Kornimate/medical-research-clean huggingface dataset:
genetic expression and prediction of response to neoadjuvant docetaxel or doxorubicin in locally advanced breast cancer

Conditions: Breast Cancer

Summary: after a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). after the fourth cycle, patients are submitted to surgery to ascertain pathological response. they then receive the opposite drug, hormones, herceptin, and radiation as indicated.

the aim of the study is to define the genetic signature which predicts the response to single drug doxorubicin versus docetaxel. 250 patients will be included. cdna microarrays will be produced and the genetic pattern will be correlated with the response to doxorubicin and docetaxel. secondary aim is the prediction of response by means of ihc determinations (her2, er, pgr, ki67, protein tau), fish (topoisomerase ii alpha, her2) and pcr (topoisomerase ii alpha).

Eligibility criteria:
inclusion criteria: * locally advanced, inoperable breast carcinoma or stage ii not amenable to breast preserving surgery (amendment introduced on november 2006) * signed informed consent exclusion criteria: * age \>75 * cardiac disease; left \<50% * hyperbilirubinemia

Keywords: breast cancer neoadjuvant chemotherapy genetic signature doxorubicin docetaxel
restricted or liberal antibiotics after appendectomy - denver health

Conditions: Appendicitis

Summary: the purpose of this study is to see if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis * working telephone number or reliable method to contact patient after hospital discharge exclusion criteria: * unable to consent * pregnant women * prisoners * immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage aids * heart failure * allergy to bupivacaine * unlikely to comply with treatment or follow-up * inpatient consultation for appendicitis * clinically suspected of sepsis based on sepsis-3 definition * current use of antibiotics for other indications * uncontrolled hyperglycemia or type 1 diabetes * surgeon preference * patient preference * research team unavailable

Keywords: post-operative antibiotics
half-dose intracoronary abciximab bolus improves the mortality outcome compared to standard intravenous regimen

Conditions: Coronary Disease; Myocardial Infarction

Summary: the aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications

patients both with acute myocardial infarction and unstable angina are prone to extensive intracoronary thrombosis, leading to acute deterioration during percutaneous coronary intervention or thrombosis of the device despite therapy. intracoronary use of abciximab has reported favourable results. we randomly assigned 84 patients to intracoronary half abciximab bolus (group a) and to standard regimen (group b).

Eligibility criteria:
inclusion criteria: * presenting with unstable angina * presenting with acute myocardial infarction * eligibility for percutaneous coronary intervention exclusion criteria: * presenting with cardiogenic shock

Keywords: angioplasty stent abciximab platelet glycoprotein gpiib-iiia complex myocardial infarction
study of the variations of albumin level for patients with unresecable stage iiic or stage iv melanoma treated by anti braf and anti mek

Conditions: Unresecable Stage IIIc or IV Melanoma

Summary: the therapeutic arsenal of metastatic melanoma has changed considerably over the past 10 years. the treatment of metastatic melanoma is now based on immunotherapy and targeted therapies, while the place of conventional chemotherapy becomes more restricted. targeted therapies are indicated for braf mutated melanomas. the mutation braf leads activation of map kinases pathway and the proliferation of melanoma cell in the body . about 50% of metastatic melanoma is braf mutated. the most frequent mutation is the v600e. the targeted therapy by anti braf and anti mek allows the double bloking of the map kinases pathway. this treatment is more efficient than that of the anti braf alone. the association of anti braf and anti mek have a global survival global rate of 41% at the 1 year, against 9% for the anti braf . in 2014, a program of extended access to the association of anti braf and anti mek (dabrafenib and trametinib) started in many french hospitals (protocol mekinist, novartis laboratory). patients who were included in this program and followed in poitiers hospital, had frequent abnormalities of albumin level without any sign of undernutrition. hypoabuminemia is a poor prognosis factor described in many cancers, including metastatic melanoma. the only prognostic factor in metastatic melanoma is the rate of ldh . the level of albumin and its prognostic impact have not been studied for patients with a metastatic melanoma and treated by anti braf and anti mek. the objective of this studie was to analyze the variations of albumin level in patients with unresecable stage iiic or stage iv melanoma treated in our center by dabrafenib and trametinib


Eligibility criteria:
inclusion criteria: * age \> 18 ans * the patients with unresecable stage iiic or iv melanoma with braf v600 e or k mutation, * treated by dabrafenib and trametinib by the program of extended access (research protocol mekinist) exclusion criteria: * age \< 18 ans * patients who had less than 3 months of treatment, * patients for which the albumin level could not be carried out before starting treatment, and after the first month
left atrial function in recurrent stroke of unknown cause

Conditions: Stroke

Summary: stroke is an important cause of disability and the third leading cause of death. approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be found). there have been few previous studies regarding risk stratification for stroke recurrence in patients with cryptogenic stroke. recent studies have suggested that left atrial (la) function is an important determinant of stroke risk. however, most studies focus on volume indices and la dimensions, we also want to investigate other echocardiographic parameters. the aim of this study is to assess the predictive value of left atrial function for the risk of stroke recurrence and/or atrial fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven atrial fibrillation (af) and no indication for anticoagulants.

study design and population the investigators used a retrospective mono-centric case-control design and analyzed all patients admitted for cerebrovascular accident (cva) or transient ischemic attack (tia) between 2011 and 2014. the investigators searched for patients who had a recurrent cva/tia and/or who were diagnosed with newly documented af during the study duration. clinical, demographic and laboratory parameters were assessed. echocardiographic parameters, measured on first admission, were analyzed using echopac version 112. statistical analysis univariate analysis was performed for all covariates using the cox proportional hazards model. likelihood ratio tests were used to determine significance for all parameters. if covariates were significant at the 25% significance level, they were used in the multivariate model. multivariate analysis was performed using the cox proportional hazards model with backward elimination model selection. the wald chi-square test was used to determine significance at 5% significance level. the program used for analysis is sas version 9.4.

Eligibility criteria:
inclusion criteria: * cva * tia exclusion criteria: * proven af or atrial flutter * prior ablation for af * valvular disease * artificial heart valves * endocarditis * presence of an atrial septum defect or moderate to large patent foramen ovale * lv akinesia * moderate to severe carotid stenosis * prior surgery for carotid artery stenosis * total occlusion of the internal carotid artery * carotid artery dissection * vertebral artery dissection * massive aortic atheromatosis * temporal arteritis * basilar artery aneurysm * ascending aortic aneurysm * subclavian steal * prior cva/tia * intracerebral hemorrhage * lacunar infarction * clotting disorder * on anticoagulants * cva/tia as a procedural complication * hyperthyroidism * patients who died in hospital after first admission for cva/tia
detect fluid early from intra-thoracic impedance monitoring

Conditions: Heart Failure

Summary: to demonstrate the safety and effectiveness of the impedance monitoring feature in st jude medical cardiac devices.


Eligibility criteria:
inclusion criteria: * must have a st. jude medical (sjm) icd or crt-d for at least 31 days * must have had an episode of acute decompensated heart failure (adhf) within the past 6 months exclusion criteria: * history of kidney disease requiring hemodialysis * refractory end stage heart failure
a phase 1 study of bms-986500 as monotherapy or combination therapy in advanced solid tumors

Conditions: Advanced Solid Tumor; Advanced Breast Cancer; Advanced Ovarian Cancer

Summary: the purpose of this study is to assess bms-986500 as monotherapy in advanced solid tumors and as combination therapy in cdk4/6 inhibitor pre-treated advanced breast cancer.


Eligibility criteria:
inclusion criteria: * participants must be ≥ 18 years of age. * participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy. * participants must have a measurable disease per response evaluation criteria in solid tumors (recist) v1.1 * participants must have a stable eastern cooperative oncology group performance status of 0 or 1. * for part 2a only, participants must have ccne1-amplified ovarian cancer exclusion criteria: * participants must not have an active brain metastasis. * participants must not have impaired cardiac function or clinically significant cardiac disease. * participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months. * participants must not have grade ≥ 2 peripheral neuropathy. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: cancer oncology solid tumor
study of atorvastatin/fenofibrate (lcp-atorfen) combination therapy in dyslipidemia

Conditions: Dyslipidemia

Summary: the current study is designed to test the efficacy, safety and tolerability of lcp-atorfen, a combination of atorvastatin and fenofibrate.

this is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of lcp-atorfen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia. after a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either lcp-atorfen, atorvastatin or fenofibrate for 12 weeks. after the completion of the 12-week phase, all eligible patients will be offered to receive open-label lcp-atorfen for another 52 weeks.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of dyslipidemia (non-hdl-c \>130 mg/dl and triglycerides \> or equal to 150 mg/dl and \< or equal to 500 mg/dl). 2. subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or \>1000 mg of fish oil per day. 3. other inclusion criteria might apply exclusion criteria: 1. tgs \> 500 mg/dl. 2. history of coronary heart disease (chd), transient ischemic attacks, stroke or revascularization procedure in the six months prior. 3. presence of an aortic aneurysm or resection of an aortic aneurysm within six months. 4. poorly controlled diabetes mellitus (glycosylated hemoglobin \>8.0% )or diabetes mellitus requiring insulin therapy. 5. known lipoprotein lipase impairment or deficiency or apo c-ii deficiency or familial dysbetalipoproteinemia. 6. history of pancreatitis. 7. known allergy or sensitivity to statins or fibrates. 8. poorly controlled hypertension. 9. other exclusion criteria might apply.

