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: Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors

Summary: RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors may help doctors learn about the long-term effects of treatment and plan the best treatment.
  PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.

Detailed description: OBJECTIVES:
  Primary
  -  Assess if temozolomide induces any changes in standard semen or sperm analysis parameters (i.e., volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology) in patients with newly diagnosed, recurrent, or progressive primary malignant brain tumors.
  OUTLINE: This is a pilot study.
  During treatment with temozolomide, patients undergo semen or sperm sample collection at baseline, 3 months, and 6 months for semen analysis. Samples are analyzed for volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed primary malignant brain tumor
  -  Newly diagnosed, progressive, or recurrent disease
  -  May have received prior radiotherapy with or without chemotherapy
  -  Scheduled to begin single-agent temozolomide chemotherapy
  -  Must be able to ejaculate
  -  Must abstain from ejaculating (e.g., not have sex or masturbate) for 2-7 days prior to study
  -  No known abnormal sperm motility and/or morphology
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100%
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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 Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)

Summary: This purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100 mg/dL in patients at risk for Heart Disease.


Eligibility: Inclusion Criteria:
  -  Men and women aged 18 to 80 at risk for Heart Disease who have LDL-C levels greater than or equal to 130 mg/dL and triglyceride level less than or equal to 350 mg/dL
  -  Patients must be able to maintain the National Cholesterol Education Program diet throughout the course of the study
  Exclusion Criteria:
  -  Patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. Additionally, patients with poorly controlled Type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known HIV positive, and uncontrolled high blood pressure

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 Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)

Summary: The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).


Eligibility: Inclusion Criteria:
  -  Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone
  -  Additionally, patients must have an LDL-C >100 mg/dL at Visit 1 or prior to initiation of statin therapy
  Exclusion Criteria:
  -  Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones
  -  Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes

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 of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

Summary: To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.


Eligibility: Inclusion Criteria:
  -  Symptomatic atrial fibrillation
  -  Atrial fibrillation documented by ECG
  -  Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.
  Exclusion Criteria:
  -  Systolic blood pressure <100 mmHg
  -  Heart rate <50 bpm
  -  Temperature >38°C
  -  QT or QTcB >440 ms
  -  QRS >140 ms
  -  Paced atrial or ventricular rhythm on ECG
  -  Serum potassium <3.5 meq/L
  -  History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
  -  History of amiodarone in last 6 months.
  -  Clinical evidence of acute coronary syndrome
  -  Acute pulmonary edema or embolism
  -  Hyperthyroidism
  -  Acute pericarditis
  -  History of failed electrical cardioversion at any time
  -  History of torsades des pointes
  -  History of familial long QT interval syndrome
  -  History of ventricular tachycardia requiring drug or device therapy
  -  History of NYHA Heart Failure Class 3 or 4.

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 of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Summary: Tumors of the central nervous system are potentially curable. For tumors of comparable histology and grade, resectability is the most important prognostic factor affecting survival particularly in children. However, the infiltrative nature of the malignant cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts toward total resection. The investigators propose to identify the borders of tumors intraoperatively using protoporphyrin fluorescence of the malignant cells and thereby provide more complete tumor resection.


Eligibility: Inclusion Criteria:
  -  patients must have clinically documented primary brain tumor for which resection is clinically indicated. Anticipated histology at resection should include:anaplastic astrocytoma, astrocytoma malignant NOS,brain stem glioma, ependymoma malignant, glioblastoma, glioblastoma multiforme, gliosarcoma, malignant oligodendroglioma, medulloblastoma, mixed astrocytoma-ependymoma
  -  prior therapy is not a consideration in protocol entry
  -  age unrestricted
  -  ECOG performance status<2(Karnofsky>60%,)
  -  life expectancy is not a consideration for protocol entry
  -  patients must have normal organ and marrow function as defined below:
  -  leukocytes _> 3,000/ml
  -  absolute neutrophil count _>1,500/ml
  -  platelets >_100,000/ml
  -  total bilirubin:within normal institutional limits
  -  AST (SGOT)/ALT (SGPT) _<2.5 X institutional upper limit of normal
  -  creatinine:within normal institutional limits or creatinine clearance >_60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal
  -  women of child-bearing potential and men must agree to use adequate contraception(hormonal or barrier method of birth control;abstinence) prior to study entry and for the duration of study participation.
  -  ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.
  Exclusion Criteria:
  -  prior therapy is not an exclusion criterion
  -  patients may not be receiving any other investigational agents history of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic adic (ALA)
  -  personal or family history of porphyrias
  -  uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  -  pregnant women are excluded, breastfeeding should be discontinued if mother is treated with aminolevulinic acid.

