Kornimate/medical-research-clean huggingface dataset:
use of a bearable continuous interstitial glucose monitoring device (guardianr) during teaching sessions to functional insulin therapy concept in patients suffering from type 1 diabetes: evaluation at 6 and 12 months

Conditions: Diabetes Complications

Summary: the objective of the project is to evaluate advantages from the use of a bearable continuous interstitial glucose monitoring device (guardianr) during educative sessions of diabetic patients dedicated to functional insulin therapy teaching. this concept of intensified treatment is based on testing and explanation of simplified decision making algorithms to adapt insulin dose to every true life conditions. as self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.

two groups of 60 patients (experimental and control groups) will be followed and evaluated at 6 and 12 months. we do think that this new tool would facilitate education of patients and lead further to a better glycemic control.

Eligibility criteria:
inclusion criteria: * subject major, from 18 to 70 years old * diabetes of type 1 defined according to the criteria of american diabetes association * insulinic treatment for at least 12 months * understood hba1c enters 6,5 and 9,5 % exclusion criteria: * minor subjects or under guardianship * unbalance kétosis current or recent * pregnancy * incapacitated to participate weekly complete educational in the functional insulin-therapy, * evolutionary severe general disease * psychiatric confusions * unbalance chronic (hba1c \> 9,5 %) connected to an absence of adapted coverage or to abnormal behaviors * pathology making not interpretable the rate of hba1c (hemoglobinopathy, anemia)

Keywords: glucose diabetes glycemia
changes of macular vasculature after uncomplicated phacoemulsification surgery using optical coherence tomography angiography

Conditions: Diabetic Retinopathy

Summary: to record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using octa, a comparative study between healthy and diabetic patients

a prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in tanta university hospital two groups will be divided: 1. group (1): cataract will no diabetic retinopathy 2. group (2): cataract associated with diabetic retinopathy. all patients will be subject to full ophthalmologic examination before the surgery. imaging will include octa. octa will be performed using cirrus oct (zeiss, inc., usa). high-quality 6 x 6 mm octa macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio with adequate centration on the fovea and optic nerve head respectively will be selected. segmentation will be used to evaluate superﬁcial and deep capillary retinal plexus projections in addition to the choriocapillaries. if errors in segmentation were detected, manual correction would be performed. the superﬁcial retinal capillary plexus (scp) will be delineated with an inner boundary at the internal limiting membrane (ilm) and an outer boundary 10 µm inside the inner plexiform layer (ipl). the deep retinal capillary plexus (dcp) will be segmented with an inner boundary 10 µm inside the ipl and an outer boundary at 10 µm beneath the outer plexiform layer (opl). the vessel density metric from enface oct angiogram will be used as an indicator of macular retinal and papillary perfusion. vessel density (vd) analysis computes the percentage of area occupied by octa detected vasculature in a measured area. choriocapillaries flow voids will be computed to assess choriocapillaries circulation. the measurements of the octa, axial length, intraocular pressure will be obtained before the phacoemulsification surgery. optical coherence tomography and iop measurements will also be obtained 1 week after surgery.

Eligibility criteria:
inclusion criteria: * - presence of a nuclear, cortical cataract or complicated cataract due to diabetic mellitus * intraocular pressure (iop) of 21 mm hg or lower * axial length (al) between 20.0 mm and 25.0 mm. exclusion criteria: * eyes with an al longer than 25.0 mm or shorter than 20.0 mm, * iop higher than 21 mm hg, * history of ocular trauma or intraocular surgery, or any abnormal intraocular findings * poor oct-a images because of severe cataracts or unstable fixation * any signs of intraoperative or postoperative complications
antibiotic use following distal and mid-shaft hypospadias repair

Conditions: Hypospadias

Summary: the purpose of this study is to evaluate the efficacy of prophylactic antibiotics following distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract infection and complications.

the rationale for using prophylactic antibiotics after hypospadias surgery is to decrease the occurrence of urinary tract infections (utis) and complications. however, even though prophylactic antibiotics are used by some pediatric urologists, to date there has been no evidence supporting the role of prophylactic antibiotics in decreasing utis or complications. this is a prospective, randomized trial involving children undergoing distal or mid-shaft hypospadias repair. subjects randomized into a group taking prophylactic dosages of antibiotics and a group not receiving post-operative antibiotics.

