araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Dietary Choice in Active Older Adult Women

Summary: The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.

Detailed description: Background: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method.
  Objectives: The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.
  Material and Methods: Participants included sedentary women (age 45-75 years) with overweight or obesity (n=111). They were randomly divided into two groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 111 participants, 90 persons completed the treatment. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility: Inclusion Criteria:
  Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study.
  Exclusion Criteria:
  History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Summary: Phase 1 will assess safety and tolerability of TPX-0005 via a standard dose escalation scheme, and determine the recommended phase 2 dose.
  Phase 2 will assess safety and efficacy of TPX-0005.


Eligibility: Key Inclusion Criteria:
  1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor (including non-Hodgkin Lymphoma) (Stage IV, AJCC v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.
  2. ECOG PS 0-1.
  3. Age ≥18 (or age ≥ 20 of age as required by local regulation).
  4. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.
  5. Prior cytotoxic chemotherapy is allowed.
  6. Prior immunotherapy is allowed.
  7. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
  8. Patients with asymptomatic CNS involvement are allowed.
  9. Life expectancy ≥ 3 months.
  Key Exclusion Criteria:
  1. Concurrent participation in another therapeutic clinical trial.
  2. Symptomatic CNS involvement.
  3. Any of the following cardiovascular history in the past 6 months: myocardial infarction, unstable angina, coronary/ peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for anti-arrhythmic medication.
  4. History of prolonged QTc interval.
  5. Known active infections (bacterial, fungal, viral including HIV positivity).
  6. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
  7. Peripheral neuropathy ≥ Grade 2.
  8. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis. Patients with a history of prior radiation pneumonitis are not excluded.

Relevance to patient case: possibly relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid.

Summary: As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery.
  Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery for diagnosis of a benign lesion.
  The aim of this study is to see whether shear-wave elastography, a new ultrasound technology can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients will not need surgery for the diagnosis of a benign lesion.
  The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound technology (shear-wave elastography - SWE) for the diagnosis of malignancy in follicular lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and are scheduled for thyroid surgery will be eligible to participate. All participants will undergo a detailed ultrasound examination prior to their surgery. The results of the ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy of SWE.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with a Follicular Neoplasm on fine needle aspiration biopsy
  -  Patients >18 years of age
  Exclusion Criteria

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Metabolic Abnormalities in Children With Epilepsy

Summary: This study is designed to use positron emission tomography to measure brain energy use. Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.
  When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also.
  Researchers can label a sugar with a small radioactive molecule called FDG (fluorodeoxyglucose). As areas of the brain use more sugar the PET scan will detect the FDG and show the areas of the brain that are active. By using this technique researchers hope to answer the following questions;
  4. Are changes in brain energy use (metabolism) present early in the course of epilepsy
  5. Do changes in brain metabolism match the severity of patient's seizures
  6. Do changes in metabolism occur over time or in response to drug therapy

Detailed description: We propose to study children with recent onset partial epilepsy, cryptogenic infantile spasms, and idiopathic Lennox-Gastaut Syndrome with serial FDG-PET to elucidate the natural history and evolution of metabolic abnormalities associated with such epilepsies. The severity of the seizure disorder, and cognitive impairment, when present, will be correlated with the presence and extent of focal and global cerebral metabolic abnormalities.

Eligibility: INCLUSION CRITERIA:
  Patients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected.
  EXCLUSION CRITERIA:
  Evidence of a structural lesion as cause for epilepsy.
  Degenerative or metabolic disease.
  Inability to comply with the protocol.

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

Summary: RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors.
  PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.

