Kornimate/medical-research-clean huggingface dataset:
difference between three-dimensional heads-up surgery system and traditional surgery methods in cataract surgery

Conditions: Cataract

Summary: to evaluate the differences between three-dimensional heads-up surgery system and traditional surgery methods of cataract surgery

to evaluate the differences between three-dimensional heads-up surgery system and traditional surgery methods of cataract surgery.prospective research.one eligible eye from patients having cataract surgery performed using the 3-d head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.all eyes in the study are operated by the same doctor. corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery.

Eligibility criteria:
inclusion criteria: 1. diagnose age-related cataract; 2. plan to perform phacoemulsification of cataract with intraocular lens implantation; 3. willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery; 4. able to understand and independently fill in the informed consent form and postoperative follow-up plan. exclusion criteria: 1. cataract caused by other reasons; 2. fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration; 3. corneal diseases, corneal endothelial cells \<1800/mm2; 4. small palpebral fissure; 5. those with a history of glaucoma, uveitis, eye trauma or eye surgery; 6. those who cannot cooperate with the inspection and have not completed the one-month follow-up

Keywords: three-dimensional surgery microsurgery phacoemulsification
the performance of a robot-assisted minimally invasive direct cochlear access for cochlear implantation

Conditions: Sensorineural Hearing Loss

Summary: the cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. the surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. however, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). in conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. the outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. to overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. this study primarily aims to explore the performance of robotic cochlear implantation surgery.


Eligibility criteria:
inclusion criteria: * subjects scheduled for ci surgery according to clinical routine * subjects who will receive a cochlear implant * signed and dated informed consent form exclusion criteria: * lack of compliance with any inclusion criteria * age under 18 years * pregnancy * distance of the planned trajectory to the facial nerve is \< 0.4 mm as per screening ct scan * distance of the planned trajectory to the chorda tympani is \< 0.3 mm as per screening ct scan * a safe inner ear access cannot be planned for preservation of rw membrane and cochlear structures * individuals where image guidance or robotic procedures are not indicated
omega-3 fatty acid for critically ill patients.

Conditions: Sepsis

Summary: sepsis is the most common reason for intensive care unit (icu) admission. sepsis flares up the systemic inflammatory response with its mediators. sepsis treatment protocols have been established in many centres with immune nutrient as adjuvant treatment. omega-3 fatty acid and other anti-oxidants formulae have been found to improve sepsis outcome. in most of the studies, immune nutrients were giving parenterally, however, nowadays the preferable route of feeding in critically ill patients is enterally. the present study was done to investigate the effect of enteral omega-3 fatty acid in septic critically ill patients.

a hundred and ten critically ill septic patients were included in the study. patients were divided into two groups fifty-five patients each. group a received enteral nutrition supplemented with omega-3 fatty acid and group b received enteral nutrition without omega-3. demographic data, sepsis characteristics, number of patients required invasive ventilation, ventilation days, icu sequential organ failure assessment score (sofa), organ failure free-days, haemodynamic failure free-days, icu stay, icu and hospital outcomes were recorded.

Eligibility criteria:
inclusion criteria: * all septic patients who could receive enteral nutrition were included in the study exclusion criteria: * patients with end stage liver or renal disease, haemodynamic instability, immunosuppression, gastrointestinal comorbidity, allergic to omega-3, received omega-3 a week prior to icu admission, patients who expected to live less than 24 hours, and patients who were mechanically ventilated on icu admission were excluded from the study.
effects of yeast beta-glucan on cognitive function in patients with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Alzheimer Disease

Summary: patients with mild cognitive impairment aged 50-80 years old were recruited in shiyan city, hubei province, and divided into intervention group and placebo group. they were given yeast β-glucan capsules and starch capsules, respectively, for 6 months, in order to explore whether yeast β-glucan can improve cognitive function of patients with mild cognitive impairment by regulating gut microbiota and its metabolites.