Eligibility criteria:
inclusion criteria: * all children between ages 6 months to 2 years under going distal or mid shaft hypospadias repair * children of parents who give informed consent * english speaking * participant must be available for follow-up 3 and 12 months post-surgery exclusion criteria: * all proximal hypospadias and redo hypospadias repairs * children who are allergic to sulfa medications * patients who have uti at time of surgery (proven by culture)

Keywords: antibiotic prophylaxis
a study of khk4827 in patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: exploratory evaluation of pharmacokinetics and safety of khk4827 in subjects with systemic sclerosis


Eligibility criteria:
inclusion criteria: * subject meets the criteria for diagnosis of the diagnostic criteria, severity classification, and clinical practice guidelines for systemic sclerosis （japanese dermatological association 2016） at the pre-examination * subject presented the first symptoms of sclerosis other than raynaud's phenomenon within 60 months before enrollment * subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mrss of 10 to \<30 at the pre-examination and who has progressing skin thickening exclusion criteria: 1. any of the following significant concomitant diseases: * type 1 diabetes * poorly controlled type 2 diabetes (hba1c \> 8.5%) * congestive heart failure (class ii to iv of the new york heart association functional classification) * myocardial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product * poorly controlled hypertension (systolic pressure \> 150 mm hg or diastolic pressure \> 90 mg hg at screening) * severe chronic lung disease (%forced vital capacity (fvc) \< 60% and %diffusing capacity of lung for carbon monoxide (dlco) \< 40%, calculated according to the reference values for spirometry, including viral capacity, in japanese adults calculated with the lms method and compared with previous values \[japanese respiratory society\]) * major chronic inflammatory diseases or connective tissue diseases other than scleroderma 2. patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion 3. patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the columbia-suicide severity rating scale (c-ssrs) at enrollment 4. patient has severe depression based on a total score of ≥ 15 on the patient health questionnaire-8 (phq-8) at enrollment

Keywords: systemic sclerosis brodalumab khk4827
reducing transphobia among adolescents through a brief video intervention

Conditions: Transgenderism; Depression

Summary: the purposes of this new study are to test among adolescent viewers the utility of brief video-based interventions to: 1. reduce transphobia; 2. reduce depression-related stigma and increase likelihood of treatment-seeking; and 3. examine the role of viewer's sex (male / female / non-binary), race (black vs non-black), and sexual orientation (straight vs lgbq) as independent factors on the outcomes of interest.

intervention videos will each be of \~100-second duration and feature four underage professionals (ages 16) acting as simulated patients. all videos will focus on an empowered presenter with depression sharing their personal story regarding depression. they will describe how social supports from family, friends, and community, as well as professional help assisted them in overcoming symptoms of the illness, as well as how being transgender may have had an impact on it. the four actors will include two males (one trans, one cis) and tow females (one trans, one cis). assessments will occur at baseline and post-intervention, and will include: 1. demographics (baseline only); 2. primary outcome: a. attitudes toward transgender men and women (attmw) scale. 3. secondary outcome: 1. transgender attitudes: feelings thermometer, modeled after norton et al 2013. 2. depression-related stigma (depression stigma scale \[dss\]);and 3. help-seeking (general help-seeking questionnaire \[ghsq\]). for each of study we intend to randomly assign \~1,000 individuals aged 14-18 as follows: randomized, in equal proportions, and stratified by sex and race, to view one of four \~100-second videos: 1. transgender male; 2. cis-gender male); 3. transgender female; 4. cis-gender female.

Eligibility criteria:
inclusion criteria: * english-speaking * living in the us * ages 14 - 18 exclusion criteria: * none
brain regions and functional neuronal network characteristics of dexmedetomidine analgesia

Conditions: Epilepsy; Radiofrequency Ablation; Intracranial Surgery

Summary: background: dexmedetomidine (dex) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. this study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of dexmedetomidine. methods: select 28 patients with the proposed intraoperative mr-guided radiofrequency ablation of epilepsy. the subjects were randomized into the dexmedetomidine group (dex group) (n=14) and the placebo group (po group) (n=14). dex group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then intraoperative functional magnetic resonance imaging scanning was started. po group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fmri scanning started after continuous 30min infusion. the intraoperative fmir scan results were compared and analyzed to find the unique analgesic brain regions of dex, and the differences of the functional neuronal network of analgesia effect between the two groups.

