Kornimate/medical-research-clean huggingface dataset:
flavonoid supplementation and endothelial function

Conditions: Healthy

Summary: flavonoids are one of the many classes of natural chemicals found in a variety of foods. people with the highest flavonoid blood levels have the lowest rates of coronary heart disease. this is considered one of the reasons why high fruit and vegetable consumption is associated with lower rates of heart disease, although it is not known if taking a flavonoid supplement provides the same protection as eating fruits and vegetables. the purpose of this study is to determine if a particular flavonoid supplement, called isotonix opc-3, taken on a daily basis, will improve the function of arterial vessels. arteries normally constrict after eating a high-fat meal. this study will examine the potential of the opc-3 to lessen this constriction response. approximately 25 people will be involved in this research project and participation will last for 10 weeks.

we propose to use a supplement made by nutrametrix (called opc-3), consisting of oligomeric proanthocyanidins derived from grape seed, pine bark, bilberry, citrus and red wine extracts, to determine effects on endothelial function, lipoproteins and inflammation. the primary outcome measure will be endothelial function as assessed by digital response to hyperemia using peripheral arterial tonometry, measured both in the fasting state and after a single standardized high-fat meal, when transient dysfunction is expected to occur. secondary outcome measures will be the lipid profile, hs-crp, and lp-pla2. the recruitment population will be healthy volunteers. the design will be a randomized, placebo-controlled, double-blind, cross-over trial lasting 10 weeks.

Eligibility criteria:
inclusion criteria: * 18 yrs of age or older * no pregnant potential exclusion criteria: * history of coronary artery disease * history of cerebrovascular disease * history of heart failure * diabetes * renal impairment * uncontrolled hypertension * untreated or clinically evident thyroid disease * currently taking medications or supplements with known or potential lipid-altering effects including: phytosterols, statins, cholestin, niacin, fibrates, psyllium fiber, bile acid sequestrants, diabetic medications, and weight control medications such as orlistat * pregnancy or breastfeeding * tobacco use - participants will be excluded with a history of smoking anytime in the past 6 months. * inappropriate for participation in a study, if in the opinion of the investigator it is questionable whether the participant will be able to comply with all aspects of the protocol (e.g. inadequate cognitive skills, possible drug abuse or dependence, suspected psychiatric problems, etc.)

Keywords: flavonoids food supplements endothelial function no conditions allowed, healthy volunteers only
safety study of isis 325568 in healthy volunteers

Conditions: Type 2 Diabetes Mellitus

Summary: the primary purpose of this trial is to assess the safety of isis 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times.

to evaluate the safety of a single subcutaneous injection of isis 325568 administered at four increasing dose levels (50, 100, 200, 400 mg/week) and to evaluate the safety and tolerability of multiple doses of isis 325568 (three intravenous doses during study week 1, followed by once weekly subcutaneous administration for 5 weeks) at each of the four dose levels

Eligibility criteria:
inclusion criteria: 1. age 18 to 65 years 2. males or females. females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or post-menopausal. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, subject or partner must be using an acceptable contraceptive method during the trial and for 9 weeks after the last dose of study drug. 3. give written informed consent to participate in study and availability for all study requirements 4. fasting plasma glucose ≤ the upper limit of the laboratory's reference range (uln) 5. hba1c ≤ uln 6. bmi \< 30 kg/m2 exclusion criteria: 1. clinically significant abnormalities in medical history or physical examination 2. abnormalities on laboratory examination (alt \> uln, ast \> uln, bilirubin \> uln, creatinine \> uln, urine protein positive by urine dipstick, platelets \< lower limit of normal and any other clinically significant laboratory findings) 3. history of clinically significant abnormalities in coagulation parameters 4. positive test result for hiv, hepatitis b virus, and/or hepatitis c virus 5. active infection requiring antiviral or antimicrobial therapy 6. subjects on chronic or acute prescription medication may be permitted after discussion with the isis medical monitor. 7. malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> 1 year) 8. any other concurrent condition which, in the opinion of the investigator, would preclude participation in this study or interfere with compliance 9. history of alcohol or drug abuse 10. undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to screening. 11. blood donation within three months of screening

Keywords: diabetes
impact of adherence to anemia management policy on repeat hospitalization in end stage renal disease (esrd)

Conditions: Anemia; Mortality

Summary: the investigators hypothesize that the post-hospitalized patient status is characterized by subacute and reversible metabolic and hematological changes that, if addressed and treated in a timely manner, would result in a reduced risk for repeat hospitalization. consequently, a structured quality improvement program, focused on increasing adherence to company wide anemia management policies (ie hemoglobin monitoring within the first 3-5 days post-hospitalization, followed by an appropriate epo dose modification within the 7 days post-hospitalization), will significantly decrease the risk of hospital re-admission in the 30 days after discharge.

