bioihbjkbjnl/mcl2 huggingface dataset:
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 Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Telaprevir; Ribavirin; Pegylated interferon alfa 2a
Intervention description: Tablet; Tablet; Solution for Injection
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Genotype 1

Summary:

      To provide access to a telaprevir-based treatment to subjects of the Control Group of Study
      VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who
      stopped treatment due to inadequate response to treatment. Safety, tolerability, and
      Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104
             (NCT00336479) or VX05-950-104EU (NCT00372385)
Metabolic Effects of Paricalcitol
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Paricalcitol; Placebo
Intervention description: Two 1 mcg soft gels by mouth daily for 8 weeks; Two soft gels by mouth daily for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic kidney disease; Vitamin D; Paricalcitol; Placebo; Kidney; Renal; Oxidative Stress; Immune cell function; Glucose; Glucose tolerance

Summary:

      The purpose of this study is to determine if treatment with paricalcitol, an active form of
      vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic
      Kidney Disease (CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Estimated glomerular filtration rate of 15-59 mL/min/1.73m2

          -  Fasting glucose 100-125 mg/dL

          -  18 years and older

        Exclusion Criteria:

          -  Diagnosed with diabetes mellitus

          -  Use of diabetes medications (insulin or oral hypoglycemics)

          -  Prior dialysis or transplantation

          -  Planning to leave the area within 6 months

          -  Participation in another clinical trial within 30 days

          -  Treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks

          -  Serum calcium more than 10.2 mg/dL

          -  Pregnancy or breast-feeding

          -  Change in dose (within 8 weeks) of Fibrates, Niacin, ACE inhibitors, Angiotensin
             receptor blockers, Thiazide diuretics, Beta-blockers, Cholecalciferol or
             Ergocalciferol

          -  Incontinent of urine

          -  Cancer (other than skin cancer) within 5 years

          -  Tuberculosis

          -  Sarcoidosis
Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
Condition: Colon Cancer; Rectal Cancer; Cancer Survivor; Colorectal Adenocarcinoma; Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IIB Colorectal Cancer AJCC v8; Stage IIC Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8
MeSH terms: Colorectal Neoplasms
Intervention: Dietary Intervention (resistant starch); Dietary Intervention (regular starch); Questionnaire Administration
Intervention description: Eat foods with resistant starch; Eat foods with regular corn starch; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded, block randomization based on sex and BMI.
Masking: Double (Participant, Investigator)
Masking description: Assignment to the active versus control group will be blinded using a computer program and will be designated as "diet A" and "diet B". Investigators will be unblinded once the study and data analyses have been completed.
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Resistant Starch; Colorectal Cancer

Summary:

      This phase II, randomized pilot trial studies the effect of the consumption of foods made
      with resistant starch compared to foods made with corn starch on biomarkers that may be
      related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods
      made with resistant starch may beneficially influence markers of inflammation, insulin
      resistance, and the composition of gut bacteria in colorectal cancer survivors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of diagnosed American Joint Committee on Cancer (AJCC) stage I-III colorectal
             adenocarcinoma.

          -  Completed all treatment of colorectal adenocarcinoma within past 4-36 months.

          -  Current Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
             (per physician).

          -  Ability to consent and follow study protocol.

        Exclusion Criteria:

          -  Active cancer.

          -  Prior diagnosis of diabetes that is currently uncontrolled (defined as hemoglobin
             [Hgb] A1c > 8.0).

          -  Active inflammatory bowel disease (i.e., patients who are symptomatic despite medical
             therapy). This includes irritable bowel syndrome, Crohn's disease, or any other
             inflammatory bowel disorder.

          -  Known food allergy/intolerances to wheat, gluten, dairy or eggs.

          -  Use of antibiotic(s) within the last 3 months prior to enrollment.

          -  Women who are pregnant and/or breastfeeding.

          -  Current body mass index (BMI) < 18.5 kg/m^2.

          -  Uncontrolled constipation.

          -  Inability to speak and fully understand English.
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
Condition: Hepatitis C Infection With HIV Co-Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections; Coinfection; Hepatitis
Intervention: LDV/SOF
Intervention description: 90/400 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to determine the antiviral efficacy, safety, and
      tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with
      acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus
      (HIV)-1 co-infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration
             less than 24 weeks

          -  Confirmed HIV-1 infection

          -  CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T
             cell count > 500/μL at screening for individuals without ART

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male with female partner

        Key Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of a non HCV etiology

          -  Coinfection with hepatitis B virus (HBV)

          -  Treatment with any investigational drug or device within 60 days of the screening
             visit.

