araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Magnification Narrow Band Imaging Colonoscopy for Hereditary Non-Polyposis Colorectal Cancer Surveillance

Summary: The purpose of this study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI)can help doctors detect more patients with at least one pre-cancerous area than conventional colonoscopy using white light alone in patients with genetically inherited high risk for bowel cancer (HNPCC).

Detailed description: Colorectal cancer is the second commonest cause of cancer death. Some people have an inherited defect in the genes which repair DNA which results in a very high risk of colorectal (bowel) cancer at a young age. This syndrome is called hereditary non-polyposis colorectal cancer (HNPCC) or Lynch syndrome. Colonoscopic surveillance of HNPCC patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed.
  Precancerous lesions in HNPCC are difficult to see and may be advanced even if as small as a few millimeters. Endoscopists have used spraying dye on the lining of bowel (Chromoendoscopy) successfully to improve detection of abnormal areas; however this is time consuming and requires extra time and equipment and despite the benefits seen in two studies is not widely used in routine clinical practice in the UK.
  Narrow Band Imaging (NBI) is a technique that relies on light to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network. It is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. With magnification it allows assessment of the fine mucosal surace pattern (pit pattern) of lesion which allows an assessment of their likelihood of being precancerous. Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon.
  We aim to see if NBI with magnification is better than standard colonoscopy for detecting precancerous areas. This is likely as it produces images similar to chromoendoscopy which is already shown to help. If a potentially precancerous area is found we will use other types of endoscopy, in particular NBI and autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non-cancerous areas.

Eligibility: Inclusion Criteria:
  -  patients with HNPCC according to the Amsterdam II criteria
  -  patients over 18 years
  Exclusion Criteria:
  -  pregnant patients
  -  unable or unwilling to give consent

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1

Summary: Primary objective:
  To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00 am between patients on Insulin glargine and NPH insulin.
  Secondary objective:
  To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).


Eligibility: Inclusion Criteria:
  Patients with type 1 Diabetes mellitus who have been treated with MDI (Multiple Daily Injection) basal/bolus insulin, regular insulin/short acting insulin analogue + NPH insulin on a stable dose (no change more than 10 %) for at least 4 weeks prior to study entry, who have an HBA1c smaller/equal 9 % (measured at visit 1) and a BMI smaller/equal 35 kg/m2. In addition, patients must have a FBG value at day 1 before skipping meal (6:00 am - 07:00 am) between 90 - 120 mg/dl (5.0 - 6.5 mmol/l).
  Exclusion Criteria:
  -  Breast-feeding
  -  History of hypersensitivity to the study medication or to drugs with similar chemical structures
  -  Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
  -  Treatment with any investigational drug in the last 30 days before study entry
  -  Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
  -  History of drug or alcohol abuse
  No subjects who have previously been treated with Insulin glargine will be enrolled in this study.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer

Summary: The primary objective of this study is to assess the effect of treatment with ABX-EGF on best overall objective response rate by modified RECIST (confirmed complete or partial response) in Japanese subjects with metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Metastatic colorectal adenocarcinoma;
  -  Subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including those who relapsed during or within 6 months from the completion of adjuvant therapy using the above agents; - Tumor expressing EGFr levels by immunohistochemistry (membrane staining must be positive in 1% of evaluated tumor cells).
  Exclusion Criteria:
  -  Subjects who have prior experimental or approved antibodies (eg, bevacizumab) within 3 months before enrollment;
  -  Subjects who have prior EGFr targeting agents;
  -  Chemotherapy other than fluoropyrimidine (including oral agents such as UFT, TS-1), irinotecan, and oxaliplatin (or raltitrexed) for colorectal carcinoma in accordance with specified regimens (leucovorin and levamisole are not considered as chemotherapy

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Coordinated Endoscopic Colorectal Cancer Screening

Summary: The investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations.

Detailed description: The investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations.
  To accomplish these aims, the investigators propose 1) to use existing physician practice-based computerized patient registration systems to define populations of 50 to 79 year-old pri-mary care patients, 2) to use mailed questionnaires to determine colorectal cancer risk factor status and prior colorectal cancer screening history, 3) to use responses from mailed questionnaires to identify persons not adhering to colorectal cancer screening guidelines, 4) to use computer driven algorithms to help physicians prepare and deliver individually tailored and written colorectal cancer screening recommendations, and 5) to develop, implement, and evaluate a centralized service for delivering high quality screening flexible sigmoidoscopy.

Eligibility: Inclusion Criteria:
  Exclusion Criteria:
  -  history of colorectal cancer or polyps
  -  flexible sigmoidoscopy within five years of enrollment
  -  barium enema within five years of enrollment
  -  colonoscopy within five years of enrollment

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

Summary: This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Detailed description: This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Eligibility: Inclusion Criteria:
  -  Adult patients 20-74 years of age
  -  Histologically confirmed colorectal cancer
  -  Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease
  -  At least one measurable lesion according to RECIST
  Exclusion Criteria:
  -  Evidence of clinically detectable ascites at study treatment start
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.
  -  Evidence of bleeding diathesis or coagulopathy
  -  Serious, non-healing wound, ulcer, or bone fracture
  -  Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

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: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

Summary: To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

Detailed description: To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III (UICC Sixth version) colorectal cancer/histological curability A (Japanese Classification of Colorectal Carcinoma, Sixth version) as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

Eligibility: Inclusion Criteria:
  -  Patients with pTNM stage IIB or III (UICC Sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability A (including laparoscopic surgery) (the curability is judged after surgery)
  -  Patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (T4) or with histologically positive lymph node metastasis (N+) (to be judged after surgery)
  -  Patients who is between 20 and 80 years old at the time of obtaining informed consent
  -  Patients with performance status of 0 - 2
  -  Patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation
  -  Patients without severe dysfunction of renal, hepatic, or bone marrow function
  -  Patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases
  -  Patients who have given consent to participate in this clinical study by himself/herself or his/her family
  Exclusion Criteria:
  -  Patients in whom the bottom of tumor reaches the peritoneal reflection
  -  Patients with lower rectal cancer (Rb), anal canal (P), or circumanal skin (E)
  -  Patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers)
  -  Women who are currently pregnant or wish to be pregnant during this clinical study
  -  Patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003

Summary: The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma.
  The primary endpoint is progression free survival rate at 18 weeks after registration

Detailed description: The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective standard therapy exists. Eligible patients must have had at least second-line chemotherapy.

