Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of two 0.25 ml or 0.5 ml doses of two different influenza vaccines in healthy children aged 6 to <60 months

Conditions: Influenza

Summary: this a multicenter phase ii trial will evaluate safety and immunogenicity of two 0.25 ml or 0.5 ml doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to \<60 months.


Eligibility criteria:
inclusion criteria: * children of 6 to \<60 months of age, whose parents/legal guardians have given written informed consent prior to study entry. * in good health as determined by: medical history, physical examination, clinical judgment of the investigator. * able to comply with all study procedure exclusion criteria: * any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease; * history of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials; * known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to visit 1, receipt of parenteral immunoglobulin known hiv infection or hiv-related disease; * bleeding diathesis; * surgery planned during the study period; * receipt of another investigational agent within 90 days * laboratory-confirmed influenza disease within 6 months prior to visit 1; * ever received two doses of an influenza vaccine before the study * receipt of an influenza vaccine within 6 months prior to visit 1; * experienced a temperature 38.0°c within 3 days prior to visit 1

Keywords: influenza vaccine children
the effect of progressive muscle relaxation exercises on fatigue severity and sleep quality in emergency department nurses

Conditions: Progressive Muscle Relaxation Exercise

Summary: emergency departments are critical units where patients with life-threatening conditions and acute illnesses receive rapid interventions. nurses working in these units aim to provide the best possible healthcare by intervening with patients at high risk of life-threatening situations. however, long working hours, inadequate working conditions, high stress, and critical patient care often lead to physiological issues among nurses. fatigue and insomnia, which are commonly linked to burnout, are among the most frequent physiological problems. insomnia is a condition characterized by poor and irregular sleep patterns occurring within a 24-hour period due to disruption of the circadian rhythm. chronic insomnia, if persistent, triggers fatigue. fatigue is a subjective condition that, when prolonged, negatively affects nurses' daily activities and reduces job performance. moreover, increasing fatigue has significant adverse effects on alertness, attention, judgment, and mood. these effects can lead to accidents, errors in practice, and injuries.

progressive relaxation exercises reduce blood levels of epinephrine and norepinephrine, oxygen consumption, blood pressure, metabolic rate, heart rate, muscle tension, lactic acid levels, pain and fatigue. on the other hand, concentration increases endorphin release, reduces insomnia and provides mental well-being. when the literature was examined, progressive relaxation exercise practices were performed on patients with rheumatoid arthritis and it was determined that there were positive effects on insomnia and fatigue levels in patients at the end of a six-week period. in another study evaluating the effectiveness of progressive relaxation exercise in dialysis patients, it was found that the fatigue level of the patients decreased. again, when the literature was examined, two studies evaluating the effectiveness of progressive relaxation exercise on intensive care nurses were found in our country. in these studies conducted with intensive care nurses, it was reported that progressive relaxation exercises had a positive effect on fatigue. in line with our research, no study was found to examine the effect of progressive relaxation exercises applied to nurses working in the emergency department on fatigue severity and sleep quality. translated with www.deepl.com/translator (free version)

Eligibility criteria:
inclusion criteria: * working in the emergency service unit, * no psychiatric disorder, * can do progressive relaxation exercises, * apply progressive relaxation exercises for one month, * no disease that prevents progressive relaxation exercise, exclusion criteria: * nurses who do not meet the inclusion criteria will be excluded from the study.

Keywords: progressive muscle relaxation exercise emergency department nurse fatigue severity sleep quality
continuity of leg movements in vlbw premature infants: from spontaneous kicking and supported stepping to independent walking

Conditions: Premature Birth

Summary: the purposes of this one-year follow-up study are twofold: (1) to prospectively examine the spontaneous kicking and the supported stepping movement in vlbw premature infants until attainment of independent walking; and (2) to assess factors (i.e. gross motor development, cardiopulmonary function, anthropometry, body composition and cognition) that could potentially influence walking attainment in vlbw premature infants.

