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: DNA Analysis of Tumor Tissue Samples From Patients With Human Papilloma Virus-Associated Cancer of the Oropharynx

Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at the DNA in tumor tissue samples from patients with human papilloma virus-associated cancer of the oropharynx.

Detailed description: OBJECTIVES:
  -  Analyze PIK3CA expression and mutation and p110α amplification and expression in tumor tissue samples from patients with human papilloma virus positive (HPV+) and human papilloma virus negative (HPV-) squamous cell carcinoma (SCC) of the oropharynx.
  -  Determine proliferation and survival after PI3K inhibition in HPV(+) and HPV(-) oropharyngeal SCC cell lines and in HPV E6 and E7 expressing cells.
  -  Determine proliferation and survival after PI3K inhibition in short-term cultures of tumor tissue samples from patients with HPV(+) and HPV(-) primary SCC of the oropharynx.
  OUTLINE: Previously collected tumor tissue samples are analyzed for HPV DNA by PCR amplification and direct sequencing of PCR products; expression of E6 protein and relative expression of PIK3CA by qRT-PCR; amplification of PIK3CA by Southern blotting; mutation of PIK3CA; expression of p110α, phospho-AKT, total AKT, and FOXO1 by polyacrylamide gel electrophoresis (PAGE) and immunoblotting; and the effect of PI3K inhibition on cell cycle and apoptosis by flow cytometry. Pharmacological studies are performed on oropharyngeal squamous cell carcinoma cell lines and short-term cultures and HPV E6 and E7 expressing cells using LY 294002 in vitro to analyze response to PI3K inhibition. Results of response to PI3K inhibition will be correlated with HPV status, PIK3CA expression, amplification, and mutation, and p110α expression.
  PROJECTED ACCRUAL: A total of 20 HPV(+) and 20 HPV(-) tumor tissue specimens from patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Undergoing operative procedures for biopsy and/or resection of squamous cell carcinoma (SCC) of the oropharynx
  -  Tumor tissue sample available from the Head and Neck Tissue Repository and Clinical Database of Vanderbilt University
  -  No tumors with human papilloma virus (HPV) DNA sequences but no expression of E6
  PATIENT CHARACTERISTICS:
  -  See Disease Characteristics
  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: PTC299 for Treatment of Neurofibromatosis Type 2

Summary: Formation of new blood vessels (angiogenesis) is important for tumor growth in neurofibromatosis type 2 (NF2). It is known that tumors make a protein called vascular endothelial growth factor (VEGF) and there are higher levels of VEGF in the tumors and blood of many patients with NF2. VEGF stimulates the formation of blood vessels that supply the tumor with nutrients and oxygen. PTC299 is an oral drug that has been shown to decrease production of VEGF in animal models of human cancer. In these animal models, oral PTC299 administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood vessel numbers in the tumor, and significantly slows or halts tumor growth. Safety studies in research animals indicate good tolerability at doses and drug levels that are higher than those planned for the clinical studies. Results from Phase 1a studies in healthy volunteers indicate that PTC299 achieves levels of PTC299 in the bloodstream that are known to be active in animal models of human tumor. This Phase 2 study is designed to test the hypothesis that PTC299 will be tolerable and will show evidence of VEGF reduction, antitumor activity, and hearing improvement when administered orally to patients with NF2.

Detailed description: The study will be conducted in 2 stages. In Stage 1 of the study, 11 patients will receive daily treatment with PTC299 administered at 100 mg/dose twice per day for up to 1 year or until tumor progression. If no subject responds with tumor shrinkage or an improvement in hearing, then the study will be stopped. If ≥1 out of 11 subjects respond, then the study will proceed to Stage 2 to enroll an additional 14 subjects for a total of 25 subjects.

