Kornimate/medical-research-clean huggingface dataset:
impact of helmet use in preschool children

Conditions: Head Injuries; Facial Injuries

Summary: * to test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education without free helmet distribution; * to test the hypothesis if helmet users in preschool children will significantly reduce head and facial injuries compared to those non-helmet users

current literature review shows that there were no definite prospective research studies that indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction particularly to head and facial injuries among preschool children of low-income families. the magnitude and seriousness of the injury problem in these children in the community could be high. many injuries may occur that are not treated in emergency departments. even the occurrence of a minor injury in the face is undesirable. these ages are learning periods to ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).

Eligibility criteria:
inclusion criteria: * age 3-5 year olds and their siblings, registered at the community action of northeast indiana (cani) head start program * the child must possess a bicycle or a riding toy to ride * the child's caregiver speaks english or spanish exclusion criteria: * age less than two or greater than 5-year olds * 3-5 year old children that do not own a bicycle or a riding toy to ride * the child's caregiver does not speak english or spanish.

Keywords: bicycle helmet
morphometric study of the legs and feet of diabetic patients in order to collect data intended to be used to measure by dynamometry the pressures exerted by several medical compression socks at the level of the forefoot

Conditions: Diabetes

Summary: the aim of the study is to collect morphometric data of legs and feet in diabetic patients in order to model in the laboratory the pressures exerted by compression stockings on different areas of the foot


Eligibility criteria:
inclusion criteria: * patients of both sexes over the age of 18 * patients with diabetes of any type, balanced or not, with or without a history of mal perforating * giving their oral agreement to participate after information exclusion criteria: * patients seen in an emergency * patient with lower limb amputee (even partial) * patients with a foot wound, whatever the etiology of the wound * presence of lymphedema * history of foot trauma with sequelae

Keywords: diabetes compression stockings
shade matching and patient satisfaction of yttria stabilized multilayered zirconia and lithium disilicate restorations

Conditions: Mutilated Teeth; Endodontically Treated Teeth

Summary: the aim of the study is to determine whether yttria stabilized multilayered zirconia restorations will differ from lithium disilicate restorations in shade matching and patient satisfaction in patients requiring full coverage restorations.

steps in short: single tooth in the esthetic zone requiring full coverage crown is prepared to receive an all-ceramic crown, the restorations will be divided into two groups: i: teeth receiving restorations fabricated from lithium disilicate ii: teeth receiving restorations fabricated from yttria stabilized multilayered zirconia. shade will be measured using intraoral spectrophotometer and evaluated. the colour difference (δe) will be calculated for each sample using the following equation: δe =\[(δl) ²+(δa) ² + (δb) ²\] ½, δe (perceptibility threshold) will be evaluated for each group. participant timeline the patient will be treated in visits designated as follows: visit 1: preoperative records, face-to-face adherence reminder session, clinical, radiographic for examination, intraoral photographs and primary impression (alginate impression) diagnostic cast construction. visit 2: teeth preparation and secondary impression using addition silicone rubber base material and temporary restoration. visit 3: placement and permanent cementation of the final restoration using resin cement.

Eligibility criteria:
inclusion criteria: 1. age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided. 2. patients able physically and psychologically to tolerate conventional restorative procedures. 3. patients with no active periodontal or pulpal diseases, having teeth with good restorations. 4. patients with teeth problems indicated for full coverage restoration (coronal fracture where partial coverage would lack retention, malposed or malformed teeth). 5. patients with root canal treated teeth requiring full coverage restorations. 6. patients willing to return for follow-up examinations and evaluation. exclusion criteria: 1. patients in the growth stage with partially erupted teeth. 2. patients with poor oral hygiene and motivation. 3. patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch). 4. patients suffer from parafunctional habits.

Keywords: shade match patient satisfaction yttria stabilized multilayered zirconia lithium disilicate
administration of statin on acute ischemic stroke patient trial

Conditions: Ischemic Stroke

Summary: investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection

it is much more important in japan than western to improve the prognosis after stroke because the prevalence and mortality rate of stroke in japan is about 3-4 times as those of acute myocardial infarction. investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection since most of previous studies with statins just showed the preventive effects from onset of primary or recurrent cerebral infarction.

Eligibility criteria:
inclusion criteria: * the informed consent will be acquired by the document. * age: 20 years of age or older. * gender: unquestioned * hospitalization, outpatient: hospital * patients by mri at the time of hospital transport, it has been confirmed diagnosed with cerebral infarction * ingestible in within 24 hours after admission in the study treatment period, patients that can be defined treatment in this clinical study implementation plan exclusion criteria: * patients with a history of hypersensitivity to the treatment agent of the present study * patients acute hepatitis, chronic hepatitis acute exacerbation, liver cirrhosis, it is believed that the liver cancer, liver function jaundice or the like is reduced, or a biliary obstruction * patients suspected of being pregnant or pregnant * patients in the administration of the cyclosporine or telaprevir * patients with moderate or severe renal impairment (scr ≧ 2.5mg / dl or egfr \<30mg / dl) * patients who received a diagnosis of acute coronary syndrome within 6 months * valvular disease, atrial fibrillation, patients with atrial thrombus * patients familial hypercholesterolemia * patient admission nihss score is greater than or equal to 3 is more than 20 or before the onset mrs score * patients with other doctors deemed inappropriate
data collection for development of a bladder sensor during urodynamics

Conditions: Urinary Incontinence

Summary: this is an explorative, single-center, feasibility study using a prototype of a future bladder sensor to collect data during urodynamics. obtained data shall be used for the continuous development of the future bladder sensor, which is intended for use for individuals suffering from urinary incontinence.

the purpose of this clinical investigation is to collect raw measurement data of the urinary bladder region of participants (patients who are scheduled for urodynamics and fulfill the in- and exclusion criteria) with the tena-proto2, for the continuous development of an algorithm to determine the bladder filling status with the future bladder sensor. secondarily, safety of the subjects will be continuously documented such as adverse events (ae) and device deficiencies (dd); aes, adverse device events (ade), severe adverse events (sae), severe adverse device effects (sade), unanticipated serious adverse device effects (usade) and dds.

Eligibility criteria:
inclusion criteria: 1. subjects who are scheduled for urodynamics 2. men and women defined by biological sex at birth 3. individuals at the age of ≥ 18 years 4. bmi \>18.5 kg/m² and ≤ 39.9 kg/m² 5. capability to understand the subject information and to provide conscious informed consent 6. signed informed consent for study participation and data protection regulations 7. willingness to conduct a urine pregnancy test for all female subjects \<55 years old (exceptions: the site team determines that the subject is not likely to become pregnant due to e.g., hysterectomy, postmenopausal) 8. capability and willingness to follow the study protocol and procedure of the urodynamics exclusion criteria: 1. subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region 2. subjects with suprapubic catheter 3. subjects with implants that can be affected by electromagnetic interference (e.g. pacemaker) 4. subjects who are pregnant or breast feeding 5. known allergies or intolerances to one or several components of the study product 6. alcohol abuse as reported by subject and/ or suspected by investigator that impacts capability to understand the subject information and to provide conscious informed consent in the discretion of the investigator 7. drug abuse as reported by subject and/ or suspected by investigator that impacts capability to understand the subject information and to provide conscious informed consent in the discretion of the investigator 8. objections of the investigator to the subject's participation in the trial due to medical reasons or any other reason for which the subject should not participate in the opinion of the investigator 9. participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel 10. sponsors, manufacturers or clinical research organization (cro) staff
drug treatment for alcoholics with post-traumatic stress disorder

Conditions: Alcoholism; Post-Traumatic Stress Disorder

Summary: this study will investigate the use of sertraline (zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. this will be a 12-week, placebo-controlled, double-blind outpatient trial. all subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol abuse or dependence and post-traumatic stress disorder. * laboratory tests for blood and urinalysis must be within normal limits. * must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions. * females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal. exclusion criteria: * have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days. * currently suicidal. * medical reasons not to receive drug therapy. * allergy or hypersensitivity to selective serotonin inhibitor antidepressants. * significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease. * liver function test greater than 2 times the normal level * require ongoing therapy with another psychoactive drug during the study period. * females who are pregnant or lactating.
quality of life and patient needs in advanced high grade gliomas

