Kornimate/medical-research-clean huggingface dataset:
cyberheart's cardiac arrhythmia ablation treatment: patients with refractory ventricular tachycardia/fibrillation

Conditions: Tachycardia, Ventricular

Summary: the objective of this clinical investigation is to evaluate: 1. the safety and efficacy of the cyberheart system, cardioplan™ software and laptop, in treating patients with refractory ventricular tachycardia (vt) using the cyberknife® radiosurgical system. 2. the cyberheart system performance with respect to the ability to contour myocardial targets that are transferred to the multi-plan® treatment planning software of the cyberknife® system for the production and delivery of a safe radiosurgical treatment plan. cardiac radiosurgery is a minimally-non invasive, painless, procedure. tissue ablation can be accomplished precisely.

this study is a prospective, multi-center (2), single arm, open label us-based feasibility study. the clinical hypothesis for the study is that the cyberheart treatment approach will be safe and with further study will not be shown to be inferior to current treatment options, may lead to a survival benefit and improved quality of life. the ablation to be performed with the cyberheart system will be targeting the anatomical site of the clinically presenting vt. the application site will be determined by morphological criteria on the 12 lead ecg along with anatomical data from mri or ct scan imaging. ablation will be performed at the designated location with the intention to produce substrate modification. the study will enroll a maximum of 10 patients.

Eligibility criteria:
inclusion criteria: * presence of an implantable cardioverter-defibrillator (icd) * patients with ischemic or non-ischemic cardiomyopathy who have had recurrent symptomatic vt that induced icd shock(s) following catheter ablation and/or antiarrhythmic drug (aad) therapy. * 60 years of age or greater. * left ventricular ejection fraction ≥ 20%. * failure of or ineligible for catheter ablation. exclusion criteria: * unable or unwilling to provide informed consent * patients with idiopathic vt * women who are pregnant * prior radiation therapy to the thorax * active ischemia or other reversible causes of vt * active non-cardiovascular illness or systemic infection * presence of thrombus in the right atrium or right ventricle on pre-procedure echocardiogram * cardiogenic shock * nyha (new york heart association) class iv heart failure. * presence of incessant vt that is hemodynamically unstable. * acute heart failure exacerbation. * revascularization in the past 90 days. * other disease process that is likely to limit survival to less than 12 months
evaluation of a new agent for treatment of advanced stage breast cancer

Conditions: Breast Neoplasm

Summary: the purpose of this study is to evaluate whether treatment with a new drug called zk-epothilone (zk-epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.

this study has previously been registered by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.bayer healthcare pharmaceuticals, inc.is the sponsor of this study.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer (meaning the cancer has spread beyond its original location) * at least one measurable lesion by ct or mri * progression of disease following previous therapy for breast cancer * have received previous treatment with anthracyclines (e.g. doxorubicin\[adriamycin or doxil\] or epirubicin \[ellence\]), taxanes (paclitaxel \[taxol or abraxane\] or docetaxel \[taxotere\]) for your breast cancer * not be pregnant * additional criteria to be determined at screening visit. exclusion criteria: * more than 3 previous chemotherapy regimens * more than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin \[trastuzumab\] or avastin \[bevacizumab) * prior treatment with epothilones (e.g. ixabepilone) * symptomatic brain metastases * additional criteria to be determined at screening visit

Keywords: breast cancer metastatic breast cancer
effect of saccharomyces boulardii in patients in the waiting list for liver transplant

Conditions: Liver Cirrhosis

Summary: the purpose of this study is to evaluate the effect of saccharomyces boulardii in patients in the waiting list for liver transplant.

increased intestinal permeability are related to the major complications of liver cirrhosis. the administration of probiotics has been suggested to improve the barrier function of the mucosa and consequently avoid the complications of the disease. the objective of this study was to evaluate the effect of saccharomyces boulardii in patients in the waiting list for liver transplant. eighteen patients were treated with saccharomyces boulardii. intestinal permeability (lactulose/mannitol ratio) and laboratory parameters were evaluated immediately before the beginning of treatment, after a thirty-day period of treatment with probiotic and at the end of the second study month (after a thirty-day period without treatment with probiotic). twenty healthy volunteers were also submitted for the intestinal permeability test.

