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: PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor

Summary: Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last half. Recently, integrated MRI-PET (Biograph mMR, Siemens, Germany) was introduced, and can provide simultaneous whole body MRI-PET imaging as well as brain-specific advanced imaging (e.g. DWI, PWI, and DCE). The purpose of the present study is to evaluate whether the simultaneous MRI-PET acquisition can improve the diagnostic yield for the patients initially presented with brain tumors, and predict the prognosis in the patients diagnosed with primary high graded astrocytoma or oligodendroglioma.

Detailed description: Materials and methods: Simultaneous MRI-PET (FDG) will be prospectively obtained in patients (n = 60) initially presented with brain tumors by using integrated MRI-PET (Biograph mMR, Siemens, Germany). We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies. We will use the imaging protocols including whole body MRI-PET and advanced brain tumor imaging (DWI, PWI and DCE). In addition, we will analyze the imaging parameters to see whether the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.
  Expected results: We expect that whole body MRI-PET is useful for the differential diagnosis of primary and metastatic brain tumors, and the multiparametric information from DWI, PWI, DCE and PET can be used for the tumor grading and prognosis prediction of the primary brain malignancies.

Eligibility: Inclusion Criteria:
  -  We will inculude the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.
  Exclusion Criteria:
  -  We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies.

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: Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

Summary: The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.


Eligibility: Inclusion Criteria:
  -  Post intracranial meningioma removal surgery 3-12 months prior to the inclusion in the study.
  -  All patients have to have persistent cognitive or neurological complaints regarding without noticeable improvement during the last month prior to their enrolment.
  -  Age 18 years or older.
  Exclusion Criteria:
  -  Dynamic neurologic/cognitive improvement or worsening during the past month;
  -  Evidence of dynamic cognitive/neurological improvement in the last month.
  -  Previous brain radiotherapy and/or radiosurgery.
  -  Steroids dependence
  -  Seizures 1 month previous to inclusion
  -  Had been treated with HBOT for any other reason 1 month prior to inclusion;
  -  Have any other indication for HBOT;
  -  Chest pathology incompatible with pressure changes;
  -  Inner ear disease;
  -  Patients suffering from claustrophobia;
  -  Inability to sign written informed consent;
  -  Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.

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: Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study

Summary: Gliclazide has greater glucose lowering efficacy than glibenclamide among type 2 diabetes mellitus patients with minor haplotype (K23/A1369) at the KCNJ11/ABCC gene locations.

Detailed description: Sulphonylurea (SU) is a glucose-lowering agent used widely to treat type 2 diabetes mellitus (T2DM). SU promotes insulin secretion from the pancreatic islet beta cell via binding and inhibition of the ATP-sensitive potassium (KATP) channel. The KATP channel is made up of two subcomponents, an inner Kir6.2 K+ channel (coded by the KCNJ11 gene) and an outer SU receptor 1 (SUR1) (coded by the ABCC8 gene). Although all SUs are mechanistically similar in terms of increasing insulin secretion, they bind to distinct regions of Kir 6.2 and SUR1 to exert their function. Different types of SU (e.g. tolbutamide, glibenclamide, glipizide, glimepiride and gliclazide) can therefore be grouped by their binding sites (A/B/A+B site) on the KATP channel [3]. Interestingly, the KCNJ11 E23K (rs5219) variant was shown to confer susceptibility to T2DM and the ABCC8 S1369A (rs757110) variant was found to be in complete linkage disequilibrium with it i.e. inherited together as a genetic block (haplotype). A recent in vitro molecular study suggested that the minor haplotype (K23/A1369) of KATP channel is sensitive to inhibition by gliclazide (binds to A-site) but not glibenclamide (binds to A+B site), and that the increased responsiveness to gliclazide was largely due to the A1369 allele. Understanding how the response to these two SUs may vary with the presence of the minor haplotype (K23/A1369) would therefore be beneficial for customization of patient treatment to achieve better clinical outcomes.

Eligibility: Inclusion Criteria:
  -  Type 2 diabetes
  -  Age 21-65
  -  HbA1c >8.0% on two consecutive visits
  Exclusion Criteria:
  -  Currently taking insulin at a regime more complex than basal insulin
  -  Not willing to perform self-blood glucose monitoring (SBGM)
  -  Renal impairment i.e. eGFR<50mls/min
  -  Pregnancy or unwilling to practice adequate contraception
  -  Taking other medications that may affect blood glucose e.g. systemic glucocorticoids.

