Kornimate/medical-research-clean huggingface dataset:
contrast-enhanced ultrasound in diagnosing patients with liver cancer undergoing yttrium-90 radioembolization

Conditions: Hepatocellular Carcinoma

Summary: this pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing patients with liver cancer who are undergoing yttrium-90 radioembolization. contrast-enhanced ultrasound may provide detailed imaging of the tumor arteries after the injection of a contrast-agent consisting of microbubbles, and may predict how much yttrium-90 will deposit in the tumor.

primary objectives: i. investigate the relationship between hepatocellular carcinoma (hcc) tumor perfusion on pre-procedural contrast-enhanced ultrasound (ceus) time intensity curve (tic) and post-procedural yttrium-90 (90y) microsphere distribution after 90y radioembolization (re). secondary objectives: i. study the potential of serial ceus tic examinations as a marker of tumor treatment response as assessed at 20 - 24 week computed tomography (ct) follow-up. outline: patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo ceus at baseline, 2 and 4 weeks, and 3 and 6 months. patients also undergo positron emission tomography/computed tomography (pet/ct) after standard of care 90y radioembolization at baseline.

Eligibility criteria:
inclusion criteria: * patients scheduled for 90y radioembolization for hcc as part of their standard of care exclusion criteria: * patients who have already received tumor treatment (either systemic or loco-regional such as previous y90re, microwave or radiofrequency \[rf\] ablation or transarterial chemoembolization \[tace\]) * pregnant or nursing * known cardiac shunt * known pulmonary hypertension * history of hypersensitivity to definity (perflutren lipid microsphere) or lumason * history of hypersensitivity to iodinated contrast agent * cannot consent for himself or herself
efficacy of wholetones® 2sleep music on health and sleep behaviors of healthy adults with insomnia symptoms

Conditions: Insomnia; Sleeplessness

Summary: (b) the investigators propose to conduct a four-week randomized controlled crossover trial on healthy adults with occasional sleeplessness to examine the efficacy of wholetones music on their health-related quality of life, sleep quality and quantity, anxiety/stress levels, mood, and emfit sleep tracker data. baseline sleep data will be obtained for the first week of the study. using a crossover design, each participant will then be randomized for 10 days to each of the following two conditions: (1) wholetones music and (2) classical music. the participants will be instructed to listed to the music for 30 minutes prior to sleep each night. the self-report assessments will be taken at day 0 (baseline), day 7, day 17, day 21, and day 31. the participants will also complete a sleep daily survey and use the emfit tracker nightly. it is hypothesized that the music conditions will result in improved sleep behaviors and self-report health outcomes compared to the classical music condition. it is also hypothesized that a dose-response will be evidenced with stronger effects found for wholetones music compared to the classical music.

to determine if the wholetones® or classical music was successful at alleviating symptoms of insomnia or sleeplessness when compared to not listening to any music, self-report data from large surveys was collected both at baseline, and during the interventions at day 17 (after the first music condition), and at day 31 (after the second music condition. participants also completed daily diaries which was comprised of 6 questions that assessed their music adherence, sleep quality, and music likeability. these were completed daily from baseline through to the end of the study. objective data was also collected during baseline period of 1-week, throughout both of the interventions (10 nights each for a total of 20 nights) and the washout period (4 nights) using the emfit tracker. this device relies on ballistocardiography, was used to objectively assess nighttime sleep in the natural environment. this sleep tracker is automatic, autonomous, and is installed under the mattress.

Eligibility criteria:
inclusion criteria: * insomnia index score indicating occasional sleeplessness exclusion criteria: * bmi over 34 * smokers * heart conditions * sleep apnea
sleep disordered breathing in children: inflammation and oxidative stress

Conditions: Sleep Disordered Breathing (SDB); Endothelial Dysfunction

Summary: the purpose of the study is to measure markers of inflammatory and oxidative stress known to be associated with cardiovascular morbidity in snoring children. in addition, to measure markers of local inflammation and to evaluate the response to treatment.


