araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Summary: This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.


Eligibility: Inclusion Criteria:
  -  Male or female diagnosed with type 2 diabetes
  -  Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor
  Exclusion Criteria:
  -  Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
  -  Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
  -  History of pancreatitis (acute or chronic)
  -  History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
  -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
  -  Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  -  Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
  -  Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m^2)
  -  History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC

Summary: This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.


Eligibility: Inclusion Criteria:
  -  Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
  -  Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery（SRS）.
  -  Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm in brain (by brain MRI).
  -  Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group（ECOG） performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl, absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; total bilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase（ALT） and aspartate aminotransferase（AST）< 1.5x ULN in the absence of liver metastases, or < 5x ULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated according to Cockcroft-gault formula).
  -  Patients should be contraceptive during the period of the trial.
  Exclusion Criteria:
  -  Patients who had received brain radiotherapy or EGFR-TKI before.
  -  Patients who can't receive WBRT.
  -  Uncontrolled intracranial hypertension after steroid or dehydration therapy.
  -  Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.
  -  Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
  -  Patients who can't take oral tablets, with active peptic ulcer diseases.
  -  Pregnancy or breast-feeding women.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Summary: Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.
  Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.
  Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.
  Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


Eligibility: Principal Inclusion Criteria:
  -  Stage III or IV NSCLC, non irradiable non operable
  -  Non squamous NSCLC histologically or cytologically confirmed
  -  No previous treatment of NSCLC
  -  EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
  -  Presence of at least one lesion that can be measured
  -  PS 0 or 1
  Principal Exclusion Criteria:
  -  Symptomatic brain metastasis or requiring immediate radiotherapy
  -  T790M mutation or exon 20 insertion
  -  Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
  -  Interstitial pneumopathy

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Human Epidermal Growth Factor Receptor 2 (HER-2) Status in Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma

Summary: The primary objective is to evaluate the concordance between human epidermal growth factor receptor 2 (HER2) status determined by the participating laboratory and by the centralized laboratory. HER2 status of samples was tested by the participating laboratories (investigator's choice of immunohistochemistry [IHC] and in situ hybridization [ISH] methods) and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH). Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.


Eligibility: Inclusion Criteria:
  -  Tumor samples with histologically confirmed gastric or gastro-esophageal junction (GEJ) adenocarcinoma, any stage
  -  Samples with sufficient tumor material for centralized analysis
  -  Samples fixed and embedded in paraffin (formalin-fixed paraffin-embedded tissue [FFPET] samples).
  Exclusion Criteria:
  - Fixatives not allowed: Bouin's solution

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: The ED50 of DEX for Providing Sedation in Different Female Age Group

Summary: Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age, and current studies with regard to the effects of age on dexmedetomidine pharmacodynamic are rare. This study was designed to explore the right DEX dose of different female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of sedation for patients is also investigated.

Detailed description: 90 patients scheduled for combined spinal epidural spinal anesthesia were included in one of three groups. In each group,determination of median effective (ED50) doses was performed by the Dixon up-and-down method, an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1 μg/kg in first three turning points and 0.05μg/kg in the last three turning points.Initial doses was 1.4μg/kg, .Sedative efficacy was defined as an OAA/S of ≤3,30 min after the beginning of drug administration.

Eligibility: Inclusion Criteria:
  1. ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
  2. Written informed consent from the patient or the relatives of the participating patient.
  3. BMI:18.0～25.0kg/m2
  Exclusion Criteria:
  1. Mental illness can not match
  2. epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. People who were language or hearing impaired
  5. Sensory block reached to T8 or higher.
  6. People who had lung infection or sleep apnea syndrome.
  7. Pregnancy
  8. Chronic renal failure
  9. Alcohol or drug abuse
  10. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score

Summary: The researching subject is aimed to obtain the clinical evidences (including real benefits， risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional Chinese medicine. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.