Detailed description: OBJECTIVES:
  -  Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
  -  Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients.
  OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor location (posterior fossa tumors vs all other brain tumors).
  Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3 hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection.
  Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are treated at the MTD.
  Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
  PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of supratentorial or infratentorial brain tumor
  -  Localized, non-disseminated
  -  Primary tumor or solitary metastasis
  -  Recurrent or progressive
  -  Unresectable
  -  Negative CSF
  -  Must have failed standard therapy including radiotherapy
  -  Measurable disease as evidenced by CT scan or MRI
  -  Single or multiple masses accessible to light administration
  PATIENT CHARACTERISTICS:
  Age:
  -  3 to 70
  Performance status:
  -  Not specified
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  Absolute neutrophil count at least 1,000/mm3
  -  May transfuse platelets
  Hepatic:
  -  PT and PTT normal
  Renal:
  -  Not specified
  Other:
  -  Not pregnant
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  At least 6 weeks since prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  -  No prior brachytherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other concurrent antitumor therapy

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Combination Chemotherapy for Patients With Brain Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent.

Detailed description: OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and topotecan (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine survival in these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor p53 expression in relation to response to TAX/TOPO/G-CSF.
  OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2 courses and until 2 courses beyond maximum response. Patients are followed every 3 months for 2 years, then every 6 months for relapse and survival.
  PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the first 20 patients.

Eligibility: DISEASE CHARACTERISTICS: Biopsy proven glioblastoma multiforme or anaplastic astrocytoma Central pathologic review at Dartmouth-Hitchcock Medical Center, including assay for tumor p53 expression No anaplastic oligodendroglioma No mixed oligodendroastrocytoma Recurrent or progressive disease following radiotherapy documented by CT or MRI within 2 weeks of entry
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 3,000 ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.0 mg/dL AST/ALT no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No documented sensitivity to E. coli-derived products No major medical or psychiatric illness that would interfere with therapy or compliance with scheduled follow-up No pregnant or nursing women Adequate contraception required of fertile patients
  PRIOR CONCURRENT THERAPY: No prior taxanes or topoisomerase I inhibitors At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) At least 4 weeks since radiotherapy

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Vinorelbine in Treating Children With Recurrent or Refractory Cancers

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.

Detailed description: OBJECTIVES: I. Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. II. Assess the toxic effects of this drug in these children.
  OUTLINE: Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6. Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
  PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory solid malignant tumors of childhood including: Soft tissue sarcoma Rhabdomyosarcoma Nonrhabdomyosarcoma Extraosseous Ewing's sarcoma CNS tumors Astrocytoma Primitive neuroectodermal tumor Atypical teratoid/rhabdoid tumors Ependymoma Recurrent neuroblastoma Measurable disease No more than 2 prior treatment regimens
  PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: For patients with solid tumors (unless marrow involvement): Absolute neutrophil count (ANC) at least 1000/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) For patients post bone marrow transplantation: ANC at least 1,000/mm3 Platelet count at least 50,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) Hepatic: Total bilirubin no greater than 1.5 times normal SGOT/SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: Seizure disorder allowed if well controlled CNS toxicity no greater than grade 2
  PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior bone marrow transplantation No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for increased intracranial pressure due to CNS tumors Radiotherapy: At least 6 months since prior radiotherapy to craniospinal axis, spine, and/or more than 50% of the bony pelvis Concurrent radiotherapy to localized painful lesions allowed if at least one measurable lesion is not in radiation field Surgery: Not specified Other: No concurrent participation in another CCG, POG, or COG therapeutic study

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms

Summary: OBJECTIVES:
  I. Assess the clinical response of patients with refractory or recurrent brain neoplasms treated with carmustine, streptozocin, and mercaptopurine.