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: BI 811283 in Various Solid Tumours

Summary: The main objective of this trial is to provide safety data in terms of drug-related adverse events (AE) for the recommendation of the dose for further trials in the development of BI 811283.
  Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic profile of BI 811283.


Eligibility: Inclusion criteria:
  Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid tumours, who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options Secure central venous access Evaluable tumour deposits Recovery from reversible toxicities of prior anti-cancer therapies Age >= 18 years Life expectancy >= 6 months Written informed consent in accordance with International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP) and local legislation Eastern Cooperative Oncology Group performance score <= 2
  Exclusion criteria:
  Serious illness, concomitant non-oncological disease (e.g. active infectious disease), or ongoing toxicity of prior therapies considered by the investigator to potentially compromise patients' safety in this trial Pregnancy or breastfeeding Known brain metastases Second malignancy requiring therapy Left ventricular ejection fraction (LVEF) < 50% in echocardiography or clinical congestive heart failure New York Heart Association grade III - IV Myocardial infarction within the last 6 months prior to inclusion or symptomatic coronary artery disease Absolute neutrophil count less than 1500 / mm3 Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 mcmol / L, SI unit equivalent) Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) Serum creatinine greater than 1.5 mg / dl (> 132 mcmol / L, SI unit equivalent) Women and men who are sexually active and unwilling to use a medically acceptable method of contraception Treatment with other investigational drugs or in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial Patients unable to comply with the protocol Active alcohol or drug abuse

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: Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)

Summary: Oral phosphate purgative is the preferred bowel regimen on the basis of better tolerability, cost effectiveness, and efficacy. There are also numerous reports of patients with even previously normal renal function developing acute and chronic kidney disease after use of oral phosphate purgative. Several uncontrolled case reports and case series suggest a potential link between oral phosphate and acute kidney injury and/or chronic kidney disease1. Its use is contraindicated in patients with preexisting renal disease because of the risk for developing acute renal failure, so called acute phosphate nephropathy, or electrolyte disturbance. Since most of the outpatients who are going to undergo a colonoscopy are exposed to this agent, it is important to detect or prevent vulnerable patients. We would seek a sensitive and rapid diagnosis method of acute kidney injury following sodium phosphate bowel preparation. Within a few hours, NGAL mRNA is highly upregulated after kidney injury, such as renal ischemia-reperfusion and cisplatin nephropathy, NGAL induction precedes the elevation of classical markers for kidney damage such as serum creatinine. The investigators will investigate the change of NGAL following sodium phosphate bowel preparation.


Eligibility: Exclusion Criteria:
  -  Who takes ACE-inhibitor, ARB
  -  Has a renal or heart disease
  -  Has a serum electrolyte disturbance

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: Evaluation of Syncope,Its Diagnosis, Treatment, Outcome and Prognosis

Summary: The investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope.


Eligibility: Inclusion Criteria:
  -  All adult patients (age 18 or older) admitted with syncope or near-syncope
  Exclusion Criteria:
  -  Patients who do not speak/read the language of the consent form
  -  Prisoners
  -  Patients who are of altered mental status or had head trauma
  -  Refusal or inability to sign 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: Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)

Summary: The study implies a 2 step study design. Patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease group are enrolled. If >=2 objective responses (SD, PR, or CR) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if >=10 patients will respond. If <2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.


Eligibility: Inclusion Criteria:
  -  Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
  -  Brain metastases >=1 cm presenting or in progression following >=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
  -  Magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in T1 and T2 before and after gadolinium enhancement.
  -  Presence of al least one bidimensionally measurable and not previously irradiated metastasis.
  -  Age <=70 years.
  -  Performance status 0-2 (ECOG-WHO scale).
  -  Blood leukocytes >=3.5 x 10^9/L and platelets >=100 x 10^9/L.
  -  Bilirubin <=25 M/L.
  -  Seric transaminases <=2 x upper limit of normal values.
  -  Creatinine <=150 M/L, creatinine clearance >=60 mL/min.
  -  Signed written informed consent.
  Exclusion Criteria:
  -  Diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
  -  Previous whole brain irradiation.
  -  Brain metastases eligible to neurosurgery or stereotactic radiation therapy.
  -  Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
  -  Pregnant or nursing women.
  -  Acute infection requiring intravenous antibiotics.
  -  Severe vomiting or medical condition which could interfere with oral medication intake.
  -  Anticonvulsant chronic therapy.

