araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

Summary: The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

Detailed description: Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is difficult to diagnose at its early stage and only 10-20% of patients are candidates for resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8 months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination therapy has high rate of side effects. This phase Ⅱ randomized controlled study compares efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather ordinary clinical settings.

Eligibility: Inclusion Criteria:
  1. Histologically or cytologically proven unresectable pancreatic carcinoma
  2. There must be measurable lesions with multislice CT
  3. ECOG Performance status 0-2
  4. No other active cancer
  5. No previous therapy such as radiotherapy, chemotherapy and immunotherapy
  6. Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min
  7. No serious complications
  8. Be able to eat food
  9. Life expectancy of more than 8 weeks duration
  10. Informed consent is obtained-
  Exclusion Criteria:
  1. Interstitial pneumonia
  2. Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
  3. Serious infection
  4. Pregnant or lactating females
  5. History of serious drug allergy
  6. Serious other complications
  7. Uncontrolled mental disorders -

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine

Summary: A dose finding study in locally advanced and/or metastatic pancreatic cancer patients


Eligibility: Inclusion criteria:
  1. Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases
  2. Adequate bone marrow, liver and renal function on everolimus treatment
  3. At least one measurable lesion according to RECIST criteria that has not been previously irradiated.
  4. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer.
  5. Age >18 years
  Exclusion criteria:
  1. Women who are pregnant or breast feeding.
  2. Documented intolerance or history of allergy to everolimus or Gemcitabine.
  3. History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
  4. Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement
  5. Chronic treatment with systemic steroids or another immunosuppressive agent
  6. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus
  7. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value < 50 % or prothrombine time more than 1,5 fold higher
  Other protocol defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Research on the Environment and Children's Health: Retinoblastoma

Summary: The purpose of the research study is to learn more about the causes of retinoblastoma and to identify possible risk factors in the parents of patients with retinoblastoma. This kind of study is called an epidemiology study and is often done by interviewing people with and without the disease. In the case of a childhood disease, the researchers ask about experiences of the parents and children before the disease developed.

Detailed description: The purpose of the study is to investigate the role of paternal exposures in the etiology of sporadic heritable retinoblastoma (RBL). The study has a matched case-control design with a sample size of 255 pairs. Cases will be children with sporadic heritable (RBL) identified from eight hospitals that together treat most of the RBL patients in the U.S. and Canada. We will use regional controls matched on year of birth and state/province of residence identified by randomdigit-dialing (RDD). Fathers and mothers of cases and controls will be interviewed by telephone about their occupational, medical, dietary, and personal exposures before the index child's conception. Blood samples will be obtained on cases and their parents for DNA isolation. The case's DNA will be used to characterize the disease-causing RB1 mutation. The parent's DNA will be used to detect the few instances in which a parent also has the RB1 mutation, i.e., the child's RBL is familial rather than sporadic.

Eligibility: Inclusion Criteria:
  -  Cases will be children with sporadic heritable RBL, i.e., bilateral RBL without a family history of the disorder.
  -  Cases will be diagnosed with retinoblastoma in an approximately 7-year period, beginning January 1, 1998 and continuing until the sample size is reached.
  -  The case family must reside in the continental U.S., Alaska, or Canada.
  -  The case family must have a telephone in the household.
  -  The patient's physician must give permission to contact the parents of the case.
  -  The biologic father or mother of the case must be available and consent to be interviewed.
  -  The father or mother must speak English or Spanish.
  -  Genetic counseling regarding RB1 gene mutation analysis must be done prior to registration onto study.
  Exclusion Criteria:
  - Cases that do not meet the above criteria will be ineligible to participate and excluded from the study.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Summary: There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
  -  To determine safety
  -  To determine overall survival
  -  To determine time to progression

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
  -  Histologically or cytologically confirmed adenocarcinoma of the pancreas
  -  At least one measurable lesion according to RECIST criteria that has not been irradiated
  -  Adequate laboratory parameters as outlined in protocol
  -  Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
  -  Negative serum pregnancy test within 14 days prior to registration
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Life expectancy < 3 months
  -  Serious, uncontrolled, concurrent infection(s)
  -  Any prior oxaliplatin or fluoropyrimidine therapy
  -  More than one prior chemotherapy regimen for unresectable or metastatic disease
  -  Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
  -  Any active second malignancy
  -  Clinically significant cardiac disease or myocardial infarction within the last 12 months
  -  Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
  -  Other serious uncontrolled medical conditions
  -  Major surgery within 4 weeks of the start of study treatment, without complete recovery
  -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  -  Known, existing uncontrolled coagulopathy

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: CT Pancreas Perfusion

Summary: 1. Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and using novel post-processing techniques, is a reliable method which can be used to differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis.
  2. Pancreatic CT perfusion can be used to monitor patients undergoing decompression treatment (endoscopic retrograde cholangiopancreatography with stent placement) for painful chronic pancreatitis, and the change in the pancreatic perfusion parameters correlate with the change in the pain parameters (pain scale and analgesic use).
  3. Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.


