araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

Summary: This is a phase I/II clinical research study with BGT226, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a Phase I dose escalation part followed by a safety expansion part and a Phase II expansion part.
  Once the MTD has been defined, the safety expansion and efficacy expansion parts of the trial will be opened for enrollment.
  Phase I safety expansion part will enroll advanced solid tumors. Phase II expansion part will enroll advanced breast cancer. An effort will be made to enrich the trial population with Cowden Syndrome patients with advanced solid malignancies.


Eligibility: Inclusion criteria:
  All patients
  -  Histologically-confirmed, advanced solid tumors
  -  Progressive, recurrent unresectable disease
  Phase II expansion part (advanced breast cancer)
  -  Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression status
  -  Disease progression/recurrence following hormonal or anti-HER-2 treatment for advanced disease
  -  At least one but not more than two prior chemotherapy regimens for the unresectable tumor
  -  Measurable disease by MRI or CT scan
  Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden Syndrome
  -  Age ≥ 18
  -  World Health Organization (WHO) Performance Status of ≤ 2
  Exclusion criteria:
  -  Hematopoietic:
  -  No diabetes mellitus or history of gestational diabetes mellitus
  -  No acute or chronic renal disease
  -  No acute or chronic liver disease
  -  No acute or chronic pancreatitis
  -  No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
  -  No acute myocardial infarction or unstable angina pectoris within the past 3 months
  -  Not pregnant or nursing and fertile patients must use barrier contraceptives
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Effects of Early Oral Feeding After Resection of Gastric Cancer

Summary: The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.

Detailed description: Most patients who undergo gastric resection for gastric cancer have maintained going on a fast of over three days after operation. Surgeons have believed that early oral feeding might worsen patients' condition by prolonged postoperative ileus. Therefore, patients received nothing by oral route until resolution of the ileus. However, the current trend toward minimal operative injury and early discharge from hospital. In addition, development of operative technique and instrument make the operation time to be short and the patients to be fast recovery, and thus it is possible to feed early in less than two days after operation. The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
  We collect fifty-eight patients for this study and divide into two groups using randomization method. In the early feeding group, patients will receive the liquid diet two day after operation followed by soft diet postoperative three day. Meanwhile, the patients who categorized into control group will start the liquid diet postoperative four day followed by soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory findings. Of course, it is supposed to be same in amount of fluid and calories between two groups.

Eligibility: Inclusion Criteria:
  Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria:
  1. Performed curative resection
  2. Have The American Society of Anaesthesiologists (ASA) score of less than 3
  Exclusion Criteria:
  1. Patients who have simultaneously other cancer.
  2. Patients who underwent gastric resection at past time.
  3. Patients who have cancer with bleeding or perforation or obstruction.
  4. Patients who have any injury to the pancreas capsule on operation.
  5. Patients who get pregnancy.
  6. Patients who are treating diabetics with Insulin.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Treating H. Pylori in Parkinson's Patients With Motor Fluctuations

Summary: The purpose of this study is to determine whether treatment of H. pylori (an infection of the stomach) improves treatment effectiveness in patients with Parkinson's disease and motor fluctuations.

Detailed description: Previous investigations have demonstrated that treatment of Helicobacter pylori with antibiotics leads to improved absorption and pharmacokinetics of levodopa. This may potentially benefit patients with Parkinson's disease who have motor fluctuations, specifically excessive "off" time, when their levodopa is not working to control symptoms. We seek to identify the frequency of H. pylori infection in this population using standard lab assays and determine whether eradication with standard triple therapy results in improved clinical response to medication.

Eligibility: Inclusion criteria:
  -  Adults diagnosed with idiopathic Parkinson's disease, Hoehn & Yahr stage 2-4 in the "off" state, with no other concomitant neurologic diseases.
  -  Stable (≥30 days) Parkinson's disease therapy, with demonstrable medication efficacy, but with wearing off phenomenon present between levodopa doses (average off time ≥3 hours off time/day).
  -  Levodopa therapy required; Any formulation (e.g. Sinemet, Sinemet CR, Stalevo) is acceptable. Parkinson's disease treatment may also include any of the following medications or classes: non-ergot dopamine agonists, COMT inhibitors, MAO-B inhibitors, amantadine, anticholinergics.
  -  Positive for H. pylori IgG Ab by serum ELISA (before inclusion in randomized treatment arms).
  Exclusion criteria:
  -  Current abdominal pain, unexplained nausea/vomiting, or gastrointestinal bleeding.
  -  History of gastric cancer, peptic ulcer, duodenal ulcer, or other gastric or duodenal lesions.
  -  History of previous gastric surgery.
  -  History of previous brain surgery for Parkinson's disease.
  -  Family history of gastric cancer.
  -  Prior treatment for H. pylori+ status.
  -  Recent use (previous 4 weeks) of proton-pump inhibitor, amoxicillin, or clarithromycin.
  -  Allergy or sensitivity to penicillin, amoxicillin, clarithromycin, or omeprazole.
  -  Use of drugs affecting gastric motility (e.g. domperidone, metoclopramide).
  -  Inability to tolerate or participate in testing in the morning in an "off" state.
  -  Inability to communicate effectively with study personnel in English.
  -  Pregnancy.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Antiangiogenic Factors in Gastric Cancer

Summary: Endogenous antiangiogenic factors are related with gastric cancer progression.

