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: Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)

Summary: Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Histologic confirmation of non-small-cell lung cancer
  -  Stable systemic disease
  -  Maximum of one prior chemotherapy regimen for metastatic systemic disease
  -  Radiotherapy for local control or palliative bony lesions is allowed
  -  Karnofsky of greater than or equal to 70%
  -  Adequate hematologic, renal and liver function
  Exclusion Criteria:
  -  Patients eligible for surgery of the brain
  -  Any previous chemotherapy for the brain metastasis
  -  Chemotherapy within 4 weeks or previous temozolomide
  -  Prior radiotherapy to the brain
  -  Radiation therapy to greater than 50% of the bone marrow
  -  Insufficient recovery from previous therapies
  -  Active nonmalignant systemic disease
  -  Inability to take oral medication
  -  Pregnant or nursing women
  -  Non use of adequate contraceptive techniques, negative urine pregnancy test is required
  -  Known AIDS related illness

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: School- and Home-Based Early Intervention for Toddlers With Autism

Summary: This study will determine the impact of early intervention on the communication and social development of toddlers with autism.

Detailed description: Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism.
  Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.

Eligibility: Inclusion Criteria:
  -  Diagnosis of autism spectrum disorder
  -  Parent or guardian willing to give informed consent for child's participation
  -  Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales
  -  English is primary language for child and family
  Exclusion Criteria:
  -  Evidence of vision or hearing impairment
  -  Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella
  -  History of severe birth trauma or traumatic brain injury
  -  Siblings with autism spectrum 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: Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

Summary: The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility: Inclusion criteria:
  -  Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
  -  ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
  -  Bone marrow function: - ANC greater than 1500/mm3.
  -  Platelet count greater than or equal to 100,000/mm3.
  -  Hemoglobin greater than 9 g/dL.
  -  Renal function: - Calculated creatinine clearance greater than or equal to 50 mL.min.
  -  Total bilirubin greater than 1.5 mg/dL.
  -  AST/ALT less than 2.5 X upper limit of normal.
  Exclusion criteria:
  -  Females who are pregnant or nursing.
  -  Pre-existing hemolytic anemia.
  -  Pre-existing peripheral neuropathy greater than or equal grade 2.
  -  Known deficiency in dihydropyrimidine dehydrogenase (DSD).

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 Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Summary: This study will evaluate the efficacy and safety of everolimus treatment of patients with advanced NSCLC. The rationale for investigating everolimus in advanced NSCLC previously treated with chemotherapy or chemotherapy plus EGFR inhibitors, like gefitinib or erlotinib, is based on following:
  -  The medical need for the better therapy for advanced NSCLC and limited efficacy of the currently available therapy in advanced NSCLC.
  -  Postulated association of relevant cell-signaling pathways targeted by everolimus with different aspects of oncogenesis, disease progression, and response/resistance to treatment.
  -  Effectiveness of everolimus and rapamycin in preclinical models of lung cancer
  -  Early reports of clinical responses to monotherapy with mTOR inhibitors in advanced NSCLC.
  There is evidence that an enhanced PI3K/Akt/mTOR pathway, which is inhibited by everolimus, may be one of the key changes accounting for different aspects of oncogenesis, disease progression, and response/resistance to NSCLC cancer treatment. The use of the mTOR inhibitor everolimus in treatment of advanced NSCLC would be a novel therapeutic approach that proposes to logically manipulate the cell's regulatory pathways to enable control of tumor growth.


Eligibility: Inclusion Criteria:
  -  Patients with advanced (unresectable or metastatic) NSCLC
  -  Tissue sample of the metastatic or primary tumor available for pathology evaluation and molecular marker analyses
  -  Patients who have received ≤ 2 chemotherapy regimens, one of which must have included cisplatinum or carboplatin, and who have documented evidence of tumor progression (Arm 1)
  -  Patients who have received ≤ 2 chemotherapy regimens, one of which must have included cisplatinum or carboplatin as well as a small molecule EGFR inhibitor (as a separate regimen) with documented tumor progression despite at least 4 weeks therapy with either gefitinib or erlotinib (Arm 2)
  Exclusion Criteria:
  -  Concurrent therapy with agents used otherwise as anticancer therapy (for example, methotrexate for rheumatoid arthritis)
  -  Any investigational drug, other than EGFR inhibitor (Arm 2), within the preceding 4 weeks
  -  Chronic treatment with steroids or another immunosuppressive agent
  -  Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  Other protocol-defined inclusion/exclusion criteria may apply

