araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma

Summary: The purpose of the study is to gather data on feasibility as well as immune and clinical efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or stage IV melanoma

Detailed description: IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a very important role in cancer immunotherapy. A desirable property for a dendritic cell vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+ T cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved immunotherapy product.

Eligibility: Inclusion Criteria:
  -  HLA A201 + phenotype
  -  Biopsy-proven melanoma, Stages III (A, B and C) or stage IV.- no evidence of disease at study entry
  -  Age: 21-75 years
  -  ECOG performance status 0-1
  -  Adequate marrow function
  -  Adequate hepatic function
  -  Adequate renal function
  -  Written informed consent
  Exclusion Criteria:
  -  Subjects with measureable non-resectable melanoma
  -  Subjects who have had chemotherapy less than 4 weeks before starting trial
  -  Subjects who received IFN-a or GM-CSF less than 4 weeks before starting trial
  -  Subjects who received IL2 less than 4 weeks before starting trial
  -  Subjects with a baseline LDH greater than 1.1 times the ULN
  -  Subjects who are HIV positive
  -  Female subjects who are pregnant
  -  Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial
  -  Subjects who have asthma and/or are on treatment for asthma
  -  Subjects with angina pectoris
  -  Subjects with congestive heart failure
  -  Subjects with history of autoimmune disease including lupus, rheumatoid arthritis or thyroiditis
  -  Subjects with active infections including viral hepatitis
  -  Subjects with a history of neoplastic disease othe than melanoma within the last 5 years
  -  History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin.
  -  Subjects who present with open wounds

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Epanova® for Lowering Very High Triglycerides

Summary: The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.


Eligibility: Inclusion Criteria:
  -  Men or women, >=18 years of age.
  -  Very high serum TG values in the range >=500 mg/dL and <2000 mg/dL (>=5.65 mmol/L and <22.60 mmol/L)
  Exclusion Criteria:
  -  Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
  -  Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
  -  Unable to discontinue use of omega-3 drugs/supplements.
  -  Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins <200 mg), or any supplement used to alter lipid metabolism.
  -  Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods.
  -  Use of tamoxifen, estrogens or progestins that has not been stable for >4 weeks prior to Visit 1.
  -  Use of oral or injected corticosteroids or anabolic steroids.
  -  History of pancreatitis.
  -  History of symptomatic gallstone disease, unless treated with cholecystectomy.
  -  Uncontrolled diabetes.
  -  Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH).
  -  History of cancer (other than basal cell carcinoma) in the past 2 years.
  -  Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure within six months prior to Visit 1.
  -  Use of anticoagulants (e.g. warfarin [Coumadin®], coumarin, heparin, enoxaparin, clopidogrel).
  -  Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1.
  -  Recent history (within six months prior to Visit 1) or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
  -  Poorly controlled hypertension.
  -  Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), glucose, glomerular filtration rate (GFR), platelet count,or hemoglobin outside of study range.
  -  Recent history (past 12 months) of drug abuse or alcohol abuse.
  -  Exposure to any investigational product, within 4 weeks prior to Visit 1.
  -  Presence of any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Nordic Adjuvant IFN Melanoma Trial

Summary: The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.

Detailed description: This is an open multicenter, prospective randomised phase III trial evaluating the efficacy of two different schedules of Interferon-alpha2b (IFN-alpha2b) administered in an adjuvant setting after adequate surgery in high risk cutaneous melanoma patients (T4N0M0/TxN1-2M0). The patients have been operated for either a thick primary melanoma (> 4 mm) without evidence of distant metastasis or have undergone surgery for regional lymph node metastases.
  The study consists of a control arm (A) and two treatment arms, B and C. The outcome in arms B and C with adjuvant treatment with IFN-alpha2b will be compared to the outcome of arm A in which the patients will only be observed after the surgery. The primary endpoint is overall survival. Secondary endpoints are relapse-free survival, safety-toxicity and health-related quality of life.

Eligibility: Inclusion Criteria:
  -  T4 N0 M0 - Thick primary melanoma: > 4.0 mm Breslow depth, without lymph node involvement, or
  -  Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or
  -  Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy.
  -  ECOG performance status of 0-1
  -  No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol
  -  Written informed consent
  Exclusion Criteria:
  -  Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma
  -  Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease
  -  Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy
  -  Female patients who are pregnant or lactating

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Does the Aid of MelaFind Affect Clinical Management Decisions

Summary: The objective of this study is to determine and compare the performance of dermatologists (in Germany) on the excision decision against the performance of MelaFind, a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is superior to the average excisions sensitivity of dermatologists.
  Another objective is to determine and compare the performance of dermatologists (in Germany) with and without the aid of MelaFind. The hypothesis is that the average excision sensitivity of dermatologists with the aid of MelaFind is superior to the average excision sensitivity of dermatologists without the aid of MelaFind.
  A similar study was previously conducted with dermatologists in the US (NCT01011153). An exploratory objective is to compare the excision decisions of dermatologists from the previous study (in the US) to dermatologists in in this study (in Germany).

Detailed description: Early detection of melanoma is critical for favorable prognosis, since patients with earlier stage melanomas have a much higher probability of survival than with later stages. The traditional method of early detection has been with serial total body skin exams where the health care provider examines all skin surfaces, including mucosa, for suspicious pigmented lesions. The diagnostic performance of dermatologists for melanoma depends on the level of dermatological training. More important than being able to make a diagnosis of melanoma on clinical impression is the ability to make an appropriate decision to excise the lesion. To aid dermatologists in the detection of early melanoma, MelaFind was developed, a non-invasive and objective multi-spectral computer vision system technology. It was designed to generate output - MelaFind Positive or MelaFind Negative- for consideration in the lesion management decisions.
  This survey study will determine and compare the average excision sensitivity to melanoma and specificity of dermatologists (in Germany) without MelaFind output to the average excision sensitivity to melanoma and specificity of dermatologists (in Germany) with MelaFind output. Another purpose is to determine and compare the sensitivity to melanoma and specificity of MelaFind to the average excision sensitivity to melanoma and specificity of dermatologists without MelaFind output.

