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

Clinical trial: A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors

Summary: This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).


Eligibility: Inclusion Criteria:
  -  Adults at least 18 years of age
  -  Easter Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Life expectancy at least 12 weeks
  -  Locally advanced or metastatic solid tumor with at least 1 measurable lesion, which has progressed during/after standard therapy
  -  Human epidermal growth factor receptor 2 (HER2)-negative among participants with breast cancer
  -  Negative pregnancy test or use of an adequate contraceptive method among women of childbearing potential
  -  Adequate hematologic, hepatic, and renal function
  Exclusion Criteria:
  -  Clinical evidence of central nervous system (CNS) metastases
  -  Prior chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or hormone therapy within 2 weeks of study Day 1
  -  History of palmar plantar syndrome Grade 2 or worse, or any unresolved residual chemotherapy effects
  -  Prior HER2-active agents, continuous intravenous (IV) 5-fluorouracil, capecitabine, or other fluoropyrimidine
  -  Any investigational agent within 28 days of study start
  -  Prior cumulative doxorubicin dose greater than (>) 360 mg/m^2 or equivalent
  -  Significant cardiovascular disease
  -  Active/uncontrolled concurrent illness or infection-
  -  Major surgery or trauma within 4 weeks of study Day 1

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 Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)

Summary: This is a research study for participants who have been diagnosed with lung cancer and are receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall objective of this study is to develop a database to collect data on participants who are undergoing VATS lobectomy or segmentectomy for lung cancer.

Detailed description: This database will be used as for quality improvement purposes. Furthermore, the database will help in collecting data in an organized fashion, which will help the investigators learn more about the details of the workup performed prior to the surgery, during the surgery, peri-operative management and early follow-up. The investigators hope that this database will help to determine a common guideline to perform VATS lobectomy or segmentectomy. By creating a common guideline for future treatment of VATS patients, the investigators predict the efficiency of the process will increase significantly without decreasing, and perhaps even improving, the quality of the procedure.

Eligibility: Inclusion Criteria:
  -  Male and female subjects
  -  Age ≥ 18 years
  -  Underwent a VATS lobectomy or segmentectomy procedure for lung cancer -- Note: patients with other malignancies are eligible if they have a primary cancer of the lung as defined above
  Exclusion Criteria:
  -  Subjects undergoing thoracotomy lobectomy or segmentectomy for lung cancer
  -  Subjects undergoing surgical procedures other than VATS lobectomy or segmentectomy for lung cancer

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

Clinical trial: Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD

Summary: To test the hypothesis that nebulized Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two treatment arms among primary lung cancer patients with COPD required single lobectomy from 3days before operation to 7 days after operation.


Eligibility: Inclusion Criteria:
  1. Newly diagnosed or existing COPD defined by GOLD, and FEV1 of<80% predicted and FEV1/FVC<70%
  2. Diagnosed as primary lung cancer by China guidelines on diagnosis and treatment of primary lung cancer
  3. .Consistent with indication of operation of pulmonary single lobectomy surgery by China guidelines on diagnosis and treatment of primary lung cancer
  4. General anesthesia and double cavity intubation was used during operation
  5. ASA Classification of Anesthesia Risk is in category 1-3 both in baseline
  6. age from 40-80 years old
  7. Smoking cessation more than two weeks before operation
  8. SP O2>90% before surgery
  9. Hemoglobin > 10g/dl
  10. Estimated duration of surgery < 4 hours
  11. 18.5<BMI < 28
  Exclusion Criteria:
  1. Patients who had taken systemic corticosteroids in the preceding 1month before baseline
  2. Patients who had pneumonia in the preceding 1month before baseline
  3. Patients with a history of recent myocardial infarction, heart failure, tuberculosis
  4. Subject with known or suspected human immunodeficiency virus infection

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

Clinical trial: Tumor-specific T Cells in Lung Cancer

Summary: Non-small cell lung cancer is characterized by aggressive growth and treatment resistance. New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear. The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.


Eligibility: Inclusion Criteria:
  -  Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group)
  -  Healthy donors (control group)
  -  written informed consent
  Exclusion Criteria:
  -  Autoimmune disease
  -  Patients receiving immunomodulatory drugs, e.g. tacrolimus
  -  Prior malignancy
  -  Pregnancy

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

Clinical trial: Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer

Summary: Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung cancer. Relatives with family history of lung cancer are at increased risk of lung cancer compared to those without a family history in pooled analysis. A prospective trial using LDCT of lung to screen the relatives with family history of lung cancer is needed.

Detailed description: Investigators invited participants with family history to join in this study under the criteria of (1) relatives of the lung cancer patients; (2) age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old; (3) compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation. The participants with (1) proved lung cancer either with or without treatment, (2) presence of hemoptysis or history of remarkable lung fibrosis, (3) any other cancer history or (4) chest CT examination within one year would be excluded from the study.
  The study was planned to enroll 1000 participants from simplex families and 500 participants from multiplex families for lung LDCT screening. Multiplex family was defined as two or more family members with lung cancers, and simplex family as one family member with lung cancer.

Eligibility: Inclusion Criteria:
  1. relatives of the lung cancer patients;
  2. age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old;
  3. compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation.
  Exclusion Criteria:
  1. proved lung cancer either with or without treatment,
  2. presence of hemoptysis or history of remarkable lung fibrosis,
  3. any other cancer history or
  4. chest CT examination within one year

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

Clinical trial: Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer

Summary: Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.

Detailed description: This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.
  To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.

Eligibility: Inclusion Criteria:
  -  Aged ≥18 and ≤80 years.
  -  ECOG performance status of 0 to 1.
  -  Life expectancy of more than 12 weeks.
  -  At least one measurable lesion exists.(RECIST 1.1)
  -  Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.
  -  Required laboratory values including following parameters:
  ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
  -  Signed informed consent.
  Exclusion Criteria:
  -  Subjects with third space fluid that can not be controled by drainage or other methods.
  -  Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
  -  Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy
  -  Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  -  Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
  -  Receiving any other antitumor therapy.
  -  Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
  -  History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  -  Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
  -  Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  -  Known history of neurological or psychiatric disease, including epilepsy or dementia.

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

Clinical trial: High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy

Summary: The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia.

Detailed description: High-flow nasal cannula oxygen (HFNC) treatment has been showed to have several clinical advantages compared with conventional oxygen therapy. Currently, no reports have described the effects of HFNC in postoperative patients after thoracic surgery. The primary objective of this study is to determine the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) in patients with lung cancer after pulmonary lobectomy.
  In the postoperative period after extubation, patients will be randomly assigned to either:
  1. standard oxygen therapy group (control group) or
  2. HFNC group (study group).
  In the control group, patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. Patients in the study group will be given HFNC treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. After 48 hours from study entry, all patients will be evaluated for possible interruption of oxygen treatment on the basis of their clinical conditions.

Eligibility: Inclusion Criteria:
  -  planned pulmonary lobectomy for lung cancer
  Exclusion Criteria:
  -  age <18 years
  -  patient refusal
  -  body mass index ≥35 kg/m2
  -  sleep apnea syndrome
  -  tracheostomy
  -  home oxygen therapy
  -  pregnancy

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 Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer

Summary: This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  It is the physician's decision to prescribe erlotinib in participants and to document their treatment
  -  Participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label
  Exclusion Criteria:
  -  Participants will be excluded if safety concerns occurred
  -  If the participant was not compliant or if the participant would wish to stop erlotinib therapy

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"Fuzzing" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs

Summary: Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Detailed description: Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Eligibility: Inclusion Criteria:
  1. Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
  2. Patients receiving chemotherapy for the first time in 6 weeks after surgery;
  3. Age from 18 Years to 70 Years;
  4. The liver and renal function were normal,and no other disease.
  5. Patients compliance is good ang can understand the situation of this study and signed informed consent
  Exclusion Criteria:
  1. Patients without clear pathological diagnosis;
  2. The expected survival period is morn than 6 months;
  3. Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
  4. Patients with pregnancy or lactation;
  5. Persons with a history of less control.

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

Clinical trial: Registry Study on Biological Disease Profile and Clinical Outcome in Patients With Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project

Summary: Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly Diagnosed or Existent Lung Cancer
  The LuCa Biology and Outcome (BiO)-Project


Eligibility: Inclusion Criteria:
  -  Patients with suspected diagnosis of lung cancer, or previously diagnosed lung cancer
  -  Age ≥ 18 years. There is no upper age limit.
  Exclusion Criteria:
  -  Severe neurological or psychiatric disorder interfering with ability to give an informed consent
  -  No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
  -  No consent for biobanking of patient's biological specimens and performance of analyses on stored material.

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 Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure

Summary: This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.


Eligibility: Inclusion Criteria:
  -  Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation).
  -  Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm according to Recist 1.1 criterion (by contrast CT).
  -  Patients who take EGFR-TKI as first/second line therapy.
  Exclusion Criteria:
  -  Patients who has taken EGFR-TKI before.
  -  Patients who take EGFR-TKI as third or more line.
  -  Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug.
  -  The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI.
  -  Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.

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

Clinical trial: EGFR Mutations on ctDNA in Patients With Advanced NSCLC

Summary: The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC;
  -  Patient had received ≤ 1 prior systemic chemotherapy regimens;
  -  Provision of blood (plasma) sample for ctDNA testing;
  -  Patient must be able to comply with the protocol;
  Exclusion Criteria:
  -  Prior received ≥2 systemic chemotherapy regimens;
  -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
  -  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: Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Summary: The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.

Detailed description: Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.
  To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility: Inclusion Criteria:
  -  Aged 18-80 Rheumatoid Arthritis patient;
  -  Patients must consent in writing to participate in the study by signing and dating an informed consent document;
  -  Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
  -  Stage I and II according to X-ray.
  Exclusion Criteria:
  -  History of neurological disease, head injury or psychiatric disorder;
  -  Pregnant women;
  -  Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
  -  Progressive apoplexy;
  -  With malignant tumors;
  -  Patients who had participated in other clinical trials within three months prior to this study.

Relevance to patient case: not relevant