Kornimate/medical-research-clean huggingface dataset:
immune response to cytomegalovirus

Conditions: Cytomegalovirus Infections

Summary: this study will evaluate immune responses against cytomegalovirus (cmv). about 80 percent of adults have been exposed to this virus. cmv typically remains dormant (inactive) in the body, causing no problems. in people with immune suppression, however, the virus can become reactivated and cause life-threatening pneumonia. the knowledge gained from this study may be useful in developing ways to improve immune responses to cmv in stem cell transplant recipients. healthy normal volunteers between 18 and 65 years of age who have been exposed to cytomegalovirus are eligible for this study. candidates will be screened with a medical history and blood tests. those enrolled will provide a 30-milliliter (6-tablespoon) blood sample once a week for 4 weeks and a final sample 2 months later. the blood will be used to design a test to detect immune responses against cmv and determine the differences in these responses among healthy individuals.

the nhlbi stem cell allotransplantation program is researching methods to improve immunity against infectious organisms following allogeneic stem cell transplantation (sct). we are particularly interested in cytomegalovirus (cmv), which can cause serious problems in patients following transplantation. in the future, we hope to design ways to improve immune responses to cmv in transplant recipients, such as vaccinating transplant donors and/or patients against this virus. in order to characterize the effect of any such intervention on cmv immunity, we first need to better understand cmv immune responses in normal, healthy persons. this involves designing and validating an in vitro assay, which can reliably and consistently detect immune responses against cmv. furthermore, we hope to define the temporal variability that exists in cmv responses in healthy individuals, which is essential for the design and implementation of all future studies. we plan to collect blood samples from 20 normal volunteers who have been previously exposed to cmv (cmv seropositive individuals). eligible individuals will be asked to donate blood on five occasions, once a week for four weeks and a fifth time, two months later. eligible individuals must be 18-65 years of age, otherwise healthy, and seropositive for cmv exposure.

Eligibility criteria:
inclusion criteria: age 18-65 cmv seropositive informed consent given exclusion criteria: cmv seronegative abnormal blood counts (hemoglobin less than 12 g/dl, platelets less than 150,000/ul, absolute neutrophil count less than 1,500/ul, absolute lymphocyte count less than 1,000/ul) known history of heart, lung, kidney, liver, or bleeding disorder diagnosis of hiv infection diagnosis or suspicion of immunodeficiency state history of intravenous drug use currently pregnant

Keywords: normal volunteer phlebotomy cytomegalovirus cmv cmv seropositve
breastfeeding and obesity on offspring body composition

Conditions: Obesity; Breast Milk Collection

Summary: the purpose of this study is to explore the effect maternal obesity and breastfeeding play on infant body composition. the investigators hypothesize in the first 6 months of life breast fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and accumulate fat at a greater rate than breast fed infants from normal weight mothers. furthermore, the investigators postulate that circulating maternal milk adipocytokines will positively correlate to total fat mass at six months of age.

the objective of this study is to determine if offspring from overweight/obese non-diabetic mothers whom breastfeed have greater total fat and trunk fat mass and accumulate fat mass at a greater rate from \~ 1 month to 6 months of life compared to breastfed infants from normal weight mothers. specific aim 1: understand how maternal obesity and breast-feeding impact body composition of the offspring. based upon the investigators preliminary data and counter to accepted dogma the hypothesis is at six months of age total fat mass, particularly in the trunk will be elevated at 6 months of age in infants whose mother was either overweight or obese vs. infants from normal weight mothers. specific aim 2: identify adipocytokines in breast milk. the postulate is breast milk from overweight and obese mothers will have greater levels of insulin, glucose, ghrelin, igf-1, il-6, tnfα, high-sensitivity c-reactive protein, and lower leptin levels than breast milk from normal weight mothers and will be correlated with offspring fat mass.

