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

Clinical trial: Phase 1 Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

Summary: This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of BLU-285, administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).


Eligibility: Inclusion Criteria:
  -  For Part 1: Histologically- or cytologically-confirmed diagnosis of unresectable GIST or another advanced solid tumor. Patients with unresectable GIST must have disease that has progressed following imatinib and at least 1 of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib or an experimental agent that targets KIT, or disease with a D842 mutation in the PDGFRα gene. Patients with an advanced solid tumor other than GIST must have relapsed or refractory disease without an available effective therapy.
  OR For Part 2:
  -  Group 1: Patients must have a confirmed diagnosis of unresectable GIST that has progressed following imatinib and at least 1 of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib, or an experimental agent that targets KIT, and the patient does not have a D842V mutation in PDGFRα.
  -  Group 2: Patients must have a confirmed diagnosis of unresectable GIST with a D842V mutation in the PDGFRα gene. The PDGFRα mutation will be identified by local or central assessment, either in an archival tissue sample or a new tumor biopsy obtained prior to treatment with BLU-285.
  -  Groups 1 and 2: A tumor sample (archival tissue or a new tumor biopsy) has been submitted for mutational testing.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  Exclusion Criteria:
  -  QT interval corrected using Fridericia's formula (QTcF) >450 milliseconds
  -  Platelet count <90,000/mL
  -  Absolute neutrophil count <1000/mL
  -  Hemoglobin <9 g/dL
  -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x the upper limit of normal (ULN) if no hepatic metastases are present; >5 × ULN if hepatic metastases are present
  -  Total bilirubin >1.5 × ULN; >3 × ULN with direct bilirubin, >1.5 × ULN in the presence of Gilbert's Disease
  -  Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Brain malignancy or metastases to the brain
  -  History of a seizure disorder or requirement for anti-seizure 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: I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia

Summary: The purpose of this study is to assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Detailed description: Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. I-scan is a novel image-enhanced endoscopy system based on the post processing of reflected light without optical filters. Targeted biopsy protocol based on i-scan with magnification will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from i-scan with magnification targeted biopsies and a standard biopsy protocol and assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Eligibility: Inclusion Criteria:
  -  patients with dyspeptic symptoms and aged 40 years or older
  -  or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
  -  or patients with family history of gastric cancer
  Exclusion Criteria:
  -  presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
  -  presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
  -  inability to provide 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: Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

Summary: The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.

Detailed description: Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended.
  This study aims to compare the diagnostic yield of gastric intestinal metaplasia from two different fluorescein sodium dosage and assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.

Eligibility: Inclusion Criteria:
  -  patients with dyspeptic symptoms and aged 40 years or older
  -  or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
  -  or patients with family history of gastric cancer
  Exclusion Criteria:
  -  presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
  -  presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
  -  inability to provide 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: Human Epidermal Growth Factor Receptor 2 (HER2) Advanced Gastric Epidemiology Study in Korea

Summary: This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated.


Eligibility: Inclusion Criteria:
  -  Formalin-fixed, paraffin-embedded tumor tissue samples with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with locally advanced, recurrent, and/or metastatic disease
  -  Sufficient invasive tumor tissue for HER2 evaluation, including surgical excision specimens or at least 6 to 8 available biopsies
  Exclusion Criteria:
  -  None specified

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

Clinical trial: Banded Versus Non-banded Roux-en-y Gastric Bypass

Summary: A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.

Detailed description: A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
  The Study design is a prospective, randomized, single center study.
  Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.
  Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)

Eligibility: Inclusion Criteria:
  -  all patients who are eligible for a primary RYGB
  Exclusion Criteria:
  -  Bariatric surgery in history
  -  Patients with a language barrier which may affect the compliance with medical advice
  -  Any kind of genetic disorders which can be of influence on the monitoring of medical advice
  -  Patients with a disease not related to morbid obesity, such as Cushing or drug related.
  -  Chronic bowel disease for example Crohn's disease or colitis Colitis.
  -  Renal impairment (MDRD <30) or hepatic dysfunction (liver function twice the normal values)
  -  Pregnancy
  -  Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors

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

Clinical trial: HIPEC, Intravenous Chemotherapy and Surgery for the Treatment of Advanced GC With Peritoneal Metastasis

Summary: Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

Detailed description: To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Eligibility: Inclusion Criteria:
  gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.
  -  Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
  -  Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  -  ECOG (Eastern Cooperative Oncology Group) : 0~2
  -  Age: 18~75 years old
  -  Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
  -  Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
  -  Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
  -  Not participating in other study projects before and during the treatment
  -  Signed the Informed Consent Form
  Exclusion Criteria:
  -  Not conforming to above inclusion criteria
  -  Distal metastasis to lung, liver, or para aortic lymph node metastasis
  -  Ever operation on the stomach
  -  Operation intolerance due to other systemic basic diseases
  -  Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
  -  Allergy to the drugs in this protocol
  -  Pregnant or lactating women
  -  Women at childbearing age and of pregnancy desire during the study

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

Clinical trial: INCB039110 Combined With INCB024360 and/or INCB039110 Combined With INCB050465 in Advanced Solid Tumors

Summary: This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 2 parts (Part 1a and Part 1b). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (INCB039110) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and INCB039110 in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b).


Eligibility: Inclusion Criteria:
  -  Male or female, age 18 years or older.
  -  Willingness to provide written informed consent for the study.
  -  Part 1a: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance).
  -  Part 1b: Subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
  -  Part 1b: Must have documented confirmed disease progression on a prior programmed cell death-1 (PD-1) pathway targeted agent or must be PD-1 pathway-targeted treatment naïve.
  -  Has baseline tumor biopsy specimen available or willingness to undergo a pre-treatment tumor biopsy to obtain the specimen.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  Exclusion Criteria:
  -  Laboratory parameters not within the protocol-defined range.
  -  Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
  -  Received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment.
  -  Has not recovered from toxic effect of prior therapy to < Grade 1.
  -  Active or inactive autoimmune process.
  -  Has received a live vaccine within 30 days of planned start of study therapy.
  -  Active infection requiring systemic therapy.

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

Clinical trial: OLGA Stage is More Appropriate in Predicting Early Gastric Cancer

Summary: The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.

Detailed description: Japanese endoscopic gastric atrophy (EGA) classification, operative link on Gastritis Assessment (OLGA), operative link on intestinal metaplasia assessment (OLGIM) and gastritis pattern are used in evaluating the severity of gastritis and intestinal metaplasia in different countries, which are risk factors of gastric cancer. The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.
  A prospective study was conducted encompassing EGC patients (cases) and non-EGC patients (controls). All patients were performed endoscopic examination and systematically biopsied. Outcome measures were assessed and compared, including EGA classification as well as the OLGA/OLGIM assessment. Helicobacter pylori(H. pylori) status was detected in the meantime. A stepwise logistic regression model was performed to analyze correlations between EGA, OLGA, OLGIM and EGC.

Eligibility: Inclusion Criteria:
  -  The age of patients is from 40-80 years
  -  Must undergo esophagogastroduodenoscopy
  Exclusion Criteria:
  -  Clinical diagnosis of advanced gastric cancer
  -  Post-subtotal gastrectomy
  -  Acute upper gastrointestinal bleeding
  -  Severe systemic diseases
  -  Lack histology

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

Clinical trial: TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

Summary: This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.

Detailed description: TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are refractory to prior treatment.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed:
  1. adenocarcinoma of the pancreas (pancreatic cancer)
  2. adenocarcinoma of the colon or rectum (colorectal cancer)
  3. adenocarcinoma of the gastric (gastric cancer)
  4. esophageal cancer
  5. gastrointestinal stromal tumor (GIST)
  -  Relapsed or refractory disease
  -  Measurable lesion by RECIST 1.1
  Exclusion Criteria:
  -  Known Hepatitis B, C or HIV infection
  -  Previous therapy with any drug that inhibits the PI3K pathway
  -  Anti-tumor therapy within 21 days of study Day 1

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

Clinical trial: Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework

Summary: During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.
  The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.


Eligibility: Inclusion Criteria:
  -  Healthy volunteers aged 18 to 85 years
  -  Male or female
  -  American Society of Anesthesia physical status classification I and II
  -  Height greater than 145 cm
  -  Ability to understand the study protocol and provide informed consent
  Exclusion Criteria:
  -  Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
  -  History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal 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: PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

Summary: This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel. The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity of the RP2D as determined in the Dose Escalation Phase.


Eligibility: Inclusion criteria:
  1. histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
  2. Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN, etc.) as assessed in a local laboratory.
  3. Has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure.
  4. Eastern Cooperative Oncology Group performance status of 0 or 1
  5. measurable or evaluable disease as determined by RECIST 1.1.
  6. Is able to swallow and retain orally administered medication
  7. adequate baseline organ function
  Exclusion criteria
  1. prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K pathway inhibitors
  2. Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or Grade 2 anemia (if hemoglobin is ≥9.0 g/dL)
  3. Has CNS metastases
  4. Has a QTc interval >450 msec or QTc >480 msec for subjects with bundle branch block (BBB)
  5. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2636771 or hypersensitivity to drug formulated in polyoxyl 35 castor oil, NF such as paclitaxel.

Relevance to patient case: definitely relevant