bioihbjkbjnl/mcl2 huggingface dataset:
PTG-300 in Subjects With Hereditary Hemochromatosis
Condition: Hereditary Hemochromatosis
MeSH terms: Hemochromatosis; Hemosiderosis
Intervention: PTG-300
Intervention description: Active treatment with PTG-300 injected subcutaneously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single Arm Study
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will be conducted at multiple sites and every patient will get treated with
      PTG-300. The objective of the study is to assess the effect of PTG-300 in treating adult
      hereditary hemochromatosis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 and older

          -  Confirmed diagnosis of HFE-related hereditary hemochromatosis with prior genotype
             testing

          -  Documented stable phlebotomy for ≥ 6 months

          -  Screening hemoglobin >11.5 g/dL

          -  Documented evidence of prior serum ferritin ≥500 ng/mL

          -  Serum ferritin >50 ng/mL and <300 ng/mL at screening

        Exclusion Criteria:

          -  Clinically meaningful laboratory abnormality

          -  Receiving iron chelation therapy

          -  Receiving erythrocytapheresis

          -  Pregnant or lactating females

          -  Infection requiring hospitalization or intravenous antimicrobial therapy, or
             opportunistic infection within 3 months of dosing; any infections requiring
             antimicrobial therapy within 4 weeks of dosing.

          -  Serious or unstable medical or psychiatric condition that would prevent subject
             providing informed consent

          -  Organ damage from iron overload

          -  Primary or secondary immunodeficiency

          -  Positive hepatitis B or hepatitis C or known human immunodeficiency virus infection

          -  Known history of autoimmune/inflammatory diseases

          -  Any surgical procedures requiring general anesthesia within 1 month prior to screening
             or planned surgery during study

          -  History of invasive malignancies within last 2 years, except non-malignant skin cancer
             and local cured prostate cancer, cervical cancer, or ductal carcinoma in situ

          -  Receipt of an investigational agent within 30 days of screening
PSMA PET and MRI in Gynecological Cancers
Condition: Gynecologic Cancer
Intervention: PSMA-based 18F-DCFPyL PET tracer
Intervention description: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Uterine cancer; Ovarian cancer; Hysterectomy; Salpingo-oophorectomy

Summary:

      The goal of this research is to determine the accuracy of PSMA positron emission tomography
      (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of
      gynecological cancer cells in the body.
    

Eligibility criteria:

        Inclusion Criteria for healthy female controls N=12 (includes up to 6 Dosimetry
        participants):

          -  Women with no suspected gynecological cancer.

          -  No contraindications for MR or PET imaging.

          -  Greater than or equal to 18 years of age.

          -  Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

        Inclusion Criteria for female controls (Dosimetry):

          -  Women with or without suspected gynecological cancer.

          -  No contraindications for MR or PET imaging.

          -  Greater than or equal to 18 years of age.

        Inclusion Criteria for gynecological cancer patients (N=40):

          -  Women with known or suspected gynecological cancer

          -  No contraindications for MR or PET imaging.

          -  Greater than or equal to 18 years

          -  Have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

        Exclusion Criteria:

          -  Women that are pregnant or breast-feeding.

          -  Age <18

          -  Inability to provide informed consent on their own behalf

          -  Severe kidney dysfunction (GFR <30 mL/min/1.73m2)
CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Cyclosporine A; Placebo
Intervention description: topical ocular, eye drops; topical ocular, eye drops
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The objective of this study was to compare the safety, efficacy, and tolerability of two
      different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for
      the treatment of the signs and symptoms of Dry Eye Disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form and HIPAA (Health Insurance Portability and
             Accountability Act ) document

          -  Patient-reported history of dry eye in both eyes

          -  Current use of over-the-counter and/or prescription eye drops for dry eye symptoms

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Women who are pregnant, nursing or planning a pregnancy

          -  Unwillingness to submit a blood pregnancy test at screening and at the last visit (or
             early termination visit) if of childbearing potential, or unwillingness to use
             acceptable means of birth control

          -  Clinically significant slit-lamp findings or abnormal lid anatomy at screening

          -  DED secondary to scarring or ocular or periocular malignancy

          -  History of herpetic keratitis

          -  Active ocular allergies or ocular allergies that are expected to be active during the
             study period

          -  Ongoing ocular or systemic infection at screening or baseline

          -  Wear of contact lenses within 3 months prior to screening or anticipated use of
             contact lenses during the study

          -  History of no response to previous topical Cyclosporine A and/or use of topical
             Cyclosporine A within 6 months prior to screening

