Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety study of gsk biologicals' gsk2202083a vaccine in healthy infants at 2, 3 and 4 months of age

Conditions: Tetanus; Diphtheria; Haemophilus Influenzae Type b; Poliomyelitis; Acellular Pertussis; Hepatitis B; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni

Summary: this study will evaluate the safety and immunogenicity of gsk biologicals' gsk2202083a vaccine co-administered with gsk biologicals' 10-valent pneumococcal conjugate (gsk1024850a) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.

in accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of gsk biologicals' human rotavirus vaccine (rotarix) at 2 and 3 months of age.

Eligibility criteria:
inclusion criteria: * a male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination. * born after a gestation period of 36 to 42 weeks inclusive. * subjects should have received one dose of hepatitis b vaccination at birth as per local recommendations. * subjects who the investigator believes that their parent(s)/lar can and will comply with the requirements of the protocol. * written informed consent obtained from the parent/lar of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration of any vaccine since birth, with exception of hbv and bacillus calmette-guérin, or planned administration during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis b, polio, hib, pneumococcal and/or menc disease. * history of seizures or progressive neurological disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * major congenital defects or serious chronic illness. the following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: • current febrile illness or axillary temperature \>= 38.5 ºc or other moderate to severe illness within 24 hours of study vaccine administration.
repeated cross sectional surveillance study to determine the respiratory syncytial virus (rsv) immunization rates in german infants

Conditions: Respiratory Syncytial Virus Immunization

Summary: in june 2024, the german standing committee on vaccination (stiko) recommended the universal immunization of infants with nirsevimab during their first rsv season. nirsevimab is a long-acting monoclonal antibody designed to provide passive immunity against rsv, significantly reducing the risk of severe rsv disease in infants. this recommendation marks the 2024/25 season as the first in which nirsevimab is broadly implemented for all infants in germany. despite the introduction of this new prevention measure, there is currently no timely monitoring system for immunization rates. understanding the uptake and coverage of nirsevimab is crucial for evaluating its impact on public health and guiding future vaccination strategies. therefore, this study aims to monitor the national immunization rates of nirsevimab in children under one year of age during the initial seasons of its widespread use. the primary objective of this study is to determine the nirsevimab immunization rate in eligible infants in their first rsv-season in germany. the study will focus on: 1. assessing the immunization rates among eligible infants (according to stiko recommendation) in their first rsv-season in germany (i.e. across all geographies) 2. assessing the immunisation rates among the "catch-up cohort", i.e. all infants born between april and september. for these infants, the stiko recommends immunization with nirsevimab in early autumn. 3. assessing the immunization rate among the "in-season cohort", i.e. all infants born during the rsv season between october and march. for these newborns, the stiko recommends immunization with nirsevimab shortly after birth, preferably during the second "well-baby visit" at the age of 3-10 days of life.


Eligibility criteria:
inclusion criteria: * be a parent of an infant born between april 2024/25/26 and march 2025/26/27, respectively * reside in germany at the time of survey completion * be at least 18 years old at the time of survey completion. * agree with privacy policy and ae (adverse event) reporting requirements before proceeding with the survey. * read and agree to the icf (informed consent form) by ticking a box before proceeding with the survey. exclusion criteria: * participation in the study (= completed the survey) in a previous wave of the current season. note: the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Keywords: rsv rsv immunization rates nirsevimab
dual-task training to prevent cognitive decline in community-dwelling older adults: a pilot pragmatic rct

Conditions: Community-dwelling Seniors

Summary: objectives: this study aims to explore the feasibility and acceptance of group-based dual-task training for prevention of cognitive decline in a pragmatic setting for community-dwelling older adults. the primary objective is to assess recruitment rate, attendance rate, retention rate and satisfaction rate of participants. study design and participants: this is a pilot pragmatic rct with waitlist control. first, a co-design approach will be adopted to develop the intervention with the older adults. then, about six participating community centres will nominate staff or volunteer to receive the training in order to lead the intervention. informed consent will be sought from the participants and baseline assessment will be conducted. the participants will be randomly allocated to the intervention and control groups in 1:1 ratio using block randomisation with varying block size. at the end of the study, one representative of each participating centre will be invited to provide qualitative feedback. measurements: the primary outcomes are the feasibility outcomes, namely the recruitment rate, attendance rate, the retention rate, and satisfaction rate of participants. secondary outcomes include completion rate of the interventionist, time to recruit target sample size, factors influencing older adults' decision to participate and staff of the community centre to organise the activity, subjective memory complaints, working memory, executive function, and cognitive status of participants. a structured questionnaire will be used to collect quantitative outcomes related to effects and satisfaction. qualitative feedback from representatives of the elderly community centres will be collected according to a semi-structured interview guide. expected results: the intervention is feasible and highly accepted by the participants and staff of the community centres. potential effect-related outcomes are to be demonstrated.