Eligibility criteria:
inclusion criteria: * gestational age between 37 and 41 weeks * singleton birth * infant in good health * 40±5 days old at enrollment * infant is being exclusively breastfed (defined as fed directly from the breast or with mother's expressed milk and receiving no formula in the last 20 days prior to enrollment) * mother of an infant being exclusively breastfed plans to continue this exclusive feeding from the time of enrollment until six months of age * parent/caregiver demonstrates an understanding of the given information and ability to record the requested data * having obtained informed consent of legal representative exclusion criteria: * congenital illness or malformation that affects infant feeding and/or growth * significant pre-natal and/or post-natal disease * infant has received any complementary feeding, i.e. any nutrition besides breast milk * in the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen) * currently participating in another clinical trial
a community pharmacist-led intervention to improve adherence to lipid-lowering treatment

Conditions: Hypercholesterolemia

Summary: the objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.

medication non-adherence represents an important threat to the health of the western people. a large number of pharmacy records based studies demonstrated that adherence to lipid lowering treatment in daily practice is substantially worse compared to adherence observed in the controlled setting of randomized controlled trials. in addition, the relationship between non-adherence with statin-treatment assessed with pharmacy records and cardiovascular outcomes has been convincingly demonstrated. this implies that pharmacy records can and should be used to identify non-adherent patients and thus patients at risk for major cardiovascular events. using this data, community pharmacists can play a more substantive role in developing the concept of pharmaceutical care. the objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.

Eligibility criteria:
inclusion criteria: * suboptimal adherent to statin treatment * older than 65 years * responsible for own medication intake exclusion criteria: * life expectancy shorter than 6 months * institutionalized * user of medication blisters

Keywords: adherence compliance statins intervention hypercholesterolemia
immune response and risk of side effects after influenza vaccination in athletes

Conditions: Influenza Virus Vaccine Adverse Reaction; Influenza Vaccine Allergy

Summary: seasonal influenza vaccination was used to assess whether induction of immunity as well as the rate of side effects is influenced by the timing of the last training session before vaccination. healthy athletes were vaccinated with the tetravalent influenza vaccine and blood samples were collected before, 1, 2 and 26 weeks after vaccination. the athletes were randomly assigned to vaccination within 2 hours after the last training session ("2h") vs. vaccination after a resting period of at least 26 hours ("26h"). all participants documented side effects and training restrictions. influenza-specific t-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. antibodies were quantified by elisa and neutralisation assay.


Eligibility criteria:
inclusion criteria: * performance-oriented training on at least five days a week, healthy athletes exclusion criteria: * current acute infection, allergy to the vaccine, immunosuppression, pregnancy, rheumatic diseases

Keywords: influenza vaccination elite athletes immune response side effects
a study of ultrasonography with elastography in skin neoplasms

Conditions: Benign and Malignant Skin Neoplasms

Summary: this study will look at high frequency ultrasound as a medical imaging modality and apply it to skin lesions. elastography is an ultrasonic method of looking at the hardness of an area. we will use this to try and differentiate between benign and cancerous skin lesions.


Eligibility criteria:
inclusion criteria: * patients with skin lesions undergoing biopsy for diagnosis. exclusion criteria: * patients with skin lesions which do not require biopsy for diagnosis.

Keywords: elastography cutaneous imaging
aesops trial 2 (aesops-2): availability of opioid harm

Conditions: Opioid Abuse

Summary: the opioid epidemic is the largest man-made public health crisis the united states has faced. the objective of trial 2 of the application of economics \& social psychology to improve opioid prescribing safety (aesops-2) study, is to discourage unnecessary opioid prescribing by increasing the salience of negative patient outcomes associated with opioid use.

in aesops-2, a multi-site study, random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual-care (control). the aesops-2 trial will take place in 3 diverse health systems in the u.s. - northwestern medicine, altamed health services, and the children's clinic. at northwestern medicine, clinicians in the intervention group receive a letter notifying them of their patient's fatal or nonfatal ed overdose. at altamed health services, and the children's clinic, clinicians in the intervention group receive a letter notifying them of their patient's nonfatal ed overdose. the primary outcome is the change in clinician weekly milligram morphine equivalent (mme) dose prescribed in 6-month periods before and after receiving the letter. the secondary outcome is the change in the proportion of patients prescribed at least 50 daily mme. group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician mme weekly dose. the aesops-2 trial will provide new knowledge about whether increasing prescribers' awareness of patients' opioid-related overdoses leads to a reduction in opioid prescribing. additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering unnecessary population exposure to these drugs.