very low birth weight (vlbw) preterm infants (birth weight \< 1,500g) sustain a high risk of neuromotor disability, as exemplified by delayed walking attainment. spontaneous kicking and supported stepping have been proposed as the early precursors to independent walking. the continuity of these early leg movements with independent walking has been established in normal term infants, but such relations remain unclear in vlbe premature infants. therefore, the purposes of this one-year follow-up study are twofold: (1) to prospectively examine the spontaneous kicking and the supported stepping movement in vlbw premature infants until attainment of independent walking; and (2) to assess factors (i.e. gross motor development, cardiopulmonary function, anthropometry, body composition and cognition) that could potentially influence walking attainment in vlbw premature infants. this study will enroll 15 vlbw premature infants born at national taiwan university hospital. infants will be scheduled for spontaneous kicking examination at 2 and 4 months of corrected age, followed by supported stepping examination at 9 and 11 months of corrected age and recorded their age of walking attainment. age of walking attainment is defined as the time when the child is first able to move for five successive steps without support. at each visit, infants will be examined for spontaneous kicking or supported stepping movements (with three-dimensional kinematic analysis of peak motion analysis system), gross motor function (with the alberta infant motor scale), cardiopulmonary function (with a pulsed oxymeter), anthropometry (with scale and tape measure), body composition (with the pediatric plicometric system) and cognition (with the chinese child development inventory- cognitive subscale). the results of this study will provide important information to help reveal the maturation process of early leg movements prior to walking attainment in premature infants. furthermore, the identified early neuromotor markers and influencing factors for walking attainment will provide physical therapists useful guidance in making early treatment plans for those premature infants who will develop motor delays.

Eligibility criteria:
inclusion criteria: * bw below 1500 gm * ga under 37 weeks exclusion criteria: * existence of congenital anomalies and genetic disease

Keywords: very low birth weight premature infants kicking stepping walking motor development kinematics
identification of biomarkers for severe pneumonia

Conditions: Biomarkers

Summary: to identify the potential serum biomarkers with regard to the severity of pneumonia, and to further evaluate the prognostic value of these markers.

first, we will collect serum samples from patients with pneumonia. then we will identify biomarkers differentially expressed between non-severe pneumonia and severe pneumonia. we will further evaluate the prognostic value of these markers for pneumonia.

Eligibility criteria:
inclusion criteria: - under 18 years old exclusion criteria: * over 80 years old

Keywords: biomarkers pneumonia severity
trial comparison of accuseal and bovine pericardial patch during endarterectomy

Conditions: Coronary Stenosis

Summary: carotid endarterectomy (cea), surgical removal of the blockage in the neck artery, is the accepted management of choice for significant blockage of the carotid artery. previous studies showed improved perioperative outcomes and prevention of recurrent blockage by the use of the patch to close the surgical incision in the artery. the ideal patch reduces bleeding and prevents recurrent blockage.this is looking at long-term results toward improvement with the use accuseal patch than bovine patch.

this study will be a prospective, randomized, evaluation comparing the outcomes resulting from the use of two different patches (accuseal vs bovine pericardial) used for cea.our proposed study will evaluate the perioperative (within 30 days of operation) and long-term (6 month, 1 year, 2 year, 3 year) complications associated with the accuseal and bovine pericardial patches. this will include thrombosis of the carotid artery, and the degree of recurrent plaque formation of the patched artery as determined by duplex ultrasound evaluation in the perioperative and long-term periods.patients will be blinded to the type of patch they received.survival analysis (kaplan-meier) (used in this case for time to the event analysis) will be used for time to restenosis, time to stroke, and time to late death.

Eligibility criteria:
inclusion criteria: * symptomatic patients with \>50% stenosis or asymptomatic patients \>60% stenosis: i.e.: patients experiencing a neurological event(s) such as a trans-ischemic attack, cerebrovascular accident, amaurosis fugax, and/or a preoperative duplex ultrasound, magnetic resonance angiogram, or angiogram indicative of severe \> 60% carotid artery stenosis. exclusion criteria: * will be enforced for those less than 18 years of age, patients who for religious reasons can not accept a bovine pericardial patch and those with a combined procedure ie: coronary artery bypass graft (cabg) and cea.

Keywords: patch for carotid endarterectomy
a study comparing the efficacy and safety of idp-120 gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: the primary objective of this study is to compare the efficacy, safety, and tolerability of idp-120 gel to idp-120 component a, idp-120 component b, and idp-120 vehicle gel in subjects with moderate to severe acne vulgaris.

this is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of idp-120 gel in comparison with idp-120 component a, idp-120 component b, and idp-120 vehicle gel at weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. idp-120 is a gel for the topical treatment of acne.

