Kornimate/medical-research-clean huggingface dataset:
prevalence of endolymphatic hydrops with a hitory of congenital cytomegalovirus infection

Conditions: Endolymphatic Hydrops

Summary: the management of patients with a history of congenital cmv infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.

the management of patients with a history of congenital cmv infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management. patients benefit as part of the care: * a clinical cochleo-vestibular examination * functional otoneurological explorations: audiogram, caloric tests, vhit, otolithic evoked potentials * from an uninjected brain mri participation in this research entails the addition of an mri sequence and an injection of contrast product (gadovist®): - 3d flair mri sequence dedicated to the exploration of the inner ear, lasting 6min30s, performed 4 hours after the initial injection of contrast product.

Eligibility criteria:
inclusion criteria: * patient over 6 months old * with a history of confirmed congenital cmv infection * suffering from symptomatic cochleo-vestibular dysfunction (average hearing threshold\> 20db in at least one ear and / or abnormal functioning of one or more sectors at the vestibular level) * for adult patients, having received informed information about the study and having signed a consent to participate in the study * for minor patients written consent of the two holders of the exercise of parental authority * affiliate or beneficiary of a social security scheme exclusion criteria: * patient benefiting from a legal protection measure * pregnant or breastfeeding woman * contraindication to mri (implanted electrical device, metallic foreign body, claustrophobia) * patient with a proven allergy to gadolinium * injection of gadolinium in the previous 7 days * known impairment of renal function ((estimated gfr \<60 ml / min / 1.73 m²)

Keywords: cmv
assess the long term efficacy and safety of ruxolitinib cream in participants with vitiligo

Conditions: Vitiligo

Summary: the purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (cohort a vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either study nct04052425 or nct04057573 (parent studies) in which the participants will have been using ruxolitinib cream bid for the previous 28 to 52 weeks depending on their initial randomization in the parent study.


Eligibility criteria:
inclusion criteria: * currently enrolled and receiving treatment in incb 18424-306 (nct04052425) or incb 18424-307 (nct04057573) studies evaluating ruxolitinib cream in participants with vitiligo. * currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment. * has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. * willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol. * male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. * ability to comprehend and willingness to sign an icf or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible. exclusion criteria: * has been permanently discontinued from study treatment in the parent study for any reason. * participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the protocol. * pregnant or breastfeeding woman. * participants who live with anyone participating in any current incyte-sponsored ruxolitinib cream study.

Keywords: incb018424
vitamin d and glucose handling evaluated by glucose clamp

Conditions: Insulin Sensitivity; Intraocular Pressure

Summary: in this study the investigators want to compare glucose handling (insulin secretion and insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of vitamin d, using a hyperglycemic clamp technique, were sugar is given intravenously for 3 hours in order to keep the blood sugar level at 10 mmol/l. those with low vitamin d levels will be randomized to treatment with vitamin d3 (cholecalciferol) 40 000 iu/week or placebo for 6 months before a new clamp is performed. the study hypothesis is that persons with low vitamin d levels have impaired glucose handling which might be improved by vitamin d supplementation.


Eligibility criteria:
inclusion criteria: * generally: subjects are recruited from the 6th tromsø study * cases: serum 25-hydroxyvitamin d-levels below the 10 percentile; low levels confirmed with new serum analyses. * controls: serum 25-hydroxyvitamin d levels 80-95 percentile, normal-high levels confirmed with new serum analyses. exclusion criteria: * diabetes * myocardial infarction or apoplexia * active cancer during last 5 years * history of kidney stone * pregnancy or premenopausal without safe anticonception * primary hyperparathyroidism * systolic blood pressure \>175 or diastolic blood pressure \>105
evaluation of the interest of the instillation of saline intraperitoneally (insi ) versus instillation of naropin the surgical site versus lung recruitment maneuvers ( pvm ) in the management of pain after laparoscopic cholecystectomy in ambulatory care

Conditions: Surgery; Pain

Summary: known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care. in order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role. as part of abdominal surgery, local anesthetics (naropin (ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. in addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera. in recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain. however, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.


