Kornimate/medical-research-clean huggingface dataset:
emergency structured clinical examination training box

Conditions: Emergencies

Summary: this is a pragmatic, randomized, controlled study carried out in the emergency department of angers university hospital. all students on placement over a 10-week period will be able to take part in the study. after a clear explanation to the students during the welcome meeting, followed by the collection of free and informed non-opposition, the students will be assigned according to the "ecox" or "traditional" approach, depending on the randomization status of the internship period. the inclusion arm will be the same for all students over the placement period. for the traditional approach (control group), students will participate in the osces of the services scheduled at the end of the internship. students will use the various revision methods usually offered to them by the faculty or in the emergency department, apart from the "ecox tool". revision methods are left to their own discretion. students will complete the internship without any knowledge of the ecox tool. for the ecox approach, students included in the intervention arm will be invited to use the ecox tool. they will have the various ecox grids and a stopwatch at their disposal in the 2 units of the emergency department. they will have around thirty evaluation grids at their disposal. the students will choose the ecox grid corresponding to their initial situation, based on the nurse's triage of the patient. they must ask the patient's permission to practice with them. they must not look at the ecox grid. as with the on-duty ecos, they will have 7 minutes to complete the interview and clinical examination. once this time has elapsed, they will have to compare their answers with the expectations of the grid. they may also be observed by a co-external study participant, a department intern or a senior staff member who is not involved in the osce evaluation. they will act as observers and complete the grid. the students will then be able to propose modifications to the grids. each completed grid will be returned to a drawer in the cubicle, to assess adherence to the tool and suggestions for grid modifications, as well as any comments. students will be able to use them as many times as they like during the course and before the service ecos.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * medical student in a non-erasmus emergency department * participating in the service ecos planned at the end of the internship * no free and informed consent from the student. exclusion criteria: * refusal to participate in the study. * student returning to the emergency department and having already participated in the study.
the effect of atorvastatin and pioglitazone on carotid atherosclerosis with the use of positron emission tomography-computed tomography (pet-ct)

Conditions: Atherosclerosis; Coronary Artery Disease

Summary: this study is a prospective randomized clinical trial and to compare the antiinflammatory effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy in carotid arteries of stable and unstable angina patients by pet/ct.


Eligibility criteria:
inclusion criteria: * the subject who has undergone percutaneous coronary intervention due to coronary artery disease ( stable angina or unstable angina) * the subject described above who has atherosclerotic plaque in his/her carotid artery by carotid ultrasonography * the subject who or a legal representative agrees to the clinical trial and gives written permission to the irb-approved form. exclusion criteria: * the subjets who have taken statins or thiazolidinedione with 4 weeks * marked elevated liver enzyme ( more than 2.5 fold compared to reference range) * renal insufficiency patients ( serum creatinine more than 2 mg/dl) * congestive heart failure ( nyha class 2-4) * acue myocardial infarction * unstable angina with st segment deviation * pregnancy * the subjects enrolled in another studies

Keywords: atherosclerosis pioglitazone atorvastatin pet ct
looping whilst restricting carbohydrates

Conditions: Diabetes; Type 1 Diabetes

Summary: to investigate the efficacy, safety and utility of hybrid closed-loop glucose control during a low carbohydrate vs. iso-energetic balanced diet in individuals with type 1 diabetes.

closed-loop systems combining an insulin pump, a glucose sensor and a dosing algorithm that adjusts insulin delivery in a glucose-responsive manner achieve significantly better glucose control than conventional therapy in type 1 diabetes. achieving satisfactory postprandial glucose control, however, continues to be challenging. the main limitation is the delayed pharmacokinetics and -dynamics of subcutaneously administered insulin with peak actions between 1 and 2 hours. conversely, glucose levels typically rise within 10minutes following carbohydrate intake. this mismatch largely explains the inability of current closed-loop systems to control postprandial glucose excursions and the increased risk of late postprandial hypoglycaemia in response to both user-derived meal bolus administration and reactive algorithm-driven insulin infusion. restricting carbohydrate may therefore significantly improve post-prandial glucose control whilst reducing hypoglycaemia. the efficacy of hybrid closed-loop operation in individuals with type 1 diabetes adhering to a low carbohydrate compared to a iso-caloric balanced diet has not been investigated to date.

