bioihbjkbjnl/mcl2 huggingface dataset:
Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease
Condition: Cancer
MeSH terms: Prostatic Neoplasms
Intervention: FACBC PET-CT Imaging
Intervention description: Participants will fast for 4 hours to normalize their neutral amino acid levels. One hour prior to the scan, participants will drink up to 450ml of standard oral contrast. Participants will lie on the scanning bed while the bed moves through the PET/CT scanner for the CT portion of the exam. After completion of the CT scan, approximately 10 units of FACBC will be injected for the PET scan portion of the exam. The bed will move through the scanner again and the PET portion of the exam will take 30 minutes. The entire visit will take about two hours.
Standard of care procedures include conventional imaging (CT and/or MRI; bone scan and/or NaF PET per institutional standards) and radical prostatectomy with extended pelvic lymph node dissection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: All participants will have the same intervention
Masking: None (Open Label)
Enrollment: 61.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; Metastatic cancer; Urogenital disorders; Oncology; Radiology

Summary:

      This study is for patients who have a high risk of metastatic prostate cancer (cancer that
      has spread outside of the prostate) who are going to have radical prostatectomy. The
      Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron
      emission tomography (PET) scan is a new imaging approach that has promising results in
      showing progression of cancer. The goal of this study is to determine if FACBC PET imaging
      will detect metastatic disease in patients with high risk prostate cancer who have negative
      conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic
      resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging
      may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary
      prostate cancer and potentially improve staging of the cancer. Additionally, the researchers
      will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis.
      They will also analyze and compare the prostate tissue, serum and urine parameters that are
      linked to higher rates of FACBC positivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High-risk prostate cancer patients eligible for standard of care surgery

               -  At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen
                  (PSA) >20, as per clinical assessment and routine guidelines

          -  Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or
             sodium fluoride (NaF) PET)

        Exclusion Criteria:

          -  Definitive findings of systemic metastasis on conventional imaging.
Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Simvastatin; Placebo
Intervention description: 40 mg Simvastatin/day; Matching Placebo
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 40 Years
Maximum age: 72 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the research is to see how simvastatin affects a substance in the body called
      beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and
      spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting
      Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid
      in the spinal fluid. This study will also see if simvastatin affects memory and thinking,
      blood flow in the brain, and blood vessel function. The investigators hope that future
      studies show whether simvastatin might prevent memory loss and decrease the chance of
      developing Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent diagnosed with Alzheimer's disease

          -  Age 40-72

        Exclusion Criteria:

          -  Active liver disease

          -  History of adverse reaction to statins

          -  Contraindication to lumbar puncture

          -  Elevated creatine kinase and creatinine lab values

          -  Use of medications known to interact with statins

          -  History of dementia or mild cognitive impairment

          -  Currently pregnant or planning to become pregnant

          -  Use of large quantities of grapefruit juice (more than 1 quart per day)

          -  Contraindications to MRI (for MRI sub-study)

          -  Currently on cholesterol-lowering medication or use in past 4 months

          -  History of heart attack, heart problems, stroke and/or diabetes

          -  Drinking more than a quart of grapefruit juice per day

          -  Metal implants, or metal debris in body (MRI)

          -  List of medications that interact with simvastatin
Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.
Condition: Lymphedema; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer
MeSH terms: Breast Neoplasms; Lymphedema
Intervention: technetium Tc 99m sulfur colloid; methylene blue; indocyanine green solution; sentinel lymph node biopsy; axillary lymph node biopsy; bioimpedance spectroscopy; quality-of-life assessment; lymphedema management
Intervention description: Given intradermally and periareolarly; Given subcutaneously; Given subcutaneously; Undergo sentinel lymph node biopsy; Undergo axillary lymph node biopsy; Correlative studies; Ancillary studies; Undergo axillary reverse mapping
Intervention MeSH terms: Pharmaceutical Solutions; Methylene Blue; Technetium Tc 99m Sulfur Colloid
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity
      of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or
      axillary lymph node biopsy with or without axillary reverse mapping works in reducing
      incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 0, I, and II Breast Cancer

          -  Not pregnant or breastfeeding

          -  Breast cancer or prophylactic mastectomy requiring axillary nodal staging

          -  Ability to read and/or comprehend consent form and questionnaires

          -  Ability to follow-up per protocol

          -  Unilateral axillary staging

        Exclusion Criteria:

          -  Stage 3

          -  Previous axillary lymph node dissection

          -  Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration

          -  Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may
             be used in these patients

          -  Patients with implanted medical devices such as a pacemaker may undergo perometry, but
             not BIS (Bioelectrical Impedance Spectroscopy)

          -  Previous diagnosis of LE (lymphedema) of either extremity

          -  Bilateral axillary staging
A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
Condition: Excessive Sleepiness; Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Intervention: JZP-110; Placebo
Intervention description: 75 mg, 150 mg, 300 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending
      dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and
      PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult
      subjects with idiopathic PD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.

          2. Hoehn and Yahr stage 1, 2, or 3.

          3. Screening and Baseline ESS scores >11.

        Exclusion Criteria:

          1. Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear
             palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).

          2. Usual nightly time in bed of <6 hours, including the night before the Baseline visit.

          3. Untreated or inadequately treated moderate to severe OSA.

          4. Has evidence at screening of severe cognitive impairment or has cognitive impairment
             that in the opinion of the investigator would prevent completion of study procedures
             or the ability to provide informed consent.
Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: S-1; Capecitabine
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Stomach cancer; Palliative chemotherapy; Capecitabine; S-1

Summary:

      A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of
      age and older. In addition, patient delay in seeking care for symptoms results in diagnosis
      at a more advanced stage than that seen in younger individuals. However, clinical trials on
      gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which
      have been reported to have clinically significant response rates and survival with mild or
      negligible toxicities, have been widely used for the patients with AGC. However, few studies
      have been conducted in elderly patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven gastric or gastroesophageal junction adenocarcinoma

          -  Metastatic or recurrent unresectable disease

          -  Measurable lesions (according to Response Evaluation Criteria in Solid Tumors
             [RECIST])

          -  Age: 65-85 years old

          -  Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2

          -  Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet
             count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)

          -  Adequate renal function (serum creatinine≤ 1.5)

          -  Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal [UNL], aspartate
             aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)

          -  No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to
             study treatment is allowed with the exception of capecitabine or S-1) Written informed
             consent was signed by the patient

        Exclusion Criteria:

          -  Previous palliative chemotherapy

          -  Known allergy to study drugs

          -  CNS metastasis

          -  Significant medical comorbidities

          -  Active ongoing infection which antibiotic treatment is needed.

          -  Previous ( within 5 years) history of other malignancy except cured non-malignant skin
             cancer and uterine cervical cancer in situ.
A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: V565; Placebo
Intervention description: Daily dosing of V565 three times a day orally for 6 weeks; Daily dosing of placebo three times a day orally for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of V565 in participants with
      active Crohn's Disease (CD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of Crohn's Disease of at least 3 months duration prior to screening

          -  Crohn's Disease Activity Index (CDAI) score of ≥220 to ≤450 during screening

          -  C-reactive protein (CRP) ≥5 mg/L (or, if CRP is normal, faecal calprotectin (FCP) ≥250
             µg/g) at screening

          -  Permitted CD medication regimen expected to remain stable during the period of the
             study

        Exclusion Criteria:

          -  Previous lack of response or current contra-indication to an anti-tumour necrosis
             factor α (anti-TNFα) agent

          -  Certain complications of Crohn's Disease that would make it hard to assess response to
             study drug

          -  Known history or suspicion of inflammatory bowel disease other than Crohn's disease

          -  History of tuberculosis (TB) or latent TB infection that has not been treated

          -  Any significant illness or condition which would preclude effective participation in
             the study

          -  GI infection as demonstrated by presence of enteric pathogens

          -  Pregnant or lactating women

          -  Abdominal surgery in the previous 6 months

          -  Unsuitable for inclusion in the study in the opinion of the investigator or sponsor
             for any reason that may compromise the subject's safety or confound data
             interpretation
Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients
Condition: Indigestion
MeSH terms: Dyspepsia
Intervention: Esomeprazole; Placebo
Intervention description: Esomeprazole 40 mg QD; Placebo
Intervention MeSH terms: Esomeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Epigastric Pain; Non-Ulcer Dyspepsia (NUD)

Summary:

      Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in
      NUD patients
    

Eligibility criteria:

        Inclusion criteria:

        A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in
        the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point
        categorical scale), which has been present at least 3 times per week for 12 weeks,
        unrelated to exercise.