Eligibility criteria:
inclusion criteria: * patient aged 18 to 80 years * patients with biliary pathology requiring cholecystectomy * patients with signed consent * patient eligible to outpatient care * no allergy to naropin * support by laparoscopy * patients affiliated to a social security s exclusion criteria: * contraindications for laparoscopy * contraindications to outpatient surgery * patients with an allergy to paracetamol or tramadol * patient with an addiction to painkillers and / or alcohol * patient with a disease causing chronic pain * patient using analgesics bearing 1 , 2 or 3 chronically * pregnant or breastfeeding women , of reproductive age without effective contraception * minor patient, * contraindication to surgery, * physical or psychological state does not allow the patient's participation in the study ,

Keywords: digestive system
a trial of routine aspiration thrombectomy with percutaneous coronary intervention (pci) versus pci alone in patients with st-segment elevation myocardial infarction (stemi) undergoing primary pci

Conditions: Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention

Summary: this is an international, randomized, controlled, parallel group study in which patients with st-segment elevation myocardial infarction (stemi) will be allocated to one of the following: manual aspiration thrombectomy with percutaneous coronary intervention (pci) or pci alone.

the hypothesis for total is that the routine use of manual aspiration thrombectomy with an aspiration catheter (export®) with pci compared to pci alone will reduce the incidence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening nyha class iv heart failure (hf) at 180 days in patients with stemi undergoing primary pci.

Eligibility criteria:
inclusion criteria: 1. patients presenting with: * symptoms of myocardial ischemia lasting for ≥ 30 minutes and * definite ecg changes indicating stemi: st elevation of greater than 0.1 mv in two contiguous limb leads or 0.2 mv in two contiguous precordial leads 2. referred for primary pci 3. randomized within 12 hours of symptoms onset and prior to diagnostic angiography 4. informed consent exclusion criteria: 1. age ≤ 18 years 2. prior coronary artery bypass surgery (cabg) 3. life expectancy less than six months due to non-cardiac condition 4. treatment with fibrinolytic therapy for qualifying index stemi event

Keywords: acute coronary syndrome pci percutaneous coronary intervention stemi thrombectomy
flaxseed compared with placebo in patients with hypercholesterolemia

Conditions: Familial or Severe Hypercholesterolemia

Summary: the aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo.

the proposed study is a 4 week randomized, double-blind, placebo-controlled clinical trial. participants will be recruited from the pediatric lipid disorder clinic at the hospital for sick children, which provides consultations to and management of children with primary lipid abnormalities. patients that meet the study criteria will be approached during their routinely scheduled clinic visits, until the sample size (n=30) be reached. patients will randomly be assigned to the intervention or the placebo group. the intervention group will be given muffins and breads containing ground flaxseed. two muffins and one slice of bread will be consumed per day to provide a total of 30g flaxseed to the experimental group. the control group will be given muffins and breads containing whole wheat flour in place of flaxseed. participants will be instructed to eat one muffin for breakfast, one muffin as an afternoon snack, and one slice of bread as an evening snack every day for a 4-week period. the muffins and breads use in the study will be baked by an independent baker.

Eligibility criteria:
inclusion criteria: * age 8 to 18 years * positive first-degree family history of hypercholesterolemia or premature atherosclerotic cardiovascular disease * elevated ldl level above 3.5 mmol/l and less than 5.0 mmol/l * entered in the national cholesterol education program step ii diet for at least 6 months exclusion criteria: * patients with secondary causes of hyperlipidemia * history of major illness or surgery 3 months or less prior to enrollment * taking lipid-lowering medications * history of gastrointestinal problems * allergies towards flaxseed

Keywords: flaxseed hypercholesterolemia children
impact of presurgical exercise on hemodialysis fistula outcomes

Conditions: Chronic Kidney Disease

Summary: the purpose of this research study is to determine whether two different types of forearm exercise, performed before fistula creation surgery, can improve surgery success and fistula maturation.

this is a randomized, double blinded controlled trial to study the impact of handgrip exercise prior to surgical creation of hemodialysis fistula on vascular remodelling and fistula maturation in chronic kidney disease patients.