Eligibility criteria:
inclusion criteria: * male or female at least 9 years of age and older * written and verbal informed consent must be obtained. * subject must have a score of moderate or severe on the evaluator's global severity assessment at the screening and baseline visit * pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits * subjects must be willing to comply with study instructions and return to the clinic for required visits. exclusion criteria: * any dermatological conditions on the face that could interfere with clinical evaluations * any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive * subjects with a facial beard or mustache that could interfere with the study assessments * subjects who are unable to communicate or cooperate with the investigator * subjects with any underlying disease that the investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study
genomic basis of neurodevelopmental and brain outcomes in congenital heart disease (chd brain and genes)

Conditions: Heart Disease Congenital

Summary: approximately 400 congenital heart disease patients will participate in the research study which will include one or more research visits for neurodevelopmental testing, brain mri, and collection of medical history including previously collected genetic sequencing results. the investigators will explore the association between genetic variants, neurodevelopmental deficits, and brain mri endophenotype. analyses will compare groups with and without deleterious de novo mutations.


Eligibility criteria:
inclusion criteria: 1. subjects in whom whole exome sequencing or whole genome sequencing has already been performed, either during the chd genes study or, for new centers (utah or uscf/stanford), after trios in existing biobanks undergo analysis by whole exome sequencing or whole genome sequencing during the pediatric cardiac genomic consortium 2 grant cycle 2. presence of deleterious mutations (damaging de novo mutations or stringently defined deleterious missense mutations) identified on sequencing (cases) or absence of such known deleterious mutations (controls) 3. males or females, age ≥8 years 4. diagnosis of congenital heart disease 5. informed consent obtained exclusion criteria: 1. history of cardiac transplant 2. a cardiac surgical procedure within 6 months of enrollment 3. known clinical genetic syndrome, characterized as a monogenic condition with an identified gene associated with abnormalities of the brain structure or function, structural heart disease, and potentially other associated features. 4. presence of cnv known to be clinically pathogenic. variants will be classified as pathogenic using accepted types of variant evidence (e.g., population data, computational data, functional data, segregation data) as detailed in the american college of medical genetics and genomics " standards and guidelines for the interpretation of sequence variants" (richards et al, gim 2015). 5. overwhelming acquired brain injury, such as a major stroke or severe ischemic injury, that would overshadow the effect of a genetic mutation on outcome in the opinion of the center investigator 6. lack of reading fluency in english or spanish
observational, real-life, retrospective, data collection, use sibutramine/topiramate in overweight comorbidities/obesity

Conditions: Overweight; Obesity

Summary: an observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be included in the study.


Eligibility criteria:
inclusion criteria: * adult patients * both sexes * diagnose of overweight with comorbidity(ies) or obesity * treatment use of sibutramine combined with topiramate * treatment prescription between 2011 and the beginning of the study exclusion criteria: * use of topiramate for other condition besides overweight with comorbidity(ies) or obesity * individual use of one of the medications (sibutramine or topiramate)
6-month intracoronary optical coherence tomography (oct) evaluation of three new generation drug eluting stent

Conditions: Recurrent Angina After Coronary Stent Placement

Summary: aim of this study is to compare at 6 months follow-up, endothelization and malapposition, evaluated by means of optical coherence tomography, in terms of number of struts not endothelized or malapposed, after the implantation of three new generation stent: cre8, biomatrix and xience.

this is a randomized study aimed at evaluating in 60 patients with either acute coronary syndromes or stable coronary artery disease submitted with pci and stenting, endothelization and malapposition at 6 months follow-up (primary endpoint), evaluated by means of optical coherence tomography in terms of number of struts not re-endothelized or malapposed, after the implantation of three new generation stent: cre8, biomatrix and xience. further clinical follow-up will be performed to evaluate mace at 12 months follow-up.

Eligibility criteria:
inclusion criteria: * patients with stable angina or acute coronary syndromes submitted to coronary angioplasty on a coronary with a vessel diameter \> 2,5 mm exclusion criteria: * known allergy to antithrombotic drugs or to other components of the stent studied planned surgery 6 months within angioplasty

Keywords: optical coherence tomography malapposition endothelization
a study on the status of nutritional risk screening and nutritional therapy in neurology hospitalized stroke patients

Conditions: Acute Stroke

Summary: stroke is the leading cause of premature death and disability, and early recognition and treatment of dysphagia is fundamental to stroke management. early and full tube feeding in the acute phase of stroke helps to address nutritional problems resulting from dysphagia and impaired consciousness and helps to reduce morbidity and mortality and poor outcomes. current guidelines for acute stroke management do not address the goal of tube feeding of enteral nutrition for energy and protein. in the treatment of acute stroke, there is a strong global focus on pharmacological thrombolysis or mechanical thrombolysis, with nutritional interventions being a less explored topic. real-world evidence on large samples, feeding attainment and outcomes, and nutrition in the acute phase of stroke is lacking in china . the aim of this study was to understand the current status of nutritional therapy in stroke hospitalization in neurology and its impact on prognosis nationwide, and to improve the standardized management process of enteral nutrition therapy in the acute phase of stroke.