Eligibility criteria:
inclusion criteria: * 1) the clinician prescribed a qualifying scheduled drug to a patient in the 12 months prior to their non-fatal or fatal overdose 2) the patient is 18 years old or older at the time of the overdose, 3) the provider practices within a health system enrolled in the study, and 4) the overdose occurs during the 12-month observation period. qualifying prescriptions include those for one of the following scheduled drugs: opioids, benzodiazepines, muscle relaxants or sedative-hypnotics. exclusion criteria: * prescriptions to patients in hospice or with active cancer

Keywords: opioid use disorder randomized control trial behavioral economics nudges
open clinical investigation to evaluate the effectiveness and safety of a topical medical device.

Conditions: Chickenpox

Summary: the primary endpoint is the change of the itching score after 3 days of the product use in comparison to the basal value.


Eligibility criteria:
inclusion criteria: 1. female and/or male 2. aged between 12 months to 11 years 3. phototype: i to iv 4. subject or parent(s)/legal representative(s) must be registered with health social security or health social insurance. 5. parent(s)/legal representative(s) having signed their written informed consent form (icf) for their children's participation in the study 6. subject and / or parent(s)/legal representative(s) able to understand the language used in the investigation centre and the information given 7. subject or parent(s)/legal representative(s) able to comply with the protocol, follow protocol's constraints and specific requirements and able to follow the medical recommendation regarding the pathology and its requirements (treatment, social eviction etc) 8. subjects presenting non severe and non complicated chicken pox exclusion criteria: 1. subject or parent(s)/legal representative(s) who is (are) unable to understand the information (for linguistic or psychiatric reasons) and to give his/her (their) consent to his/ her (their child) participation 2. subject taking part or planning to participate in another clinical trial during the study in the same or another investigation centre 3. subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship 4. subject or parent(s)/legal representative(s) admitted in a sanitary or social facility 5. subjects planning a hospitalization during the study 6. severe or complicated chicken pox (surinfection, profuse eruption, pneumonia, etc) 7. having an acute, chronic, or progressive disease or dermatological condition liable to interfere with the study data or considered by the investigator hazardous for the subject or incompatible with the study requirements 8. having personal medical history liable to interfere with the study data or considered by the investigator hazardous for the subject or incompatible with the study requirements 9. being under any treatment for a severe or complicated chicken pox considered by the investigator liable to interfere with the study data or incompatible with the study requirements (antiviral (herviran) or antibiotics...) 10. having taken any previous treatment considered by the investigator liable to interfere with the study data or incompatible with the study requirements 11. systemic antibiotics within 1 week before the inclusion or required during the study 12. systemic immunosuppressive treatment within 6 months before the inclusion or required during the study
efficacy and safety of single doses of indacaterol delivered via a single dose dry powder inhaler (sddpi) compared to placebo in patients with persistent asthma

Conditions: Asthma

Summary: the study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an sddpi in patients with persistent asthma. all patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. each treatment day will be followed by a washout-period of 1 week


Eligibility criteria:
inclusion criteria: * males and females 12 - 75 years of age with a diagnosis of persistent asthma * daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent * fev1 at visit 1 at least 50% of the predicted normal value * fev1 reversibility at least 15% exclusion criteria: * use of tobacco products within 6 months prior to visit 1 or a smoking history of more than 10 pack years * chronic obstructive pulmonary disease (copd) * seasonal allergy where asthma is likely to deteriorate during the period of the study * emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months * a respiratory tract infection within the previous 6 weeks other protocol-defined exclusion criteria may apply

Keywords: asthma, indacaterol, long acting β2-agonist
the influence of the individual auditory-cognitive need on the aided benefit using different feature settings

Conditions: Speech Intelligibility; Hearing Loss, Sensorineural

Summary: the goal of this clinical trial is to optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral phonak audéo paradise/lumity 70 hearing aids. the main questions it aims to answer are: does cognitive functioning affect hearing aid benefit? how can hearing aid fitting be optimized based on the individual auditory-cognitive profile? the hypothesis posits that cognitive abilities influence the effectiveness of hearing aids, alongside hearing status. furthermore, if features of hearing aids improve speech understanding and listening effort, it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids. the study will consist of three groups: one control group and two groups where one different feature will be modified. participants will be tested at baseline measurement, including: * screening tests * audiological tests * questionnaires * cognitive tests * real-ear-measurement following this, participants will be divided in one of the three groups, after which speech audiometry will be repeated. after a 4-week acclimatization period, the second measurement will take place, repeating speech audiometry and questionnaires. subsequently, the hearing aid settings will be restored to their initial configuration.


Eligibility criteria:
inclusion criteria: * dutch-speaking individuals aged between 45-80 years old * individuals with normal vision (with glasses or lenses if needed) * individuals with age-related hearing loss * individuals with bilateral hearing aids (phonak audéo paradise/lumity 70) * individuals who are capable to give consent to participate in the study themselves exclusion criteria: * user of cochlear implants * use of influencing medication (for example: rilatin and antidepressants) * learning disabilities (for example: dyslexia and dyscalculia) * (history of) neurological problems (brain tumor, epilepsy, history of stroke, ...)
determining drug levels of beta-lactam antibiotics in severe burned patients

Conditions: Antibiotics; Severe Burn; Intensive Care

Summary: at antibiotic stewardship of the university hospital of schleswig-holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. to compare drug levels of beta-lactam antibiotics, it is the aim of this study to measure pharmacokinetics of piperacillin/tazobactam in icu patients with and without severe burns.


Eligibility criteria:
inclusion criteria: general * adult * receiving beta-lactam antibiotic piperacillin/tazobactam * antibiotic therapy of 3 or more days * given informed consent group 1 * severe burn group 2 * no severe burn exclusion criteria: * already in another study * no useful blood sample
school-based randomized trial of sunsmart interventions

Conditions: Skin Neoplasm

Summary: the objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. the intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure.

childhood sun exposure not only increases melanoma risk, but may establish lifetime patterns of exposure and protection. individuals receive a substantial proportion of lifetime exposure to ultraviolet radiation (uvr) during childhood, and severe sunburns before age 20 may increase lifetime risk of developing melanoma. the objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. the intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure. building on the previously existing sunsmart program the investigators have been conducting in 20 local los angeles schools in partnership with usc's joint education project (jep), this study will implement a randomized controlled trial among 5th-6th graders (aged 10-14), comparing this new education-feedback approach to the existing sunsmart education-only program, testing knowledge, attitudes and behavior before and after the intervention. in a subset of students, the investigators will collect real time uv exposure data using personal dosimetry as a gold standard measure of change in uv exposure behaviors. the study design randomizes at least 18 schools to 9 intervention or 9 non-intervention (control) schools, and students within each school all have pre- and post-tests. the investigators will also select classrooms from each school across conditions to have students wear dosimeters pre- and post- intervention/control. using a hierarchical cluster analysis with the school unit taken as random and students as repeated measures within school, the investigators will test the primary hypothesis that improvements in sun exposure behaviors are significantly higher than baseline at post-test in the intervention than control group, and that this may even occur without significant differences in sun exposure knowledge and attitudes between the two groups. the investigators will additionally test the hypothesis that total uv exposures obtained from uv dosimetry are significantly lower than baseline in the intervention than control group after intervention.

Eligibility criteria:
inclusion criteria: * child in classrooms from selected schools in the los angeles metropolitan area. exclusion criteria: * all children will participate in the educational activities, unless they opt out of pre- and post-test questionnaires or are absent from school for any of the education sessions.
pmma vs polysulfone in sars-cov-2 infection hemodialysis patients

Conditions: SARS-CoV-2 Infection

Summary: controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with covid-19.

controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with covid-19. patients will be dialysed according to the usual dialysis schedule of three weekly sessions. the study has a duration of 8 days in order to include 4 haemodialysis sessions. the first and third haemodialysis sessions will be dialysed with ps membrane and the second and fourth sessions with pmma membrane, both dialysers with a surface area of 1.8 m2.

Eligibility criteria:
inclusion criteria: * age ≥18 years . * patient on chronic haemodialysis admitted to the hospital with a diagnosis of infection by covid-19. * signature of informed consent or legal representative. * estimated duration of admission greater than 8 days (4 haemodialysis sessions). * patient with haemodynamic stability, understood as systolic blood pressure ≥ 100 mmhg. exclusion criteria: * refusal to sign the consent form. * patients who for clinical reasons are unable to follow a regular dialysis schedule of three sessions per week. * allergy (documented or suspected) to either of the two membranes involved in the study. * patient with haemodynamic instability (mean arterial pressure \< 100 mmhg).

Keywords: haemodialysis sars-cov-2 infection cytokines