Kornimate/medical-research-clean huggingface dataset:
reducing intensive care unit (icu) related anxiety through a structured information program

Conditions: Heart Diseases

Summary: according to current evidence and psychological theorizing, the provision of information seems to be a promising way to reduce the anxiety of patients that is related to their scheduled icu stay. an icu-specific information program will be investigated in a randomized controlled clinical trial involving 120 patients undergoing elective open heart surgery and 20 patients undergoing abdominal surgery. it is expected that the patients in the test group will experience less anxiety and icu related discomfort than patients in the control group.

objective: according to current evidence and psychological theorizing the provision of information seems to be a promising way to reduce anxiety of patients. in the case of surgical patients, admission to the intensive care unit (icu) is strongly associated with uncertainty, unpredictability and anxiety for the patient. thus, icu-specific information could have a high clinical impact. for this reason this study will evaluate the efficacy of an icu-specific information program for patients who undergo elective cardiac, abdominal or thoracic surgery and are scheduled for icu stay. methods: the trial is designed as a prospective randomized controlled trial including an intervention and a control group. the control group receives the standard preparation currently conducted by surgeons and anesthesists. the intervention group additionally receives a standardized information program with specific procedural, sensory and coping information about the icu. in addition the moderating effect of certain personality characteristics (need for cognition, high trait anxiety) will be investigated to identify groups of patients who benefit most from the information program. expected results: a clinically relevant difference in anxiety and unpleasant experiences related to the icu is expected after discharge from the icu. power calculation (alpha = 0.05; beta = 0.20; delta = 8.50 score points) resulted in a required sample size of n = 120 cardiac surgical patients (n = 60 vs. n = 60). furthermore, n = 20 abdominal or thoracic surgical patients will be recruited (n = 10 vs. n = 10). conclusion: the proposed study promises to strengthen evidence on the effects of a specific, concise information program and thus should contribute to evidence based nursing (ebn).

Eligibility criteria:
inclusion criteria: * elective open heart or abdominal surgery including scheduled icu stay * informed consent exclusion criteria: * elective surgery without icu stay * informed consent denied

Keywords: anxiety intensive care unit (icu) preoperative information randomized controlled trial (rct) chronic heart disease
outcomes of neonatal acute kidney injury in premature infants

Conditions: Acute Kidney Injury; Chronic Kidney Disease

Summary: the objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (aki), on the future risk of chronic kidney disease (ckd) by establishing a patient registry and biorepository. serum and urine samples will be collected serially from premature infants admitted to the neonatal intensive care unit (nicu) at albert einstein college of medicine/weiler hospital and subsequently followed in the nicu follow-up and pediatric nephrology ambulatory subspecialty clinics. the biorepository will be linked to a comprehensive clinical database.

this is an observational pilot study to enhance understanding of the pathophysiology and epidemiology associated with effects of aki in premature infants and the role that neonatal aki plays in future development of ckd. in eligible preterm infants, blood and urine samples will be collected at pre-specified time points during hospitalization and at outpatient follow-up appointments at 6 months, 1 year, 2 years, and 5 years of age and stored in the biorepository. blood pressure will be measured and recorded at nicu discharge and at all follow-up visits. a renal ultrasound will be performed to monitor renal growth at 2 and 5 years of age. all data will be entered into a comprehensive clinical database, including laboratory results.

Eligibility criteria:
inclusion criteria: * preterm infants less than 32 weeks/ gestational age admitted to the neonatal intensive care unit at weiler hospital (the children's hospital at montefiore). exclusion criteria: * known major congenital anomalies of the kidney and urinary tract (cakut) including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal hypoplasia, obstructive uropathy * other genetic syndromes or medical conditions that preclude enrollment per judgment of the attending neonatologist

Keywords: preterm acute kidney injury biomarkers chronic kidney disease
comparison of intraosseous anaesthesia using a computerized system (quicksleeper) to conventional anesthesia

Conditions: Deep Caries; Molar Incisor Hypomineralisation

Summary: the purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (quicksleeper) to a conventional infiltration anesthesia. our hypothesis is that anesthesia via quicksleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration. design: split-mouth design and parallel-arm design

local anesthesia is commonly used in oral health care and intra-mucosal infiltration anesthesia is most commonly used by practitioners. anesthesia may cause children a great deal of anxiety because of the fear of the injection. the latter can be painful if the product is delivered too quickly in the mucosa. recent developments in the techniques and anesthesia systems allow reducing pain during the injection. in particular, computerized systems (electronically assisted local anesthesia) allow a slow injection limiting pressure. moreover, these systems look like a pen which prevents the negative impression of the image related to the syringe metal. the intraosseous electronically-assisted anesthesia could be an interesting alternative to conventional infiltration anesthesia by making the act less stressful but also less painful for the child.

Eligibility criteria:
inclusion criteria: * split-mouth randomized controlled trial: patients with at least two first permanent molars requiring the same treatment with anesthesia * parallel-arm radnomized controlled trial: patients with first permanent molar requiring treatment with anesthesia * vital pulp * patient did not take any pain medication 48 hours before randomization * non-opposition of the child and two holders of parental participation in the study * treatments can be conservative treatment or endodontic treatment limited to pulpotomy. exclusion criteria: * patients with periodontal disease (periodontal pockets or tooth mobility) or radiological defects (necrosis, furcation or periapical radiolucency) * disabled or autistic patients * patients with cancer, heart disease or sickle cell anemia

Keywords: mih of the first permanent molar
early-myo-cmr-ii registry

Conditions: Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)

Summary: the purpose of this registry is to depict the myocardial tissue characteristics in nstemi patients by cmr and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. information will be collected prospectively in about 2000 nstemi patients in 10 sites. subjects will be followed for up to 5 years.

this is a prospective, multi-center, non-randomized, observational registry study of nstemi patients that undergo cmr examination. information of other cardiac imagings and clinical outcomes are also prospectively collected in the database. this project will establish a prospective registry of 2000 nstemi patients in 10 sites with follow-ups of up to 5 years. the aim of the project will be as following: 1. to investigate myocardial pathological features and functional changes in nstemi patients. 2. to identify cmr-derived indices that are associated with adverse clinical outcomes. 3. to compare cmr with other alternative cardiac imaging modalities (i.e., echocardiography or spect) on prognostic prediction in nstemi patients. 4. to compare myocardial tissue characteristics and functional changes in stemi (data derived from early-myo-cmr) and nstemi patients. 5. to verify grace score classification in nstemi from cmr imaging view.

Eligibility criteria:
inclusion criteria: nstemi patients who have had cmr imaging performed and have provided written consent. patient older than 18 years old with non-st-segment elevation myocardial infarction (nstemi): 1. ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization, 2. one of the two following criteria: 1. new st-segment depression ≥ 0.1 mv (≥1 mm), or transient (\< 30 minutes) st-segment elevation ≥ 0.1 mv (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram, 2. elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin t, troponin i, or ck-mb level above upper limit of normal, 3. patients who have had cmr imaging performed and have agreed to comply with the follow up requirements. exclusion criteria: 1. patient who is unable to comply with the follow-up schedule. 2. patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study. 3. patient has a life expectancy of less than 6 months due to any condition.
effect of visual feedback from the spirogym mobile application

Conditions: Parkinson Disease, Breathing Exercises, Visual Feedback

Summary: the previous pilot study showed that two weeks of intensive expiratory muscle strength training (emst) coupled with spirogym were sufficient to significantly improve the participants' voluntary peak cough flow (pcf). the improvement was quantitatively comparable to the results of other intensive emst studies with longer durations. when interpreting such rapid improvement, the impact of spirogym's visual feedback was considered. it was assumed that visual feedback increased training effort compared to regular training without immediate control. the aim of this study is to evaluate the effect of visual feedback provided by the spirogym mobile application on performance during expiratory muscle strength training in patients with parkinson's disease.

the study will be conducted as a prospective crossover experimental design. patients with parkinson's disease will complete two emst sessions (at 75% of maximum expiratory pressure), separated by a two-week period. one emst session will include feedback via the spirogym mobile application, while the other will be conducted without such feedback. the order of these conditions will be randomly assigned. primary hypothesis visual feedback provided by the spirogym application during expiratory training will result in higher muscle activation, as measured by surface electromyography (semg), compared to training without visual feedback. secondary hypothesis 1. participants using visual feedback during expiratory training will demonstrate greater expiratory performance, reflected by higher noise intensity recorded by the spirogym application, than participants training without visual feedback. 2. participants will report lower perceived difficulty and higher motivation to perform expiratory training exercises when visual feedback is provided, compared to when it is absent.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinsons disease * stable dopaminergic medication (stable dose for at least 1 month) exclusion criteria: * other neurological disorders * significant cognitive impairment * major psychiatric disorder * history of head or neck cancer or previous surgical interventions in the neck region. * illness during the study period
gastrointestinal anastomosis using monoplus® suture

Conditions: Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms; Digestive System Neoplasm; Stomach Tumor; Small Intestine Tumor; Colon Tumor; Rectum Tumor

Summary: the primary aim of this study is to collect clinical data on the performance of monoplus® suture applied in routine clinical practice. diverse parameters are to be used to assess the safety and efficacy of monoplus® suture for gastrointestinal anastomosis construction. this study has been designed to implement an action within the framework of a proactive post market clinical follow up (pmcf) activity.


Eligibility criteria:
inclusion criteria * adult patients undergoing an elective open or laparoscopic primary tumor resection within gi tract (stomach, small intestine, large intestine , colon and rectum. * age ≥ 18 years * asa ≤ iii * written informed consent exclusion criteria * asa ≥iv * emergency operations * peritonitis * surgical interventions in the pancreas, oesophagus * patients with traumatic perforations * pregnant and/or breast-feeding women * patients who had received chemotherapy within the last 4 weeks or radiotherapy on the treated region within the last 2 weeks * patients who were receiving immunosuppressant therapy

Keywords: tumor disease stomach tumor small intestine tumor colon tumor rectum tumor need for anastomosis
the effect of hiv tat protein on hcv replication in an in-vitro model system

Conditions: Human Immunodeficiency Virus (HIV); Hepatitis C, Chronic

Summary: investigators in the division of infectious diseases and the departments of biochemistry and molecular biology of the george washington university medical center are carrying out a research study to determine why patients with human immunodeficiency virus (hiv) and hepatitis c virus (hcv) co-infection (hiv/hcv) have a more rapid and progressive course of hcv infection, leading to fatty infiltration of the liver and cirrhosis.

samples will be collected from 4 groups of patients with hiv/hcv infection, identified by the virologic control of either hiv, hcv, or both. sera will be used in an in-vitro hepatocyte model of hepatitis c infection to better understand the pathogenesis of hiv/hcv co-infection, and to gain insight into intracellular mechanisms.

Eligibility criteria:
inclusion criteria: * meets one of the following criteria: 1. detectable hiv rna and detectable hcv rna 2. undetectable hiv rna (treated) and detectable hcv rna 3. undetectable hiv rna (treated) and undetectable hcv rna 4. undetectable hcv rna (mono-infected) 5. detectable hcv rna (mono-infected) 6. detectable hiv rna (mono-infected) participants will be men and women, ages 18 and older, and who are patients being seen in the clinics of the medical faculty associates, and meet the above criteria. exclusion criteria: * none

Keywords: hiv/hcv coinfection tat protein hcv
effect of panax ginseng on the cognitive performance in alzheimer's disease

Conditions: Alzheimer's Disease; Memory Decline

Summary: we investigate the clinical efficacy of panax ginseng in alzheimer's disease (ad).

alzheimer's disease (ad) is characterized by a progressive decline of memory and intellectual abilities, interfering activity in daily living, the overall quality of life, and ultimately leads to death. although pharmacologic treatments are currently approved for treating mild- to moderate ad using acetylcholinesterase inhibitors (acei) or memantine, the nmda antagonist, for the advanced stage of ad, the therapeutic efficacies need to be further improved. for millennia, ginseng or its components have been used to treat medical conditions, and the pharmacologic effects have been demonstrated in cardiovascular, endocrine and immune system (attele et al., 1999). in means of memory and learning, a number of studies suggested that ginseng can attenuate learning deficits of damaged or ageing brains in rodent models (kennedy et al., 2003; zhao and mcdaniel, 1998; nitta et al., 1995). in studies with human healthy participants, correspondently, both acute and chronic dosage of ginseng increased the cognitive performance (kennedy et al., 2001; kennedy et al., 2003; d'angelo et al., 1986; sorensen and sonne, 1996). in this study, we we will investigate the contribution of ginseng treatment in increasing the cognitive improvement of ad patients. in addition, we will test various bio-markers and hematopoietic progenitor cell count in those included patients using their blood samples. patients with ad as well as memory decline will be included

Eligibility criteria:
inclusion criteria: * alzheimer's disease exclusion criteria: * other neurologic disease

Keywords: alzheimer's disease, ginseng, cd34
glasses for adolescent delayed sleep-wake phase disorder

Conditions: Delayed Sleep-Wake Phase Disorder

Summary: the purpose of this study is to determine if evening amber glasses combined with stable wake times will show an increase in total sleep time (tst) and an advance in sleep onset times (shift earlier) compared to the control group.

we propose a 3-week field study that examines the efficacy, acceptance, and compliance of using evening amber glasses to block evening light combined with a stable wake time in adolescents (14-17 years) with dswpd (international classification of sleep disorders \[icsd-3\] criteria).3 after 1 week of baseline measurements, subjects will be instructed to wear glasses (which allow 14% entry of ambient light exposure) starting 7 h before individually calculated midsleep time measured during the preceding week. this corresponds to the time when adolescents are most sensitive to phase delaying light according to co-i crowley's recently published phase response curve (prc) to light in adolescents (figure 1).22 this "amber glasses + stable wake time" group will be compared to a control group: adolescent dswpd patients who will wear clear-lensed glasses (which allow 100% of ambient light to reach the eyes, otherwise identical in appearance) in the evening at the same times as the alternate group, but without scheduled wake times. outcome measures will include tst and sleep onset time derived from wrist actigraphy, daytime subjective sleepiness, salivary dlmo, and assessments of acceptance and compliance.

Eligibility criteria:
inclusion criteria * regular school attendance in the setting of a fixed start time. * adherence to icsd-3 dswpd diagnostic criteria. * average spontaneous weekend wake time ≥1 hour than school day wake time. * initiation of school-night sleep at 12 a.m. or later, ≥50% of the time, during a 14-day period (items 3-4 to be determined by sleep logs and actigraphy). as there are no discrete clock times associated with the icsd-3 dswpd description, this cutoff is based on data obtained from the 2006 sleep in america poll and experiences gleaned from prior recruitment. exclusion criteria * a positive urine drug abuse screen will disqualify the individual from further participation. * subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log. * alcohol and nicotine use will also be screened to qualify for the study. we will also screen for alcohol immediately before each dlmo assessment because alcohol acutely suppresses melatonin. * patients receiving medications that might contribute to sleep disturbances and/or affect treatment responses will be considered ineligible (e.g., hypnotics, antidepressants, stimulants, non-steroidal anti-inflammatory drugs (nsaids), beta blockers). * all subjects will be asked to refrain from caffeine use on the days of phase assessments, and to cease ingestion at least 6 hours prior to nightly bedtime. * the ishihara color blindness test will be done and patients who are color blind/deficient will be disqualified from participating in the study.
post-operative pain control in opioid tolerant patients: fentanyl challenge protocol versus standard of care

Conditions: Pain, Postoperative

Summary: this study will evaluate the value of dosing pain medications based upon a patient's pre-operative tolerance to pain medications. study participants will be assigned to one of two groups, a treatment group and a control group. the treatment group will be given pain medications after surgery based upon their measured response to pain medications prior to surgery. the control group will be given pain medications based upon the normal dosing routine as is currently practiced. both groups will be closely monitored for side effects and have their pain scores recorded for the first 48 hours following surgery.

this study will focus on patients who are opioid-tolerant pre-operatively, a patient population which typically has both higher pain scores and more complications related to analgesics than opioid naïve patients. currently, there is no standardized system for determining an adequate pain control regimen for a patient post-operatively. at this institution, pain medications are dosed per physician preference. the most widely-discussed method for calculating tolerance to opioids relies on converting a patient's daily opioid consumption to a morphine equivalent dose and basing a pain regimen upon that number. this method does not account for variability of response to different medications or dosing forms however. it would be advantageous to have a method of dosing opioid pain medications in this population that is both safe and effective.

Eligibility criteria:
inclusion criteria: 1. age \> 18 2. anticipated need for pca dosing post-operatively 3. will undergo major general, plastic, vascular, thoracic or spine surgery 4. have taken opioid medications orally or transdermally daily for the past 30 days exclusion criteria: 1. patients assessed to have a difficult airway 2. known sensitivity or allergy to fentanyl
atrial fibrillation without hemodynamic instability in the intensive care unit

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (icu) of a hospital. it is usually a transient occurrence that resolves as the patient recovers from their underlying condition. however, patients who develop af can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. not all patients with af will have unstable heart function but those who have rapid heart rates can worsen quickly. the goals of treatment for af with a rapid heart rate but no unstable heart function are two fold. patients can be treated by controlling the heart rate and/or by attempting to convert the af to a normal heart rhythm. the heart rate can be controlled by medication and the af can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the af with medication for patients who only have the rapid heart rate. the objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with af who have a rapid heart rate without unstable heart function.

see above

Eligibility criteria:
inclusion criteria: * new onset afib exclusion criteria: * hemodynamically unstable

Keywords: atrial fibrillation amiodarone