malnutrition is a common geriatric syndrome with a disproportionate incidence in geriatric and neurology inpatients. in recent years, national nutritional surveys of geriatric inpatients have shown that about 2/3 of geriatric inpatients have nutritional problems; only half of neurology inpatients at high risk receive nutritional support, and inadequate nutrition exacerbates primary disease, increases complications, makes hospital stays longer, and ultimately affects patient survival outcomes. to increase comprehensive and up-to-date research on the current status of nutritional therapy in geriatric and neurology inpatients, and to lay the foundation for future standardized treatment and standardized management, we conducted a nationwide survey on the current status of nutritional risk screening and treatment in geriatric and neurology inpatients. the aim is to raise the level of clinicians' awareness of malnutrition and nutritional risk in hospitalized patients, standardize clinical practice, and properly implement nutritional support to improve patients' clinical outcomes.

Eligibility criteria:
inclusion criteria: * newly admitted stroke patients admitted to neurology, age ≥18 years, within 7 days of onset, expected survival \>3 months (i.e., not end-stage), expected neurology stay 7-10 days； * at risk of malnutrition (must ≥ 2 points) or at nutritional risk (nrs2002 ≥ 3 points), sign an informed notice. exclusion criteria: * transferred during treatment, contraindications to nutritional therapy (e.g., hemodynamic instability, gastrointestinal bleeding (bleeding \>100 ml), other nutritional studies, pregnancy.

Keywords: stroke; dysphagia;nutrition management；
burden of disease in hypophosphatasia (hpp)

Conditions: Hypophosphatasia

Summary: hypophosphatasia (hpp) is a rare, inherited metabolic disease caused by inactivating mutations in the alkaline phosphatase (alpl) gene, coding for the tissue-nonspecific alkaline phosphatase (tnap). penetrance and disease severity is very heterogenous, ranging from stillbirth to adult-onset manifestations. especially the latter are again characterized by an extremely broad spectrum of symptoms. this scope of variability makes it difficult to attribute individual patients' symptoms to the disease and distinguish them from hpp independent health issues. especially in adult hpp patients, musculoskeletal problems, including (fragility-) fractures / bone bruise, joint pain, reduced mobility, muscular weakness and pain and reduced muscular endurance appear to reflect the prevailing burden of disease, especially with respect these patients dis-abilities of daily life. to expand current knowledge of the natural history of the disease as well as on disease specific musculoskeletal deficits in hpp, all adult patients with established diagnosis of hpp known at the orthopedic institute, university of würzburg, will be offered to participate in a single, multimodal assessment of their disease history, current symptoms and disabilities, lab evaluations and clinical and technical analysis of their musculoskeletal status and capabilities. patients will be invited to a day long visit to the clinic in order to perform the following assessments: a) epidemiologic / anamnestic information b) physical examination c) structured questionnaires d) laboratory examinations e) clinical functional testing f) technical examinations


Eligibility criteria:
inclusion criteria: * adult males and females (age ≥ 18 years) * established diagnosis of hypophosphatasia * reduced serum/plasma alp (alkaline phosphatase)-activity below age and sex specific reference range of the respective test kit applied (measured at least twice with a minimum 4 week interval) * at least one of the items below: * genetically secured alpl-mutation * elevated plp (pyridoxal 5-phosphate) (urine or serum), above uln (upper level of normal) * symptoms of the disease * signed informed consent exclusion criteria: * current / previous treatment with asfotase alfa * current participation in another clinical study
flexible-dose long-term extension study of lu af11167 in patients with schizophrenia with prominent negative symptoms

Conditions: Schizophrenia

Summary: a study to evaluate the long-term safety and tolerability of flexible doses of lu af11167 in patients with schizophrenia during the 24-week treatment period


Eligibility criteria:
inclusion criteria: * the patient completed study 17972a. * the patient and the patient's caregiver or identified responsible person is able to read and understand the informed consent form. * the patient has signed the informed consent form specific for study 17972b. * the patient can potentially benefit from 24 weeks of treatment with lu af11167 according to the investigator's clinical judgment. exclusion criteria: * the patient has any current primary psychiatric disorder other than schizophrenia diagnosed during study 17972a * the patient, in the opinion of the investigator, is at significant risk of suicide other in- and exclusion criteria may apply