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

Clinical trial: A Roll Over Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

Summary: The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.


Eligibility: Inclusion Criteria:
  -  Participants enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible
  -  Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form (eCRF)
  -  For women who are not postmenopausal (≥ 12 months of non−therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug
  -  For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.
  Exclusion Criteria:
  -  Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study
  -  Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study
  -  Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation
  -  Pregnant or breastfeeding women
  -  Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study
  -  Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator
  -  Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib
  -  Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the participant before trial entry

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

Clinical trial: X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

Summary: The main purpose of the study is to evaluate safety and efficacy of X-396(Ensartinib) capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.

Detailed description: This is a phase II, multicenter, single-arm study in which the safety and efficacy of X-396(Ensartinib) will be assessed in adult Chinese patients with ALK-positive(rearrangement) non-small cell lung cancer previously treated with crizotinib. Approximately 144 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer.
  -  Evidence of positive ALK.
  -  Patients must have demonstrated progression during or after crizotinib treatment.
  -  Age 18 years or older at the time of informed consent.
  -  Eastern cooperative oncology group performance status (ECOG PS) of 0-2
  -  Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
  -  Asymptomatic CNS metastases do not require the use of steroids or anticonvulsants.
  -  Willingness and ability to comply with the trial and follow-up procedures.
  -  Ability to understand the nature of this trial and give written informed consent.
  Exclusion Criteria:
  -  Prior use of ALK TKIs with the exception of crizotinib.
  -  Patients currently receiving cancer system therapy.
  -  Use of an investigational drug within 4 weeks prior to the first dose of study drug.
  -  Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
  -  Patients with a known allergy or delayed hypersensitivity reaction to drugs.

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

Clinical trial: Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

Summary: Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.

Detailed description: The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.

Eligibility: Inclusion Criteria:
  1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay.
  2. Age of 18 years or older.
  3. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment.
  4. Participants must have hemoglobin > 10 mg/dL.
  5. Ability to understand and willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. Hepatitis (all types) in patient's medical record
  2. HIV documented in patient's medical record
  3. Hemoglobin < 10 mg/dL
  4. Less than 18 years of age
  5. Histologically confirmed NSCLC Stage I-IIIA
  6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue

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

Clinical trial: PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

Summary: To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.

Detailed description: 60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.

Eligibility: Inclusion Criteria:
  -  Diabetic foot according to The Wagner is 2-3 graded;
  Exclusion Criteria:
  -  Type 1 diabetes mellitus,presence of autoimmune diabetes;
  -  Gestational diabetes;
  -  Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.

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

Clinical trial: Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients

Summary: Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia

Detailed description: -  Brief Protocol: Treat the patients taking Taxotere+Epirubicin +Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE)treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
  -  Targeted patients: breast cancer
  -  Subjects were randomly divided into two groups. The test group received recombinant human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg treatment. Positive control group received recombinant human granulocyte colony stimuli Factor injection therapy
  -  Number of patients: 80

Eligibility: Inclusion Criteria:
  -  Age 18-65.
  -  Diagnosed breast cancer, suitable for TEC or TE .
  -  ECOG performance status 0 or 1.
  -  Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
  -  No obvious abnormal ecg examination.
  -  TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
  -  Cr, BUN≤2.5×ULN.
  -  Signed informed consent.
  Exclusion Criteria:
  -  Chemotherapy within past 4 weeks.
  -  Uncontrolled inflammatory disease,axillary temperature≥38℃.
  -  Merging other malignant tumor.
  -  Pregnancy or nursing status.
  -  Participation in another clinical trial with and investigational product within 3 months prior to study entry.
  -  Severe diabetes mellitus, or poor blood sugar controller.
  -  Allergic disease or allergic constitution. History of protein allergy.
  -  History of drug addiction and alcoholism.
  -  Hematopoietic stem cell transplantation or organ transplantation.
  -  Antibiotics were treated within 72 hours before chemotherapy.
  -  Long-term use of hormones or immunosuppressive agents.
  -  Severe mental or neurological disease.
  -  Chronic disease of severe cardiac, kidney and liver.
  -  Other conditions that would be excluded from this study according to doctors'judgment.

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

Clinical trial: Evaluation of the Accuracy of the Vessel Navigator Tool for Catheterization of Supra-aortic Vessels - ARCHIBALD

Summary: This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms or arteriovenous malformations.

Detailed description: Catheterization of is performed for the diagnosis and treatment of cerebrovascular diseases. It is performed under X-ray scopy in frontal incidence with possible variations of the angulation of the arch to optimize the visualization of vessels 'origin (brachiocephalic trunk, left and right common carotid arteries, subclavian arteries).
  Before the beginning of catheterization, a conventional arterial roadmap with iodine injection is usually performed. The Vessel Navigator (VN) developed by Philips allows the use of pre-acquired angio-scan or angio-MRI image by superimposing it (X-ray Fusion) on X-ray scopy to provide the arterial tracing (Fusion Roadmap).
  An angio-MRI (Philips 3 Tesla MRI) imaging of the aortic arch will be first performed (as part of preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations). A first operator will perform the arteriography under the usual conditions without using the VN. A second operator will have access to the fusion imaging and will assess the accuracy of the coregistration. Snapshots will be taken by the second operator.