background: dexmedetomidine (dex) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. this study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of dexmedetomidine. methods: select 12 patients with the proposed intraoperative mr-guided radiofrequency ablation of epilepsy. the subjects were randomized into the dexmedetomidine group (dex group) (n=14) and the placebo group (po group) (n=14). dex group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then intraoperative functional magnetic resonance imaging scanning was started. opi group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fmri scanning started after continuous 30min infusion. the intraoperative fmir scan results were compared and analyzed to find the unique analgesic brain regions of dex, and the differences of the functional neuronal network of analgesia effect between the two groups.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of epilepsy and eligible for radiofrequency ablation 2. 20-50 years old; 3. american society of anesthesiologists rated (asa) i-ii 4. body mass index (bmi)18.5\~27.9 kg·m2. exclusion criteria: 1. pre-existing neuropsychiatric disorders; 2. emergency surgery; 3. coma; 4. depression; 5. cognitive impairment; 6. implanted with metal devices.
rapid evaluation of baclofen for treatment of cocaine abuse/dependence - 6

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. in this study, baclofen is tested.

16-week participation plus a 2 week lead in period. participants are assigned randomly to placebo or baclofen. participant attend group meetings 3 x/week.

Eligibility criteria:
inclusion criteria: m/f ages 18-65. cocaine dependence according to diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria. self-reported use within the last 30 days. agreeable to conditions of study and signed informed consent. exclusion criteria: psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on ethanol (etoh) or benzodiazepines or other sedative-hypnotics. acute hepatitis. other medical conditions that deem participation to be unsafe.

Keywords: cocaine dependence
bioequivalence study for fixed dose combination zemimet® sr tab. 50/1000 and coadministration of gemigliptin 50 mg and metformin 1000 mg.

Conditions: Type 2 Diabetes

Summary: to determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg fdc tablet (zemimet® sr tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (zemiglo tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (glucophage xr 1000 mg) as individual tablet in healthy subjects under fasting conditions


Eligibility criteria:
inclusion criteria: * body mass index between 18.0 to 30.0 kg/m2. * normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. * non-pregnant woman (negative pregnancy test) and not currently breast feeding * female subjects abstain from either hormonal methods of contraception * male subjects who are willing or able to use effective contraceptive * have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study. exclusion criteria: * history serious hypersensitivity reactions * history or evidence of clinically significant diseases or any significant ongoing chronic medical illness * history or evidence of family diabetes * history or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma * history or evidence of shock or severe dehydrate or severe infection * history or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period * history or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse * history of problems with swallowing tablet or capsule * history of sensitivity to heparin or heparin-induced thrombocytopenia * any condition possibly affecting drug absorption * have renal creatinine clearance (clcr) \< 45 ml/min based on serum creatinine results at the screening laboratory test * 12-lead ecg demonstrating qtc \>450 msec, a qrs interval \>120 msec or with an abnormality considered clinically significant at screening
impact of postanesthesia care unit delirium on postoperative quality of recovery

Conditions: Postoperative Neurocognitive Disorders; Delirium; Postoperative Recovery; Anesthesia

Summary: postanesthesia care unit (pacu) delirium is subtype of postoperative delirium that occurs early after anesthesia and surgery during the recovery period. the consequences of pacu delirium have not been investigated thoroughly. so far it is unknown, whether patients with pacu delirium experience impaired postoperative quality of recovery. the aim of this observational study is to assess the impact of pacu delirium on quality of recovery 24 hours after general anesthesia for elective non-cardiac surgery.


Eligibility criteria:
inclusion criteria: * elective non-cardiac surgery * general anesthesia * fluency in german exclusion criteria: * expected postoperative icu stay
efficacy of scapulothoracic exercises on postural stability, proprioception, muscular features and mandibular functions

Conditions: Temporomandibular Joint Dysfunction Syndrome; Forward Head Posture

Summary: the goal of this randomized, double-blind, clinical trial is to investigate the effects of scapulothoracic exercises on postural stability, muscle strength, muscular endurance, mandibular functions and proprioception in sedentary individuals aged 18-45 years with head forward posture and temporomandibular joint dysfunction (cranio-cervico-mandibular malalignment). the main questions it aims to answer are: • do scapulothoracic exercises given in addition to cervical posture exercises have an effect on postural stability, proprioception, muscle strength, muscular endurance and mandibular functions in individuals with cranio-cervico-mandibular malalignment? researchers will compare conventional neck exercises (control group) and scapulothoracic exercises applied in addition to conventional neck exercises (treatment group) to see the effects of scapulothoracic exercises on the neck and jaw area.

the investigators aimed to investigate the effects of scapulothoracic exercises on postural stability, muscle strength, muscular endurance, mandibular functions and proprioception in sedentary individuals aged 18-45 years with cranio-cervico-mandibular malalignment including head-first posture and temporomandibular joint dysfunction problems.

Eligibility criteria:
inclusion criteria: * male and female students and employees between the ages of 18-45, * individuals with a craniovertabral angle (cva) \<50° and a fonseca questionnaire score between 20-100, * individuals with a helkimo clinical dysfunction index score between 1-25, * individuals with a low level of physical activity according to the international physical activity questionnaire. exclusion criteria: * serious problems of the musculoskeletal system, including the cervical and thoracic spine, * presence of serious chronic diseases such as hypertension, diabetes, cancer, * presence of neurological disease at a level that will affect balance and postural control, * being pregnant, * tooth and jaw problems in the last 6 months, * individuals with a total denture or prosthesis on the anterior teeth.

Keywords: musculoskeletal rehabilitation temporomandibular joint treatment scapulothoracic exercises cranio-cervico-mandibular malalignment
reference values and determinants of 6-minute walk test

Conditions: Stroke

Summary: the first aim of this study was to investigate the reference values of 6-minute walk test (6mwt) distance in patients with chronic stroke. the second aim was to determine the factors predicting 6mwt distance in patients with chronic stroke.

there may be large variations in the distance of 6mwt according to the stroke severity. investigation of factors related to 6mwt may be helpful in determining and targeting appropriate strategies for gait rehabilitation. accordingly, the first aim of this study was to investigate the reference values of 6-minute walk test (6mwt) distance in patients with chronic stroke. the second aim was to determine the factors predicting 6mwt distance in patients with chronic stroke.

Eligibility criteria:
inclusion criteria: 1. having first ever stroke 2. the time elapsed after the stroke is more than 6 months and less than 10 years 3. 18-80 years old 4. those who could walk independently with no assistance or device and who could walk with an intermittent or continuous light touch to assist balance or coordination exclusion criteria: exclusion criteria: 1. a history of severe musculoskeletal, cardiopulmonary, or psychiatric disease that can inhibit measurements 2. patients who had received a neurologic diagnosis other than stroke, such as parkinson's disease or multiple sclerosis 3. patients with impaired level of consciousness and evidence of gross cognitive impairment (scored below 10 points in the mini-mental state examination

Keywords: walking
the influence of water and salt intake on copeptin levels during moderate alcohol consumption

Conditions: Alcohol Drinking

Summary: the main interest of this study is to investigate the influence of moderate alcohol consumption (beer) on salt-water homeostasis. therefore, 10 healthy volunteers will participate in 4 intervention: * beer alone * beer and water * beer and salt (stock/bouillon) * water alone during the study day, copeptin, sodium, osmolality and urinary sodium/osmolality will be measured at 6 timepoints.


Eligibility criteria:
inclusion criteria: * healthy males exclusion criteria: * any acute or chronic illness * history of alcohol dependency * alcohol consumption \>2 units/day * active nicotine abuse * gluten intolerance * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant * participation in another study with investigational drug within the 30 days preceding and during the present study * enrolment of the investigator, his/her family members, employees and other dependent persons * epileptic seizures within the last year * bmi \<18.5 or ≥25.9kg/m2

Keywords: copeptin salt-water homeostasis
efficacy and safety of bgg492 as adjunctive treatment in patients with partial onset seizures

Conditions: Partial Onset Seizures

Summary: this study will assess the efficacy and safety of bgg492 as adjunctive treatment in patients with partial onset seizures.


Eligibility criteria:
inclusion criteria: * outpatients ≥ 50 kg (110 lb) of weight. * a diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures. * uncontrolled partial seizures despite having been treated with at least two different antiepileptic drugs (aeds) within the last 2 years prior to screening. * at least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period. * cohort 1 patients must be receiving stable treatment with 1 or a maximum of 2 aeds.cohort 2 patients must be receiving stable treatment with 1, 2, or 3 aeds. exclusion criteria: * presence of only non-motor simple partial seizures. * history of psychogenic seizures. * absences, myoclonic seizures e.g. in the context of primary generalized epilepsy. * previous history of lennox-gastaut syndrome. * status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization. * pregnant or nursing (lactating) women. other protocol-defined inclusion/exclusion criteria may apply

Keywords: seizure frequency nervous system diseases brain diseases neurologic manifestations adjunctive treatment aeds antiepileptic drug