Kornimate/medical-research-clean huggingface dataset:
voice quality changes with ianb anesthesia

Conditions: Anesthesia, Local; Voice Change

Summary: background: inferior alveolar nerve block anesthesia is commonly used in dental procedures, but its effect on the voice quality is not well understood. the aim of this study is to investigate the effect of mandibular anesthesia on the acoustic voice quality index. objective: the primary objective of this study is to determine the effect of mandibular anesthesia on the acoustic voice quality index. design: this is a within-subject study design. participants will be recruited from a local dental clinic and will be adults aged 18 years or older. the participants will have the acoustic voice quality index measured before and after the administration of mandibular anesthesia. the parameters that will be measured include acoustic voice quality index and self ........ the data will be analyzed using appropriate statistical techniques. expected outcome: the study is expected to provide insights into the effect of mandibular anesthesia on the acoustic voice quality index. the results of this study may help in understanding the impact of mandibular anesthesia on voice quality and may have implications for dental practitioners and patients who receive mandibular anesthesia.


Eligibility criteria:
inclusion criteria: * able to provide informed consent * able to communicate in the local language * no history of voice disorders or speech therapy * no history of any diseases or conditions that could affect voice quality. exclusion criteria: * pregnant or breastfeeding women * individuals with a history of allergies or adverse reactions to anesthesia * individuals with a history of any diseases or conditions that could affect voice quality

Keywords: voice quality anesthesia, dental mandibular nerve lingual nerve speech acoustics
use of determine learning-based cardiodynamicsgram (cdg) for rapid and precise stratification of chest pain in emergency department

Conditions: Chest Pain; Acute Coronary Syndrome

Summary: chest pain accounts for 10-20 percent of all emergency department visits. the stratification of chest pain is always a challenge. electrocardiograms (ecg) have been used in clinical practice for 100 years, which is too important to be replaced due to its advantages of non-invasive, simple, rapid and inexpensive. ecg contains numerous signals derived from depolarization and repolarization of cardiomyocytes. however, the interpretation of ecg hasn't improved much in a hundred years. based on determine-learning, cong w's team developed an technique called "cardiodynamicsgram (cdg)", which is an outstanding method to identify myocardial ischemia. this study will further investigate the accuracy of cdg in stratification of patients with chest pain in emergency department.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * those with suspected acs who have symptoms of acute chest pain, visiting in the emergency department exclusion criteria: * those who diagnosed with st-segment elevation myocardial infarction (stemi) * those with hemodynamic instability (cardiogenic shock, cardiac arrest) * those with malignant arrhythmias(ventricular tachycardia, ventricular fibrillation, third-degree atrioventricular block) * those with aortic coarctation, or acute pulmonary embolism * those who has an unanalysable ecg report due to loosened leads, unstable baseline, or signal interference, etc.
use of tirosint®-sol or tablet formulations of levothyroxine in pediatric patients with congenital hypothyroidism (ch)

Conditions: Congenital Hypothyroidism

Summary: this is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with ch. subjects will be randomized in a 2:1 ratio to treatment (tirosint®-sol) or control (conventional therapy with levothyroxine sodium crushed tablets).

newly diagnosed neonates will be randomly assigned to start therapy with lt4 at the initial dose recommended by the standard of care (soc). infants already on lt4 therapy will continue at the same daily dose within the randomly assigned treatment group (dose adjustments are allowed, if needed based on laboratory parameters and clinical response). once enrolled, subjects will be treated and followed for 12 months (±1.5 months), participating in 7-8 study visits, consisting of 6-7 inclinic and 1-2 (or more if follow-up visits are required) telemedicine (tm) visits. the total number of visits depends on the age at inclusion.