Eligibility: Inclusion Criteria:
  -  Preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.
  Exclusion Criteria:
  -  Patients with contraindication to intravenous contrast.
  -  Patients with catheterization of the supra-aortic vessels in an emergency settings (Stroke, acute bleeding)

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

Clinical trial: Ketorolac on Posterior Thoracolumbar Spinal Fusions

Summary: To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs.


Eligibility: Inclusion Criteria:
  -  Over 18 years of age
  -  Elective thoracolumbar posterior lumbar instrumented interbody fusion
  -  Minimally invasive spine surgery (MIS)
  -  3 or fewer levels
  -  Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)
  -  Consent to study participation
  Exclusion Criteria:
  -  Active tobacco smoker or history of tobacco smoking in the past 6 weeks
  -  Previous history of surgery at operative level(s)
  -  History of chronic inflammatory/rheumatological condition
  -  History of systemic steroid use in the past 3 months
  -  Auto/Workers' compensation patients
  -  Traumatic pathology at the operative levels
  -  Infection at the operative levels
  -  Tumor at the operative levels
  -  Major psychiatric illness as diagnosed by psychiatrists and on major anti- psychotic/depressants
  -  Patients on chemotherapeutic agents in the last 6 months
  -  Patients who has a history of allergy to Ketorolac
  -  Patients with a history of chemical addiction requiring professional rehabilitation and/or assistance
  -  Patients with current creatinine > 1.5mg/dl
  -  Patients with history of coagulopathy
  -  Patients with history of hepatic impairment
  -  Patients with uncontrolled cardiovascular disease

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

Clinical trial: Randomized Phase 2 Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-05/ECHO-306-05)

Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
  -  Measurable disease based on RECIST 1.1
  -  Life expectancy of at least 3 months.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Adequate organ function per protocol-defined criteria.
  -  Provide tumor tissue sample.
  Exclusion Criteria:
  -  Known untreated central nervous system metastases and/or carcinomatous meningitis
  -  History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
  -  Symptomatic ascites or pleural effusion.
  -  Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  -  Active autoimmune disease that has required systemic treatment in past 2 years.
  -  Has had an allogeneic tissue/solid organ transplant.
  -  Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  -  Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  -  History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
  -  Use of protocol-defined prior/concomitant therapy.

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

Clinical trial: The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord

Summary: The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of human knee OA

Detailed description: This is a single-centre, quadruple blined, randomized controlled trail with a total of 9 knee osteoarthrits patients as participants, who will be randomly assigned into high dose group, moderate dose group or low dose group. The participants in the high dose group will receive the treatment of high dose MSCs (1×10^8cells/3mL) anticular injection.The dose of the MSCs in medium dose group is 5×10^7cells/3mL, and the dose in the low dose group is 1×10^7cells/3mL. Unexplained local and systemic symptoms will be assessed to determine the the maximum tolerated dose of mesenchymal stem cells in anticular injection.

Eligibility: Inclusion Criteria:
  ① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -
  Exclusion Criteria:
  ① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.-

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

Clinical trial: Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

Summary: This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB A317 in combination with standard platinum-based chemotherapy in subjects with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Subjects with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., subjects with adenocarcinoma component accounting for > 50% will be allocated to non-squamous NSCLC cohort.) Subjects with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.


Eligibility: Inclusion Criteria:
  1. Male or female, aged 18-75 years on the day of signing informed consent.
  2. Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.
  Note: Subjects with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
  3. Have had no prior systemic therapy for advanced or metastatic disease. Prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease.
  4. Subjects must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded [FFPE] blocks or at least 10 unstained FFPE slides) with an associated pathological report.
  Exclusion Criteria:
  1. Subjects with a sensitizing mutation in EGFR gene or an ALK fusion oncogene (specifically for subjects with non- squamous NSCLC). Subjects with unknown mutation/fusion status of EGFR and/or ALK must take the respective test at the investigational sites (or other designated sites) prior to enrolment.
  2. Prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
  3. Prior therapies targeting PD-1, PD-L1 or PD-L2

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

Clinical trial: P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation

Summary: The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.


Eligibility: Inclusion Criteria (abbreviated):
  Skeletally mature adults between 22 and 75 years old (inclusive);
  Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam;
  Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;
  Involved disc(s) between L2 and S1;
  Exclusion Criteria (abbreviated):
  Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia;
  Active malignancy;
  Nondiscogenic source of symptoms (e.g. tumor, etc.);
  Multiple level symptomatic degenerative disc disease;
  Previous spinal instrumentation or a previous interbody fusion procedure at the involved level;
  More than one level to be operated;

Relevance to patient case: not relevant