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: Positron Emission Tomography/Computed Tomography Scanning Before Surgery in Patients With Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Esophageal Cancer, or Head and Neck Cancer

Summary: RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease.
  PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.

Detailed description: OBJECTIVES:
  -  To determine the ability of preoperative fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning in assessing tumor angiogenesis in patients with potentially operable non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
  -  To determine the ability of preoperative fludeoxyglucose F 18 PET/CT scanning in assessing prognosis by means of measuring angiogenesis in these patients.
  OUTLINE: All patients undergo fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning for staging, tumor perfusion measurement/angiogenesis, and glucose metabolism. If staging confirms operable disease, then the patient proceeds to surgery as planned. Resected tumor tissue samples are examined for tumor angiogenesis in the various cancer types.
  Some patients undergo a half-dose of rubidium Rb-82 or 18F-fluoromisonidazole or [18F]-ML-10 PET scan or fluorescence angiography. Patients with colorectal cancer undergo a CT scan for perfusion of the tumor after the staging PET/CT. Patients with breast cancer undergo infrared thermometry as well as a MRI scan for staging and to predict angiogenesis.
  After completion of study therapy, patients are followed up at 1 month and then every 6 months for 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer
  -  Potentially operable disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Not specified
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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: A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma

Summary: This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer)
  -  Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test
  -  Previously treated patients must have failed at least one prior treatment regimen; if patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be >/= 28 days; patients must have recovered fully from toxicities of all prior therapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Evaluable disease (measurable for disease progression according to RECIST criteria)
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  Active CNS lesions
  -  History of or known spinal cord compression or carcinomatous meningitis
  -  Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
  -  Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix
  -  Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
  -  Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug

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: Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

Summary: Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted.
  However, there are not sufficient evidences for single incision colon surgery in colon cancer.
  The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer.

Detailed description: After several randomized clinical trials, laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has been attempted. Several studies reported the feasibility of single incision colon surgery.However, there are not sufficient evidences for single incision colon surgery, especially in colon cancer.
  The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for the efficacy and postoperative morbidity and mortality will be assess for the safety.

Eligibility: Inclusion Criteria:
  -  Patients should sign a written informed consent
  -  Age between 18-80
  -  Patients have sigmoid colon cancer that was proved by pathology
  -  Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
  -  Adequate kidney function Creatinine ≤ 1.5 mg/dl
  -  No remarkable evidence of heart dysfunction and lung dysfunction
  Exclusion Criteria:
  -  Distant metastasis
  -  Tumor diameter > 5 cm
  -  Other organ invasion
  -  Intestinal obstruction and stent insertion status
  -  Patient was used steroid
  -  Patients undergo emergency surgery with multiple symptoms
  -  Other organ cancer history (except who had radical excision for skin cancer)
  -  Presence of other serious disease
  -  Mentally ill patients
  -  Legally unable to participate in clinical trial
  -  Lactating or pregnant women
  -  Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
  -  Not eligible to participate for other reasons by doctor's decision

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: A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma

Summary: This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage [DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.


Eligibility: Inclusion Criteria:
  -  Participants with histologically confirmed melanoma (unresectable Stage IIIc and Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer [AJCC])
  -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to (</=) 1
  -  Participants must
  1. be previously untreated for locally advanced/unresectable or metastatic melanoma or
  2. previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or
  3. progressed on vemurafenib while participating in a Phase I (including clinical pharmacology studies), II, or III clinical study or expanded access programs (EAP) immediately prior to enrollment in this study or
  4. progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study.
  -  Life expectancy >/=12 weeks
  Exclusion Criteria:
  -  History of prior significant toxicity from another RAF or MEK pathway inhibitor requiring discontinuation of treatment
  -  Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment
  -  Experimental therapy within 4 weeks prior to first dose of study drug treatment except vemurafenib
  -  Major surgery within 4 weeks of first dose of study drug treatment or planning a major surgery during the 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 AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

Summary: The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed colorectal cancer
  -  KRAS wild type metastatic colorectal cancer
  -  Progression of disease on at least 2 prior therapy to have included 5FU, or oxaliplatin or bevacizumab or irinotecan
  -  Prior treatment with cetuximab is allowed (full dose tolerated), provided that the patient never required a dose reduction due to toxicities
  -  Must have at least one measurable lesion
  -  Must be 18 years of age or older
  -  ECOG performance status 0-1
  -  Life expectancy must be greater than 12 weeks
  -  For women of childbearing potential, a negative pregnancy blood test must be obtained less than 3 days prior to the first AUY922 infusion
  Exclusion Criteria:
  -  Colorectal cancer with a KRAS mutation or in which the KRAS genotype status is unknown
  -  Metastasis to the CNS
  -  Prior treatment with any Hsp90 inhibitor compounds
  -  Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
  -  Radiotherapy, conventional chemotherapy: within 2 weeks
  -  Palliative radiotherapy: within 2 weeks
  -  Nitrosoureas, monoclonal antibodies, such as trastuzumab and mitomycin: within 6 weeks
  -  Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday-Wednesday-Friday dosing, weekly etc.) of systemic anti-cancer treatment for which the recover period is not known, or investigational drugs (i.e. targeted agents) within a duration of ≤ 5 half lives of the agent and their active metabolites (if any)
  -  Treatment of therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2mg, for line patency permitted]
  -  Known sensitivity to cetuximab
  -  Unresolved ≥ grade 1 diarrhea
  -  Malignant ascites that require invasive treatment
  -  Concurrent medications that are substrates, inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 and cannot be switched or discontinued or switched to an alternative drug prior to commencing AUY922 dosing need special consideration on a case by case basis
  -  Major surgery ≤ 2 weeks prior to randomization or who have not recovered from such therapy
  -  Impaired cardiac function

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: Adjuvant Colon Cancer w/ ELOXatin®/5 FU Based Regimen: ACCELOX

Summary: Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX

Detailed description: It's a study of adjuvant colon carcinoma using ELOXatin/5-FU based chemotherapeutic regimen called ACCELOX as a definitive curative therapy.

Eligibility: Inclusion Criteria:
  -  Patients with Adjuvant Colon Cancer
  Exclusion Criteria:
  -  Patients with diagnosis other than Colon Cancer.

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: A Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination With Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer

Summary: A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer

Detailed description: A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer

Eligibility: Inclusion Criteria:
  -  Patients with diagnosed Metastatic Colorectal Cancer
  Exclusion Criteria:
  -  Patients with diagnosis other than Metastatic Colorectal Cancer

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: Implementation of Laparoscopy-assisted Surgery for Colon Cancer

Summary: The purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.

Detailed description: Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes

Eligibility: Inclusion Criteria:
  -  Age >17 years
  -  diagnosis of colon cancer either endoscopically, radiologically or histologically proven
  -  No evidence of disseminated disease on CT scan
  -  T1-3 according to preoperative CT scan
  -  written informed consent to participate
  Exclusion Criteria:
  -  preoperative diagnosis of locally advanced tumor (T4)
  -  suspicion of pathological lymph nodes outside anticipated resection area
  -  contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns
  -  lack of informed consent

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: Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.
  Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  histologically/cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus - Unacceptable ocular/retinal conditions
  Other protocol-defined inclusion/exclusion criteria may apply

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: Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

Summary: This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.


Eligibility: Inclusion Criteria:
  -  Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
  -  T2-4 NX M0 disease
  -  ECOG performance status 0-1
  -  adequate hematological status
  -  adequate renal function
  -  adequate hepatic function
  -  adequate metabolic function
  Exclusion Criteria:
  -  pregnant or breast feeding women
  -  previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  -  arterial or venous thromboembolism within 6 months before enrollment
  -  clinically significant cardiovascular disease within 1 year before enrollment
  -  history of interstitial lung disease

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: MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

Summary: This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.


Eligibility: Inclusion Criteria:
  Patients with histologically or cytologically confirmed and non-resectable advanced solid tumors for which no further effective standard therapy exists.
  -  The patients' tumors must contain documented activating somatic BRAFV600E* , NRAS or KRAS mutations (except for pancreatic cancer)
  -  All patients enrolled MUST provide fresh or archival tumor samples at baseline to enable central confirmation of BRAF or KRAS/NRAS mutations
  -  Measurable, or non-measurable but evaluable disease as determined by RECIST
  -  Adequate bone marrow function
  -  Adequate hepatic and renal function
  -  Adequate cardiovascular function
  -  Negative serum β HCG test (female patients of childbearing potential only) within 72 hrs prior to first dose
  Exclusion Criteria:
  -  Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
  -  Current evidence of retinal disease; or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO (e.g., optic disc cupping, visual field defects, IOP > 21 mm Hg)
  -  Impaired cardio-/vascular function or clinically significant cardiovascular diseases, including any of the following:
  -  History/evidence of acute coronary syndromes (including MI, unstable angina, CABG, coronary angioplasty, or stenting) ≤ 6 months prior to starting study drugs
  -  Thromboembolic event (DVT, CVA, PE) ≤ 6 months prior to starting study
  -  Symptomatic CHF, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality
  -  Uncontrolled arterial hypertension, defined as BP > 140/100 mmHg (average of 3 consecutive readings)
  -  History of melena, hematemesis or hemoptysis within the last 3 months
  -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: 10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting

Summary: The purpose of this study is to determine the effects of group treatment including physical activity referral (PAR) on level of physical activity and quality of life in patients diagnosed with type 2 diabetes and/or hypertension in a primary health care setting

Detailed description: A sedentary lifestyle and low levels of physical activity in populations are major health problems today and contribute substantially to poor health and diseases such as type 2 diabetes and hypertension. An increased and systematic effort to increase physical activity in the Swedish population in general, and in patients with type 2 diabetes/hypertension in particular, is important. Written prescriptions of physical activity with follow-up (i.e., PAR), is a cost-efficient way to increase physical activity in individuals.
  The aim of this trial is to study whether physical activity is increased by a group method involving PARs in patients with hypertension and/or type 2 diabetes compared with a control group that receives usual care in the same primary care setting. Follow-up will be performed at 6 and 12 months.
  This trial is being conducted to determine whether it is possible to offer PARs to more patients in a way that requires less effort and resources. The intervention in this study requires 10 minutes of a health care worker's time per patient during a 6-month period. Each patient requires 100 minutes with an instructor who oversees the group intervention.
  Group treatment is given 3 weeks after baseline and at 6 months. Follow-up at 12 months involves data collection, but no intervention.
  An empowerment process, with the 5-A-model as framework, will be used in the clinical intervention.
  All participants will be required to fill in questionnaires and wear an ActiGraph GTM1/GTM3 for 7 days at baseline and at 6 and 12 months.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of hypertension or type 2 diabetes since 10-09-2009 at St Hans Primary Health Care Center, Lund, Sweden
  Exclusion criteria:
  -  Dementia
  -  Psychosis
  -  Drug abuse
  -  Mental retardation
  -  Inability to walk without assistance
  -  Inability to speak Swedish

Relevance to patient case: not relevant