araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors

Summary: This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective immune response and help prevent flu in patients who are receiving chemotherapy for CNS tumors

Detailed description: PRIMARY OBJECTIVES:
  I. The primary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in hemagglutinin inhibition (HI) titers from the pre-vaccination baseline.
  SECONDARY OBJECTIVES:
  I. A secondary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40.
  II. The secondary objectives of this pilot study include an assessment of the relationship between a variety of clinical factors and seroconversion following influenza vaccination.
  III. Subgroup analyses will include an investigation of seroconversion and treatment (actively receiving chemotherapy, radiation therapy or both), disease status (active treatment vs long term followup), and use and dose of glucocorticoids.
  TERTIARY OBJECTIVES:
  I. An additional area of interest which will be further explored in this pilot study is an assessment of the relationship between serologic markers of immune function and response to vaccination.
  OUTLINE:
  Patients receive trivalent influenza vaccine intramuscularly (IM) on day 0.
  After completion of study treatment, patients are followed up at 14 days, 21 days, and 3 and/or 6 months.

Eligibility: Inclusion Criteria:
  -  Patients must have a clinical diagnosis of a primary central nervous system tumor
  -  Patients must be eligible to receive the influenza vaccine
  -  Patients must be able to provide written informed consent
  Exclusion Criteria:
  -  Patients unable to receive the influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillan-Barré syndrome, or other contraindication to the vaccine
  -  Patients who have received the 2011-2012 annual influenza vaccine prior to being considered for enrollment on this study

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen

Summary: This study is a retrospective analysis of an homogeneous population of patients with aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups with a clinical and therapeutical relevance.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed newly diagnosed aggressive B-cell lymphoma according to the current World Health Organisation Classification, from 2001 to 2007.
  2. Any stage of disease.
  3. Treatment with R-CHOP or R-CHOP like regimens (+/- transplant).
  4. Age at least 18 years.
  5. Availability of tissue biopsy at diagnosis for a possible centralized revision.
  6. Availability of data on clinical involvement, laboratory, treatment and follow up.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Studying Gene Expression and Location in Samples From Patients With Brain Tumors

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to brain tumors.
  PURPOSE: This research studies gene expression and location in samples from patients with brain tumors.

Detailed description: OBJECTIVES:
  -  To determine the expression and subcellular localization of nei endonuclease VIII-like 3 (NEIL3) in brain tumors.
  OUTLINE: Tissue microarray samples are analyzed for NEIL3 expression and subcellular localization by immunohistochemical methods.

Eligibility: DISEASE CHARACTERISTICS:
  -  Tissue microarrays (TMA) samples from the Biopathology Core
  -  Samples from patients diagnosed with brain tumors
  -  Progenitor, or blast, cell origin
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Autonomic Phenotype Before and After Akt Inhibition

Summary: Some Akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. There are no current data on whether this autonomic failure presents in humans at clinically used doses. We will test the hypothesis that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.


Eligibility: Inclusion Criteria:
  -  Diagnosed with melanoma with a BRAF mutation and relapse following therapy with a BRAF inhibitor
  -  Enrolled in a clinical trial through the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor
  -  Able and willing to provide informed consent
  Exclusion Criteria:
  -  Factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
  -  Unable to give informed consent

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function

Summary: This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator (CFTR) function.

Detailed description: CFTR Mutations associated with residual function or defective messenger ribonucleic acid (mRNA) splicing include the following:
  R117H, E56K, P67L, D110E, D110H, R117C, R347H, R352Q, A455E, D579G, S945L, L206W, R1070W, F1074L, D1152H, S1235R, D1270N, 2789+5G->A, 3849+10kbC->T, 3272-26A->G, 711+5G->A, 3120G->A, 1811+1.6kbA->G, 711+3A->G, 1898+3A->G, 1898+1G->A, 1717-1G->A, 1717-8G->A, 1342-2A->C, 405+3A->C, 1716G/A 1811+1G->C, 1898+5G->T, 3850-3T->G, IVS14b+5G->A, 1898+1G->T, 4005+2T->C, 621+3A->G, 621+1G->T.

Eligibility: Inclusion Criteria:
  -  Male or female participants with confirmed diagnosis of CF
  -  Clinical evidence of residual CFTR function based on any 1 of the following: 1) Clinically documented residual exocrine pancreatic function, 2) Sweat chloride value less than equal to (<=) 80 millimole per liter (mmol/L) at screening, or 3) Age of diagnosis greater than equal to (>=) 12 years and at least 1 copy of a CFTR mutation associated with residual CFTR function or defective mRNA splicing
  -  FEV1 >= 40 percent (%)
  -  12 years of age or older
  -  Willing to agree to meet the contraception requirements
  -  Able to swallow tablets
  Exclusion Criteria:
  -  A copy of any of the following CFTR mutations: G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, or G1349D
  -  Unable to perform spirometry
  -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1
  -  Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies

Summary: Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects.
  This study compares both agents in favoring cerebral relaxation during elective supratentorial procedures for tumor resection.
  Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer side effects than 20% mannitol.


Eligibility: Inclusion Criteria:
  -  Patients scheduled for elective supratentorial craniotomy for tumor resection
  -  Presumed preoperative diagnosis of : astrocytoma (any grade), meningioma (any sub-type) or cerebral metastasis (any primary neoplasm)
  Exclusion Criteria:
  -  Age < 18 years
  -  Reintervention
  -  Glasgow coma scale < 13
  -  Emergency surgery or American Association of Anesthesiologists physical status class 4 or 5
  -  Prone or lateral positioning
  -  Hypo or hypernatremia (serum sodium below 135 or above 150 meq/L)
  -  Osmotherapy (either mannitol or hypertonic saline) given in the last 24 hours
  -  Congestive heart failure (LVEF < 40% or restrictive diastolic dysfunction on echocardiography)
  -  Chronic renal failure (creatinine clearance < 30 ml/min)
  -  Pregnancy
  -  Obesity (BMI > 40)

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: p-AKT Expression on Clinical Outcomes in Malignant Lymphoma

Summary: PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway. However, clinical information about the significance of p-AKT expression in malignant lymphoma is not fully understood yet. In this study, we investigated the overexpression of p-AKT and its prognostic implication in malignant lymphoma.

Detailed description: Recently, among diverse oncogenic signaling pathways, a number of studies have focused on the significance of oncogenic PI3K/AKT (phophatidylinositol 3-kinase/serine-threonine kinase, also known as protein kinase B [PKB]) pathway. PI3K(phosphatidylinositol 3-kinase)/AKT pathway phosphorylates and activates AKT as phosphorylated AKT (p-AKT) and plays a critical role promoting malignant phenotype and has prognostic significance in various solid cancers.
  However, a systematic approach on the impact of p-AKT overexpression on clinical outcomes has not been performed in malignant lymphoma.

Eligibility: Inclusion Criteria:
  1. the patients were pathologically confirmed of malignant lymphoma, according to the World Health Organization classification;
  2. the patients had adequate paraffin-embedded biopsy specimen or unstained slides for immunostaining of p-AKT.
  Exclusion Criteria:
  1. Primary central nervous system lymphoma was excluded in this study

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Randomized Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.

Summary: In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon radiotherapy in patients with skull base meningiomas. There will be two treatment arms with photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional fractionation. The study is designed as descriptive study on feasibility of the investigated therapies aiming at a comparison of toxicities. The study will serve as a basis for further larger randomized protocols comparing efficacy of the therapies, assuming toxicity is comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and quality of life.


Eligibility: Inclusion Criteria
  Patients meeting all of the following criteria will be considered for admission to the trial:
  -  Histologically or imaging confirmed skull base meningioma
  -  macroscopic tumor - Simpson Grade 4 or 5
  -  age ≥ 18 years of age
  -  Karnofsky Performance Score >=60
  -  For women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.)
  -  Female participants: No pregnancy present (pregnancy test required)
  -  Ability of subject to understand character and individual consequences of the clinical trial
  -  Written informed consent (must be available before enrolment in the trial)
  Exclusion criteria:
  Patients presenting with any of the following criteria will not be included in the trial:
  -  refusal of the patients to take part in the study
  -  previous radiotherapy of the brain
  -  histologically confirmed atypical or anaplastic meningioma
  -  optic nerve sheath meningioma (ONSM)
  -  Patients who have not yet recovered from acute toxicities of prior therapies
  -  Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
  -  Pregnant or lactating women
  -  Participation in another clinical study or observation period of competing trials, respectively.

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy

Summary: This randomized trial examines possible enhancements in live quality and neurocognitive functions in patients after radiotherapy of the neurocranial area with hippocampal sparing. Although the hippocampus has a crucial role in regard to neurocognition and memory, hippocampal region has been relatively disregarded in radiotherapy of neurocranium so far. Brain metastases in the hippocampal region are very rare and an infiltration of the hippocampus by meningioma or by pituitary adenoma just occurs when volume of the tumor is very high. This study aims to reduce the radiation dose in the hippocampal region to improve the quality of live and neurocognitive functions in patients without degrading prognosis or increasing probability of brain metastases in hippocampal region.
  Primary endpoint of the trial is quality of live and neurocognitive functions in patients after radiation of neurocranial region with hippocampal sparing compared with conventional radiotherapy of the neurocranial region without hippocampal sparing. Secondary endpoints are cerebral recurrence rate in hippocampal region and overall survival. It is planned to include a total number of 150 patients.


Eligibility: Inclusion Criteria:
  -  minimum age 18
  -  diseases indicating a radiotherapy of neurocranial area (histologically or image-guided confirmed (skull base)meningioma,pituitary adenoma,brain metastases, SCLC)
  -  indication for a local radiotherapy in neurocranial area or for a radiation of whole neurocranium
  -  Karnofsky-State ≥ 50%
  -  patient has understand content of study protocol
  -  Signed study-specific consent form prior to therapy
  Exclusion Criteria
  -  pregnant or nursing women
  -  Fertile patients who refuse effective contraception during study treatment
  -  persistent drug and/or alcohol abuse
  -  prior radiotherapy of neurocranial region
  -  patients not able or willing to behave according to study protocol
  -  in the case of malignancy: more than 3 brain metastases
  -  in the case of malignancy: brain metastases in hippocampal region or in the hippocampus avoidance zone
  -  GTV in hippocampal region or in the hippocampus avoidance zone
  -  patients in care
  -  patients who are not able to speak German
  -  conditions that preclude the application of MRT (e.g. magnetic implants, cardiac pacemaker)
  -  on-treatment participation on other trials

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Feasibility Study of Auditory Brainstem Implant in Young Children

Summary: Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.


Eligibility: Inclusion Criteria:
  -  Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
  -  If previously received a cochlear implant, must demonstrate lack of benefit from that device
  Exclusion Criteria:
  -  Medical contraindication to craniotomy/intracranial surgery
  -  Severe cognitive or developmental delays

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Neurofibromatosis (NF) Registry Portal

Summary: The NF Registry is a database of patient-reported experiences of living with neurofibromatosis. It also serves as a referral source for clinical trials.

Detailed description: Patients and parents of patients will be made aware of the Neurofibromatosis (NF) Registry through various non-commercial information sources such as the Children's Tumor Foundation (CTF) website, CTF-affiliated NF clinics, CTF educational and fundraising events, and other nonprofit organizations and foundations such as the National Organization for Rare Diseases (NORD) and the Agency for Healthcare Research and Quality's (AHRQ) Registry of Registries.
  The NF Registry will be accessed by individual subjects via a web-based patient portal. The portal first provides informed consent information. Following consent, the registrant creates an account by choosing a unique username and password. An account can be created by an adult patient with the disorder, or by the parent or guardian of a child with the disorder. Account creators are required to enter identifiable contact and demographic data.
  After the account is created, a patient profile can be completed via on-line questionnaires. There are separate questionnaires for NF1, NF2, and Schwannomatosis. The questionnaires ask about about the affected individual's medical and family history of the disease, testing and diagnosis, clinical manifestations (e.g., tumor types and locations) interventions and therapies, and quality of life. They also ask permission from the patient or his or her parent or guardian to be contacted by email (via CTF) in regard to relevant clinical trials and studies.
  Participant's responses are used to compile charts and graphics of de-identified aggregate data. Registered patients may view this data.
  Researchers may request access to de-identified data. They may also request that CTF send emails of study recruitment materials to specific patient subgroups.
  Data capture for the NF Registry is being done under contract with PatientCrossroads (San Mateo, CA), a state-of-the-art web-based patient opt-in registry that also performs this function for 250 other rare disease registries.
  Participants will be asked to update their information at least once a year. Their information will be stored in the NF Registry for an indefinite period of time.
  This longitudinal study is intended as a resource for patients and researchers. There is no specific outcome measure or anticipated endpoint.

Eligibility: Inclusion Criteria:
  -  Diagnosed with NF1
  -  Diagnosed with NF2
  -  Diagnosed with Schwannomatosis
  Exclusion Criteria:
  -  Failure to complete account registration

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

Summary: The aim of the study is to compare different strategies for prevention of venous thromboembolism related to intracranial meningioma surgery. The investigators identified three hospitals where two have a very restrictive approach with respect to anticoagulant therapy while at the third hospital the use of anticoagulation the day before surgery was initiated as routine prophylaxis.
  Based on this "natural experiment" it will be explored whether the use of anticoagulant prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with increased risk of postoperative hemorrhage as compared to the 2 cohorts where this intervention were absent.


Eligibility: Inclusion Criteria:
  -  First included patient 1.january 2007 and latest included patient 1.july 2013 (allows for 30 day follow up with respect to morbidity)
  -  Histological verification of a meningioma (of any grade) from the current surgery
  Exclusion Criteria:
  -  Intracranial surgery or venous thromboembolism the last 3 months

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Phase IV Bioseal Study in Brain Tumor Surgery

Summary: The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.


Eligibility: Inclusion Criteria:
  -  Subjects between 18 and 75 years of age
  -  Undergoing elective meningioma surgery and having a tumor cavity
  -  Presence of an appropriate Target Bleeding Site (TBS) as identified intra-operatively by the surgeon requiring an adjunct to achieve hemostasis
  -  Able and willing to comply with procedures required by protocol
  -  Signed and dated written informed consent prior to any study related procedures.
  Exclusion Criteria:
  -  Subjects undergoing emergency surgery
  -  Subjects with any intra-operative findings that may preclude conducting of the study procedures
  -  Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS
  -  Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products
  -  Subjects who have a history of traumatic head injury
  -  Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period
  -  The subject, in the opinion of the investigator, would not be suitable for participation in the study
  -  Subjects who participated in another trial within 30 days prior to the planned start of treatment.

Relevance to patient case: not relevant