the post-hospitalization quality improvement project will be piloted across 30 fresenius clinics. targeted enrollment of 1500 episodes of hospitalization in which the patient returns after discharge to resume outpatient dialysis. patient outcomes will be followed for up to 30 days from the time of discharge from hospital.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission * enrolled in a facility-based anemia management program exclusion criteria: * enrolled in hospice * previous hospitalization within the past 30 days (ie. patients discharged from a repeat hospitalization) * anticipated discharge from the outpatient dialysis facility within 30 days (ie anticipated transfer to another facility or hospice)

Keywords: esrd anemia hospitalizations mortality
effect of prm-125 on ambulatory blood pressure

Conditions: Hypertension

Summary: evaluation of once-daily prm125 on ambulatory blood pressure in adults with hypertension

approximately 60 subjects with primary hypertension are treated for 8 weeks with prm125 to determine if ambulatory blood pressure is changed.

Eligibility criteria:
inclusion criteria: * primary hypertension exclusion criteria: * medical conditions that preclude evaluation and/or adversely effect subject safety
acute satiety and metabolic response of daily consumption of a fruit juice

Conditions: Healthy

Summary: the "clabel+ innovative natural, nutritious and consumer-oriented clean label food" is a research and technological development project centered on responding to the challenges facing the food industry. it is focused on the concept of "clean label", which emerges as one of the major current trends in the sector, given the growing number of consumers who are increasingly aware and eager for information, who are looking for alternative, more transparent and natural food products. thus, one of the aims of the clabel+ project is to research the macronutrients and phenolic compounds present in food matrices and achieve a clean label positioning for the final products developed. this single group assignment clinical trial aims to evaluate the effect of daily consumption of a fruit juice, developed as part of the collaborative project clabel+, on gut microbiota composition and diversity in healthy adults. it is also intended to study the acute metabolic effect, namely in terms of appetite control, and lipid and glucose metabolism.


Eligibility criteria:
inclusion criteria: * men or women * adults (age ≥ 18 years) * filling informed consent exclusion criteria: * obesity (body mass index ≥ 30.0 kg/m2). * daily consumption of fruit juices in the month prior to the start of the study. * individuals with diagnosed food allergies or intolerances to the components being tested. * use of pro/prebiotics or fibre as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment. * use of laxatives 6 weeks before recruitment. * recent weight loss or weight gain of more than 10% in the last 3 months. * adherence to restrictive weight loss diets or specific dietary pattern (e.g., palaeolithic diet, atkins, flexitarian, ketogenic, vegan). * diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease, or diabetes mellitus. * having taken antibiotics within the 12 weeks prior to beginning the study. * excessive consumption of alcoholic beverages (\>14 and \>8 units/week for men and women, respectively). * pregnant or breastfeeding. * participation in another clinical trial within the past 3 months that the principal investigator believes may compromise the results of the trial (e.g., clinical trial with an effect on the composition and diversity of the gut microbiota).
early physical therapy intervention in preterm infants

Conditions: Preterm Infant; Physical Therapy; Early Intervention; NICU; Home; Motor Development

Summary: the hypothesis of this study is that early physical therapy intervention, initiated during the nicu stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age). there is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants. the principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age. the secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.


Eligibility criteria:
inclusion criteria: * preterm infants, gestational age between 28-34 weeks * families with ability to take care of the child, without chronic or mental illness * long-term parental presence in the hospital (at least 10h/day) exclusion criteria: * children diagnosed with congenital disease or brain injury (lpv, hiv), before or during the study * children undergoing major surgery (cardiac intervention, ductus, thoracic intervention) * children with musculoskeletal deformities
randomized clinical trial, open, multicenter parallel, no suspension inferiority prophylactic treatment with valganciclovir in kidney transplant cmv-seropositive cellular immunity to develop cd8 + cmv-specific treatment after induction thymoglobulin.

Conditions: Kidney Transplant Infection

Summary: hypothesis: valganciclovir prophylaxis can be discontinued before 3 months in cmv-seropositive renal transplant recipients receiving induction thymoglobulin when developing cmv-specific cellular immunity after transplantation. objective meet the efficacy and safety of valganciclovir prophylaxis suspend in cmv-seropositive kidney transplant recipients with cd8 + cellular immunity cmv-specific transplant, receiving thymoglobulin induction and maintain cellular immunity-specific cd8 + cmv after transplantation. design: noninferiority clinical trial (study a) in cmv-seropositive kidney transplant recipients with cmv-specific cellular immunity pretransplant (quantiferon reactive cmv) received induction with thymoglobulin patients meeting inclusion criteria will be randomized to: * control arm: valganciclovir prophylaxis until day +90 as recommended by the international consensus document of the tts (transplantation 2013:96:333-360). * experimental arm: prophylaxis with valganciclovir and determination of cmv-specific cellular immunity day +15, +30, +45 and +60. prophylaxis was discontinued when the patient developed cmv-specific cellular immunity. patients who did not develop cmv specific immunity continue prophylaxis until day +90. analysis: the incidence of cmv disease according to the strategy used was calculated using kaplan-meier curves that were compared using the log-rank test.


Eligibility criteria:
inclusion criteria: * renal transplant cmv-seropositive * cd8+ tcell cmv especific pretransplant (cmv-reactive quantiferon pretrasplant) * \> 18 years (adult) * receiving thymoglobulin induction therapy * receiving valganciclovir prophylaxis * written informed consent for trial entry exclusion criteria: * multivisceral transplants including kidney-pancreas. * hiv-infected patients * patients who can not comply with the monitoring protocol.

Keywords: cytomegalovirus, seropositive
vitamin c for prevention of urinary tract infections in the spinal cord injured

Conditions: Urinary Tract Infection; Spinal Cord Injury

Summary: after spinal cord injury, patients have frequent urinary tract infections (uvi). vitamin c is usually prescribed to prevent such infection, but the efficacy of the treatment is poorly documented. in the study, patients will be randomised either to receive vitamin c daily, or not, for one year, and clinical episodes of uvi will be registered. the null hypothesis is that vitamin c will not reduce the number of uvi episodes by 30%.

the study is an investigator-blind randomised parallel study on the efficacy of vitamin c to prevent urinary tract infections in stable, ambulatory spinal cord-injured patients. to be included, patients should have had at least 3 previous uvi episodes over the last two years. 40 patients are included. patients are randomised to receive either 1 g vitamin c b.i.d. over 1 year, or no vitamin c. the main outcome is the number of clinical uvis that have been treated with antibiotics.

Eligibility criteria:
inclusion criteria: * spinal cord injury * 3 or more episodes of uvi over previous 2 years exclusion criteria: * pregnancy * age \<18 * continuous use of antibiotics, hippuric acid or crane berry juice

Keywords: uvi spinal cord injury prevention vitamin c
effect of cognitive empathy training on dementia caregivers

Conditions: Caregivers of People Living With Dementia; Dementia

Summary: the goal of this project is to investigate the effect of cognitive empathy training on mental health, inflammation, and immune function in caregivers of people living with dementia (plwd), and to examine the underlying psychological and neurobiological mechanisms. the primary aim is to establish the effectiveness of cognitive empathy training in improving caregiver mental health and immune function, and in decreasing caregiver inflammation the secondary aim is to investigate the psychological and neurobiological mechanism by which cognitive empathy training improves caregiver well-being

in the u.s., over 7 million people currently live with alzheimer's disease and related disorders (adrd), a number projected to exceed 16 million by 2060. family caregivers, numbering more than 11 million, play a crucial role in managing the care of these individuals, often bearing significant emotional and financial burdens. in 2021, the cost of care for dementia reached $593 billion, with families contributing a substantial portion. caregivers frequently experience negative mental and physical health impacts due to chronic stress, including increased rates of depression and inflammation. research indicates that caregiving leads to decreased immune function, with elevated epstein-barr virus antibody titers serving as a marker for immune health. interventions aimed at supporting caregivers, such as psychoeducational programs, have shown benefits, particularly in enhancing coping skills. additionally, fostering cognitive empathy in caregivers may improve their mental health and the quality of care provided to individuals with dementia, potentially mitigating some of the adverse health effects associated with caregiving stress.

Eligibility criteria:
inclusion criteria: * caregivers must live with their care recipient * caregivers must have a zarit burden scale score of 19 or higher * caregivers must have no plans to move their care recipient to an institutional setting within the next year * caregivers must be able to read and write english * care recipient not in hospice * access to a mobile phone that can take and email photographs exclusion criteria: * subjects with a history of seizures or other neurological disorders, alcoholism, or any other substance abuse * subjects with a history of psychiatric illness (excluding depression and anxiety disorders) will also be excluded * subjects with a history of head trauma based on survey * subjects with mri contra-indications

Keywords: cognitive empathy people living with dementia caregivers
percutaneous cryoablation of central kidney tumours with temporary renal artery occlusion

Conditions: Kidney Cancer

Summary: percutaneous cryoablation is an alternative to urological surgery for t1a tumours, whose oncological efficacy decreases for the most central tumours due to a cold sink effect.


