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

Clinical trial: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)

Summary: This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Metastatic colorectal cancer
  -  Prescribed to receive Avastin according to registered indication
  Exclusion Criteria:
  -  Patients not eligible for Avastin treatment according to the Summary of Product Characteristics

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

Clinical trial: Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

Summary: The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.


Eligibility: Inclusion Criteria:
  -  Histological diagnosis of colorectal adenoma carcinoma
  -  Stage IV disease
  -  Presence of at least one measurable target lesion (according to RECIST), and not previously radiated.
  -  Age ≥ 18 e ≤ 75 years
  -  ECOG Performance status 0-1
  -  Life expectancy >3 months
  -  Adequate recovery from surgery, with at least 28 days from surgery to date of pre-study biopsy.
  -  Adequate contraception for male and female patients of child bearing potential
  -  informed consent
  Exclusion Criteria:
  -  More than one previous line of therapy for metastatic disease
  -  Prior treatment with bevacizumab or oxaliplatin (previous treatment with irinotecan,, cetuximab, fluoropyrimidine, folic acid are permitted)
  -  Primary tumor that is stenosing and/or that infiltrates the entire thickness of the intestinal wall
  -  Regular use of NSAIDs or aspirin
  -  Bleeding disorders or coagulopathy
  -  Concurrent anticoagulant therapy
  -  Suspected or cerebral metastases (to verify in the presence of symptoms)
  -  Neutrophils < 2000 / mm3, platelets < 100,000 / mm3, hemoglobin < 9g/dl
  -  Creatinine > 1.5 times the upper normal limit
  -  GOT and/or GPT > 2.5 times the upper normal limit, bilirubin > 1.5 times the upper normal limit in absence of liver metastases
  -  GOT and/or GPT > 5 times the upper normal limit, bilirubin > 3 times the upper normal limit in presence of liver metastases
  -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ
  -  Congestive heart failure, ischemic coronary events within past 12 months, uncontrolled cardiac arrhythmia
  -  Uncontrolled hypertension
  -  Active or uncontrolled infection
  -  Any concomitant condition that, in the investigator's opinion, would contraindicate the use of any of the study drugs
  -  Pregnancy or lactation
  -  Central nervous system disorders or peripheral neuropathy > grade 1 (CTCAE v. 4.0)
  -  Inability to comply with follow up procedures 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: Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia

Summary: The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.

Detailed description: The investigators will evaluate the efficacy of FITS for the detection of advanced colorectal neoplasia compared to colonoscopy. This study was designed as multicenter randomized interventional study. The expected period are 36months. A total 13 tertiary hospitals will participate in the study.
  Subjects will be randomly allocated to FITS group and colonoscopy group. Subjects who undergo FITS will be performed by following colonoscopy to confirm the efficacy of FITS. In colonoscopy group, subjects as a control group would be performed colonoscopy.

Eligibility: Inclusion Criteria:
  -  Asymptomatic subjects aged 45 - 75 years
  -  Subjects who will give the written consent
  Exclusion Criteria:
  -  Subjects with past history of colorectal cancer
  -  Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC)
  -  Subjects with familial history of colorectal cancer more than 2 familial member in direct line
  -  Subjects with inflammatory bowel disease(IBD)
  -  Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification
  -  Subjects with past history of colectomy
  -  Subjects with history of colonoscopy within 5 years
  -  Subjects with history of sigmoidoscopy within 3 years
  -  Subjects with history of CT colonoscopy within 10 years
  -  Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months

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

Clinical trial: A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

Summary: The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

Detailed description: The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)
  RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.

Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of metastatic colorectal adenocarcinoma
  -  a wild-type RAS tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of KRAS exons 2, 3, and 4, and NRAS exons 2, 3, and 4
  -  Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
  -  Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment.
  -  Age at least 18 years
  -  ECOG Performance Status 0-2
  -  Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dL
  -  Bilirubin level less than 1.5 times ULN
  -  AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)
  -  Serum creatinine less than 1.5 times ULN
  -  Effective contraception, if the risk of conception exists
  -  Life expectancy at least 3 months
  -  Written informed consent
  Exclusion Criteria:
  -  Symptomatic brain metastasis
  -  Interstitial pneumonitis or pulmonary fibrosis
  -  Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
  -  Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications
  -  Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment

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

Clinical trial: Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool

Summary: Little is known about the impact of risk assessment tools on decision-making by patients and clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one of the most prominent risk assessment tools available, no study has quantified its usability or impact on decision-making or uptake of screening. In this study, we will measure patients' satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its impact on their decision-making and behavior. In addition, we will assess the impact of adding information about their chance of having an advanced adenoma.


Eligibility: Inclusion Criteria:
  -  Age 50-75 years old
  -  No colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year.
  -  Appointment with healthcare practitioner in upcoming month or within the past six months at one of five Indiana University Health primary care sites.
  Exclusion Criteria:
  -  Undergoing workup for signs or symptoms consistent with colon cancer, such as weight loss, iron-deficiency anemia, change in bowel habits, or rectal bleeding.
  -  Enrolled in "Trial of a Computer-Based Presentation of Quantitative Information about Colorectal Cancer Screening"; Dr. Schwartz's study that recently completed enrollment.
  -  Diagnosis with any of the following conditions: Ulcerative colitis, Crohn disease, Familial adenomatous polyposis (FAP), Hereditary Nonpolyposis Colorectal Cancer (HNPCC), Personal history of colorectal cancer or adenomatous polyp
  -  Inability to speak and read English

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

Clinical trial: A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia

Summary: The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.
  It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.
  Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).
  The main criterion evaluation will be the surgical and endoscopic rates during the time.
  The treatments offered such as surgical, endoscopic ones or none of them will be followed.
  Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

