Kornimate/medical-research-clean huggingface dataset:
mpp programming study

Conditions: Heart Failure

Summary: the purpose of this study is to compare the efficacy of cardiac resynchronization therapy (crt) device programming with hemodynamic measurements to device programming without hemodynamic measurements.


Eligibility criteria:
inclusion criteria: * be scheduled to undergo implant of a st. jude medical (sjm) crt-d system with approved standard indication by esc/ehra guidelines * have the ability to provide informed consent for study participation and be willing and able to comply with the clinical investigation plan (cip) described evaluations and follow-up schedule exclusion criteria: * have high ventricular rate (\>90 bpm) during persistent or permanent atrial fibrillation despite available treatment * be in nyha iv functional class * have a recent myocardial infarction within 40 days prior to enrollment * have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months * have had a recent cva or tia within 3 months prior to enrollment * have had intravenous inotropic support in the last 30 days * be less than 18 years of age * be pregnant or planning to become pregnant during the duration of the investigation.
gingivitis treated with chlorhexidine 0.12% mouthwash in young adults

Conditions: Age Problem

Summary: the aim of this study will evaluate the effectiveness of 0.12% chlorhexidine solution as an anti-inflammatory agent and reducing the presence of biofilm in young adults.

thirty patients with gingivitis ages 18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will be selected and evaluate at baseline and after 4 weeks.

Eligibility criteria:
inclusion criteria: * presence of gingivitis * probing depth (pd) with maximum 3 mm * minimum of 20 teeth * age between 18 and 30 years old exclusion criteria: * patients with periodontal disease (pd ≥ 4mm with clinical attachment loss) * diabetes * osteoporosis * pregnant or lactating females * smokers * users of immune suppressive medication * phenytoin or cyclosporine * calcium channel blockers * antibiotics * nonsteroidal anti-inflammatory drugs * hiv+ or aids

Keywords: gingivitis periodontal treatment
the effect of brief versus individually tailored dietary advice on change in lipids, blood pressure, and diet in patients with inflammatory joint disease

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis

Summary: a randomized controlled study comparing brief dietary intervention with a personal, tailored dietary advice (60 min) on change in ldl-c and change in diet.

patients with inflammatory joint diseases (ijd) as rheumatoid arthritis (ra), spondylo arthropathy (spa) and psoriatic arthritis (psa) are at high risk of atherosclerotic cardiovascular disease. international recommendations for the prevention of cardiovascular disease recommend smoking cessation, physical activity, and dietary changes as part of treatment. despite the evidence that behavioral counseling reduces overall cardiovascular risk, it is often an overlooked and underemphasized by clinicians. as of today, there is a knowledge gap regarding the efficacy of less intensive counseling sessions needed to obtain changes in dietary habits and clinical effects on cvd risk factors. therefore, a brief dietary advice would be preferable if it could give a positive change in dietary habits and cholesterol. we have previously shown in a pilot study (8) that a 4 min. brief advice compared to a 60 min. personal tailored advice by a dietician on heart-friendly diet gave a similar change in dietary habits and ldl-c after 8 weeks in patients with ijd. the aim of the diet study is to perform a randomized controlled study comparing brief intervention (4 min) with a personal tailored dietary advice (60 min) on change in ldl-c and change in diet.

Eligibility criteria:
inclusion criteria: * patients with either ra, psa, or as, between 30-80 years with an increased risk of future cvd, estimated using the cvd risk calculator. i.e. any risk \&gt; 5 -10 % predicted by systematic coronary risk evaluation (score2) algorithm. also, patients with very high risk (predicted risk \&gt;10%) as well as established atherosclerotic cvd (ascvd) including previous myocardial infarction, coronary intervention (coronary artery bypass grafting or percutaneous coronary intervention), transient ischemic attack/strokes, atherosclerotic diseases of arteries as in the carotid artery or peripheral arterial disease (pad) will also be included. exclusion criteria: 1. heart failure with systolic ef\&lt;40% 2. kidney failure with gfr \&lt; 35 3. liver failure 4. mental disorder rendering the patient unable to comply with the protocol 5. being able to speak the language of the country 6. reduced cognitive function 7. substance abuse
evaluation of antioxidant and anti-inflammatory effect of matcha tea intake on periodontal health

Conditions: Gingival Disease

Summary: aim of the study: this study aims to evaluate the antioxidant and beneficial effects of matcha tea daily intake on periodontal health. objectives: * to evaluate the salivary level of antioxidants (catalase, total antioxidant capacity) after matcha tea intake compared to green tea over a period of one month. * to evaluate the clinical periodontal parameters including bleeding on probing (bop), probing pocket depth (ppd) and plaque index (pi) after matcha tea intake compared to green tea over a period of one month. * to evaluate the salivary levels of il-1b after matcha tea intake compared to green tea over a period of one month.


Eligibility criteria:
inclusion criteria: * • having at least 20 teeth, * underwent no medical treatment during the last 3 months before examination and sampling, * non-smoker, * no history of systemic disease, * gingivitis patient (having \>10% bleeding sites with no ppd \>3 mm). exclusion criteria: * • wore orthodontic appliances, * pregnant or currently in the breast-feeding period, * periodontitis patient, * smoker, * has a history of systemic disease.
electronic hand hygiene monitoring and icu infection rates

Conditions: Cross Infection

Summary: if patients acquire a new infection whilst in hospital this can cause significant morbidity, prolonged hospitalisation and even death. indeed, there is much public concern about infections such as mrsa. patients who require intensive care are probably at the greatest risk. appropriate hand hygiene by healthcare workers can reduce infection rates and is a key goal of many patient safety initiatives. worldwide, hand hygiene compliance has been estimated at only 38.7% despite the intervention being simple and cheap. reasons for poor compliance include lack of time, skin irritation, lack of facilities, intensity of workload and forgetfulness. furthermore, since cross infection may not be apparent for some days, staff may not associate their (lack of) actions with having caused harm. measuring compliance levels enables staff to understand whether they could improve. direct observation of staff is labour intensive and is not continuous or universal. we will monitor hand hygiene compliance with a newly developed electronic system (medsense, general sensing inc.). we will use the data to provide feedback to the staff in several ways. we hypothesise that comprehensive personalised feedback will reduce healthcare associated infections. we will undertake the study in three intensive care units.

all patients admitted to three intensive care units will be monitored for healthcare associated infections. in parallel the units will be cluster randomised to implement the electronic compliance monitoring in three different ways: * unit level feed back every week of current compliance for each of three staff groupings (doctors, nurses, allied health professionals) * personalised feedback in the form of an email at the end of a shift stating an individuals performance relative to the average for their professional grouping. * real time feedback in the form of a badge worn by the healthcare worker that vibrates when the system thinks they have missed or are about to miss an opportunity for hand hygiene. all healthcare workers will receive the level of feedback defined in the randomisation for the duration of the three intervention periods. the units will cross-over with an interventing two week wash out period. all personal feedback will be confidential and private to the individual.

Eligibility criteria:
inclusion criteria: * all patients admitted to the intensive care units * all healthcare workers caring for the patients on the intensive care units. exclusion criteria: * healthcare workers with skin sensitivity to both alcohol hand rub and soap

Keywords: critical care feedback
effect of tyrosine supplementation on cognitive performance and mood during military stress

Conditions: Reaction to Severe Stress, Unspecified

Summary: the objective of this research is to determine if tyrosine, an amino acid found in protein-containing foods, will mitigate the cognitive deficits and adverse effects on behavior and mood produced by exposure to military stress. this study was conducted at the us navy survive, evade, resist, escape (sere) school at brunswick, maine (me). tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain neurotransmitter that is critical for the central nervous system (cns) response to various types of acute stress. psychological stress increases catecholamine turnover in the brain, increasing the requirement for tyrosine to support synthesis of norepinephrine. animal and human studies have shown that tyrosine supplementation can produce beneficial effects on cognitive and physiological functions during exposure to a variety of acute stressors. this project will determine if volunteers treated with supplemental tyrosine during stressful phases of sere training experience less degradation in cognitive performance and mood than volunteers treated with placebo. tyrosine or placebo will be administered in a specially developed food bar provided to volunteers. the bar is part of a prototype of ration-component designed for use during assault operations. a between-subjects, double blind experimental design will be employed. tyrosine, an amino acid found in most protein-containing foods, has been tested in hundreds of volunteers without adverse effects. approximately 100 volunteers will be recruited from several sere classes to ensure up to 80 volunteers complete the study. they will be tested during several portions of sere. a comprehensive but brief battery of cognitive tests, as well as saliva samples, and heart rate data will be collected in a manner that does not interfere with ongoing training. hypotheses: 1. exposure to the stressors of sere school will adversely impact cognitive performance and mood of volunteers. 2. the adverse effects of psychological stress on cognitive performance and mood during sere school will be reduced when volunteers are given supplemental tyrosine compared to placebo treatment.


Eligibility criteria:
inclusion criteria: * active duty military enrolled in the us navy sere school, brunswick, me. * fluent in english (non-native english speakers can be enrolled). exclusion criteria: * none. \[all volunteers enrolled in sere school require a medical clearance. no additional inclusion or exclusion criteria are necessary.\]
better lifestyle counseling for african american women during pregnancy

Conditions: Overweight or Obesity; Pregnancy Related; Sleep Disturbances; Sleep Hygiene; Pregnancy Complications; Diversity; Stress, Psychological; Fitness Trackers; Exercise; African Americans; Disparities in Pregnancy Complications; Sleep Disparities

Summary: the purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in african american women.

this is a randomized controlled parallel-group trial with two arms. potential subjects will be identified from the ob clinics at ui health systems, the university of illinois at chicago. after baseline assessments, the subjects will be randomized to the attention control arm (birth-prep) or better intervention.

Eligibility criteria:
inclusion criteria: * african american pregnant woman. * women between 16 and 22 gws. * overweight or obese - pregravid body mass index \>25.0 kg/m2. * singleton gestation. * established prenatal care at the university of illinois hospital \& health sciences. * system obstetric (uihhss' ob) clinics. able to understand, speak and write in english. exclusion criteria: * multiple gestations. * night-shift work. * diagnosed sleep disorders. * known fetal chromosomal or anatomical abnormalities. * diagnosed mood disorders. * gestational diabetes in early pregnancy. * glycated hemoglobin (hba1c) ≥ 6.5%. * hypoglycemic medications. * stimulant medication or taking a sleeping aid. * active drug abuse/excessive alcohol intake.

Keywords: sleep, pregnancy, intervention, glucose metabolism,
community oral nutrition support trial

Conditions: Malnutrition

Summary: the purpose of this study is to determine the best form of dietary intervention to undernourished elderly individuals in care homes. the research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice as the first line treatment for malnutrition.

a prospective, randomised, parallel, open-label trial, study in malnourished care home residents, without obvious dementia, to compare the effects of two common forms of nutritional support; dietary advice (da) and oral nutritional supplements (ons), on quality of life (qol) and other outcomes including weight, nutritional intake and appetite. the residents were randomised to receive either da provided by a dietitian or ons for a period of 12 weeks. the primary outcome measure was qol and the secondary outcome measure was dietary intake.

Eligibility criteria:
inclusion criteria: * male or female * age \> 50 years * at risk of malnutrition * competent to provide written informed consent and to answer questions * able to eat and drink * willingness to take part in the trial and to follow the trial protocol exclusion criteria: * requirement for tube or parenteral nutrition * galactosemia * receiving current oral nutritional supplementation * palliative care * chronic renal disease requiring dialysis * liver failure * malignancy * participation in other studies

Keywords: quality of life supplement care home elderly malnutrition
a pharmacokinetic/pharmacodynamic (pk/pd) and safety evaluation of oseltamivir [tamiflu] in the treatment of infants 0 to <12 months of age with confirmed flu infection

Conditions: Influenza

Summary: this study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir \[tamiflu\] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. patients positive for influenza virus on day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). the anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.


Eligibility criteria:
inclusion criteria: * infants \</=12 months of age * laboratory confirmed diagnosis of influenza within 96 hours prior to first dose * influenza symptoms for \</=96 hours prior to first dose exclusion criteria: * preterm infants less than 40 weeks (corrected for gestational age) * weight less than 5th percentile for age (corrected for gestational age) * concurrent gastrointestinal conditions that preclude enteric absorption of the drug * bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrollment * active or uncontrolled respiratory, cardiac, hepatic, cns or renal disease at baseline * symptomatic inborn errors of metabolism
impact of an icu diary on the well-being of patients and families. a prospective multicenter mixed study

Conditions: Stress Disorders Post Traumatic

Summary: the purpose of this study is to assess the influence of an icu diary implemented during the icu stay on the psychological well-being of patients and families after icu discharge.

implementation of an icu diary in a randomized design in 36 icus in france the icu diary contains entries from staff and families or relatives quantitative description of psychological well-being of the patients and families or relatives are evaluated 3 months after icu discharge qualitative evaluation of how the patient uses the diary is scheduled by a phone interview 6 months after icu discharge. an amendment of the ethic committee permitted to increase in 2016/02 both the number of eligible patients to 700 and the number of centers.

Eligibility criteria:
inclusion criteria: * patients with his family admitted in an icu and mechanically ventilated more than 48 hours exclusion criteria: * patients without families admitted in an icu and mechanically ventilated more than 48 hours * patients or families not fluent in french * patients moribund * patients with a neurologic or psychiatric disease responsible for admission or pre-existing before the icu admission * patients admitted after a cardiac arrest * deaf and mute patients

Keywords: family ptsd anxiety disorders depression disorders qualitative research
tennis elbow trial

Conditions: Lateral Epicondylitis

Summary: epi-x is a multicentered randomized controlled clinical trial of chronic lateral epicondylitis with parallel group design and two phases. in the first phase physical exercise treatment is given in the intervention group and expectance in the reference group. in phase 2 eccentric exercise versus concentric is tested.

chronic lateral epicondylitis is defined as the presence of a "tennis elbow" for more than 3 months. it is a common condition in the general population and often results in long-term sick-leave. the etiology is unknown. a large number of treatments have been tried but none is generally accepted. however, in achilles tendinitis a new treatment has been shown effective. it consists of eccentric exercise, i.e. work during stretching rather than shortening of the muscle (concentric exercise). the latter is currently the most common treatment method. this project is a randomised controlled clinical trial of eccentric versus concentric exercise in 205 patients with chronic lateral epicondylitis. pain and muscle strength were recorded at start of treatment and after 1,2,3,6 and 12 months. activities of daily life (adl) and well-being were recorded at start of treatment and after 3, 6 and 12 months. in addition, blood specimens for a number of neural peptides have been sampled. moreover, the involvement of the peripheral nervous system in the elbow area has been examined in a subsample of patients. a biopsy from 20 patients per treatment group and from 20 healthy subjects, and a positron emission tomography (pet) scan of 23 patients were performed to allow qualitative and quantitative examination of neural fibres, peptides and receptors. the health economy of the two treatments will be investigated using data from this project and from available registers.

Eligibility criteria:
inclusion criteria: * verified tennis elbow for more than three months * age 20-75 years * informed consent exclusion criteria: * inability to understand or follow instructions * inability to read or fill in questionnaires * inability to participate at measurement sessions * supinator syndrome * compartment syndrome of anconeus muscle * rhizopathy of arm * inflammatory joint or soft tissue disease including fibromyalgia * previous surgery because of tennis elbow

Keywords: tennis elbow epicondylitis pain muscle strength quality of life rct tendinitis chronic tennis elbow
correlation of serum adropin to testosterone and adiponectin in obese men

Conditions: Obesity; Dyslipidemias

Summary: obesity is associated with low testosterone in men and with dyslipidemia. adropin hormone is negatively correlated with body mass index and is associated with dyslipidemia. correlation between adropin and testosterone will be evaluated.

obesity, a worldwide epidemic is associated with multiple adverse health outcome as diabetes mellitus, hypertension and cardiovascular diseases caused mainly by dyslipidemia linked to obesity. low testosterone levels in obese men were found associated with dyslipidemia. adropin is a new metabolic hormone that was first isolated in liver and brain tissues, it was observed that mice fed on a high-fat diet (hfd) had a rapid increase in adropin expression compared to control values. in human also, adropin levels were negatively correlated with body mass index (bmi) and were associated with dyslipidemia. adiponectin is a protein that is mainly produced by white adipose tissue and has an important role in lipid metabolism. serum adiponectin concentrations were decreased in obese compared to normal weight men and significantly correlated with testosterone level.

Eligibility criteria:
inclusion criteria: age from 18 years to 50 years. clinically free except from obesity exclusion criteria: * diabetes mellitus hypertension heart failure kidney disease smoking

Keywords: adropin adiponectin testosterone obese men
radiological evaluation of 3d printed porous collars in hip and knee resection prostheses: pilot study.

Conditions: Bone Tumor

Summary: this study aims to evaluate the osseointegration of 3d printed porous collars in hip and knee resection prostheses, in order to eliminate one of the causes of diaphyseal osteolysis, which often lead to loosening of the implants, and therefore to guarantee a further improvement in fixation of the implants in terms of both primary and secondary stability.

non-interventional, retro-prospective, non-pharmacological multicenter pilot study. the objective of the study is the radiological and clinical evaluation of collar osteointegration porous 3d printed in hip and knee resection prostheses. aims to enroll patients undergoing resection prosthesis surgery hip and knee with the use of 3d printed porous collars, performed according to normal practice clinic at the institutions participating in the study. it is structured in a retrospective part which will evaluate the patients for whom follow-up data is available at the time of the start of the study up to at least 1 year after the operation. and a prospective part (both with regard to patients not yet subjected to intervention, at the start of the study, according to the inclusion criteria, both regarding those in follow-up for whom data are not available according to the time of observation required (1 year)) which will begin once all the necessary authorizations have been obtained administrative requests.

Eligibility criteria:
inclusion criteria: * age \> 18 years at the time of surgery. * patients undergoing hip and knee resection prosthesis surgery with the use of collars porous 3d printed. * date of intervention: starting from the regular entry into use of 3d printed porous collars at the reference center. * patients operated on for primary tumor outcomes. * patients operated on for infection. * patients operated for revisions with severe loss of bone substance. * patients capable of giving informed consent and obtaining written informed consent (prospective part/patients in follow-up). exclusion criteria: * patients lost to follow-up and/or for whom radiographic and clinical documentation is not available corresponding to the post-operative moment and the clinical follow-up visit (6 months and 1 years).

Keywords: radiological evaluation clinical evaluation