Eligibility: Inclusion Criteria:
  -  Age ≥18 years
  -  Diagnosis of NF2
  -  Presence of vestibular schwannomas
  -  Evidence of progressive increase in vestibular schwannoma size or worsening hearing loss due to vestibular schwannoma
  -  Adequate functional status (Karnofsky Performance Score ≥60)
  -  Adequate bone marrow, liver, kidney function
  -  If sexually active, willingness to use effective barrier or medical contraception
  -  For women of childbearing potential, no pregnancy or breast-feeding
  -  Discontinuation of other therapies (except corticosteroids) for the treatment of NF2 and resolution of any acute toxic effects of prior therapies
  -  Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions
  -  Willingness to provide informed consent
  Exclusion Criteria:
  -  Uncontrolled hypertension, major bleeding, HIV infection, or recent acute cardiovascular event
  -  Prior exposure to another anti-angiogenic therapy (eg, bevacizumab, sunitinib)

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: First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas

Summary: The purpose of this study is to determine whether multiple cutaneous neurofibromas in patients with neurofibromatosis type 1 can be removed with an erbium-YAG-laser.

Detailed description: With a prevalence of 1 in 3-5000 births, neurofibromatosis Type I is one of the most common genetic defects. The mode of inheritance is autosomal dominant and affects a gene (NF1), which is responsible for the production of the tumor suppressor protein neurofibromin. The consequence is an uninhibited expansion of neural tissue which leads amongst others to cosmetic disfigurement of the patients. In comparison to the plexiform neurofibromas the cutaneous tumors do not undergo malignant transformation.
  Excision and CO2 laser vaporisation were established as standard treatment but cause unattractive scars.
  In one operation more than 500 neurofibromas can be removed with an Erbium: YAG laser (2940 nm). The tumors are dissected by shooting holes into the skin and vaporising the neurofibromas in-between or underneath. Specimen are harvested after Er: YAG-, CO2 - and electrosurgical treatment to evaluate the difference of thermal necrosis histologically and photographs are taken to assess the cosmetic results.

Eligibility: Inclusion Criteria:
  -  Patients with multiple cutaneous neurofibromas with the request for tumor removal
  Exclusion Criteria:
  -  Pregnancy

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: Actigraphic Measurement of a Neurosurgical Procedure

Summary: The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Detailed description: Actigraphic measurements, repeated verbal fluency and multi-symptom operationally defined observations will be recorded for an 11 to 12 day baseline period and continued following neurosurgical tumor resection until a repeat MRI is completed three months after the procedure.

Eligibility: Inclusion Criteria:
  -  Diagnosis of incidental meningioma
  -  Single subject preparing to receive neurosurgical intervention
  Exclusion Criteria:
  -  Inability to wear actigraphy device

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 Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)

Summary: This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination with standard treatment in participants with advanced solid tumors to be conducted in conformance with Good Clinical Practices.
  Six different treatment regimens will be investigated in combination with robatumumab.
  The study will be divided into two parts. Part 1 will consist of initial safety evaluation and dose-finding of robatumumab in combination with each treatment regimen. Part 2 will consist of an expansion of each robatumumab regimen at a newly established dose level, to better define safety, tolerability, and initial efficacy in specific target populations.


Eligibility: Inclusion Criteria:
  -  Be willing and able to provide written informed consent for the study.
  -  Be ±18 years of age of either sex and of any race/ethnicity;
  -  Part 1: Have a histologically or cytologically confirmed advanced malignant solid tumor;
  -  Part 2: Have a histologically or cytologically confirmed, with measurable disease (as defined by Response Evaluation Criteria in Solid Tumors [RECIST]), advanced, malignant solid tumor.
  -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
  -  Have adequate organ function within 3 weeks prior to first study drug administration.
  Exclusion Criteria:
  -  Not have known treated or untreated leptomeningeal metastasis or a metastatic central nervous system lesion.
  -  Not have a history of another malignancy
  -  Not have received prior therapy with any anti-insulin-like growth factor receptor 1 (anti-IGF-1R) monoclonal antibody.
  -  Not have received radiation therapy within 2 weeks prior to first study drug administration.
  -  Not have received radiation therapy to >25% of his/her total bone marrow during his/her lifetime.
  -  Not have undergone major surgery within 3 weeks prior to first study drug administration.
  -  Not have known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy.
  -  Not have known active hepatitis B or C.
  -  Not have any serious or uncontrolled infection.
  -  Not have uncontrolled diabetes mellitus.
  -  Not have had any of the following within 6 months prior to first study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder.

