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

Clinical trial: Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma

Summary: Primary Objectives:
  1. To evaluate clinical tolerance and response to curcumin alone and in combination with Bioperine in patients with multiple myeloma.
  2. To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin + Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin.
  3. To evaluate the biologic effects of curcumin alone and in combination with Bioperine on the expression of NF-kB and related genes in the Multiple Myeloma (MM) cells.

Detailed description: Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. Bioperine is a pepper extract that increases the absorption of nutrient supplements.
  In this study, 6 patients at a time will be randomly assigned (as in the toss of a coin) to one of two groups of 3 patients each. One group (Arm A) will receive curcumin alone. The other group (Arm B) will receive curcumin in combination with Bioperine. There is an equal chance of being in either group. While on study you may receive standard supportive care as appropriate.
  Both of the study agents will be taken by mouth two times a day. Each group will have five dose levels of curcumin, starting with the lowest dose. After 6 patients have been enrolled in the first level (3 in each arm), the next group will be treated at a new dose level. You will always receive the same dose during your treatment, which will continue for at least 12 weeks unless there is evidence that the disease has gotten worse or intolerable side effects occur. You may receive treatment up to one year depending on your response to treatment.
  You may be treated as outpatient and may receive your treatment at home. You will be asked to return to M. D. Anderson every 4 weeks for evaluation and physical exam.
  This is an investigational study. A total of up to 30 evaluable patients will take part in the study. All will be enrolled at M. D. Anderson.

Eligibility: Inclusion Criteria:
  -  Patients with multiple myeloma who have been previously untreated, are asymptomatic and without serious or imminent complications; or have relapsed or failed treatment with conventional therapy.
  -  Adequate hematologic, renal, and hepatic functions.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  Exclusion Criteria:
  -  Previously untreated patients with high tumor mass; symptomatic or impending fractures.
  -  Patients with significant cardiac disease.
  -  Patients with comorbid condition which renders patients at high risk of treatment complications.
  -  History of significant neurological or psychiatric disorders.

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

Clinical trial: Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis

Summary: CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis.
  This however has never been validated on a histological level. In this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and a PET-scan prior to surgery.
  The resection specimen will be compared to the preoperative imaging.


Eligibility: Inclusion Criteria:
  -Patients with non small cell lung cancer and atelectasis, who are eligible for surgery.
  Exclusion Criteria:
  -  age < 18 years
  -  pregnancy

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

Clinical trial: Cervical I/F Cage for Anterior Cervical Fusion

Summary: The purpose of this study is to determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate

Detailed description: This is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent levels of the cervical spine. Patients will be randomly assigned in a ration of 1:1 between the investigational and control groups.
  Comparison: The device will be compared to a control group consisting of the 3 accepted standard of care treatments (autograft, autograft with an anterior plate, or allograft with an anterior plate). For two level fusions, the control group will be limited to autograft with a plate or allograft with a plate. Based on the current literature, it is believed that there is no difference between the three treatments in terms of clinical success, fusion success, or safety issues. However, amongst the investigators there are preferred treatments. Each investigator will choose one or more of the control treatments at study initiation. Patients will then be randomized in a 1:1 Cage:control randomization schema. Approximately 240 subjects will be enrolled at 20 sites. Eligible patients will have symptomatic degeneration of one or two adjacent cervical discs, have failed six weeks of non-surgical treatment, have sufficiently severe enough symptoms to warrant surgery, and have had no prior fusion surgery on the cervical spine.

Eligibility: Inclusion Criteria:
  -  Persistent recurrent neck and/or shoulder and arm pain refractory to 6 weeks of non-surgical therapy.
  -  Radiographic evidence of significant disc degeneration at one or two adjacent cervical levels (C4-7)
  Exclusion Criteria:
  -  Significant degeneration at more than two cervical levels,
  -  Prior surgical treatment of the cervical spine; laminotomy or foraminotomy allowed,
  -  Gross instability due to trauma,
  -  Disability in the lumbar spine,
  -  Infection in the disc or spine, past or present,
  -  Any active infection at time of surgery,
  -  Tumor in the spine,
  -  Significant osteoporosis or metabolic bone disease,
  -  Pregnant, lactating or wishes to become pregnant within duration of the study,
  -  Refusal to accept the use of autograft tissue.

