Kornimate/medical-research-clean huggingface dataset:
s-100b as pre-head ct scan screening test after mild traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the purpose of the study is to determine if a specific blood protein, s-100b, can help predict who will have a traumatic abnormality on head ct scan after a concussion. we will compare the levels of this protein in the subject's blood to the initial head ct scan and to how the subject is feeling one month after injury. we hope that the information we collect in this trial will help us determine who needs a head ct scan after a concussion and who may be more likely to have trouble recovering from a concussion.

the primary objective of this study is to determine the ability of a serum s-100b to predict traumatic abnormalities on brain ct scan after mild traumatic brain injury (mild tbi). the secondary objective is to determine the relationship between initial s-100b levels and cognitive outcome at one month.

Eligibility criteria:
inclusion criteria: * patients presenting with head trauma to any of the ahcc/ernes eds, meeting the following criteria will be eligible to participate: * presence of mild tbi per study definition * arrival at the ed within 4 hours of injury * ed workup includes a head ct (controls are eligible if they present to the outpatient lab for routine bloodwork during enrollment hours) exclusion criteria: * time of injury not able to be determined * head ct not done as part of clinical emergency care * incarcerated * non-english or spanish speakers * absence of parent/guardian for minor subjects * subject and/or parent/guardian do not have capacity to consent * head injury due to birth trauma, anoxia, inflammatory, toxic, infectious or metabolic encephalopathies that are not complications of head trauma * ischemic or hemorrhagic stroke without associated trauma (controls are excluded if they have any of the following:history of brain tumor, melanoma and/or alzheimer's disease; history of concussion, bone fracture or stroke (cva or tia) in the past month; history of surgery in the past month; inability to obtain consent from subject and/or parent due to lack of capacity or absence of parent/guardian of minor; inability to speak or read english; incarceration)

Keywords: tbi, traumatic brain injury, s100b, head ct scan
real-world clinical response to cenobamate early add-on in france, germany and spain

Conditions: Focal Epilepsy with and Without Secondary Generalization

Summary: aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in france, germany, and spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 asms before starting treatment with cenobamate (including previous and concomitant asms).


Eligibility criteria:
inclusion criteria: 1. male and female patients ≥18 years old at the time of cenobamate treatment initiation. 2. patients with a diagnosis of epilepsy with focal-onset seizures, with or without secondary generalization. 3. patients under titration phase (i.e., maintenance dose not reached yet according to clinical judgement) with cenobamate as adjunctive therapy in third or fourth line with 1 to maximum 2 (for third line)/3 (for fourth line) concomitant anti-seizure medications (asms). 4. patients who have not been adequately controlled despite treatment with 2 or 3 (maximum) asms before cenobamate treatment initiation (including concomitant asms started before initiating cenobamate). 5. patients with available retrospective data in medical charts, seizure diaries or patient's notes, including reliable information about seizure frequency (intended as the number of seizures and the corresponding time period) in the last 3 months before cenobamate treatment initiation. 6. written informed consent (including consent for the processing of personal data) signed by the patient, or by the legally designated representative in case of patient lacking capacity, prior to entering the study following local regulation. exclusion criteria: 1. patients who meet any of the contraindications to the administration of cenobamate according to its approved summary of product characteristics (smpc). 2. patients with progressive neurodegenerative central nervous system (cns) diseases or (benign or malignant) brain tumors. 3. patients with unstable psychiatric diagnosis, including suicidal ideation and behavior within 6 months prior to enrolment, current psychotic disorder, or acute mania. 4. patients with known substance abuse or dependence (except for caffeine and nicotine). 5. patients participating in any interventional study from cenobamate treatment initiation until enrolment visit. 6. patients with ongoing pregnancy or breast-feeding from cenobamate treatment initiation until enrolment visit. 7. patients who are seizure-free in the last 3 months before cenobamate treatment initiation.

Keywords: focal-onset seizures epilepsy
the effects of coffee main constituents (caffeine and chlorogenic acid) supplementation on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes

Conditions: Type 2 Diabetes Nonalcoholic Fatty Liver

Summary: the purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. supplementation will be daily and will supervise for 6 months.


Eligibility criteria:
inclusion criteria: * patient diagnosed with type 2 diabetes based on american diabetes association (ada) definition or who only take oral antidiabetic drug. * capscore \>263 exclusion criteria: * criteria: * taking any kind of antibiotics two weeks before recruitment; * history of alcohol consumption ; * pregnancy or lactation; * professional athletes; * other liver disease (viral/etc); * high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs; * a history of cardiovascular disease; * renal disease, celiac disease, cirrhosis; * history of upper gastrointestinal surgery ; * a history of hypothyroidism or cushing's syndrome; * history of drug dependence; * body mass index (bmi) ≥35 kg/m2; * a restrictive diet or weight change ≥ 5 kg during the 3 months prior to study; * any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study; * use of weight loss medications
a study of oral oteseconazole (vt-1161) for the treatment of patients with recurrent vaginal candidiasis (yeast infection)

Conditions: Recurrent Vulvovaginal Candidiasis

Summary: recurrent vulvovaginal candidiasis (rvvc), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vvc in the past 12 months. several properties of oteseconazole (vt-1161) suggest that it might be a safer and more effective treatment for rvvc than other oral antifungal medicines. this study will evaluate the effectiveness and safety of oteseconazole (vt-1161) for the treatment of rvvc and consists of 2 parts. the first part of the study is a 2-week period for the treatment of the patient's current vvc episode with 3 150mg doses of fluconazole. the 2nd part consists of 12 weeks, when the patient will take either oteseconazole (vt-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period. in addition, at participating sites, an amendment to the study allows us patients who complete the initial 48 weeks without experiencing a confirmed rvvc episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (vt-1161). this study is identical to vmt-vt-1161-cl-011.


Eligibility criteria:
key inclusion criteria: * 3 or more episodes of acute vvc in the past 12 months * positive koh or gram stain test * total vulvovaginal signs and symptoms score of ≥3 at screening visit * total vulvovaginal signs and symptoms score of \<3 at baseline visit * must be able to swallow pills key exclusion criteria: * presence or a history of another vaginal or vulvar condition(s) * evidence of major organ system disease * history of cervical cancer * poorly controlled diabetes mellitus * pregnant * recent use of topical or systemic antifungal or antibacterial drugs * recent use of immunosuppressive or systemic corticosteroid therapies
post-market study to capture information regarding performance of lyric2

Conditions: Hearing Loss

Summary: randomized post market study comparing lyric to lyric2 capturing information regarding comparative performance and safety.

randomized post market study comparing extended wear hearing aids lyric to lyric2 capturing information regarding comparative performance and safety.

Eligibility criteria:
inclusion criteria: * aged 18-90 years at the time of enrollment in the study * mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear * fluent in english * willingness to comply with all study requirements exclusion criteria: * scuba dives or sky dives * underwater swimming or dives into the water * handicaps that would restrict participation in all the evaluations * hearing loss of neural or central origin * unrealistic expectations regarding benefits and limitations inherent in the devices * chemotherapy within the last six months * compromised immune system * radiation to head or neck * perforated tympanic membrane * history of cholesteatoma * active outer or middle ear pathology * high levels of anticoagulant therapy * insulin-dependent and/or uncontrolled diabetes * contact dermatitis * bleeding disorder * unwillingness or inability to comply with all study requirements

Keywords: mild to moderate hearing loss
claudication, systematic evaluation of limp on treadmill

Conditions: Peripheral Artery Disease

Summary: vascular claudication is a common cause of functional limitation. this painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (pad) patient leading gradually to a state accented inactivity. the characterization of the claudication as it results from a proximal or distal ischemia has never carried out. investigators will analyze dynamic pedometer parameter throughout walking tests in pad patients with claudication

patients referred for exercise tests on treadmill for the quantification of walking ability will gave a recording of their walking parameters through an instrumented treadmill recording biomechanic parameters (surface electromyography, walking pace; force of the foot/treadmill interface, length of the step.. etc.) analysis will be performed until walking is stopped due to usual claudication during a constant load 2 miles per hour 10% slope treadmill procedure.

Eligibility criteria:
inclusion criteria: * referred for treadmill testing * age \> 18 * claudication * covered by the french healthcare system * consent to participate exclusion criteria: * unstable angina * history of lower limb osteo articular rheumatologic disease * lower limb amputation * cardiac or respiratory failure * neurologic disease
longitudinal study for central nervous system vasculitis

Conditions: Central Nervous System Vasculitis; CNS Vasculitis; CNSV; Vasculitis

Summary: primary central nervous system vasculitis (cnsv) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. the purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in cnsv.

primary central nervous system vasculitis (cnsv) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. originally described in the early 1950s, research in the disease has been slow to progress, largely limited by the rarity of the disease and the lack of biologic materials for basic and translational investigations. to date, the bulk of research in the field has been clinical, largely consisting of retrospective case series, predominately from single sites, focusing on correlations among clinical, imaging, and histopathology data. collectively these series suggest the existence of clinically-relevant subsets. such studies, while enhancing our knowledge of this rare disease, are limited by small numbers of patients (especially those confirmed by histopathology), and the near absence of detailed investigations into the biomolecular and immunopathogenic basis of the disease. development of this longitudinal cohort and multicenter approach offers the potential to generate new insights, generate new questions, and further our understanding of its natural history, pathophysiology, genetic basis, and discovery of biomarkers to assess disease activity and prognosis. study visits will occur every 3 months for this first year, and then annually for two more years. blood collection will occur at every visit. a physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.

Eligibility criteria:
inclusion criteria: i. diagnostic criteria for cnsv 1. the presence of an acquired and otherwise unexplained neurologic deficit 2. the presence of either classic angiographic or histopathologic features of angiitis in the cns 3. no evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features ii. ≥18 years of age exclusion criteria: i. unwilling to sign informed consent.
affect study for patients with intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, and ventriculitis

Conditions: Intraventricular Hemorrhage; Subarachnoid Hemorrhage; Subdural Hematoma; Ventriculitis

Summary: the goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by active controlled irrigation and drainage (irraflow) compared to passive external ventricular drainage (evd). subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the irraflow device or evd device and followed for one month post-procedure to compare outcomes between the subject groups.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years of age 2. need of drainage for one of the following underlying conditions: intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis 3. indication for active treatment evaluated by treating physician for underlying conditions; intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis 4. signed informed consent obtained by subject or legally authorized representative exclusion criteria: 1. subject has fixed and dilated pupils 2. pregnant women 3. presence of moyamoya 4. history or presence of clotting disorder. 5. platelet count less than 100,000, inr greater than 1.4
efficacy of diuretics in kidney disease

Conditions: Chronic Kidney Disease; End Stage Renal Disease

Summary: this study will determine the efficacy of diuretics in patients with chronic kidney disease.

participants with chronic kidney disease will undergo two 1-week study periods (single-dose diuretic versus single-dose placebo) separated by 1-2 weeks of washout in a cross-over design. blood and urine samples will be collected at the end of each study period to determine the effect on urine output and to assess the kidney clearance and levels of uremic solute. participants will weigh themselves daily.

Eligibility criteria:
inclusion criteria: * stable chronic kidney disease patients able to provide consent * stable dialysis patients who produce urine and able to provide consent exclusion criteria: * use of antibiotics for last two months or expected antibiotic use * recent hospitalization or other event resulting in instability of food intake
placenta accreta; total lower uterine segmentectomy with cervico-corporeal anastomosis

Conditions: Placenta Accreta

Summary: to study feasibility and safety of total lower uterine segmentectomy with cervico-corporeal anastomosis in conservative management of placenta accreta

placenta accreta represents a real challenge in modern obstetric care as its incidence is increasing in a parallelism with increased css rates. its management represents another challenge and a multidisciplinary team with clear plans and alternative strategies that fulfill different situation and address different patient needs must be clearly settled in every referral center dealing with placenta accreta. hysterectomy without trials of placental separation seems to be the standard and logical procedure. however hysterectomy needs to be a total or at least including the entire invaded lower uterine segment. hysterectomy is associated with significant blood loss, and loss of future fertility. there are several fertility conservation approaches with variable success rates, complications, technical demands and costs. uterine plication sutures has been reported as successful uterine conservation strategy but subsequent intrauterine adhesions, weak uterine scar and uterine necrosis might culminate in a functionless uterus. the present work describes total lower uterine segmentectomy with cervical-corporeal anastomosis as a relatively less invasive uterine conservation strategy with minimization of blood loss and transfusion needs. furthermore, total lower uterine segmentectomy with cervico-corporeal anastomosis has the merits of leaving behind a strong scar and a well-functioning uterus.

Eligibility criteria:
inclusion criteria: pregnant women diagnosed with placenta accreta by us and doppler accreta invading the entire or most of the lus women who welling uterine conservation, planned and elective cs for women diagnosed with accreta, and accepting participation exclusion criteria: women who don't accept participation, women who desire hysterectomy. women who diagnosed with accrete and placenta separated easily women with concomitant pathology and requiring hysterectomy .
theoretical compared with hands-on training of vaginal breech management

Conditions: Vaginal Abnormality - Baby Delivered

Summary: this trial aims to assess the hypothesis that hands-on training of vaginal breech delivery on a pelvic model is significantly better in terms of a technical skills scoring system compared to frontal teaching.

primary endpoint is a score describing technical proficiency, ie the osats score, consisting of 25 items. each item, if done correctly, is awarded one point. the maximum osats score is 25. secondary endpoints are performance time in seconds, cinfidence using a scale from 1-5 with one being very confident and 5 having no confidence when performing the procedures, and self-assessment using a scale of 1-5 with 1 being the optimal grade. this is a two-arm study. the experimental arm uses a hands-on training and the control arm a frontal teaching approach. the allocation is randomized and single-blinded.

Eligibility criteria:
inclusion criteria: * informed consent * able to understand german * medical student exclusion criteria: * significant language barrier * previous experience with vaginal breech training
incubation of alcohol craving during abstinence

Conditions: Alcohol Dependence

Summary: in order to determine whether the 'incubation of craving' phenomenon also occurred in alcoholics, investigators employed an experimental approach to investigate the time course of cue-induced craving in alcoholism. eighty male participants were randomly divided into four groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced alcohol craving . another group including 19 patients was repeatedly tested for the cue-induced alcohol craving at the above abstinence days. other psychological and physiological measures were administered at the four abstinence time points.

all subjects provided written informed consent after a full explanation of the protocol design.

Eligibility criteria:
inclusion criteria: * met the criteria of dsm-iv for alcohol dependence * aged 18-60 years,male exclusion criteria: * current or past history of diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) axis i disorders * with other serious physical diseases (respiratory disorders, cardiovascular disease and so on) * other drug abuse except for nicotine

Keywords: incubation craving alcohol dependence
prevention of corticosteroid-induced glucose intolerance

Conditions: Glucose Intolerance

Summary: glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

Eligibility criteria:
inclusion criteria: * corticosteroid treatment exclusion criteria: * congestive heart failure pedal edema

Keywords: corticosteroid treatment inflammatory diseases