Eligibility criteria:
inclusion criteria: * 1. aged 50-80 years; * 2. permanent residents of shiyan city; * 3. meet the diagnostic criteria of mci: * 4. willing to cooperate in completing questionnaire survey and clinical examination, and sign informed consent; * 5. did not participate in other clinical trials in the past 3 months. exclusion criteria: * 1. alcohol or drug abuse; * 2. patients with neurological diseases that may cause cognitive dysfunction, including cerebrovascular diseases, stroke, brain tumors, parkinson's disease, active epilepsy, etc.; * 3. history of severe head trauma; * 4. severe sensory and perceptual impairment, unable to complete the cognitive function measurement; * 5. history of mental illness such as depression, mania, anxiety, or take psychiatric drugs; * 6. serious heart, lung, liver, kidney dysfunction, malignant tumors, etc.; * 7. suffering from autoimmune diseases; * 8. trauma, spinal injury or any disease that may affect the motor function of the limb; * 9. recent infectious diseases, acute gastrointestinal diseases; * 10. take antibiotics, probiotics, prebiotics or biostime products within the last 1 month.

Keywords: mild cognitive impairment alzheimer disease montreal cognitive assessment gut microbiota
effect of ethanol intoxication on the anti-hypoglycemic action of glucagon

Conditions: Type 1 Diabetes Mellitus

Summary: this study will test the hypothesis that a bac (blood alcohol content) of 0.1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes.

this study will test the hypothesis that a bac (blood alcohol content) of 0.1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes. the study will aim to quantify the effect of a blood alcohol content on the anti-hypoglycemic efficacy of glucagon using a hyperinsulinemic -normoglycemic clamp technique in volunteers with type 1 diabetes in a randomized crossover trial.

Eligibility criteria:
* inclusion criteria: * age 21 to 80 years old with type 1 diabetes for at least one year. * diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (novolog), insulin lispro (humalog), or insulin glulisine (apidra) for at least one week prior to enrollment. * alcohol exposure on at least one occasion in the last year consisting of at least 4 drinks in one sitting. * exclusion criteria: * unable to provide informed consent. * unable to comply with study procedures. * unable to refrain from the consumption of alcohol at least 24 hours prior to study start. * current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject. * pregnancy (positive urine hcg), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception. * aldehyde dehydrogenase deficiency as determined by a screening questionnaire * end stage renal disease on dialysis (hemodialysis or peritoneal dialysis). * history of pheochromocytoma (because glucagon has been reported to precipitate hypertensive crisis in the setting of pheochromocytoma). fractionated metanephrines will be tested in patients with a history increasing the risk for a catecholamine secreting tumor: * paroxysms of tachycardia, pallor, or headache. personal or family history of men 2a, men 2b, neurofibromatosis, or von hippel-lindau disease, episodic or treatment of refractory (requiring 4 or more medications to achieve normotension) hypertension. * history of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache. * inadequate venous access as determined by study nurse or physician at time of screening. * liver failure or cirrhosis * hemoglobin \< 12 gm/dl. * history of problem drinking or alcoholism, regardless of whether active or in remission. * use of benzodiazepines or barbiturates or opiates or other central nervous system depressant drugs that could act synergistically with ethanol to lower the level of consciousness * any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.

Keywords: type 1 diabetes bionic pancreas artificial pancreas insulin glucagon alcohol alcohol clamp
long term comparative effectiveness of once weekly semaglutide versus standard of care in a real world adult us population with type 2 diabetes - a randomized pragmatic trial

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to compare the effects of semaglutide (ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting. the participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: group 1: semaglutide (ozempic®) (by injection into skin) group 2: standard of care antidiabetic medication (oral or injectable). the participant has an equal chance of being in either of the treatment groups. neither the participant nor the study doctor or study staff will be able to pick which group the participant is in, but the participant will know which study drug the participant has been assigned to. the study doctor will provide the participant with a prescription for the study diabetes medication based on the treatment group the participant is assigned. the participation will last about 2 years.


Eligibility criteria:
inclusion criteria:- * informed consent obtained before any study-related activities. study-related activities are any procedures that are carried out as part of the study. * male or female, age 18 years or older at the time of signing informed consent. * type 2 diabetes mellitus diagnosis. * treatment with either 1 or 2 oral antidiabetic medications. * current member of a commercial or medicare health plan with pharmacy benefits. * recorded hbalc value within the last 90 days prior to randomization. * further intensification with an additional antidiabetic oral or injectable medication is indicated to achieve glycemic target at the discretion of the study physician according to approved labelling. exclusion criteria: * previous randomization in this study * treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication in a period of 30 days before the day of eligibility assessment. temporary/emergency use of any type of insulin is allowed, as is prior insulin treatment for gestational diabetes. * contraindications to semaglutide according to the food and drug administration approved label. * female who is pregnant, breastfeeding or intends to become pregnant * participation in another clinical trial.
modeling of amiodarone effect on heart rate control in critically ill patients with atrial tachyarrhythmias

Conditions: Atrial Fibrillation; Atrial Tachycardia

Summary: aims amiodarone is the gold-standard medication to control heart rate in critically ill patients with atrial tachyarrhythmias (ats); however, effective doses and covariates influencing its efficacy remain unknown. the investigators therefore performed pharmacodynamic modeling of heart rate reduction induced by amiodarone in these patients. methods and results this observational study included 80 consecutive severely ill patients receiving amiodarone to treat ats. a total of 1348 time-heart rate observations with 361 amiodarone dose administrations were analyzed during a period of up to 6 days after hospital treatment initiation using a nonlinear mixed-effect model. pretreatment with amiodarone before intensive care administration, paroxysmal versus persistent at, catecholamine infusion, and fluid and magnesium loading were among the covariates assessed in the model. in case of paroxysmal at in a patient not pretreated with amiodarone, a 300 mg intravenous loading dose combined with an 800 mg oral dose on the first day, followed by 800 mg/day orally for 4 days was effective in achieving a heart rate between 80 and 115 bpm within the first day, and to maintain it during the next 4 days. corresponding doses were twice as high in patients with persistent at. use of intravenous magnesium (p\\0.02) and fluid loading (p\\0.02) was associated with an earlier and greater heart rate decrease, while use of dobutamine had an opposite influence (p\\0.05). conclusions in critically ill patients with at, the dose of amiodarone required to control heart rate is influenced by the type of at and by other easily measurable conditions which may allow better individualization of amiodarone dosing.


Eligibility criteria:
inclusion criteria: * critically ill patients who had received at least one dose of amiodarone to treat or prevent at during their hospitalization in the icu. exclusion criteria: * patients with paced rhythm or incomplete charts were excluded
evaluation of coldzyme® on experimentally induced common cold.

Conditions: Common Cold

Summary: this study evaluates the performance of coldzyme® mouth spray on prevention of common cold symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy volunteers. half of participants will receive coldzyme® mouth spray while the other half will receive placebo.

88 subjects will be inoculated with rhinovirus 16 via the nasal route. the subjects will be randomized 1:1 to coldzyme® or placebo. treatment (6 doses per day) will be applied for 11 days from the day of inoculation. the subjects will visit the investigational clinic on 6 occasions. during these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. all subjects will have a diary for scoring of cold symptoms.

Eligibility criteria:
inclusion criteria: * healthy male or female subjects between 16-70 years. the investigator judges the definition of healthy by detailed medical history and physical examination. * females of childbearing potential: shall use reliable method of birth control. reliable methods are hormonal contraceptives (combination pills, injections or implants), intrauterine device, condom or declared absence of sexual contact. post-menopausal woman is defined as absence of menstrual discharge for at least two years. * signed informed consent form prior to any study-related procedures. * willingness and ability to adhere to the prohibitions and restrictions specified in this protocol. * perceived to have had at least one cold per year exclusion criteria: * smoker, during the last 12 months * any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough. * presence (at screening) of serum rhinovirus 16 neutralising antibody titers at greater than or equal to one in two dilution. * active allergic rhinitis, asthma or chronic obstructive pulmonary disease during study period. * nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc. * females: pregnant, breast-feeding or intentions to become pregnant during the study. * evidence or history of drug or alcohol abuse. * use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol and ibuprofen) within 2 weeks prior to the first administration of investigational product. * use of any over the counter cold prophylaxis products such as coldzyme®, c-vitamins, zinc or echinacea within 1 month prior to the first administration of investigational product. * participation in other clinical trial with medical investigational product within 60 days prior to the first administration of investigational product. * hypersensitivity/allergy to any of the device ingredients * individuals with close contact to at risk patient group: * infants (less than 6 months); * the extremely elderly or infirm; * pregnant women; * patients with severe lung disease (asthma/cystic fibrosis (cf)/copd); * patients with immunosuppression.
genetic, microenvironmental, and immunological factors in unresectable pancreatic ductal adenocarcinoma

Conditions: Pancreas Cancer

Summary: pancreatic ductal adenocarcinoma (pdac) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of pdac to chemotherapeutic agents, making this a lethal disease. the investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (eus-fnb) tissue samples from unresectable pdac patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.


Eligibility criteria:
inclusion criteria: * patients referred to eus with fnb for suspected pancreatic cancer unresectable or metastatic based on imaging findings * availability of biopsies obtained during eus-fnb * histological diagnosis of pancreatic ductal adenocarcinoma of any stage * patients must be fit for chemotherapy administration * they have to express their willingness to be followed up at our pancreatic high volume centers * age \>18 and \<80 years * able to sign informed consent exclusion criteria: * histological diagnoses other than pancreatic ductal adenocarcinoma * pregnancy or lactation

Keywords: pancreatic cancer endoscopic ultrasound (eus) personalized medicine
study to document the phenomenon of vitamin d deficiency and its added value in patients with low-energy osteoporotic hip fracture, in daily practice in greece.

Conditions: Vitamin D Deficiency; Osteoporosis; Bone Loss, Age-Related; Fracture of Hip

Summary: vitamin d, through its action on calcium metabolism, is essential for bone physiology. vitamin d deficiency can affect muscle function and increase the risk of falls in the elderly, while severe deficiency is common in patients with fragility fractures. vitamin d and calcium supplementation, in addition to anti-osteoporosis treatment after surgery or conservative treatment, can ensure optimal recovery and survival, especially in patients with a hip fracture. the goal of vitamin d supplementation is to bring the serum 25-(oh)-d concentration above 30 ng/ml. clinical pathways have been developed to support orthopedic surgeons in improving the medical management of patients after orthopedic/surgical fracture management. pathways include advising primary care physicians and orthopedic surgeons on diagnostic and therapeutic approaches, promoting their appropriate use without compromising quality of care, and educating patients on non-pharmacological management of their disease (physical therapy, lifestyle habits life and nutrition). this is an observational cohort study that will record data on the use of vitamin d in daily practice in patients with low-energy fractures. the aim of this study is to measure vitamin d levels in the patient and provide these patients according to daily practice with appropriate supplementation for a period of one year, observing if there is a good functional outcome and a reduction in the risks of new fractures.


Eligibility criteria:
inclusion criteria: * patients \> 18 years old * patients with a low energy fracture * vitamin d levels \< 30 ng/ml * patients with available medical history before and after initiation of study treatment * patients providing informed consent for this study exclusion criteria: * pregnant or breastfeeding women * patients receiving different osteoporosis treatment * patients with known hypersensitivity to vitamin d * patients participating in another similar study at the same time with other drugs * patients with vitamin d contraindications according to the medical instructions for use * patients with a fracture due to a traffic accident
adult all treatment at diagnosis

Conditions: Leukemia, Lymphocytic, Acute

Summary: the present study has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of all patients.


Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia (all) * negative myeloperoxidase stain * phenotype t (all-t) and b(all-b) exclusion criteria: * creatinine \> 2.5mg/dl after adequate hydratation * lvef \<50% * presence of documented infections not responding to antibiotic and/or antifungal therapy * presence of concomitant malignant diseases * absence of any psychological condition that does not allow to intake high doses of cortisone * patients who have received any antineoplastic chemiotherapy for more than 5 days * patients who have received any steroids for more than 10 days

Keywords: all adult
an observational study in patients with breast cancer and bone metastases receiving ibandronate (bondronat)

Conditions: Breast Cancer

Summary: this open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. in this observational study, ibandronate (bondronat) will be prescribed and used in accordance with the standards of care. data will be collected for 12 months.


Eligibility criteria:
inclusion criteria: * all criteria in accordance with the summary of product characteristics of bondronat (ibandronate) * adult patients greater than (\>) 18 years of age * histologically confirmed breast cancer * confirmed bone metastasis (by bone scintigraphy, x-ray, computed tomography or magnetic resonance imaging) * life expectancy \>6 months * no previous bisphosphonate therapy * patients signed written informed consent form before study start exclusion criteria: * all criteria in accordance with the summary of product characteristics of bondronat(ibandronate) * hypersensitivity to the active substance or any of the excipients of bondronat (ibandronate) * hypersensitivity to bisphosphonates