araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

Summary: The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.

Detailed description: The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
  -  Aged 18~75 years
  -  Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
  -  With at least one measurable lesion
  -  White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L
  -  Life expectancy ＞3 months
  -  Eastern Cooperative Oncology Group performance status of ≤1 at study entry
  -  Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study
  -  Have signed informed consent
  Exclusion Criteria:
  -  Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
  -  The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
  -  Organ transplant patients
  -  Patients with active bleeding or new thrombotic diseases
  -  Patients with body temperature ＞38.5℃ for more than 3 days
  -  Total bilirubin ＞1.5 fold of upper limit of normal (ULN), ALT/AST＞1.5 fold of ULN or serum creatine ＞1.5 fold of ULN
  -  Patients with symptomatic brain-metastasis
  -  Pregnant or lactating women
  -  Patients with mental disorder

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion

Summary: Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer. Currently, the management of malignant ascites and pleural effusion is a considerable clinical challenge. The investigator hypothesized that tumor cell-derived microparticles packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for Phase II clinical trials.

Detailed description: Ascites or pleural effusion were first removed from patients. The patients were then locally injected with microparticles packaging chemotherapeutic drugs 4 times a week. The therapeutic effects and side effects were recorded.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of malignant ascites or malignant pleural effusion
  Exclusion Criteria:
  -  Non-malignant ascites or pleural effusion

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Study of CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer

Summary: This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of CH5424802/RO5424802 in patients with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of patients will receive escalating doses of CH5424802/RO5424802 orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose (600 mg) daily in two oral doses.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic non-small cell lung cancer (NSCLC)
  -  ALK-rearrangement confirmed by FDA approved test
  -  NSCLC that has failed crizotinib treatment
  -  Measurable disease as defined by RECIST v1.1
  -  Eastern Cooperative Oncology Group (ECOG) performance status </= 2
  -  Adequate hematologic, hepatic and renal function
  Exclusion Criteria:
  -  Prior therapy with ALK inhibitor other than crizotinib
  -  Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
  -  History of serious cardiac dysfunction
  -  History of or current active infection with hepatitis B, hepatitis C or HIV
  -  Clinically significant gastrointestinal abnormality that would affect absorption of the drug
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer

Summary: Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown.
  Aim: To explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether they have cachexic state at diagnosis.
  Methods: This study will be conducted at the Institut universitaire de cardiologie et de pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated whether or not they have a cachexic state. The evaluation will need two visits separated by 5 days.
  During the evaluation the following tests will be done:
  -  Anthropometric measures
  -  Level of daily physical activity
  -  Pulmonary function test
  -  Maximal incremental cardiopulmonary exercise test on ergocycle
  -  Endurance test on ergocycle
  -  Muscle function tests
  -  Magnetic stimulation
  -  Quadriceps biopsy


Eligibility: Inclusion Criteria:
  -  Men and women with a primary lung cancer diagnosis
  Exclusion Criteria:
  -  Already have undertaken surgery, chemotherapy or radiotherapy treatment
  -  Having an other cancer in the last five years
  -  Taking anticoagulation therapy

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: the Quality of Life Assessment of Lung Cancer Patients in China

Summary: The goal of this study is assess the quality of life of advanced non-small cell lung cancer (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all the subscales and constructs of FACT-L. The assumption is the quality of life will be better after 2 cycle of chemotherapy.

Detailed description: 1. Lung cancer is the most deadly cancer in the world, 85% lung cancer are non-small cell lung cancer (NSCLC). The quality of life of NSCLC patients become more and more important, because of most NSCLC is incurable.
  2. The recruitment will take place in 20 center all over the country and 500 patients will enrolled.

Eligibility: Inclusion Criteria:
  -  age: >18 and <75 years old
  -  pathological or cytological diagnosis confirmed advanced non-small cell lung cancer
  -  Eastern Cooperative Oncology Group Performance Status: 0-2
  -  have never receive any kind of anti-cancer chemotherapy
  -  agree to regularly assessment of quality of life
  -  sign the informed consent form
  Exclusion Criteria:
  -  Currently attending any antitumor drug clinical trials
  -  Pregnancy or breast-feeding women
  -  Currently receiving anti-tumor chemotherapy, or received any antitumor chemotherapy previously.
  -  not suitable to participate in this test

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China

Summary: The purpose of this study is to verify clinical utility of a simple blood test comprising of four protein- based markers for risk stratification of patients presenting symptoms related to lung cancer.

Detailed description: The study is a multicenter, prospective case-control research. Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest CT, and other 600 in suspected group. When inclusion into the two groups, clinical information and 10mL blood sample of the patient will be recorded and tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. The correlation between cancer biomarker panel, CT scan result and clinical pathological diagnosis will be investigated through cases follow up. The sample size estimated above was set up according to sensitivity and specificity of biomarkers in pre-study, based on lung cancer incidence of the population. To compare the diagnostic accuracy among different cancer biomarkers through T-test, Mann-Whitney U and receiver operating characteristic (ROC) curve with SPSS 15.0 software. In statistic analysis, 0.05 is set as the p value for significance. Effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be analyzed.

Eligibility: Inclusion Criteria:
  -  Non-suspected lung cancer group (600 cases)
  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung nodule lesion in the chest (based on local CT result);
  4. Without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
  -  Suspected lung cancer group (600 cases)
  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung cancer lesion in the chest (based on local CT result);
  4. With the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
  Exclusion Criteria:
  -  Histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion;
  -  Already treated by chemotherapy or surgery

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Analysis of Plasma Tumor DNA in Lung Cancer Patients

Summary: The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in <50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.


Eligibility: Inclusion Criteria:
  -  Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
  -  Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Patients who refuse the blood samplings

Relevance to patient case: possibly relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Summary: Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  EGFR mutation or six months or longer benefit from EGFR TKIs
  -  Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
  -  Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.
  Exclusion Criteria:
  -  Inability to take oral drugs

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents

Summary: The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.

Detailed description: This is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this study will be approximately 13 weeks.

Eligibility: Inclusion Criteria:
  -  patients with a diagnosis of type 2 diabetes mellitus
  -  patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated office DBP of >= 70 mmHg at screening and at Week -2
  -  patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
  -  patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening
  Exclusion Criteria:
  -  a history of diabetic ketoacidosis
  -  type 1 diabetes mellitus (T1DM)
  -  pancreas or beta-cell transplantation
  -  fasting C-peptide <0.70 ng/mL (0.23 nmol/L)
  -  body mass index <30 kg/m2
  -  has ongoing, inadequately controlled thyroid disorder
  -  has a history of cardio-renal disease that required treatment with immunosuppressive therapy.

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Pilot Trial of Interpersonal Psychotherapy for the Treatment of Depression in Patients With Prostate, Colorectal, Lung and Pancreatic Cancer

Summary: There is now overwhelming evidence documenting the efficacy of psychotherapy in the treatment of depression in the general population. Surprisingly, however, given the high prevalence of depression in cancer patients, there are very few studies on the efficacy of psychotherapy in this population. Published studies of psychotherapy in cancer patients generally include patients with high heterogeneity of psychiatric diagnosis and frequently include patients without a psychiatric diagnosis, with the aim of preventing the appearance of a psychiatric disorder. This heterogeneity complicates the interpretation of the efficacy and specificity of these interventions. Specifically, the efficacy of psychotherapy for major depression in patients with cancer is unknown.

Detailed description: Interpersonal psychotherapy (IPT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) in several controlled trials. This study will test the efficacy of IPT in a group of prostate, colorectal, lung and pancreatic cancer patients with a diagnosis of major depressive disorder.
  We will test the efficacy of IPT using a variety of outcome measures at different time points of the treatment. Those scales will evaluate the patient's depressive symptoms, psychosocial functioning and quality of life. Patients that are deemed eligible for the study will have IPT for twelve weeks. Patients will receive twelve 50-minute sessions over 16 weeks. To facilitate access to treatment, sessions 1,2,3,4, 8 and 12 will be in person, while all others will in be person or over the telephone according to the patient's choice. Sessions will be audiotaped and periodically reviewed by experienced supervisors to assess therapist's adherence to IPT technique. This taping will be optional and is covered in a separate consent form. This pilot study is to prove feasibility and acceptability of IPT in this population and to show preliminary efficacy.

Eligibility: Inclusion Criteria:
  -  A primary psychiatric diagnosis of Major Depressive Disorder as defined by DSM-IV
  -  Diagnosis of prostate, colorectal, lung or pancreatic cancer (stage 1-4)
  -  A score of 16 or above in the 17-item HAM-D (Hamilton depression scale)
  -  Male or female ages 18-75.
  -  Ability to give consent
  -  English and/ or Spanish Speaking
  Exclusion Criteria:
  -  Lifetime history of psychosis or bipolar disorder
  -  History of substance abuse or dependence in the three months prior to the study.
  -  Current suicide risk.
  -  Patients who have ever failed IPT in the context of cancer.
  -  Patients who are receiving effective medication for depression
  -  Patients with T3, T4 and THS abnormal values

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Summary: To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
  -  treatment-naïve or have received no more than 3 systemic treatment regimen(s)
  -  Positive for translocation or inversion events involving the ROS1 gene
  -  Negative for translocation or inversion events involving the ALK gene
  -  Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
  -  Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
  -  At least 1 measurable tumor lesion as per RECIST v1.1
  -  Female or male, 18 years of age or older
  -  ECOG performance status 0 to 1
  -  Adequate organ function
  -  Signed and dated informed consent
  -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
  -  Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment
  Exclusion Criteria:
  -  Current treatment on another therapeutic clinical trial
  -  Prior therapy specifically directed against ALK or ROS1 fusion genes
  -  Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
  -  known interstitial fibrosis or interstitial lung disease
  -  myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
  -  Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec
  -  Pregnant or breast feeding
  -  Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
  -  Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
  -  Evidence of active malignancy within last 3 years

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Rapid Learning for Lung Cancer

Summary: A retrospective, data mining project that re-uses routine patient care data for decision support systems.

Detailed description: By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.

Eligibility: Inclusion Criteria:
  - Patients notes as suffering from lung cancer in at least one clinical data source.

Relevance to patient case: not relevant