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

Clinical trial: Effect of Bright Light on Mood and Sleep in Parkinson's Disease

Summary: The purpose of this clinical trial is to investigate whether light therapy is a suitable treatment option for depression and insomnia in Parkinson's disease.

Detailed description: The quality of life of patients with Parkinson's disease and their caretakers is mainly influenced by so called non-motor symptoms. This includes neuropsychiatric consequences of the disease like depression and sleeping problems. The incidence of depressed mood in patients with Parkinson is approximately 50%, the incidence for sleeping problems is 90%. These symptoms are often overlooked and even if recognized, inadequately treated. The treatment of mood and sleep disturbances in Parkinson patients is hampered by adverse effects, incomplete responses to the usual treatments and the absence of specific treatment options for these symptoms in Parkinson's disease. On the basis of the hypothesis of disturbed functioning of the suprachiasmatic nucleus in Parkinson's disease it is expected that stimulation of this nucleus by bright light therapy will result in improved functioning on multiple different domains: mood, sleep, motor functions, quality of life and circadian rhythms. Because there are virtually no side effects and the possibility of home treatment, light therapy is expected to be highly appreciated by the patients.

Eligibility: Inclusion Criteria:
  -  Parkinson's disease
  -  depression
  Exclusion Criteria:
  -  psychosis
  -  mania
  -  suicidality
  -  retinopathy
  -  previous light treatment
  -  use of photosensitising medication

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 III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

Summary: This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.


Eligibility: Inclusion Criteria:
  -  Postmenopausal women
  -  Breast cancer that is locally advanced or metastatic
  -  HER2 negative disease, and a known positive hormone receptor status (common breast cancer classification tests)
  -  A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
  -  Prior treatment with AIs
  -  Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  More than 1 prior chemotherapy given for locally advanced or metastatic disease
  -  Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant
  -  Symptomatic CNS metastases
  -  Concurrent malignancy or malignancy within 3 years prior to start of study treatment
  -  Certain drugs or radiation within 2-4 weeks of enrollment
  -  Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
  -  Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
  -  Hyper sensitivity to fulvestrant treatment excipients
  -  Certain scores on an anxiety and depression mood questionnaire given at screening
  -  Acute viral hepatitis or history of chronic or acute HBV, HCV, HAV, HDV, HEV
  -  Other protocol defined 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: Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes

Summary: Different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of gastric cancer patients with type 2 diabetes.

Detailed description: Different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of gastric cancer patients with type 2 diabetes.
  The investigators will observed fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of the patients preoperation, 14 days postoperation 3 month and 6month postoperation. The investigators will observed the effect of blood glucose to different digestive tract reconstruction after gastrectomy of gastric cancer with type 2 diabetes

Eligibility: Inclusion Criteria:
  1. 18-75 years old,gastric cancer ,can be performed operation
  2. with type 2 diabetes,fasting blood glucose > 6.1mmol/L
  3. without serious underlying diseases which may affect the metabolism and nutrient uptake
  4. without serious underlying diseases which may affect anesthesia and operation
  5. can be performed subtotal or total gastrectomy, predicted survival period > 6months
  6. no other abdominal operation
  7. preoperation consultation
  8. informed consent
  Exclusion Criteria:
  1. recurrent,metastasis or die
  2. patient requests for quit
  3. 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: Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

Summary: i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.
  ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.
  iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.

Detailed description: Gastric cancer remains the world's second leading cause of cancer-related deaths. The prognosis for patients with this cancer clearly depends on stage at diagnosis. At least for the intestinal subtype of gastric adenocarcinoma, a cascade of histopathologic lesions has been defined: chronic gastritis, atrophic chronic gastritis, intestinal metaplasia (IM), and intraepithelial neoplasia (IN). The identification of these lesions and follow-up of patients in whom they are found could lead to diagnosis of gastric cancer at an early stage, thus improving patients' survival. The diagnosis of these lesions, which often appear in flat mucosa, is currently based on histopathologic examination of endoscopic biopsy specimens. However, conventional white-light endoscopy (WLE) for this purpose has high interobserver variability and a poor correlation with histopathologic finding.
  Confocal laser endomicroscopy (CLE), producing both conventional WLE and confocal microscopic images, can provide a direct histological observation of the in vivo tissue without the need for biopsy. Recently, CLE has shown its value for diagnosing gastric IM, intraepithelial neoplasia and carcinoma. However, none of those CLE criteria for gastric IM, IN or carcinoma (CA) has been validated in various endoscopic centers, hence reducing the reliability and clinical application of them.

Eligibility: Inclusion Criteria:
  -  Male or Female aged 18－80
  -  Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis
  Exclusion Criteria:
  -  Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer
  -  Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium
  -  Inability to provide informed consent and other situations that could interfere with the examination protocol

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

Clinical trial: Gastric Cancer Screening and Alarm Symptoms in Early Gastric Cancer

Summary: Most of the early gastric cancer are asymptomatic. Symptoms of advanced gastric cancer are weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal bleeding. Gastric cancer found according to warning symptoms such as gastrointestinal bleeding, weight loss usually can not be cured. Therefore, early gastric cancer can not be detected and impossible to treatment if endoscopy is performed according to the warning signs. National gastric cancer screening is conducted in men and women of more than 40 years old. The purpose of screening for gastric cancer is discovering a case of possible cure, so increasing the survival rate. The purpose of this study is review of the feasibility of screening for gastric cancer.


Eligibility: Inclusion Criteria:
  -  gastric cancer patients in St.mary`s hospital
  Exclusion Criteria:
  -  gastric lymphoma, gastric GIST patients in St.mary`s hospital

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

Clinical trial: Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers

Summary: Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy.
  Oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers.
  The aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.