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: SB-743921 In Patients With Solid Tumors

Summary: The purpose of this study is to find a dose of SB-743921 in adult patients with solid tumors or lymphoma who have progressed on standard therapy or who have relapsed. SB-743921 is dosed by 1-hour intravenous infusion every 3 weeks. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of the drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with SB-743921. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility: Inclusion criteria:
  -  Histologically or cytologically confirmed diagnosis of: a) Advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy; OR b) B-cell or T-cell lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate) AND/OR for which salvage chemotherapy, radiotherapy, or bone marrow transplantation is not indicated or has been refused by the patient.
  -  ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
  Exclusion criteria:
  -  Pre-existing hemolytic anemia.
  -  Pre-existing peripheral neuropathy greater than or equal grade 2.
  -  Absolute neutrophil count less than 1,500/mm3.
  -  Platelets less than 100,000/mm3.
  -  Hemoglobin less than 9 g/dL.
  -  Total bilirubin greater than1.5 mg/dL.
  -  AST/ALT greater than 2.5 X upper limit of normal.
  -  Creatinine clearance less than or equal to 60 mL/min.

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: Ispinesib In Combination With Carboplatin In Patients With Solid Tumors

Summary: The purpose of this study is to determine the dose regimen of Ispinesib in combination with carboplatin in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion and carboplatin is dosed by 30 minute intravenous infusion every 3 weeks (on the same day). A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility: Inclusion criteria:
  -  Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
  -  ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
  Exclusion criteria:
  -  Females who are pregnant or nursing.
  -  Pre-existing hemolytic anemia.
  -  Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens.
  -  Absolute neutrophil count less than 1,500/mm3.
  -  Platelets less than 100,000/mm3.
  -  Hemoglobin less than 9 g/dL.
  -  Total bilirubin greater than1.5 mg/dL.
  -  AST/ALT greater than 2.5 X upper limit of normal.
  -  Creatinine clearance less than or equal to 50 mL/min (calculated by the Cockcroft Gault Formula).
  -  Known contra-indications to the use of carboplatin, cisplatin, or other platinum-containing compounds.

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: SB-715992 In Combination With Docetaxel In Patients With Solid Tumors

Summary: The purpose of this study is to determine the dose regimen of SB-715992 in combination with docetaxel in patients with solid tumors. SB-715992 and docetaxel were dosed by 1-hour intravenous infusion every 3 weeks (on the same day). A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with SB-715992. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility: Inclusion criteria:
  -  Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
  -  ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
  Exclusion criteria:
  -  Females who are pregnant or nursing.
  -  Pre-existing hemolytic anemia.
  -  Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens.
  -  Absolute neutrophil count less than 1,500/mm3.
  -  Platelets less than 100,000/mm3.
  -  Hemoglobin less than 9 g/dL.
  -  Total bilirubin greater than1.5 mg/dL.
  -  AST/ALT greater than 2.5 X upper limit of normal.
  -  Creatinine clearance less than or equal to 60 mL/min (calculated by the Cockcroft Gault Formula).
  -  Known contraindications to the use of docetaxel or to other drugs formulated with polysorbate 80.

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: Analysis of Tissues From Patients in Trial of Myo-Inositol to Prevent Lung Cancer

Summary: This study will examine tissue specimens from patients participating in a trial of high-dose myo-inositol to prevent lung cancer. The trial, conducted at the British Columbia Cancer Agency-Vancouver Cancer Center (BCCA-VCC), includes people who have pre-cancerous changes in the air passages of their lungs.
  The BCCA-VCC trial was designed to determine side effects of taking large amounts of the food supplement myo-inositol for longer than a month and if the supplement can help smokers stop smoking.
  The current study will look at the levels of a substance called Akt in tissue samples obtained from air passages of subjects in the BCCA-VCC trial. Akt is activated by tobacco components and can be found in lung tumor specimens and pre-cancerous lesions. Myo-inositol may affect Akt levels and help prevent progression of pre-cancerous lesions to cancer.
  People participating in the BCCA-VCC phase 1 myo-inositol trial are eligible for this study. Tissue samples obtained from air passages of these patients during their participation in that study will be sent to the National Cancer Institute for analysis of Akt levels.

