araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy?

Summary: There are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one lung ventilation. The overloading of fluid administration could be related to the development of pulmonary edema in patents after thoracic surgery. But fluid restriction may cause major organ hypoperfusion during the surgery. The purpose of this study is to evaluate the ability of stroke volume variation as an indicator for a fluid responsiveness in patient who receives pulmonary lobectomy via thoracotomy.

Detailed description: Perioperative fluid management during thoracic surgery is a significantly important, because it is quite difficult to prevent pulmonary edema due to the fluid overload and compromise perfusion of vital organ. So, it is essential to maintain optimal organ perfusion by appropriate fluid management during thoracic surgery. Stroke volume variation (SVV) is derived from pulse contour analysis and it is known that SVV ≥12~15% correlate with fluid responsiveness, defined as a significant increase in cardiac output with fluid loading, dung two-lung ventilation. It is a parameter derived from changes in stroke volume (SV) that is according to the heart-lung interaction during mechanical ventilation. positive pressure ventilation induces cyclic changes in left ventricular SV that are related mainly to the expiratory decrease in right ventricular filling and ejection. This is a reflected by variations in the SV. However both ventilator issues, such as tidal volume, PEEP, chest and lung condition, and the cardiovascular condition, such as heart rate, rhythm, ventricular function, cardiac afterload, arterial compliance may affect SVV. Recently some studies reported that SVV could predict fluid responsiveness in mechanically ventilated patients under various conditions. But it is still unclear whether SVV could predict fluid responsiveness during one lung ventilation with the chest open via a thoracotomy. During one-lung ventilation, the shunted blood flow through the non-ventilated-lung dose not contribute to the generation of SVV. And with the chest opening by thoracotomy, the pressure generated by ventilator would not be transmitted to the pulmonary vessels but rather to the atmosphere. So, the purpose of this study is to evaluate the ability of SVV as an indicator a fluid responsiveness particularly in patients undergoing one-lung ventilation with thoracotomy and to found the optimal threshold value of SVV for fluid management during thoracic surgery.

Eligibility: Inclusion Criteria:
  -  The patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital
  Exclusion Criteria:
  -  The patients with known cardiac disease include arrythmia
  -  American society of anesthesia physical status III, IV, V

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS

Summary: The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab.
  This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.


Eligibility: Inclusion Criteria:
  -  Women >= 18 years.
  -  Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with positive margins.
  -  Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS during vaccinations.
  -  Women of childbearing age with a negative pregnancy test documented prior to enrollment.
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
  -  Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
  -  Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
  Exclusion Criteria
  -  Pregnant or lactating.
  -  Positive for HIV or hepatitis C at baseline by self-report.
  -  Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR> 1.5 and partial thromboplastin time > 50 sec
  -  Major cardiac illness MUGA or ECHO <50% EF.
  -  Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Summary: Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.
  Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.
  Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility: Inclusion Criteria:
  -  Age > 19
  -  Written informed consent
  -  ECOG 0-2,
  -  Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
  -  Adequate organ function
  Exclusion Criteria:
  -  Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
  -  Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
  -  Prolonged QT interval in ECG (QTc >450 msec)
  -  Pregnant, lactating women
  -  Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Characterization of Methylation Patterns in Lung Cancer

Summary: In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Detailed description: Lots of information about the relationship between changes in methylation patterns and various diseases are accumulated in recent years. Characterization of methylation changes that occur in cancer may contribute to the development of methods for early detection of cancer by detecting cancer cells in liquids. Early detection of such changes and their correlation examining different cancers may lead to a diagnostic tool for the early detection of cancers and improve the treatment of these patients. Detection by molecular analysis can be a sensitive method and non-invasive early diagnosis of the disease In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Eligibility: Inclusion Criteria:
  -  Patients with suspected lung tumor
  Exclusion Criteria:
  -  Patients who have active disease other than lung cancer during the sample collecting

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Summary: Stage I：preoperative therapy
  -  Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy
  -  Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;

Detailed description: The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.

Eligibility: Inclusion Criteria:
  -  1.Pathological tissue were gastric cancer by gastric and liver biopsy.
  2.Immunohistochemistry confirmed HER-2 (+)or FISH(+).
  3.gastric cancer with liver metastasis were not able to resectable lesions.
  4.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
  5.ECOG performance status 0-1.
  6.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3 7.Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN); ALT / AST≤2.5 upper limit of normal range (ULN) (≤5.0 x ULN if hepatic metastasis); serum creatinine≤1.5 pper limit of normal range (ULN), Serum albumin≥30g/L.
  8.expectancy must be more than 3 months. 9.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.
  10.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later.
  11.The operation can complete the D2 operation(LNM≥15).
  12.LVEF≥50%
  Exclusion Criteria:
  -  1. Patients with other extrahepatic metastasis Include peritoneal metastasis.
  3. Patients with other malignancy in 5 years.
  4. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome.
  5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, romboembolism, heart failure, clinical symptoms of heart disease.
  6.Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.
  7.Patients have history of organ transplantation.
  8.Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
  9.Patients combined antitumor drug outside the research program.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure

Summary: The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.

Detailed description: An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure

Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC.
  -  Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
  -  Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
  -  Patient must be able to comply with the protocol
  Exclusion Criteria:
  -  Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
  -  Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
  -  Histologically confirmed small cell lung cancer or other metastatic tumors
  -  Patient with no histologic or cytological diagnosis.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring

Summary: The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer, including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition of cancer cell involved pleura.
  The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could be correlated with the prognosis. This study was performed to examine the properties of CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary therapy as a surrogate indicator for survival.


Eligibility: Inclusion Criteria:
  -  Histologically proved lung cancer
  Exclusion Criteria:
  -  History of other cancers within the past 5 years
  -  Pregnancy or breast milk feeding
  -  TB pleuritis and peritonitis

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer

Summary: Immune-based therapies (vaccines) are a new focus of clinical investigation. These therapies try to assist a patient's immune system (a system in our bodies that protects us against infection) in killing tumors. One form of such therapy is the dendritic cell combined with HER-2/neu (a type of protein over-expressed in some cancers) vaccine. Dendritic cells are immune cells that can tell your immune system to fight infection. In laboratory testing, these cells may also help the immune system attack tumors such as breast, kidney cancer or skin cancer. The purpose of this research study is to determine if it is both possible and safe to administer" this vaccine to patients with any HER2+ cancer.

Detailed description: We have demonstrated that administration of HER-2/neu pulsed DC1 in patients with DCIS results in strong immunologic responses as well as clinical responses during a brief 4 or 6 week neoadjuvant vaccination. In subsets of patients with cancer HER-2 is over-expressed including subsets of breast, gastric, pancreatic, brain, lung, and colon cancer. This trial is designed for compassionate use of a HER-2/neu pulsed DC1 in patients with metastatic HER-2 positive cancer, who have no longer standard options to eliminate disease.

Eligibility: Inclusion Criteria:
  1. Age ≥ 18 years.
  2. Subjects with active metastatic HER-2 positive cancer, at least 1+ by IHC, that have already received standard therapy who have exhausted other treatment options.
  3. Subjects with HER-2 1+ need to be HLA 2 or HLA A3 positive. There are no HLA restrictions for HER-2 2+ or 3+.
  4. Women of childbearing age with a negative pregnancy test documented prior to enrollment.
  5. Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
  6. Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study.
  7. Subjects who have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
  Exclusion Criteria:
  1. Pregnant or lactating females.
  2. Subjects with positive HIV or hepatitis C at baseline by self report.
  3. Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec
  4. Subjects with major cardiac illness MUGA or ECHO < 50% EF.
  5. Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI.
  6. Subjects receiving current therapy that may suppress immune system, such as steroids, chemotherapy at the discretion of the PI.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

Summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

Detailed description: This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

Eligibility: Inclusion Criteria:
  -  Age: at least 20 years of age
  -  Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
  -  Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
  -  At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
  -  World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
  -  Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
  -  At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
  -  Adequate hematological and biological function
  -  Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
  -  Male patients should be documented to be sterile or agree to use barrier contraception
  -  Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia
  Exclusion Criteria:
  -  Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
  -  Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
  -  Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
  -  Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
  -  History of any other malignancy
  -  Clinically significant uncontrolled condition(s)
  -  Active or chronic pancreatitis
  -  Anyone with cardiac abnormalities or history
  -  Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
  -  Pregnant or breast feeding
  -  In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Functional Status in Patients Undergoing Curative Treatment for Lung Cancer

Summary: This trial investigates the impact of curative lung cancer treatment on functional status and exercise tolerance. Furthermore this trial investigates possible underlying causes and consequences of deconditioning.

Detailed description: Preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. The underlying mechanisms and impact of this change has not yet been investigated. In light of this, our trial will prospectively follow a convenience sample of 70 patients with lung cancer who are treated curatively. Patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy). The aims of the study are to
  1. Investigate the influence of curative treatment for lung cancer on functional and maximal exercise tolerance (primary outcome).
  2. Investigate the metabolic changes underlying changes in exercise tolerance during curative treatment for lung cancer (primary outcome).
  3. Investigate the relationship between changes in exercise tolerance, daily physical activity, pulmonary function and skeletal muscle function during curative treatment for lung cancer (secondary outcome).
  4. Investigate the relationship between changes in exercise tolerance and self-reported quality of life, functional status, feelings of anxiety and depression and symptoms during curative treatment for lung cancer (secondary outcome).
  5. Investigate the relationship between physical activity and exercise tolerance on one hand and comorbidities, hospitalisations and cancer-related and all-cause mortality on the other hand after curative treatment for lung cancer (exploratory outcome).

Eligibility: Inclusion Criteria:
  -  curative treatment for lung cancer
  Exclusion Criteria:
  -  presence of other neoplasms
  -  progressive neuromuscular and neurological diseases
  -  unstable cardiac disease
  -  pulmonary hypertension
  -  interstitial lung disease
  -  orthopedic conditions that significantly impair functional status
  -  mental or psychiatric disorders that impair the ability to comply with study procedures.
  -  a history of cerebrovascular accident with remaining functional consequences
  -  a history of lung cancer
  -  lack of knowledge of the Dutch, French or English language will be excluded

Relevance to patient case: not relevant