bioihbjkbjnl/mcl2 huggingface dataset:
Curcumin in Treating Patients With Familial Adenomatous Polyposis
Condition: Familial Adenomatous Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli
Intervention: Curcumin; Laboratory Biomarker Analysis; Placebo
Intervention description: Given PO; Correlative studies; Given PO
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies curcumin in treating patients with familial
      adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of
      rectal polyps or colorectal neoplasia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with familial adenomatous polyposis who have undergone subtotal colectomy
             with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir),
             and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or
             reservoir

          -  Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis
             without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy

        Exclusion Criteria:

          -  Female patients of childbearing age not on effective birth control

          -  Pregnant women

          -  White blood cell count (WBC) < 3500/ml

          -  Platelet count < 100,000/ml

          -  Blood urea nitrogen (BUN) > 25mg%

          -  Creatinine > 1.5mg%

          -  Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin,
             curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the
             duration of the trial

          -  Malignancy other than nonmelanoma skin cancer

          -  Active bacterial infection

          -  Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic
             despite medication or current erosive esophagitis on endoscopy)

          -  Patients with a history of peptic ulcer disease

          -  Patients on warfarin or plavix
Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Intervention: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams
Intervention description: 18F-DCFPyL whole body PET/CT scan administered at the following timepoints:
PET1 - Prior to scheduled nephrectomy
PET2 - to establish a new baseline PET before systemic therapy
PET2A - Post-surgery and prior to start of standard of care systemic therapy
PET2B - 12-16 weeks from start of first line systemic therapy (immune-based or anti-angiogenic)
PET3 - If first line systemic therapy did not include anti-angiogenesis therapy and new systemic therapy does include anti-angiogenesis therapy
PET3A - Prior to start of additional anti-angiogenesis therapy
PET3B - 12-16 weeks from the start of additional anti-angiogenesis therapy
PET4 - obtained at clinical progression or 2 years following initial systemic therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: This study is a single cohort study without randomization or stratification.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clear Cell; Kidney Cancer; RCC

Summary:

      The primary objective of this research is to evaluate response to systemic therapy, including
      anti-angiogenesis therapy and/or immune-based therapies via 18F-DCFPyL prostate-specific
      membrane antigen (PSMA)-based positron emission tomography/computed tomography (PET/CT) in
      patients with metastatic renal cell carcinoma (RCC) and to compare qualitatively with
      conventional imaging response criteria - Response Evaluation Criteria In Solid Tumors (RECIST
      1.1) and histopathological endpoints including isolation, enumeration and staining of
      Circulating Tumor Cells (CTC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with locally advanced (>/=cT3) or metastatic clear cell RCC as
             proven by biopsy.

          -  Adults, 18 years of age or older.

          -  Surgical candidates who have clinical indication for nephrectomy and standard-of-care
             biopsy of metastatic disease followed by possible standard of care systemic
             anti-angiogenesis based treatment regimen

          -  Have consented to participate in the University of Wisconsin Carbone Cancer Center
             Biobank.

        Exclusion Criteria:

          -  Patients who have received prior RCC systemic therapies

          -  Prior history of prostate cancer

          -  Prior history of any other malignancy within the last 2 years, other than skin basal
             cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
             superficial bladder cancer

          -  Unable to lie flat during or tolerate PET/CT

          -  Serum creatinine > 2 times the upper limit of normal
Women's Isoflavone Soy Health (WISH) Trial
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: 25 gm soy protein supplement; Placebo
Intervention description: 25 gm soy protein supplementation administered in equally divided dosage twice daily (12.5 gm); Milk protein administered twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: Female
Minimum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Atherosclerosis; Cardiovascular Diseases; Carotid artery intima-media thickness (CIMT); Cognition; Complementary and alternative medicine; Daidzein; Genistein; Glycitein; Intervention; Isoflavones; Menopause; Prevention; Postmenopausal; Randomized controlled study; Soy; Soy Protein; Subclinical Vascular Disease; Ultrasonography; Women

Summary:

      The purpose of this study is to determine whether soy supplementation can reduce hardening of
      the arteries and cognitive decline in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal, defined as no vaginal bleeding for at least 1 year and serum estradiol
             level lower than 20 pg/ml

        Exclusion Criteria:

          -  Signs, symptoms or personal history of cardiovascular disease

          -  Diabetes mellitus or fasting serum glucose of 126 mg/dL or greater

          -  Fasting plasma triglyceride of 500 mg/dL or greater

          -  Serum creatinine greater than 2.0 mg/dL

          -  Uncontrolled hypertension

          -  Untreated thyroid disease

          -  Life expectancy less than 5 years

          -  Current use of hormone replacement therapy (HRT)

          -  Soy, nut, or related food allergies

          -  More than 5 alcohol drinks per day or substance abuse
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Condition: Coronary Microvascular Dysfunction
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: CLBS16
Intervention description: GCSF-mobilized autologous CD34 cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo
      selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with
      no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary
      infusion of CLBS16.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age ≥18

          -  History of and currently experiencing angina at least 3 times per week

          -  No obstructive coronary artery disease

          -  On stable medical therapy for 30 days prior to enrollment

          -  Must agree to use a reliable and acceptable method of contraception for the duration
             of participation

          -  Written informed consent

        Exclusion Criteria:

          -  Myocardial infarction within 90 days

          -  Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or
             CABG)

          -  Diagnosis of other specific cardiac disease

          -  Must meet LVEF and GFR requirements

          -  Current use of coumadin or DOACs

          -  Hypersensitivity to G-CSF, apheresis or study product components

          -  Positive for HIV, hepatitis B or hepatitis C

          -  Active inflammatory or autoimmune disease, or chronic immunosuppressive state

          -  Drug abuse

          -  Pregnant or lactating

          -  Malignant neoplasm within 5 years

          -  History of Sickle Cell Disease

          -  Participation in another clinical study within 90 days
Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study
Condition: Tobacco Use in Childbirth; Smoking Cessation; Pregnancy Related
Intervention: Fish oil; Placebos
Intervention description: Fish oil supplementation; Olive Oil capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blinded, placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, placebo control with medications dispensed by the Investigational Drug Service
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: n-3 polyunsaturated fatty acids; tobacco use; pregnancy

Summary:

      The purpose of this feasibility study is to obtain pilot data in preparation for an upcoming
      R01 submission. The goals of that submission will be to conduct a clinical trial of n-3
      LCPUFAs for smoking cessation in pregnant women. For this proposal, the investigators will
      develop, test, and refine the recruitment strategy and collect data demonstrating the
      investigators ability to successfully recruit pregnant women who are actively smoking. The
      investigators will collect side effect, tolerability, and adherence data regarding the
      intervention. Finally, the investigators hope to gather preliminary effect size data to allow
      more formal estimates of sample size. The investigators hypothesize that pregnant smokers
      randomized to n-3 LCPUFA supplementation will have higher smoking cessation rates and less
      nicotine cravings compared to women allocated to placebo. The investigators intend to use
      this preliminary data to inform a future randomized, double-blind, placebo-controlled trial
      of n-3 LCPUFA supplementation for tobacco cessation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 or ≤ 45 years of age

          -  Currently reporting daily cigarette use (≥ 1 CPD, no averages, must have daily use)

          -  Between 6 and 36 weeks gestation

        Exclusion Criteria:

          -  Allergy to fish or seafood

          -  Currently using fish oil supplements and unwilling to stop prior to and during the
             trial

          -  Unstable psychiatric disease: Defined as requiring hospitalization or active
             medication changes (medication changes or up titration) within the preceding 3 months

          -  Unstable pregnancy-related medical problems (pre-eclampsia, premature labor,
             threatened abortion, oligohydramnios, placenta previa, hyperemesis gravidarum, HELLP
             syndrome, Intrauterine growth restriction, cholestasis of pregnancy, Rh negative
             disease, gestational hypertension, placenta accreta)
IBUPAP Study for Pain Management in Children
Condition: Pain Management
Intervention: Ibuprofen; APAP
Intervention description: Oral Ibuprofen at 10 mg/kg dose; Oral APAP at 15mg/kg dose
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Current literature supports ibuprofen and APAP are the most commonly used analgesics in the
      pediatric ED for acute traumatic/non-traumatic pain. However, the analgesic benefits of
      combination ibuprofen and APAP in this specific setting does not exist, but instead only as
      it applies to pediatric patients with postoperative pain. Thus, we have designed a
      double-blind, randomized, controlled clinical trial to evaluate analgesic efficacy, safety
      and feasibility of combination therapy to potentially broaden its clinical application in the
      pediatric ED. The investigators' hypothesize that combination oral ibuprofen and APAP therapy
      is superior to either drug alone and is an excellent analgesic modality for controlling acute
      traumatic/non-traumatic pain in the pediatric ED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 3-17 years old presenting to the pediatric ED