Detailed description: Human transbronchial biopsy specimens collected under protocol study numbers CDR0000302633; BCCA-U98-0411; BCCA-C02-0298 will be immunohistochemically stained for activated Akt using phospho-specific antibodies. These samples are part of a phase I chemoprevention trial of myo-inositol being conducted in Vancouver, BC by the British Columbia Cancer Agency in collaboration with the National Cancer Institute (NCI). The transbronchial specimens will be sent to the NCI for analysis of activated AKT. The study aims to determine whether myo-inositol, a putative inhibitor of the upstream kinase phosphatidylinositol 3-kinase, can alter activated Akt levels in smokers with bronchial dysplasia.

Eligibility: -  INCLUSION CRITERIA:
  Any patients entered into phase 1 myo-inositol trial are eligible for inclusion, provided that they have consented to tissue analysis in the original consent form.
  EXCLUSION CRITERIA:
  None anticipated at this time.

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 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)

Summary: This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.


Eligibility: Inclusion Criteria:
  -  Participants must be at least 18 years of age.
  -  Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head & neck (H&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC).
  -  Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
  -  Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H&N and esophageal cancer.
  -  Participants must have at least one measurable lesion.
  -  Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  -  Participants must have adequate hematologic, renal, and liver functions.
  -  Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
  -  Participants of childbearing potential must agree to use a medically accepted method of contraception.
  Exclusion Criteria:
  -  Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
  -  Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
  -  Participants who received prior temozolomide or dacarbazine treatment

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: Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693

Summary: This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies or for which there is no approved therapy
  -  Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
  Exclusion Criteria:
  -  Prior anti-cancer therapy within the prior 28 days.
  -  History of diabetes.
  -  Coronary artery disease/myocardial infarction, acute coronary syndromes within the past 6 months.
  -  Use of theophylline and warfarin within 14 days prior to the first dose of study drug.
  -  Current use of oral corticosteroids (note: Inhaled corticosteroids are permitted.)
  -  Participation in an investigational study within the prior 28 days.
  -  Pregnant or breast-feeding.

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 Induction of IL-6 by NF-kB in PBMC in OSA

Summary: Aim of study:
  1. To compare the level of IL-6 mRNA expression in peripheral blood monocytes between normal subjects and patients with OSAS
  2. To compare the activation of NF-B in peripheral blood monocytes between control subjects and patients with OSAS; Check the correlation between level of L-6 mRNA expression and activation of NF-kB
  3. To determine the effect of CPAP on the activation of NF-kB and IL-6 in peripheral blood monocytes in patients with moderate –severe OSAS

Detailed description: Obstructive sleep apnea syndrome (OSAS) has emerged in recent years as an important risk factor for cardiovascular morbidity. The mechanisms responsible for developments of cardiovascular sequelae in patients with OSA include hypoxia, hypercapnia, exaggerated negative intrathoracic pressure and bursts of sympathetic activity provoking surges in blood pressure and heart rate. Meanwhile, increase of inflammatory mediators, which included C-reactive protein (CRP), oxidative stress, adhesion molecules, vascular endothelial growth factor (VEGF) and proinflammatory cytokines (interleukin (IL) -1, IL-2, IL-6, IL-8, IL-10 and tumor necrotic factor- (TNF-)), also involve in the development of cardiovascular disease in patients with OSAS.
  According to our preliminary study, serum levels of IL-6 and CRP were higher in patients with OSAS than control subjects and levels of both IL-6 and CRP were highly correlated with the lowest pulse oxygen saturation. Hypoxia triggered the production of IL-6 through the induction of NFB, which was demonstrated in ischemic heart disease and pancreatitis. However, this mechanism has not been prooved in OSAS.
  Therefore, we conduct this study to prove our hypothesis (1) The mRNA expression of IL-6 in peripheral blood monocytes was significantly higher in patients with OSAS than control subjects (2) The activation of NF-k B in peripheral blood monocytes was more significant in patients with OSAS than control subjects, and the level of NF- kB activation is associated with the level of IL-6 mRNA expression (3) CPAP therapy could lower both the activation of NF-kB and IL-6 mRNA expression in patients with moderate-severe OSAS.

Eligibility: Inclusion Criteria:
  -  severe obstructive sleep apnea (AHI>=30 /hr) male older than 18 y/o
  Exclusion Criteria:
  -  refuse participate, chronic lung disease active infection neurologic event

Relevance to patient case: not relevant