Detailed description: PROTOCOL OUTLINE:
  Patients receive mercaptopurine IV on days 1-3, carmustine by continuous infusion on days 3-5, and streptozocin IV over 20 minutes on days 2-5. Patients receive treatment every 42 days, for up to 4 courses.
  Completion date provided represents the completion date of the grant per OOPD records

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics-- Histologically proven refractory or recurrent brain neoplasms Glioblastoma multiforme Anaplastic astrocytoma Gliosarcoma Anaplastic oligodendroglioma Mixed anaplastic glioma Unequivocally progressive primary brainstem tumors following primary therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosoureas or mitomycin Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed --Patient Characteristics-- Age: Not specified Performance status: ECOG 0-2 Karnofsky 60-100% Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4 times normal Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: FEV1 greater than 1 L if symptomatic pulmonary disease present Other: No other concurrent malignancies Not pregnant or lactating Negative pregnancy test Fertile patients must use effective contraception

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Magnetic Resonance Imaging in Treating Children With Progressive Low-Grade Astrocytoma

Summary: RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability to determine the growth rate of progressive astrocytoma.
  PURPOSE: Phase II trial to study the effectiveness of magnetic resonance imaging in treating children who have progressive low-grade astrocytoma.

Detailed description: OBJECTIVES: I. Determine if tumor growth rate can be decreased by targeting areas of increased choline activity, as measured by magnetic resonance spectroscopic imaging, in pediatric patients with progressive low grade astrocytoma treated with surgical resection and/or focal radiotherapy. II. Improve the quality of life without use of aggressive surgery or radiotherapy in this patient population.
  OUTLINE: Patients undergo magnetic resonance spectroscopic imaging (MRSI) over 60 minutes prior to surgery and/or radiotherapy. Patients are assigned to one of two treatment arms based on tumor accessibility and may crossover to either arm. Arm I: Patients undergo conventional surgery. Arm II: Patients with inaccessible tumors undergo focal radiotherapy. Following surgery and/or radiotherapy, patients are followed every 4 months for up to 2 years with MRSI or MRI for tumor response and growth.
  PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study over 2 years.

Eligibility: DISEASE CHARACTERISTICS: Diagnosis of low grade astrocytoma in the hypothalamus, brain stem, or thalamus of 5 cm on T2 weighted scans Incomplete surgical resection Previously treated with evidence of tumor progression No hemispheric or cerebellar masses
  PATIENT CHARACTERISTICS: Age: 12 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
  PRIOR CONCURRENT THERAPY: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Computer Assisted Instruction Weight Management for Low Literacy Populations

Summary: To develop and evaluate a computer assisted instruction (CAI) weight management program in an adult population with low literacy at Sheehan Memorial Hospital's Family Care Center (FCC), an outpatient clinic serving the inner city of Buffalo, New York.

Detailed description: BACKGROUND:
  This was the first study in patient care informatics in which nutrient analysis methodology was used on a day-to-day basis to motivate low literate individuals to improve their food choice behavior and physical activity. The deliverables of this investigation included revised and enhanced software, professional documentation, and a participant workbook. These materials were designed so that they could be integrated into any risk factor reduction program for low literacy populations.
  DESIGN NARRATIVE:
  The CAI featured voice recognition, giant cursor movement, and a graphics-based environment using pictures to facilitate an exceptionally easy to use and understand software program and booklet. The voice recognition technology was linked with compact disk read only memory (CD ROM) to visually display food choices and physical activities for ease of recording data by the individual. The software was formatted so that health professionals could select preference levels which corresponded to the motivational level of the individual. The four-session CAI intervention had two planned maintenance sessions. The output was personalized and in color. It was designed to identify problematic foods in the diet, improve food selections, and increase physical activity. Stars were printed for adherence to individual goals.
  One hundred and fifty (150) men and 150 women, between age 20 and age 44, with a reading level of 8th grade or less, who were between 20 percent and 40 percent over their ideal body weight, were randomly assigned to three groups. The design compared a control group without the intervention, a group experiencing the CAI intervention and hands-on computer use, and a group experiencing the intervention but not the CAI component or computer use. All groups were pretested, posttested, and follow-up tested at six months and twelve months following baseline. The primary outcome measures were weight loss, nutrient intake, and physical activity. Data were analyzed using a two-way analysis of covariance and appropriate t-tests.
  The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility: No eligibility criteria

Relevance to patient case: not relevant