araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer

Summary: Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.


Eligibility: Inclusion Criteria:
  -  Patients who suffer from locally advanced or metastatic pancreatic cancer
  -  Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
  -  ECOG performance status 0 to 1
  -  Signed written informed consent.
  -  White blood cell count (WBC) >= 3x10^9/L with neutrophils >= 1.5 x 10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 5.6 mmol/L (9 g/dL).
  -  Total bilirubin < 2 x upper limit of normal.
  -  AST and ALT < 2.5 x upper limit of normal, or < 5 x upper limit of normal in case of liver metastases.
  -  Serum creatinine < 1.5 x upper limit of normal
  -  Normal ECG without QT prolongation
  Exclusion Criteria:
  -  Resectable pancreatic cancer
  -  Previous chemotherapy (for adjuvant or metastatic disease)
  -  Any investigational drug within the 30 days before inclusion.
  -  Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
  -  Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
  -  Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
  -  Clinically symptomatic brain or meningeal metastasis. (known or suspected)
  -  Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
  -  History of any of the following cardiac events within the past 6 months: myocardial infarction (including severe/unstable angina; coronary/peripheral artery bypass graft; symptomatic congestive heart failure (CHF) > NYHA Class II; cerebrovascular accident or transient ischemic attack; pulmonary embolism
  -  Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of up to 3 anti-hypertensive drugs
  -  Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
  -  Previous malignancy (other than pancreatic cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor [Ta, Tis and T1].
  -  History of organ allograft
  -  Patients requiring long-term cortisone therapy
  -  Patients requiring oral anticoagulation treatment (such as marcoumar)

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: DNA Microarray Study of Pancreas Cancer

Summary: Pancreas cancer and precancerous cysts can be difficult to diagnose. Sometimes biopsies do not show cancer when cancer is actually present. We hypothesize that genetic differences exist in tissue that is malignant compared to nonmalignant. When patients present with a pancreas mass or cyst, we biopsy it by fine-needle aspiration during upper endoscopy with ultrasound guidance. We would like to use tissue obtained via endoscopic ultrasound guided fine needle aspiration to perform DNA microarray analysis, and compare the differences in gene expression level in the benign tissue compared to cancerous tissue in order to improve our diagnostic capabilities. DNA microarray measures gene expression level rather than germline mutations. The true diagnosis will be based on cytology, surgical pathology, or clinical followup. The performance of the microarray test as a diagnostic test will be compared to the performance of cytology.


Eligibility: Inclusion Criteria:
  -  Adults aged 18 or older who are able to give informed consent who present for an endoscopic ultrasound to evaluate a pancreas mass or cyst or for suspicion of cancer.
  Exclusion Criteria:
  -  Unable to give informed consent, pregnant or nursing, contraindication to endoscopic ultrasound, no mass or cyst found on ultrasound

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Proton Therapy for Unresectable Cancer (CA) of Pancreas

Summary: The purpose of this study is to find out what effects, good and/or bad, proton radiation and chemotherapy has on you and your pancreatic cancer.

Detailed description: Chemotherapy:Capecitabine on radiation days
  Proton radiation over 7 weeks
  Consolidation Chemotherapy:Gemcitabine

Eligibility: Inclusion Criteria:
  Pathologically confirmed adenocarcinoma of the pancreas.
  Patients must be medically inoperable or have unresectable disease
  Exclusion Criteria:
  -  Evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites.
  -  Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
  -  Prior surgical resection.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

Summary: The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.

Detailed description: For years Fluorouracil was the established treatment for pancreatic cancer with median survival times up to 8 months. Since 1997 Gemcitabine is also a standard therapy with in comparison to Fluorouracil a significant better clinical benefit.
  But after progression of the disease under a palliative first-line therapy there is no established second line therapy for pancreatic cancer.
  So the purpose of this study is to test the combination of Oxaliplatin and Docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy to get a reasonable second line concept.

