araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)

Summary: Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism. The investigators will conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. Sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).


Eligibility: Inclusion Criteria:
  -  Age 8 to 17 years
  -  Body mass index equal to or greater than 95th percentile for age and sex
  -  Presence of prediabetes, as defined by American Diabetes Association Guidelines (fasting blood glucose of 100-125 mg/dl and/or A1C blood test measure of 5.7-6.4%)
  -  Subject and parent/guardian understands the study protocol and agrees to comply with it
  -  Informed Consent Form signed by the parent/guardian and assent signed by the subject
  Exclusion Criteria:
  -  Subjects using vitamin supplements containing vitamin k
  -  Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
  -  Subjects presenting chronic degenerative and/or inflammatory diseases
  -  Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
  -  Subjects receiving corticosteroid treatment
  -  Subjects using oral anticoagulants
  -  Subjects with a history of soy allergy
  -  Subjects who have participated in a clinical study more recently than one month before the current study

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

Summary: The purpose of this study is to determine wether D3 lymph node dissection gives superior oncological outcomes compared to standard D2 lymph node dissection in colon cancer

Detailed description: The design involves random allocation of eligible patients to D3 or D2 lymph node dissection group in 1:1 ratio. The extent of colonic resection itself is not influenced by the randomization and is predefined by the investigator prior to randomization.
  Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience with evaluation of non-editted video-recordings of procedures.
  Routine quality control includes requirement to photograph vessels with the clip to determine the extent of lymph node dissection performed and a thorough morphological assessment of the specimen.
  After surgery patients are treated according to local standards with no difference wether D2 or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered as per protocol.
  This is a superiority trial evaluating statistical superiority. With the 50% five year survival according to national registry for colon cancer, expecting 10% improvement in survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual period followed by 5 year follow up is required for a power of 80%.
  The intent-to-treat principle is used for the data analysis.

Eligibility: Inclusion Criteria:
  -  histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
  -  clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
  -  indications for surgical colonic resection
  -  ECOG status 0-2
  -  At least 18 years of age
  -  Written informed consent
  Exclusion Criteria:
  -  Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
  -  Pregnancy or breast feeding
  -  Medical contraindications for surgical treatment
  -  Synchronous malignancy
  -  Non-resectable distant metastases
  -  Colon obstruction, perforation or bleeding complicating the tumor
  -  Indications for isolated transverse colon resection
  -  Neoadjuvant chemotherapy

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

Summary: The purpose of the study is to determine if probiotic bacteria have a beneficial effect on the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.


Eligibility: Inclusion Criteria:
  -  At least one malignant tumor in the colon
  Exclusion Criteria:
  -  Study subjects with adenomas, or
  -  who received recent antibiotic therapy or
  -  consumed probiotics regularly were excluded.

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: 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: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas

Summary: RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
  PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas.

Detailed description: OBJECTIVES:
  -  Evaluate the efficacy of recombinant interferon alpha (IFN alpha) as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas.
  -  Determine the nature and extent of central nervous system (CNS) toxicities associated with the use of alpha interferon in current doses and schedules.
  OUTLINE: This is a two arm, randomized study. The first arm includes all histologically benign meningiomas. The second arm includes all other pathologies.
  All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8 weeks. Treatment continues without interruption as long as there is no tumor recurrence or progression and toxicity is acceptable.
  Treatment continues without dose adjustment for the first 8 weeks as long as there are no toxic effects of grade III or greater. Dosage for subsequent courses is one dose level below the dose that produced toxicity of grade III or greater.
  PROJECTED ACCRUAL: 20 patients will be entered per year into each arm.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven tumors:
  -  Unresectable meningioma
  -  Atypical meningioma
  -  Malignant meningioma
  -  Angioblastic meningioma
  -  Hemangiopericytoma
  -  Recurrent or progressive, unresectable tumor after failing radiation therapy or refused radiation therapy following 2 surgeries
  PATIENT CHARACTERISTICS:
  Age:
  -  16 and over
  Performance status:
  -  Karnofsky at least 60%
  Life expectancy:
  -  At least 3 months
  Hematopoietic:
  -  AGC at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  SGPT less than 2.0 times normal
  -  Alkaline phosphatase less than 2.0 times normal
  -  Bilirubin less than 1.5 mg/dL
  Renal:
  -  BUN less than 1.5 times normal OR
  -  Creatinine less than 1.5 times normal
  Other:
  -  No active infection
  -  No diseases that obscure toxicity or dangerously alter drug metabolism
  -  No serious intercurrent medical illness
  -  Not pregnant
  -  Fertile patients must use adequate contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent biologic therapy
  Chemotherapy:
  -  Prior chemotherapy allowed and recovered from all myelotoxicity secondary to the therapy
  Endocrine therapy:
  -  Prior hormonal therapy allowed
  -  No concurrent hormonal therapy
  Radiotherapy:
  -  Prior radiotherapy allowed
  Surgery:
  -  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: S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

Summary: RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.