Detailed description: Gastric cancers have been known to secrete the proangiogenic cytokine VEGF in vitro and in vivo. Tumor VEGF expression is correlated with the severity of disease in patients with gastric cancer and some authors have suggested using circulating VEGF as a prognostic factor or tumor marker.In addition to producing proangiogenic cytokines, recent data demonstrate that tumors can produce antiangiogenic cytokine as well. It has been suggested that, in humans, the generation of antiangiogenic compounds in the presence of a primary tumor suppresses the growth of distant metastases. This phenomenon has been demonstrated in mice and in patients with clear cell renal cancer, breast cancer, and colorectal cancer. However, the presence of endogenous antiangiogenic cytokines in patients with gastric cancer has not been reported.

Eligibility: Inclusion Criteria:
  -  Histologic diagnosis of gastric adenocarcinoma
  -  No other forms of cancer therapy, such as chemotherapy or radiotherapy for at least 3 weeks before the enrollment in study
  -  Performance status of 0, 1, 2 on the ECOG criteria
  -  ASA class I, II
  -  Patient compliance that allow adequate follow up
  -  Informed consent from patient or patient's relative.
  Exclusion Criteria:
  -  Second primary malignancy
  -  EMR (Endoscopic mucosal resection) indication
  -  Laparoscopic gastrectomy
  -  Radiologic or clinical evidence of metastasis

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)

Summary: Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.


Eligibility: Inclusion Criteria:
  -  Aged 75 years or less
  -  Adenocarcinoma of stomach
  -  Advanced, metastatic, or recurrent
  -  No prio chemotherapy for advanced disease
  -  Adequate performance status
  -  Adequate major organ functions
  Exclusion Criteria:
  -  Severe comorbid illness or active infections
  -  Pregnancy or lactating women
  -  GI obstruction or malabsorption syndrome

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer

Summary: The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method

Detailed description: Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.

Eligibility: Inclusion Criteria:
  -  Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
  -  Age 80 years or younger
  -  No distant metastasis
  Exclusion Criteria:
  -  Carcinoma in the remnant stomach
  -  Stage intravenous (IV)
  -  History of laparotomy
  -  History of serious heart disease
  -  Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
  -  Absence of informed consent

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

Summary: The patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.

Detailed description: The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery.

Eligibility: Inclusion Criteria:
  -  Patients undergoing standard gastric surgery for cancer
  Exclusion Criteria:
  -  gallbladder disease

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Proteiomic Fingerprints of Gastric Juice

Summary: No accurate, inexpensive and non-invasive test for gastric cancer screening is currently available. The investigators' recent study identified a1-antitrypsin and other proteins as potential biomarkers of gastric cancer in gastric juice. The aim of this study was to develop a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in gastric juice.

Detailed description: Patients and methods: The study consisted of two parts: (1) investigating the differences in gastric juice biomarker concentrations between gastric cancer patients and controls, and (2) screening gastric cancer using string test to obtain gastric juice followed by immunoassay for biomarker concentration.

Eligibility: Inclusion Criteria:
  -  healthy subjects and gastric cancer patients documented by endoscopy.
  Exclusion Criteria:
  -  the use of proton pump inhibitors or histamine-2 receptor antagonists within 4 weeks prior to the study
  -  coexistence of two kinds of gastroduodenal lesions
  -  coexistence of severe systemic diseases

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Alpha Lipoic Acid and Insulin Resistance

Summary: Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening visit, their insulin resistance will be measured. Subjects will then be given either alpha lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of alpha lipoic acid on insulin sensitivity.

Detailed description: We propose to perform a placebo-controlled study of Alpha Lipoic Acid (LA) administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. The insulin sensitivity of 180 subjects will be initially estimated by measuring fasting glucose and insulin levels (homeostasis model assessment) and oral glucose tolerance test (OGTT). The 60 most insulin resistant subjects will then be randomized to 6 weeks of therapy with either 600 mg three times a day of LA or placebo. To quantitate the ALA-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, OGTT using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment. We believe these studies will (1) confirm the beneficial effect of CR-ALA on insulin sensitivity; (2) further our understanding of the molecular mechanisms of LA action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the Metabolic Syndrome, and coronary artery disease (CAD), a demonstration of the beneficial effects of LA on insulin action could ultimately have important public health consequences.

