Kornimate/medical-research-clean huggingface dataset:
the role of primary motor cortex and prefrontal cortex for facilitation of motor system and working memory

Conditions: Central Nervous System Diseases

Summary: the investigators hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.

excitatory (\>3hz) rtms could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal gyrus.

Eligibility criteria:
inclusion criteria: 1. ischemic or hemorrhagic cerebrovascular lesion, 2. parkinson's disease exclusion criteria: * seizure * with metal implantation * dementia or severe cognitive impairment
achieving blood pressure control through enhanced discharge

Conditions: Hypertension

Summary: the primary aim of the study is to determine if enhanced discharge from the emergency department will improve blood pressure control and self-care management. enhanced discharge will include a hypertension intervention delivered by a touch-screen kiosk over a three month period.

a targeted sample of patients with uncontrolled blood pressure at the time of their emergency department visit discharge will be randomized into either standard or enhanced discharge. to control for medication effects in achieving blood pressure control, both groups will receive similar blood pressure medication while actively participating in the study.

Eligibility criteria:
inclusion criteria: * present with uncontrolled blood pressure to the emergency department (\>140/90 for non-diabetics and \>130/80 for diabetics) * self-reported history of hypertension exclusion criteria: * end-stage renal disease * no history of hypertension * do not present with uncontrolled blood pressure

Keywords: patient education hypertension patient activation
study on the diagnosis and management of cll in italy by gimema

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type

Summary: retrospective and prospective multicenter observational clinical and biological data collection from all patients with newly diagnosed cll, sll or mbl. retrospective cohort: all cases with a diagnosis between january 1st 2010 and august 31th 2021. prospective cohort: all patients with a diagnosis between september 1st 2021 and september 1st 2025.

this is a retrospective and prospective multicenter observational study designed by the gruppo italiano malattie ematologiche dell'adulto (gimema). the study consists of clinical and biological data collection from all patients with newly diagnosed cll, sll or mbl (according to the who 2007 and 2018 diagnostic criteria). the retrospective part aims at including all cases followed at participating centers with a diagnosis between january 1st 2010 and august 31th 2021 (planned study initiation), while the prospective part will include all patients with a documented diagnosis of cll, sll or mbl between september 1st 2021 and september 1st 2025 by the first immunophenotypic/histological evaluation. the data is collected through electronic case report form accessible by the participating centers on a dedicated platform.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years at diagnosis 2. one of the following diagnoses that meet the international diagnostic criteria (iwcll2018 and who2017) 1. chronic lymphocytic leukemia (cll) 2. small lymphocytic lymphoma (sll) 3. cll-like monoclonal b-cell lymphocytosis (mbl) 3. retrospective cohort: cll/sll/mbl diagnosis between january 1st 2010 and august 31th 2021. 4. prospective cohort: cll/sll/mbl diagnosis between september 1st 2021 and september 1st, 2025. 5. signed written informed consent according to ich/eu/gcp and national local laws (if applicable) exclusion criteria: * - -
assessment of gut absorption of experimental medication bms-986165 in healthy males

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate sites of gut absorption of bms-986165 in males


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening * estimated glomerular filtration rate (egfr) \> 80 ml/min/1.732 calculated with the chronic kidney disease epidemiology collaboration formula exclusion criteria: * any significant acute or chronic medical illness * current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug * acute diarrhea, or constipation within 3 weeks prior to randomization * any major surgery within 4 weeks of randomization other protocol defined inclusion/exclusion criteria could apply
allogeneic bone paste versus allogeneic bone powder

Conditions: Bone Resorption; Dental Diseases

Summary: autogenous bone graft has been considered the gold standard in guided bone regeneration (gbr) technique used for bone augmentation. however, there are disadvantages associated with autograft use such as limited amount of available bone and increased morbidity for the patient at the sampling site. several biomaterials have been used as a replacement of the autogenous bone. viral-inactivated bone allograft powder is an alternative that has proven efficacy and tolerance. this study aims to assess the non-inferiority of viral-inactivated allogeneic bone paste compared to a viral-inactivated cortico-cancellous allogenic bone powder in achieving the ideal bone volume.


Eligibility criteria:
inclusion criteria: 1. patient aged ≥ 18 years old 2. patient able to read, understand and give written consent to participate in the study 3. patient affiliated with a social security system or beneficiary of such a system 4. partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume 5. presence of a bone deficit requiring horizontal and / or vertical bone augmentation (stage 4 or 5 of the benic and hammerle classification) treated by gbr for delayed placement of up to 4 dental implants 6. possibility of acquisition by cbct for the required protocol visits exclusion criteria: 1. general contraindication to bone graft and implant surgery 2. pregnant woman or planned pregnancy during the study period or breast-feeding woman; 3. patient who has had a bone augmentation by gbr during the previous 12 months, in the area targeted for filling with the allogeneic material 4. patient who received less than 3 months ago a cbct acquisition at the operative site 5. patient simultaneously requiring more than one gbr augmentation in the same quadrant 6. patient with signs of local infection at the targeted graft site 7. systemic, metabolic or autoimmune disease that may adversely affect healing of soft and bone tissue (eg, unbalanced type 1 or type 2 diabetes) 8. use of treatments (chemotherapy or radiotherapy) or drugs (bisphosphonates, chronic steroids) known to potentially interfere with tissue healing 9. patient presenting a dental plaque objectified by an oral examination (loe silness ≥ 2 on more than 50% of the dental surfaces) 10. patient smoker of more than 10 cigarettes a day 11. any other condition that, in the investigator's opinion, would be detrimental to the safety of the patient or fail to meet the requirements of the protocol
effectiveness of three oral devices as mouthguard in electroconvulsive therapy. randomized crossover clinical trial.

Conditions: Temporomandibular Joint Dysfunction Syndrome; Tooth Injuries; Dental Occlusion, Traumatic

Summary: this observer-blind crossover intervention study aims to determine the most effective type of device as oral mouthguard in modified-electroconvulsive therapy (m-ect) comparing three types of devices: standard, prefabricated and manufactured in the dental laboratory. patients from the ect unit of psychiatric department of the university hospital of bellvitge will use the three devices at a random sequence during the twelve treatment sessions, so each device (a, b, c) will be used for two weeks, that is, for four consecutive sessions.

treatment with electroconvulsive therapy will involve the application of 12 m-ect sessions at the rate of two sessions for six weeks according to the protocol established in the ect unit of the department of psychiatry at the university hospital of bellvitge. two devices, sb and ca, will be prepared for each patient and placed in mouth before anesthesia by one operator. this operator will assign a randomized sequence of use of the three devices (sb, ca or sm). device sm will be the sole protector that will be placed after the anesthesia by nurse. the outcome assessor will the scans pre- and post-session m-ect and collect data, accede the surgery room before the session with the patient conscious and perform the exploration. this outcome assessor will leave the operating room during the procedure for the application of m-ect an come back an hour later for the post-examination session.

Eligibility criteria:
inclusion criteria: * patients should have an intellectual level that allows a proper communication and must agree to cooperate in all tests and exams required by the study protocol. * obtaining written informed consent for participating in the project (model consent form) * the patient must have enough teeth in the upper arch or being a carrier of a stable removable prosthesis. exclusion criteria: * being in a maintenance ect program. * receiving ect during the six months prior to the index episode. * pregnancy and lactation.
sevoflurane in chronic obstructive pulmonary disease exacerbation

Conditions: COPD Exacerbation; Invasive Mechanical Ventilation

Summary: prospective, open-label, single-center, study to investigate the effect of sevoflurane sedation compared to a propofol-controlled arm during copd exacerbation requiring invasive mechanical ventilation in icu. primary outcome measure: evolution of airway resistance before and after sevoflurane in copd patients, secondary outcomes measures: respiratory mechanics (maximum pressure, peepi and peeptot, trapped volume), gas exchange by the help of blood gases, the heterogeneity of alveolar ventilation by electro-impedancemetry, evolution of pulmonary inflammation, trophicity and contractility of the diaphragm,


Eligibility criteria:
inclusion criteria : * copd exacerbation * invasive mechanical ventilation and sedation for a planned duration of at least 24 hours * consent * age ≥ 18 years * affiliation or beneficiary of a social security scheme exclusion criteria : * contraindication to the administration of sevoflurane (personal or family history of malignant hyperthermia, allergy or halogenated anesthetic accident, chronic myopathy, halogenated toxic hepatitis, uncontrolled intracranial hypertension, unexplained leukocytosis after anesthesia with a halogenated agent) * contraindication to the administration of propofol (known hypersensitivity to propofol, soy, peanut or any of the excipients of the emulsion, antecedent of propofol related infusion syndrome) * refusal of consent * guardianship * age \< 18 years * pregnant or lactating woman

Keywords: copd exacerbation sevoflurane airway resistance
neurophysiologic correlates of hypersomnia

Conditions: Major Depressive Disorder; Primary Hypersomnia; Bipolar Disorder; Narcolepsy; Primary Insomnia

Summary: the goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to determine if this decreases daytime sleepiness in these patients. the primary study hypotheses are that individuals with hypersomnolence will have reduced slow wave activity (swa) during sleep and increased waking theta/alpha activity during wake in specific brain regions. a secondary hypothesis is that acoustical slow wave induction in hypersomnolent patients will increase swa during sleep, reduce theta/alpha activity during wake, and improve subjective sleepiness.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual edition iv criteria for neuropsychiatric disorders enumerated in study population description exclusion criteria: exclusionary criteria for all subjects will include: evidence of a clinically significant sleep disorder that would cause hypersomnolence (e.g. moderate to severe obstructive sleep apnea, restless legs syndrome, shift-work sleep disorder), history of significant head trauma or loss of consciousness \> 30 minutes; current smoking of more than 15 cigarettes per day; \>3 caffeinated beverages per day; significant neurologic or medical illness; active drug/alcohol abuse/dependence (within 6 months of enrollment), women who are pregnant, \<6 months post-partum, nursing or planning to become pregnant during the study; left-handedness (due to effects on sleep topography); and imminent risk for self-harm or suicide.
phase ii/iii clinical study of r484iv (ibandronic acid) for primary osteoporosis

Conditions: Primary Osteoporosis

Summary: to evaluate the efficacy and safety of r484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (ris) by oral administration every day. to evaluate also the dose response of r484iv.


Eligibility criteria:
inclusion criteria: * patients with fragile bone fracture * patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (yam). * patients with 1 - 5 bone fractures in 4th thoracic spine (th4) - 4th lumbar spine (l4) * ambulatory exclusion criteria: * patients with disease lowering bone volume secondarily (secondary osteoporosis) * patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug * patient with disorder delaying the passage of food through esophagus
physiologic effects of sleep restriction

Conditions: Sleep Deprivation

Summary: evidence suggests a relationship between sleep deprivation and cardiovascular disease. the investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. the investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.

evidence suggests a relationship between sleep deprivation and cardiovascular disease. voluntary sleep restriction is common, with 28% of the us adult population reports getting 6 or fewer hours of sleep per night, and those who do are 24% more likely to have cardiovascular disease and have twice the risk of hypertension. insufficient sleep may conceivably be one of the most common, and most preventable, cardiovascular risk factors. the investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. the investigators will combine our cardiovascular studies with state-of-the art sleep monitoring and neurocognitive tests to provide unambiguous data on the physiologic effects of sleep restriction. together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of cardiovascular disease, and suggest strategies to reduce this risk.

Eligibility criteria:
inclusion criteria: * age 18-40 years * no chronic medical conditions other than seasonal or environmental allergies * on no prescription medications other than second generation antihistamines (cetirizine, fexofenadine, desloratadine, loratadine, etc), oral contraceptive pills, or intrauterine devices. * bmi 18.5-35 kg/m2 * both normotensive and prehypertensive people are eligible and will be studied * not a current smoker or tobacco user * not pregnant or breast feeding and not intending to become pregnant or breast feed exclusion criteria: * the investigators will exclude subjects who have any medical or psychiatric disorders * history of anxiety or depression, and those taking any medications other than non-sedating antihistamines or oral contraceptives. * those found to have depression on a depression screening tool (bdi-ii) will be excluded. current smokers will be excluded. * all female subjects will undergoing a screening pregnancy test and excluded if positive. * subjects found to have significant sleep disorders will be excluded.

Keywords: sleep deprivation sleep restriction
effect of dexmedetomidine on quality of recovery in non-functioning pituitary adenoma patients undergoing endoscopic transsphenoidal surgery

Conditions: Non-functioning Pituitary Adenoma

Summary: in multiple previous studies that have explored the use of dexmedetomidine in transsphenoidal tumor resection surgery, dexmedetomidine showed many beneficial effects like reducing the requirement of analgesics and anesthetics, improving hemodynamic stability and decreasing the emergence time, extubation time and visual analog scale at emergence. therefore, the investigators hypothesized that dexmedetomidine would decrease neuroendocrine stress response and improve the quality of postoperative recovery.


Eligibility criteria:
inclusion criteria: * non-functioning patients undergoing endoscopic transsphenoidal tumor surgery under general anesthesia exclusion criteria: * patients who do not agree to participate in the study * patients with contraindication to dexmedetomidine * patients with previous history of endoscopic transsphenoidal tumor surgery * patients who take anticoagulants or have bleeding disorder * patients with conduction block or cardiovascular disease * patients with psychiatric disease such as dementia, delirium * patients have difficulty filling out the qor-15 questionnaire * pregnant or lactating women * patients who have allergies to propofol, remifentanil, fentanyl or rocuronium * patients with myasthenia gravis or myasthenic syndrome

Keywords: non-functioning pituitary adenoma endoscopic transsphenoidal tumor surgery dexmedetomidine quality of recovery
metabolomics-based sleepiness markers

Conditions: Sleep Deprivation; Sleepiness; Insufficient Sleep Syndrome

Summary: estimating that people sleep on average up to two hours less over the last decades, sleepiness and fatigue need to be considered as significant societal problems of the modern world. jurisdiction is precise on how to deal with overtired offenders since they were not allowed to use machines or vehicles in the first place, similar to drunk individuals or consumers of illicit drugs. in contrast to alcohol or illicit drug use, however, there are no quick roadside or workplace tests as objective (analytical) biomarkers for sleepiness. investigators hypothesize that increasing sleep drive or impaired wakefulness can be assessed by qualitative or quantitative fluctuations of certain metabolites in biological specimens, e.g., accumulation or decrease of endogenous substances related to sleep debt. thus, this sleep study provides the necessary biological samples of either sleep-deprived, sleep-restricted, or control subjects, which are then analysed for appropriate metabolite biomarkers utilizing an untargeted metabolomics approach. in addition to established impairment tests, a state of the art driving simulator will be employed to objectively measure driving performance under all study conditions. participants will also rate their subjective sleepiness using validated questionnaires.


Eligibility criteria:
inclusion criteria: * understanding and spoken command of german language * good health condition * body mass index between 18.5-24.9 kg/m2 * habitual average sleep duration between 7-9 hours / night * habitual consumption of 3 or fewer caffeinated beverages / day * habitual consumption of 5 or fewer alcoholic beverages / week * good sleep quality: pittsburgh sleep quality index score ≤ 5 * reasonable oral hygiene (≥1 tooth brushing / day) * normal or corrected-to-normal vision * car driving license holder since at least 2 years (obtained in a country with right hand traffic) and regular driver (≥ 1 per week) exclusion criteria: * two or more time zone crossings in the last 3 months * habitual napper * history or presence of neurological disorder, psychiatric disorder, cardiovascular disorder, dental disorder or any disorder that could pose a risk in participating or that could possibly influence study measurements * history or presence of a sleep disorder (screening night) * use of illicit drugs (urinary drug screening) * use of current medication (urinary drug screening) known to influence study measurements * extreme chronotype (reduced morningness-eveningness-questionnaire score ≤7 or ≥22) * current smoker * habitual use of energy drinks (\>1 / week) * severe skin allergies or hypersensitivities * food allergies * hospital stay in past 6 months * shift worker, night worker * recent past (last 3 months) or present covid-19 infection * fainting at the sight of blood or needles * participation in a clinical study less than 30 days ago or is currently participating in other clinical studies * simulator sickness syndrome * refusal to sign informed consent

Keywords: metabolomics sleep biomarker impairment
phase i study of gemcitabine or s-1 adjuvant therapy after hemihepatectomy for biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: to decide maximum tolerated dose and/or recommended dose of gemcitabine or s-1 adjuvant therapy after hemihepatectomy

there is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. for example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. herein, we planned this study to decide more safety adjuvant protocol(recommend dose) for gemcitabine and s-1 after hemihepatectomy using continual reassessment method analysis. in this study, we decided that tolerable ratio of dose-limiting toxicity would be less than 10%.

Eligibility criteria:
inclusion criteria: 1. biliary tract cancer (\>= uicc stage ib) 2. r0 or r1 resection due to biliary tract cancer (btc) 3. ecog performance status must be 0 or 1 4. the patient underwent no other treatment than surgery for btc 5. neutrophil must be over 1500/μl, platelet must be over 100,000/μl, ast and alt must be less than five times the normal limit, total bilirubin must be less than three times the normal limit, and creatinin must be less than 1.2 mg/dl. 6. the patient can intake drugs per os. 7. from 4 to 12 weeks after the surgery 8. written informed consent exclusion criteria: 1. existence of active double cancer 2. the patient suffered from severe drug allergy 3. sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on) 4. any active infections exist. 5. pregnancy 6. severe mental disorder 7. others