Conditions: Quality of Life; Brain Tumor; Glioblastoma; Glioma; Anaplastic Astrocytoma

Summary: there is limited knowledge regarding the quality of life and needs of patients with advanced high grade gliomas, especially during the end of life. by doing this research, we are able to assess caregiver and patient symptoms and needs during the end of life phase of patients with brain tumors.

purpose: this is a pilot study to prospectively assess the symptoms and quality of life of patients and with advanced high grade glioma and their care takers. specific aims: the aim of this study is to investigate the symptoms of patients with advanced high grade glioma. patients who failed 3rd line chemotherapy and who require at least occasional assistance will be prospectively followed and their symptoms will be prospectively assessed. patient's caregiver will be interviewed following the death of the patient to assess clinical symptoms in the last weeks of life and around the time of death. methods: patients will undergo clinical symptom assessment via questionnaire. patients will be followed by regular semi-structured phone interviews. should a patient pass, four weeks following this, the patient's care giver will be interviewed.

Eligibility criteria:
inclusion criteria: * age \>18 * tissue proven diagnosis of a high grade brain tumor * disease progression by mri * therapy resistant tumor to 2nd line chemotherapy * karnofsky performance scale (kps) score of 60 or less * patient will need to assign caregiver exclusion criteria: * none
integrative self-care approaches for hcp wellbeing

Conditions: Burnout, Professional

Summary: the purpose of this pilot study is to assess the impact of a hospital-based integrative self-care program (e.g., a. reiki and b. caring science and mindful practice \[csmp\] course) for interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers on their wellbeing.

the primary research procedures are: * participants will complete an online pre-training survey via redcap, including a demographic questionnaire, and questions related to physical function, depression, anxiety, fatigue, sleep disturbance, social roles/activities, resilience, burnout, covid-19 experience, caring science, and reiki knowledge and application. * participants will participate in the 4-week (virtual) csmp and (in-person) reiki training course. * participants will complete the online post-training survey with the same questions included in the pre-training survey. * data analysis will be conducted by the research team using descriptive statistics, bivariate analysis, and multivariate linear/logistic regression analysis to assess for relationships between the reiki and csmp training and hcp wellbeing. the research team will enroll up to 20 participants comprising of interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers. all parts of the protocol will be conducted at csmc.

Eligibility criteria:
inclusion criteria: * healthcare provider must: * be 18 years or older * be full-time employee of a csmc hospital/clinic * mds/dos must have admitting privileges to a hospital and/or have private practice/ or be a current medical resident enrolled in a cedars sinai medical residency program * provide direct patient care in hospital and/or clinic * consent to participating in the study exclusion criteria: * healthcare provider who do not meet all the inclusion criteria and/or reports: * they do not provide direct patient care * do not consent to participating in the study
abiokin - antibiotic kinetics

Conditions: Critical Illness; Infection

Summary: the purpose of this study is to investigate the pharmacokinetic properties in critically ill patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem, piperacillin/tazobactam, vancomycin). the primary objective is the identification of the clinical parameters affecting the kinetics of these drugs and the study of the contribution of extracorporeal depuration techniques to the elimination of these molecules. the secondary objective is to describe and compare the therapeutic therapies adopted in the intensive care units participating in the project. for each molecule, the study will involve 300 patients admitted to intensive care units. for each patient five blood samples will be collected on average, in order to measure drug plasma concentrations. patient clinical conditions will be collected through an electronic clinical record. finally, on the basis of those data, pharmacokinetic models will be developed to describe the evolution in time of drug plasma concentrations.


Eligibility criteria:
inclusion criteria: * patients undergoing antibiotic therapy with amikacin, linezolid, meropenem, piperacillin/tazobactam, or vancomycin. * patients whose antibiotic therapy started during the stay in icu or less than 24h before admission to icu. * patients with anticipated length of stay in icu of at least 24h. * patients with already-placed catheter exclusion criteria: * patients undergoing antibiotic prophylaxis * lack of informed consent

Keywords: anti-infective agents pharmacokinetics critically ill patients
study with an autologous dermo-epidermal skin substitute for the treatment of burns in adults and adolescents

Conditions: Burns

Summary: this phase iib trial aims to evaluate the efficacy and safety of ehsg-kf (synonym denovoskin) in comparison to meshed stsg in adults and adolescents with partial deep dermal and full thickness burns.

this multicentre phase iib clinical trial will target adults and adolescents with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed stsg.

Eligibility criteria:
inclusion criteria: * age: ≥12 years of age * deep partial thickness and/or full thickness burns requiring surgical wound coverage * expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in the netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. \>20% tbsa burns can be taken as guideline, but tbsa is not an inclusion criterion. * signed informed consent exclusion criteria: * patients tested positive for hbv, hcv, syphilis or hiv * patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (child-pugh class b or c), severe malnutrition, or other concomitant illness which, in the opinion of the investigator, has the potential to significantly delay wound healing) * severe drug and alcohol abuse * pre-existing coagulation disorders as defined by inr outside its normal value, ptt \>uln and fibrinogen \<lln prior to the current hospital admission and / or at the investigator's discretion * patients with known allergies to amphotericin b, gentamicin, penicillin, streptomycin, or bovine collagen * previous enrolment of the patient into the current phase ii study * participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study * patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) * pregnant or breast feeding females * intention to become pregnant during the clinical course of the study (12 months) * wounds in the head and neck area as study target area (only applicable for study patients in the netherlands) * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: burns scar skin wound healing tissue engineering dermis epidermis thermal injuries
cohort study: perceptual urge sensation

Conditions: Urinary Bladder, Overactive; Osteoporosis

Summary: over the past few years it has become clear that our understanding of bladder physiology is inadequate to explain urge incontinence. this has forced us to re-evaluate what we know and do not know about bladder function and dysfunction. this has led to the identification and study of novel systems within the bladder that may contribute to abnormal sensations. the investigators now suspect that the organic changes occurring in the bladder are not the whole story. for one group of patients with pathological urge there is growing evidence suggesting that there may be a strong psychological component. the idea now being put forward is that normal afferent peripheral information is perceived as abnormal and excessive, resulting in an increased desire to go to the bathroom: 'perceptual urge'. it is important to identify this group of patients since it will direct their treatment towards more cognitive approaches. also, if such a psychological aetiology can be eliminated it would lead to a more focused and effective management of peripheral pathology with surgery or pharmacology.


Eligibility criteria:
inclusion criteria (for patients with oab): * patients older than 18 years with oab diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days of these three days they keep a micturation diary with a vas score for urge sensation. patients should have at least one episode of urge: sudden compelling desire to void which can not be postponed. * well versed in dutch. inclusion criteria (for patients with osteoporosis): * patients older than 18 years with osteoporosis joined into the fast guide cohort program. * well versed in dutch. exclusion criteria (for patients with oab): * patients with stress-urinary incontinence * presence of post void residual urine \> 100cc determined by ultrasound * presence of urinary tract infection, determined by urine sticks. patients with urinary tract infection will be treated by antibiotics. after resolution of the infection, the patient can re-enter the study if the urine is sterile at that moment. exclusion criteria (for patients with osteoporosis): * urinary complaints or urologic history * presence of postvoid residual urine \> 100cc determined by ultrasound * presence of urinary tract infection, determined by urine sticks. patients that present with urinary tract infection will be definitively excluded from participation.

Keywords: overactive bladder self-consciousness perceptual urge sensation
famciclovir oral pediatric formulation in children 1-12 years of age with varicella zoster infection

Conditions: Chickenpox; Herpes Zoster

Summary: varicella zoster virus causes chickenpox in children and shingles in adults. chickenpox is usually a self-limiting illness characterized by fever and a rash. serious complications can include secondary bacterial infections, pneumonia, and encephalitis. anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. this study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.


Eligibility criteria:
inclusion criteria: * male or female children 1-12 years of age * clinical or laboratory evidence of varicella zoster infection * patients suspected of having varicella zoster infection exclusion criteria: * patients unable to swallow * concomitant use of probenecid * positive pregnancy additional protocol-defined inclusion/exclusion criterial may apply. for detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228

Keywords: chickenpox herpes zoster children famvir varicella zoster virus