Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin in healthy male volunteers

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.


Eligibility criteria:
inclusion criteria: * age: 20 - 40 years * sex: male * body weight: greater than 55 kg * written informed consent exclusion criteria: * known allergy to fimasartan and digoxin * existing cardiac or hematological diseases * existing hepatic and renal diseases * existing gastrointestinal diseases * acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder * positive drug or alcohol screening * smokers of 10 or more cigarettes per day 3 month ago * participation in a clinical trial during the last 2 months prior to the start of the study

Keywords: fimasartan drug interaction
live kidney donor study

Conditions: Kidney Transplantation; End Stage Renal Disease

Summary: kidney transplants from living donors now account for 40% of all the kidney transplants done in the united states. however, the current information on how donating a kidney can affect the donor's long term health needs further investigation. the purpose of this study is to collect data on a large number of live kidney donors and create and analyze a comprehensive database. information about the number of living kidney donors, including those who have experienced kidney failure, heart problems, and death will be gathered for the database. investigators will then use the database to identify the risks of kidney failure, associated conditions, and death after living donation. the database will also be used to identify characteristics that put donors at higher risk for health problems after donation.

kidney transplantation is the preferred treatment to dialysis for most people with kidney failure. however, the current waiting time to receive a kidney from a deceased donor is greater than 5 years in some parts of the united states. kidneys from living donors have increased the number of kidneys available for transplantation and decreased the waiting period for those needing a transplant. living kidney donation also provides several advantages over deceased donor kidneys, including more timely transplantation and longer function of the transplanted kidney. despite these facts, there is inadequate information about whether living kidney donation may have serious adverse effects on the donor's health. long-term data on the health risks of living donation are needed. the purpose of this study is to establish and analyze a database of information on living donors who have or are going to donate a kidney at three transplant centers with longstanding live kidney donation programs through june 2011. donor and recipient characteristics as well as specific data on kidney failure, heart disease, and death will be collected. national databases such as the scientific registry of transplant recipients, the social security death master file, the national death index and records maintained by the centers for medicare and medicaid services for patients with end stage renal disease (esrd) will be used to supplement data provided by the participating transplant centers. after establishing the database, researchers expect to 1) determine the long-term risk of live kidney donation and 2) identify donor characteristics associated with higher risk for health problems after donation. death, cause of death, and incidence of esrd will be compared to those rates reported by the centers for disease control and prevention for the u.s. population during the same time period. there will be no study visits for this study. investigators will gather data from the medical charts of all live kidney donors from the three transplant centers through june 2011.

Eligibility criteria:
inclusion criteria: * donated kidney at one of the three participating study centers exclusion criteria: * none

Keywords: kidney transplant live donor transplant
development, piloting and evaluation of an evidence-based informed consent form for total knee arthroplasty

Conditions: Consent Forms; Osteoarthritis, Knee; Arthroplasty, Replacement, Knee

Summary: every medical intervention requires informed consent. informed consent may include comprehensible information about the necessity and kind of the intervention, material risks and consequences or alternative treatments. practitioners frequently use consent forms to support the physician-patient conversation and to document informed consent. studies show, that informed consent forms used in practice, are heterogeneous. this study aims at investigating the effects of evidence-based informed consent forms for total knee replacement and related anaesthesia procedures. evidence-based informed consent forms include best and latest evidence in lay language. it is hypothesized that evidence-based informed consent forms - compared to standard consent forms - improve patients' risk perception, reduce anxiety of complications and reduce the nocebo effect (unspecific negative effects caused by the way of communicating risks). to compare evidence-based and standard informed consent forms, an interrupted time series pilot study will be conducted. it is planned to include 220 patients, who are scheduled for elective total knee replacement surgery. the accompanying qualitative analyses ensure that the (german) legal requirements for informed consent are met.


Eligibility criteria:
inclusion criteria: * patients are scheduled for an elective total knee arthroplasty surgery * patients are at least 18 years old * patients are able to understand and speak german * patients are mentally competent to give consent and answer questions exclusion criteria: * patients with revision * patients with posttraumatic arthrosis

Keywords: informed consent consent form risk communication anxiety nocebo effect total knee arthroplasty
treating violence-related ptsd and substance risk in low-income, urban adolescents

Conditions: Posttraumatic Stress Disorder; Substance Use Disorders

Summary: this project will provide initial feasibility and efficacy data for the implementation of narrative exposure therapy (net) to urban, at-risk youth. posttraumatic stress and substance use outcomes, as well as participant responses to the intervention, will be examined.

the goal of the proposed study is to gather preliminary feasibility and efficacy data for an innovative intervention (narrative exposure therapy: net) to promote adolescent mental health related to interpersonal trauma (ipt). among those at highest risk for interpersonal violence and its sequelae are youth from urban, low-resourced neighborhoods. post-traumatic stress disorder (ptsd) is a common outcome associated with ipt. substance misuse (sub) is a frequent concomitant of ptsd. net is a promising intervention to reduce ptsd symptoms and associated psychological distress, via the supported reconstruction (narrative telling) of the traumas. net has a critical advantage over existing ptsd treatments in that it can be delivered in a brief format, in community settings where at-risk adolescents are likely to be found. despite its promise in treating adolescent distress, net has yet to be tested as an intervention for those who have interpersonal trauma-related ptsd. further net's influence on sub has not been examined. accordingly, the objective of this project is to conduct a pilot study (n=30) to estimate net treatment effects on ptsd symptoms and sub in ipt-exposed urban adolescents (ages 16-21). both feasibility and preliminary efficacy data will be collected to serve as pilot work for a larger-scale nih proposal. recruitment and intervention will be set within community partners where the adolescents already are connected and are receiving social or psychological services. outcome data will be collected at: (t0) baseline, and at 1(t1), and 3 months (t2) follow-up assessments. participant responses to the intervention will be assessed post-intervention. change in ptsd, sub will be estimated with effect sizes and inferential tests. preliminary evidence of efficacy and feasibility will pave the way for further net development to offer a patient-oriented, community-based, intervention that will promote adolescent mental health for those at greatest risk for health access and outcomes disparities.

Eligibility criteria:
inclusion criteria: * adolescents (ages 16-25), * positive ptsd diagnosis (caps diagnosis) * positive lifetime incidence of interpersonal violence-related trauma. exclusion criteria: * actively suicidal with an immediate referral to the community agency crisis staff * severe cognitive delay * active psychosis
vitamin c and atrial fibrillation after cardiac surgery

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine if vitamin c decreases the chance of developing atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery. this irregular heartbeat is a common occurrence following cardiac surgery, and occurs in about one third of patients. it poses extra risks to people who develop it. our hypothesis is that vitamin c will decrease the incidence of postoperative atrial fibrillation.

the development of atrial fibrillation (af) following cardiac surgery is relatively common, occurring in approximately 25-60% of patients. coronary artery bypass graft surgery (cabg) carries the lowest risk of af development, with an incidence of approximately 25-30%, followed by cardiac valve and combined cabg/cardiac valve surgeries, with incidences up to 60%. af development in patients undergoing cardiac procedures has been linked to increases in postoperative morbidity and mortality, including an increase in readmission to the icu, stroke, reintubation, and 30-day and 6-month mortality. patients who develop af have also been shown to experience longer hospital stays, both in the icu and overall. while some other medications have been shown to decrease the risk of af development, the use of beta-blockers peri- and postoperatively have shown the most promise, and are the standard of care for patients undergoing cabg surgery. however, patients experiencing af have been shown to experience cardiac production of peroxynitrite, corresponding to a hypothesis that af occurs through oxidative stress. due to this correlation, supplementation of ascorbate has been proposed as a treatment to reduce the risk of af development following cardiac surgery. ascorbate is a potent peroxynitrite antagonist, and may therefore reduce oxidative stress and af development following cardiac surgery. this trial aims to assess the efficacy of ascorbic acid in reducing the incidence of postoperative af in patients undergoing elective or urgent cabg surgery, cardiac valve surgery, or a combination of the two. our hypothesis is that ascorbic acid will decrease the incidence of postoperative af development.

Eligibility criteria:
inclusion criteria: * adults 50 years of age or older * undergoing elective or urgent coronary artery bypass graft surgery, valve surgery, or a combination of the two exclusion criteria: * prior cardiac surgery * history of atrial fibrillation * permanent or temporary pace maker * currently taking digoxin or vaughan williams class i or iii antiarrhythmic medications * known hyperoxaluria * history of renal calculi * history of allergic or hypersensitivity reaction to ascorbic acid products * currently taking 1 g or more of ascorbic acid supplementation daily

Keywords: atrial fibrillation ascorbic acid thoracic surgery cardiac arrhythmias cardiac surgery vitamin c postoperative complications antioxidants inflammation
preventive sodium lactate and traumatic brain injury

Conditions: Head Trauma

Summary: the goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. the investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.

* intracranial hypertension is the most severe complication of severe head injury. this may lead to cerebral death or severe neurological outcome. to improve the prognosis of these patients,intracranial pressure must be maintained in normal range while maintaining cerebral perfusion pressure. among numerous strategies, osmotherapy is frequently proposed to decrease intracranial pressure, using mannitol or hypertonic saline. recently, it has been found that hypertonic sodium lactate infusion is more efficient to decrease intracranial hypertension compared with an equivalent volemic and osmotic mannitol administration.thus, we hypothesized that a preventive sodium lactate infusion in severe head trauma could decrease the number of intracranial hypertensive episodes. * methods and objectives : to compare in a randomized double-blind fashion two group of patients, i.e., those receiving a standard isotonic saline infusion (control group) with those receiving half-molar sodium lactate for 48 hours following admission in icu. the primary endpoint is the number of any treatment required to control intracranial hypertensive episodes occurring during the first 48 hours following admission in icu. secondary endpoints are the effect of sodium lactate infusion on : intracranial pressure evolution;neurological outcome at 6 months (glasgow outcome scale); cerebral blood flow evaluated by transcranial doppler; and daily water balance * protocol consisted to measure as soon as possible baseline intracranial pressure and cerebral perfusion pressure, then immediately to begin the administration of 0.5 ml/kg/h intravenous isotonic saline perfusion or half-molar sodium lactate during 48 hours in a randomized double-blind fashion. management of patients is the same for all patients. treatment required for intracranial hypertensive episode is decided by a senior physician in charge of the patient. sample size has been calculated considering that 50% of these patients will develop at least one intracranial hypertensive episode, each of them requiring at least 2 treatments. based on previous results, we hypothesized that sodium lactate will decrease the number of required treatment by 2, leading to a sample size of 30 patients per group * follow up : 48 hours for treatments of intracranial hypertensive episodes; 6 months for the neurological outcome (glasgow outcome scale)

Eligibility criteria:
inclusion criteria: * severe head trauma with a glasgow coma scale less than 9 exclusion criteria: * prehospital cardiac arrest * severe hemorrhage shock * severe circulatory or respiratory failure * medullar trauma * prehospital osmotherapy

Keywords: intracranial hypertension neurological outcome osmotherapy
efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia

Conditions: Schizophrenia

Summary: to assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia (according to diagnostic and statistical manual of mental disorders \[dsm\]-iv-tr criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization * total panss score of ?60 at screening * history of schizophrenia of ?10 years (from onset of prodromal symptoms) exclusion criteria: * axis-i dsm-iv-tr diagnosis other than schizophrenia * less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic * currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
multimodal investigation of cortico-basal ganglia-thalamo-cortical network dynamics in dystonic patients with deep brain stimulation

Conditions: Dystonia

Summary: the goal of this prospective open label study is to elucidate the pathophysiology of dystonia and to understand how deep brain stimulation (dbs) influences brain networks. the investigators will enroll patients with dystonia implanted with dbs of the globus pallidus internus (gpi) with sensing implantable neurostimulators, capable of measuring gpi local field potentials (lfps). the main questions it aims to answer are: * does dbs influence pallidal lfps in the long term? * how the basal-ganglia-thalamo-cortical circuit is modified after dbs? * do lfps changes correlate with clinical improvement? participants will undergo to serial clinical evaluations, magnetoencephalography (meg) and functional magnetic resonance imaging (fmri) studies. primarily, the data obtained from our study might help in clarifying basic pathological electrophysiological features of dystonia. these features might be secondarily used in future to provide a framework for an effective application of closed-loop dbs in dystonia.


Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic or genetic dystonia who have already undergone dbs surgery of the globus pallidus internus * patient implanted with a neurostimulator capable of chronically recording lfps and which is fully compatible with magnetic fields up to 3 tesla. * age\>12 years exclusion criteria: * evidence of cns pathology or any other acquired conditions (perinatal, infective, toxic, neoplastic, vascular, psychogenic) responsible for the dystonia phenomenology, * focal distribution of dystonia * contraindications to brain mri or eeg/meg * adult subjects unable to express consent to inclusion in the study * pregnancy, and breastfeeding.

Keywords: dystonia movement disorders deep brain stimulation dbs local field potentials biomarker magnetoencephalography meg fmri
nicotine lozenge to reduce smokeless tobacco use

Conditions: Tobacco Use Disorder

Summary: smokeless tobacco (st), which includes both chewing tobacco and snuff, has as many health risks associated with its use as cigarettes. while there are many treatment programs that focus on stopping tobacco use, there are no interventions that specifically focus on reducing tobacco use. this study will evaluate the effectiveness of nicotine lozenge at reducing tobacco use in st users.

individuals who use st are at risk for developing heart disease, stroke, high blood pressure, and cancer. other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. many individuals who use st recognize the health risks associated with st, but either do not want to quit or feel that it is impossible to quit. for these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. the need exists for a program specifically aimed towards reducing, rather than quitting, tobacco use. the purpose of this study is to evaluate the effectiveness of nicotine gum at reducing st use, as well as assessing the motivation to either quit or sustain lower levels of st use. this 8-week study will enroll frequent users of st. participants will be randomly assigned to receive either nicotine lozenge plus behavioral counseling or behavioral counseling alone. all participants will be asked to alternate use of their usual st brand with nicotine lozenge or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by 75% the following 4 weeks. participants will be required to maintain a daily tobacco use diary. study visits will occur once a week. tobacco levels will be monitored with urine tests, and questionnaires will be completed to assess tobacco use. follow-up evaluations will occur 12 and 26 weeks following the end of treatment.

Eligibility criteria:
inclusion criteria: * no interest in stopping st use within 90 days of study entry * using st at least 6 times a day in the 6 months prior to study entry * willing to use contraception throughout the study exclusion criteria: * current use of tobacco or nicotine products, other than st * current unstable medical condition * use of any medication that may affect tobacco use or be affected by a reduction in tobacco use * meets dsm-iv diagnostic criteria for any psychiatric disorder or substance abuse disorder within 6 months of study entry * use of any psychotropic medication within 6 months of study entry * pregnant or breastfeeding

Keywords: nicotine dependence tobacco dependence
intraoral 30% glucose effect in newborns

Conditions: Epilepsy; Hydrocephaly

Summary: newborn often sedated during mri but sedation itself creates adverse events and management is more challenging in the mr environment. the investigators describe the investigators initial experience with oral 30% glucose administration through a pacifier during mri for imaging of newborns. using this technique, majority of newborns can complete mri examination without the need for sedation and also offers the availability of administering sedatives to unsuccessful patients.

19 consecutive newborns over 10 months period were assessed retrospectively. 0.5-1 ml 30% glucose solution was administered orally and after suckling, the motionless and sleepiness of newborn was evaluated. if the target conditions was not achieved, 0.5-1 ml increments of glucose was added. after 2 consecutive oral glucose administration the newborns who did not keep motionless or sleep and had motion artefacts sedated with midazolam. the outcome measure was the success of the procedure which was determined by providing qualitative images appropriate for interpretation following 30% glucose administration. the routine blood glucose level measurement of the newborns after imaging procedures in the icu was also performed for each patient.

Eligibility criteria:
inclusion criteria: * newborns admitted from newborn intensive care unit for mr imaging exclusion criteria: * intubated newborns

Keywords: intraoral 30% glucose, newborn, mri