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: [18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors

Summary: The purpose of this study is to help us understand gliomas, one type of brain tumor. This research protocol makes pictures of gliomas. We will take pictures of the glioma before and after treatment. The pictures are made with a positron emission tomography (PET) scanner. PET scans use radioactive markers to "see" cancer cells. We plan to use two different radioactive markers, [18F]FACBC and [18F]FLT, to "see" if the glioma responds to the treatment being recommended by the doctor. We are investigating whether one or both of these types of PET scans can help us to better understand gliomas and their response to treatment.
  We expect these pictures will give us information the your tumor and may help us to understand why the treatment that the patient is receiving is affecting the tumor the way that it is. We also hope to collect information about the amount of radioactivity exposure. We will measure radioactivity exposure to the tumor, brain and other organs.


Eligibility: Inclusion Criteria:
  -  Registered patient at MSKCC.
  -  Child-bearing age females must be non-pregnant,(documented by a negative pregnancy test within the last 2 weeks), non-lactating, and must be using adequate contraception or be surgically sterile.
  -  Patients with gliomas
  -  Patients planning to start anti-AKT and/or anti-VEGF directed therapies .
  -  Patients with measurable disease on MRI or CT neuroimaging.
  Exclusion Criteria:
  -  Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).
  -  Patient cannot tolerate lying still for a 60 minute session in the PET tomograph.

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: The Neuroprotective Effects of RPC on the Neurosurgery

Summary: The current study is designed to clarify the neuroprotective effect of remote ischemic precondtioning on the patients underwent neurosurgery.

Detailed description: BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after neurosurgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective neurosurgery, a randomized trial will be performed in current study.
  DESIGNING Thirty patients undergoing craniotomy for supratentorial meningioma will be randomize assigned to neurosurgery with RIPC or conventional neurosurgery (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points.
  EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury.
  CONCLUSIONS:
  In patients undergoing elective craniotomy for supratentorial meningioma, RIPC reduces the incidence of postoperative cerebral injury.

Eligibility: Inclusion Criteria:
  -  Patients referred for primary elective neurosurgery were invited to participate in the study at the time of scheduling for operation
  Exclusion Criteria:
  -  Potential participants were excluded if they were >70 years of age
  -  Required concomitant procedures other than neurosurgery
  -  Had experienced an acute coronary syndrome or myocardial infraction within 3 months
  -  Were unable to give informed consent
  -  Were taking sulfonylurea oral hypoglycemic agents or nicorandil drug therapy because these agents have been shown to effect preconditioning.

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 and Survival Estimates in Palliative Therapy

Summary: The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores.

Detailed description: -  At presentation a clinical survival estimate is obtained in each patient.
  -  Survival is also estimated using published prognostic scores in palliative care.
  -  Prognostic scores based on blood samples, general symptoms, complaints, and performance status are calculated and validated, respectively
  -  Each patient completes questionnaires on psychological distress
  -  Survival estimates are limited to 6 months.
  -  Each patient is followed for at least 6 months.

Eligibility: Inclusion Criteria:
  -  oncologic disease confirmed
  -  incurable locally advanced or metastatic disease
  -  palliative treatment intended
  -  age > 18
  -  able to understand the study protocol
  -  able to complete the forms with assistance if necessary
  Exclusion Criteria:
  -  therapy with curative intent
  -  regular clinical follow-up visit without disease progression
  -  ongoing therapy

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: Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This laboratory study is looking at tissue samples from patients with glioblastoma multiforme to identify biomarkers that may improve the selection of patients for epidermal growth factor receptor inhibitor therapies.

Detailed description: OBJECTIVES:
  Primary
  -  Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with erlotinib hydrochloride, temozolomide, and radiotherapy on clinical trial NCCTG-N0177.
  Secondary
  -  Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with gefitinib after radiotherapy on clinical trial NCCTG-N0074.
  OUTLINE: This is a multicenter study.
  Tissue samples from patients enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074 are analyzed by microarray analysis and immunohistochemistry for biological markers predicting progression-free survival and overall survival. Biological markers include epidermal growth factor expression, vIII mutant p53 gene, P-AKT, p7056k, S6, 4EBP1, STAT-3, PLC-g, Erk, ErbB2, ErbB3, ErbB4, platelet-derived growth factor receptor, IGF1R, interleukin-6, FADD, and MGMT.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.

Relevance to patient case: not relevant