Eligibility: Inclusion Criteria:
  -  Cancer confirmed by histology or cytology
  -  At least one measurable lesion
  -  Advanced disease refractory to standard therapy or for which no standard therapy exists
  -  Life expectancy of at least 3 months
  Exclusion Criteria:
  -  Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma
  -  Body weight below 45 kg
  -  Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
  -  Confirmed diagnosis of HIV
  -  Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II
  -  Chemotherapy or radiotherapy less than 4 weeks prior to entry
  -  Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
  -  Participation in a clinical trial less than 30 days prior to entry in the study

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients

Summary: Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and lopinavir/r levels when compared to Caucasian patients. Until now, the pharmacokinetics of atazanavir have not been explored in a Thai population. We postulate that ATV levels, as with other PIs, are higher in Thai people. Therefore, the level of ATV in ATV/RTV 300/100 OD may be higher than the acceptable range and could be associated with ATV related toxicity.

Detailed description: We are interested in once daily ATV/RTV 200/100 mg OD because of the convenience, reduction in ATV doses which may improve adherence while reducing toxicity and cost. There are limited prospective studies evaluating pharmacokinetic and long term efficacy and safety of atazanavir/ritonavir once daily dose in combination of NRTIs in HIV-1 pretreated patients. We believe that the PK parameters of ATV/RTV given at 200/100mg daily in Thai patients will be equivalent to the ATV/RTV 300/100mg once daily dosing in Caucasian patients when combined with 2NRTIs, and that the once daily regimen will have better safety, tolerability profile, and cost saving while maintaining good CD4 and VL outcome. If, the pharmacokinetic profile of ATV/RTV 200/100 mg OD + 2NRTIs is in acceptable range or comparable with standard dose of ATV/RTV 300/100 mg OD, long term efficacy will be explored later.

Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Adults HIV patients currently using ATV/RTV 300/100 mg OD plus 2 NRTIs
  -  HIV RNA < 50 copies/ml
  Exclusion Criteria:
  -  Inability to understand the nature and extent of the study and the procedures required.
  -  ALT/ AST more than 5x upper limit
  -  Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
  -  Use of concomitant medication that may interfere with the pharmacokinetics of atazanavir, and ritonavir
  -  History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
  -  Active drug abuse or heavy alcoholic drinking
  -  History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
  -  Active drug abuse or heavy alcoholic drinking

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Acupuncture Treatment in Adults Undergoing Diagnostic OGD : A Double-Blind Placebo Controlled Randomized Trial

Summary: To find out how the application of acupuncture needles to the proposed acupuncture points: Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during Esophago-gastro-duodenoscopy (EGD)

Detailed description: Acupuncture is being used as one part of Chinese medicine for more than 2,500 years in treating diseases. Recent functional magnetic resonance imaging demonstrated that acupuncture can suppress the “pain” area in the brain so as to reduce the pain that felt by human subjects. Western medicine proposed the acupuncture mechanisms as to “provoke the release of endogenous substances” from central nervous system so in reducing pain. Many studies had been done using acupuncture in reducing pain for post-operation period, however, most of them were not very systematic and even some of them are leak of control group. Furthermore, to our knowledge, the use of acupuncture for reducing anxiety during EGD has not been previously investigated.

Eligibility: Inclusion Criteria:
  -  18-70 undergoing elective unsedatant diagnostic EGD
  -  belonging to American Society of Anesthesia (ASA) classes 1 to 2
  Exclusion Criteria:
  -  History of gastrectomy, esophagectomy, Whipple’s operation and other gastrointestinal operations
  -  ASA class 3 to 4
  -  Pregnancy
  -  Allergy to acupuncture needles
  -  Request sedation
  -  Previous experiences of EGD

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

Summary: RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.
  PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer.

Detailed description: OBJECTIVES:
  -  Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer.
  -  Collect detailed clinical, pathological, and chemotherapy data from these patients.
  -  Identify genetic factors that relate to treatment response and outcome in these patients.
  OUTLINE: Blood samples are collected and relevant genes and regions are amplified by PCR. PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms. Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes.
  Clinical and family history data is also collected by questionnaire.
  PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of metastatic colorectal cancer
  -  Currently receiving chemotherapy at Weston Park Hospital
  PATIENT CHARACTERISTICS:
  -  Not Specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

Summary: This study will assess the safety of RAD001 when given together with cetuximab and irinotecan


Eligibility: Inclusion criteria:
  -  Age ≥ 18 years old and ≤ 65 years old.
  -  Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor.
  -  Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.
  -  Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.
  -  Patients with a WHO performance status of 0 or 1.
  Exclusion criteria:
  -  Patients with Gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
  -  Patients who are homozygous for the UGT1A1*28 allele as determined by sequencing.
  -  Patients who have received previous irinotecan-based therapy.
  -  Prior treatment with an mTOR inhibitor.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant