araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study

Summary: The purpose of this study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a method of facilitating spinal fusion in patients with degenerative disc disease.

Detailed description: This clinical trial was conducted to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System for posterolateral fusion treatment of patients with symptomatic degenerative disc disease versus the control group of autogenous bone with the CD HORIZON® Spinal System.
  The investigational treatment was the open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System. One investigational implant was placed across two adjacent transverse processes on each side of the spine during the spinal fusion procedure.
  The control treatment was the bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.

Eligibility: Inclusion Criteria:
  Each patient participating in this clinical trial must meet all of the following inclusion criteria:
  1. Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history of pain and radiographic studies:
  2. Requires fusion of a single level disc space from L1 to S1.
  3. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.
  4. If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery.
  Exclusion Criteria:
  A patient meeting any of the following criteria is to be excluded from this clinical trial:
  1. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
  2. Had previous spinal fusion surgical procedure at the involved level.
  3. Requires spinal fusion at more than one lumbar level.
  4. Has been previously diagnosed with osteopenia.
  5. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
  6. Has a history of autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis).
  7. Has a history of exposure to injectable collagen or silicone implants.
  8. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP 2/CRM implantation.
  9. Has received any previous exposure to any/all BMP's of either human or animal extraction.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System

Summary: To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System

Detailed description: The purpose is to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System.

Eligibility: Inclusion Criteria:
  1. The patient will undergo anterior cervical fusion with the VueLock™ Anterior Cervical Plate System for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion.
  2. The patient must be available for follow-up during the study.
  3. The patient must be skeletally mature (epiphyses closed).
  Exclusion Criteria:
  1. Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
  2. Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
  3. Pregnant or nursing females.
  4. Patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

Summary: The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

Detailed description: Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.
  In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.
  The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.

Eligibility: Inclusion Criteria:
  -  Histologically verified adenocarcinoma in colon or rectum with metastatic spread.
  -  No mutations in the KRAS gene.
  -  Resistance to 5-FU, oxaliplatin and irinotecan.
  -  Age ≥18 years.
  -  PS 0-2.
  -  Measurable disease according to RECIST criteria.
  -  Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
  -  Oral and written informed consent.
  Exclusion Criteria:
  -  Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
  -  Verified or clinically suspected CNS metastasis.
  -  Other experimental treatment.
  -  Serious medical disease according to investigator's judgement.
  -  Pregnant or breastfeeding women.
  -  Hypersensitivity to the active substance or to one or more of the auxiliary substances.
  -  Patients with interstitial pneumonitis or pulmonary fibrosis.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials

Summary: To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

Detailed description: This is a roll over study aimed to provide continued access to axitinib (monotherapy or combination, according to treatment received in prior axitinib study) to patients who have documented stable, or responding disease, or received clinical benefit (as defined by protocol) at the time of the prior study closure.

Eligibility: Inclusion Criteria:
  -  Patients who were assigned to an axitinib (AG-013736) containing treatment arm in a previous clinical trial
  -  Patients who were receiving axitinib (AG-013736) tablets at the time their previous trial ended
  -  Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous axitinib (AG-013736) protocol should be used to determine stable or responding disease).
  -  Patients who have progressive disease (PD) but have experienced "clinical benefit" as defined in the study protocol
  Exclusion Criteria:
  -  Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Study of DMXAA (Now Known as ASA404) in Solid Tumors

Summary: This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.

Detailed description: This is a dose escalation study conducted at a single center in New Zealand. Patients received dimethylxanthenone acetic acid (DMXAA) IV over 20 minutes once every three weeks, up to a maximum of 12 courses.
  Cohorts of 3 patients received escalated doses of DMXAA until the maximum tolerated dose (MTD) was determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicity.
  Patients had solid tumors for which there was no standard therapy or were refractory to conventional therapy.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed solid tumor that is not amenable to any standard therapy or is refractory to conventional therapy
  2. Performance status WHO 0-2
  3. Life expectancy greater than 3 months
  4. Hemoglobin at least 90 g/L; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3
  5. Bilirubin within normal limits; ALT less than 2 times upper limit of normal (ULN); Alkaline phosphatase less than 2 times ULN
  6. Creatinine less than 130 umol/L
  7. INR and APTT within normal limits
  8. Fertile patients must use effective contraception
  9. At least 4 weeks since prior anticancer therapy and recovered from toxic effects
  Exclusion Criteria:
  1. Concurrent malignancy except cone biopsied carcinoma in situ of the cervix and adequately treated basal or squamous cell carcinoma of the skin
  2. Other serious medical condition
  3. Uncontrolled infection or serious infection within the past 28 days
  4. Pregnant or lactating
  5. Treatment with glucocorticosteroids within previous two weeks

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

Summary: RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.
  PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.

Detailed description: OBJECTIVES:
  Primary
  -  Identify factors predictive of treatment failure in patients with solid tumors treated with epoetin beta while undergoing chemotherapy.
  Secondary
  -  Evaluate the impact of achieving target hemoglobin levels (i.e., hemoglobin > 11 g/dL) after 8 weeks of treatment with epoetin beta.
  -  Evaluate changes in hemoglobin levels from baseline to after 8 weeks of treatment with epoetin beta.
  -  Evaluate the tolerability of epoetin beta in these patients.
  -  Evaluate the quality of life of these patients.
  OUTLINE: This is a multicenter study.
  Patients receive epoetin beta subcutaneously once a week for ≥ 8 weeks in the absence of disease progression or unacceptable toxicity.
  Patients complete a quality-of-life questionnaire (FACT-An) at baseline and after 8 weeks of treatment.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of solid tumor
  -  Hemoglobin 9-11 g/dL
  -  Planning to receive epoetin beta for ≥ 8 weeks while undergoing chemotherapy for cancer
  PATIENT CHARACTERISTICS:
  -  WHO performance status 0-2
  -  Not pregnant or nursing
  -  Not incarcerated or under guardianship
  -  No psychological, familial, social, or geographical reason that would preclude study follow-up
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  More than 6 months since prior epoetin
  -  No concurrent chemoradiotherapy

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of non-small cell lung cancer
  -  positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
  -  may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
  -  Tumors can be measurable or non measurable
  Exclusion Criteria:
  -  prior treatment with PF-02341066
  -  received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
  -  current enrollment in another therapeutic clinical trial

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of non-small cell lung cancer
  -  positive for the ALK fusion gene (test provided by a central laboratory)
  -  must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
  -  tumors must be measurable
  Exclusion Criteria:
  -  prior treatment with PF-02341066
  -  current treatment in another clinical trial

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer

Summary: RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) PET imaging, may help find and diagnose cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment.
  PURPOSE: This phase I trial is studying FLT PET imaging in patients with cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Evaluate the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging to measure tumor proliferation and the DNA synthetic pathway (thymidine kinase levels) in patients with cancer.
  Secondary
  -  Determine the efficacy of FLT PET imaging in detecting lesions and estimating response to treatment.
  OUTLINE: Patients undergo up to four 3'-deoxy-3'-[18F] fluorothymidine positron emission tomography imaging procedures.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets one of the following criteria:
  -  Histologically confirmed solid tumor or hematologic malignancy
  -  Awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging
  PATIENT CHARACTERISTICS:
  -  Able to lie still in the PET scanner
  -  Girth and weight must be suitable to enter the gantry
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Relative Drug Exposures Of Two Formulations of PF-02341066

Summary: The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over, single-dose study employing administration of two PF-02341066 formulations in the fasted state to healthy adult volunteers.


Eligibility: Inclusion Criteria:
  -  Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram(ECG) and clinical laboratory tests).
  Exclusion Criteria:
  -  Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  -  Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  -  Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory Follicle-stimulating hormone(FSH) test results at Screening.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

Summary: The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of HBV infection. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.


Eligibility: Inclusion Criteria:
  -  Aged 18~60 years.
  -  Serum HBsAg positive.
  -  Ultrasonographic evidences of cirrhosis.
  Exclusion Criteria:
  -  history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
  -  Prothrombin time is less than 30s.
  -  Cirrhosis caused by other reasons except HBV infection.
  -  Severe problems in other vital organs(e.g.the heart,renal or lungs).
  -  Liver tumor on ultrasonography, CT or MRI examination.
  -  Pregnant or lactating women.
  -  Imaging evidences of vascular thromboses.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Genetic Investigation of Solid Tumors Cohort

Summary: The objective of this study is to obtain blood samples, solid tumor and/or benign hyperplasia samples to learn more about genetic differences that are linked to the formation of solid tumors.

Detailed description: Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop solid tumors. Even though it has been firmly established that if an individual carries these DNA variants they have an increased chance of developing a solid tumor the underlying biological mechanisms for most of these associations are largely unknown.
  In addition to inherited DNA variants that are associated with the development of solid tumors it is well established that during the development and growth of solid tumors the DNA in these cancer cells undergo somatic changes (mutations). These somatic DNA changes have been studied over the past decade and frequently are specific chromosomal translocations and amplifications associated with the development of particular solid tumors. In some instances, examining the chromosomal translocation and amplification has lead to the discovery of proteins contributing to solid tumor pathology.
  the human 8q24 interval that has strong genetic associations with solid tumor development has also been noted as frequently amplified in solid tumors and serves as a predictor of poor survival in prostate cancers.

Eligibility: Inclusion Criteria:
  1. Age 18 years or older
  2. Eligible to have their blood drawn
  3. Be reliable, cooperative and willing to comply with all protocol-specified procedures
  4. Able to understand and grant informed consent
  5. Diagnosis of a solid tumor
  Exclusion Criteria:
  1. Has a significant chronic medical condition which would potentially confound interpretation of the individual's phenotype.
  2. Treatment with any investigational agents or devices within thirty days preceding enrollment in the study.
  3. Been administered or taken any CNS sedatives or depressants in the 12 hours prior to informed consent process

Relevance to patient case: not relevant