Keywords: lcp-atorfen non-hdl cholesterol triglycerides hdl cholesterol ldl cholesterol atorvastatin fenofibrate
safety and efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (ipf)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis.

this is a phase 3, randomized, double-blind, placebo-controlled, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis (ipf). approximately 320 patients at approximately 50 centers will be randomly assigned (1:1) to receive pirfenidone 2403 milligrams or placebo equivalent administered in divided doses three times per day (tid) with food. the primary outcome variable will be the absolute change in percent predicted forced vital capacity from baseline to week 72. patients will be randomized by geographic region. patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. a data monitoring committee (dmc) will periodically review safety and efficacy data to ensure patient safety. after week 72, patients who meet the progression of disease (pod) definition, which is a ≥ 10% absolute decrease in percent predicted forced vital capacity or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (dlco), will be eligible to receive permitted idiopathic pulmonary fibrosis therapies in addition to their blinded study drug. permitted idiopathic pulmonary therapies include corticosteroids, azathioprine, cyclophosphamide and n-acetyl-cysteine (with restrictions).

Eligibility criteria:
primary inclusion criteria: * diagnosis of idiopathic pulmonary fibrosis * 40 to 80 years of age * forced vital capacity ≥ 50% predicted value * carbon monoxide diffusing capacity (dlco) ≥ 35% predicted value * either forced vital capacity or carbon monoxide diffusing capacity (dlco) ≤ 90% predicted value * no improvement in past year * able to walk 150 meters in 6 minutes and maintain saturation ≥ 83% while on no more than 6 liters per minute supplemental oxygen primary exclusion criteria: * unable to undergo pulmonary function testing * evidence of significant obstructive lung disease or airway hyper-responsiveness * in the clinical opinion of the investigator, the patient is expected to need and be eligible for a lung transplant within 72 weeks of randomization * active infection * liver disease * cancer or other medical condition likely to result in death within 2 years * diabetes * pregnancy or lactation * substance abuse * personal or family history of long qt syndrome * other ipf treatment * unable to take study medication * withdrawal from other ipf trials

Keywords: idiopathic pulmonary fibrosis lung pirfenidone intermune
t-provisional stenting vs mini-crush in chronic total occlusions (cto)

Conditions: Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Disease; Coronary Artery Stenosis

Summary: the aim is to compare the results of using t-provisional and mini-crush stenting techniques in patients with bifurcation lesions in the cto segment.


Eligibility criteria:
inclusion criteria: * patients considered for coronary angioplasty with stenting due to ischemic heart disease (stable angina, unstable angina, non-st myocardial infarction). * bifurcation side branch diameter \>2 mm in cto segment, verified by coronary angiography * successful cto recanalization * signed, documented informed consent prior to admission to the study exclusion criteria: * age \ 75 years * left main artery bifurcation lesion * reocclusion ctos * renal insufficiency (gfr/mdrd \<30 ml/min) * subject has a platelet count \ 700,000 cells/mm3. * known non-adherence to double anti-platelet therapy (dapt) * lvef \<30% * continuing bleeding * acute coronary syndrome (st-elevation myocardial infarction) * anamnesis of previous cabg * pregnancy

Keywords: coronary stenosis drug-eluting stent coronary angioplasty with stenting ischemic heart disease chronic total occlusion bifurcational lesion bifurcational stenting
phase i dose escalation of stereotactic radiosurgical boost for locally advanced esophageal cancer

Conditions: Esophageal Neoplasms; Carcinoma, Squamous Cell; Adenocarcinoma; Esophageal Cancer

Summary: to study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating the acute and late toxicity of treatment.

this study will evaluate the safety and feasibility of delivering radiation dose escalation using hypofractionated radiosurgery in locally advanced esophageal cancer. the dose escalation will be delivered using an image-guided radiosurgical boost to the tumor volume, following a neoadjuvant regimen consisting of oxaliplatin, capecitabine, and conventionally fractionated radiotherapy. in addition, we will evaluate the utility of pet-fdg before and after neoadjuvant chemoradiation in predicting the pathologic response to pre-operative treatment. we will study the effect of this regimen on pathologic complete response rates and complete resection rates at surgery among patients with locally advanced esophageal cancer and determine patterns of failure and rates of progression-free survival. finally, we plan to characterize in an exploratory manner the correlation between molecular markers and pathologic findings following pre-operative chemoradiation.

