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

Clinical trial: Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer

Summary: The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.


Eligibility: Inclusion Criteria:
  1. Age between 18 to 75 years old
  2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  3. Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
  4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  6. ASA (American Society of Anesthesiology) class I to III
  7. Written informed consent
  Exclusion Criteria:
  1. Pregnant and lactating women
  2. Suffering from severe mental disorder
  3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
  5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
  6. History of other malignant disease within the past 5 years
  7. History of previous neoadjuvant chemotherapy or radiotherapy
  8. History of unstable angina or myocardial infarction within the past 6 months
  9. History of cerebrovascular accident within the past 6 months
  10. History of continuous systematic administration of corticosteroids within 1 month
  11. Requirement of simultaneous surgery for other disease
  12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  13. FEV1＜50% of the predicted 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: Protease Activated Receptor-2 and Gastrointestinal Dysfunction in Critical Illness

Summary: Gastrointestinal (GI) dysfunction affects up to 50% of medical and surgical critically ill children. GI dysfunction, specifically gastric dysmotility and loss of epithelial barrier integrity, is associated with significant morbidity in critical illness. The mechanisms underlying GI dysfunction in critical illness are not well understood. GI dysfunction in surgery and critical illness has been associated with inflammation. There is evidence to suggest the protease-activated receptor 2 (PAR2) is a link between inflammation and GI dysfunction. PAR2 is a G-coupled receptor present throughout the GI tract. PAR2 mediates GI motility and epithelial barrier integrity. PAR2 is activated by PAR2 agonists, specifically GI serine proteases and zonulin, released under conditions of inflammation. In this study the investigators will examine the relationship between inflammation and PAR2 activation by PAR2 agonists and subsequent GI dysfunction in pediatric critically ill surgical patients. The overall hypothesis of this study is that PAR2 activation by PAR2 agonists, GI serine proteases and zonulin, released due to inflammation results in gastric dysmotility and loss of epithelial barrier integrity. In this study, the investigators will examine whether PAR2 agonist expression is increased and correlates with GI dysfunction in critically ill surgical pediatric patients. This proposal fills a knowledge gap in the understanding of mechanisms for GI dysfunction in critical illness, and will be applicable to all surgical and medical critically ill children.

Detailed description: The investigators in this study aim to examine a plausible mechanism by which gastrointestinal dysfunction, gastric dysmotility and loss of epithelial barrier integrity, occur in critical illness. Specifically, the investigators will examine whether an increase in PAR2 agonist levels, zonulin and serine proteases, are associated with gastric dysmotility and loss of epithelial barrier integrity in critical surgical illness in children. The investigators will examine GI function, gastric motility and epithelial barrier integrity, and PAR2 agonist levels, zonulin and serine protease, in participants before surgery and after surgery. Specifically, children undergoing posterior spinal fusion, a known significant inflammatory trigger, and with planned admissions to the intensive care unit will be enrolled. Gastrointestinal function and PAR2 agonist levels will be tested non-invasively in blood and stool.

Eligibility: Inclusion Criteria:
  -  2 years and older
  Exclusion Criteria:
  -  Liver dysfunction
  -  Renal dysfunction
  -  Pre-diagnosed gastroparesis/ delayed gastric emptying
  -  Pre-diagnosed gastrointestinal malabsorption
  -  Contraindication to acetaminophen administration

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

Clinical trial: Comparing the Diagnostic Role of PET/MRI and of PET/CT Among Patients With Gastric Cancer

Summary: The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared.

Detailed description: A prospective comparison of PET/MRI and PET/CT for gastric cancer will be performed,to evaluate the value of PET/MRI in predicting the preoperative staging and resectability of gastric cancer and investigate the role of PET/MRI in gastric cancer diagnosis.The evaluation parameters are the diagnostic accuracy of gastric cancer staging( including the overall accuracy, sensitivity, and specificity) and the receiver operating characteristic (ROC).

Eligibility: Inclusion Criteria:
  1. Histological diagnosis of gastric cancer
  2. No previous treatment history for gastric cancer
  3. Without complications of obstruction,bleeding and so on
  4. Without severe diabetes,the levels of blood glucose <6.2 mmol/L .
  5. No cardiac pacemarker,never stimulator or other metal substitute materials in vivo.
  Exclusion Criteria:
  1. With other neoplastic disease.
  2. Suffering acute inflammatory disease
  3. History of chemo-radiotherapy
  4. Suffering prostate hyperplasia,glaucoma

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

Clinical trial: K-BASKET, TAS-117, PI3K/AKT Gene Aberration

Summary: The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of K-BASKET trial.