Eligibility criteria:
inclusion criteria: 1. adult (age\>18 years old) with chronic kidney disease 2. hemodialysis is their renal replacement therapy (rrt) modality 3. deemed eligible for an arteriovenous fistula 4. anticipated rrt start \< 3 months (from the time of vascular surgery assessment) if predialysis 5. scheduled surgical creation of fistula aniticpated \>= 8 weeks 6. able to follow instructions for an exercise intervention 7. able to provide informed written consent exclusion criteria: 1. life expectancy \< 6 months 2. need for urgent vascular access (i.e. \<4 weeks) 3. pre-existing fistula distal to site of newly scheduled fistula 4. ipsilateral central stenosis or occlusions not amenable to correction 5. contraindications or unable to perform handgrip exercise * unable to withstand transiently raised systolic blood pressure (sbp) by 35 mmhg, and diastolic (dbp) by 25 mmhg * severe upper extremity arthritis or other pain 6. contraindications to general exercise * poorly controlled blood pressure - sbp\>180, dbp\>90; sbp\<110, dbp\<50 * nyhc iv heart failure

Keywords: chronic kidney disease hemodialysis vascular access arteriovenous fistula forearm exercise
response to combined sons and ons in chronic cluster headache

Conditions: Chronic Cluster Headache

Summary: the purpose of this study is to demonstrate the safe use of the primus system in subjects with chronic cluster headache. this is a single-centre, open label, prospective, first in human study to collect initial clinical data on the primus system for the treatment of chronic cluster headache.


Eligibility criteria:
main inclusion criteria: * able and willing to provide informed consent * documented chronic cluster headache for at least 1 year as per ichd-3 criteria * attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment * documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) * stable on preventive treatment for at least two weeks prior to enrolment. * agree to refrain from starting new prophylactic cluster headache medication or other preventive treatments, from 4 weeks before entering the baseline period throughout the duration of the study * mri available (not older than 4 years prior to study enrolment) or willing to undergo an mri to exclude structural lesions potentially causing headache * able and willing to complete a headache diary main exclusion criteria: * any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms * concomitant neuromodulation, except tvns * previous failure to any implantable neuromodulation device for neurovascular headache * have an existing active implantable medical device nearby the implant location (e.g. dbs, cochlear implant, ...) * metal implants in the skull (e.g. skull plates, seeds) nearby the implant * have a pacemaker or implantable cardioverter defibrillator (icd) * suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months * use of botulinum toxin injections in the past 12 weeks * calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment * women of childbearing age who are pregnant, nursing or not using contraception
post-operative antibiotics; effects on risk of infection after cochlear implant surgery

Conditions: Postoperative Infection

Summary: currently there is little consensus regarding postoperative antibiotic prophylactic treatment and its effect on the postoperative infection rate after cochlear implantation. the literature on this subject is contradictory, and very limited. the aim is to assess the impact of postoperative antibiotic treatment on post-operative infection rate, and thereby discuss if postoperative antibiotic treatment has any benefits in the preventing treatment against infectious complication.


Eligibility criteria:
inclusion criteria: * all patients undergoing cochlear implantation at this facility from 2010 to 2022 exclusion criteria: * none
evaluate the accuracy of raman ivd analyzer in the diagnosis of gliomas during surgery

Conditions: Glioma

Summary: compare the data obtained from the raman analyzer and paraffin pathology examination on the same external brain tissue sample. evaluate the effectiveness and safety of the raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.

based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. compare the results between the raman analyzer and the paraffin pathological. and calculate the sensitivity, the specificity, and other indicators of raman analyzer. during surgery, core or marginal tissue samples were taken from subjects. the test samples size:0.2cm\<length diameter ≤ 2cm. the sample testing result is based on the raman test points. then take the same tissue sample for paraffin pathological diagnosis. statistical description of all data, including baseline data, all efficacy indicators, and all safety data. the measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; provide frequency and composition ratio for counting data. the baseline data was analyzed using the full analysis set (fas); the effectiveness analysis adopts fas and pps; the security analysis uses the security dataset (ss).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, regardless of gender; * patients who plan to undergo brain lesion tissue resection surgery or have preoperative clinical diagnosis of gliomas and plan to undergo biopsy; * patients with clinical diagnosis of initial solitary gliomas, or initial solitary intracranial masses or initial non occupying lesions that do not exclude gliomas (such as intracranial metastatic lesions, intracranial infectious lesions, intracranial demyelinating lesions, central nervous system lymphoma, etc.), who have not received radiotherapy or chemotherapy in the past based on their medical history; * the patient or their guardian can understand the research purpose, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form; * it is possible to obtain tissue samples with a length diameter greater than 0.2cm. patients diagnosed with initial solitary glioma should take core or marginal tissue, while patients diagnosed with initial single intracranial mass or initial non mass lesions but maybe with gliomas should be taken core tissue. exclusion criteria: * investigator judge that it is not suitable for inclusion.

