bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies
Condition: Indolent or Intermediate Grade B-cell Malignancy
MeSH terms: Neoplasms
Intervention: Rituximab
Intervention description: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Hypersensitivity Reactions; B-cell malignancies

Summary:

      The purpose of this study is to assess the feasibility of a 60 minute rapid infusion
      rituximab protocol in the institution's outpatient infusion center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-89

          -  Diagnosis of indolent or intermediate grade B-cell malignancy

          -  Patients receiving rituximab-based therapy at a dose of 375mg/m2, regardless of weight

          -  First dose given within 3 months of the second dose

          -  Infusion scheduled for outpatient administration at The Arthur G. James Cancer
             Hospital and Richard J. Solove Research Institute

        Exclusion Criteria:

          -  Diagnosis of aggressive lymphoma

          -  Absolute lymphocyte count > 10 x 103 cells/µL

          -  New York Heart Association (NYHA) classification Grade II or greater congestive heart
             failure

          -  Enrolled on another clinical trial

          -  Allergy to murine-containing medications

          -  Grade III or IV hypersensitivity reaction during the initial infusion of rituximab

          -  Prisoners

          -  Pregnant women

          -  Mentally or physically unable to give consent
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: 400 µg Brimonidine Tartrate Implant; 200 µg Brimonidine Tartrate Implant; Sham (no implant)
Intervention description: 400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.; 200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.; Sham in one or both eyes on Day 1 and Month 6.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal
      implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment)
      in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1.
      Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the
      safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy
      from age-related macular degeneration. Patients will be followed for up to 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Geographic atrophy in both eyes due to age-related macular degeneration

          -  Visual acuity between 20/40 to 20/320

        Exclusion Criteria:

          -  Known allergy to brimonidine

          -  Uncontrolled systemic disease or infection of the eye

          -  Recent eye surgery or injections in the eye

          -  Female patients who are pregnant, nursing or planning a pregnancy
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Pertuzumab; Trastuzumab; FEC; Docetaxel; TCH
Intervention description: 840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly.; 8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks.; 5-fluorouracil 500 mg/m^2, epirubicin 100 mg/m^2 and cyclophosphamide 600 mg/m^2.; 75 mg/m^2 for the first dose; 100 mg/m^2 if no dose limiting toxicity occurs.; Trastuzumab followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m^2. All treatments were given every three weeks by the IV route.
Intervention MeSH terms: Docetaxel; Trastuzumab; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment
      regimens in participants with locally advanced, inflammatory or early stage human epidermal
      growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be
      randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with
      5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6,
      or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles
      4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab
      will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly,
      trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m^2
      iv, increased to 100 mg/m^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard
      doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a
      total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on
      study treatment is 4-12 months, and target sample size is 200-300.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female participants, age >/=18 years

          -  advanced, inflammatory or early stage unilateral invasive breast cancer

          -  HER2-positive breast cancer

          -  baseline left ventricular ejection fraction (LVEF) >/=55%

        Exclusion Criteria:

          -  metastatic disease (Stage IV) or bilateral breast cancer

          -  previous anticancer therapy or radiotherapy for any malignancy

          -  other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma

          -  clinically relevant cardiovascular disease

          -  current chronic treatment with corticosteroids of >10mg methylprednisolone or
             equivalent
Imaging of Peri-operative (periOP) Lung Injury
Condition: Acute Lung Injury; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Injury; Acute Lung Injury
Intervention: SPECT-CT imaging; AxV-128/Tc; Whipple procedure; Major surgery
Intervention description: Injection of AxV-128 labeled with 99mTc followed by SPECT CT; Injection of AxV-128 labeled with 99mTc; A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.; Additional surgical procedure(s) that is clinically indicated. Standard of care.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute lung injury; Chronic obstructive pulmonary disease (COPD); Whipple procedures; pancreatico-duodenectomies

Summary:

      The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission
      computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury.
      The investigators will study patients undergoing major surgery, specifically Whipple
      procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and
      after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate COPD (Global Initiative for Chronic Obstructive Lung Disease
             (GOLD) stage II: forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) <0.70
             and FEV1 50-79% normal) undergoing Whipple procedures or other major surgeries

          -  Patients with normal lung function undergoing Whipple procedures or other major
             abdominal surgeries

        Exclusion Criteria:

          -  Age < 18 years
High Resolution PET-MRI Before Prostate Cancer HIFU
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 18F-Fluciclovine
Intervention description: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diagnostic imaging; High-Intensity Focused Ultrasound; HIFU; 18F-Fluciclovine; high resolution diffusion-weighted imaging

Summary:

      This prospective trial aims to determine if enhanced prostate imaging using two novel imaging
      technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers
      not seen on standard multiparametric prostate MRI in patients considered candidates for focal
      HIFU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prostate biopsy consisting of ≥ 10 tissue cores sampled

          -  PSA </=20 ng/mL

          -  cT1-cT2c

          -  Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to
             one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic
             biopsy cores positive and >/= 50% of core involvement in at least one core

          -  Patient considering focal HIFU therapy

        Exclusion Criteria:

          -  Previous local therapy for prostate cancer

          -  Inability to receive PET tracer

          -  Inability to receive MRI

          -  Suggestion of extracapsular extension or seminal vesicle invasion on imaging

          -  Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)

          -  Any other condition which, in the investigator's option, may make the patient a poor
             candidate for participation in a clinical trial.
Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: ubenimex
Intervention MeSH terms: Ubenimex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World
      Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening.

      This study is a Phase 2, open-label, extension study to evaluate long-term safety and
      efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have completed Study EIG-UBX-001 through Week 24.

          -  In the opinion of the Principal Investigator, has been generally compliant with study
             requirements during Study EIG-UBX-001.