Eligibility: Inclusion Criteria:
  1. Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration
  2. Progressive disease who failed to previous standard treatment.
  3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
  4. Eastern Cooperative Oncology Group performance status 0 or 1
  5. Able to take medications orally
  6. Adequate organ function
  7. A life expectancy of at least 60 days
  Exclusion Criteria:
  1. Previous treatment with anti-PI3K or AKT directed therapies
  2. Known hypersensitivity to any drugs similar to TAS-117 in structure or class.
  3. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
  4. Current evidence of retinopathy that requires ophthalmological therapy.
  5. History or current evidence of cardiac arrhythmia and/or conduction abnormality.
  6. Treatment with any of the following within the specified time frame prior to study drug administration:
  -  Major surgery within prior 4 weeks
  -  Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration.
  -  Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks).
  7. A serious illness or medical condition(s)
  8. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia).
  9. Patients with the risk of hypokalemia
  10. Receiving oral steroid medication.
  11. Pregnant or lactating female

Relevance to patient case: possibly relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients

Summary: Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.


Eligibility: Inclusion Criteria:
  -  ECOG performance status of 0 to 1.
  -  Life expectancy of more than 12 weeks.
  -  Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of the gastroesophageal junction included).
  -  Recurrent or metastatic gastric cancer that has progressed following first line-therapy.
  -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline
  -  Subjects who have overall good overall general condition.
  -  Signed informed consent.
  Exclusion Criteria:
  -  Subjects who received any previous treatment with any PARP inhibitors.
  -  Subjects who received any previous treatment with any taxanes.
  -  More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
  -  Less than 4 weeks from the last clinical trial.
  -  Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
  -  Unstable hypertension.
  -  Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
  -  Subjects with brain metastases.
  -  Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  -  Subjects with a known hypersensitivity to fluzoparib, apatinib, paclitaxel or any of the excipients of the product.
  -  Ongoing infection (determined by investigator).
  -  History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  -  Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
  -  Pregnant or breast-feeding women.

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

Clinical trial: Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

Summary: The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Detailed description: Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.This study is a randomized controlled trial. The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Eligibility: Inclusion Criteria:
  -  18 y.o. ≤age≤75 y.o.;
  -  Diagnosis of esophageal gastric varices by gastroscopy;
  -  Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;
  Exclusion Criteria:
  -  age <18 y.o. or age > 75 y.o.;
  -  Never had the variceal bleeding episode before;
  -  Do not have endoscopic injection of tissue adhesive;
  -  The cefotiam contraindications: such as allergies, pregnancy etc;
  -  combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);
  -  Known infection before endoscopic treatment (Fever, microbial cultures positive, et al.);
  -  Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics;
  -  Acute variceal bleeding within 5 days;
  -  Refuse to participate

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

Clinical trial: Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant

Summary: Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrant


Eligibility: Inclusion Criteria:
  -  patient is male or female 18 years or older
  -  Patient is identified PIK3CA mutant status
  -  Patient has confirmed HER2-negative advanced breast cancer (aBC)
  -  Patient must be diagnosed with aBC with documented progression on or after CDK 4/6 treatment (adjuvant or metastatic setting)
  -  Patient has histological and/or cytological confirmed ER+ and/or PgR+ aBC
  -  Patient has either measurable disease per RECIST v1.1 or at least one predominantly lytic bone lesion must be present
  -  ECOG function of greater or equal to 2
  -  Patient has adequate bone marrow function
  -  Patient has adequate liver and renal function
  Exclusion Criteria:
  -  patient has received prior treatment with any PI3K inhibitors
  -  patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
  -  Patient has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancer
  -  Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy
  -  History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
  -  Bilateral diffuse lymphangitis carcinomatosis
  -  Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
  -  At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
  -  Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least 4 weeks after treatment as determined by clinical examination and brain imaging (MRI or CT) during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment
  -  Patient with severe liver impairment (Child Pugh score B/C
  -  Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
  -  Patient has documented pneumonitis which is active and requiring treatment

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 Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA

Summary: Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced immune response is not clear. Long non-coding RNA (lncRNA) has recently emerged as key post-transcriptional regulators of gene expression, differentiation. The investigators had a preliminary results which THRIL (TNFα and hnRNPL related immunoregulatory lincRNA) and PACER(p50-associated COX-2 extragenic RNA) played a potential role in H.pylori induced inflammatory cascade. However, there wasn't a previous study about expression of THRIL, PACER in a human tissue. Therefore, the investigators aimed to evaluate the expression of THRIL, PACER in patients with gastrointestinal disease according to H.pylori infection.