Eligibility criteria:
inclusion criteria: * adult subject (≥18 years) * subject who has undergone cryoablation of a central kidney tumour with temporary occlusion of the renal artery by an endovascular balloon at the hus during the period 01/01/2018 to 30/12/2021 * subject who has not expressed his/her opposition, after information, to the re-use of his/her data for the purpose of this research. exclusion criteria : * subject having expressed his/her opposition to participate in the study * subject under legal protection, guardianship or curatorship

Keywords: kidney cancer central kidney tumours renal artery occlusion cryoablation urological surgery t1a tumours cold sink effect endovascular balloon clamping renal hilum
steroid sparing effect of nasal corticosteroid in asthma and rhinitis

Conditions: Asthma; Allergic Rhinitis

Summary: up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. the use of inhaled corticosteroids reduces symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related deaths. similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves quality of life. while there is evidence that combined treatment of the nose and the lungs with topical steroids improves symptoms and underlying inflammation, it is unclear whether such control can be achieved using a smaller dose of inhaled steroid in combination with nasal steroid. it is therefore the intention of this study to evaluate if combination steroid therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis using sensitive markers of airway inflammation.


Eligibility criteria:
inclusion criteria: * mild to moderate atopic asthmatics with fev1 ≥ 60% on ≤ 1000 ug bdp and concomitant persistent allergic rhinitis (spt +ve and pc20 \< 4 mg/ml) * male or female aged 18-65 years * informed consent * ability to comply with the requirements of the protocol exclusion criteria: * severe asthmatics as defined by an fev1 ≤ 60% or pef variability \> 30% or with continual daytime or nocturnal symptoms. * nasal polyposis grade 2/3, deviated nasal septum ≥ 50% * the use of oral corticosteroids within the last 3 months * recent respiratory tract infection (2 months) * significant concomitant respiratory disease * any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol * any significant abnormal laboratory result as deemed by the investigators * pregnancy, planned pregnancy or lactation * known or suspected contra-indication to any of the imp's * concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Keywords: asthma allergic rhinitis fluticasone methacholine
exergaming training among hypertensive patients

Conditions: Hypertension

Summary: since hypertension affects all body systems and importantly postural balance control. so, the evidence indicates a strong link and connection between balance and hypertension through somatosensory, visual, vestibular, musculoskeletal, and cns integration of inputs from both peripheral and motor systems. therefore, to fill this gap of how much balance and each of its aspects/components are affected, this study will be done for a detailed examination of this genuine integration and clinical interaction among hypertensive with game-based techniques on all three balance components (concerning intensity, frequency, duration and dosage of vret). secondly, on the other hand (cr) programs, have shown very low compliance with recommended physical activity, which is why; by utilising this alternative, virtual reality exergaming can be used as a quick, appropriate and equivalent alternative to traditional exercise programs. also, in future, it could be suggested with promising effects in the provision of engaging, goal-oriented training for patients with hypertensive besides a sound, economical and clinically beneficial alternative to traditional cardiac rehabilitation. finally, by exploring detailed clinical integration of postural balance with hypertension using virtual reality the study will be able to highlight hypertension as a potent risk factor for future impaired balance and risks of falls. thereby, hypertension's early identification (considering all biological, psychological, and social factors) and prevention may avert hypertensive to future debilitating complications and outcomes as a result of it.


Eligibility criteria:
inclusion criteria: 1. diagnosis of community dwelling controlled hypertensive (particularly stage 1, 130 to 139 (systolic) or 80 to 89 (diastolic) or stage 2 hypertension from 140 or higher (systolic) or 90 (diastolic) if present with any (controlled diabetes or overweight patients) with a medical referral form for medical specialist with physiotherapeutic treatment provided by the local public or private healthcare system 2. any race or gender with age 20 or older 3. no history of any orthopedic, neurological, pulmonary or psychological disorders, cognitive impairments etc. 4. had not performed physical activity in the previous three months. exclusion criteria: 1. grade iii or grade iv heart failure according to the new york heart association (nyha) functional classification. 2. recent acute myocardial infarction; unstable angina; acute pericarditis. pulmonary hypertension; uncontrolled diabetes mellitus; hypertensive crises or uncontrolled hypertension or pregnancy 3. patients who had three consecutive absences during the intervention 4. unable to answer or understand the gaming or exercise protocols and quality of life questionnaires and fulfil the exercise protocols, due to any severe cognitive deficit 5. pain with ambulation or dizziness when standing or walking. 6. contraindications to treadmill walking or vr gaming

Keywords: balance exergaming gait brain derived neurotrophic factor biomarker biopsychosocial