          -  treating physician deems patient required ibuprofen Tylenol or both for pain relief

        Exclusion Criteria:

          -  documented or suspected pregnancy, (2)

          -  parental refusal,

          -  allergies to NSAIDS or APAP

          -  inability to tolerate oral medications or contraindications to oral medication route

          -  received analgesics within 4 hours prior to ED presentation

          -  inability to use pain scales
Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)
Condition: Aging
Intervention: acarbose
Intervention description: acarbose treatment with meals
Intervention MeSH terms: Acarbose
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 70 Years
Maximum age: 95 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study addresses a "lifespan approach to healthy development and aging" with direct
      relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot
      study to: i) better estimate power for a larger trial, ii) establish the safety and potential
      beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the
      effects of acarbose on the microbiome likely play a role in its enhancement of longevity
      and/or healthy aging. These are essential initial steps for translating acarbose into an
      anti-aging human therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 70-95

          -  participants will be in good health with all chronic diseases (hypertension, coronary
             artery disease, etc.) clinically stable.

          -  participants must have adequate cognitive function to be able to give informed
             consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

        Exclusion Criteria:

          -  unstable ischemic heart disease

          -  clinically significant pulmonary disease

          -  history of immunodeficiency or receiving immunosuppressive therapy

          -  history of a coagulopathy or receiving a medical condition requiring anticoagulation

          -  an estimated glomerular filtration rate of <30ml/min

          -  uncontrolled hypercholesteremia >350mg/dl;

          -  uncontrolled hypertriglyceridemia >500mg/dl

          -  diabetes

          -  history of skin ulcers or poor wound healing

          -  smoking

          -  liver disease treatment with drugs known to affect cytochrome P450 3A (diltiazem,
             erythromycin)
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
Condition: Leukemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: ibrutinib; venetoclax; Placebo
Intervention description: ibrutinib administered orally once daily (three 140 mg capsules); venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.; placebo capsules to match ibrutinib administered orally once daily
Intervention MeSH terms: Venetoclax
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participants with confirmed undetectable minimal residual disease (uMRD) in the MRD cohort are triple masked.
Allocation was not randomized for the Fixed Duration (FD) cohort.
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease
      (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib +
      venetoclax in subjects with treatment-naïve CLL or SLL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic
             Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at
             least 1 IWCLL criteria for requiring treatment.

          -  Measurable nodal disease by computed tomography (CT)

          -  Adequate hepatic, and renal function

          -  Adequate hematologic function

          -  absolute neutrophil count >750/µL

          -  platelet count >30,000 /μL

          -  hemoglobin >8.0 g/dL

        Exclusion Criteria:

          -  Any prior therapy used for treatment of CLL/SLL

          -  Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk
             for tumor lysis syndrome (TLS)
A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Guselkumab dose 1; Guselkumab dose 2; Guselkumab dose 3; Placebo
Intervention description: Participants will receive guselkumab dose 1 IV.; Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.; Participants will receive guselkumab dose 3 SC in Group 3.; Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab
      in adult participants with moderate to severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days)
             prior to the baseline visit as determined by the investigator through participant
             interview and/or review of the medical history

          -  Have HS lesions present in at least 2 distinct anatomic areas (examples include but
             are not limited to left and right axilla; or left axilla and left inguinocrural fold)

          -  Had an inadequate response to an adequate course of appropriate oral antibiotics for
             treatment of HS (or demonstrated intolerance to, or had a contraindication to oral
             antibiotics for treatment of their HS) in the investigator's opinion

          -  Have a total abscess and inflammatory nodule (AN) count of greater than or equal to
             (>=) 3 at the screening and baseline visit

          -  Must agree to daily use (throughout the entirety of the study) of one of the following
             over-the-counter treatments to the body areas affected with HS lesions: either soap
             and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan,
             or benzoyl peroxide, or a dilute bleach bath

        Exclusion Criteria:

          -  Any other active skin disease or condition (example, bacterial, fungal or viral
             infection) that could have interfered with assessment of HS

          -  Has a draining fistula count of greater than (>) 20 at the baseline visit

          -  Receipt of prescription topical therapies for the treatment of HS within 14 days prior
             to the baseline visit

          -  Receipt of systemic non-biologic therapies for the treatment of HS less than (<) 4
             Weeks prior to the baseline visit

          -  Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4
             Weeks prior to the baseline visit