Eligibility: Inclusion Criteria:
  1. Over 19 years old
  2. Patients with gastric ulcer
  3. Patients with duodenal ulcer
  4. Patients with stomach cancer
  5. Patients with gastrointestinal discomfort symptoms
  Exclusion Criteria:
  1. Patients who has done helicobacter pylori eradication
  2. Patients who has undergone gastrectomy
  3. Patients who has undergone endoscopic submucosal dissection
  4. Patients with active upper gastrointestinal bleeding

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

Clinical trial: Zenith Alpha™ Abdominal Endovascular Graft

Summary: The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.


Eligibility: Inclusion Criteria:
  -  A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft
  Exclusion Criteria:
  -  Life expectancy less than (<) 2 years
  -  Inability or refusal to give informed consent by the patient or legally authorized representative
  -  Unwilling or unable to comply with the study follow-up

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

Clinical trial: FOLFIRI Versus Docetaxel and Cisplatin as a Second-line Chemotherapy After Failure of First-line Chemotherapy in Advanced Gastric Cancer

Summary: Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy.
  Palliative chemotherapy had proven to be better overall survivals and quality of life in unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic regimen as a first line therapy. But response rate of those regimens is about 50 percent. Disappointingly most of cases are about to experience progression of disease.
  Second line regimens of palliative chemotherapy are also have shown its efficacy and recommended within patients with better performance status. But There is still lack of evidences in gastric cancer patients second line chemotherapy. Several phase II trial those subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in combination with paclitaxel would increase response rate in patient previously treated for advanced gastric cancer compared with FOFIRI regimen.


Eligibility: Inclusion Criteria:
  1. Older than 19 years old and younger than 75 years old
  2. Pathologically confirmed gastric cancer
  3. Inoperable stage at diagnosis
  4. experienced diseases progression in first line palliative chemotherapy
  5. ECOG performance status 0 or 1
  6. Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
  7. Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
  8. Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
  9. Subjects who given written informed consent after being given a full description of the study
  Exclusion Criteria:
  1. double primary cancer other than gastric cancer
  2. history of palliative radiation therapy
  3. Pregnant or on breast feeding
  4. Neuropathy grade > 3
  5. Active infection
  6. Symptomatic cardiopulmonary diseases
  7. Active hepatitis of liver cirrhosis
  8. Impaired renal function
  9. Impaired psychologic bone marrow function
  10. Psychologic disorder, Severe neurologic disorder.
  11. hypersensitivity to chemotherapeutic agent

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

Clinical trial: The Origin of Infrapyloric Artery

Summary: Infrapyloric artery(IPA) is of great importance for gastric cancer patients. According to previous study, the origin of IPA varies greatly among different studies. This trial aims to tell the distribution of IPA origin in Chinese patients.

Detailed description: Infrapyloric artery(IPA) is of great importance for gastric cancer patients. In early gastric cancer patients, the pylorus-preserving gastrectomy requires the preserving of IPA. In advanced gastric cancer patients, the subgroup of No. 6 lymph node might be associated with IPA. In JGCA gastric cancer classification guidelines, the No. 6 lymph nodes is defined as lympn nodes along the first branch and proximal part of the right gastroepiploic artery(RGEA) down to the confluence of the right gastroepiploic vein and the anterior superior pancreatoduodenal vein. However,if IPA origins from the gastroduodenal artery(GDA) or anterior superior pancreatoduodenal artery(ASPDA), the lymph nodes along the IPA can not be grouped into the No. 6 lymph nodes. Thus, a new definition of No. 6 lymph nodes is needed on the basis of the origin of IPA.
  Previous studies about IPA origin are few and the origin of IPA varies greatly among different studies.

Eligibility: Inclusion Criteria:
  -  Patients with gastric cancer who needs to receive total or distal gastrectomy.
  -  Signed informed consent
  Exclusion Criteria:
  -  IPA not dissected, photoed or video-recorded.

Relevance to patient case: not relevant