Eligibility: Inclusion Criteria:
  -  Dated and signed informed concent
  -  Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV)
  -  Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy
  -  Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity
  -  Age >= 18 years
  -  Karnofsky index > 60%
  -  Expected live span > 12 weeks
  -  Sufficient bone marrow reserve: Granulocytes >= 1.5 x 109/L and Platelets >= 100 x 109/L and Hemoglobin >= 9 g/L
  -  Serum Bilirubin < 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed)
  -  AST/ALT < 2.5 x upper normal limit
  Exclusion Criteria:
  -  Every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. Inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible
  -  Pregnancy or lactation
  -  Patients able to reproduce that do not adhere to strict contraception
  -  Presence of brain metastasis
  -  Severe, uncontrolled infection
  -  Preexisting peripheral neuropathy > grade I
  -  Preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia
  -  Justified disbelief in the compliance of the patient
  -  Parallel participation in another clinical trial

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Epidemiological Study In Hypertensive Patients: Assessment Of Risk Factors Prevalence And Of Patients' Management

Summary: To assess the pattern of hypertension in the population in terms of presence of additional risk factors (ARF) and cardiovascular risk stratification.

Detailed description: routine physician visits

Eligibility: Inclusion Criteria:
  -  Age 18 to 80 years old
  -  Patients with hypertension: newly diagnosed and /or already diagnosed and treated , whether at goal or not for the blood pressure level;
  -  Patients with no history of CHD/CVD
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Summary: The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.
  The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)


Eligibility: Inclusion criteria:
  1. Signed and dated written informed consent in accordance with the GCP and local legislation.
  2. Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.
  Exclusion criteria:
  1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
  2. Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) who:
  -  are nursing or pregnant,
  -  or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.
  3. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
  4. Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
  5. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients

Summary: The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.

Detailed description: The pancreas is a large gland located behind the stomach. One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide. Insulin helps the cells to take in glucose. The liver makes glucose and insulin normally acts to decrease or shut off the liver's production of glucose. However, in patients whose pancreas no longer makes insulin or makes low levels of pancreatic polypeptide the liver cannot perform these duties as well. Studies have shown that these important functions of the liver are improved for these patients when pancreatic polypeptide is given together with their insulin. Because PP increases the liver's sensitivity to insulin and thereby reduces the amount of glucose produced by the liver, this will result in fewer swings in blood sugar levels both in the upper and lower range. With fewer swings in blood glucose, a patient should decrease the amount of insulin used. One of the main benefits of lowering total insulin requirement is a reduction in the development of dangerous low blood sugar levels.

Eligibility: Inclusion Criteria:
  -  Male and female volunteers between the ages of 18-75 with:
  -  10 subjects who are status post pancreatic resection and 10 volunteers who are Type 1 diabetic for > 8 years (volunteers must have a stable glycemic profile that includes use of an insulin pump to control their blood glucose) with or without prior pancreatic resection.
  -  HbA1c levels ≤ 8.5.
  Exclusion Criteria:
  -  Lactating or pregnant females.
  -  Brittle or Labile diabetics: Volunteers with extremely erratic patterns of glucose control with large fluctuations in glucose levels for no obvious reason.
  -  Allergy to beef or beef by-products.
  -  Hypoglycemia within the past year requiring medical or other assistance to correct.
  -  Known autonomic neuropathy.
  -  Documented blood glucose under 60 mg within the past year and hypoglycemic unawareness.
  -  Durations of type 1 DM ≤ 8 years.
  -  Not currently on pump therapy.
  -  Type 1 DM who has a BMI ≥ 35.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer

Summary: The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.

Detailed description: Gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first line therapy for advanced pancreatic cancer. After disease progression, there is no standard treatment available. In animal studies and a previous phase I trial, PEP02 has shown anti-tumor activity and preliminary efficacy in pancreatic cancer. In addition, a phase II study of free-form irinotecan single agent has already shown encouraging activity as second-line treatment for patients with advanced pancreatic cancer refractory to gemcitabine. The liposome formulation of PEP02 theoretically has therapeutic advantages over free-form irinotecan, such as site-specific delivery and extended release of drug. Hence PEP02 may be able to provide better efficacy than free-form irinotecan.
  The primary purpose of this phase II study is to evaluate the activity of PEP02 as a second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine treatment. The primary goal is to measure the 3-month survival rate. An optimal Simon's 2-stage design will be used for this exploratory phase II study.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
  -  Metastatic disease
  -  Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen
  -  Karnofsky performance status equal or more than 70
  Exclusion Criteria:
  -  With active CNS metastases
  -  With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1)
  -  Major surgery or radiotherapy within 4 weeks
  -  Prior participation in any investigational drug study within 4 weeks
  -  With prior irinotecan treatment

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders

Summary: RATIONALE: Gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future.
  PURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders.

