Kornimate/medical-research-clean huggingface dataset:
physiologic mechanisms in pediatric traumatic brain injury (tbi)

Conditions: Traumatic Brain Injury

Summary: the aims of this study explore the relationships between cerebral vasospasm, apolipoprotein-e (apo-e) genotype, physiologic symptoms, and neurocognitive outcomes that may either intensify or ameliorate secondary injury, for children with a traumatic brain injury. exploring the apo-e genotype will help us know if injury response is altered in certain children and will aid in developing interventional approaches.

the purpose of this study is to advance knowledge of neurocognitive outcomes in pediatric traumatic brain injury (tbi) patients by exploring the relationships between physiologic factors of cerebral vasospasm, apolipoprotein e (apo-e) allele, biomarkers, and neurocognitive outcomes. this study is a funded project within duke university school of nursing national institutes of health/national institute of nursing research (nih/ninr) p30 center of excellence grant. this study will continue on with some of the work of a small intramural grant study determining the feasibility of conducting pediatric tbi research at duhs. it will advance the measurement of vasospasm by translating the use of the transcranial doppler (tcd) ultrasound to neuromonitoring in children. to date, this will be the first pediatric study examining the relationship of cerebral vasospasm, apo-e, and biomarkers with neurocognitive outcomes. unlike adult tbi patients, cerebral vasospasm, apo-e, and biomarker collections have yet to be examined in pediatric neurotrauma patients in the duke university health system. although neurocognitive outcomes are a standard of care for tbi patients at duke university health system (duhs), the data has yet to be examined within the realm of pediatric neurodiagnostic physiologic measures. by obtaining preliminary data in 35 patients, it will allow for the evaluation of multi-diagnostic measures in pediatric tbi patients, as well as provide data for future funding for a larger regionally-scale study.

Eligibility criteria:
inclusion criteria: 1. tbi patients admitted to the pediatric intensive care service (picu)or pediatric progressive care unit 2. range in age from birth to 15 years 3. tbi with a glasgow coma scale of 3-15 4. acoustic window for adequate transcranial doppler (tcd) ultrasound 5. english or spanish speaking or understanding parent/legal guardian to consent 6. access for a buccal swab for genotyping exclusion criteria: 1. non-english or spanish speaking parents/legal guardian 2. children with a previously diagnosed neurodevelopmental delay

Keywords: pediatric traumatic brain injury tbi apolipoprotein e apo-e vasospasm genetics physiologic mechanisms neurocognitive outcomes endothelin 1
vulvar disease in nigeria observational study

Conditions: Vulvar Diseases; Vulvar Atrophy; Dermatoses

Summary: vulvar disease in nigeria a look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in nigeria


Eligibility criteria:
inclusion criteria: * biological females - afab exclusion criteria: * none-afab
sars-cov-2 seroprevalence and seroconversion among employees of the universitair ziekenhuis brussel during the 2020 covid-19 outbreak

Conditions: Sars-CoV2

Summary: a novel zoonotic coronavirus was discovered in wuhan (hubei province, china) mid-december 2019 and was named severe acute respiratory syndrome coronavirus 2 (sars-cov-2). the virus rapidly spread to the rest of the world, including europe and explicitly affects the respiratory system, generating coronavirus disease 2019 (covid-19). this study is a monocentric interventional prospective cohort study. after signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. sample storage and analysis will be performed at the laboratory of microbiology of the uz brussel. * to document sars-cov-2 seroprevalence among employees of the uz brussel at day 0 (i.e. at beginning of the study, planned early may 2020), month 2 and month 5. * to document number of sars-cov-2 seroconversions among employees of the uz brussel over a period of 5 months.


Eligibility criteria:
inclusion criteria: * any adult employee of the uz brussel who provided a signed informed consent to participate in the study. exclusion criteria: * uz brussel employees whose contract expires within 6 months of study initiation, with the exception of resident trainees (if training continues in another hospital, resident trainees will be asked to perform the last sampling when leaving the uz brussel). * staff not active during the inclusion period
respiratory mechanics registry for ards patients

Conditions: Acute Respiratory Distress Syndrome

Summary: this registry was proposed to investigate the epidemiology of respiratory mechanics in patients with ards through collecting data from a qi project which was constituted with systematic assessments of respiratory mechanics and gas exchange.

the amount of respiratory impairment in patients with acute respiratory distress syndrome (ards) is variable and applying the same ventilator regimen to every patient is questionable. in order to individualize ventilator management, monitoring respiratory mechanics may help to decide ventilator settings or set limits. a systematic assessment of respiratory mechanics and gas exchange response in patients who meet the criteria for ards has been initiated as a quality improvement (qi) project in the department of critical care at st. michael's hospital. the qi project aims to facilitate the use of these parameters for ventilatory management. measurements include: respiratory system, lung and chest wall mechanics (elastance and resistance), oxygenation response to positive end-expiratory pressure (peep), and estimate of alveolar recruitability using a simplified bedside maneuver\[1\]. placement of an esophageal catheter is considered when the ratio of arterial oxygen partial pressure to fractional inspired oxygen (pao2/fio2) ≤200 mmhg\[2\]. audits are performed to see whether the measurements influence ventilatory management. collecting these data into a registry will elicit helpful epidemiological information since the current epidemiological knowledge surrounding respiratory mechanics abnormalities in ards is limited. a registry with a large sample size may inform future recommendations. the investigators therefore propose to introduce the collected data from our qi program into an ards registry. similar data obtained from other centers may also contribute to the registry in the future. the primary objective of the registry will be to investigate the epidemiology of abnormal respiratory mechanics in patients with ards.

Eligibility criteria:
inclusion criteria: * all patients admitted to the medical-surgical icu, trauma-neuro icu, and cardiovascular icu who meet the berlin definition of ards and receive invasive ventilation. exclusion criteria: * severe hemodynamic instability: \> 30% variation of mean arterial pressure and/or heart rate (hr) in the last 2 hours or the need for a high dose of vasopressors (higher than 0.5 µg/kg/min of norepinephrine); * patients who present with a known esophageal problem, active upper gastrointestinal bleeding, or any other contraindication for the insertion of a gastric tube.
low field magnetic stimulation (lfms) in mood disorders: 6 treatments

Conditions: Bipolar Depression; Unipolar Depression

Summary: to demonstrate the efficacy of multiple applications of low field magnetic stimulation (lfms) as an antidepressant treatment in subjects with mood disorders.

the low field magnetic stimulation (lfms) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. the field and timing parameters of the lfms pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. the mechanism of action for the antidepressant effects of lfms is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. this is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions. previous investigations of lfms included depressed subjects with bipolar disorder. this study will evaluate the antidepressant effects of multiple lfms treatments in bipolar disorder and major depressive disorder.

Eligibility criteria:
inclusion criteria: 1. subjects must be significantly depressed, currently. 2. subjects must not have serious physical illnesses, neurological diseases or dementias. 3. subjects will meet dsm-iv criteria for bipolar disorder type i or ii, major depressive disorder, post traumatic stress disorder, or obsessive compulsive disorder, and be currently depressed. 4. subject must have a ham-d score \> 17, ymrs score \ 18. 5. subjects must be capable of providing informed consent. 6. subjects must have an established residence and phone. 7. subjects may be medicated or unmedicated. exclusion criteria: 1. dangerous or active suicidal ideation. 2. pregnant or planning on becoming pregnant. 3. substance abuse (cannot meet dsm criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month). 4. mixed mood state or rapid cycling. 5. presence of a pacemaker, neurostimulator, or metal in head or neck.

Keywords: depression bipolar depression lfms electromagnetic stimulation
study of long-term treatment with hypertonic saline in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: a phase iv clinical trial, multicentric (3 hospitals in madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. the purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cystic fibrosis * over 6 years old * fev1 over than 30% * must be able to perform a spirometry * must be able to perform induced sputum * must tolerate the maximum dose of 10 ml hypertonic saline * no oral neither intravenous treatment within the previous 2 weeks before the beginning of the study * no treatment with hypertonic saline in the 2 weeks before exclusion criteria: * no clinical diagnosis of cystic fibrosis * no tolerance of 10 ml of hypertonic saline * positive pregnancy test * no tolerance of beta2-agonist * treatment with corticosteroids * fev1 \< 30% * liver and/or lung transplantation * oxygen treatment * hospital admission within the 4 previous weeks * oral or intravenous antibiotic treatment within the 2 previous weeks * smokers * pulmonary colonisation with burkholderia cepacia complex

Keywords: hypertonic saline cystic fibrosis pulmonary inflammation pulmonary exacerbation
pharmacokinetic evaluation of an 8 -week treatment with inhaled tobramycin

Conditions: Pseudomonas Infections

Summary: this study is designed to provide data about the pharmacokinetics (pk), safety and tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered via a 'soft mist' nebulizer in cystic fibrosis (cf) subjects. each treatment period will last 8 weeks. additionally the pk of patients with a normal forced expiratory flow in 1 second (fev1) (fev1≥80% predicted) will be compared to patients with an abnormal fev1 (fev1\<80% predicted).


Eligibility criteria:
inclusion criteria: * male and female subjects aged ≥6 years at the time of screening, with an informed consent form signed by patient and if appropriate by parent/legal guardians, prior to any study-related procedure. * confirmed diagnosis of cf by the presence of one or more clinical features of cf in addition to a quantitative pilocarpine iontophoresis sweat chloride test of \>60 meq/l; or identification of well-characterized disease-causing mutations in each cftr gene; or an abnormal nasal transepithelial potential difference characteristic of cf. * p aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage \[bal\]) at the screening visit and within 6 months prior to screening. exclusion criteria: * history of sputum (or bal) culture yielding burkholderia cepacia (b cepacia) within 2 years prior to screening and/or sputum culture yielding b cepacia at screening. * fev1 \<25% of normal predicted values for age, sex, and height based on knudson criteria at screening. * hemoptysis of more than 60 cc at any time within 30 days prior to study drug administration. * known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. * gfr\<60ml/min/1.73m2 calculated with the formula by schwartz, bun 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria. * history of tinnitus or pathologic audiometry * diagnosis of allergic bronchopulmonary aspergillosis (abpa) at screening * initiation of treatment with macrolide antibiotics within 28 days prior to study drug administration (subjects may be taking macrolide antibiotics at the time of enrollment, but they must have initiated treatment at least 28 days prior to study drug administration). * use of loop diuretics within 7 days prior to study drug administration. other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic infection with p. aeruginosa in cystic fibrosis subjects
assessment of accuracy and aesthetics following automated mandibular defect reconstruction using ai

Conditions: Mandibular Tumor

Summary: the aim of the study is to evaluate accuracy of automated mandibular defect reconstruction using artificial intelligence and assessing impact on aesthetic and occlusion outcomes using patient-specific reconstruction plates.

the digital surgical process often requires an expected mandibular reference model. currently, the common digital surgery process, is to mirror repair or manually look for other similar mandibles for local data fusion and smoothing processing. a more accurate expected reference model is difficult to achieve, time consuming and difficult to promote in clinical practice. moreover, rapid routing processing often has poor accuracy. for cumulative bilateral lesions, massive lesions, obvious displacement or lesions cross the middle line, there is still no effective method to predict the expected reference model in clinical practice. the main objective for conducting this study is to propose an improved algorithm to overcome the drawbacks of recent studies using 3d unet and to test the predictability and clinical value of virtually generated 3d models of defected mandible in real patients.

Eligibility criteria:
inclusion criteria: * patients with mandibular tumors, cysts or any benign disease resulting in mandibular continuity defect. * age group: from 18 - 55 years old. * no sex predilection. * cts or cbcts of only healthy mandibles from an online database and real data. exclusion criteria: * patients with mandibular malignant lesions. * children age group from 2-17. * cts of maxilla. * elderly patients to be excluded due to the normal physiologic bony change.

Keywords: artificial intelligence patient specific reconstruction plates
diffusion mri in cervical spondylotic myelopathy (csm)

Conditions: Cervical Spondylotic Myelopathy

Summary: patients who have been diagnosed with cervical spondylotic myelopathy will be asked to undergo an mri using diffusion basis spectrum imaging (dbsi) technology. the patients will have this mri preoperatively and at 24 months postop. the investigators believe that with this imaging, biomarkers will be able to be seen to assist in prediction of long term outcomes in patients with spinal cord compression. these patients will be compared to healthy cohorts who will also undergo an mri using the dbsi technology.

csm is the most common form of spinal cord injury and is the leading cause of progressive disability in patients over the age of 65. a major shortcoming limiting the clinical management of csm is the lack of quantifiable metrics to 1) base clinical decisions and 2) predict potential for functional recovery following surgical intervention. dbsi mri will provide imaging biomarkers to more reliably predict a patient's clinical course, response to therapy, and long-term prognosis. patients who are diagnosed with csm will have an mri using the dbsi technology preoperatively and at 24 months. surgical patients will be assessed with the neck disability index (ndi), disability of the arm, shoulder and hand (dash), hand grip dynamometer and manual muscle testing (mmt), the modified japanese orthopaedic association scale (mjoa), and the major depression inventory (mdi), the short form-36 (sf-36) and nurick scoring. a control group of healthy volunteers will have an mri using the dbsi technology when enrolled and then again between 12-24 months later.

Eligibility criteria:
inclusion criteria: * history of ongoing spinal cord compression, * clinical evidence of csm as determined by signs and symptoms including, but not limited to loss of manual dexterity, extremity weakness, sensory abnormalities, quadriparesis, loss of proprioception, and positive babinski's or hoffman's sign. exclusion criteria: * pregnant * having an mri incompatible device * having a known diagnosis of amyotrophic lateral sclerosis, multiple sclerosis, rheumatoid arthritis, concomitant thoracic and/or lumbar stenosis, spine tumor or hiv-related myelopathy and having systemic instability or being deemed unable to tolerate standard mri sequencing.

Keywords: myelopathy diffusion mri spinal cord injury spinal cord compression spondylosis cervical
clinical study to evaluate the tolerability, safety and efficacy of enteric-coated mycophenolate sodium, after equimolar conversion from mycophenolate mofetil (mmf), in patients with stable renal transplant receiving tacrolimus

Conditions: Prevention of Acute Rejection After Kidney Transplantation

Summary: the aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from mmf to enteric-coated mycophenolate sodium in stable renal transplant patients.


Eligibility criteria:
inclusion criteria: * first or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously; * immunosuppressive therapy with tacrolimus and mycophenolate mofetil (mmf); exclusion criteria: subjects expected to discontinue tacrolimus therapy; * patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline; * patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dl) or worsening renal function in the previous two months.

Keywords: kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium, tacrolimus.
saliva and plasma exosomes for oral leukoplakia malignant transformation diagnosis and oral cancer prognosis monitoring

Conditions: Oral Leukoplakia; Oral Cancer

Summary: the goal of this observational study is to test the expression levels of salivary and plasma exosomal mir-185 in patients with oral leukoplakia and oral squamous cell carcinoma. the main questions it aims to answer are: * is it possible to identify the cancer risk of oral leukoplakia in its early stages by detecting salivary and plasma exosomal mir-185? * is it possible to monitor the cancer risk of oral leukoplakia and the prognosis of oral cancer using salivary exosomal mir-185? participants will be asked to: * cooperate with the investigators in completing the oral examination. * take saliva and plasma before the biopsy surgery. * perform the biopsy surgery following the usual diagnostic procedures. * attend regular follow-up appointments (every 3 months) for the duration of the study.

the first part of the study is a cross-sectional study in which the investigators will detect the expression level of salivary exosomal mir-185 in the participants at a single time point. the second part of the study is a prospective cohort study, in which the investigators will conduct regular follow-ups on the participants enrolled in the first part.

Eligibility criteria:
inclusion criteria: * males or females aged 30\~80 years. * clinical diagnosis consistent with oral leukoplakia and oral cancer. * individuals with local stimulating factors correlated with oral lesions (including residual roots, residual crowns, poor oral restorations, cheek biting, and tongue biting habits). * oral lesions not subjected to any treatment, including laser, photodynamic therapy, radiotherapy, and chemotherapy. exclusion criteria: * pathological diagnosis of another disease rather than oral leukoplakia or squamous cell carcinoma. * females who were pregnant or breastfeeding. * individuals who had malignancy, severe and precariously controlled diabetes mellitus, episodes of cardiovascular disease, hepatic or renal dysfunction, respiratory disease, hematologic disease, or immune abnormalities in the past year. * individuals with a psychiatric disorder. * other conditions deemed inappropriate for study participation by the researchers.

Keywords: oral cancer oral leukoplakia exosome mir-185 diagnosis prognosis