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer

          -  Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and
             maintenance therapies administered as single agent treatment will not count as a
             chemotherapy regimen

          -  Relapsed/progressive disease as confirmed by CT scan

          -  Have biopsiable and measurable disease. Note: biopsy is optional for patients known to
             harbor a deleterious gBRCA mutation

          -  Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue
             available for planned analyses

        Exclusion:

          -  History of prior cancers except for those that have been curatively treated, with no
             evidence of cancer currently (provided all chemotherapy was completed >6 months prior
             and/or bone marrow transplant >2 years prior to first dose of rucaparib).

          -  Prior treatment with any PARP inhibitor

          -  Symptomatic and/or untreated central nervous system metastases

          -  Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that
             would, in the opinion of the Investigator, interfere with absorption of rucaparib

          -  Hospitalization for bowel obstruction within 3 months prior to enrollment
Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Atacicept 75 mg; Atacicept 150 mg; Atacicept 150 mg
Intervention description: Participants who received atacicept 75 milligram (mg) as once-weekly subcutaneous injection in the core study ADDRESS II continued to receive this dose during this LTE study. Participants in this reporting arm received the medication up to a maximum of 143.7 weeks.; Participants who received placebo in the core study ADDRESS II switched to receive atacicept 150 mg as once-weekly subcutaneous injection for up to a maximum of 97.7 weeks during this LTE study.; Participants who received atacicept 150 mg in core study ADDRESS II continued to receive atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus Erythematosus, Systemic; Atacicept 75 and 150 mg; LTE

Summary:

      This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II
      core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of
      atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed
      the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the
      discontinuation criteria were invited to enter this long-term extension (LTE) study
      NCT02070978.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who had completed the 24-week treatment period of study EMR-700461-023
             (ADDRESS II core trial)

          -  Women of childbearing potential who had a negative pregnancy test

          -  Other protocol defined inclusion criteria were applied

        Exclusion Criteria:

          -  Active neurological symptoms of SLE that were deemed severe or progressive

          -  Diagnosis of any demyelinating disease, such as, but not restricted to, multiple
             sclerosis (MS) or optic neuritis

          -  Pregnancy

          -  Active clinically significant viral, bacterial, or fungal infection, or any major
             episode of infection that in the investigator's opinion makes the participants
             unsuitable to continued participation in the study

          -  Other protocol defined exclusion criteria were applied
A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Dacomitinib; Dacomitinib
Intervention description: Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg.; Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small cell lung cancer; T790M mutation. dacomitinib

Summary:

      This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each
      two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of
      patients, those whose tumor has a documented T790M mutation, and those without this mutation.
      All patients will receive repeated cycles of dacomitinib until disease progression,
      occurrence of unacceptable toxicity, or other withdrawal criteria are met.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).

          -  Evidence of T790M mutation to enroll in Cohort A.

          -  Evidence of measurable disease by radiographic technique.

          -  Adequate organ function.

        Exclusion Criteria:

          -  Patients with T790M mutation who stopped any prior EGFR-directed therapy without
             evidence of disease progression.

          -  Symptomatic brain metastases.

          -  Uncontrolled or significant cardiovascular disease.

          -  Pregnant or breastfeeding.
Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury
Condition: Hemorrhage; Shock; Wounds and Injuries
MeSH terms: Hemorrhage; Wounds and Injuries
Intervention: Tranexamic Acid; Placebo
Intervention description: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.; Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of TXA on the immune system, its
      pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with traumatic injury that are ordered to receive at least 1 blood product
             and/or

          2. Patients admitted to the Emergency Department with a traumatic injury and require
             immediate transfer to the operating room to control the bleeding

          3. Able to receive the study drug within 2 hours from estimated time of injury **Please
             note that in circumstances where the patient initially met inclusion/exclusion
             criteria (i.e. received blood products in the ED before a full evaluation of their
             injuries is complete) but is later found to only have a soft tissue involved injury or
             does not have a traumatic bleeding source), the Investigator may determine that the
             patient should not be randomized into the trial and the patient should be considered a
             screen failure

        Exclusion Criteria:

          1. Patients known to be < 18 years of age

          2. Suspected Acute MI or stroke(thromboembolic and/or hemorrhagic) on admission

          3. Known inherited coagulation disorders

          4. Known history of thromboembolic events (DVT, PE, MI, Stroke)

             • Please note that past medical history of hemorrhagic stroke is permitted, but not
             current admission with hemorrhagic stroke

          5. Known history of seizures and/or seizure after injury/on admission related to this
             hospitalization

          6. Suspected or known pregnancy

          7. Known to be lactating

          8. Suspected or known prisoners

          9. Futile care

         10. Known current state of immunosuppression (i.e. on high dose steroids,
             chemotherapeutics, etc.)

         11. Unknown estimated time of injury 12). Patients wearing an "Opt Out" TAMPITI Study
             bracelet 13). Known presence of subarachnoid hemorrhage.

        14.) Isolated injuries to hands and/or feet (distal) 15.) Administration of
        antifibrinolytics pre-hospital and/or during this ED admission prior to enrollment
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
Condition: Richter Syndrome
MeSH terms: Syndrome
Intervention: Obinutuzumab; Ibrutinib; CHOP
Intervention description: 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6; 560mg po daily; cyclophosphamide, doxorubicin, vincristine, and prednisone
Intervention MeSH terms: Obinutuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment based on fitness of participants
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: leukemia; richter

Summary:

      This research study studies the combination of ibrutinib and obinutuzumab with or without the
      standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients
      with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine
      Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal
      needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by
      targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may
      be a better treatment for patients with Richter's Transformation. Depending on fitness, the
      patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP
      (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also
      called vincristine, and P= prednisolone or prednisone (corticosteroids).
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmed Richter's transformation in treatment naïve and previously treated chronic
             lymphocytic leukemia/small lymphocytic lymphoma patients

          -  may have had prior exposure to ibrutinib and other B-cell signaling receptor agents

          -  Adequate hematologic function

          -  Adequate liver and kidney function

          -  Willing and able to participate in all required evaluations and procedures in this
             study protocol

          -  Female subjects of childbearing potential must not be pregnant upon study entry

          -  Male and female subjects who agree to use highly effective methods of birth control

        Exclusion Criteria:

          -  known allergy to any of medications

          -  chemotherapy taken within 21 days of study treatment

          -  targeted therapy within 10 days of study treatment

          -  BCR inhibitors within 24 hours of study treatment

          -  major surgery within 4 weeks of first dose of study treatment

          -  women who are pregnant

          -  known infection with HIV or Hepatitis C

          -  Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug