araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

Summary: Recently, sorafenib which can target VEGFR and PDGFR demonstrated 13-16% of response rate in patients with recurrent/metastatic salivary gland cancers, suggesting that VEGFR and PDGFR might be important role in salivary gland cancers. Accordingly, several trials with various anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in salivary gland cancer are ongoing.
  Nintedanib (BIBF1120) is a potent small molecule triple receptor tyrosine kinase inhibitor (PDGFR/ FGFR1-2 and VEGFR1-3). VEGFR-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. In vitro, the target receptors are all inhibited by nintedanib in low nanomolar concentrations. In in vivo nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg, leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts of a broad range of differing human tumors.
  Based on this background, in this study, the investigators would like to conduct a phase II study of Nintedanib (BIBF 1120) in patients with recurrent or metastatic salivary gland cancer of the head and neck to evaluate efficacy and safety.


Eligibility: Inclusion Criteria:
  -  Histologically proven salivary gland cancer of the head and neck (According to WHO classification, mucoepidermoid cancer, adenoid cystic carcinoma, or adenocarcinoma/salivary duct cancer are eligible)
  -  Recurrent or metastatic salivary gland cancer of the head and neck patients who failed one line of systemic chemotherapy
  -  age ≥ 18 years
  -  At least one measurable tumor lesion according to RECIST 1.1
  -  ECOG performance status 0-2
  -  Adequate hematologic function (absolute neutrophil count > 1,500/m/, platelets > 100,000/ml, haemoglobin > 9.0 g/dl), hepatic function (alanine transaminase/aspartate transaminase < 5 x ULN, total bilirubin < 1.5 x ULN), renal function (creatinine clearance > 45 ml/min)
  -  Written informed consent
  Exclusion Criteria:
  -  Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment, or arrhythmia
  -  Hemorrhagic or thromboembolic events in the past 6 months
  -  Major injuries in the 10 days prior to start of the study
  -  Patients with post-obstructive pneumonia or uncontrolled serious infection
  -  Pregnant or nursing women
  -  Uncontrolled symptomatic brain metastasis
  -  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, and well treated thyroid cancer

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Long-term Outcome of HER2-amplified Metastatic Breast Cancer: A Retrospective Analysis

Summary: The aim of this study is to analyze cases of human epidermal growth factor receptor (HER) 2-positive metastatic breast cancer (MBC) of the last 10 years at the University Hospital of Zurich to assess the efficacy of the treatment with trastuzumab in HER2-positive MBC and to find out associations between different variables and the outcome. The aim is to find out probable prognostic factors and patterns of disease progression. Prognostic factors could optimize treatment approaches and result in a delay of disease progression.

Detailed description: Human epidermal growth factor (HER2) is a receptor tyrosine kinase and regulates diverse functions in normal cells such as growth, differentiation and survival of cells. In 25-30 per cent of breast cancer HER2 gene is amplified, what result in abnormally high levels of encoded HER2 protein in malignant cells. Overexpression or amplification of HER2 is associated with an aggressive form of breast cancer seen by significantly shortened disease-free survival and overall survival.
  Trastuzumab, a humanized monoclonal antibody against the extracellular domain of HER2, inhibits the growth of breast tumor cells by receptor internalization, inhibition of cell-cycle progression and recruitment of immune-effector cells. Trastuzumab, as the first anti-HER2 therapy, is approved since 1998 in the United States and since 2000 in European countries for the treatment of HER2-overexpressing metastatic breast cancer (MBC). Single therapy as well as combination with chemotherapy has significantly improved the outcome of these women. Shown by longer time to disease progression, longer duration of response, lower rate of death at 1 year, longer survival and a 20 per cent reduction in the risk of death.
  But still is little known about the long-term outcome nor patterns of disease progression of HER2-positive MBC. A few case reports showed a prolonged complete remission in HER2-positive MBC under an anti-HER2 treatment (trastuzumab, T-DM1, pertuzumab). These cases had some common characteristics such as negative hormone receptor status and metastasis to the live. Another hypothesis is a worse prognosis for patients with early development of CNS metastases.

Eligibility: Inclusion Criteria:
  -  Received at least 1 dose of trastuzumab in metastatic setting at the University hospital of Zurich from 01/2004 to 12/2014.
  -  HER2+ status confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) ≥ 2.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer

Summary: This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.

Detailed description: This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.
  All patients received five cycles of weekly docetaxel and cisplatin, each of 1 day's duration. Thoracic RT includes the delivery of 65 Gy in 25 fractions on weekdays for a total of five weeks.
  Nimotuzumab group was treated with five doses of weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while placebo group was treated with five doses of placebos.
  150 patients are needed to be enrolled for an 80% power to detect an improvement in overall survival from 15 months to 25 months.

Eligibility: Inclusion Criteria:
  -  histologically confirmed squamous cell lung cancer
  -  patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  -  unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI
  -  ECOG performance status 0-1
  -  Previously treated with chemotherapy or treatment-naive
  -  no previous chest radiotherapy, immunotherapy or biotherapy.
  -  hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
  -  serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
  -  bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
  -  FEV1 >0.8 L
  -  CB6 within normal limits
  -  patients and their family signed the informed consents
  Exclusion Criteria:
  -  adenosquamous carcinoma
  -  previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
  -  contraindication for chemotherapy
  -  women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
  -  women who has the probability of pregnancy without contraception
  -  tendency of hemorrhage
  -  in other clinical trials within 30 days
  -  addicted in drugs or alcohol, AIDS patients
  -  uncontrollable seizure or psychotic patients without self-control ability
  -  severe allergy or idiosyncrasy
  -  not suitable for this study judged by researchers

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Aspirin on CTCs of Advanced Breast and Colorectal Cancer

Summary: The purpose of this study is to determine whether Aspirin could affect the number and subtype of circulating tumor cells of metastatic breast cancer and colorectal cancer.

Detailed description: BACKGROUND:
  -  Invasion and metastasis are the main reason of death in metastatic cancer, and abundant evidence find circulating tumor cells(CTCs) take the core position in breast and colorectal cancer metastasis.
  -  Platelets play multiple role to facilitate the epithelial to mesenchymal transition of tumor cells and protect CTCs to survival in the circulation, which enrolled in the whole process of metastasis.
  -  Several clinical trials and observational study have validate the primary and secondary prevention effect of aspirin to both breast and colorectal cancer.
  OBJECTIVES:
  -  Determine the effect of aspirin on CTC number of metastatic breast and colorectal cancer;
  -  Determine the effect of aspirin on CTC subtype (epithelial/mesenchymal/mixed type) of metastatic breast and colorectal cancer.
  ELIGIBILITY:
  -  Adults age from 18-75 years old.
  -  Patients were diagnosed for metastatic breast or colorectal cancer by pathology.
  -  Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted. Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted.
  -  No disease of hemorrhagic tendency or history of non-steroid drug allergy.
  -  CTCs≥5 / 7.5ml blood
  STUDY DESIGN:
  -  Aspirin will be administered orally once a day in 28-day cycles.
  -  The CTC was evaluated every 28 days for 2 months.

Eligibility: Inclusion Criteria:
  -  Adults age from 18-75 years old.
  -  Patients were diagnosed for metastatic breast or colorectal cancer by pathology.
  -  Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted.
  -  Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted.
  -  PS score ≤ 3
  -  Anticipated survival time ≥ 3 months
  -  CTCs≥5 / 7.5ml blood
  Exclusion Criteria:
  -  Allergic to aspirin or other types of non-steroid
  -  History of hemorrhage of digestive tract or other hemorrhagic disease
  -  Plan to receive surgery within the time frame of the trial
  -  Medication history of aspirin or other types of anti-platelets drug within one months before the trial
  -  Women in pregnant or lactation period
  -  Any psychological or objective problem may influence the compliance of the patients

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects

Summary: Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. Few results are available on the use of activated charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). The objective of this study is to evaluate the effect of activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.


Eligibility: Inclusion Criteria:
  -  affiliated or beneficiary of a social security category
  -  having signed the inform consent form
  -  having signed the genetic consent form
  -  BMI between 18.5 and 25
  -  normal clinical exam
  -  normal biological exam
  Exclusion Criteria:
  -  contra-indication to rivaroxaban
  -  contra-indication to activated charcoal
  -  previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease smoker
  -  Organic lesion likely to bleed
  -  severe liver disease
  -  severe kidney failure
  -  previous surgery within one month

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

Summary: Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.

Detailed description: This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.