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment or compliance with the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis
Intervention: LDV/SOF; VDV; RBV
Intervention description: LDV/SOF (90/400 mg) FDC tablet administered orally once daily; VDV 80 mg tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis C; Gilead; GS-9451

Summary:

      This study is to evaluate the antiviral efficacy, safety, and tolerability of combination
      therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV)
      ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1
      hepatitis C virus (HCV) infection and cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years, with chronic HCV genotype 1 infection

          -  Documentation as treatment-experienced having received pegylated interferon (Peg-IFN)
             + RBV ≥ 4 weeks of duration without an additional agent in the regimen without
             achieving sustained viral response (SVR)

          -  Presence of compensated cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Must use specific contraceptive methods if female of childbearing potential or
             sexually active male

          -  Not pregnant or a nursing female

        Exclusion Criteria:

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Multivalent; Prevnar 13; PPSV23; Saline
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine; Placebo
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 444.0
Sex: All
Minimum age: 60 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy
      adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be
      randomized equally to receive either a single intramuscular dose of multivalent pneumococcal
      conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month
      later with a dose of PPSV23 (control group).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but
             not including, the 65th birthday) at enrollment.

          2. Healthy adults, including adults with preexisting stable disease, defined as disease
             not requiring significant change in therapy or requiring hospitalization within 3
             months before receipt of investigational product, as determined by medical history,
             physical examination, laboratory screening, and clinical judgment of the investigator.

          3. Female subjects who are not of childbearing potential.

        Exclusion Criteria:

          1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.

          2. History of microbiologically proven invasive disease caused by S pneumoniae.

          3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
             pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
             or without dialysis, clinically unstable cardiac disease, or any other disorder that,
             in the investigator's opinion, excludes the subject from participating in the study.
Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations
Condition: Frontotemporal Lobar Degeneration (FTLD); Frontotemporal Dementia (FTD); Tauopathies
MeSH terms: Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Tauopathies; Frontotemporal Lobar Degeneration
Intervention: 18F-AV-1451
Intervention description: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: FTLD; FTD

Summary:

      The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect
      depositions of a protein, called tau, in the brains of people with a mutation in the tau gene
      that causes deposition of the protein, and in people without the mutation. Up to three
      18F-AV-1451 scans will be performed (one per year) on control subjects without MAPT
      mutations, presymptomatic mutation carriers, and symptomatic mutation carriers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Members of families with established MAPT mutations, who either have the capacity to
             consent to participate in the protocol, or else have designated a surrogate/proxy to
             consent to participate in this study

        Exclusion Criteria:

          -  Unwillingness to participate

          -  Usage of medication which significantly prolongs QT interval

          -  Pregnancy or plans for pregnancy within 90 days after participating in study
A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial
Condition: Spasticity
MeSH terms: Muscle Spasticity
Intervention: Tizanidine; Placebo; Moxifloxacin
Intervention MeSH terms: Moxifloxacin; Tizanidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study
      with a nested crossover comparison to define the ECG effects of tizanidine compared to
      placebo and the positive control, moxifloxacin, in healthy men and women. The study will be
      conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the
      protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women of childbearing potential should have a negative urine pregnancy test prior to
             Screening and Day -2 of the trial

          -  All subjects of childbearing potential must practice a highly effective method of
             birth control excluding oral contraceptives for the duration of the trial and up to 3
             months after the last dose of investigational product. Oral contraceptives are not
             allowed, based on the precaution listed in the Zanaflex package insert.

          -  Have a body mass index (BMI) ranging between 19 and 30 kg/m2

          -  Comprehend and be able to provide written informed consent

          -  Be willing and able to comply with all trial requirements

        Exclusion Criteria:

          -  Female who is either pregnant, breastfeeding or planning to become pregnant

          -  History of hypersensitivity or allergic reaction to tizanidine or moxifloxacin or any
             of the tablet components

          -  Any condition possibly affecting drug absorption, metabolism or excretion including
             previous surgery for removal of parts of stomach, bowel, liver, gall bladder, or
             pancreas

          -  History of Long QT Syndrome or a first-generation relative with this condition

          -  Evidence or history of clinically significant allergies except for untreated,
             asymptomatic, seasonal allergies at time of dosing, hematological, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or
             neurological disease. Determination of clinical significance is to be made at the
             Investigator's discretion

          -  History or presence of any malignant or benign neoplasm considered by the investigator
             to be clinically significant

          -  History of drug or alcohol abuse or dependence within the last year

          -  Have an active infectious disease