Eligibility criteria:
inclusion criteria: * patients in the waiting list for liver transplant with viral, alcoholic or cryptogenic cirrhosis exclusion criteria: * patients younger than 18 years or older than 65 years. * patients with renal failure, congestive heart failure, nephrotic syndrome, diabetes and thyroid diseases that interfered with absorption, flux of water and solutes and intestinal motility, in order to avoid interference with the intestinal permeability tests

Keywords: probiotic liver transplant permeability
hap/vap diagnosis in critically ill septic patients using a multiplex pcr array

Conditions: HAP - Hospital Acquired Pneumonia; VAP - Ventilator Associated Pneumonia

Summary: multicenter, randomized, controlled, open-label trial to assess if semiquantitative multiplex pcr assay, as compared to conventional microbiology, can reduce the percentage of patients without microbiological diagnosis in the first 24 hours from hap/vap suspicion, thus allowing early de-escalation.

hospital-acquired pneumonia and ventilator-associated pneumonia are leading cause of morbidity and mortality in intensive care unit due to the underlining clinical conditions of critically ill patients and the high rate of multidrug resistance among causative agents. in patients with sepsis and septic shock, early and appropriate antibiotics are essential for improving clinical outcome, often requiring the use of broad-spectrum combinations. the optimal use of antimicrobials is part of current implementation programs aimed to reduce the administration of not-necessary antibiotics, the bio-ecologic pressure and the possible side effects . in this context the application of rapid, molecular microbiological tests on respiratory samples is of overwhelming interest, due to the potential of reducing the time to inappropriate antibiotic therapy and of prompting de-escalation. during last years a new multiplex pcr assay for pneumonia diagnosis (film-array pneumonia panel plus, biofire, salt lake city, ut, usa) has been implementing in the clinical practice, showing very high rates of negative and positive predictive values. the hypothesis is that molecular test on lower respiratory tract samples may reduce the time to microbiological diagnosis, thus allowing early antibiotic de-escalation.

Eligibility criteria:
inclusion criteria: * suspicion of hap/vap (clinical/radiological/laboratory criteria); * availability to perform tracheal aspirates or broncoalveolar lavage within 1 hour from clinical suspicion * life expectancy ≥ 48 hours * signed written informed consent. exclusion criteria: * pregnancy, * concomitant participating in other interventional trial * refusal to sign informed consent
stability of the microbiome in ibd and ibs

Conditions: Microbiota

Summary: in this study the investigators aim to investigate the changes of the intestinal microbiome in three different cohorts (ibd, ibs, healthy) after applying the uniform disruptive factor of osmotic diarrhea induced by macrogol. the investigators hypothesis is that ill people will show more severe changes of the microbiome than healthy people and that these changes persist longer.

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Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease and irritable bowel syndrome and stable therapy since three months * patients with the indication for colonoscopy exclusion criteria: * age under 18 * pregnancy * new therapy planned * change of therapy within the last three months * acute exacerbation of the inflammatory bowel disease * colon pathologies of other origin: colocarcinoma, illnesses with diarrhea (f.e.microscopic colitis), short bowel syndrome, malabsorption, colectomy * intake of antibiotics in the last three months * intake of probiotics in the last month * intake of antibiotics or probiotics during the study * new proton pump inhibitor therapy * significant change of nutrition in the last three months * holidays outside europe in the last month * gastroenteritis in the last three months * intake of laxatives * nonsteroidal antiinflammatory drugs should be avoided and documented
dash after tbi study: decreasing adrenergic or sympathetic hyperactivity after traumatic brain injury

Conditions: Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Traumatic Brain Injury

Summary: the investigators intend to determine the effect of adrenergic blockade on 1) short-term physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe traumatic brain injury (tbi). the primary hypothesis is that adrenergic blockade after severe tbi will be associated with increased ventilator-free days.

severe traumatic brain injury (tbi) is associated with sympathetic hyperactivity resulting in catecholamine excess, abnormal heart rate variability, agitation and sympathetic storms, deep white matter changes, and poor neuropsychological outcomes. notably, persistent sympathetic hyperactivity after tbi results in higher days of mechanical ventilation and longer intensive care unit (icu) length of stay (los). while there are data describing limited portions of this response, the full spectrum of sympathetic hyperactivity after severe tbi has not been systemically described or methodically intervened upon. we will perform a double-blinded, randomized, placebo-controlled pilot trial in a 100 patient cohort in which one group will receive centrally acting sympatholytic drugs, propranolol and clonidine, and the other group, placebo, within 48 hours of severe tbi. the length of therapy will be 7 days. the primary question studied is whether ventilator-free days will be increased after therapy. secondary endpoints include plasma and urine catecholamine levels, heart rate and blood pressure variability, responses to autonomic cold pressor testing, assessments of coma, sedation, and agitation, sedative requirements, analgesic use, antipsychotic medication use, coma-free days, ventilator-free days, intensive care unit (icu) length of stay, and survival. also, neuropsychological outcomes will be measured at icu discharge, 3 months, and 12 months. interim analysis: at approximately 50% targeted accrual, n=46 randomized subjects, an interim analysis will be performed with a priori (planned) futility and efficacy rules, which are dsmb and irb approved.

Eligibility criteria:
inclusion criteria: * age: 16 years to 64 years * glasgow coma scale score less than or equal to 8 (severe tbi) with injury on ct * screen within 24 hours of injury exclusion criteria: * pre-existing heart disease (i.e. coronary heart disease) * pre-existing cardiac dysrhythmia * allergy to study drugs * penetrating brain injury * pre-existing brain dysfunction (i.e. prior severe tbi, debilitating stroke) * impending brain herniation (i.e. loss of bilateral corneal reflexes) * craniectomy or craniotomy * spinal cord injury * myocardial injury * severe liver disease * current use of beta-blockers and/or alpha-2-agonist * withdrawal of care expected in 24 hours * prisoners * pregnant women * unable to follow-up through final visit

Keywords: sympathetic hyperactivity traumatic brain injury agitation severe tbi tbi catecholamines heart rate variability adrenergic alpha-agonists adrenergic beta-antagonists cognitive impairment
"let's get organized" in adult psychiatric/habilitation care

Conditions: Neurodevelopmental Disorders; Mental Disorder

Summary: this project aims to evaluate and establish evidence for a novel, group-based intervention that can help people with cognitive limitations due to mental or neurodevelopmental disorders to improve their ability to manage time and organize activities. this might provide an important step towards establishing healthy life habits, getting or maintaining employment, and managing family life. time management is a necessary skill for maintaining healthy life habits and daily occupations in modern society. people with limited cognitive function due to, for example, mental or neurodevelopmental disorders, have documented difficulties in time management, which is also related to issues with self-efficacy. common interventions for persons with poor time management are time-assistive devices and products, but studies show that these devices alone are not enough to cover these people's needs. structured training is needed, but there is a lack of structured interventions to enhance time management skills. the intervention program "let's get organized" (lgo) is a manual-based group intervention aiming to enhance time management, targeted to persons with mental or neurodevelopmental disorders. in a recent feasibility study the lgo showed promising results. this project aims to evaluate to what extent the lgo intervention is effective in improving time management, and satisfaction with daily occupations. the proposed project is a randomized-controlled trial carried out in ten psychiatric units in sweden. participants (n=104) will be randomly assigned to either lgo group intervention or individual occupational therapy intervention for ten weeks .the primary outcome of the study is self-reported time management measured by the assessment of time management skills. secondary outcomes are occupational balance, self-efficacy, parental competence and cost-effectiveness.


Eligibility criteria:
inclusion criteria: * confirmed or suspected diagnosis of a mental disorder, such as affective disorder or schizophrenia, or neurodevelopment disorder, such as autism spectrum disorder or attention deficit hyperactivity disorder/attention deficit disorder * self-reported difficulties in time management in daily life to an extent that affects functioning in daily life negatively exclusion criteria: * intellectual disability

Keywords: time management group intervention executive function
systemchange™ intervention on medication adherence in older adults with heart failure

Conditions: Medication Adherence; Heart Failure; Aging

Summary: the purpose of this pilot rct study is to evaluate the acceptability and feasibility of a systemchange™ intervention to improve medication adherence in older adults with heart failure. the intervention focuses on changing the individual's environment by incorporating medication taking into existing routines using small experiments with feedback, and receiving support from people who impact routines.


Eligibility criteria:
inclusion criteria: * age 50 years or older * hf diagnosis confirmed by their physician utilizing their most recent ejection fraction * prescribed diuretics * self-administering medications * able to open an electronic cap * able to speak, hear and understand english * not hospitalized, * no cognitive impairment as determined by a score of 4 or greater on the 6-item mini-mental status exam.
genetic study of familial factors in patients with colon cancer

Conditions: Colorectal Cancer

Summary: rationale: genetic studies may help in understanding the genetic processes involved in the development of some types of cancer. purpose: clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

objectives: * identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps. * correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients. * correlate colon neoplasia susceptibility with the presence of cox-2, spla2, and dnmt genes in these patients. * identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.

Eligibility criteria:
disease characteristics: * diagnosis of colon cancer or polyps at age 70 or under * has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under * no history of familial adenomatous polyposis syndrome * no hereditary nonpolyposis colon cancer, according to amsterdam criteria * no known i1370k adenomatous polyposis of the colon susceptibility variant * enrolled on 1 of the following clinical trials: * clb-9581 * clb-89803 * clb-80001 note: patients do not need to be receiving protocol therapy. patients who are outside the treatment protocol's follow-up range are eligible. patients who discontinued therapy for any reason, including toxic effects, are eligible. patient characteristics: age * 70 and under at diagnosis other * no significant psychiatric illness that would preclude giving informed consent * no inflammatory bowel disease (in patient or sibling)

Keywords: adenocarcinoma of the colon stage i colon cancer stage ii colon cancer stage iii colon cancer stage iv colon cancer
continuous endotracheal tube cuff pressure monitoring

Conditions: Postoperative Complications Related to Endotracheal Intubation

Summary: tracheal tube cuff pressure in the range of 20 to 30 cmh2o is considered safe, but it is quite common to encounter cuff pressure outside this range in patients with tracheal intubation. moreover, objective cuff pressure measurement and monitoring are not routinely applied, especially in general anesthesia practice. overinflation of the cuff can potentially impair tracheal mucosal blood flow. this may lead to various tracheal injuries such as mucosal inflammation, mucosal ischemia, tracheal ulceration, tracheal stenosis, tracheoesophageal fistula, and tracheal rupture. conversely, inadequate cuff inflation can lead to inadequate ventilation and microaspiration. the importance of routine cuff pressure measurement and pressure adjustment to keep the pressure in the desired range is emphasized in preventing such side effects in intubated patients. despite this recommendation for routine intracuff pressure measurement, the methods used to measure and monitor cuff pressure vary from subjective estimation techniques to objective measurements, and there is a lack of specific protocols and documents in the current literature. for this purpose, in this study, it was aimed to perform continuous cuff pressure measurement monitoring using the transducer of the invasive pressure monitoring device, which is routinely used in arterial or central venous pressure monitoring, and to test the effectiveness of this method in reducing cuff-related complications including sore throat, hoarseness, and dysphagia compared to the intermittent monitoring method.


Eligibility criteria:
inclusion criteria: * 18-65 years of age adult patients * elective non-head-neck surgical procedures under nitrous oxide (n2o)-free general anesthesia * patients orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers * surgeries with neutral head-neck position exclusion criteria: * emergency surgery * laparoscopic surgery * head and neck surgeries including nose, mouth, pharynx, larynx and throat * surgeries with non-supine patient position * patients with preoperative sore throat, cough, hoarseness or dysphagia, history of smoking, asthma or copd, severe cardiovascular disease, inability to obtain consent, having any lesions detected in the pharynx or larynx during laryngoscopy * use of double lumen tracheal tube * use of a naso- or orogastric tube or any pharyngeal catheter * intraoperative nitrous oxide use * difficult intubation or repeated endotracheal intubation attempt * patients who strain during endotracheal extubation * high peep (greater than 5 cmh2o) application

Keywords: cuffed endotracheal tube, intracuff pressure, pressure transducer
rectal cancer trial on defunctioning stoma

Conditions: Rectal Cancer

Summary: the hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.

the assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.

Eligibility criteria:
inclusion criteria: * absence of intraoperative adverse events according to the study protocol and the operating surgeon. exclusion criteria: * presence of intraoperative adverse events according to the study protocol and the operating surgeon.

Keywords: rectal cancer surgery symptomatic anastomotic leakage defunctioning stoma tme surgery
susceptibility testing guided versus empirical therapy for refractory h. pylori infection

Conditions: Helicobacter Pylori Infection

Summary: aim: therefore, we aimed to 1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory h. pylori infection 2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors. methods: this will be a multi-center, open labeled trial patients: 360 patients with failure to h. pylori eradication for at least two times will be enrolled determination of antibiotic resistance of h. pylori: agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics. treatment regimens and assignment: eligible patients will be randomized to receive either one of the treatments (a) susceptibility testing guided therapy or (b) empirical therapy outcome measurement: primary end point: eradication rate will be evaluated according to intent-to-treat (itt) analyses. secondary end point: 1. eradication rate according to per protocol analysis (pp analysis); 2. frequency of adverse effects.


Eligibility criteria:
inclusion criteria * adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for h. pylori infection will be enrolled.

Keywords: helicobacter pylori,susceptibility testing,empirical,third-line treatment
effect of continuous positive airway pressure (cpap) on hypertension and cardiovascular morbidity-mortality in patients with sleep apnea and no daytime sleepiness

Conditions: Sleep Apnea; Hypertension; Cardiovascular Diseases

Summary: the objective of the study is to evaluate the effect of cpap over the incidence of cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea. the hypothesis of the study is the following: the existence of sleep disordered breathing in the general population is associated to an increased incidence of arterial hypertension and to an increased risk of suffering cardiovascular disease. cpap corrects respiratory disorders during sleep. treatment with cpap in subjects with sleep disordered breathing without daytime sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular complications. the end points of the study are new diagnosis of arterial hypertension and new cardiovascular events. all patients, after randomization, will be followed for three years.


Eligibility criteria:
inclusion criteria: * epworth \<10 * apnea-hypopnea index ≥20 exclusion criteria: * presence of any chronic disease * presence of cardiovascular disease * refusal to sign informed consent * drug addiction and/or alcoholism