Eligibility criteria:
inclusion criteria: * female and male subjects aged 18 years or older * diabetes mellitus type 1 as definded by who for at least 2 years or c-peptide negative (\ 4 mmol/l) * hybrid-closed-loop insulin therapy (minimed 670g) for at least 2 months * hba1c \<= 9 % * the subject is willing and capable of adhering to the diet plan. exclusion criteria: * physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator. * excess alcohol consumption (\> 3 units/day for men, \> 2 units/day for women) * pregnancy, planned pregnancy or breast feeding * current participation in another clinical trial * total daily insulin dose \>2 iu/kg/day * nephrolithiasis * hereditary dyslipidemia * liver steatosis

Keywords: artificial pancreas hybrid closed-loop low carbohydrate diet glucose control
tele-monitoring of patients with home mechanical ventilation (hmv) trough telemedicine system (myvent)

Conditions: Ventilatory Failure

Summary: the purpose of this study is to improve hmv treatment adherence using an integrated telemedicine platform (myvent system)

the investigators propose a study to evaluate the effect of using tele-monitoring in the follow-up of patients with hmv in order to improve their compliance and evaluate its cost-effectiveness. telemedicine will be provided by an integrated platform composed by a website and a smartphone application for achieve a real feedback between patients and clinicians. design: prospective randomized clinical study that will include 184 patients with hmv. the study will be divided in two phases, the first one consisting on the website and app system development and the second one consisting on a clinical trial where the two follow-up systems (standard care vs myvent group) will be compared. randomization: patients will be randomised into two groups, hmv treatment management with standard care vs. telemedicine follow up. intervention: group 1:myvent group: patients will be followed up by tele-monitoring support. myvent system will be updated with data extracted from the ventilation equipment. this information and the results of the complementary tests will be sent to the clinician. moreover, with myvent app patients will receive information about their treatment and advices to improve therapy if needed. group 2: standard care. in this group all the visits will be performed at hospital following daily clinical practice.

Eligibility criteria:
inclusion criteria: * men and women over to 18 years old. * signed informed consent. * good knowledge about the use of smartphones. * patients with chronic obstructive pulmonary disease (copd), obesity-hypoventilation syndrome and chest wall disorders who had started hmv at least three months before their inclusion. exclusion criteria: * chronic pathology limiting life expectancy less than 1 year. * psychiatric limiting problems. * pregnancy

Keywords: hmv tele-monitoring telemedicine chronic hypercapnic respiratory failure
tae and mwa combination therapy in early-stage hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Hepatoma; Liver Cancer, Adult; Liver Cell Carcinoma; Liver Cell Carcinoma, Adult

Summary: this is a single-center, prospective rct to study the effectiveness of tace and mwa combination therapy with mwa monotherapy for the treatment of early hcc. primary outcome is 2-year intrahepatic disease-free survival.

this single-center, prospective randomized controlled trial (rct) is designed to compare the outcomes and clinicopathologic results of trans arterial embolization (tae) and microwave ablation (mwa) combination therapy with mwa monotherapy for the treatment of early (stages 0 and a) hepatocellular carcinoma (hcc). the primary aim of this study is to test the following hypothesis: 2-year intrahepatic disease-free survival does not differ between patients receiving the experimental therapy (mwa + tae) and patients receiving the standard therapy (mwa alone) as treatment for early stage hcc. secondary aims are: 1) to determine the clinical feasibility of tae + mwa in hcc patients with a small tumor burden using patient demographics and disease characteristic data and 2) to determine the effect of tae on radiographic tumor characteristics in this patient cohort. the primary outcome is 2-year intrahepatic disease-free survival, which is measured from time of randomization and is defined as the absence of local or regional recurrence of hcc as determined by diagnostic imaging. local recurrence is defined as an enhancing lesion contiguous with the ablation zone that is present on subsequent imaging but was not present on the initial post-ablation scan. regional recurrence is defined as hepatic recurrence that is not adjacent to the ablation site.

