Kornimate/medical-research-clean huggingface dataset:
fractional flow reserve versus angiography for guiding selective percutaneous coronary intervention in st-segment elevation myocardial infarction

Conditions: Fractional Flow Reserve; ST-segment Elevation Myocardial Infarction; Percutaneous Coronary Intervention

Summary: to assess the outcomes of patients with st-segment elevation myocardial infarction (stemi) assigned to fractional flow reserve (ffr) and angiography-guided selective percutaneous coronary intervention (pci).

the investigators retrospectively collect stemi patients received selective pci from jan 2012 to dec 2015. clinical follow-up is performed from the date of ffr assessment to dec 2016 or death, which is up to 5 years. the primary endpoint is major adverse cardiac events, composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. the primary endpoints are cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. all deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established. reinfarction is defined as myocardial infarction after the pci procedure. unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure. all patients were received ffr-guided pci or angiography-guided pci before enrollment, and the investigators do not assign specific interventions to the subjects during the study. so this study might be considered to be observational.

Eligibility criteria:
inclusion criteria: * age\>18 years * documented acute st-segment elevation myocardial infarction * onset of symptom \>6 days before percutaneous coronary intervention * eligible for pci exclusion criteria: * cardiogenic shock or hemodynamic instability * highly tortuous or calcified arteries * infarct related artery with a diameter \< 2.5mm * a life expectancy\< 2 years * intolerance to anti-platelet drugs * left main disease (≥ 50% stenosis) * contraindication to adenosine * hypertrophic cardiomyopathy
inflammatory mediators in obstructive sleep apnoea syndrome; mechanisms of production and the effect of long term antioxidants administration

Conditions: Obstructive Sleep Apnea Syndrome

Summary: obstructive sleep apnea syndrome (osas) is associated with elevated plasma levels of il-6 and tnf-α, which cannot be accounted for by obesity (vgontzas et al sleep med rev 2005;9:211-24, ciftci et al cytokine 2004;28:87-91\]. obstructive apneas-hypopneas are accompanied by strenuous diaphragmatic contractions before the ensuing arousals and re-establishment of airway patency. we have shown that strenuous diaphragmatic contractions induced by resistive loading lead to elevated plasma levels of il-6, tnf-α, and il-1β (vassi-lakopoulos et al ajrccm 2002;166:1572-8) with concomitant up-regulation of the cytokines within the diaphragmatic myofibers (vassilakopoulos et al ajrccm 2004;170:154-61). osas patients exhibit frequent episodes of hypoxemia during the night. loaded breathing is a form exercise for the respiratory muscles, and both acute and chronic hypoxia lead to an augmented plasma il-6 response to exercise compared to normoxia (lundby et al eur j appl physiol 2004;91:88-93). in osas, monocytes have oxidative stress (dyugovskaya et al ajrccm 2002;165:934-9) and produce more cytokines (tnf-α) in vitro (minoguchi et al chest 204;126:1473-9). hypothesis #1: plasma levels of il-6 and tnf-α are increased during the night in osas patients secondary to the intermittent strenuous diaphragmatic contractions and the episodes of hypoxia-reoxygenation associated with the obstructive apneas-hypopneas. hypothesis #2: monocytes from sleep apnea patients, exhibit augmented intracellular expression of il-6 and tnf-α during the night. hypothesis #3: oxidative stress is a stimulus for cytokine upregulation in osas.


Eligibility criteria:
inclusion criteria: * obstructive sleep apnea syndrome diagnosis exclusion criteria: * narcolepsy or idiopathic hypersomnia * chronic obstructive disease, * neuromuscular or endocrinological disease, * autoimmune systemic disease, * psychological disorders, * use of non steroids antinflammatory drugs, * use of cortisone drugs, * recent or concomitant systemic infections * upper or lower airway infections

Keywords: osas sleep apnoea il6 tnfα oxidative stress antioxidants
coagulopathy and sirs during ecc in intensive care

Conditions: Disorder of Circulatory System

Summary: this observational clinical study investigates cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different extracorporeal circulation (ecc) and circulatory support devices under intensive care conditions.

the complex interplay between the various factors contributing to the ecc-related coagulopathy and inflammation in intensive care settings is only poorly understood so far. furthermore, it is unclear, how coagulopathy and inflammation shall be monitored and which anticoagulants may be employed to decrease complications associated with specific ecc systems. therefore, the use of laboratory analyses, anticoagulation and anti-platelet therapy varies between different ecc systems and intensive care units. a better understanding of the mechanisms of the activation and interaction of platelets and leukocytes, plasmatic coagulation, complement, cytokines and endothelium will highlight starting-points to increase the safety and efficacy of ecc in intensive care medicine. the investigation of these phenomena in different ecc systems under clinical conditions is therefore the goal of this study. in order to achieve the study goal, we will investigate cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different ecc systems under intensive care conditions.

Eligibility criteria:
inclusion criteria: need for therapy with extracorporeal circulation / circulatory support due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases exclusion criteria: 1. history of previously diagnosed hereditary coagulation and/or platelet disorders 2. refusal to receive blood transfusion 3. participation in other clinical research studies involving evaluation of other investigational drugs or devices within 30 days of randomization 4. diagnosis of hepatitis b, hepatitis c, and hiv 5. age \> 85 years

Keywords: extracorporeal circulation, ventricular assist device
intraocular lens implant registry study

Conditions: Intraocular Lens Complication; Intraocular Lens Rotation; Intraocular Lens Associated Postoperative Inflammation; Lens Opacities

Summary: the goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.

a variety of intraocular lens implants are available for patients undergoing cataract surgery and new technologies are continuously being developed in this field. in the planned monocentric retro- and prospective clinical study, a database to optimize outcomes with modern intraocular lens implants will be established to further improve anatomical and functional outcomes. patients treated with an intraocular lens implant will be included. the retrospective evaluation of data includes data routinely collected prior to study inclusion (preoperative, intraoperative, postoperative up to the 1st study visit). prospectively, refraction, visual acuity, examination findings, intraocular pressure and complications are recorded 1-6 months postoperatively. depending on the type of iol, results of further non-invasive measurements are also recorded. optional follow-up visits with the aforementioned examinations are possible up to 10 years postoperatively.

Eligibility criteria:
inclusion criteria: treatment with an intraocular lens implant 18 years of age or older patient consent full legal capacity exclusion criteria: dementia pregnancy breastfeeding
evaluation of a decision aid for deep brain stimulation surgery for parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of this clinical trial is to learn if a decision aid can help patients with parkinson's disease make a decision about undergoing deep brain stimulation surgery. the main questions it aims to answer are: * is the decision aid acceptable to patients with parkinson's disease considering deep brain stimulation surgery? * does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision? researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid. participants will: * receive the decision aid at the beginning of the evaluation process or towards the end * complete surveys at 5 visits (remote or in-person) over approximately 6 months


Eligibility criteria:
inclusion criteria: * adults with a diagnosis of parkinson's disease referred for deep brain stimulation surgery evaluation at the university of colorado exclusion criteria: * atypical parkinsonism * diagnosis of dementia

Keywords: deep brain stimulation decision aid
efficacy and safety of indacaterol in adults (40 years and above) with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (copd) in china and in two other countries.


Eligibility criteria:
inclusion criteria: * adults aged ≥ 40 years * diagnosis of chronic obstructive pulmonary disease (copd) (moderate to severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2007) and: 1. smoking history of at least 10 pack years 2. post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥ 30% of the predicted normal value 3. post-bronchodilator fev1/fvc (forced vital capacity) \< 70% exclusion criteria: * patients who have received systemic corticosteroids for a copd exacerbation in the 6 weeks prior to screening or during the run-in period * patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * any patient with active cancer or a history of cancer with less than 5 years disease-free survival time * patients with a history of long qt syndrome or whose qtc interval (bazett's) measured at screening is prolonged * patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period * patients unable to successfully use a dry powder inhaler device or perform spirometry measurements other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: copd indacaterol long-acting β2-agonist adults
naloxone in treating constipation in patients who are receiving opioids for chronic pain

Conditions: Constipation, Impaction, and Bowel Obstruction; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine. purpose: phase iii trial to determine the effectiveness of naloxone in relieving constiption in patients who are receiving opioids for chronic pain.

objectives: i. assess the long-term safety and efficacy of oral naloxone in treating opioid-induced constipation in patients with chronic malignant or non-malignant pain. outline: this is a multicenter study. patients receive oral naloxone twice daily. each patient receives an escalating dose until the minimum effective dose or the maximum dose allowed is reached. the minimum effective dose is defined as the dose at which a patient has at least 4 bowel movements within 7 days. patients receive the minimum effective dose for 7 days and then continue long-term treatment for a maximum of 72 weeks. patients receiving the maximum dose allowed with fewer than 4 bowel movements per week will discontinue study therapy. projected accrual: approximately 600 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: moderate to severe opioid-induced constipation previously enrolled on protocols nal-0396, nal-0397, and/or nal-0398 or low frequency of bowel movements, defined as fewer than 3 per week during the past 2 weeks, and either of the following: score of "some", "quite a bit", or "very much" on the constipation distress scale laxative or enema dependence daily opioid intake equivalent to at least 30 mg of oral morphine for chronic pain of malignant or non-malignant origin stable dose of opioid analgesic agent for at least 2 weeks no score of "excruciating" on verbal pain scale no history of partial or complete bowel obstruction no constipation secondary to factors other than opioids (e.g., autonomic neuropathy or intra-abdominal adhesions) patient characteristics: age: over 18 performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: potassium normal other: no uncontrolled endocrinopathy or diabetes no psychiatric disorder or encephalopathy that would preclude study no clinically significant medical conditions that would preclude study not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: concurrent chemotherapy allowed provided patient has completed at least 1 course prior to study endocrine therapy: concurrent hormonal therapy allowed provided dosage is stable for at least 2 weeks prior to study radiotherapy: no concurrent palliative radiotherapy to spine, abdomen, or pelvic area surgery: not specified other: at least 30 days since other investigational drug

Keywords: unspecified adult solid tumor, protocol specific constipation, impaction, and bowel obstruction
evaluation of the h-coil transcranial magnetic stimulation tms device - safety and feasibility study for acute and maintenance treatment in major depressive episode

Conditions: Major Depressive Disorder

Summary: this is a prospective open label study of acute and maintenance treatment of mdd. the acute phase consists of daily treatments for 4 weeks. maintenance will be twice a week for eight weeks followed by 10 weeks of once a week treatments.


Eligibility criteria:
inclusion criteria: * mdd patients exclusion criteria: * risk factors for convulsions

Keywords: mood evaluation
weight loss and maintenance for individuals with intellectual developmental disabilities (idd)

Conditions: Weight Loss

Summary: individuals with intellectual developmental disabilities (idd) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (pa). overweight and obesity are independent risk factors for chronic disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the general population and those with idd. the investigators modified the stop light diet (sldm) to include reduced energy pre-packaged meals (pm) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (f/v) per week. the investigators will compare participants who use the sldm with participants who use a reduced energy and fat diet with meal plans, based off of the current american dietetic association recommended car for weight reduction plan.


Eligibility criteria:
inclusion criteria: * diagnosis of mile to moderate idd as determined by a community service provider operating in kansas under the auspices of a community developmental disability organization (cddo) * able to understand and give informed consent * if there is a guardian with power of attorney, both the guardian and participant must give informed consent * participants must live in a supported living condition either at home or with no more than 1-4 residents and have a care giver (ie. parent, staff) who assists with food shopping, meal planning, and meal preparation * overweight or obese determined by a bmi \> 25 kg/m2 * able to walk * clearance provided from physician * able to communicate preferences exclusion criteria: * uncontrolled hypertension * severe heart disease * cancer diagnosis * positive for hiv

Keywords: diet obesity chronic disease
evaluation of the accuracy of corneal epithelial thickness mapping with sd-oct

Conditions: Cornea

Summary: evaluate the accuracy of the rtvue-xr and ivue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.


Eligibility criteria:
inclusion criteria: normal * able and willing to provide consent. * able and willing to complete required exams. corneal conditions * able and willing to provide consent. * able and willing to complete required exams. * history of refractive surgery, contact lens, dry eye or keratoconus. exclusion criteria: normal * history of refractive surgery, contact lens, dry eye or pathology. * blepharitis or meibomitis * unable to complete required exams. corneal conditions • unable to complete required exams.
assessment of photodynamic therapy with annatto and led for the treatment of halitosis in mouth-breathing children

Conditions: Halitosis

Summary: objective: to assess the effectiveness of antimicrobial photodynamic therapy (apdt) employing an annatto-based (20%) dye combined with blue led for the treatment of halitosis in mouth-breathing children. methods: fifty-two children six to twelve years of age with diagnoses of mouth breathing and halitosis (score of ≥ 3 on breath alert® portable breath meter) were randomly allocated to two groups (n = 26). group 1: brushing, dental floss and apdt applied to middle third of the dorsum of the tongue. group 2: brushing, dental floss and tongue scraper. breath meter results before, immediately after treatment as well as seven and 30 days after treatment were compared. the normality of the data will be determined using the shapiro-wilk test. parametric data will be submitted to analysis of variance and nonparametric data will be compared using the kruskal-wallis test. the results of each treatment in the different periods of the study will be compared using the wilcoxon test.


Eligibility criteria:
inclusion criteria: * diagnosis of mouth breathing (performed using the calibrated glatzel mirror test, water retention test and a questionnaire); * halitosis presenting a score equal or greater than 2, in the breath alert analysis. exclusion criteria: * nasal breathers; * dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine); * undergoing orthodontic and/or orthopedic treatment; * undergoing cancer treatment; * systemic alterations (gastrointestinal, renal, hepatic); * under antibiotic treatment for up to 1 month before the research; * fissured or grooved tongue.
pharmacokinetic and pharmacodynamic evaluation of doripenem in critically ill trauma patients

Conditions: Sepsis

Summary: the study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. the investigators will measure blood drug concentrations and calculate how much the drug distributes in the body and how fast it is removed from the body. there is little information on how drugs are cleared in critically ill patients and the wrong dose of a drug could make it ineffective. the investigators will use this information to predict the most reasonable dose to treat infections effectively in these patients.

understanding the pharmacokinetic (pk)/pharmacodynamic (pd) characteristics of an antibiotic can provide insight into developing appropriate dosing regimens. it is even more imperative at the present time to maximize pk/pd parameters since there are no new novel antimicrobial agents to treat resistant gram-negative infections. this approach allows us to achieve superior pd parameters and treat bacteria that would have been resistant to standard dosing due to higher minimum inhibitory concentrations (mics). doripenem exhibits time-dependent bactericidal activity and the pharmacodynamic parameter predicting clinical and bacteriologic outcomes is the percentage of the dosing interval that free drug concentrations remain above the minimum inhibitory concentration (t \> mic) of the infecting pathogen sepsis is known to influence drug pharmacokinetics and pharmacodynamics as a result of changes in hemodynamics, capillary permeability, third spacing, acid-base status, serum proteins, and organ function. moreover, trauma patients tend to be younger with fewer comorbidities. they are hypermetabolic and are often given aggressive fluid resuscitation resulting in increased renal clearance of drugs and a larger volume of distribution. as a consequence of these differences in pk parameters, the calculated pd parameters will likely differ resulting in sub-optimal t\> mic. for time-dependent antibacterial agents such as doripenem, the t \> mic is one of the most important pharmacodynamic parameters in predicting clinical efficacy, therefore it is imperative to evaluate the pk parameters in this particular population.

Eligibility criteria:
inclusion criteria: * patients are 18 years of age or older * admitted to emory surgical intensive care unit (icu) service * have a diagnosis of sepsis that requires empiric antimicrobial therapy * obtained written informed consent from the patient or a first-degree relative if the patient is unable to give informed consent due to his/her medical condition prior to initiation of any study procedure exclusion criteria: * surgical icu length of stay less than 24 hours * acute or chronic renal dysfunction (urine output less than 0.5 ml/kg/hr or calculated creatinine clearance of less than 50 ml/min) * pregnancy * known allergy to beta-lactam antibiotics * non-english-speaking patients

Keywords: pharmacokinetics pharmacodynamics doripenem trauma sepsis trauma patients with sepsis