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: Relationship of pAKT to Survival in Patients With Node-Positive Breast Cancer

Summary: This study will examine the relationship of a protein called pAKT to survival of breast cancer patients with one or more positive axillary lymph nodes. Akt plays a role in cell survival, tumor formation, and the development of drug resistance.
  The study will use tumor tissue obtained from 2,000 patients enrolled in a National Surgical Adjuvant Breast and Bowel Project study that is evaluating whether adding the drug paclitaxel (Taxol (Registered Trademark)) to a treatment regimen of doxorubicin (Adriamycin (Registered Trademark)) and cyclophosphamide (Cytoxan (Registered Trademark)) improves disease-free survival and overall survival in patients with node-positive breast cancer. The current study will measure levels of pAkt in the tissues and correlate the results with clinical outcome to see if pAkt levels are associated with improved patient survival.

Detailed description: Taxanes (paclitaxel and docetaxel) have emerged as the most powerful chemotherapeutics in breast cancer over the past decades. The B-28 clinical trial from the National Surgical Adjuvant Breast and Bowel Project (NSABP) assesses the efficacy of adding paclitaxel to the doxorubicin/cyclophosphamide regimen in the treatment of patients with axillary node positive breast cancer. The primary aim of B-28 is to determine whether four cycles of paclitaxel (Taxol (Registered Trademark)) (T) following four cycles of postoperative Doxorubicin (adriamycin (Registered Trademark) (A) and cyclophosphamide (C) will more effectively prolong disease-free survival (DFS) and survival (S) than four cycles of AC alone in patients with operable breast cancer who have one or more histologically positive axillary lymph nodes. The B-28 clinical trial tissue microarray consists of specimens from 2,000 cases enrolled. The tissue microarray set is an ideal platform for evaluating predictive markers of doxorubicin and/or paclitaxel response or resistance.
  Akt, a serine/threonine protein kinase regulated by the phosphatidylinositol 3-kinase (PI3K), is of importance in cell survival, tumorigenesis, and recently shown, chemoresistance. It confers survival advantage to cells by transducing signals from growth factor receptors that activate PI3K. The primary aim of this study is to evaluate whether the levels of phosphorylated AKT are associated with disease-free and overall survival in patients with node-positive breast cancer treated with AC and/or AC followed by paclitaxel.

Eligibility: -  INCLUSION CRITERIA
  The NSABP B-28 trial enrolled women from 1995 to 1998 with operable breast cancer with pathologically positive axillary lymph nodes.

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: Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients

Summary: Objectives: This study is looking at the level of vascular endothelial growth factor (VEGF) circulating in the blood stream of patients diagnosed with either a meningioma or a glioma. The questions that will be addressed include:
  1. Can VEGF level alert us to tumor progression or recurrence before MRI changes occur?
  2. Is the VEGF level an indicator of the response to treatment?
  3. Does the VEGF level correlate with tumor histology and behavior?
  4. Is there a relationship between VEGF level and outcome?


Eligibility: Inclusion Criteria:
  -  any patient presenting with glioma or meningioma
  Exclusion Criteria:
  -  a different type of brain tumor

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: Sugammadex Hypersensitivity Study (Study P06042)

Summary: This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period.
  In total 450 participants (all healthy subjects) were to be randomized to receive one of three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36, and Day 78 of the study in order to determine the safety of each treatment dose.

Detailed description: All subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was stable, and the investigator considered it safe for the subject to leave the study center. Four sites participated in this trial.

Eligibility: Inclusion Criteria:
  -  18-55 years of age
  -  Serum tryptase <=11.4 mcg/L and fasting triglyceride levels within normal limits
  -  Safety laboratory tests and vital signs must have been within normal limits
  -  Screening electrocardiogram must have been clinically acceptable and parameters within normal limits
  -  Body Mass Index between 19 and 32 kg/m^2
  -  Females must have agreed to use contraceptives
  -  Other certain administrative criteria as described in the protocol
  Exclusion Criteria:
  -  Females who were pregnant or intending to become pregnant
  -  Subjects who would not be able to participate optimally in the study, in the opinion of the investigator
  -  Certain surgical or medical conditions, recent infections, or mental instability
  -  Positive test for certain drugs or history of alcohol or drug abuse
  -  Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
  -  Blood donation in the past 60 days
  -  A history of unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia
  -  History of anaphylaxis from any cause, suspected history of hypersensitivity to cyclodextrins, or multiple drug hypersensitivities
  -  Heavy smoker
  -  Received certain medications in the past
  -  History of allergy, hypersensitivity, or intolerance to epinephrine at greater risk of developing adverse reactions after epinephrine administration
  -  Other certain administrative criteria as described in the protocol

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 SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)

Summary: Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.