Eligibility criteria:
inclusion criteria: (i) aged 65 years and above, (ii) eligible to enrol in activities organised by the community centres, (iii) no communication problems, (iv) able to understand and follow instructions, (v) able to read and write chinese. exclusion criteria: contraindications to chair-based or stepping exercises.

Keywords: dual-task cognitive training older adults train-the-trainer
fever and wheezing events in children after us influenza vaccines using text messaging

Conditions: Fever; Wheezing

Summary: children 2-11 years of age who are given the influenza vaccine (inactivated influenza (iiv) or live attenuated influenza vaccine (laiv)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. on the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. if fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. on day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. they will also be asked about medications taken and care sought. the purpose of this study is to assess the feasibility of collecting this data.


Eligibility criteria:
inclusion criteria: 1. are 2 through 11years of age, 2. have a visit at a study site anytime during the study period, 3. receive first dose or second dose of laiv4 or iiv in the season, 4. the parent has a cell phone with text messaging capabilities, and 5. the parent and child \> 7 years of age speaks english or spanish at the columbia sites or english at the boston site. exclusion criteria: 1. presence of fever ≥100.4 at time of vaccination, 2. administration of any antipyretic in the 6-hour period prior to vaccination, 3. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever, 4. parent only speaks a language other than english or spanish at the columbia sites or english at the boston site. 5. enrollee is a child \>7 years of age who only speaks a language other than english or spanish at the columbia sites or english at the boston site. 6. parent's inability to read and send text messages, 7. sibling already enrolled this season (or cell phone # already used for another child) 8. chronic medical condition considered by acip to be a precaution or contraindication for laiv1 (except for asthma), 9. current asthma exacerbation, or exacerbation in the last 2 weeks 10. use of oral or other systemic steroid within the last 2 weeks
time of postpartum hemoglobin assessment and blood loss during delivery

Conditions: Hemorrhage, Postpartum

Summary: this is a prospective cohort study of patients delivering at columbia university medical center/ allen hospital. for the primary research question, the investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation with estimation of blood loss (ebl) and quantitative blood loss (qbl).

postpartum hemorrhage is a leading cause of maternal mortality and morbidity worldwide. early intervention is dependent on care providers ability to accurately estimate ongoing blood loss. studies in the past have shown that obstetricians and midwives tend to overestimate blood loss when the lost volumes are small while tend to underestimate by as much as 40 to 50 percent when a large volume of blood is lost. multiple studies have shown that routine hemoglobin assessment in postpartum patients after uneventful delivery either vaginal or via cesarean section, is not necessary. this leads to increased cost of care without any added benefit and causes inconvenience to the patients. however knowing how imprecise blood loss estimation can be it is reasonable to screen women for anemia prior to discharge.

Eligibility criteria:
inclusion criteria: all antepartum patients receiving prenatal care at the broadway practice and plan to deliver at allen hospital in nyc. exclusion criteria: patients who gave consent to participate in the study but did not deliver at allen hospital.

Keywords: postpartum hemoglobin
effect of blueberry consumption on metabolic syndrome & dna damage

Conditions: Metabolic Syndrome; Insulin Resistance; DNA Damage

Summary: obesity usually brings with it disturbances in the body that increase the chances of developing serious diseases like diabetes and cancer. these disturbances include one or more symptoms of a condition called "metabolic syndrome" that often leads to diabetes. high levels of damage to the dna that makes up our chromosomes have also been observed in obese people. it is possible that these two disturbances are connected. the goal of this project is to test this whether consumption of blueberries will improve these abnormalities.