Eligibility criteria:
inclusion criteria:- confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus by pathologist. * endoscopic ultrasound or ct evidence of tumor penetration through the esophageal wall or involvement of regional lymph nodes, without evidence of distant metastasis * no prior chest radiation therapy * no prior chemotherapy for esophageal cancer * age greater than 18 years * no infections requiring antibiotic treatment * able to care for self * patients must have acceptable liver, kidney and bone marrow function. * the effects of the chemotherapy drugs on the developing human fetus are unknown. women of child-bearing potential and men must agree to use adequate contraception. exclusion criteria:- patients receiving any other investigational agents * evidence of distant metastases * uncontrolled medical illness * any malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. * pregnant and breastfeeding women are excluded. * hiv-positive patients
clinical trial of yh14755 in subjects with dyslipidemia and type ii diabetes

Conditions: Dyslipidemia; Type II Diabetes

Summary: randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of yh14755 in subjects with dyslipidemia and type ii diabetes.

this is a phase 3 trial to evaluate the safety and efficacy of yh14755 in subjects with dyslipidemia and type ii diabetes. in yh14755 treatment group, 88 subjects will be assigned and the subjects administer yh14755 for 16 weeks. in metformin treatment group, 88 subjects will be assigned and the subjects administer metformin for 16 weeks. in rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer rosuvastatin for 16 weeks.

Eligibility criteria:
inclusion criteria: * signed informed consent * subjects with dyslipidemia and type ii diabetes * 6.5% ≤ hba1c level ≤ 9.0% and ldl-c level ≤ 250mg/dl(6.5 nmal/l) at screening * bmi ≤ 45kg/m2 * subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit. * 19 years later, men and women under the age of 75 exclusion criteria: * pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study * subject with type i diabetes * subject with hypertension which does not controlled by treatment(have blood pressure \> 160/110mmhg) * have a known allergy to drugs * have administered cyclosporine * have administered obesity treatment within 12 weeks prior to screening visit * participated in any other clinical trials within 30 days prior to the first administration * subject who is judged to be ineligible by investigator
stool testing for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to determine if pancreatic cancer/pre-cancer can be detected in early stages through the molecular analysis of stool samples. investigators hypothesize that analysis of stool samples using digital melt curve (dmc) analysis, can be used as a sensitive and specific method to detect the common genetic abnormalities present in pancreatic cancers and pre-cancerous lesions of the pancreas.

pancreatic ductal adenocarcinoma (pdc) remains the fourth leading cause of cancer-related death in the united states. this is largely due to the fact that most patients present with advanced, unresectable disease, highlighting the critical need for a screening test for this disease. stool testing is an approach that has not been explored for use in pdc screening. with the advent of stool-based dna tests, it may be possible to target genetic abnormalities that have been recently characterized in pdc tumorigenesis. aim: the aim of this study is to determine if deoxyribonucleic acid (dna) alterations present in pancreatic cancer and precancerous intrapapillary mucinous neoplasms (ipmn) can be reliably recovered in matched stool. methods: this is a case-control prospective study to determine the utility of a stool-based digital melt curve (dmc) assay in pdc screening. a total of 30 patients (18 with pancreatic cancer, 12 with ipmn) who will be undergoing pancreatic resection will be enrolled. pancreatic neoplastic tissue will be isolated from their surgical specimens and the genes most commonly mutated in pdc will be sequenced from extracted dna. in addition, hypermethylation at common promoter sites will be assessed by methylation-specific pcr. the genetic and epigenetic alterations isolated in pancreatic tissue will be utilized as the targets for stool dmc assay. blinded technicians will process stool specimens from control patients as well as a matched control. the primary outcomes of this study will be the sensitivity and specificity of the stool dmc assay in detecting genetic mutations present in tumor or ipmn lesions.

Eligibility criteria:
inclusion criteria: * 18 years of age and older. * tissue-confirmed or radiological evidence of either pancreatic adenocarcinoma or intrapapillary mucinous neoplasm(ipmn). * scheduled for surgical resection of the adenocarcinoma or ipmn. * able to give informed consent exclusion criteria: * history of colorectal, gastric cancer, esophageal, or head-and-neck cancer. * endoscopic procedure conducted less than 1 week prior to enrollment. * unwillingness or inability to sign informed consent.

Keywords: pancreatic cancer intraductal papillary mucinous neoplasm (ipmn) stool-based digital melt curve (dmc) assay surgical resection for pancreatic cancer hereditary pancreatic cancer syndrome genetic mutations linked to pancreatic cancer