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

Clinical trial: A Trial of the ALK Grass Tablet in Subjects With Hayfever

Summary: This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).


Eligibility: Eligibility Criteria:
  -  A history of grass pollen induced rhinoconjunctivitis
  -  Positive skin prick test to grass
  -  Positive specific IgE to grass

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

Clinical trial: SPECT/CT in Endocrine and Neuroendocrine Tumors

Summary: The value of fusion of functional and anatomical data has been described using several fusion techniques for various nuclear medicine procedures and morphologic imaging modalities (SPECT-CT, SPECT-MRI, Coincidence-CT). We hypothesize that NM -CT data has advantages over the data obtained using separately performed NM study and conventional anatomic imaging as CT. We hypothesize that more accurate localization of the radio-isotope activity on NM images will improve diagnostic accuracy and will have an impact on patient management:
  Improved accuracy of NM study will improve tumor localization, the evaluation of the extent of disease and the post therapy follow up.
  It will direct other diagnostic procedures to lesions otherwise undetected, or exclude the need for more invasive procedures. It can also guide invasive procedures and radiation-therapy planning, thus improving therapy results and avoiding unnecessary treatment-related side effects.

Detailed description: The value of fusion of functional and anatomical data has been described using several fusion techniques for various nuclear medicine procedures and morphologic imaging modalities (SPECT-CT, SPECT-MRI, Coincidence-CT). We hypothesize that NM -CT data has advantages over the data obtained using separately performed NM study and conventional anatomic imaging as CT. We hypothesize that more accurate localization of the radio-isotope activity on NM images will improve diagnostic accuracy and will have an impact on patient management:
  Improved accuracy of NM study will improve tumor localization, the evaluation of the extent of disease and the post therapy follow up.
  It will direct other diagnostic procedures to lesions otherwise undetected, or exclude the need for more invasive procedures. It can also guide invasive procedures and radiation-therapy planning, thus improving therapy results and avoiding unnecessary treatment-related side effects.

Eligibility: Inclusion Criteria:
  -  Patient referred for NM scintigraphy to assess the presence of endocrine or neuroendocrine tumors.
  -  Patient signed informed consent
  Exclusion Criteria:
  -  The study will not be performed in pregnant or lactating women.
  -  Patient will not be able or willing to tolerate the scan until its completion.

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

Clinical trial: Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

Summary: This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.


Eligibility: Inclusion Criteria:
  -  Previous enrollment in Immunex protocols
  -  No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment.
  -  Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential.
  -  No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
  -  Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.
  -  Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
  -  Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study.
  -  Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in 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: Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

Summary: The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).


Eligibility: Inclusion Criteria:
  -  Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1
  -  Normal organ and marrow function
  -  No other malignancies within 5 years, except for non-melanoma skin cancer
  Exclusion Criteria:
  -  Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
  -  Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
  -  Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered > 30 days before study enrollment
  -  Receiving anticoagulation therapy with warfarin (low-dose warfarin < 1 mg/day, heparin and low molecular weight heparins are permitted)
  -  The subject meets any of the following cardiac criteria:
  -  Corrected QT interval (QTc) of > 460 msec
  -  Family history of congenital long QT syndrome or unexplained sudden death
  -  History of sustained ventricular arrhythmias
  -  Has a finding of left bundle branch block
  -  Has an obligate pacemaker
  -  Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node dysfunction
  -  Has uncontrolled hypertension
  -  Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
  -  Has a serum potassium or serum magnesium level that falls outside the normal range
  -  The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
  -  Uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Known HIV

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

Clinical trial: Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects

Summary: The purpose of the trial is to determine if treatment of asthma patients allergic to house dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).