Detailed description: A replay centralized pathological lesion slides corresponding to the different lesion will be done

Eligibility: Inclusion Criteria:
  -  intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia
  -  compliant patient
  -  endoscopic follow possible
  -  no settler cancer
  -  no serious pathology such as cancer
  Exclusion Criteria:
  -  settler cancer
  -  serious pathology such as cancer
  -  no compliant patient
  -  endoscopic follow not possible

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

Clinical trial: Aquatic Exercise Program for Knee Osteoarthritis

Summary: The aim of PICO study is to design an aquatic exercise program specific for obese individuals with knee osteoarthritis which the main goals are OA symptoms management and the improvement of physical fitness. The author's opinion is that the musculoskeletal pain is the main constraint for any kind of mobility and its control should be considered as an important goal in the weight management's programs. Therefore the PICO project proposes an aquatic exercise program to controlling pain and other symptoms management, showing that it is possible to live with the disease, and motivating the change in lifestyle, thus preventing the installation or worsening of KOA. In this way, five hypotheses were formulated: H1. 3 months of aquatic exercise is enough to improve KOA symptoms and functionality in obese individuals; H2. The gait parameters of obese individuals with KOA can be improved by aquatic exercise; H3. Beyond the exercises skills, aquatic exercise group classes can work with an educational component, promoting lifestyles changes. H4: Pain reduction and a better psychological status can lead an increase of functionally, increasing amount of physical activity. H5: Even if the main goal is not weight management, the aquatic exercise program can lead a weight reduction or body composition change.

Detailed description: The PICO program is an overall body fitness and mind intervention through aquatic exercise involving as well an education component, created specifically for individuals with KOA. Its a single-blinded, one center, and randomized controlled trial with 3 months duration. Participants will be randomized into one of two groups: aquatic exercise (AE) and control group (CG) which will participate in an educational program with the same hourly load.

Eligibility: Inclusion Criteria:
  -  The study sample will consist of 60 adults, community-dwelling (Lisbon) people with: (1) age 40-65 years; (2) 28.0 ≤ BMI ≤ 45 kg/m2; unilateral or bilateral KOA (3) knee pain (4) grade I-III radiographic tibiofemoral OA or tibiofemoral plus patellofemoral OA (5) a sedentary lifestyle, defined as not participating in a program that incorporates more than 30 minutes per week of formal exercise within the past 6 months; (6) being independent with mobility capacity; and (7) reading and writing knowledge.
  Exclusion Criteria:
  -  Subjects with skin diseases, unstable medical conditions and with hip or knee replacement, knee surgery within the past 6 months and participants who had any type of knee injections within the past 3 months will be excluded of PICO.

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

Clinical trial: An Observational Study of Bevacizumab in Chinese Patients With Metastatic Colorectal Cancer

Summary: This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab
  Exclusion Criteria:
  -  non-metastatic colorectal cancer patients not recieved bevacizumab

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

Clinical trial: Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer

Summary: Efficacy of Dovitinib for Squamous NSCLC.


Eligibility: Inclusion Criteria:
  -  histologically confirmed squamous NSCLC
  -  Previously treated with one or two lines of chemotherapy
  -  FGFR amplification (FISH > 5 copies of genes)
  -  20 years or older
  -  ECOG PS 0-2
  Exclusion Criteria:
  -  active infection
  -  uncontrolled brain metastasis
  -  unstable angina or MI

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

Clinical trial: Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo

Summary: QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.


Eligibility: Inclusion Criteria:
  -  Caucasian, male healthy subjects of 18 to 45 years of age.
  -  Body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
  -  Subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
  -  Healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings.
  -  Non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
  -  Have a high probability for compliance with and completion of the study.
  Exclusion Criteria:
  -  Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
  -  Acute disease state within 7 days before study day 1.
  -  History of drug abuse within 1 year before study day 1.
  -  History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day.
  -  Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
  -  Positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA)
  -  History of any clinically important drug allergy.
  -  Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
  -  Consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
  -  Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
  -  Donation of blood (i.e. 450 ml) within 90 days before study day 1.

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

Clinical trial: Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

Summary: To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer

Detailed description: This is a multi-centre, observational, non-interventional study. Patients with metastatic colorectal cancer eligible for Bevacizumab in combination with chemotherapy treatment will be enrolled in this trial.

Eligibility: Inclusion Criteria:
  -  with histologically confirmed metastatic colorectal cancer
  -  patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment
  -  Written informed consent
  -  Unlimited line of treatment (first-line or second line is not limited)
  Exclusion Criteria:
  Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert:
  -  Recent history of serious hemorrhage or hemoptysis of ≥1/2 teaspoon of red blood
  -  Proteinuria at baseline: Patients discovered to have ≥ 2 grams of proteinuria/24 hours *
  -  The measurement of 24-hour proteinuria level is recommended for patients with moderate to high proteinuria risk indicated by clinical judgement. The treatment with bevacizumab should be delayed when proteinuria is ≥2g/24 hours.
  -  Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds
  -  Pregnant or lactating women
  -  Excluding patients known to be allergic to bevacizumab or any of the excipients

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

Clinical trial: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Summary: This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.


Eligibility: Inclusion Criteria:
  -  KRAS and NRAS wild type metastatic colorectal cancer
  -  Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
  -  Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
  -  At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]
  Exclusion Criteria:
  -  More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
  -  Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
  -  Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
  -  Prior radiation to the pelvis or abdomen
  -  Patients with history of interstitial lung disease.

Relevance to patient case: not relevant