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: Effect of Implant Position on Magnetic Resonance Image Distortion

Summary: Patients with Neurofibromatosis type 2 (NF2) almost always develop acoustic neuromas in both ears. As a result of the tumours themselves or the treatment of the tumours, many patients become profoundly deaf in both ears. It is possible to restore a degree of hearing by placing a hearing implant in the brainstem adjacent to the hearing pathways within the brain. This is termed an auditory brainstem implant (ABI).
  The aim of this study is to find the optimum head position in relation to the MRI magnet field, which would produce least area of image distortion in patients with ABIs. This will be of benefit in optimising the MR imaging in future patients with implants.

Detailed description: Auditory brainstem implants (ABI) are placed against the auditory centres in the brainstem if it is not possible to implant the cochlea or if the cochlear nerve, which conveys neural signals from the cochlea to the brainstem, is damaged or absent. The latter device is usually used in patients with Neurofibromatosis type 2 (NF2) who develop bilateral benign inner ear tumours called vestibular schwannomas as well as other neurological tumours1. These patients often become bilaterally profoundly deaf either as a result of the disease or because of surgery to remove the tumours and require an ABI.
  Patients with NF2 require monitoring of their tumours. In the absence of an auditory implant it is possible to use magnetic resonance imaging. This is the gold standard imaging technique as it gives excellent views of the soft tissues of head. However, there has been concern regarding the use of MRI in patients with auditory implants until recently because of potential problems such as demagnetisation of the magnet within the implant, implant magnet displacement and risk to the integrity of the implant electronics. In addition, the magnet field of the implant magnet results in imaging artefact (manifesting as a signal void) around the implant site that limits the information that can be obtained.

Eligibility: Inclusion Criteria:
  - Any patient over the age of 18 with NF2 who has an auditory implant (cochlear or auditory brainstem implant) in situ and requires MRI scanning.
  Exclusion Criteria:
  Children under the age of 18 years Claustrophobia Bilateral implants
  Contraindications and relative contraindications for MRI (as per the Radiology Department MRI protocol) including:
  Pacemaker Certain metallic heart valves Ferromagnetic implanted materials and foreign bodies

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: Information Presentation Formats

Summary: Prevention and early detection of medical problems can greatly reduce health care costs, yet time and again, people avoid or ignore services that could help detect medical problems early enough to prevent or reduce the severity of potential problems. The investigators seek to understand whether the elicitation of symptom admission by patients can predict people's perceived risk of the medical condition and voluntary pursuit of medical information.

Detailed description: We will present individuals with medically accurate information about a medical condition and measure people's perceptions of their own likelihood to having that medical condition. This will include an opportunity for people to pursue more information by directing them to a website that features more information about the condition. The initial information provision will vary slightly in presentation (method of eliciting symptoms will vary), and the rate at which individuals visit the subsequent medical website to receive more information will be recorded as a measure of information seeking behavior. Rates will be compared across symptom elicitation conditions to determine which formats are most effective at encouraging information seeking about health issues. No personally identifying information will be collected, and all results will be reported in aggregate. Critically, no deception will be used: Participants will only be provided with information that is as accurate as possible (given existing knowledge in the health/medical fields).

Eligibility: Inclusion Criteria:
  -  18 or older
  -  American
  Exclusion Criteria:
  -  Mechanical Turk approval rate below 95%

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: Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Summary: This study tests the efficacy of an 8-week, Skype-based, group resiliency training intervention (The Relaxation Response Resiliency Program) for improving psychological stress in patients with Neurofibromatosis. A control group will receive a general health education curriculum. The investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program.
  A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a sub-population: patients with NF2 who are hard of hearing.


Eligibility: Inclusion Criteria:
  1. Age 18 or older
  2. Can read and speak English at or above the 6th grade level
  3. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis
  Exclusion Criteria:
  1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
  2. Recent (within past 3 months) change in antidepressant medication
  3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
  4. Unable or unwilling to sign the informed consent documents
  5. Unable or unwilling to complete psychological assessments online via the REDCap system.
  6. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.

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: Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

Summary: The purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.


Eligibility: Inclusion Criteria:
  -  Aged over 18
  -  History of breast cancer
  -  Medical prescription for an adjuvant hormonal treatment (anti-estrogens and / or aromatase inhibitors) as monotherapy or in combination with other treatments
  -  Affiliated to a social security scheme
  Exclusion Criteria:
  -  Refusal to participate, patient protected by guardianship.
  -  Patient unable to understand the study or unable to follow the education sessions.
  -  Patient with documented cognitive or psychiatric history.
  -  Geographical remotness (more than 100 Kms).

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: Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients

Summary: The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors.

Detailed description: Patients with locally advanced gastric cancer (T3-4 and/or N+) are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound.
  The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy. Chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20.
  Estimate whether R0 resection rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the stomach
  -  Age ≥18 years old
  -  Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  -  Body mass index ≥ 18
  -  No prior chemotherapy or chemoradiotherapy
  -  TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
  -  No evidence of metastasis (M0)
  -  Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)
  Exclusion Criteria:
  -  Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
  -  Patients with evidence of severe or uncontrolled systemic disease
  -  Medically unfit for chemotherapy
  -  Tumors involving the esophageal junction, comprising siewert I to III

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: A Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Patients With Metastatic Her 2- Negative and Aggressive Disease Criteria

Summary: The purpose of this study is to identify a powerful and easy predictive/prognostic marker to drive patients under bevacizumab.


Eligibility: Inclusion Criteria:
  -  Patients aged >= 18 years
  -  Patients with HER2-negative MBC. Mandatory to have the HER2/estrogen receptor(ER)/progesterone receptor (PR) status
  -  Patient who met criteria for first-line treatment with chemotherapy plus bevacizumab (standard doses) by local, regional or national guidelines or authorities
  -  Patients with measurable disease (RECIST criteria v1.1) or patients with no measurable but assessable disease
  -  Molecular phenotype as triple negative metastatic breast cancer and ER[+] tumors need to fulfill at least one of the two clinical criteria (metastatic relapse on adjuvant endocrine therapy or progression to at least one prior line of endocrine therapy for advanced disease or aggressive disease criteria [at least two criteria: taxane based regimen in the {neo}adjuvant setting, metastatic relapse within 2 years from the end of chemotherapy for early breast cancer, liver metastasis, three or more organs with metastatic involvement, symptomatic visceral disease])
  -  Eastern Cooperative Oncology Group (ECOG) 0-2
  -  Signed informed consent form
  Exclusion Criteria:
  -  Patient has received prior chemotherapy for metastatic disease
  -  Patient requiring major/minor surgery within 3 weeks prior to administration of the first dose of study treatment
  -  Patient has received an investigational therapy within 4 weeks prior to study entry
  -  Patient has known symptomatic brain metastases
  -  Patient with non-measurable or assessable disease, exclusive blastic bone disease, pleural, pericardial or abdominal effusion as only evidence of disease
  -  Patient in chronic daily treatment with corticosteroids (doses> 10 mg / day of methylprednisolone or equivalent), except inhaled steroids
  -  Pregnant or breastfeeding patient. A serum pregnancy test will be taken up to 7 days prior to study treatment, or up to 14 days prior to study treatment (in the latter case another urine test will be taken within 7 days prior to study treatment to confirm the result)
  -  Women of childbearing potential (defined as those who have had their last menstrual period <2 years and are not surgically sterilized) who are not using hormonal contraceptives or highly effective birth control (e.g. intrauterine device) during the study
  -  Patient has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  -  Patient with significant renal, hematological or liver function alteration according to investigator's criteria
  -  Patient has serious medical risk factors involving any of the major organ systems

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: PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

Summary: This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel. The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity of the RP2D as determined in the Dose Escalation Phase.


Eligibility: Inclusion criteria:
  1. histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
  2. Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN, etc.) as assessed in a local laboratory.
  3. Has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure.
  4. Eastern Cooperative Oncology Group performance status of 0 or 1
  5. measurable or evaluable disease as determined by RECIST 1.1.
  6. Is able to swallow and retain orally administered medication
  7. adequate baseline organ function
  Exclusion criteria
  1. prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K pathway inhibitors
  2. Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or Grade 2 anemia (if hemoglobin is ≥9.0 g/dL)
  3. Has CNS metastases
  4. Has a QTc interval >450 msec or QTc >480 msec for subjects with bundle branch block (BBB)
  5. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2636771 or hypersensitivity to drug formulated in polyoxyl 35 castor oil, NF such as paclitaxel.

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: Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of sirolimus in patient with Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of sirolimus in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration( H1047R, E542K, E545K, PTEN LOSS) Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=75 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with sirolimus

Relevance to patient case: not relevant