Eligibility: Inclusion Criteria:
  -  Healthy, not exercising regularly
  Exclusion Criteria:
  -  Diabetes, Impaired glucose tolerance, Heart disease, Liver disease, HIV, abnormal TSH results, other abnormal lab values

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: A Phase I Study of MK2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (2206-003 AM5)

Summary: The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors.


Eligibility: Inclusion Criteria :
  -  Participants must have locally advanced or metastatic solid tumors.
  -  Participant is male or female greater than or equal to 18 years of age.
  -  Participant must have a performance status less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  -  Female participants of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication.
  -  Participants in the MK-2206 + carboplatin/paclitaxel and MK-2206 + docetaxel treatment arms will be limited to no more than 3 prior cytotoxic therapies for metastatic or recurrent diseases.
  -  Participant is able to swallow capsules and has no surgical or anatomical condition that will prevent the Participant from swallowing.
  Exclusion Criteria:
  -  Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks.
  -  Participants must be least 4 weeks post-surgery and do not expect major surgery in the study duration.
  -  Participant is currently participating or has participated in a study with an investigational compound or device within 30 days.
  -  Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  -  Participant with a primary central nervous system tumor.
  -  Participant has known hypersensitivity to the components of study drug.
  -  Participant has a history or current evidence of heart disease.
  -  Participant has evidence of clinically significant bradycardia (slow heart rate).
  -  Participant has uncontrolled high blood pressure.
  -  Participant at significant risk for hypokalemia (low potassium levels).
  -  Participant is a known diabetic
  -  Participant has known psychiatric or substance abuse disorders.
  -  Participant is a user of illicit drugs.
  -  Participant is pregnant or breastfeeding.
  -  Participant is Human Immunodeficiency Virus (HIV) positive.
  -  Participant has known history of Hepatitis B or C or active Hepatitis A.
  -  Participant has symptomatic ascites or pleural effusion.
  -  Participant is receiving treatment with oral corticosteroids.
  -  Participant is using a potent cytochrome P(450) 3A4 (CYP3A4) inhibitor or inducer.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: DNA Analysis of Tumor Tissue Samples From Patients With Human Papilloma Virus-Associated Cancer of the Oropharynx

Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at the DNA in tumor tissue samples from patients with human papilloma virus-associated cancer of the oropharynx.

Detailed description: OBJECTIVES:
  -  Analyze PIK3CA expression and mutation and p110α amplification and expression in tumor tissue samples from patients with human papilloma virus positive (HPV+) and human papilloma virus negative (HPV-) squamous cell carcinoma (SCC) of the oropharynx.
  -  Determine proliferation and survival after PI3K inhibition in HPV(+) and HPV(-) oropharyngeal SCC cell lines and in HPV E6 and E7 expressing cells.
  -  Determine proliferation and survival after PI3K inhibition in short-term cultures of tumor tissue samples from patients with HPV(+) and HPV(-) primary SCC of the oropharynx.
  OUTLINE: Previously collected tumor tissue samples are analyzed for HPV DNA by PCR amplification and direct sequencing of PCR products; expression of E6 protein and relative expression of PIK3CA by qRT-PCR; amplification of PIK3CA by Southern blotting; mutation of PIK3CA; expression of p110α, phospho-AKT, total AKT, and FOXO1 by polyacrylamide gel electrophoresis (PAGE) and immunoblotting; and the effect of PI3K inhibition on cell cycle and apoptosis by flow cytometry. Pharmacological studies are performed on oropharyngeal squamous cell carcinoma cell lines and short-term cultures and HPV E6 and E7 expressing cells using LY 294002 in vitro to analyze response to PI3K inhibition. Results of response to PI3K inhibition will be correlated with HPV status, PIK3CA expression, amplification, and mutation, and p110α expression.
  PROJECTED ACCRUAL: A total of 20 HPV(+) and 20 HPV(-) tumor tissue specimens from patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Undergoing operative procedures for biopsy and/or resection of squamous cell carcinoma (SCC) of the oropharynx
  -  Tumor tissue sample available from the Head and Neck Tissue Repository and Clinical Database of Vanderbilt University
  -  No tumors with human papilloma virus (HPV) DNA sequences but no expression of E6
  PATIENT CHARACTERISTICS:
  -  See Disease Characteristics
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer

Summary: Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.

Detailed description: 18 out of 32 cases were eligible for analysis. Four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. At the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. Besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. Peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.

Eligibility: Inclusion Criteria:
  -  patients with operable local gastric adenocarcinoma
  Exclusion Criteria:
  -  previous abdominal surgery
  -  previous open or blunt abdominal trauma
  -  history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity.
  -  All other gastric malignancies such as lymphomas, GIST, carcinoids

Relevance to patient case: not relevant