Eligibility criteria:
inclusion criteria: * children ages 6 months-18 years * suspected sleep-disordered breathing or will attend the pre-operative ent clinic for adenoidectomy or adenotonsillectomy exclusion criteria: * craniofacial abnormalities * neurological disorders * genetic disorders * infectious disease * chronic inflammatory disease * any underlying chronic medical condition
pressure injuries' prevention in newborn infants admitted to nicu

Conditions: Newborn; Pressure Injury

Summary: nasal continuous positive airway pressure (ncpap) is a respiratory support for neonates with respiratory distress syndrome (rds) and represents the gold standard for rds treatment in many neonatal intensive care units (nicu). respiratory supports providing synchronized nasal intermittent positive pressure ventilation may further enhance the success of non-invasive respiratory support. the most significant risk factor associated to ncpap management is nasal trauma. nasal injuries represent a source of pain and discomfort for infants. in some cases, they could become a site of infection and cause functional, cosmetic, long term outcomes as erythema or necrosis of the columella nasi. the aim of this study is to evaluate the effectiveness of nursing interventions to reduce the incidence of pressure injuries during ncpap support in infants admitted to nicu. it is hypothesized that implementation of some preventive interventions could improve nursing care quality and reduce nasal pressure injuries.

previous studies highlighted that nasal trauma, due to ncpap support, is caused by the following risk factors: * very low birth weight (\< 1500 g) * gestational age \< 32 weeks * ncpap duration \> 5 days * nicu stay of \> 14 days however, previous studies results are mixed regarding factors affecting nasal injuries in neonates supported with ncpap. interventions indicated as protective are: * appropriate size of mask or nasal prongs and headbands * use of hydrocolloid as nasal barrier dressing * a frequent alternation of the ncpap device (nasal prongs or mask) * a frequent assessment of skin integrity in this study a cohort of neonates (experimental group) will be prospectively enrolled and compared to a cohort of neonates born in 2018 (retrospective group) with similar characteristics. the nicu clinical procedures for skin integrity are similar for both cohorts but the experimental group will receive them with different frequency and modality based on previously defined risk factors that each newborn present. hence, aim of this study is: - to asses the effectiveness of specific nursing care interventions on the incidence of pressure injuries due to ncpap support in neonates admitted to nicu.

Eligibility criteria:
inclusion criteria: * informed consent signed from both parents or legally authorized representative * infants receiving noninvasive respiratory support with nasal continuous positive airway pressure (ncpap) or synchronized nasal intermittent positive pressure ventilation (snippv) exclusion criteria: * pre-existing nasal lesion

Keywords: cpap nicu nasal trauma
effects of simvastatin on biochemical parameters and outcome of ivf-icsi in pcos patients

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to determine whether simvastatin is effective in the improvement of ivf-icsi outcome in pcos patients.

simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial proliferation \& decreasing steroidogenesis (production of progesterone \& testosterone).polycystic ovary syndrome (pcos) is associated with increased cardiovascular risks and is characterized by ovarian theca-interstitial hyperplasia\& hyperandrogenism .this study will test the hypothesis that simvastatin improves biochemical parameters\& ivf-icsi outcome in pcos patients.

Eligibility criteria:
inclusion criteria: * pcos patients * age \<40 years * fsh\<10 iu/l exclusion criteria: * endometriosis grade 3 \&4 * history of tubal surgery * hydrosalpinx * history of mellitis diabetes

Keywords: pco simvastatin ivf embryo transfer
ventilator-associated pneumonia/hospital-acquired pneumonia requiring mechanical ventilatory support

Conditions: Pneumonia

Summary: the purpose of the study is to find out if high dose antibiotic (meropenem, merrem® i.v.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant pseudomonas aeruginosa, acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. the study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.


Eligibility criteria:
inclusion criteria: * onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility * diagnosis of hospital-acquired pneumonia requiring mechanical ventilatory support * patient or patient's legal guardian must sign written informed consent for study participation, pretreatment, and day 7 bronchoscopy exclusion criteria: * patients with hospital-acquired pneumonia caused by pathogens resistant to merrem * patients with allergies to cephalosporins, penicillins and carbapenems * patients taking anticonvulsant therapy for a known seizure disorder * patients with lung cancer * patients with cystic fibrosis, acquired immune deficiency syndrome (aids), neutropenia, active tuberculosis, or patients taking immunosuppressive therapy in preparation for or following an organ transplant. * patients who are pregnant or breast feeding * patients who are unlikely to survive * patients with certain infections in another area requiring treatment with additional antibiotics * patients with other underlying conditions that would make it difficult to interpret response to study drug. * patients who have been part of another clinical study 30 days before entry into this study. * patients with hypotension (systolic bp \< 85mmhg) or acidosis (arterial ph \<7.25 or serum bicarbonate \<15 mg/dl) despite attempts at fluid resuscitation * patients with profound hypoxia