          -  Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any
             planned ocular and/or lid surgeries over the study period

          -  Presence of an uncontrolled systemic disease

          -  Presence of a known allergy and/or sensitivity to the study drug or its components
Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Brentuximab Vedotin
Intervention description: Starting dose: 1.2 mg/kg by vein on Day 1 for the first 2, 21 day cycles. Dose increased to 1.8 mg/kg by vein after the second cycle for all subsequent cycles.
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Lymphoma; Hodgkin lymphoma; HL; CD30 positive Hodgkin Lymphoma; Anaplastic large cell lymphoma; ALCL; Allogeneic Stem Cell Transplantation; ASCT; Graft-versus-host disease; GVHD; Brentuximab Vedotin; SGN-35; Adcetris

Summary:

      The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab
      vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or
      haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab
      vedotin can help to prevent the disease from coming back.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with CD30 positive Hodgkin Lymphoma (HL) or anaplastic large cell lymphoma
             (ALCL) that have undergone allogeneic or haploidentical SCT in the past 60 days
             (matched related or matched unrelated donors only).

          2. Age 18 to 65 years.

          3. Performance status: Zubrod 0-1 or Karnofsky 80-100.

          4. Serum creatinine < 1.5 mg/dL or creatinine clearance greater than or equal to 40
             cc/min as defined by MDRD method from National Kidney Disease Education Program
             (NKDEP).

          5. Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).

          6. SGPT < 200 IU/L unless related to patient's malignancy.

          7. Evidence of neutrophil and platelet engraftment, defined as platelet count equal or
             greater than 50,000 mm3 independent of platelet transfusion and ANC equal or greater
             to 1000 without growth factor support for at least 5 days.

          8. Patients with previous exposure to brentuximab pre-transplant are eligible for the
             study.

        Exclusion Criteria:

          1. Pregnancy or breast-feeding (women of childbearing potential, any female who has
             experienced menarche and who has not undergone surgical sterilization or is
             post-menopausal with a positive serum pregnancy test.

          2. Presence of steroid-refractory acute graft-versus-host disease (GVHD).

          3. Patients that underwent allogeneic transplantation as a treatment of graft failure.

          4. Dual refractory CMV reactivation to foscarnet and ganciclovir or evidence of CMV
             disease.
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Condition: Gout
MeSH terms: Gout
Intervention: Placebo; AC-201; Febuxostat
Intervention description: Placebo twice daily from Day 1 to Week 12; AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12; Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL
Intervention MeSH terms: Febuxostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR
      in an initial dosing period, followed by the addition of a ULT to test the efficacy and
      safety of the combination and prophylaxis of gout flares during ULT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female age 20 to 65 years, inclusive.

          2. Meets ≥6 of the 12 American College of Rheumatology preliminary criteria (1977) for
             the classification of acute arthritis of primary gout (Appendix 2), OR have proven
             tophus or documented monosodium urate (MSU) crystals in the joint fluid.

          3. Serum uric acid ≥7.5 mg/dL and ≤10 mg/dL at screening with ≥1 gouty arthritis flare
             within one year prior to screening, OR serum uric acid ≥9 mg/dL and ≤10 mg/dL at
             screening with or without prior gout flares.

        Exclusion Criteria:

          1. Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2
             weeks prior to screening.

          2. Occurrence of a gouty arthritis flare within 1 week prior to screening or during the
             screening period through baseline.

          3. Use of colchicine within 1 week prior to screening.

          4. Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.

          5. Allergy, contraindication, or intolerance to febuxostat.

          6. Severe renal impairment.

          7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >2
             times the upper limit of laboratory normal range (>2x ULN) at screening.
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Clostridium Infections
Intervention: FMT; Antimicrobials
Intervention description: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.; Patients randomized to the control group will receive antimicrobials targeting C. difficile.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CDI; C difficile; C diff; Clostridium difficile

Summary:

      The purpose of the study is to determine the safety and efficacy of Fecal Microbiota
      Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI)
      as compared to standard antibiotic therapy. Patients who have tested positive for CDI within
      90 days of an admission for relapse of CDI will be approached to participate in this
      open-label, randomized controlled trial. Patients will either be randomized to the
      intervention group (receive FMT via retention enema) or the control group (receive
      antimicrobials targeting CDI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active C. difficile infection, defined as > 3 diarrheal stools per day
             and a positive C. difficile PCR assay

          -  Hospitalized patient presenting with first relapse of CDI occuring between 15 and 90
             days after an index episode of CDI

        Exclusion Criteria:

          -  Pregnancy

          -  Neutropenia (absolute neutrophil count <1000/microliters)

          -  Contraindication for retention enema

          -  Food allergy not controlled in the donor diet
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Condition: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, Non-Hodgkin
Intervention: asparaginase Erwinia chrysanthemi
Intervention MeSH terms: Asparaginase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Erwinaze; asparaginase; Eusa Pharma; Pharmacokinetic study; NSAA

Summary:

      This study will utilize Erwinaze via intravenous administration in patients between the ages
      of 1 and 30 who have experienced an allergy to their frontline therapy. The study will
      determine the proportion of patients with 2 day nadir serum asparaginase activity levels that
      are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,

          -  Ages >/= 1 and </= to 30 years at the time of initial diagnosis

          -  Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma

          -  Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli
             asparaginase or Calaspargase pegol

          -  Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining
             dose of either Pegaspargase or Calaspargase pegol

          -  Direct bilirubin less than or equal to Grade 2

          -  Amylase and lipase within normal limits (per institutional standards)

          -  Signed informed consent by the patient is greater than or equal to 18 years or by the
             parent if the patient is younger than 18 years old.

        Exclusion Criteria:

        -
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
Condition: Edematous; Synovitis; Foreign Body Reaction; Osteolysis
MeSH terms: Synovitis; Osteolysis; Foreign-Body Reaction; Foreign Bodies
Intervention: Placebo; Apatone®B
Intervention description: Two capsules taken twice daily with meals; Two capsules taken twice daily with meals
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: total joint arthroplasty; synovitis; ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion); osteolysis; periprosthetic metallosis

Summary:

      This research study is being conducted to determine if taking oral (by mouth in pill form)
      Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and
      improve function of non-infected symptomatic postoperative total joint replacements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postoperative Total joint replacement with osteoarthritis as the underlying pathology

          -  Proven non-infected symptomatic Total Joint Arthroplasty (TJA) (joint implanted for
             >12 months post-op)

          -  Age (50 to 85 years of age); based on a 10% trim of the age distribution for Summa
             Health System TJAs (7/1/08-6/30/2009).

        Exclusion Criteria:

          -  An infection of any kind (prior to, or during the study)

          -  Rheumatoid arthritis as the underlying pathology

          -  Cortisone injection received <6 months prior to study enrollment

          -  Insulin dependent diabetes

          -  Diagnosed immunodeficiency

          -  On dialysis or have poor kidney function

          -  Anti-coagulant medication (e.g., Coumadin or >100mg of Aspirin daily)

          -  Anti-seizure medication (e.g., Dilantin)

          -  Steroidal medication (e.g., Prednisone, Advair or Symbicort)

          -  NSAIDS (e.g., Celebrex or Toradol); a 14-day washout period will be allowed

          -  bisphosphonates (e.g., Fosamax, Actonel, Aredia, Didronel, Boniva or Reclast)

          -  hormonal therapy (e.g., Estrogen, Progesterone or Testosterone)

          -  Cancer (active or in remission)

          -  Planned concurrent vitamins exceeding a standard daily multivitamin or exceeding the
             Recommended Daily Allowance (RDA) for individual vitamins if used alone; a 72 hour
             wash out period will be allowed

          -  A glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  Pregnant or lactating; females who are in their reproductive years must have a
             negative serum pregnancy

          -  Lactose intolerant

          -  Citric acid intolerant
A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: lenalidomide
Intervention description: 25mg oral capsules continuous days 1-21 each of a 28 day cycle
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma; CC-5013; Revlimid; Lenalidomide

Summary:

      To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle
      cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven mantle cell lymphoma

          -  Patients must have documents relapsed, refractory or PD after treatment with
             bortezomib

          -  Must have measureable disease on cross sectional imaging by CT

          -  Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2

          -  Willing to follow pregnancy precautions

        Exclusion Criteria:

          -  Any of the following laboratory abnormalities

               -  Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)

               -  Platelet count < 60,000/mm3 (60 x 109/L)

               -  Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or
                  alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) > 3.0 x upper
                  limit of normal (ULN), except in patients with documented liver involvement by
                  lymphoma.

               -  Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and
                  documented liver involvement by lymphoma.

               -  Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min

               -  Patients who are candidates for high dose chemotherapy/allogeneic stem cell
                  transplant are not eligible

               -  History of active central nervous system (CNS) lymphoma within the previous 3
                  months

               -  Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis

               -  Prior history of malignancies, other than MCL, unless the patient has been free
                  of the disease for ≥ 3 years

               -  Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C