Detailed description: The purpose of this project is to further evaluate the role of traditional Chinese medicine in the treatment of advanced gastric cancer through clinical registration along with real world study.
  The patients who suffer from advanced gastric cancer often have a very short time survival . Their total survival time is only 4.3 months after the best supportive care. At present palliative chemotherapy is still the main method for advanced gastric cancer .
  In recent years, the results of international multi center phase III clinical trial show that the patients with combination chemotherapy have 8.6 months to 13.0 months survival time.
  In China, the clinical curative effect of traditional Chinese medicine in the treatment of advanced gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the Traditional Chinese Medicine may prolong the survival and improve the quality of life in patients with advanced gastric cancer.
  Real World Study emphasizes in epidemiological theories, clinical observational study, cross-sectional study and cohort study. The observational study of registry (registry study in clinical practice) is particularly widely used.
  Clinical practice of traditional Chinese medicine in the treatment of advanced gastric cancer often relies on the accumulation of years of medical experiences and sometimes new treatment measures. There must be some objective evidences that with reasonable design, rigorous process, scientific statistics to evaluate the value of traditional Chinese medicine intervention in the comprehensive treatment of advanced gastric cancer patients in order to meet the needs of clinical practice and medical development in China.

Eligibility: Inclusion Criteria:
  -  gastric adenocarcinoma without operation or recurrence after operation or metastasis
  -  diagnosed within three months
  -  KPS score≥60
  -  expected survival time was above 3 months
  -  HB ≥80g/L 、WBC≥4.0×109/L、 N ≥2.0×109/L 、PLA ≥80×109/L
  -  normal function with heart 、kidney and liver
  Exclusion Criteria:
  -  not gastric adenocarcinoma
  -  simultaneous diagnosis with other malignant tumor
  -  participate in clinical trials of new drugs not listed in China
  -  combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: The Safety and Feasibility of Laparoscopic Total Gastrectomy for Remnant Gastric Cancer

Summary: The purpose of this study is to explore the safety, feasibility, long-term and oncological outcomes of laparoscopic total gastrectomy for remnant gastric cancer.

Detailed description: A prospective single-arm study designed to further evaluate the of of laparoscopic total gastrectomy for remnant gastric cancer will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility: Inclusion Criteria:
  -  Age from 18 to 75 years
  -  Carcinoma in the remnant stomach encompasses all carcinomas arising in the remnant stomach following a gastrectomy, irrespective of the histology of the primary lesion (benign or malignant) or its risk of recurrence, the extent of resection, or method of reconstruction.
  -  cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  -  No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  -  Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  -  American Society of Anesthesiology score (ASA) class I, II, or III
  -  Written informed consent
  Exclusion Criteria:
  -  Women during pregnancy or breast-feeding
  -  Severe mental disorder
  -  History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
  -  Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  -  History of other malignant disease within past five years
  -  History of unstable angina or myocardial infarction within past six months
  -  History of cerebrovascular accident within past six months
  -  History of continuous systematic administration of corticosteroids within one month
  -  Requirement of simultaneous surgery for other disease
  -  Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  -  FEV1＜50% of predicted values

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Comparison of Vagus Nerve-preserving RADG and Conventional RADG for AGC

Summary: Through comparative observation of robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve) operative and postoperative indicators, and evaluating the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.

Detailed description: Compare the robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve). Observe the operative and postoperative indicators, and evaluate the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.