Eligibility: Inclusion Criteria:
  -  histologically verified colorectal cancer
  -  clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
  -  age: 18-70 years
  -  ECOG 0-2
  -  adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
  -  no prior cancer and/or chemotherapy
  -  signed informed consent
  Exclusion Criteria:
  -  patients with a history of prior malignancy
  -  pregnant or lactating patients
  -  known or suspected brain metastasis

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification Refractory solid tumor and/or specific sensitivity to pazopanib 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.
  To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  FGFR2 amplification ,Refractory solid tumor and/or specific sensitivity to 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.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, pazopanibPlatelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with pazopanib

Relevance to patient case: possibly relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

Summary: A prospective, single center, cohort study for surveillance of metabolic parameters in patients who will receive chemotherapy after surgical resection of colorectal cancer

Detailed description: Primary objective - Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy
  Secondary objective - Pre-operative incidence of diabetes and characteristics of metabolic parameters of patients with colorectal cancer; Incidence of developed poorly controlled glucose level in diabetic patients with colorectal cancer after post-operative chemotherapy; 3-year recurrence-free survival according to status of diabetes and metabolic parameters; 5-year recurrence-free survival according to status of diabetes and metabolic parameters

Eligibility: Inclusion Criteria:
  -  Who will get surgical resection for colorectal cancer
  -  Who has diagnosed with diabetes
  -  Who met the criteria for testing of diabetes in asymptomatic adult individuals
  -  Criteria for testing for diabetes in asymptomatic adult individuals
  -  overweight (BMI>25 kg/m2*) and have additional risk factors (physical inactivity, first-degree relative with diabetes, high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander), women who delivered a baby weighing 0.9 lb or were diagnosed with GDM, hypertension (>140/90 mmHg or on therapy for hypertension), HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL (2.82 mmol/L), women with polycystic ovarian syndrome, HbA1C >5.7%, IGT, or IFG on previous testing, other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans), history of CVD)
  Exclusion Criteria:
  -  Previously exposed to surgery or chemotherapy for colorectal cancer
  -  Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence
  -  Presence of CNS metastasis
  -  Not able or willing to give informed consent
  -  Any patients judged by the investigator to be unfit to participate in the study

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Pain Coping Skills for Colorectal Cancer Survivors

Summary: Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. The investigators have developed a pain management intervention for colorectal cancer survivors that focuses on addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain and comorbid psychological distress as a concern during a clinic-based survivorship care consult will be recruited. Participants will be randomized into either: Telephone-Based Coping Skills Training (CST) for pain and comorbid psychological distress or standard care. The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain and psychological distress. The standard care control condition will receive resources and referrals related to managing survivorship health.


Eligibility: Inclusion Criteria:
  -  >21 years old
  -  personal history of colorectal cancer
  -  finished active cancer treatment within the past 12 months
  -  reported pain as a concern as well as psychological distress on a National Comprehensive Cancer Network screener
  -  able to speak and read English
  -  able and willing to give informed consent
  Exclusion Criteria:
  -  currently undergoing active cancer treatment
  -  have a major mental illness (e.g., schizophrenia)
  -  have a mental illness that is not being treated/controlled (e.g., bipolar disorder)

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Comparative Intervention Study of Stress Reduction in Corporate Health Management

Summary: Aim of the study is the evaluation of the effects (psychological and physiological) of an hrv-biofeedback training, a mindfulness training and a combination of both training methods for stress reduction.


Eligibility: Inclusion Criteria:
  -  Healthy adults
  -  Working in the business in which the study is conducted
  Exclusion Criteria:
  -  Cardiac disease
  -  Thyroid disease (intake of glucocorticoids)
  -  Actual psychological illness
  -  Intake of psychotropic drugs
  -  Intake of other medication changing HRV

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Continuous Infusion for Pain Relief

Summary: SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?


Eligibility: Inclusion Criteria:
  -  ASA physical status I-II
  -  18-45 years of age, inclusive
  -  elective caeserean section under spinal anesthesia
  Exclusion Criteria:
  -  - contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
  -  existing neurological deficit
  -  inability to understand the informed consent and demands of the study

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Colorectal Cancer Study: Screening v.s. Other Diagnostics

Summary: The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after FOBT) has a better pTNM classification than colorectal cancer diagnosed byl other diagnostics (diagnostic colonocopy, CT, MR etc.).

Detailed description: Multicentre prospective observational study. 12 centres across the Czech rep. included. Study approved by Ethical Committee. Informed consent signed by every patient. Study coordinator in each centre. Patient registry availble in every centre. Patient informations stored under ID in secured internet database (RedCap) run by ICRC (The International Clinical Research Center of St. Anne's University Hospital Brno). Statistical validation of data and analysis (descriptive statistics, two-sample T-Test, Mann-Whitney test, Fisher exact test and Chi-Square test).

Eligibility: Inclusion Criteria:
  -  newly diagnosed colorectal cancer
  Exclusion Criteria:
  -  unsigned informed consent
  -  mental disorder

Relevance to patient case: not relevant