Keywords: ventilator-associated nosocomial
zeplast- ped: zero_plasma trial in small infants undergoing cardiac surgery

Conditions: Bleeding; Cardiac Defect; Surgery--Complications; Fibrinogenopenia; Acquired; Transfusion-Related Acute Lung Injury; Transfusion-Associated Circulatory Overload; Congenital Heart Disease

Summary: in pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. fresh frozen plasma (ffp) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of transfusion related acute lung injury (trali), further worsening the postoperative outcome. in the adult patient ffp employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (pcc). we designed this phase ii pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.

the study population will be randomized to two groups: zeplast and control, respectively. the two groups will receive the same priming solution (containing red blood cells and albumin 5%) and heparin/protamine management. in both groups coagulation will be assessed with rotational thromboelastometry (rotem - extem, intem, heptem and fibtem tests) after heparin antagonization. in case of bleeding, coagulopathies will be treated differently: * in the zeplast group, fibrinogen deficiency (fibtem maximum clot firmness mcf \ 100 s) will be treated with 20 mg/kg of prothrombin complex concentrate; * in the control group, coagulopathies will be treated with 10-20 ml/kg of ffp. in case of refractory bleeding, pcc and fibrinogen can be administered as a rescue treatment. further rotem tests will be performed at 24 and 48 hours post surgery. outcome parameters will be collected at the same timepoints.

Eligibility criteria:
inclusion criteria: * newborns and infants with weight lower than 10 kg undergoing cardiac surgery with extracorporeal circulation: * informed consent signed by both parents or legal guardian. exclusion criteria: * emergency surgery; * known congenital coagulopathy or suspected based on anamnesis; * participation to other clinical trials; * known hypersensitivity to components and excipients of ffp , prothrombin complex concentrate or fibrinogen concentrate.

Keywords: bleeding pediatric cardiac surgery fresh frozen plasma fibrinogen concentrate prothrombin complex concentrate
effect of fgm on glucose control in diabetic patients

Conditions: Diabetes Mellitus

Summary: the aim of the study is to assess the eﬀect of fgm on glycemic control compared with smbg using a randomised controlled study design in adults with type 2 diabetes.

flash glucose monitoring (fgm) is a newly introduced glucose monitoring system. the aim of the study is to assess the eﬀect of fgm on glycemic control compared with standard blood glucose monitoring (smbg) using a randomised controlled study design in adults with type 2 diabetes. subjects will use unmasked fgm once a month or smbg to monitor glucose level for 3 months. patients in the smbg group will wear masked fgm to collect glycaemic variability data for comparison to the intervention group of the study. the primary outcome, hba1c, will be cpmpared at baseline and 3 month. glucose control parameters provided by unmasked and masked fgm will be compared in the two groups, including mean blood glucose (mbg), coefficient of variation (cv), area under the curve (auc), time in range(tir), etc.

Eligibility criteria:
inclusion criteria: 1. \>18 years old; 2. diagnosed as having diabetes who were willing to perform the study and complete the data collection; 3. in stable condition prior to the study. exclusion criteria: 1. pregnancy or attempting to conceive; 2. known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin; 3. skin lesions, scarring, redness, infection, or edema at the sensor application sites; 4. patients whose conditions were extremely severe and not stable.
objective sleep behavior in relation to a nigth competition in athletes.

Conditions: Sleep; Athlete; Sleep Deprivation

Summary: sleep is a crucial factor for athletes' health and recovery. many variables are able to negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high volume or high-intensity training period, and a nigth competition too. therefore, the aim of this pilot study is to evalute how sleep quality changes in relation to a late nigth competition in athletes.


Eligibility criteria:
inclusion criteria: * both genders * age between 18 and 45 * sport activity for \> or = to 8 hours/week. * signed informed consent exclusion criteria: * smoking * part-time or shift worker. * use of medications able to influence sleep * any medical conditions (injury) contraindicating physical exercise as diagnosed by a sports medicine physician

Keywords: sleep athlete sleep profiler
integrated eating aversion treatment manual-parent version

Conditions: Feeding and Eating Disorders of Childhood

Summary: the purpose of this study is to further develop the integrated eating aversion treatment (ieat) manual, which is designed to address chronic food aversion in children with chronic food refusal. this study will evaluate the feasibility and efficacy of the ieat manual when it is used in the home home environment with caregivers.

the purpose of the current study is to further develop the integrated eating aversion treatment (ieat) manual and address the unmet needs of many children with chronic food refusal by providing a technology-based treatment that makes it easy for parents to understand how to duplicate the models of institutional care. the study seeks to expand upon this treatment by introducing the manual and procedures in an electronic form to be implemented by caregivers in a home environment. the study team aims to enroll 20 participants with chronic food refusal and formula or feeding tube dependence. participants will be randomly assigned to receive the ieat manual intervention with the technology supported manual or a control group (10 participants per group). the intervention with the ieat manual will involve 10 biweekly outpatient appointments of about 45 minutes in length. target behaviors will be assessed during each treatment meal. participants will be assessed pre-treatment and at a one month follow-up to assess long term effects. parents in the control group will provide a food diary once a month, for 5 months. those assigned to the control group will be able to cross-over to receive the ieat treatment manual following completion of post-study measures. screening, collecting data for outcomes measures, and the intervention will be conducted at the each participant's home. data will be collected on parent compliance with the treatment manual and child food acceptance, nutritional intake, and refusal behaviors.

Eligibility criteria:
inclusion criteria, for the child: * the child demonstrates failure to meet appropriate nutritional and/or energy needs based on diagnostic and statistical manual (dsm)-v criteria (american psychiatric association, 2013) for avoidant/restrictive food intake disorder * present with partial food refusal as evidenced by greater than 50% of caloric needs met by bottle, formula, or tube feedings * have a medical history significant for an organic factor (e.g., gastrointestinal issues) which precipitated or played a role in the development of feeding concern inclusion criteria, for the parent/caretaker: * must be english literate * must have access to an ipad or a computer exclusion criteria, for the child: * patients with active medical diagnoses requiring hospitalization or significant oversight from a physician * patients with active medical, structural, or functional limitations preventing safe oral intake of pureed foods (e.g., aspiration, upper airway obstruction) exclusion criteria, for the parent/caretaker: * caregivers do not commit to implementing the structured feeding protocol at least 2 times daily

Keywords: gastrointestinal disorders nutrition behavioral
family weight management study

Conditions: Obesity; Diabetes

Summary: the purpose of this study is to address the healthy people 2010 obesity prevention objective. this study will test the effects of a comprehensive family weight management program on the bmi z-score of 7-12 year-old children with a bmi \> 85th percentile who receive primary care in a large municipal bronx hospital. the intervention framework will draw on social marketing theory and the transtheoretical model of behavioral change to incorporate successful obesity prevention strategies. a two-arm randomized controlled clinical trial (rct), which will enroll (n =506) 7-12 year old children with a \> 85th bmi percentile, will compare the experimental intensive intervention to a standard (control) intervention. the standard intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2)quarterly follow-up, 3) and a monthly newsletter. the intensive intervention will add: 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) tailored support using a "toolbox" approach from community health workers as extensions of the family weight management professional education staff, and 4) monthly after-core follow-up groups. the study will determine if children randomized to the experimental intensive intervention will have greater improvement in bmi change (z-scores) than those randomized to the control standard intervention. the study will also evaluate the effects on the experimental intervention on lifestyle variables and assess intervention costs. the re-aim evaluation will address: reach: how many of the eligible children/ families were referred and how many of those referred actually enrolled? we will use bmi data in the computerized medical records to evaluate the proportion and the appropriateness of the referrals. efficacy/effectiveness: how did the experimental intervention affect bmi (changes in z-score), and key biomarkers when followed as planned? adoption: how acceptable were the intervention(s) to the primary care medical team and the children/families in the pediatric clinics etc? (from process measures and post intervention surveys) implementation: how many of the intervention activities were provided as planned? quality control measures will be used to evaluate the integrity of the intervention(s). maintenance: how much of the intervention effect is sustainable? individual effects will be evaluated based on the 24 month follow data. institutional effects evaluation will include the potential to maintain services using third-party coverage.


Eligibility criteria:
inclusion criteria: bmi greater than 85th percentile for sex, age 7-12 years exclusion criteria: health or condition that would interfere with study participation, unwilling or inability to provide parent/guardian consent or child ascent, intention to move from area -

Keywords: children obesity weight loss prevention diabetes risk cardiometabolic