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

Clinical trial: Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB

Summary: The aim of the present study was to assess whether it was necessary to conduct magnifying endoscopy with narrow band imaging (ME-NBI) targeted biopsy compared with endoscopic forceps biopsy (EFB) from white light endoscopy in diagnosing early gastric cancer (EGC). Meanwhile, the investigators proposed the most cost-effective way to diagnose EGC.

Detailed description: ME-NBI has been widely used for the diagnosis of stomach diseases, especially in the early diagnosis of gastric cancer. The aim of the present study was to evaluate diagnostic efficacy of ME-NBI targeted biopsy and ME-NBI combined with targeted biopsy compared with EFB from white light endoscopy and ME-NBI combined with EFB.
  A prospective study was conducted encompassing suspected EGC. All patients were performed white light endoscopic examination with EFB and then ME-NBI with ME-NBI targeted biopsy. Outcome measures were assessed and compared, including diagnostic efficacy of EFB from white light endoscopy,ME-NBI combined with EFB, ME-NBI targeted biopsy and ME-NBI combined with targeted biopsy.

Eligibility: Inclusion Criteria:
  -  consecutive patients with gastric lesions detected by white light endoscopy and suspected of EGC
  Exclusion Criteria:
  -  they had advanced gastric cancer
  -  lesions were histopathologically confirmed to be submucosal tumors
  -  they had a history of gastrectomy
  -  tissue biopsy wasn't obtained during last white light endoscopy
  -  they couldn't tolerate another endoscopic examination

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

Clinical trial: EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract

Summary: Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:
  - Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.

Detailed description: Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.
  In this study the investigators want to compare the Endodrill instrument with FNA (both modalities EUS-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper GI-tract. Patients diagnosed with suspected submucosal tumors in the upper GI-tract will be enrolled to this study. They will first go through examination with EUS. If the suspicion of a submucosal tumor is confirmed, the investigator will perform both EUS guided FNA and Endodrill biopsies in the same patient.The harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.

Eligibility: Inclusion Criteria:
  -  All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy
  Exclusion Criteria:
  -  Mental illness
  -  Extreme co-morbidity

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

Clinical trial: Study of ONO-4538 in Gastric Cancer

Summary: The purpose of study is to evaluate the efficacy and safety of ONO-4538 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.


Eligibility: Inclusion Criteria:
  -  Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer)
  -  Have measurable lesions as defined in RECIST Guideline Version 1.1
  -  ECOG PS score 0 or 1
  -  Have a life expectancy of at least 3 months
  Exclusion Criteria:
  -  Have multiple cancers
  -  Have a current or past history of severe hypersensitivity to any other antibody products
  -  Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
  -  Patients with active, known or suspected autoimmune 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: A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer

Summary: Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy.
  Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.


Eligibility: Inclusion Criteria:
  -  ECOG 0-1
  -  ASA I-III
  -  Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  -  Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
  -  The gastric tumors are located in the stomach, are macroscopically resectable by subtotal or total gastrectomy with D2 lymph node dissection.
  -  Written informed consent
  Exclusion Criteria:
  -  Clinically apparent distant metastasis
  -  Free cancer cells
  -  Bulky lymph node metastasis is detected by abdominal CT
  -  Previous treatment with radiation therapy for any tumors.
  -  Previous surgery for the present disease
  -  Pregnancy
  -  Psychiatric 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: SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment

Summary: Cricoid force is applied during airway management to prevent pulmonary aspiration of regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia assistant. Currently this is performed WITHOUT monitoring and the force applied is determined by the individual's "educated hand" that is derived from his/her experience from past training and practice. Studies have shown that the actual force applied by nurse and anaesthesia assistant is inconsistent and deviates from the optimal force. Under application of cricoid force results in ineffective cricoid pressure and the risk of pulmonary aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia, long Intensive Care Unit stay and even death. Over exertion of cricoid force results in distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on manikin with and without direct feedback. Nurses were instructed to apply a range of force of 30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was used. Unblinded nurses performed significantly better with feedback using the load sensor then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid force is developed to give feedback and guide the operator to exert and maintain the TARGET cricoid pressure during rapid sequence induction (RSI).
  In this study we aim to verify the sensor system with a manikin and compare the forces applied by nurses with the sensor system and without.

Detailed description: A total of 21 nurses or anesthetists will be recruited Inclusion criteria include healthy subjects Exclusion criteria include (1) pregnant subjects (2) history of back pain or injury
  Cricoid pressure applied on manikin will be measured
  1. By electronic medical grade weighing scale
  2. By sensor system electronically

Eligibility: Inclusion Criteria:
  - Healthy status
  Exclusion Criteria:
  -  Pregnant state
  -  History of problems/ surgery to neck or spine.

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

Clinical trial: Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes

Summary: The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.
  The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.

Detailed description: A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:
  -  Small samples of patients, mostly low-quality comparative studies
  -  Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy)
  -  Absence of subgroup analysis in significant research fields
  -  Lack of information on the surgical techniques adopted
  A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:
  -  Achieving a large sample of patients
  -  Collecting multiple variables, allowing for the making of a comprehensive statistical report
  -  Standardizing the methodology to be adopted, thus increasing accuracy
  -  Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities.

Eligibility: Inclusion Criteria:
  -  Histologically proven gastric cancer
  -  Preoperative staging work-up performed by upper endoscopy and/or endoscopic ultrasound, and CT scan and in accordance to international guidelines
  -  Early Gastric Cancer
  -  Advanced Gastric Cancer
  -  Patients treated with curative intent in accordance to international guidelines
  Exclusion Criteria:
  -  Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, Krukenberg tumors, involvement of other organs
  -  Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score > 4
  -  History of previous abdominal surgery for gastric cancer
  -  Synchronous malignancy in other organs
  -  Palliative surgery

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

Clinical trial: Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer

Summary: Apatinib dose titration in Advanced or Metastatic Gastric Cancer


Eligibility: Inclusion Criteria:
  1. ≥ 18 and ≤ 70 years of age
  2. Histological confirmed advanced or metastatic adenocarcinoma of the stomach
  3. Have failed for at least 2 lines of chemotherapy
  4. Life expectancy of at least 12 weeks
  5. Eastern Cooperative Oncology Group Performance Status of 0 or 1
  6. At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
  7. Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
  8. More than 4 weeks for operation or radiotherapy or cytotoxic agents
  9. Adequate hepatic, renal, heart, and hematologic functions
  Exclusion Criteria:
  1. Pregnant or lactating women
  2. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  3. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
  4. Any factors that influence the usage of oral administration
  5. Evidence of central nerves system metastasis
  6. Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure
  7. proteinuria ≥ (+)
  8. International Normalized Ratio > 1.5 and activated partial thromboplastin time > 1.5 × Upper limit of normal（ULN）
  9. Certain possibility of gastric or intestine hemorrhage
  10. Less than 4 weeks from the last clinical trial
  11. Prior VEGFR inhibitor treatment
  12. Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc

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

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: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Laparoscopic Versus Open Resection of Cancer Stomach

Summary: The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).
  There are two main types of techniques (open & laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is superior in early postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open resection (less safety margin & less lymphadenectomy) but because of the ongoing advances on laparoscopic surgery these results needs more and more revision.
  So the investigators conduct this randomized controlled trial aiming at comparing open and laparoscopic resection of cancer stomach to choose the best surgical procedure for resection of cancer stomach.

Detailed description: The surgical procedure for resection of cancer stomach aiming at resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).
  # Tumor resection;
  Will be done by one of the following techniques:
  1. laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour)
  2. Open gastrectomy (according to the site of tumor). # Lymphadenectomy; Will be done according to Japanese Gastric Cancer Association guidelines for optimal lymph node dissection levels for Early Gastric Cancer (1):
  -  D1+alpha -(perigastric lymph node dissection) for mucosal cancer, for which EMR is not indicated and for histologically differentiated submucosal cancer of < 1.5 cm in diameter;
  -  D1+ beta for preoperatively diagnosed submucosal cancer without lymph node metastasis (N0), for which D1+ alpha is not indicated, and for early cancer < 2.0 cm in diameter with only perigastric lymph node metastasis (N1);
  -  D2 for early cancer > 2.0 cm in diameter. Follow up: all patients will be followed up clinically for the outcomes for each surgical technique.

Eligibility: Inclusion Criteria:
  -  All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1-3, N0-1, M0).
  Exclusion Criteria:
  -  Pregnancy.
  -  Infiltration to the( pancreas ,liver ,colon or vital vascular structure).
  -  Metastasis to the (liver, lung, brain, paraaortic LN involvement).
  -  Peritoneal deposit.
  -  Surgically unfit patient.

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

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