araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Genetic Study of Familial Factors in Patients With Colon Cancer

Summary: RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.
  PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

Detailed description: OBJECTIVES:
  -  Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
  -  Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
  -  Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
  -  Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer or polyps at age 70 or under
  -  Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under
  -  No history of familial adenomatous polyposis syndrome
  -  No hereditary nonpolyposis colon cancer, according to Amsterdam criteria
  -  No known I1370K adenomatous polyposis of the colon susceptibility variant
  -  Enrolled on 1 of the following clinical trials:
  -  CLB-9581
  -  CLB-89803
  -  CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible.
  PATIENT CHARACTERISTICS:
  Age
  -  70 and under at diagnosis
  Other
  -  No significant psychiatric illness that would preclude giving informed consent
  -  No inflammatory bowel disease (in patient or sibling)

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension

Summary: To evaluate the effects of two different antihypertensive medications in the drug class of beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.


Eligibility: Inclusion criteria:
  -  Patients at screening must be insulin producing Type II diabetics (C peptide positive).
  -  Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9 diastolic).
  -  Must be on stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
  -  Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).
  -  Must be on a stable antidiabetic regimen (drug treated or diet alone).
  Exclusion criteria:
  -  Patients using beta-blocker therapy.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

Summary: This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.


Eligibility: Inclusion Criteria:
  -  adult patients >=18 years of age;
  -  colon cancer;
  -  complete tumor resection.
  Exclusion Criteria:
  -  prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Preoperative Assessment of Colon Tumor

Summary: The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.


Eligibility: Inclusion Criteria:
  -  Colorectal cancer
  -  Colorectal tumor
  Exclusion Criteria:
  -  Active diverticulitis
  -  Pacemaker
  -  Metal in the body
  -  Claustrophobia

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril

Summary: The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.


Eligibility: Inclusion Criteria:
  -  male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria
  -  patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry
  -  patients who give written, signed, informed consent.
  -  patients with/without mild /moderate hypertension.
  -  patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment.
  -  patients without any accompanying systemic disease
  Exclusion Criteria:
  -  pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception
  -  patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis
  Other protocol-defined exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Study Evaluating Isovorin in Colon Cancer

Summary: The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.


Eligibility: Inclusion Criteria:
  -  Dukes C, Cure A colon cancer diagnosed histologically or cytologically
  -  Normal organ function of bone marrow, heart, liver and kidney
  -  Age 20-75
  Other inclusion applies
  Exclusion Criteria:
  -  Serious bone marrow suppression, infection, heart disease or complication
  -  Familial adenomatous polyposis or hereditary nonpolyposis
  -  Pregnant or breastfeeding women
  Other exclusion applies

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep

Summary: The purpose of this study is to ascertain if the use of Nexium for 7 days prior to taking a colon prep for a colonoscopy will decrease the side effects that are associated with the colon preparation

Detailed description: The high incidence for colon cancer make it an ideal target for screening. In the United Staes there are approximately 100,00 new cases of colon cancer yearly. Typically the progression from polyps to cancer requires years. This permits a screening procedure to identify polyps befoere they are cancerous. Colon cleansing is required prior to colonoscopy. The gastrointestinal syptoms associted with colonic preps are common and oftn assoicated wwith upper gastrointestinal disorders including GERD, non-ulcer syspepsia, and gastric dysmotoility such as gastropareesis.

Eligibility: Inclusion Criteria:
  -  Subject 18 or older undergoing out-patient colonoscopy
  Exclusion Criteria:
  -  Pregnant females Use of protein Pump Inhibitor within last 4 weeks Use of prescription strength H-2 Blocker within last 4 weeks Use of over the counter strength H-2 Blocker greater than 2x's a week Hospitalized patients PEG-EL purgative contraindicated.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus

Summary: This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.


Eligibility: Inclusion Criteria:
  - Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes,
  Exclusion Criteria:
  Pregnant or breast feeding, Type 1 diabetes
  Other protocol criteria apply

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

Summary: 1. To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan.
  2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan.
  3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.

Detailed description: RATIONALE: Many studies have tested the combination of cisplatin and irinotecan. Side effects have been well described. The two drugs are synergistic.
  The standard of care for colon cancer is the combination of 5-FU, leucovorin and irinotecan (Saltz regimen). Recently, oxaliplatin has been introduced for the treatment of colon cancer. Combination of oxaliplatin with 5FU (Folfox4) have shown comparable activity to the Saltz regimen. Furthermore, one author recently published on the triple combination of oxaliplatin, 5FU and irinotecan, with impressive clinical activity in colon cancer.
  There is some evidence that 5FU impairs DNA repair. One of the putative resistance mechanism to topoisomerase I inhibitors is increased DNA repair. We therefore hypothesize that inhibition of DNA repair by capecitabine may increase the activity of the combination of cisplatin and irinotecan.
  This study is open to all patients with solid tumor who have failed a line of chemotherapy

Eligibility: Inclusion Criteria:
  -  All patients, 18 years of age or older, with incurable advanced cancer for whom there is no effective therapy are eligible.
  -  Patients must have a life expectancy of at least 12 weeks.
  -  Patients must have a Zubrod performance status of 0-2.
  -  Patients must sign an informed consent.
  -  Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
  -  Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
  Exclusion Criteria:
  -  Patients with symptomatic brain metastases are excluded from this study.
  -  Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
  -  Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
  -  Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
  -  Patients whose cancer progressed while receiving 5-FU, cisplatin or irinotecan.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Resveratrol for Patients With Colon Cancer

