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

Clinical trial: Safety Study of Dantrolene in Subarachnoid Hemorrhage

Summary: Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP.
  Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. However, the first human studies have only been observational and over a short period of time.
  This study will evaluate the safety and tolerability of intravenous dantrolene given every 6 hours over seven days to patients with or at risk for cVSP after SAH. The goal is to determine if future efficacy studies should be done to determine if treatment with Dantrolene may improve the outcome of patients with cVSP after SAH.

Detailed description: Once eligibility criteria are met, patients will be randomized to either dantrolene-IV or placebo (equiosmolar, volume-equivalent sterile water with 5% mannitol as dantrolene-IV also contains 5% mannitol). Study subjects will be visited daily by a study nurse to determine side effects, tolerability, record hemodynamic measures and laboratory values. Patients will have daily serum Na, osmolality, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALK) measured. In addition, daily bedside transcranial doppler will be performed by a blinded examiner. Patients will undergo cerebral angiograms per clinical routine. Angiographic measurements of arterial narrowing will be performed by a blinded radiologist. Specific stop criteria are pre-defined.

Eligibility: Inclusion Criteria:
  -  Documented aneurysmal SAH by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or angiography
  -  Secured aneurysm (coiled or clipped)
  -  Enrollment achievable within 14 days after SAH
  Exclusion Criteria:
  -  Pregnancy
  -  Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT >120 Units/L, AST >120 Units/L, alkaline phosphatase >345 Units/L (three times upper limit of normal)
  -  Patients on verapamil
  -  Patients with brain edema and/or elevated intracranial pressure (>25mm Hg)
  -  Patients treated with hypertonic saline or mannitol prior to enrollment
  -  Patients with too severe SAH with low likelihood of survival (Hunt & Hess 5)

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, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Summary: This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of malignancy other than NSCLC
  -  positive for translocation or inversion event involving the ALK gene locus
  -  positive for ALK amplification events
  -  positive for ALK activating point mutations
  Exclusion Criteria:
  -  mutations of amplifications involving the c-Met gene but not the ALK gene
  -  concurrent treatment on another therapeutic clinical trial
  -  prior therapy specifically directed against ALK

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

Clinical trial: A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers

Summary: An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.

Detailed description: Taste assessment of new formulation. Subjects will not ingest the drug.

Eligibility: Inclusion Criteria:
  -  Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 75 years, inclusive.
  -  Subjects must be trained sensory panelists.
  -  An informed consent document signed and dated by the subject or a legally acceptable representative.
  -  Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures.
  Exclusion Criteria:
  -  A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history.
  -  A history of hypersensitivity to any inactive ingredients employed in the formulation(s).
  -  Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study.
  -  Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API.
  -  Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.

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

Clinical trial: A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung

Summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.


Eligibility: Inclusion Criteria:
  -  Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
  -  Positive for translocation or inversion events involving the ALK gene locus
  -  No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
  -  Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.
  -  18 years of age or older with the exception of India which has an upper age limit of 65 years old
  Exclusion Criteria:
  -  Current treatment on another therapeutic clinical trial.
  -  Prior therapy directly targeting ALK.
  -  Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
  -  Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
  -  Pregnancy or breastfeeding.
  -  Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
  -  Known HIV infection
  -  Known interstitial lung disease or interstitial fibrosis
  -  Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

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

Clinical trial: Research of the EML4-ALK Gene Expression in the Pleural Effusion or Tumor Tissue From Lung Cancer Patients

Summary: We wants to analyse the EML4-ALK mutation rate in the patients who have non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  20 or more than 20 years of age
  -  The pathological diagnosis confirmed lung cancer
  -  Patients have achieved pleural effusion, or surgical biopsy to obtain tumor tissue specimens
  -  The patient had signed inform consent
  Exclusion Criteria:
  -  pleural effusion or tumor tissue can not be obtained
  -  the patient is not suitable to join the research according to the judgement by the investigator

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

Clinical trial: Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitor medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been shown to shrink tumors in some patients with lung cancer. While the investigators know how this drug works to stop the growth of tumors that depend on change in the gene named ALK (also called EML4-ALK), the investigators do not know why the drug stops working. The investigators would like to examine the tumor to help us better understand why crizotinib has stopped working as well as it once did. The tumor will be examined with multiple tests to look for the reason that crizotinib stopped working.


Eligibility: Inclusion Criteria:
  -  ≥18 years of age
  -  Histologically proven diagnosis of NSCLC at MSKCC Tumor positive for a translocation or inversion event involving the ALK gene locus
  -  Clinical response to treatment with crizotinib as defined by either:
  Radiographic partial or complete response defined by RECIST or WHO
  OR:
  Radiographic stable disease for at least 8 weeks
  -  Radiographic progression of disease amenable to biopsy while on treatment with crizotinib as defined by RECIST or WHO
  -  Signed informed consent
  Exclusion Criteria:
  -  Deemed by their treating physician to be medically unfit for biopsy
  -  Women who are pregnant or breast-feeding

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

Clinical trial: Minimally Invasive Surgery in Treating Patients With Spinal Tumors

Summary: This randomized clinical trial studies minimally invasive surgery in treating patients with spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor resection are less invasive types of surgery for spinal tumors and may have fewer side effects and improve recovery

Detailed description: PRIMARY OBJECTIVES:
  I. Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.
  SECONDARY OBJECTIVES:
  I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function. III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.
  OUTLINE: Patients are randomized to 1 of 2 treatment arms.
  ARM I: Patients undergo posterior spinal tumor resection on day 0.
  ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.
  After completion of study treatment, patients are followed up for 6 months.