unbalanced diets rich in refined carbohydrate calories, saturated fats, and trans fats, but low in vitamins, minerals, fiber, polyphenolics and ω-3 fatty acids are common in the united states, particularly among the obese. insulin resistance and high levels of dna damage commonly accompany obesity. there also appears to be a relationship between oxidative dna-damage and biomarkers that characterize metabolic syndrome. the bioactivity of blueberries is usually attributed to their high content of polyphenolics which can reduce oxidative dna damage. since oxidative damage to mitochondrial dna is a suggested causal factor leading to increased insulin resistance, we will test if blueberry consumption can be an ameliorative dietary factor for insulin resistance as well. if blueberry consumption both shifts metabolism away from insulin resistance and reduces dna damage, it may be a useful tool to assist in understanding relationships between these two obesity-associated conditions.

Eligibility criteria:
inclusion criteria: 1. age 30-60 years; 2. bmi \> 30; 3. blood pressure \<140/90 mmhg without antihypertensive medicines or with a stable dose of antihypertensive medicines (no change in last 3 months).; 4. insulin resistance (homa/ir) \> 2.0; 5. willing to restrict intake of high polyphenol-containing foods during the trial period; 6. willing to forego intake of nutritional supplements other than a multivitamin; 7. willing to maintain their current daily level of exercise throughout the study. exclusion criteria: 1. known diabetes mellitus according to the 2013 ada criteria; 2. medications known to affect glucose metabolism; 3. weight loss pharmacotherapy; 4. lipid-lowering medication; 5. untreated thyroid or chronic liver, renal, or cardiovascular disease; 6. smoking; 7. pregnancy- a negative urine pregnancy test will be documented for any women participants of childbearing age prior to enrollment. 8. history of allergic reactions to blueberries. 9. any pathological condition known to alter white blood cell count over the previous 6 months; 10. exposure to drugs known to cause mutations or radiation within the previous 6 months; 11. alcohol consumption greater than 2 drinks/d for males and 1 drink/d for females.

Keywords: insulin diabetes obesity dna damage metabolic syndrome
virtual care to improve post-intensive care syndrome

Conditions: Post Intensive Care Syndrome

Summary: the goal of this interventional trial is to learn about whether a virtual clinic can help patients with post-intensive care unit syndrome regain functional ability. participants will participate in a 12-month online clinic where they will receive physiotherapy, nutritional planning, mental health support and cognitive strengthening. functional capacity will be measured throughout the clinic. after, they will be asked questions about their clinic experience, and complete a questionnaire.

virtual care to improve post-intensive care syndrome (v-pics) is a multidisciplinary virtual clinic designed to address the three components of post-intensive care syndrome (pics): physical impairment, cognitive decline and mental health challenges. this initiative targets icu survivors who received mechanical ventilation for a minimum of 48 hours. referred patients will access live sessions with healthcare professionals who will guide at-home strategies to address pics including physiotherapy, nutritional planning, mental health support and cognitive strengthening. the clinic will provide an integrated approach to addressing the challenges faced by icu survivors. the feasibility of this virtual clinic will be assessed by measuring patient satisfaction, clinic effectiveness and levels of engagement and attendance. the study's findings will inform the creation of a robust multi-centre clinical trial that will contribute to the creation of a national standard of pics care and increase health system efficiencies.

Eligibility criteria:
inclusion criteria: * over 18 years of age * received mechanical ventilation for a minimum of 48 hours in the icu * discharged from the hospital in the 2 months prior to study start exclusion criteria: * individuals originating from an assisted living/ long-term care facility * lack a capacity for informed consent * have end-stage illnesses * present a significant fall risk * cannot speak english or french * do not have the technological skills or caregiver support to ensure digital literacy
preliminary testing of cafe move for primary prevention of physical frailty

Conditions: Aging

Summary: this project explores a novel means of health promotion and prevention of age-related physical frailty, which is designed to overcome barriers to access and promote autonomy in managing physical health.

the purpose of this investigation is to field-test a physical function assessment paradigm, designed to inform people of their physical function relative to peers of similar demographic characteristics (e.g., similar age, sex, height, etc.), to promote recommended preventive health behaviors. the physical function assessment paradigm is known as cafe move. our primary research hypothesis is that people will advance along the stages of behavior change (i.e., more likely to participate in recommended preventive healthcare for physical function), after accessing cafe move assessments. this study is a single cohort (n=36 participants), double-baseline design, intended primarily to collect pilot data. the results will inform the design of a larger controlled trial. this study will examine the safety, feasibility, acceptability, and preliminary efficacy of café move. briefly, we will make café move available to at-risk populations (i.e., independent-living older adults) via the following approach. first, during a 3-month control phase, we will monitor participants' health behaviors and engagement with preventive health offerings via periodic phone surveys. we will then make café move available and subsequently monitor health behaviors and engagement with preventive health offerings. this design will allow us to examine feasibility of the café move intervention, to better understand the reach of the program within and across communities, and to determine variance and covariance for the outcome measures of interest.

Eligibility criteria:
inclusion criteria: * legally autonomous to consent * lives independently * ability to sit, stand, and walk without the assistance of another person exclusion criteria: * not legally autonomous to consent * institutionalized

Keywords: frailty physical function strength mobility balance
appetite: plant protein and exercise solutions for the prevention of undernutrition in older adults.

Conditions: Appetite Loss; Physical Inactivity; Undernutrition; Anorexia of Aging; Aging; Ageing Well

Summary: the appetite trial aims to investigate the efficacy of innovative plant protein fibre (ppf) products (developed in a previous workpackage) as part of a personalised diet with/out physical activity on appetite and incidence of undernutrition in older persons from three european countries at high risk of undernutrition.

it is normal that dietary intake decreases as we age due to reduced activity and muscle mass. however, appetite is a key determinant of dietary intake, and poor appetite can result in undernutrition. in many instances, older adults do not recognise their appetite has decreased significantly as the decline is slow and progressive. protein and fibre are often poorly consumed in the diets of older adults with decreased appetite, but essential for health and well-being. interventions designed to increase appetite, or increase dietary intake despite a reduced appetite, should therefore be key to preventing undernutrition (i.e. protein-energy malnutrition as well as nutrient deficiencies). however, treatment strategies for poor appetite are not well-established. in this multi-centre randomised controlled trial conducted in ireland, germany, and italy, a two-by-two factorial design will define the individual and combined impact of two intervention conditions over 12 weeks: 1) personalised diet with focus on plant-based protein plus fibre; and 2) physical activity. at each centre, 60 older adults (180 in total) will be randomly allocated to one of the following four groups over a 12 week period: 1) personalised diet plus physical activity program (pd + pa), 2) usual diet plus physical activity (pa), 3) personalised diet and no pa (pd), and 4) control (usual diet, no pa). using identical procedures, two testing visits will be completed before and after the 12 intervention or control period.

Eligibility criteria:
inclusion criteria: * community-dwelling, * age 65+ years, * bmi 19.5-30.4kg/m2, * inactive (\<150 minutes of moderate to vigorous physical activity per week and no regular resistance training), * have proof of covid-19 vaccination exclusion criteria: * major cognitive impairment (mmse ≤24), * uncontrolled clinical depression (ces-d \>16), * medical condition or current medication known to impact appetite or energy intake, * other medical condition that may impact ability to participate in study or study outcomes, * heavy smoker (\>10/day), * plans to relocate out of the study area within the next 6 months, * inability to come to study centre/pa program location, * currently participating in another intervention study, * inability to participate in physical activity, * unable to walk across a room, * allergic to or unwilling to consume any of the study test foods, * loss of taste or smell associated with covid-19, * unwilling to be randomised to any intervention group.

Keywords: appetite energy intake nutrition older adults physical activty
breath analysis by ion mobility spectrometry

Conditions: Lung Diseases

Summary: recognition of disease specific clusters of volatile organic compounds in patients with different lung diseases, using breath analysis with ion mobility spectrometry. lung diseases of interest are: * copd * tumors * airway infection * interstitial lung disease * sleep apnea hypothesis: breath analysis with ion mobility spectrometry can differentiate pulmonary disorders.

recruitment of patients with different lung diseases goes on. first sub-group analysis of patients with copd,lung cancer and sarcoidosis is done in order to create a training set of voc-clusters for further validation in a bigger population of patients.

Eligibility criteria:
inclusion criteria: * any patient * ages 18-90 years old exclusion criteria: - patient who are not able to perform an exhalation manoever.

Keywords: lung tumor pleural tumor interstitial lung disease airway infection copd sleep apnea ion mobility spectrometry breath analysis