Eligibility: Inclusion Criteria:
  -Only board certified dermatologists
  Exclusion Criteria:
  -May not have previously participated in MELA Protocols 20061, 20081 or 20063

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Flaxseed Lignan (Brevail)

Summary: PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries.
  This study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (PCOS) patients.


Eligibility: Inclusion Criteria:
  -  Must be 18 to 40 year old female with:
  -  Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score >8, and/or hyperandrogenemia defined as total testosterone >80ng/dl or bioavailable testosterone >8.4 ng/dl.
  -  Mentally competent.
  Exclusion Criteria:
  -  Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
  -  Long-term or chronic use of oral antibiotics.
  -  Hysterectomy.
  -  FSH >15.
  -  Pregnancy/lactation.
  -  Consumption of flaxseed within the last month.
  -  Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
  -  Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients

Summary: The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.

Detailed description: The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.

Eligibility: Inclusion Criteria:
  1. Chronic hepatitis C patients
  -  positive anti-HCV antibody more than 6 months
  -  serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
  -  not indicated for antiviral therapy with interferon and ribavirin
  2. Chronic alcoholic hepatitis
  -  significant alcohol drinking history and no other cause of chronic hepatitis
  -  serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
  Exclusion Criteria:
  -  Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis
  -  decompensated liver cirrhosis
  -  platelet < 50,000/uL or white blood cell < 1,500/uL
  -  need and willing for antiviral therapy
  -  significant renal dysfunction (GFR < 30 mL/min/kg) or history of renal stone
  -  hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks
  -  pregnancy, lactating woman

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients

Summary: The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels
  This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim of the study is to maintain serum phosphorus level and establish equivalence between COS and sevelamer carbonate tablets.

Detailed description: Total 40 subjects will be randomized for participation into the study The subjects are Hemo-dialysis Dependent Chronic Kidney Disease (CKD) Stage 5D patients who are able to give informed consent to the study, and taking the phosphate binder sevelamer carbonate tablets.

Eligibility: Inclusion Criteria:
  -  Male or female subjects ≥18 years of age able to give written informed consent to the study
  -  Hemodialysis dependent chronic kidney disease stage 5D patients
  -  Taking sevelamer carbonate tablets or sevelamer hydrochloride as phosphate binder monotherapy
  -  Taking 3 or more sevelamer carbonate or sevelamer hydrochloride tablets per day
  Exclusion Criteria:
  -  Estimated life expectancy of less than 6 months and for cancer patients, an Eastern Cooperative Oncology Group (ECOG) Performance Status >1
  -  Active malignancy within the past 5 years. Basal or squamous cell skin cancer is not exclusionary. History of malignancy is not an exclusion
  -  Known hypersensitivity reaction to calcium-based phosphate binders
  -  Anticipated renal transplantation during the study
  -  Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Systemic Dickkopf-related Protein 1 (DKK1)During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors

Summary: The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. The investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the adipogenic pathway.
  The investigators will conduct a longitudinal cohort study of post menopausal women with hormone-responsive breast cancer that will be treated AIs. The study will observe anthromorphic and serum marker changes during the first year of their treatment.


Eligibility: Inclusion Criteria:
  -  Post Menopausal Breast cancer patients with planned treatment of aromatase inhibitors.
  -  18 years or older
  Exclusion Criteria:
  -  BMI >30 or <18
  -  Osteoporosis as defined by protocol.
  -  Subjects currently on bisphosphonate therapy.
  -  History of primary or secondary hyperparathyroidism
  -  History of Hypo-or Hyperthyroidism
  -  History of Vitamin D levels below LLN
  -  History of creatinine clearance below the EGFR
  -  History ofLiver function tests above 1.5 times ULN including LDH, SGOT, SGPT, Alkaline phosphatase, and Bilirubin
  -  History of documented cirrhosis of the liver
  -  History of chronic heparin use
  -  History of chronic glucocorticoid therapy

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma

Summary: The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily, the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose CPM.


Eligibility: Inclusion Criteria:
  -  Any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with clinicopathologic stage IIB, IIC, III or IV that has been completely resected
  -  Patients must be able to provide informed consent.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Life expectancy of at least 6 months.
  -  Adequate hematologic function.
  -  Adequate renal function
  -  Adequate hepatic function
  -  Patients of both genders must agree to practice effective birth control during the study period and for at least 4 weeks after the last treatment.
  Exclusion Criteria:
  -  Patients whose primary site of melanoma is ocular.
  -  Are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma.
  -  Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy.
  -  Have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses.
  -  Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects of these conditions).
  -  Documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis.
  -  Any form of primary or secondary immunodeficiency. This would include hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation.
  -  Requirement for systemic steroid therapy or immunosuppressive therapy.
  -  Have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines.
  -  Have been diagnosed with another invasive cancer within the past 3 years.
  -  Radiographic evidence of melanoma recurrence.
  -  Pregnant or lactating women.
  -  Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

Summary: CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.


Eligibility: Inclusion Criteria:
  For the dose escalation phase:
  1. Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.
  2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
  3. Evidence of measurable disease
  Exclusion Criteria:
  1. Previous therapy with a MEK inhibitor.
  2. Symptomatic or untreated leptomeningeal disease.
  3. Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.
  4. Known acute or chronic pancreatitis.
  5. Clinically significant cardiac disease
  6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818
  7. Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
  8. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
  9. History of thromboembolic or cerebrovascular events within the last 6 months
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant