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

Clinical trial: Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program

Summary: The primary objective of this chart review study is to evaluate the outcomes of subjects with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) who have not undergone surgical resection of the colon.
  A secondary objective of this study is to compare 1) the colonoscopic and pathology histories including history of ampullary adenoma in the duodenum over family generations, 2) the use of chemopreventive medications, and 3) clinical features of subjects who pursued prophylactic surgical resection of the colon with those that have elected to continue routine colonoscopic surveillance in an effort to better characterize factors (e.g. polyp burden, ampullary adenoma and level of dysplasia, etc) which may influence management decisions.

Detailed description: The UTMDACC family history database will be queried for the presence of cases meeting the above criteria (attenuated Familial Adenomatous Polyposis (FAP), classical AFP [i.e. identifiable APC mutation], and/or a compatible family history or personal adenoma burden of > 50 adenomas).
  The data related to the patients with attenuated FAP and classical AFP who underwent endoscopic surveillance or surgery will be collected through chart review and all data is retrospective as of February 15, 2016.
  The University of Texas MD Anderson Cancer Center (UTMDACC) medical record number for these cases will be used to identify the patient in ClinicStation: 1) records of endoscopy procedures, 2) operative reports, and 3) associated clinic notes will be reviewed for: a) whether the above evaluation criteria have been met, b) age, c) gender, d) age at initial colonoscopy, e) total number of colonoscopies, f) number of adenomas identified, g) cancer diagnoses, h) chemopreventive medications, i) type of surgery, j) number of hospitalizations, k) length of hospital stay, l) identification of an underlying APC mutation, and ll) family history information. The UT MDACC family history database will also be reviewed for updated family history information including ampullary adenomas and outcomes of genetic testing for identified cases.

Eligibility: Inclusion Criteria:
  1. Participants with either a genetic diagnosis of AFAP/FAP (i.e. an identifiable APC gene mutation), and/or a compatible family history and pathology including history of ampullary adenoma in the duodenum over family generations, or personal adenoma burden of > 50 adenomas are to be included.
  Exclusion Criteria:
  1. Participants who do not have with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP).

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

Clinical trial: Aortic Calcification and Vitamin K Antagonists

Summary: The vitamin K antagonists (VKA) are necessary drugs of prevention and treatment of thrombo-embolic disease. The AVKAL study assesses the impact of VKA treatment on the aortic calcifications development. This is a biomedical research without health product, transversal and monocentric study which compares the aortic calcifications levels of two populations : one treated by VKA and the other which has never been treated by VKA.

Detailed description: The vitamin K antagonists exercise their anticoagulant effect by preventing the vitamin K dependant gamma-carboxylation of coagulation II, VII, IX and X factors which forms the final step of their activation.
  They inhibit the vitamin K epoxide reductase VKORC1 enzyme, which is responsible of the vitamin K epoxide recycling in vitamin K hydroquinone (its reduced form). The carboxylation also can be inhibited by the Matrix Gla protein (MGP), inhibitor factor of vascular calcifications.
  Warfarin (the most used VKA at the word level) is employed on animal for produce vascular calcifications by inhibiting the MGP activation.
  Epidemiologic data indicate that warfarin could increase the calcifications of cardiac valves and coronary arteries. However, these studies were not interested in abdominal aorta's calcifications which are considered like an important marker of cardiovascular risk and did not concern the fluindione which is the most used VKA in France. Even if a class effect seems logical, the investigators can't dismiss the local effects, different to warfarin. In these studies, the calcifications assessment were rarely quantitative and the MGP levels were not measured. The vascular calcifications constitute a potential adverse effect of VKA which could limit their benefit in certain populations.
  In this work there is an assumption that the aortic calcifications levels are upper in patients receiving VKA than in patients who are not receiving VKA and the aortic calcifications increase is owed to the non-activation of MGP.
  The main objective is to assess if the taking of VKA is associated with the aortic calcifications development in patients receiving VKA.
  Investigators will compare 2 populations: one group treated by VKA treatment for at least 6 months and one focus group which have never been treated by VKA treatment.

Eligibility: Inclusion Criteria:
  -  patients having a abdominal scanner without injection planned at CHU Amiens
  -  group treated by VKA: VKA treatment for at least 6 months
  -  group not treated by VKA: no antecedent of AVK treatment
  Exclusion Criteria:
  -  abdominal scanner contre indication
  -  progressive cancer
  -  scanner planned by emergency department
  -  patient having had acute cardiovascular accident in the last 3 months

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

Clinical trial: Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

Summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility: Inclusion Criteria:
  -  Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
  -  Age ≥ 18 years
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  Exclusion Criteria:
  -  Patients whose health-cons indicates a blood sample 10mL
  -  Age < 18 years
  -  Pregnant or breast feeding females
  -  Persons deprived of liberty or under supervision

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

Clinical trial: A Real World Study to Evaluate Effectiveness of Avastin (Bevacizumab) for First Line Treatment of Patients With Metastatic Colorectal Cancer and Known KRAS Status

Summary: This non-interventional study will meta-analyze overall survival outcomes among the participants with metastatic colorectal cancer (mCRC) with available V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) status, who received firstline treatment with bevacizumab containing treatment regimen in routine clinical practice. The study leveraging secondary data from existing cohorts in the United Stats of America (USA), Germany, Australia, and Denmark.


Eligibility: Inclusion Criteria:
  -  Participants with metstatic colorectal cancer (mCRC) diagnosed at any point prior to March 2014 (United States [US] - Vector Oncology Protocol Sponsored by US Roche Pharma Medical Affairs), diagnosed between September 2006 and March 2015 (Germany - Tumourregister Kolorektales Karzinom [TKK] Registry Study Supported by German Roche Pharma Affiliate), diagnosed between September 2009 and December 2014 (Australia - Treatment of Recurrent and Advanced Colorectal Cancer [TRACC] Registry Supported by Roche Pharma Australia), diagnosed between 2009 and 2013 (Denmark - Roche Diagnostic Sponsored Study and Aarhus University Hospital, Department of Clinical Epidemiology)
  -  Participants have been treated in first line with bevacizumab or Anti-EGFR treatment regimen or chemotherapy alone
  -  Participants have to have available data on overall survival (OS), KRAS testing status, and left/right tumor location status
  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: Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma

Summary: The clinical trail of Cinobufacini injection combined with Oxaliplatin regimen on gastrointestine carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives Cinobufotalin 20ml mixed with 5% Glucose injection 500ml from the first day of chemotherapy until seven days in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.Mainly to study of oxaliplatin into Cinobufacini injection leads to the influence of the peripheral nerve toxicity.Clinical evaluation includes neural electrophysiological test,chemotherapy drug toxicities,quality of life(QOL),etc.Blood biochemistry tests mainly include inflammatory cytokines,peroxidase reaction,immune cell number ratio and stress hormone,etc.


Eligibility: Inclusion Criteria:
  -  Age:18-70
  -  male and female
  -  signed the informed consent form.
  -  Diagnosis:Gastrointestinal cancer diagnosed by imaging,cell and pathology report.
  -  Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months.
  -  Indication for Chemotherapy,no contraindication.
  -  First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy.
  -  At least 8 weeks after last biotherapy.
  -  Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.
  Exclusion Criteria:
  -  Chemotherapy is contraindicated.
  -  Have the primary disease can cause the neuropathy.
  -  A history of other malignant tumor in recent 5 years.
  -  Less than 6 months after last chemotherapy or radiotherapy.
  -  Less than 8 weeks after last biotherapy.
  -  Cinobufotalin allergy.
  -  Had received transplantation surgery,less than 2 weeks after last major surgery.
  -  Other researchers think is not suitable for this clinical trail.

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 Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer

Summary: The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.


Eligibility: Inclusion Criteria:
  -  Advanced or metastatic cancer.
  -  Able to swallow tablets.
  -  For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations.
  -  Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy.
  Exclusion Criteria:
  -  Active infection (fungal, viral, or bacterial).
  -  Active cancer in your brain or spinal cord.
  -  Acute or chronic leukemia.
  -  Serious heart condition.
  -  Disease that requires immunosuppressant therapy.
  -  Diagnosis of inflammatory bowel disease.
  -  Major small bowel resection that interferes with your body's ability to absorb the oral medicine.
  -  Participated in other clinical trials investigating prexasertib or ralimetinib.
  -  Pregnant or breastfeeding.
  -  Other pre-existing conditions or medical history which your doctor will explain to you.

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

Clinical trial: The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater

Summary: The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.

Detailed description: The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.

Eligibility: Inclusion Criteria:
  -  Cap-assisted endoscopy
  -  Referral to endoscopic examination of ampulla of Vater
  Exclusion Criteria:
  -  Patients with surgically modified anatomy.
  -  Obstruction of the upper gastrointestinal tract.
  -  Contra-indication for endoscopy.
  -  Absence 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 Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma

Summary: Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.


Eligibility: Inclusion Criteria:
  1. General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;
  2. Pathology diagnosed;
  3. Brain, heart, lung, liver, kidney are at good condition before surgery;
  4. No mental disorder, no conscious obstacle, no limbs disability.
  Exclusion Criteria:
  1. Severely complication after surgery;
  2. Contraindication of the acupuncture;
  3. Patients with mental disease;
  4. Patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.

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

Clinical trial: Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla

Summary: Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.


Eligibility: Inclusion Criteria:
  -  Indication of Esophagogastroduodenoscopy independent from the study
  -  Written informed
  -  Age ≥ 18 years
  Exclusion Criteria:
  -  Absence of written informed consent
  -  Contraindication or absence of informed consent regarding sedation with Propofol
  -  Postoperativ changes of the upper GI-tract
  -  Intention of endoscopic intervention
  -  Suspicion of upper GI-bleeding
  -  Suspicion of stenosis of the esophagus
  -  Stent in the papilla duodeni major
  -  ASA (American Society of Anesthesiologists) classification ≥ 3

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

Clinical trial: Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla

Summary: Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side*viewing duodenoscope for complete examination of MDP.


Eligibility: Inclusion Criteria:
  -  indication for elective upper endoscopy
  -  age over 18 years
  -  ability to provide informed consent
  Exclusion Criteria:
  -  surgically altered upper gastrointestinal tract
  -  known or suspected upper gastrointestinal strictures
  -  upper gastrointestinal bleeding
  -  biliary stent
  -  planned endoscopic intervention
  -  American Society of Anesthesiologists class III or higher
  -  contraindication for or refusal of sedation with Propofol
  -  inability to give 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: Healthcare Cost and Resource Utilization Related to Metastatic Renal Cell Carcinoma Treatment With Intravenous and Oral Agents

Summary: A retrospective study to evaluate healthcare cost and resource utilization for patients with metastatic renal cell carcinoma who have been treated with IV or oral agents


Eligibility: Inclusion Criteria:
  -  Diagnosis with metastatic renal cell carcinoma
  -  Prescription/administration of one of the IV or oral agents examined in the study
  Exclusion Criteria:
  -  Patients with other primary cancer diagnosis before RCC diagnosis
  -  Patients with pregnancy or HIV/AIDS

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

Clinical trial: Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

Summary: This trial will evaluate Hu5F9-G4 in combination with cetuximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. Cetuximab is a monoclonal antibody drug that is used for treatment of certain types of colorectal cancer as well as head and neck cancer.
  The major aims of the study are: (Phase 1b) to define the safety profile and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with cetuximab, and (Phase 2) to evaluate the objective response rate of Hu5F9-G4 in combination with cetuximab in patients with advanced colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histological Diagnosis
  -  Phase 1b only: Advanced solid malignancy with an emphasis on colorectal, head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
  -  Phase 2:
  -  KRAS Mutant CRC: Advanced KRAS mutant CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy
  -  KRAS Wild Type CRC: Advanced KRAS wild type CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-EGFR antibody, such as cetuximab, panitumumab or others.
  -  Adequate performance status and hematological, liver, and kidney function
  -  Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy
  Exclusion Criteria:
  -  Active brain metastases
  -  Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents.
  -  Phase 2 only: second malignancy within the last 3 years.
  -  Known active or chronic hepatitis B or C infection or HIV
  -  Pregnancy or active breastfeeding

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 to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)

Summary: Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism. The investigators will conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. Sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).


Eligibility: Inclusion Criteria:
  -  Age 8 to 17 years
  -  Body mass index equal to or greater than 95th percentile for age and sex
  -  Presence of prediabetes, as defined by American Diabetes Association Guidelines (fasting blood glucose of 100-125 mg/dl and/or A1C blood test measure of 5.7-6.4%)
  -  Subject and parent/guardian understands the study protocol and agrees to comply with it
  -  Informed Consent Form signed by the parent/guardian and assent signed by the subject
  Exclusion Criteria:
  -  Subjects using vitamin supplements containing vitamin k
  -  Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
  -  Subjects presenting chronic degenerative and/or inflammatory diseases
  -  Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
  -  Subjects receiving corticosteroid treatment
  -  Subjects using oral anticoagulants
  -  Subjects with a history of soy allergy
  -  Subjects who have participated in a clinical study more recently than one month before the current study

Relevance to patient case: not relevant