Eligibility: Inclusion Criteria:
  1. a. Suspected pancreatic adenocarcinoma, age 35 to 99 years.
  2. a. Chronic pancreatitis with chronic pain, age 18 to 99 years. Must be a confirmed diagnosis by either CT, endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP).
  2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan.
  2c. To answer pain questionnaire before first CT perfusion scan.
  2d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire.
  3a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by CT, MRI, or EUS or
  3b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum immunoglobulin G4 (IgG4), or histological confirmation.
  Exclusion Criteria:
  1a. Pancreatic ductal adenocarcinoma tumors with vascular involvement but without vascular occlusion.
  1. b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size.
  2. a. Chronic pancreatitis with diffuse and extensive pancreatic calcification.
  3. a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis .
  Any Cohort:
  4. Pregnant.
  5. Prior iodine contrast reactions.
  6. Iodine allergy.
  7. Decreased kidney function being a serum creatinine greater than 1.5mg/dl.
  8. Any contraindication to having a CT scan with iodine contrast.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma

Summary: Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of the investigators is to determine the prognostic value of ECLNI in a prospective consecutive series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998 and 2005.

Detailed description: Presence and extent of extracapsular lymph node involvement (ECLNI) will be scored by reviewing all original pathological slides.
  ECLNI is defined as metastatic adenocarcinoma extending through the nodal capsule into the perinodal fatty tissue.
  Observers: 1 experienced board-certified GI pathologist, blinded for follow-up results.
  Follow-up data are obtained by reviewing patients charts and by a telephone survey of the patient's GP/gastroenterologist in November 2007.
  Statistical analysis:
  -  Common closing date: 1/11/2007
  -  Kaplan-Meier survival analysis (Log-Rank, Wilcoxon)
  -  Cox logistic regression (uni/multivariate)

Eligibility: Inclusion Criteria:
  -  DPAC
  -  Primary resection
  Exclusion Criteria:
  -  Positive section margins
  -  non DPAC, other tumor
  -  Postoperative mortality
  -  Neoadjuvant chemo/radiotherapy

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Tight Glycemic Control by Artificial Pancreas

Summary: This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.

Detailed description: This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.

Eligibility: Inclusion Criteria:
  -  This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
  Exclusion Criteria:
  -  weight loss greater than 10% during the previous 6 months
  -  signs of distant metastasis
  -  respiratory, renal,or heart disease
  -  Patients provided written informed consent prior to enrollment

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

Summary: This study evaluated that strict control of perioperative blood glucose following pancreatic resection by using an artificial pancreas would improve postoperative surgical site infection.

Detailed description: This study recruited 50 patients undergoing elective pancreatic resection for pancreatic diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusion of insulin determined by the control algorithm of the artificial pancreas.

Eligibility: Inclusion Criteria:
  -  patients undergoing elective pancreatic resection for pancreatic diseases.
  Exclusion Criteria:
  -  weight loss greater than 10% during the previous 6 months
  -  sign of distant metastasis
  -  respiratory, renal, or heart disease

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

Summary: The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
  -  ECOG performance status <1
  -  Measurable disease
  Exclusion Criteria:
  -  Severe or uncontrolled systemic disease
  -  Clinically significant cardiac event such as myocardial infarction
  -  Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis

Summary: PH-10 is a formulation of rose bengal disodium (RB) for topical administration to the skin. PH-10 is capable of undergoing photochemical reactions when activated by ambient light. This phase 2 study will assess whether topical PH-10 applied once daily to mild, moderate or severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of the skin when activated by ambient light.


Eligibility: Inclusion Criteria:
  -  Men or women, age 18 or older.
  -  Mild, moderate or severe atopic dermatitis.
  -  Presence of atopic dermatitis areas outside the head and face with a baseline Investigator Global Assessment (IGA) of 2 (mild disease), 3 (moderate) or 4 (severe disease) at screening.
  -  Written informed consent by the subject or legal guardian.
  Exclusion Criteria:
  -  Women who are pregnant, attempting to conceive, or nursing an infant.
  -  Subjects who have received phototherapy (UVB, PUVA) or systemic therapy (immunosuppressants, cytostatics, corticosteroids) within 4 weeks.
  -  Subjects who have received systemic antibiotics within 2 weeks.
  -  Subjects who have received topical therapy (tar, corticosteroids) within 7 days.
  -  Subjects who have received investigational drugs in a clinical research study within 4 weeks.
  -  Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of initiation of study treatment.
  -  Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
  -  Subjects with clinical conditions that may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Molecular Analysis of Retinoblastoma

Summary: Retinoblastoma is a childhood tumor of the retina that affects approximately 1 in 18,000 children. Retinoblastoma is more prevalent in Central America, where most patients present with advanced intraocular and extraocular disease. Therefore, we have formed collaboration with Central American investigators to provide us with frozen retinoblastoma tumors from patients undergoing routine enucleation. The objective of this protocol is to begin to identify the mutations and gene expression changes that occur in retinoblastoma cells following RB1 gene inactivation in order to more effectively target chemotherapy for treating bilateral retinoblastoma.

Detailed description: This is a biology protocol with no treatment regimen associated. Following routine enucleation of the retinoblastoma affected eye, a portion of the tumor will be removed and flash frozen and sent to St. Jude for RNA and DNA analysis. Some tissue will undergo histopathological analysis and tissue microarrays will be isolated.

Eligibility: Inclusion Criteria:
  -  Must have clinical diagnosis of retinoblastoma (to be confirmed histologically after enucleation)
  -  Legal guardians must willing to sign an informed consent indicating that they are aware of this study and its possible benefits. Legal guardians will be given a copy of the consent form.
  -  Patient is being seen at this AHOPCA institution:
  Exclusion Criteria:
  -  Ophthalmologist or oncologist is concerned that sampling will interfere with staging.
  -  Diagnosis other than retinoblastoma.
  -  Affiliated hospital is unable to provide pathologic evidence of retinoblastoma.

Relevance to patient case: not relevant