Eligibility criteria:
inclusion criteria: * male and female patient aged 0 to 9 months * primary ch diagnosis with elevated tsh and low or normal ft4, requiring treatment with lt4, under either of the following conditions: * neonates newly diagnosed with primary ch and needing to initiate lt4 therapy, or * infants previously diagnosed with primary ch and who are already on lt4 therapy for at least 3 weeks; * provide and comply with the informed consent. exclusion criteria: * preterm neonates with a gestational age \< 37 weeks; * low birth weight (lbw) or very low birth weight (vlbw) neonates (weight \< 2.5 kg) or vlbw infants (weight \< 1.5 kg); * neonates in neonatal intensive care units or requiring admission to nicu or neonates/infants hospitalized or requiring hospitalization or in fragile health conditions (e.g. with serious health problems or complications); * neonates with ch diagnosis \> 4 weeks after delivery; * diagnosis of primary gastrointestinal disease: * gastroesophageal reflux requiring medical therapy (beyond thickening of formula or position); * anatomic defects (e.g. intestinal atresia, malrotation, tracheoesophageal fistula, pyloric stenosis, hirschsprung's disease, gastroschisis); * dietary allergy (e.g. cow's milk protein allergy); * malabsorption related to cystic fibrosis, celiac disease and others; * necrotizing enterocolitis requiring surgical resection; * known or suspected adrenal insufficiency (e.g. congenital adrenal hyperplasia, hypopituitarism); * diagnosis of congenital cardiac disease, cardiac insufficiency or risk for cardiac failure; * diagnosis of chromosomopathy; * diagnosis of central hypothyroidism; * hypersensitivity to glycerol; * concomitant anticonvulsant medications, liothyronine, combination of lt4 and liothyronine, thyroid extracts and/or chronic or long-term use of systemic glucocorticoids * history of nonadherence with medication or medical visit schedule; or * any condition for which, participation would not be in the best interest of the patient or that could limit protocol specified assessments.
effectiveness of cognitive rehabilitation for amnestic mild cognitive impairment

Conditions: Mild Cognitive Impairment; Cognitive Impairment

Summary: different cognitive rehabilitation intervention methods have been developed for the treatment of cognitive dysfunctions seen in mild cognitive impairment (mci). the aim of this study was to examine the effectiveness of cognitive rehabilitation intervention applied with the telerehabilitation method in elderly patients with amnestic-mci. participants included in the study according to inclusion and exclusion criteria were randomly assigned to the telerehabilitation and face-to-face groups. a 12-week cognitive rehabilitation intervention was applied to both groups. pre- and post-intervention cognitive skills of the participants were evaluated using the loewenstein occupational therapy cognitive assessment-geriatric (lotca-g).

a single-blinded, feasibility randomized controlled trial (rct) investigated changes in the cognitive functions of older adults with amnestic-mci after cr interventions applied face-to-face and with telerehabilitation. the study was designed according to the consort statement. approval for the study was granted by the local ethics committee. written informed consent was obtained from all participants prior to the study. the demographic characteristics of the participants were recorded, including age, sex, education level, and marital status. all participants underwent a cognitive function assessment using the loewenstein occupational therapy cognitive assessment-geriatric twice, once before the intervention and again after the 12-week intervention. all participants were assessed in occupational therapy clinical practice units. participants were randomized to either the face-to-face group (ff) or the tele-rehabilitation group (tr) using a computer-generated randomization technique. after the randomization, cognitive rehabilitation intervention for both methods consist of 45-minute twice a week for 12 weeks. all participants received the intervention individually.

Eligibility criteria:
inclusion criteria: * age between 65 and 75 years * diagnosed with amnestic-mci by medical doctors * access to technological equipment; and * ability to understand and follow verbal instructions. exclusion criteria: * secondary chronic disease that may affect cognitive functioning; * auditory and visual problems that may affect rehabilitation implementation and communication; and * attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) during the study period.
epithelial thickness map

Conditions: Keratoconus

Summary: in keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. it has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. in keratoconus screening the 5 mm diameter of the corneal centrum may be sufficient while studies have shown that the cone apex is located in this area. aim of this study is to assess agreement and repeatability of epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas. secondary objective is to evaluate the differences between healthy and keratoconus eyes using epithelial thickness map data. this is a prospective monocentric study that includes patients divided into two groups: patients with keratoconus and a control group formed out of patients without corneal pathologies. for each patient only one eye will be included and corneal measurements will be performed, focused on the corneal epithelium thickness.

in total 50 eyes of 50 patients will be included, divided into two groups: study group comprised of 20 eyes with diagnosed keratoconus and a control group formed out of 30 healthy eyes. patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation. after each measurement patients will be asked to blink in order to allow adequate tear-film recovery. each patient will be measured three times with both devices. only one visit will be necessary. the order in which the measurements will be performed (anterion or ms-39) will be randomised using randomised.org. the corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-bowman interfaces. main outcome variable: - mean differences in central corneal epithelial thickness between the devices investigated (+ limits of agreement (1.96xsd) between the investigated devices) secondary outcome variables: * repeatability coefficient (within subject standard deviation - sd) and coefficient of variation of the two devices * comparison in epithelial thickness between normal and keratoconus eyes * sensitivity and specificity of swept-source oct device in keratoconus diagnosis

Eligibility criteria:
inclusion criteria: * patient with diagnosed keratoconus (diagnosed using tomography and topography map changes and slit-lamp changes) and patients with healthy cornea * age 21 and older * signed informed consent exclusion criteria: * previous ocular surgery * associated corneal pathologies (e.g. trauma, edema, scarring) * in women of childbearing age, a pregnancy test will be performed before inclusion into the study.
in vitro nmr spectroscopy in neurological diseases

Conditions: Neurological Diseases

Summary: the search for metabolic abnormalities in patients with neurological disorders represents an important challenge 1) to identify new potentially treatable inherited metabolic diseases, and 2) to identify biomarkers or new treatments in more common neurodegenerative or neurogenetic disorders. this approach is currently limited by the fact that techniques aiming at identifying abnormal metabolites in human fluids (metabolomics) only detect subsets of molecules and that no general assays is available to detect abnormalities in the metabolism of complex molecules that takes place within cell organelles. as a consequence, only limited parts of the metabolism can be studied simultaneously. the aim of this study is to evaluate whether nrm spectroscopy of body fluids (urines, cerebrospinal fluid) could allow to detect new metabolic abnormalities in patients with complex neurological diseases.

it is now established that most inborn errors of metabolism may present in adulthood as a neurological disorder. the diagnosis of these diseases is essential because, unlike the so-called neurodegenerative diseases, metabolic diseases are often accessible to specific treatments. conversely, many patients are followed for a complex neurological disease of unknown cause. we hypothesize that a significant proportion of these patients carry yet undetected inborn error of metabolism. recently, the use of nuclear magnetic resonance spectroscopy (nmrs) has uncovered new metabolic diseases leading sometimes to specific treatments. however, the place of this technique in the investigation of patients with complex neurological diseases remains to be determined. the primary goal of this project is to assess the interest of nmrs in urine and csf to search metabolic abnormalities, not detected by conventional biochemical techniques. it is an open study. the study will be conducted in close collaboration between the neurology and genetic departments of the pitié-salpêtrière hospital, on the one hand and the nuclear medicine department of poitiers in the other. 250 patients will be included over a period of 2-3 years and will be divided into 4 groups: group 1: patients with complex neurological disease of unknown cause (200 patients) for whom urines and csf will be collected. group 2: positive controls (25 patients): patients with already known metabolic disease for whom we already have csf or urines. group 3: negative controls (25 patients): patients with non metabolic neurological disorders of known cause hospitalized for a lumbar puncture.

Eligibility criteria:
inclusion criteria: * group 1: any patient with an unexplained complex neurological disease * group 2: patients with known inborn error of metabolism * group 3: patients with known non metabolic disease exclusion criteria: * none

Keywords: magnetic resonance spectroscopy neurological diseases metabolic inborn errors of metabolism complex neurological diseases of unknown cause
evaluation of the long-term safety and tolerability of metoprolol versus nebivolol in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. these drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension

approximately 50 million americans have hypertension defined as a systolic blood pressure (sbp) greater then or equal to 140 mmhg and/or a diastolic blood pressure (dbp) greater then or equal to 90 mmhg. to control blood pressure, more than 2 agents are required in many patients. the current study is a randomized, titration-to-effect, open-label, multi center study. patients will be randomized to either nebivolol or metoprolol. the dose of the randomized treatment can be titrated as needed to achieve blood pressure control. if necessary, additional antihypertensive agents (calcium antagonist, diuretic, etc.) can be added to achieve control. patients will be seen every 1-3 months for approximately 18 months to assess long-term safety, tolerability and effectiveness of nebivolol versus metoprolol.

Eligibility criteria:
inclusion criteria: * completion of previous nebivolol study * stage 1-2 hypertension (htn) at baseline of first study exclusion criteria: * recent myocardial infarction or stroke * contraindications to beta blocker therapy

Keywords: safety and tolerability study hypertension beta-blockers
dose-response curve: interventions to prevent and treat radiodermatitis

Conditions: Radiodermatitis

Summary: dose response curve to define the security and tolerable dose to be used for prevention and treatment of radiodermatitis in patients with breast or head and neck cancer.

the study is being conducted in center for high complexity oncology (cacon) located at the university hospital of brasília (hub). has as its target population subjects diagnosed with breast and head and neck cancer undergoing radiotherapy. three doses of urea cream are being tested. participants are subjected to simple randomization technique, in which the members of the study are directly allocated in groups set forth, without any intermediate step. patients are identified, go to a nursing consultation for general orientations about treatment. after the consultation, patients are invited to participate in the study. the patient should express its acceptance through the informed consent form. data are being collected through interviews and medical records. patients are being evaluated during three weeks, considering the toxicity of the intervention and the beginning of radiodermatitis. to evaluate the skin reaction will be applied scale of the radiation therapy oncology group (rtog) - acute radiation morbidity scoring criteria, common terminology criteria for adverse events (ctcae) and radiation-induced skin reaction assessment scale (risras). for reliable assessment and record of the evolution throughout the treatment and study, patients will be photographed weekly (d0, d5, d10, d15). will be photographed major regions subject to evaluation: frontal, right side profile and left side profile with photographic camera nikon p510. the data will be inserted into statistical package for social sciences (spss), version 18.0, for the analysis.

Eligibility criteria:
inclusion criteria: * being an adult, over the age of 18 years old * owning diagnosis of breast or head and neck cancer * being first referred to the radiotherapy protocol * have absence of radiodermatitis and integrates skin to start radiotherapy * not have presented anticipated reaction of hypersensitivity to chamomile or any plant of the family asteraceae or compositae or urea. * demonstrate conditions to continue the intervention in their home environment when needed. exclusion criteria: * medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.

Keywords: radiodermatitis head and neck neoplasms breast neoplasms urea matricaria chamomilla chamomile
genomics of fibrin clot structure in patients with constitutional dysfibrinogenemia

Conditions: Hereditary Dysfibrinogenemia

Summary: hereditary dysfibrinogenemia results from monoallelic mutation in one of the fibrinogen genes (fga, fgb, fgg). the spectrum of molecular abnormalities is broad, leading to several subtypes of coagulation disorders with specific biological and clinical features. the correlation between the genotype and the phenotype is poor, and the clinical course of patients, from major bleeding to recurrent thromboses, is unpredictable. fibrin clot structure is a determinant of the risk of thrombosis in cardiovascular diseases. in all individuals, fibrin networks define the propensity of clot to be more resistant to removal or, on the contrary, susceptible to fragmentation leading to bleeding complications. besides fibrinogen variants, other relatively common genetic polymorphisms in coagulation and fibrinolytic pathways may affect the fibrin clot structure and therefore act as modifiers of the blood clot function. in this proposal, the investigators will analyze properties (polymerization, fibrinolysis, viscoelastic properties, permeation) and ultrastructure (size, number, packaging, architecture of fibrin fiber by confocal microscopy and scanning electron microscopy) of plasma-based clots in relation to the presence of genetic modifiers (polymorphisms). polymorphisms will be detected using a whole exome sequencing (wes) in a selected panel of genes of the coagulation and fibrinolytic pathways. the gene panel of 28 genes will include the three fibrinogen genes plus 25 potential modifier genes including f5, f2, pai-1, procr and mthfr. the overall clot phenotype will be correlated to the presence of prothrombotic polymorphisms and to the patient's clinical phenotype. the investigators plan to include about 100 patients with dysfibrinogenemia. the combination of integrative hemostasis models with genetic dataset will provide a global view of the patient's individual hemostatic profile. this may allow to better predict the clinical outcome and help provide a more personalized therapeutic strategy and precision medicine. in addition, the development of models allowing a reliable global assessment of fibrin clot architecture will be the basis for further research in other acquired diseases involving thrombotic or bleeding events.


Eligibility criteria:
inclusion criteria: * patient with confirmed hereditary dysfibrinogenemia * able to give his/her informed consent to participate * affiliated to the french health insurance exclusion criteria: * refusal to participate * pregnant and breastfeeding women, * protected adults (individuals under guardianship by court order), * adults deprived of their liberty

Keywords: hereditary dysfibrinogenemia fibrin clot polymorphism
action of epigenetic modifiers in cystic fibrosis treatment

Conditions: Cystic Fibrosis; Healthy Subjects

Summary: epigenetic modifiers has been showed to rescue f508del-cftr channel to apical membrane of epithelial cell lines. in this study, the investigators evaluate epigenetic modifiers effects firstly on cftr rescue, then on secretion and synthesis of inflammatory factors (il-8, lxa4 and scgb1a1) and mucines (muc5ac and muc5b) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from cf patients or controls.


Eligibility criteria:
general inclusion criteria : * informed consent * benefit from disease insurance regimen * men and women inclusion criteria for cf patients * 2 severe cf mutations * age superior or equal to 12 inclusion criteria for controls : * age superior or equal to 18 * no smoker (for 5 years) general exclusion criteria : * participation to an other interventionnal study * subject in exclusion period * law protected subject * pregnant and breast fooding specific exclusion criteria: * xylocaine hypersensibility * porphyria * severe hepatic failure * epilepsy * severe cardiac failure * local anesthesic contra indication specific control subject exclusion criteria: * respiratory disease * cystic fibrosis * acute infection \< 6 weeks * on treatment * antibiotic treatment \< 3 months

Keywords: cystic fibrosis nasal epithelia mucins