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: A Phase 2a/2b Multicenter, Open-Label Study to Evaluate NKTR 102 in Combination With Cetuximab Versus Irinotecan in Combination With Cetuximab in Second Line Colorectal Cancer Patients

Summary: Study 07-PIR-02 is a Phase 2 study designed to evaluate the safety and efficacy of NKTR-102 (PEG-irinotecan) for the treatment of patients with colorectal cancer (CRC). The study is comprised of two sequential components - Phase 2a and Phase 2b. The Phase 2a portion is an open-label, dose-finding trial in multiple solid tumor types that are refractory to standard curative or palliative therapies. The primary endpoint of the Phase 2a is to establish the /recommended Phase 2 Dose (RPTD) of NKTR-102 by measuring the frequency of Dose Limiting Toxicity (DLT). The Phase 2b portion is an open-label, randomized, two-arm study in patients with second-line metastatic colorectal cancer and study participants will be randomized (1:1) to receive either NKTR-102 and cetuximab or irinotecan and cetuximab. The primary endpoint of the Phase 2b portion of the trial is progression-free survival. Secondary endpoints for both the Phase 2a and 2b portion include response rate, response duration, overall survival, standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.

Detailed description: The Phase 2a portion of this study is completed. The following entries reflect the Phase 2a portion of this study only. The Phase 2b portion of the study was not enrolled. Based on emerging data regarding the corresponding low efficacy of cetuximab in patients with KRAS mutations, as well as revised NKTR-102 clinical development plans, the Phase 2b portionof the study was not completed.

Eligibility: Inclusion Criteria:
  -  Male and non-pregnant, non-lactating female patients with an ECOG performance score <3 who have any type of solid tumor refractory to standard therapy and who have adequate bone marrow and organ function at screening.
  Exclusion Criteria:
  -  Patients must not have used any CYP3A4 inducers or inhibitors with 2 weeks prior to the first day of study drug treatment.

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

Summary: To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.

Detailed description: The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease.
  This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).

Eligibility: Inclusion Criteria:
  -  Subject was referred for colonoscopy for one of the following reasons:
  -  Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.
  -  Any subject ≥ 18 years of age with:
  -  Positive findings in the colon on a GastroIntestinal (GI) radiographic study
  -  Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
  -  Suspected or known ulcerative colitis
  Exclusion Criteria:
  -  Subject has dysphagia
  -  Subject has congestive heart failure
  -  Subject has renal insufficiency
  -  Subject is known or is suspected to suffer from intestinal obstruction.
  -  Chronic use of laxatives
  -  Subject has a cardiac pacemakers or other implanted electro medical devices.
  -  Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
  -  Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  -  Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
  -  Subject has any condition, which precludes compliance with study and/or device instructions.
  -  Age < 18 years
  -  Subject suffers from life threatening conditions
  -  Subject is currently participating in another clinical study
  -  Subject has known slow gastric emptying time

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 Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension

Summary: This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.


Eligibility: Inclusion Criteria:
  -  Male or female outpatients, 50 years of age and older with a diagnosis of essential hypertension
  -  Successful high quality colonoscopy at baseline including visualization of the entire colon and the cecum as confirmed by a photograph and collection of the rectal and cecal mucosal biopsy samples
  -  All rectal, colon or cecal polyps found at baseline colonoscopy must be completely resected endoscopically at the time of the procedure.
  -  Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation have been clearly explained to them (written informed consent).
  Exclusion Criteria:
  -  Previously treated in an aliskiren study.
  -  Current evidence of inflammatory bowel disease, the presence of colonic ulcerations (or other indices of colitis of any type) or colorectal carcinoma including carcinoma in situ found at baseline colonoscopy.
  -  History of gastrointestinal carcinoma, Crohn's disease, ulcerative colitis, microscopic colitis.
  -  History of familial polyposis or hereditary nonpolyposis colorectal cancer.
  -  History of confirmed diverticulitis within 12 months of Visit 1.
  -  History of celiac disease (gluten intolerance).
  -  History of or current evidence on the baseline colonoscopy of melanosis coli.

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: Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

Summary: The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.

Detailed description: Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.