          -  Agrees to use a medically acceptable method of contraception throughout the entire
             study period.

          -  Willing and able to comply with scheduled visits, treatment plans, and laboratory
             tests and other study procedures.

        Exclusion Criteria:

          -  Is pregnant or lactating.

          -  Concurrent regular use of another leukotriene pathway inhibitor.

          -  Any reason that, in the opinion of the investigator, precludes the patient from
             participating in the study.

               1. Any condition that is unstable or that could jeopardize the safety of the patient
                  and his/her compliance in the study

               2. A serious uncontrolled medical disorder/condition that in the opinion of the
                  investigator would impair the ability of the patient to receive protocol therapy

          -  An ongoing, drug-related, serious adverse event (SAE).

          -  Significant/chronic renal insufficiency.

          -  Transaminases (alanine transaminase, aspartate transaminase) levels >3 × upper limit
             of normal (ULN) and/or bilirubin level >2 × ULN.

          -  Absolute neutrophil count <1500 mm3.

          -  Hemoglobin concentration <9 g/dL at Screening.
Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: emixustat hydrochloride; Placebo
Intervention description: Tablet for oral administration; Placebo tablets for oral administration contain only inactive ingredients
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor
      biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to provide written informed consent

          -  Documented diagnosis of type 1 or type 2 diabetes mellitus

          -  Meets specific ocular criteria for the study eye including but not limited to, the
             presence of PDR with or without diabetic macular edema in study eye for which
             treatment can be deferred for at least 4 weeks after Day 1 visit

          -  Media clarity, pupillary dilation, and subject cooperation sufficient to obtain
             adequate assessments

        Exclusion Criteria:

          -  Any condition that would preclude participation in the study (e.g., unstable medical
             status including blood pressure, cardiovascular disease or glycemic control)

          -  History of myocardial infarction or other acute cardiac event

          -  History of chronic renal failure requiring dialysis or kidney transplant

          -  Prior participation in any clinical study of emixustat

          -  Treatment with any investigational study drug within 30 days of screening

          -  Known allergy to fluorescein sodium for injection in angiography

          -  Treatment with specific prohibited medications or therapy beginning 4 weeks prior to
             screening and throughout the duration of the study

          -  History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to
             randomization

          -  Pre-specified laboratory abnormalities at screening

          -  Specific ocular characteristics in the study eye

          -  Male subjects who are not surgically sterile and are not willing to practice a
             medically accepted method of birth control with their female partner of childbearing
             potential from screening through 30 days following completion of the study

          -  Female subjects of childbearing potential who are not willing to practice a medically
             accepted method of birth control with their non-surgically sterile male sexual partner
             from screening through 30 days following completion of the study

          -  Female subjects who are pregnant or lactating
Dose Confirmation Trial of AAV5-hFIXco-Padua
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: AAV5-hFIXco-Padua (AMT-061)
Intervention description: Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label, single-dose, single-arm, multi-center trial
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemophilia,; Gene Therapy; Bleeding; Factor IX; FIX; viral vector; Padua

Summary:

      This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a
      treatment + post-treatment follow-up phase, and a long-term follow-up phase.

      The IMP AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5)
      containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic
      acid (cDNA) under the control of a liver-specific promoter. The IMP is identified as
      AAV5-hFIXco-Padua (AMT- 061). The pharmaceutical form of AMT-061 is a solution for
      intravenous infusion.

      The administered dose of AMT-061 will be 2 x 10^13 gc/kg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male

          2. Age ≥18 years

          3. Subjects with congenital hemophilia B classified as severe or moderately severe

          4. >20 previous exposure days of treatment with FIX protein

        Exclusion Criteria:

          1. History of FIX inhibitors

          2. Positive FIX inhibitor test at screening

          3. Select screening laboratory values > 2 times upper normal limit:

          4. Positive human immunodeficiency virus (HIV) at screening, not controlled with
             anti-viral therapy

          5. Active infection with Hepatitis B or C virus at screening

          6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy
Safety of SonoVue on Pulmonary Hemodynamics
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: SonoVue; Placebo
Intervention description: dose of 4.8 mL administered intravenously one time; Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary hypertension; Right heart Catheterization

Summary:

      This is an intra-subject crossover comparative safety study to evaluate the effect of
      intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provides written informed consent male or female at least 18 years of age scheduled to
             undergo right heart catheterization for clinical reasons

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Significant arrhythmia or non-sinus rhythm that may affect the ability to assess
             pulmonary hemodynamics by catheterization

          -  Known allergy to one of the ingredients in the investigational product or to any other
             contrast agents including ultrasound contrast agents

          -  Previously entered into the study or received an investigational compound within 30
             days before admission into the study

          -  Unstable pulmonary and/or systemic hemodynamic condition that would affect the ability
             to evaluate the pharmacological or hemodynamic effect of the investigational products
Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
Condition: Thalassemia; Iron Overload
MeSH terms: Thalassemia; Iron Overload
Intervention: Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)
Intervention description: All subjects will be given Deferasirox 20-30 mg/kg for 7 days per week. All subject will be given Deferoxamine 50 mg/kg for 3-7 days per week. The number of days for Deferoxamine will be determined by liver iron concentration at baseline.
Intervention MeSH terms: Deferasirox; Deferoxamine
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: 8 Years
Healthy volunteers: No
Keywords: Thalassemia; Chelation; Iron Overload; Thalassemia patients with Iron overload

Summary:

      This is a pilot study looking at the safety and efficacy of giving combination chelation with
      deferasirox and deferoxamine. The hypothesis is that combination chelation is safe in
      decreasing overall iron in patients with thalassemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Transfusion Dependent Thalassemia

          -  If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented
             endocrinopathy or cardiac finding

          -  Older than 8 years

        Exclusion Criteria:

          -  Participating on another interventional clinical trial