        C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating
        (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea;
        however, the dominant symptom must be epigastric pain/discomfort.

        D. Capable of and willing to give informed consent and comply with all study requirements.

        Exclusion criteria:

        A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C.
        Patients requiring chronic treatment with any medication inducing GI symptoms (e.g.,
        certain antibiotics, codeine, etc.).

        D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or
        presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions.
        G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable
        bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.

        I. History or presence of other known organic disease that might explain the dyspepsia
        symptoms (e.g., symptomatic gallstones).

        J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater
        than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of
        beer or 16 fluid ounces of wine) per day.

        M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence
        of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors
        (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks
        maximum).
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
Condition: Fabry Disease; Chronic Kidney Disease, Stage IV (Severe)
MeSH terms: Fabry Disease; Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Fabrazyme (agalsidase beta); Fabrazyme (agalsidase beta)
Intervention description: 1.0 mg/kg every 2 weeks; 3.0 mg/kg every 2 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Fabry Disease patients with Severe Renal Disease

Summary:

      This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose
      of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.
    

Eligibility criteria:

        Inclusion Criteria:

          -  provided written informed consent prior to any study-related procedures being
             performed.

          -  be ≥16 years old.

          -  have a current diagnosis of Fabry disease (defined as abnormal α-galactosidase (α GAL)
             enzyme levels or Fabry genotype).

          -  have one of the following clinical conditions present at enrollment: serum creatinine
             level greater than 3.0 mg/dL (an average of two values at least one week apart), or be
             currently on dialysis, or be status post kidney transplant by greater than 3 months.

          -  have the ability to comply with the requirements of the protocol

          -  have a negative pregnancy test, if a female patient of childbearing potential. In
             addition, all female patients of childbearing potential must use a medically accepted
             method of contraception throughout the study.

        Exclusion Criteria:

          -  if they did not meet the specific inclusion criteria.

          -  if they had participated in a study employing an investigational drug within 30 days
             of the start of their participation in this trial.

          -  had previously received enzyme replacement therapy (ERT) for their Fabry disease.

          -  had diabetic nephropathy.

          -  were pregnant or lactating.

          -  were unwilling to comply with the requirements of the protocol.
The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: HD IL2
Intervention MeSH terms: Aldesleukin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Kidney; Renal Cell; Metastatic; interleukin-2; select

Summary:

      High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug
      Administration (FDA) for the treatment of metastatic kidney cancer and is a standard
      treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer
      that can produce a remission of disease that lasts after treatment is completed. However,
      most patients who receive IL-2 do not benefit and all patients experience potentially
      dangerous side effects.

      Recent research has suggested that certain patients may respond better to IL-2 than others.
      The Cytokine Working Group is currently conducting a clinical trial that aims to identify and
      confirm this research and narrow the application of IL-2 to those patients most likely to
      benefit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed renal cell carcinoma that is metastatic or
             unresectable.

          -  If patients have measurable disease restricted to a solitary lesion, its neoplastic
             nature should be confirmed by cytology/histology.

          -  Patients must provide access to tissue blocks containing adequate tumor for
             interpretation and analysis.

          -  Patients must have measurable disease.

          -  Patients must have good performance status (ECOG 0 or 1; Karnofsky PS 100-80%).

          -  Patients must have adequate organ function.

          -  Patients must have no contraindication of vasopressor agents.

          -  Patients must be ≥ 18 years of age.

        Exclusion Criteria:

          -  Patients who have received systemic therapy for metastatic disease.

          -  Patients with organ allografts.

          -  Patients who require or are likely to require systemic corticosteroid therapy for
             intercurrent illness.

          -  Patients with any significant medical disease other than the malignancy (e.g. COPD,
             patients with ascites or pleural effusions), which in the opinion of the investigator
             would significantly increase the risk of immunotherapy.

          -  Patients with a history of another malignancy within the past 5 years other than
             surgically cured non-melanoma skin cancer, carcinoma-in-situ or Stage I carcinoma of
             the cervix.