araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

Summary: This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our population of patients.


Eligibility: Inclusion Criteria:
  -  HCC diagnosis according to the American Association for the Study of Liver Diseases (AASLD) 2010 criteria
  -  Tumor Stage
  -  liver only disease
  -  tumor thrombus at segment is allowed
  -  no extra hepatic metastases
  -  tumor encompassing less than 50% of hepatic volume
  -  previous treatment with Transarterial Chemo Embolization (TACE) - patient must have performed at least 2 sessions of TACE and have signs of viable tumor in CT or MRI performed 30-40 days after last TACE
  -  presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in CT or MRI).
  -  Maximum lesion size of 10 cm.
  -  Liver residual volume equal or more than 700cc or 40% of total liver volume
  -  Child-Pugh A or absence of hepatic cirrhosis
  -  absence of encephalopathy or ascitis on clinical exam
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Lab exams:
  -  hemoglobin > or equal 8 mg/dl
  -  neutrophils > or equal 1.200/mm³
  -  platelets > or equal 45.000/mm³
  -  alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 6 times the upper normal limit
  -  bilirubin equal or < 2 mg/dl
  -  international normalized ratio (INR) < 1.7
  -  serum creatinine equal or < 1.5 times the upper normal limit or creatinine clearance > or equal 60 ml/min
  -  Albumin >2.8 mg/dl
  -  not being pregnant - a negative pregnancy test is required (for women). Patients in fertile age should use a contraceptive method during treatment and 4 months after.
  Exclusion Criteria:
  -  Patients with more than 5 discrete lesions in the liver
  -  Main or common biliary duct invasion
  -  Patients with main portal vein tumor thrombus or more than 2 portal branch thrombus
  -  Patients in systemic treatment (sorafenib, chemotherapy). There should be an interval of at least 4 weeks between any medication for treatment of HCC and the current study treatment
  -  Previous radiation to upper abdomen
  -  Patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if HCC prognosis is worse
  -  Patients with ischemic myocardial infarction within the last 6 months
  -  Patients with large esophageal varices with red color sign or bleeding within the last 3 months
  -  Patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer
  -  Patients with severe anorexy, constipation, dehydration, diarrhea or vomiting
  -  Patients unable to understand and sign written informed consent

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Lapatinib Plus Trametinib in KRAS Mutant Malignancies

Summary: This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt), CRC, NSCLC, or pancreatic cancer. Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt CRC, NSCLC or pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of metastatic CRC, NSCLC or pancreatic cancer; for PART B: treated with first line therapy for metastatic disease only.
  -  Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20)
  -  Age ≥ 18 years
  -  Able and willing to give written informed consent
  -  WHO performance status of 0 or 1 (part A and B)
  Exclusion Criteria:
  -  Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
  -  History of another primary malignancy
  -  Symptomatic or untreated leptomeningeal disease
  -  Symptomatic brain metastasis
  -  History of interstitial lung disease or pneumonitis
  -  Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
  -  Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment
  -  Patients with left ventricular ejection fraction (LVEF) < 50%

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Summary: The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Detailed description: Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Eligibility: Inclusion Criteria:
  -  Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)
  -  Patients aged between 18 and 80 years
  -  an estimated life expectancy of more than 3 months
  -  Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria
  -  TNM stage III-IV
  -  no evidence of cancer of another organ.
  -  no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed
  -  Karnofsky index of ≥60%
  -  ECOG index ≥2
  -  previous technically successful stenting or ENBD derange
  -  Accept of informed consent
  Exclusion Criteria:
  -  Clinically significant cardiovascular disease
  -  coagulation disorders
  -  contraindication of Endoscopic
  -  pregnant or breastfeeding women
  -  known sensitivity sensitivity to investigated agents or components
  -  recent invasive procedure
  -  prior chemotherapy or radiotherapy for biliary cancer
  -  refusal of informed consent

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment

Summary: The investigators will recruit and enroll individuals that may have the KRAS-variant or other microRNA binding site mutations to join registry studies. The investigators will allow individuals to obtain their results through a physician at the completion of the studies. The investigators current focus is breast cancer.

Detailed description: The investigators have identified germ-line microRNA binding site mutations that predict an increased risk of cancer, endometriosis and associated infertility, and unique tumor biology and response to treatment. The goal of this protocol is to further determine the mechanisms of these mutations, such as the KRAS-variant, and their associations with human health, such as cancer. The investigators will collect saliva samples from individual patients who are eligible and choose to enroll in these studies, to test for the KRAS-variant and/or other mutations under study. With specific permission, the investigators will keep excess DNA to further investigate and discover additional similar mutations. The investigators purpose is to have participants answer questionnaires about lifestyle factors in an ongoing manner, to understand the impact of different factors on cancer risk for patients with these mutations.

Eligibility: Inclusion Criteria:
  -  Personal or family history of cancer
  Exclusion Criteria:
  -  Younger than 18
  -  Non-english speaking and unable to understand and sign the consent

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma

Summary: This surveillance's objectives are:
  1. Unknown adverse reactions
  2. Incidences of adverse drug reaction
  3. Factors considered to have effect to safety and effectiveness


Eligibility: Inclusion criteria:
  Patients with Hepatocellular carcinoma
  Exclusion criteria:

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer

Summary: BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.


Eligibility: Inclusion Criteria:
  -  Males or females at least 18 years of age
  -  Diagnosis of NSCLC with locally advanced or metastatic disease
  -  Positive for KRAS mutation or Squamous cell histology
  -  Previously treated with one platinum-based chemotherapy
  -  Disease status must be that of measurable and/or evaluable disease
  -  Performance status of 0 to 1 on the ECOG Scale
  -  Prior chemotherapy completed at least 3 weeks prior to study enrollment
  -  Prior radiation therapy allowed to < 25% of the bone marrow
  -  Patient compliance and geographic proximity that allow adequate follow-up
  -  Adequate organ function
  -  Patients with reproductive potential must use contraceptive methods
  -  Signed informed consent from patient
  Exclusion Criteria:
  -  Active infection
  -  Pregnancy or planning to become pregnant
  -  Breast feeding
  -  Serious concomitant systemic disorders
  -  Second primary malignancy
  -  Patients who are symptomatic from brain metastasis
  -  Presence of detectable (by physical exam) third-space fluid collections
  -  More than 1 prior cytotoxic chemotherapy regimen for advanced disease
  -  Prior treatment with docetaxel
  -  History of severe hypersensitivity reaction to polysorbate 80
  -  Peripheral neuropathy at study entry
  -  Patients known to be HIV positive
  -  Patients known to be seropositive for hepatitis C hepatitis B
  -  Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: The Pre-operative Pathway in Pancreatic Head Malignancy-assessment of the Diagnostic Accuracy of Staging CT Scan

Summary: Our aim is to assess the ability of scans to distinguish the organ of origin of pancreatic head malignant tumours and to predict the resectability based on the preoperative imaging. To achieve this, a retrospective review of the preoperative CT scans will be conducted for all patients with pancreatic head malignancy treated at the Peninsula Hepato-Pancreatico-Biliary (HPB) cancer unit between January 2006 till January 2014.

Detailed description: Pancreatic cancer arises from the glandular part of the pancreas and is the fifth most common cause for cancer related death in the UK. It. Ampullary carcinoma arises from the epithelium of the ampulla of Vater into which the common bile duct and pancreatic duct drain. Cholangiocarcinoma arises from the bile duct epithelium, and may occur within the intra-pancreatic portion of the distal common bile duct mimicking a pancreatic malignancy. Cancers arising from these origins often cause obstructive jaundice and are hard to distinguish. Surgery is indicated for the treatment of these types of malignant tumours, and the definitive final diagnosis is usually not known until the specimen is examined. This situation does not allow specific treatment to be given pre-operatively, so-called 'neo-adjuvant therapy'. The rationale for this approach is that in a proportion of patients the tumour will be made smaller by this treatment, which may facilitate surgical resection.

Eligibility: Inclusion Criteria:
  -  All patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital between Jan 2006 and Jan 14 will be included.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

Summary: The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.