Eligibility: Inclusion Criteria:
  1. Male or female, aged less than 70 years and more than 18 years;
  2. Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3;
  3. The lesion is in the middle and lower stomach;
  4. Magix routine upper gastrointestinal barium meal, endoscopic ultrasonography, abdominal CT and chest X ray examination, clearly no nerve invasion and adjacent organ invasion and distant metastasis;
  5. The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication;
  6. The preoperative abdominal CT or abdominal ultrasound without biliary disease and gallbladder stones;
  7. No history of gastrointestinal dysfunction and other malignant tumor history;
  8. The patients voluntarily participate in the study and signed informed consent.
  Exclusion Criteria:
  1. Older than 70 years old or because of chemotherapy surgery and complications after intolerance;
  2. The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis;
  3. Have a history of abdominal surgery or chemotherapy before surgery;
  4. The recent cardiovascular hemorrhagic or ischemic disease;
  5. The amount of abnormal glucose tolerance or diabetes;
  6. Not suitable for robotic surgery, such as body short that mechanical arm can not have enough activity range;
  7. The history of biliary calculi or gastrointestinal dysfunction;
  8. The other is not suitable for receiving robot surgery;
  9. Participated in other clinical studies in the last month;
  10. Other researchers not suitable for participation in the study of (HIV infection and intravenous drug addict), or other effects of this clinical study results analysis of the situation.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

Summary: This study aims to assess the impact of preoperative oral carbohydrate drink on gastric emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore, investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate in elective gastric cancer surgery, providing direct evidence for clinical practice.

Detailed description: In clinic, administration of oral carbohydrate 2-3 hours before surgery has been widely applied in elective colorectal surgery. However, no direct evidence has been showed that whether it is safe to do so in gastric cancer patients who are fit for elective radical gastric resection.
  This study aims to discuss the impact and safety of oral administration of 5% glucose solution 250ml 2-3 hours before elective gastric cancer surgery. It is an equivalence study, which refers to a single-center, prospective, single blind, and randomized controlled study design. Eighty-eight patients with gastric adenocarcinoma are going to be enrolled in the study, who will be allocated into control or treatment group. Patients in control group follow the traditional routine of 6-8 hours preoperative fasting, while those in the treatment group will orally intake 250ml 5% glucose solution 2-3 hours before surgery. The primary end-point is the preoperative gastric residual volume. The secondary end-points include preoperative PH of gastric fluid, assessment of perioperative psychosomatic conditions, rate of perioperative complications, level of insulin sensitivity, recovery of bowel function, and the length of hospital stay, etc.

Eligibility: Inclusion Criteria:
  -  18< Age <80
  -  Gastric adenocarcinoma, proved by endoscopic biopsy
  -  Fit for elective radical resection
  -  ASA <Ⅲ and NYHA <Ⅲ
  -  17.5< BMI <27.5 kg/m2
  -  Informed consent
  Exclusion Criteria:
  -  Patients with symptoms of pyloric obstruction or gastric residual volume ≥100ml confirmed by preoperative endoscopy
  -  Patients with impaired bowel function, using drugs disturbing gastric secretion and gastric emptying within 24 hours, or with high risk of aspiration
  -  Patients with a previous history of medium/large abdominal operation, or with a previous history of diffuse peritonitis
  -  Patients with diabetes or impaired glucose tolerance, or with abnormality in other endocrine hormones
  -  Patients with potential difficult airway
  -  Noncurative resection
  -  Intraoperative blood loss ≥500ml
  -  Patients with preoperative chemoradiotherapy
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Summary: Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. The investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.

Detailed description: Recently, laparoscopic approach has been a option for gastric cancer, especially early gastric cancer. There are growing interest in quality of life in addition to recurrence or survival. There are few report about peristalsis and no report for quality of life according to a direction of peristalsis.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma in stomach
  -  Scheduled as laparoscopic distal gastrectomy (tumor located lower or middle third)
  -  Planned with gastrojejunostomy after gastrectomy
  -  Clinical stage T1N0M0 or T2N0M0
  -  ECOG 0 or 1 (The Eastern Cooperative Oncology Group)
  -  ASA score class I-III (The American Society of Anesthesiologists)
  -  patient has given their written informed consent to participate in the study
  Exclusion Criteria:
  -  Simultaneously combined resection of other organ (including cholecystectomy)
  -  Active other malignancy
  -  Requiring total gastrectomy
  -  Chronic inflammatory bowel disease or other chronic disease related to bowel motility
  -  Uncontrolled diabetes or patients with diabetic complications
  -  Vulnerable patients

Relevance to patient case: not relevant