Eligibility: Inclusion Criteria:
  -  A history of house dust mite induced asthma
  -  Use of inhaled corticosteroids (ICS)
  -  Positive skin prick test to house dust mites
  -  Positive specific IgE to house dust mites
  Exclusion Criteria:
  -  FEV1 lower than 70%

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 PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

Summary: Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.

Detailed description: A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.
  PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.
  Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.

Eligibility: Inclusion Criteria:
  -  failed (within last 2 yr) or intolerant of at least one steroid AND at least one immunosuppressant AND at EXACTLY one biologic
  -  CDAI between 250 and 450, inclusive
  -  endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both
  -  CRP of at least 5 mg/l (0.5 mg/dl)*OR* CDAI of at least 300
  -  weight between 40 and 150 kg, inclusive
  -  adequate renal function
  -  negative PPD test (or evaluated low risk of TB activation)
  Exclusion Criteria:
  -  HIV or hepatitis infection active
  -  allergy to CT contrast agents, or to bovine or porcine products
  -  symptomatic fibrostenotic Crohn's disease
  -  permanent ostomy
  -  biologic therapy within past 90 d
  -  prednisone greater than 20 mg/d within past month
  -  short-bowel syndrome
  -  total parenteral nutrition
  -  abnormal liver function
  -  malignancy active within past 5 years (except completely resected basal or squamous cell carcinoma of skin)
  -  enteric pathogens, including C. difficile
  -  history of colonic mucosal dysplasia
  -  current or prior evidence of TB (unless risk of activation or re-activation deemed low)

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

Clinical trial: Impaired Immunity in Patients With Cancer: Influence of Cancer Stage, Chemotherapy, and Cytomegalovirus Infection

Summary: According to a survey from Department of Health in 2004, cancer has been the leading cause of death in the Taiwan area. In 2004, people died of cancer, accounting for 27.2 percent of all deaths. The major reason of the superior grade is that cancer has the ability to escape the surveillance of immune system. It is also a main issue to address in medical research.
  Dendritic cells (DCs), the most potent APC, are located at sites of pathogen entry, acquire antigens from pathogens or pathogen-infected cells, and process these antigens for both class I and class II presentation. Upon antigen encounter, they termed immature DCs, undergo a maturation process, they are capable to present captured antigens to T cells. This maturation step allows DC migration to trigger adaptive immune responses. These features make DCs very good candidates for therapy against various pathological conditions including malignancies.
  Therefore, two concepts in this project will be concerned: one is enhancement of T cell immunity and the other is improvement of the efficiency of DC-tumor fusion. The strategy of enhance T cell is using well-known cytokines, such as IL2, and IL7 to expand the tumor-specific CD4 and CD8 T cells before DC-vaccine treatment. In the past, scientists utilized polyethyleneglycol to fuse cancer cells and dendritic cells. However, the results were devastating. Two new approaches of the DC vaccine will be applied to this study: DC-tumor fusion and DC phagocytosed apoptosed tumor cells. Whole tumor cells will be fused with DCs by combining hypotonic buffer and electrical-based fusion protocols. The safety of hybrid cell vaccination has been shown in clinical trials with some encouraging anti-tumour effects. However, data are as yet insufficient to assess a clear therapeutic benefit. Hopefully, the combination of two strategies will improve the efficiency of DC vaccine and boost survival of cancer patients.
  As we have gained a clearer understanding of the cellular and molecular events that modulate antigen presentation and T cell activation in vivo, new strategies have emerged, allowing the development of more potent second generation DC vaccines.


Eligibility: Inclusion Criteria:
  -  For observational study: health volunteers and cancer patients
  -  For DC vaccine: patients with solid tumor
  Exclusion Criteria:
  -  leukemia

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 Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Summary: PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.


Eligibility: Inclusion Criteria:
  -  Advanced malignancies (except leukemias), histologically proven at diagnosis; Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS
  -  Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
  -  Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)
  Exclusion Criteria:
  -  Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort
  -  Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
  -  Active or unstable cardiac disease or heart attack within 3 months of starting study treatment

Relevance to patient case: not relevant