Eligibility: Inclusion Criteria:
  -  Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
  -  Estimated life expectancy of more than 3 months
  -  ECOG performance status of 0 to 1 at study entry
  -  Adequate bone marrow function
  -  Adequate liver function
  -  Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
  -  Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
  -  Informed Consent
  Exclusion Criteria:
  -  Central nervous system (CNS) metastases or prior radiation for CNS metastases.
  -  Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
  -  Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
  -  Evidence of gastrointestinal bleeding
  -  Exposure to Cetuximab
  -  Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
  -  KRAS mutant Status
  -  Patients with serious toxicity to previous irinotecan-based chemotherapy
  -  Other serious illness or medical conditions

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer

Summary: The technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. The purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer.


Eligibility: Inclusion Criteria:
  -  Stage I - III colon cancer patients
  Exclusion Criteria:
  -  cancer located at the low rectum which were located within 10 cm of the dentate, recurrent or metastatic colon carcinoma, adjacent organ invasion tumor, prior chemotherapy or radiation, cancer with intestinal obstruction, past intestinal surgery

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: Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer

Summary: RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer.
  PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer.
  Secondary
  -  To establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes.
  OUTLINE: Data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. Registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. The information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. Registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research.
  Registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. Tissue samples from a previous biopsy may also be obtained. Samples will be stored for future research studies.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets any of the following criteria:
  -  Patients and family members with a known hereditary colorectal cancer or polyposis syndrome
  -  Patients who meet Amsterdam I, II, or Bethesda criteria
  -  Patients with a family history suggestive of a hereditary colorectal or polyposis syndrome
  -  Patients diagnosed with colorectal cancer at < 50 years old
  -  Patients are identified through surgical, oncological, gynecological, and gastrointestinal programs, as well as outside referrals, self referral, and the Vanderbilit Tumor Registry
  PATIENT CHARACTERISTICS:
  -  See Disease Characteristics
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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: Lactobacillus Plantarum 299v in Colon Surgery

Summary: Intestinal pathogenes are often involved in postoperative complications after colon surgery. Probiotic bacteria, i e live bacteria which have beneficial effects on the host when ingested, have been shown to reduce bacterial translocation in animal studies. However, in humans studies results have varied. The purpose with this study was to find whether high doses of Lactobacillus plantarum 299v affects the potentially pathogenic microflora of the gut, bacterial translocation and cell proliferation in patients undergoing planned colon surgery.


Eligibility: Inclusion Criteria:
  -  planned resection of colon for malignant or benign disease
  -  all ages
  Exclusion Criteria:
  -  unable to understand instructions and perform preoperative intake of study preparation
  -  rectal surgery
  -  present or past history of endocarditis
  -  congenital or acquired valvular 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: Vitamin D and Type 2 Diabetes - a Cross Sectional Study

Summary: The purpose of the study is to describe vitamin D status among patients with type 2 diabetes and to determine the association between serum 25-hydroxyvitamin D and glycemic control, markers of inflammation and blood pressure

Detailed description: It has been estimated that 1 billion people worldwide have vitamin D deficiency or insufficiency. It is well known that vitamin D deficiency causes osteoporosis, increases the risk of fracture and causes muscle weakness. But there is now evidence that calcium malnutrition and hypovitaminosis D are predisposing conditions for various common chronic diseases such as malignancies (particularly colon, breast and prostate) chronic inflammatory and autoimmune disease (inflammatory bowel disease, multiple sclerosis) as well as metabolic disorders (metabolic syndrome, hypertension).
  It has also been reported that vitamin D deficiency may predispose to glucose intolerance, altered insulin secretion and type 2 diabetes mellitus.
  The purpose of this study is to determine vitamin D status among type 2 diabetics in our outpatient clinic and examine the relationship between vitamin D status , calcium and phosphorous metabolism, inflammatory markers, glycemic control, blood pressure and lipid profile.
  Moreover the patients are asked to answer a questionnaire regarding lifestyle, exercise, sun exposure and food intake.

Eligibility: Inclusion Criteria:
  -  Type 2 diabetes mellitus
  -  Patients of Danish extraction
  -  Written consent
  Exclusion Criteria:
  -  Renal failure (Urea > 12 mmol/l)
  -  Age < 18 years
  -  malabsorption

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: Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay

Summary: Epigenomics is developing a colon cancer screening assay based on differential methylation of specific CpG sites for the detection of early stage disease. A genome-wide methylation analysis and oligonucleotide array study using DNA from various stages of colon cancer and normal tissue have been completed to obtain candidate CpG markers. Based on results obtained in the above studies, Epigenomics has moved to the final stages of feasibility with a specific, highly sensitive real-time marker assay that is able to detect colon cancer DNA in blood plasma.