Summary: Resveratrol is purported to possess cancer preventive activity, especially for colon cancer, though its mechanisms of action are not well defined. Resveratrol is found in the skin of grapes and has anti-oxidative and pro-apoptotic effects on cancer cell lines in vitro. The main dietary sources of resveratrol are grapes, grape products, and red wine, and small amounts may be found in mulberries. A prior report and compelling preliminary data from our laboratory suggest that resveratrol modulates Wnt signaling, a signaling pathway which is activated in over 85% of colon cancers. In this proposal, studies were performed to define the actions of resveratrol on the Wnt signaling pathway in a clinical trial in which patients with colon cancer received treatment with Resveratrol, and correlative laboratory studies examined its effects directly on colon cancer and normal colonic mucosa. These studies provided data on the mechanisms of resveratrol action and provided a foundation for future prevention trials, correlative studies and therapeutic clinical research with this agent.

Detailed description: Patients will be treated with a two-week course of resveratrol. The initiation of the treatment will be approximately 14 days before standard of care surgical resection of tumor. Resveratrol will be ingested as 20 mg pills or in the form of freeze-dried grape extract which is prepared by the California Table Grape Commission used under GMP guidelines for human consumption.
  The first two patients receiving resveratrol will be treated at a dose of 20 mg/day, the third and fourth patients at a dose of 80 mg/day, and the fifth and sixth patients with a dose of 160 mg/day. All patients receiving grape extract will receive 125 mg/day that will have to be mixed with one 8 oz glass of water. There will be no dose adjustments. If a patient has any side effects which are attributed to the resveratrol, it will be discontinued.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed with colon cancer by colonoscopic biopsy and tissue obtained under UCI04-05.
  -  Patients with a plan for surgical resection at UCIMC within 2-4 weeks of enrollment.
  Exclusion Criteria:
  -  Surgical resection to be performed at a facility other than UCIMC.
  -  Patients under 18 years of age.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Cellular Immune Augmentation in Colon and Rectal Cancer

Summary: While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.


Eligibility: Inclusion Criteria:
  -  Patient must have: metastatic, disseminated or recurrent colon or rectal cancer
  -  Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly
  -  Patient must be able to be taught to administer GM-CSF subcutaneously
  Exclusion criteria:
  -  Known allergic or other adverse reaction to GM-CSF
  -  Chemotherapy administration more frequently than bi-weekly
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Summary: The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.


Eligibility: Inclusion Criteria:
  -  Males and females (ages 18-75 years)
  -  Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
  -  Must have been following a restrictive diet
  -  Diagnosis of combined dyslipidemia
  Exclusion Criteria:
  -  Homozygous familial hypercholesterolemia
  -  Conditions which may cause secondary dyslipidemia
  -  Uncontrolled diabetes mellitus
  -  Abnormal pancreatic, liver, or renal function
  -  Abnormal serum creatine kinase (CK) above the pre-specified level
  -  Significant heart disease

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Determinants of Vitamin K Metabolism

Summary: The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body stores of vitamin K.

Detailed description: Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K supplementation and bone health of women in a narrow age group. This study is the first to assess the role of dietary and other factors that influence the response to vitamin K status and bone turnover to vitamin K depletion and repletion in adults. This study also compares the absorption efficiency and body retention of vitamin K relative to current vitamin K status. Men and women [21 younger (18-40y) and 21 older (55+y)] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K supplementation period (500 ug/d). Coagulation times will be monitored during the dietary restriction period. Serial measurements of vitamin K status markers and of bone turnover markers will show the response of vitamin K to dietary manipulation for both age groups under identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore, measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin K. The findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin K may have in chronic disease prevention.

Eligibility: Inclusion Criteria:
  Exclusion Criteria:
  -  kidney, GI, or liver disease requiring treatment
  -  prescribed osteoporosis medications in the previous 3 months
  -  use of acid reducers more than twice per week
  -  blood clotting disorder and/or abnormal clotting time
  -  warfarin or anticoagulant use in the previous 12 months
  -  diabetes
  -  smoking
  -  hormone therapy in the previous 3 months
  -  oral contraceptive use in the previous 3 months; pregnancy
  -  strict vegetarian diet

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Frequency of Circulating Tumour Cells in Stage II and Stage III Colon Cancer Patients

Summary: This study will determine whether a new diagnostic test called the Cell Search Assay can detect circulating colon cancer cells in patients who have had surgery for colon cancer and had visible cancer removed. Other parts of the study will look at whether the presence of the circulating tumor cells in blood predicts whether a patient will have their colon cancer return.


Eligibility: Inclusion Criteria:
  -  stage II or III colon cancer
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

Summary: The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.


Eligibility: Inclusion Criteria:
  -  Age 20-60
  -  Subjects are in good health.
  -  Subjects have willingness and the ability to understand and provide informed consent for participation in the study.
  Exclusion Criteria:
  -  Subjects who are currently using any anticoagulation therapy (Warfarin, Heparin, Aspirin)
  -  Subjects who have a history of bleeding disorders.
  -  Subjects who are unable to understand the protocol or to give informed consent
  -  Subjects with mental illness
  -  Subjects who are pregnant or nursing.
  -  Subjects who have active systemic or local infection
  -  Subjects with systemic or local skin disease.
  -  Subjects with systemic illness.

Relevance to patient case: not relevant