Detailed description: OBJECTIVES:
  -  Determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea.
  -  Assess the quantitative and qualitative toxic effects of this drug in this patient population.
  OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity.
  Patients are followed at 3 months, 6 months, and then every 6 months for 3 years.
  PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed unresectable primary, recurrent, or residual benign meningioma
  -  Measurable disease by CT scan or MRI
  -  Must have disease progression within the past 10 years OR progressive neurologic deficit within the past 6 months
  -  Must have undergone prior radiotherapy with subsequent disease progression OR refused radiotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  SWOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC at least 4,000/mm^3
  -  Platelet count at least lower limit of normal
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior cytotoxic chemotherapy for meningioma
  -  Prior mifepristone allowed
  -  No other concurrent chemotherapy
  Endocrine therapy:
  -  Concurrent glucocorticoids and hormone replacement therapy allowed if stable dose maintained for at least 72 hours prior to CT scan or MRI
  -  No concurrent antitumor hormonal therapy
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 6 months since prior radiotherapy
  -  No concurrent radiotherapy
  Surgery:
  -  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: S9903: Whole Brain Radiotherapy Followed By Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic radiosurgery may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by stereotactic radiosurgery in treating patients who have brain metastases from malignant melanoma.

Detailed description: OBJECTIVES: I. Estimate the 6 month intracranial progression rate and 6 month overall survival rate in patients with limited brain metastases from malignant melanoma undergoing whole brain radiotherapy followed by stereotactic radiosurgery boost. II. Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
  OUTLINE: Patients undergo whole brain radiotherapy 5 days a week for 3 weeks, followed 3-5 weeks later by stereotactic radiosurgery. Patients are followed every 3 months until death.
  PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven malignant melanoma at primary or any metastatic site Bidimensionally measurable disease by MRI scan Must have 1-6 enhancing brain metastases If at least 2 lesions are present, only 1 lesion may be greater than 3 cm in maximum diameter
  PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier or immunotherapy Chemotherapy: No concurrent chemotherapy with whole brain radiotherapy Prior systemic chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior stereotactic or conventional radiotherapy to any field of the brain Surgery: Prior surgical resection of brain metastases allowed (provided 1 or 2 measurable brain metastases remain)

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: NF2 Natural History Consortium

Summary: OBJECTIVES:
  I. Define the growth rates and clinical course of NF2-related tumors in patients with neurofibromatosis type 2. Associate growth rate with physical function.

Detailed description: PROTOCOL OUTLINE: Data on the clinical course and growth rate of NF2-related tumors in patients with neurofibromatosis 2. Patients are evaluated each year on a cranial and a spinal MRI, eye tests, hearing tests, quality of life, neurological tests, and physical functioning.

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics--
  -  Diagnosed with neurofibromatosis 2 on or after 01/01/93
  -  Must meet one of the following conditions:
  Bilateral vestibular schwannoma OR Family history of neurofibromatosis 2 (first degree family relative) AND Unilateral vestibular schwannoma at under 30 years OR Any 2 of the following: Meningioma Glioma Schwannoma Juvenile posterior subcapsular lenticular opacity/juvenile cortical cataract
  -  No plans to treat vestibular schwannoma in next 12 months
  --Prior/Concurrent Therapy--
  -  Not specified
  --Patient Characteristics--
  -  Age: 5 and over

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: 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: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

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 hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.

Detailed description: OBJECTIVES:
  -  Determine complete, partial, or stable response to hydroxyurea in patients with recurrent and/or nonresectable meningioma.
  -  Determine response at 2 years to this regimen in these patients.
  -  Determine overall and disease free survival of these patients after this regimen.
  -  Determine quality of life of these patients.
  -  Determine the toxicities of this regimen in these patients.
  OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (I vs II or III).
  Patients receive oral hydroxyurea daily for 2 years.
  Quality of life is assessed before treatment, then every 3 months for 2 years.
  PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven progressive meningioma that is not curable by surgery
  PATIENT CHARACTERISTICS:
  Age:
  -  16 and over
  Performance status:
  -  Karnofsky 70-100%
  Life expectancy:
  -  Over 3 months
  Hematopoietic:
  -  WBC at least 3,000/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 2 times upper limit of normal (ULN)
  -  AST and ALT no greater than 2 times ULN
  -  Alkaline phosphatase no greater than 2 times ULN
  Renal:
  -  Creatinine no greater than 2 times ULN
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception during and for 6 months after study
  -  No other malignancy
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy
  -  No other concurrent chemotherapy
  Endocrine therapy:
  -  Concurrent corticosteroids allowed for control of intracranial pressure
  Radiotherapy:
  -  Prior radiotherapy allowed
  -  No concurrent radiotherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  At least 1 year since prior experimental 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: An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors

Summary: This is a study to gather some information on the safety and efficacy of the penetrating auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.

Detailed description: Neurofibromatosis Type 2 (NF2) is characterized by multiple tumors of the cranial and spinal nerves, and, in particular, by bilateral acoustic tumors. Surgical resection of these tumors generally results in the transection of the VIIIth nerve, destruction of the cochlea and auditory nerve, and total hearing loss. Due to the loss of the auditory nerve, these patients are not candidates for cochlear implantation. The Auditory Brainstem Implant (ABI) provides the only available intervention to restore some auditory sensation to these patients. An ABI is an implantable prosthesis that produces sound sensation by electrical stimulation of the ascending auditory pathway at the level of the cochlear nucleus.
  The PABI may be placed surgically during tumor resection. Efficacy will be assessed using psychophysical and standard speech reception measures.

Eligibility: Inclusion criteria:
  -  Diagnosis of neurofibromatosis type 2
  -  Speak English as a primary language
  Exclusion criteria:
  -  Physical, psychological, or medical conditions that contraindicate the surgical procedure

Relevance to patient case: possibly relevant