Detailed description: From public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of CRC screening initiatives; as stated by Sidney Winawer, MD, "the best test is the one that gets done." Current CRC screening guidelines include FOBT, sigmoidoscopy (alone or with FOBT), or colonoscopy. Non-invasive screening is conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 16% in the US) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for CRC detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, first-line screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.
  Epigenomics has identified methylated gene regions that are specific for colorectal cancer or pre-malignant tissue. Aberrantly methylated genes represent attractive candidate markers for cancer screening, as cancer-specific methylation changes occur early in tumorigenesis, appear to be stable, yield a positive amplifiable signal, and can be assayed with high analytical sensitivity. Since methylation occurs early and in distinct genomic areas, it is possible to achieve high clinical sensitivity with a small number of methylated DNA markers. Studies have shown that aberrantly methylated DNA markers can be detected in tissue and body fluids and are highly correlated to colorectal cancer.

Eligibility: Inclusion Criteria:
  -  Group 1 diagnosis of colorectal cancer
  Exclusion Criteria:
  -  Group 2 diagnosis of colorectal 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: A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes

Summary: The purpose of this study is to see if a patient's ability (and/ or parent) to read, write, and do basic math problems affects blood sugar control in children with type 1 diabetes mellitus.

Detailed description: "Literacy" is defined as an individual's ability to read, write, and speak English, and compute and solve problems at levels of proficiency necessary to function on the job and in society, to achieve one's goals, and develop one's knowledge and potential, according to the National Literacy Act of 1991. The National Work Group on Health and Literacy reported that between 40 and 44 million persons in the United States have rudimentary literacy skills, and are unable to understand written materials that require only basic reading proficiency. Illiteracy has become an increasingly important problem, especially as it relates to healthcare. Literacy skills are paramount to effective self-management of type 1 and type 2 diabetes mellitus. And, "Diabetes Self-Management Education" is the cornerstone of care for all individuals with diabetes who want to achieve successful health-related outcomes. Self care of diabetes plays a major role in achieving DCCT recommended level of hemoglobin A1C. Deficient self-management will lead to uncontrolled diabetes, resulting in multisystem complications, increasing exponentially the burden on our healthcare system. Structured education of individuals tailored to combat poor literacy skills is imperative in helping these individuals achieve good glycemic control. Hence we would like to evaluate literacy in our clinic so appropriate educational material can be developed to help patient with T1DM who have low literacy.

Eligibility: Inclusion Criteria:
  -  Type 1 or type 2 diabetes mellitus
  -  Parent/ legal guardian must be present if child is less than 18 years of age.
  -  Diagnosis of type 1 or type 2 diabetes mellitus must have been made at least 1 year earlier.
  -  Parent/ legal guardian and/ or child must have completed all 3 mandatory diabetes education classes.
  -  English and/or Spanish speaking only.
  Exclusion Criteria:
  -  Any form of mental retardation or cognitive disorder in parent/ legal guardian.
  -  Mental retardation or cognitive disorder in a child who is in Grade 6 or higher.

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: Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

Summary: This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.

Detailed description: Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).

Eligibility: Inclusion Criteria:
  -  Biopsy proven of colon cancer
  -  Preoperatively suspected as clinical stage III colon cancer
  -  Lesion located Descending colon, sigmoid colon and upper rectal cancer
  Exclusion Criteria:
  -  Could not perform curative resection
  -  Intestinal obstruction, perforation, intra-abdominal abscess
  -  Severe medical illness
  -  Immunopathy

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: QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma

Summary: This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI


Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
  -  Mutant-type KRAS tumor at screening
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
  -  Adequate hematology, renal, hepatic, and coagulation function
  Exclusion Criteria:
  -  History or known presence of central nervous system metastases
  -  History of other malignancy
  -  Prior irinotecan-based chemotherapy for advanced/metastatic disease
  -  Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
  -  Uncontrolled cardiovascular disease

Relevance to patient case: possibly relevant