Eligibility: Inclusion Criteria:
  -  Has not yet started treatment for the identified cancer
  Exclusion Criteria:
  -  medically compromised patients
  -  congenital syndromes
  -  being treated with radiotherapy or chemotherapy.

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

Clinical trial: Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Summary: Helicobacter pylori infection is associated with gastric cancer in epidemiological studies. However, it is still unknown whether H. pylori eradication is useful and required to prevent gastric cancer.
  Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients.
  In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.


Eligibility: Inclusion Criteria:
  -  Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
  -  Informed consent should be signed
  Exclusion Criteria:
  -  Gastric cancer history
  -  Other malignancy within the past 5 years
  -  Hereditary cancer family member (HNPCC, FAP)
  -  Peptic ulcer history
  -  Peptic ulcer, esophageal cancer, gastric cancer case found at EGD
  -  H. pylori eradication treatment history
  -  Previous serious side effect to antibiotics
  -  Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
  -  Pregnant or nursing women
  -  Psychiatric disorder that would preclude compliance, alcoholics
  -  Refuse 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: De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

Summary: This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
  Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.

Detailed description: Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.

Eligibility: Inclusion Criteria:
  1. Pathologically proven unresectable NSCLC
  2. 20 years of age or older
  3. Planned treatment with Iressa®
  4. Patients with activating EGFR mutation (del 19, L858R)
  5. Available detailed smoking history
  6. Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
  7. Available blood sample
  8. At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
  9. Written informed consent
  Exclusion Criteria:
  1. More than 3rd line treatment
  2. Previously treated with other EGFR-TKI
  3. Life expectancy of less than 12 weeks
  4. Pregnant or lactating female
  5. Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
  6. Unsuitable patient in this treatment as determined by doctor.

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

Clinical trial: Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy

Summary: The purpose of this study is to find out more about differences of the quality of life in patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction. To find a better reconstruction for patients who received total gastrectomy.

Detailed description: Total gastrectomy has been indicated mainly for advanced gastric cancer located from the upper to middle third of the stomach or multiple gastric cancers.The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestines is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines ' lower down.
  Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It often is associated with a limitation of postoperative quality of life (QOL). To improve postoperative nutritional status and QOL, surgeons have tried to establish ideal reconstruction after total gastrectomy and the optimum procedure for reconstruction has been discussed.
  This study will compare the postoperative quality of life (QOL) of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes patients feel better.

Eligibility: Inclusion Criteria:
  -  • Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed at other institutions but slides must be confirmed at SHCA, as is routine care at our institution) , and the patients be assessed must be carried out total gastrectomy by three specialists.
  -  Patients 20-75 years old
  -  Normal organ function, able to tolerate surgery, no clear contraindication for surgery
  -  No evidence of metastases of adjacent organs
  -  be able to provide follow-up over 2 years
  -  No specific treatment for gastric cancer before surgery
  -  In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
  -  The subjects were able to understand and comply with the trial protocol, and signed informed consent.
  Exclusion Criteria:
  -  • Synchronous or metachronous (less than five years) and with other malignancies.
  -  Cirrhosis and portal hypertension
  -  Associated with blood diseases
  -  Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
  -  Suffering from a serious neurological diseases or psychological diseases affecting the life

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

Clinical trial: Perioperative Immunonutrition, Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients

Summary: Perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity and may improve quality of their life. Patients with gastric cancer will be divided into four groups depending on the type of artificial nutrition. Group I (enteral feeding) and II (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional therapy during the postoperative period, group III (oral arginine) and IV (parenteral immunonurition) patients will be treated nutritionally both prior to and after the surgery. The lymphocytes and their subpopulations, interleukin IL-1B,-6,-23, and the phagocytic, and bactericidal activity of blood platelets will be determined before and after nutritional therapy.

Detailed description: Surgical treatment of gastric cancer is associated with a high risk of perioperative complications. Morbidity of cancer patients increases in concert with the clinical stage of the malignancy. It is postulated that a reduction in perioperative morbidity and improved quality of life of patients with advanced gastric cancer can be achieved by proper preparation to surgery, among others. One of such methods is the implementation of immunostimulating nutritional therapy during the perioperative period.The stage of cancer will be graded according to TNM classification. The patients will be randomly assigned to four clinical groups based on the type of nutritional therapy implemented.

Eligibility: Inclusion Criteria:
  -  gastric cancer
  Exclusion Criteria:
  -  for group III constituted gastric cancer associated with severe gastrointestinal obstruction

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 Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors

Summary: This is a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part is to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up. At a minimum, patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.

Detailed description: This is a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part is to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM).
  Once MTD/RP2D has been determined, patients will be enrolled in two Phase II arms. Patients with PIK3CA mutated or amplified hormone receptor positive breast carcinoma will be enrolled in Arm 1; patients with PIK3CA mutated or amplified ovarian carcinoma will be enrolled in Arm 2. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up. At a minimum, patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.

Eligibility: Inclusion criteria:
  -  Written informed consent.
  -  Patients aged ≥ 18 years (male or female).
  -  Patients with the following histologically/cytologically-confirmed advanced solid tumors with documented somatic PIK3CA mutations or amplifications in tumor tissue:
  -  Hormone receptor positive breast carcinoma
  -  Ovarian carcinoma
  -  Other tumors upon agreement with sponsor
  -  Adequate organ function
  -  Negative serum pregnancy test
  Exclusion criteria:
  -  Patients with known history of severe infusion reactions to monoclonal antibodies.
  -  Patients with primary CNS tumor or CNS tumor involvement.
  -  History of thromboembolic event requiring full-dose anti-coagulation therapy any time prior to enrollment.
  -  Clinically significant cardiac disease.
  -  History of another malignancy within last 2 years.
  -  Pregnant or nursing (lactating) women.
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: possibly relevant