Detailed description: OBJECTIVES:
  Primary
  -  To collect clinical data and family histories and blood and/or tissue samples from patients diagnosed with pancreatic diseases, including pancreatic cancer, for use in future studies.
  -  To collect information regarding food preparation and intake in these patients.
  Secondary
  -  To make available to researchers medical data and biospecimens to enable them to develop better ways to screen people at risk for pancreatic conditions, including pancreatic cancer.
  -  To investigate genes or substances that increase susceptibility of developing pancreatic conditions.
  -  To find agents that may help prevent, treat, or cure these conditions.
  -  To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.
  OUTLINE: This is a multicenter study.
  Patients complete two 1-hour surveys assessing health, clinical and family history of pancreatic conditions including cancer, and food preparation and intake. Patients also complete a 15- to 30-minute follow up survey at 6 months and 1 year to assess health, health practices, and family history. A review of the patient's medical information is obtained from the medical record.
  Blood samples are collected for future research studies. Oral cells and stool samples may also be collected for future studies.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis or suspicion of at least one of the following:
  -  Pancreatic cancer
  -  Pancreatic mass
  -  Islet cell tumor
  -  Intraductal papillary mucinous neoplasms (IPMN)
  -  Hereditary pancreatitis
  PATIENT CHARACTERISTICS:
  -  Able to understand and read English
  -  Mentally competent and able to provide informed consent
  -  Has not donated blood within the past 8 weeks
  PRIOR CONCURRENT THERAPY:
  -  At least 7 days since prior blood transfusion
  -  At least 7 days since prior surgery

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma

Summary: RATIONALE: Collecting and storing samples of blood and tissue from family members of patients with cancer to test in the laboratory may help the study of cancer in the future.
  PURPOSE: This clinical trial is collecting blood and tissue samples from family members of patients with pancreatic disease, pancreatic cancer, and melanoma.

Detailed description: OBJECTIVES:
  -  To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma.
  -  To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.
  OUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Has at least 2 blood relatives with pancreatic cancer (both must be related)
  -  Has at least 1 blood relative with pancreatic cancer and 1 with melanoma (both must be related)
  PATIENT CHARACTERISTICS:
  -  Mentally competent and able to provide informed consent
  -  Able to understand and read English
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia

Summary: Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. Biomarker is not available for detection of malignant potential of OED till now. p16 is an important tumor suppressor gene, which is inactivated frequently by methylation of CpG island in early stage of carcinogenesis. The present cohort study is to investigate whether p16 methylation is correlated with malignant transformation of OED.

Detailed description: -  Background: Identification of malignant potential of oral epithelial dysplasia (OED) is virtually impossible on histopathological grounds alone. Inactivation of p16 gene by CpG methylation is an early frequent event during oral carcinogenesis. To investigate the predictive value of p16 methylation on malignant potential in OED, we carried out the prospective cohort study.
  -  Methods: 101 patients with histologically confirmed mild or moderate OED were included in the present study. Baseline information of p16 methylation status of the OED lesions from 93 cases was obtained by methylation-specific PCR. Progression of the OEDs lesions was examined in 78 cases histologically during the 45.8 months double-blind followup survey (78/93). The association between p16 methylation and progression of OED was analyzed with SPSS13.0 software. All P-values were two-sided.

Eligibility: Inclusion Criteria:
  -  histological diagnosis of mild or moderate grade OED; and
  -  enough amount of tissue sample from OED lesion for genomic DNA extraction; and
  -  available of methylation status of p16 CpG island in the extracted DNA sample.
  Exclusion Criteria:
  -  histological diagnosis of severe grade OED or malignant disease; or
  -  amount of tissue sample is not enough for preparation of genomic DNA (20ng); or
  -  quality of the prepared DNA is not good enough for detection of p16 methylation; or
  -  OED treatment history by LASER, radiotherapy, or chemotherapy

Relevance to patient case: not relevant