Eligibility: Inclusion Criteria:
  -  Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.
  Exclusion Criteria:
  -  Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).

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: Fluorine F18-EF5 and Fludeoxyglucose F18 Positron Emission Tomography in Assessing Hypoxia and Glycolysis in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F18-EF5 to find oxygen and fludeoxyglucose F18 to find sugar in tumor cells may help in planning treatment for patients with non-small cell lung cancer.

Detailed description: PURPOSE: This clinical trial is studying fluorine F18-EF5 and fludeoxyglucose F18 positron emission tomography in assessing hypoxia and glycolysis in patients with stage I, stage II, or stage III non-small cell lung cancer.Detailed DescriptionOBJECTIVES:
  I. To determine whether there is an association between Akt activation and hypoxia as determine by 18F-EF5 PET scanning in patients with NSCLC.
  II. To determine whether there is an association between Akt activation and increased glycolysis as determined by 18F-FDG PET imaging in patients with NSCLC.
  OUTLINE: Within 6 weeks prior to surgery, patients undergo fluorine F18 (18F)-EF5 PET at 10 minutes and 90 minutes after injection of 18F-EF5. Patients also undergo fludeoxyglucose F18 (18F-FDG) PET at 1 hour and 3 hours after injection of 18FFDG.
  After completion of study treatment, patients are followed periodically for 5 years.

Eligibility: Inclusion Criteria:
  -  Subjects must have a histologically confirmed NSCLC or clinical and imaging evidence of a de novo mass that is likely to be a NSCLC, stage I, II, or IIIA, for which surgery would be indicated for routine medical indications
  -  ECOG performance status between 0 and 2
  -  Subjects must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
  -  WBC > 2,000/mm^3
  -  Platelet count > 100,000/mm^3
  -  Total bilirubin
  -  Serum AST and ALT
  -  Serum creatinine
  -  Negative serum pregnancy test if a female of childbearing age
  Exclusion Criteria:
  -  History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5
  -  Uncontrolled intercurrent illness that would limit compliance with study requirements
  -  Pregnant women and women who are breastfeeding are excluded
  -  Subjects who have been treated with neoadjuvant radiation or chemotherapy prior to their biopsy or excision are excluded because the impact of these therapies upon the degree of hypoxia of the tumor is unknown

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: K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

Summary: Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the mildest form of the disorder affects up to 15-20% of the population.
  In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE patients are treated once daily for 4 weeks. The population for this study is patients with mild to moderate SE.
  The primary endpoint for this study is the efficacy of K301 compared to placebo which was based on the sum score for erythema and desquamation after 4 weeks of daily application. Secondary endpoints are to evaluate safety and tolerability as well as efficacy.


Eligibility: Inclusion Criteria:
  -  Male or female (including fertile women)
  -  18-70 years of age
  -  Seborrhoeic eczema of the scalp for at least 2 months
  -  Presenting erythema and desquamation of mild to moderate intensity
  -  Signed written informed consent
  Exclusion Criteria:
  -  Seborrhoeic eczema or any other cutaneous disease of the face or scalp requiring a specific topical treatment (corticosteroids, antifungals, selenium sulphide, antibiotics, retinoids, benzoyl peroxide or a-hydroxyacids) during the previous 15 days
  -  Oral treatment with cyclines, lithium, antifungals or inhaled corticosteroids during the previous month
  -  Use of systemic corticosteroids and retinoids during the previous 2 months
  -  Seborrhoeic eczema associated with Parkinson's disease or HIV infection
  -  Current or any history of ear, nose, and throat carcinoma
  -  Current or any history of severe concomitant disease according to Investigator's judgement
  -  Allergy to any of the tested treatment components
  -  Subject who has been previously enrolled in the phase II study K40-3 investigating Kaprolac® K40

Relevance to patient case: not relevant