Detailed description: The LUMINIST study will enrol patients who are ineligible for the SELECT-1 (NCT01933932) or SELECT-2 (NCT01750281)RCTs. Within this NIS patients will be followed longitudinally for treatment information and outcomes. The final dataset will enable linkage at the individual patient level of the clinical information datasets collected within LUMINIST to the exploratory biomarker data generated from samples collected as part of SELECT-1 screening. This will enable the examination of various molecular markers in patients with v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type and some KRAS mutation positive (KRAS+) patients. The LUMINIST study aims to enable the investigation of various molecular segments in NSCLC, based on patient consent and where permitted by local legislation, some of which have not yet been discovered. The availability of a longitudinal dataset of clinical information linked to tumour samples will be a valuable tool to readily assess the clinical utility of potential new biomarkers. The determination of current standards of care and outcomes in future molecular segments of interest will provide valuable new insights to the scientific community.

Eligibility: Inclusion Criteria:
  1. Provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated by local regulations
  2. Female and male adults (according to each country regulations for age of majority)
  3. Patients who are not eligible or choose not to enter selumetinib SELECT-1 or SELECT-2 trials
  4. Patients with confirmed histological diagnosis of NSCLC
  Exclusion Criteria:
  1. Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla

Summary: This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.

Detailed description: Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.

Eligibility: Inclusion Criteria:
  * Duodenal and ampullary lesion > 10mm
  -  Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
  -  Aged 18 years or older
  Exclusion Criteria:
  -  Lesion less than 10mm
  -  Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
  -  Aged younger than 18 years

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Vitamin K Supplementation in Patients on Hemodialysis

Summary: The purpose of this study is to determine whether vitamin K supplementation will improve anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation. Patients who participate will receive vitamin K1 three times a week on dialysis days for a period of four months. INR levels collected during this period will be compared to the four month period prior to receiving the vitamin K1 to determine if vitamin K improves the standard deviation of INRs and time in therapeutic range.

Detailed description: Patients on hemodialysis with atrial fibrillation are at increased risk of stroke. These patients often take warfarin to reduce this risk. Warfarin is a drug that is used to prevent clots in the bloodstream. The dose of warfarin varies from person to person, and its effect is measured using a blood test called the international normalized ratio (INR). In most patients with atrial fibrillation the goal is to keep the INR between 2 and 3. Patients on hemodialysis often have unstable INR levels. Vitamin K supplementation has been shown to improve INR control in patients on warfarin but has not yet been studied in hemodialysis patients.
  In this study, patients on hemodialysis receiving warfarin for atrial fibrillation will receive vitamin K 400 mcg orally three times a week on dialysis days for 4 months. INR levels in the four months before and the four months while receiving vitamin K will be reviewed.
  The primary end point will look at INR stability and be measured by calculating the standard deviation of INR values before and after receiving vitamin K. The goal of this study is to determine whether vitamin K supplementation improves INR control in patients on hemodialysis taking warfarin for atrial fibrillation.

Eligibility: Inclusion Criteria:
  -  greater than 18 years of age
  -  Receiving in-house hemodialysis for at least 6 months
  -  Previously diagnosed with atrial fibrillation
  -  On warfarin for at least 6 months with a target INR of 2-3
  Exclusion Criteria:
  -  are unable to provide informed consent
  -  have a mechanical heart valve
  -  are receiving supplements containing vitamin K
  -  have a known hypersensitivity to vitamin K

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy

Summary: Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.

Detailed description: XELOX
  -  Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
  -  Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).

Eligibility: Inclusion Criteria:
  1. age ≥ 18
  2. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
  3. unresectable or metastatic
  4. progression after treatment with first line gemcitabine-based chemotherapy
  5. ECOG performance status of 0~2
  6. measurable or evaluable lesion per RECIST 1.1 criteria
  7. adequate marrow, hepatic, renal and cardiac functions
  Exclusion Criteria:
  1. severe co-morbid illness or active infections
  2. pregnant or lactating women
  3. History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
  4. active CNS metastases not controllable with radiotherapy or corticosteroids
  5. known history of hypersensitivity to study drugs

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)

Summary: Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.


Eligibility: Inclusion Criteria:
  1. Healthy adults between 18 and 65 years old
  2. Subject understands the study protocol and agrees to comply with it
  3. Informed Consent Form signed by the subject
  Exclusion Criteria:
  1. Subjects using vitamin supplements containing vitamin k
  2. Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
  3. Subjects presenting chronic degenerative and/or inflammatory diseases
  4. Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
  5. Subjects receiving corticosteroid treatment
  6. Subjects using oral anticoagulants
  7. Subjects with a history of soy allergy
  8. Subjects who have participated in a clinical study more recently than one month before the current study

Relevance to patient case: not relevant