Keywords: glioma raman intraoperative surgery
pecarn emergency care registry

Conditions: Pediatric Emergency Care

Summary: the objectives of this study are to: develop an emergency care visit registry for pediatric patients for quality improvement purposes and to support future research; to use the emergency care visit registry to collect stakeholder-prioritized emergency care performance improvement measures for important pediatric medical and trauma conditions; and report emergency care performance improvement measures.


Eligibility criteria:
inclusion criteria: * all patients (0-18) who registered in the ed exclusion criteria: * greater than 18 years of age for ed patients
peripherical neuromuscular electrical stimulation in systemic autoimmune myopathies

Conditions: Electrical Remodeling; Rheumatic Diseases; Myopathy

Summary: systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases with progressive skeletal muscle weakness. the relevance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.

systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily affect the skeletal muscles. despite these advances, this group of diseases still continues to be associated with high morbidity and functional disability, mainly due to the proximal muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of these patients. on the other hand, the importance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.

Eligibility criteria:
inclusion criteria: * classification criteria - eular/acr 2017 * classification criteria - connors et al. * objective muscle limb weakness exclusion criteria: * neoplasia * using heart pacemarker * using visceral metalic clips * infections (hiv, htlv-1, hepatitis, etc) * pregnancy * previous historical of convulsions or epilepsies

Keywords: systemic autoimmune myopathies peripherical neuromuscular electrical stimulation myositis
metronomic chemotherapy in a real-world population of advanced breast cancer patients

Conditions: Breast Cancer

Summary: the goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. the main question it aims to answer is: how effective is metronomic chemotherapy in advanced breast cancer? specific benefit groups of metronomic chemotherapy.


Eligibility criteria:
inclusion criteria: 1. females, \>18 years old; 2. diagnosed with advanced breast cancer when using metronomic chemotherapy; 3. at least one clinical evaluation, including physical examination and imaging, according to the instructions of the supervising physician during the use of metronomic chemotherapy. examinations include ultrasound, computed tomography, and magnetic resonance imaging; 4. metronomic chemotherapy can be used alone, and patients who use it in combination with other drugs can also be included; 5. the clinical pathological information that needs to be collected is complete. exclusion criteria: 1. taking the drug for less than 2 weeks; 2. losing follow-up after taking the therapy; 3. the patient's breast cancer was still in the early stage when taking the therapy.

Keywords: breast cancer metronomic chemotherapy capecitabine
incretin regulation of insulin secretion in monogenic diabetes

Conditions: Monogenic Diabetes

Summary: the purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.

monogenic diabetes patients and healthy matched controls will be admitted to the university of chicago clinical resource center for a total of 4 nights. the following will take place on separate days: 1. oral glucose tolerance test (ogtt): consume sugary drink and blood samples will be collected at multiple time points 2. isoglycemic glucose infusion (igi) test: glucose will be infused via a vein in the arm and and blood samples will be collected at multiple time points 3. ogtt during glp-1 infusion 4. igi during exendin-9 infusion

Eligibility criteria:
monogenic diabetes subjects: inclusion criteria: * diagnosis of monogenic diabetes * previously participated in us neonatal diabetes registry (irb 15617b) or genetics of diabetes mellitus (irb 6858) * age: 18 years + exclusion criteria: * pregnancy * acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate \<50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (hct \< 36%), or uncontrolled hypertension healthy controls: inclusion criteria: * good general health * stable weight for 6 months * age: 18 years + exclusion criteria: * pregnancy * acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate \<50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (hct \< 36%), or uncontrolled hypertension