araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

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 liposomal doxorubicin in treating patients with liver or bile duct cancer.

Detailed description: OBJECTIVES: I. Determine the response rate and toxicity of doxorubicin HCl liposome in patients with carcinomas of the liver and bile ducts.
  OUTLINE: Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days. Filgrastim (G-CSF) is administered subcutaneously starting on day 2 and continuing for 10-14 days. Disease is restaged after every 3 courses. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first year, and then every 6 months thereafter.
  PROJECTED ACCRUAL: There will be 17-26 evaluable patients accrued into this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the liver or bile ducts including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder cancer Measurable or evaluable disease by CT scan (ascites, pleural effusions, and bone metastases are not considered evaluable)
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 mg/dL No severe cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: Left ventricular cardiac ejection fraction at least 45% Other: No allergy to egg or egg products Not pregnant or nursing Effective contraception required of all fertile patients
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior doxorubicin At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Dolastatin 10 in Treating Patients With Metastatic Or Recurrent Liver, Bile Duct, or Gallbladder Cancer

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 dolastatin 10 in treating patients with metastatic or recurrent liver, bile duct, or gallbladder cancer.

Detailed description: OBJECTIVES: I. Determine the objective response rate, time to progression, and survival of patients with previously untreated advanced hepatobiliary cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population.
  OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients are followed until death.
  PROJECTED ACCRUAL: A total of 14-35 evaluable patients will be accrued for this study within 9 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed metastatic, locally advanced, or recurrent cancer of the liver (hepatoma), bile duct, or gallbladder (cholangiocarcinoma) Bidimensionally measurable disease The following are not considered measurable lesions: Lesions seen on colonoscopic examination or barium studies Bone metastases CNS lesions CEA, CA19-9, or AFP levels Ascites No CNS disease only No symptomatic brain metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 OR Platelet count at least 75,000/mm3 in patients with clinically documented sequestration or hemodilution unrelated to primary bone marrow insufficiency Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant underlying medical or psychiatric illness No active infections No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced or metastatic hepatobiliary cancer No other concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to only site of measurable disease At least 6 weeks since prior radiotherapy and recovered No concurrent radiotherapy to any lesion Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

Summary: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for cancer of the bile duct, gallbladder, or pancreas.
  PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct, gallbladder, or pancreas.

Detailed description: OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction.
  OUTLINE: Patients are stratified according to tumor location (proximal vs distal). Patients receive porfimer sodium IV over 3-5 minutes on day 1, followed by percutaneous or endoscopic laser light treatment on day 3. Patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses. Patients are followed weekly for 1 month, and then monthly for 1 year.
  PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven malignant bile duct obstruction with obstructive jaundice Primary carcinoma of bile duct, gallbladder, or pancreas OR Metastatic bile duct disease Successful insertion of a percutaneous drain or endoscopic stent Unresectable disease OR Resectable disease but refusal of surgery Prior biliary plastic or metallic stent allowed, if requiring stent replacement due to recurrent jaundice or routine plastic stent change No erosion of biliary tumors into major blood vessels No evidence of bile duct perforation
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin at least 2 mg/dL Renal: Not specified Other: No history of allergies or hypersensitivity to porphyrins No porphyria No cholangitis or pancreatitis
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy or brachytherapy to the abdomen Surgery: See Disease Characteristics Other: No other prior or concurrent experimental or investigational drugs

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.
  PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma.
  -  Determine survival without local relapse in these patients treated with this regimen.
  -  Determine overall survival of these patients treated with this regimen.
  -  Determine the effectiveness of this adjuvant therapy in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive high-dose radiotherapy 5 days a week for 5 weeks. Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment. Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity.
  Patients are followed for survival.
  PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed pancreatic adenocarcinoma
  -  Complete macroscopic resection of tumor within past 30 days
  -  No residual visceral or peritoneal metastasis
  -  Involvement of Vater's ampulla or extrahepatic bile duct allowed
  -  No vesicular or intrahepatic cholangiocarcinomas
  PATIENT CHARACTERISTICS:
  Age:
  -  18 to 75
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,500/mm^3
  -  Platelet count greater than 100,000/mm^3
  Hepatic:
  -  Alkaline phosphatase less than 3 times normal
  -  Bilirubin less than 1.5 times normal
  Renal:
  -  Creatinine less than 1.5 times normal
  Cardiovascular:
  -  No serious cardiac failure
  Pulmonary:
  -  No serious respiratory failure
  Other:
  -  No other untreatable malignant tumors
  -  No serious psychological, familial, social, or geographical conditions that would preclude study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy for pancreatic adenocarcinoma
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No prior radiotherapy for pancreatic adenocarcinoma
  -  No prior radiotherapy in an anatomically proximal region to treatment area
  Surgery:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct

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 combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.

Detailed description: OBJECTIVES: I. Determine the response rate, in terms of WHO objectives and clinical benefit, in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated with gemcitabine, leucovorin calcium, and fluorouracil. II. Determine the tolerance of this regimen in this patient population. III. Determine the survival without disease progression in patients treated with this regimen. IV. Determine the overall survival in patients treated with this regimen.
  OUTLINE: This is a multicenter study. Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2. Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response may continue chemotherapy for up to 1 year. Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks, or may undergo surgical resection. Fluorouracil-based chemotherapy (with or without radiotherapy) may then resume after surgery. Patients are followed for survival.
  PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed pancreatic or biliary duct adenocarcinoma Metastatic or locally advanced No cerebral metastasis Surgically unresectable
  PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: More than 12 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Alkaline phosphatase less than 5 times normal Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.5 times normal No uncontrolled or persistent hypercalcemia Cardiovascular: No severe cardiac failure Pulmonary: No severe respiratory failure Other: No other malignant tumor considered incurable or untreatable No uncontrolled pain No psychological, familial, social, or geographical reasons that would preclude study
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids except as antiemetic Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Thalidomide in Treating Patients With Myelofibrosis

Summary: Phase II trial to study the effectiveness of thalidomide in treating patients who have myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells.

Detailed description: PRIMARY OBJECTIVES:
  I. To investigate whether thalidomide, a potent inhibitor of angiogenic and fibrogenic growth factors, is an effective therapeutic agent in patients with MMM. Specifically, to assess whether thalidomide improves anemia and/or organomegaly in patients with MMM.
  II. To assess the effects of thalidomide on the myelofibrotic stroma with respect to microvascular architecture and angiogenesis, collagen and reticulin deposition, and the expression of the mediating growth factors bFGF, TGF-b, and PDGF, and their respective receptors.
  OUTLINE: This is a multicenter study.
  Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 1 additional year of therapy.
  Patients are followed every 6 months until 5 years from study entry.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed myelofibrosis with myeloid metaplasia
  -  Agnogenic myeloid metaplasia
  -  Post-polycythemic myeloid metaplasia
  -  Post-thrombocythemic myeloid metaplasia
  -  No metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7), or acute myelofibrosis
  -  No chromosomal translocation t(9;22) or bcr/abl gene rearrangement
  -  Presence of reticulin fibrosis in bone marrow and leukoerythroblastosis and dacrocytosis in peripheral blood
  -  Presence of anemia (hemoglobin less than 10 g/dL), palpable splenomegaly, or hepatomegaly
  -  Performance status - ECOG 0-2
  -  Absolute neutrophil count greater than 750/mm^3
  -  Platelet count less than 400,000/mm^3
  -  WBC less than 50,000/mm^3
  -  Bilirubin no greater than 2 mg/dL (if total bilirubin elevated, direct bilirubin must be normal)
  -  AST no greater than 3 times upper limit of normal (ULN)
  -  Alkaline phosphatase no greater than 3 times ULN
  -  Creatinine no greater than 1.5 mg/dL
  -  Creatinine clearance at least 60 mL/min
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile women must use at least 1 highly active method AND 1 additional effective method of contraception for at least 4 weeks before study, during study, and for at least 4 weeks after study
  -  Fertile men must use effective contraception during study and for at least 4 weeks after study
  -  No uncontrolled infection
  -  No concurrent condition that would preclude study
  -  No peripheral neuropathy
  -  At least 1 month since prior interferon, pirfenidone, anagrelide, or epoetin alfa
  -  At least 1 month since prior hydroxyurea or other chemotherapy
  -  At least 1 month since prior corticosteroids or androgen derivatives

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who Are Undergoing Radiation Therapy

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Multiple CT scans may improve the accuracy of radiation therapy for prostate cancer.
  PURPOSE: Phase I trial to study the effectiveness of multiple CT scans in guiding the treatment of patients who have prostate cancer and are undergoing radiation therapy.

Detailed description: OBJECTIVES:
  -  Compare the accuracy of radiotherapy delivery using multiple CT scans to guide patient positioning vs the standard portal image guided procedure in patients with prostate cancer undergoing external beam radiotherapy.
  -  Determine the reduction in the proportion of patients with large target positioning errors using the CT-guided procedure.
  -  Determine organ motion and setup errors over the course of radiotherapy in order to develop efficient clinical intervention strategies in these patients.
  OUTLINE: Patients undergo radiotherapy over 9 weeks. Patients undergo a CT scan immediately prior to receiving radiotherapy on treatment days 3-8 and then weekly thereafter. On 3 different days, patients also undergo CT scan immediately after radiotherapy. If the CT scans indicate a correction that exceeds the action level currently in effect, then beginning with the next treatment, the patient's position with respect to the radiation field is adjusted.
  PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Undergoing external beam intensity-modulated radiotherapy for prostate cancer
  -  Able to maintain treatment position for about 40 minutes
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  Surgery:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Summary: The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.


Eligibility: Inclusion Criteria:
  -  Patients must have type I or type II Diabetes Mellitus.
  -  Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months.
  -  Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
  -  Must be 18 years or older.
  -  Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.
  Exclusion Criteria:
  -  History of significant liver problems.
  -  Have poor kidney function.
  -  Drink an excess of alcohol or abuse drugs.
  -  Have recently participated or currently participating in a Medical study in which you receive an experimental drug.
  -  Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Summary: The purpose of this protocol is to determine if an investigational drug known as LY333531 is effective in treating nerve malfunction in diabetes.


Eligibility: Inclusion Criteria:
  -  Patients must have type I or type II Diabetes Mellitus.
  -  Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months.
  -  Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be insulin therapy.
  -  Must be 18 years or older.
  -  Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.
  Exclusion Criteria:
  -  History of significant liver problems.
  -  Have poor kidney function.
  -  Drink an excess of alcohol or abuse drugs.
  -  Have recently participated or currently participating in a Medical study in which you receive an experimental drug.
  -  Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: A Study for the Treatment of Painful Diabetic Neuropathy

Summary: The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

Detailed description: The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.

Eligibility: Inclusion Criteria:
  -  Male or female outpatients at least 18 years of age.
  -  Patients with pain due to diabetic neuropathy in both legs.
  -  Females must not be pregnant or plan to become pregnant during the study.
  -  Stable Glycemic control.
  -  Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.
  Exclusion Criteria:
  -  You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.
  -  You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.
  -  You have participated in a study for an investigational drug within the last 30 days.
  -  You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.
  -  You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.

Relevance to patient case: not relevant