Eligibility: Inclusion Criteria:
  -  Patients must have a diagnosis of primary, secondary or metastatic spine tumor and be undergoing any posterior spinal fusion with or without anterior fusion anywhere from occiput to sacrum
  -  Greater than 3 month life expectancy
  -  Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  -  All subjects must have the ability to understand and the willingness to sign a written informed consent
  Exclusion Criteria:
  -  Patients who are not surgical candidates for spine tumor removal, determined by the surgical team
  -  Patients who have undergone previous spine surgery for tumor removal will be excluded
  -  Patients with renal cell carcinoma
  -  As there is an emphasis on blood loss and length of surgery, the critical variable for homogeneity is the vascularity of the tumor; hypervascular spine tumors are regarded by surgeons as amongst the most challenging of cases; by far the three most common hypervascular metastatic tumors are those arising from renal cell carcinoma, thyroid carcinoma and melanoma; these pathologies are usually regarded as a distinct subset for this reason in the majority of studies; because we rarely encounter the later two pathologies in our practice, we chose to include only the former; however, to further homogenize our study population we will exclude all three of the known hypervascular metastatic spine tumors
  -  Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

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

Clinical trial: Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)

Summary: Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)


Eligibility: Inclusion Criteria:
  -  Liver failure caused by HBV
  -  Model for End-Stage Liver Disease (MELD) ＜ 30
  Exclusion Criteria:
  -  Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on.
  -  History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment.
  -  Severe problems in other vital organs (e.g.the heart,renal or lungs).
  -  Tumor on ultrasonography, CT or MRI examination.
  -  Pregnant or lactating women.
  -  HIV infection.

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

Clinical trial: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke

Summary: The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.

Detailed description: This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.

Eligibility: Inclusion Criteria:
  1. Patients aged 18 to 80 years, within 7 days of the onset of symptoms
  2. Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
  3. The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
  4. Signed informed consent
  Exclusion Criteria:
  1. Lacunar syndrome
  2. Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
  3. Hematological causes of stroke
  4. Severe respiratory, hepatic, or renal disorders
  5. Presence of severe febrile illness or viral diseases
  6. Malignant diseases
  7. Presence of autoimmune diseases
  8. Positive response of penicillin skin test, or multiple drug allergies
  9. Breast-feeding or pregnant women

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

Clinical trial: Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease

Summary: The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).


Eligibility: Inclusion Criteria:
  Clinical
  -  Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
  -  Discopathy refractory to conservative treatment (drugs, physical therapy.)
  -  Evolution greater than or equal to 6 months. Radiological
  -  Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
  -  NMR: grades IV and V of Pfirman.
  Exclusion Criteria:
  -  Rejection of surgical treatment.
  -  Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
  -  Immunosuppressive treatment.
  -  Congenital or acquired anatomical abnormality that prevents the surgical procedure.
  -  Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
  -  High surgical risk (ASA> IV), or contraindication to anesthesia.

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

Clinical trial: Dynesys Spinal System Post Market 522 Study

Summary: The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.

Detailed description: Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.

Eligibility: Inclusion Criteria:
  1. Skeletally mature between the ages of 20-80
  2. Candidate for posterior lateral fusion between T1-S1 with autograft
  3. Degenerative spondylolisthesis with evidence of neurologic impairment or failed previous fusion (pseudoarthrosis)
  4. Symptoms of leg and/or back pain
  5. Non-responsive to conservative/non-surgical treatment for at least three (3) months
  6. Must be willing and able to comply with study requirements; including complete necessary study paperwork and return for required follow-up visits
  Exclusion Criteria:
  1. Active systemic or local infection
  2. Obesity
  3. Use of interbody device
  4. Pregnancy
  5. Mental illness
  6. Incarceration
  7. Alcohol or drug abuse
  8. Severe osteoporosis or osteopenia
  9. Use in the cervical spine
  10. Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
  11. Soft tissue deficit not allowing sound closure
  12. Any medical or physical condition that would preclude the potential benefit of spinal implant surgery
  13. Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device
  14. Active malignancy or other significant medical comorbidities
  15. Any medical or mental condition which would put the patient at high risk due to the severity of surgery
  16. Inadequate pedicles of the thoracic, lumbar and sacral vertebrae
  17. Patient unwilling or unable to follow postoperative instructions

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 CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

Summary: The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

Detailed description: CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding CMAB009 to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.

Eligibility: Inclusion Criteria:
  -  histologically confirmed metastatic colorectal adenocarcinoma
  -  KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
  -  has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
  -  ECOG performance status 0 to 1
  -  Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve
  Exclusion Criteria:
  -  Previous irinotecan or anti-EGFR therapies
  -  hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
  -  liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
  -  Renal function: serum creatinine, more than 1.5 times the upper limit of normal
  -  Patients with symptomatic central nervous system metastases

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

Clinical trial: Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

Summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.

Eligibility: Inclusion Criteria:
  -  All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)
  Exclusion Criteria:
  -  Patients not administered XALKORI in spite of enrolled.

Relevance to patient case: not relevant