Eligibility criteria:
inclusion criteria: * primary diagnosis of hepatocellular carcinoma (hcc) * hcc classification of stage 0 (very early) or stage a (early) according to barcelona clinic liver cancer (bclc) staging system criteria * adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic transarterial embolization (tae) and/or microwave ablation (mwa) as treatment for hcc * willing and able to give informed consent exclusion criteria: * radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases * evidence of residual disease at first post-mwa computed tomography examination * body mass index (bmi) \> 35 * previous history of hepatic resections * severe renal dysfunction (creatinine clearance of \<40 ml/min) * pregnant or nursing women

Keywords: therapeutic embolization ablation techniques transarterial embolization tae microwave ablation mwa
monocentric feasibility study for a new medical device for the treatment of anal fissure with botulinum toxin

Conditions: Anal Fissure

Summary: monocentric feasibility study for a new device for the treatment of anal fissure with botulinum toxin.

anal fissure is a common anal disease. this is a longitudinal tear in the distal part of the anal canal. the fissure provokes a spasm of the internal anal sphincter and as such pain and eventually bleeding. there are currently 3 different treatments. all available treatments tend to relax the anal sphincter, which reduces pain and promotes fissure healing. the first treatment consists in the local application of cream into the anal canal. the second option is the injection of botulinum toxin into the internal or external anal sphincter. finally the third option is a surgical intervention, most frequently a lateral sphincterotomy. although the usefulness of botulinum toxin to treat anal fissure has been demonstrated, the results vary. this is most likely largely due to the fact that there is no standardized way to inject botulinum toxin and that there is a significant learning curve. in addition, the gesture is not without risk for the operator. the objective of the study is to assess the feasibility of injecting botulinum toxin into the anal canal with a new medical device for patients with anal fissure. the trial is a mono-centric pilot study conducted on 4 patients. the study is open, prospective and all patients will be treated with the botulinum toxin injected using the new medical device. the device (single-use) under investigation and the botulinum toxin will be made available free of charge to the patient.

Eligibility criteria:
inclusion criteria: * adult patients suffering from anal fissures for a minimum of 6 weeks. * informed consent signed exclusion criteria: * contraindication to the use of botulinum toxin or any known allergies * pregnant or breastfeeding women * immune deficiency, immunosuppression * anticoagulant treatment * previous pelvic radiotherapy * acute anal inflammation (eg.proctitis) * internal hemorrhoids of grade 2 or higher * anal fissure that did not respond to a previous treatment by botulinum toxin * history of lateral sphincterotomy * cardiopulmonary disease leading to reduced function of the cardiopulmonary system
peripheral reading

Conditions: Central Visual Impairment

Summary: the purpose of this study is to evaluate reading performance in the visual periphery by simulating central vision loss using a computer-controlled gaze-contingent display with an eye tracker. participants will read a page of text at a comfortable rate. several manipulations hypothesized to improve reading will be tested, such as an inverted-text "spotlight" of a single word that follows the participant's gaze.

participants will view paragraphs of multiple sentences of text with their central vision blocked computationally with a "simulated scotoma." participants will be free to move their eyes around the page of text at a comfortable rate. the three outcomes described elsewhere will be evaluated. in different blocks, text will contain one or more of several dynamic assistive manipulations that are hypothesized to enhance reading: 1) inverting the text at a given position, with instructions for the participant to attend to that location, which simulates a "surrogate fovea" of a patient with central vision loss. 2) horizontally expanding text to alleviate within-word crowding. 3) highlighting the next word with a visible indicator to encourage proper eye movements.

Eligibility criteria:
inclusion criteria: * normal vision * english language exclusion criteria: * less than 20/20 vision in either eye * abnormalities which affect vision (amblyopia, keratoconus, etc.) * ortho-k lenses
metabolic syndrome cohort in korea

Conditions: Metabolic Syndrome

Summary: patients with metabolic syndrome living in seoul area are included in this prospective registry for more than 10 years. all enrolled patients undergo thorough medical history survey. enrolled patients will have coronary ct, 2d echocardiogram, treadmill test, pulse wave velocity, augmentation index, carotid intima-media thickness, and abdominal fat mass evaluation. moreover, lipid profiles and inflammatory markers such as hscrp, il-6, tnf-alpha, vcam-1, icam-1, adiponectin, mmp-9 will be measured. all participants will repeat the test and survey every year in korea university hospital.


Eligibility criteria:
inclusion criteria: 3 out of 5 criteria * central obesity: men ≥ 90 cm women ≥ 85 cm * plasma triglycerides ≥ 150 mg/dl * hdl cholesterol men \< 40 mg/dl, women \< 50 mg/dl * blood pressure ≥130/85 mm hg (or treatment for hypertension) * fasting plasma glucose ≥ 100 mg/dl * age between 30 to 64 * consent to our registry protocol exclusion criteria: * patients who could not undergo coronary ct, 2d echocardiogram, treadmill test, and pulse wave velocity.

Keywords: patients with metabolic syndrome age between 30 to 64: central obesity (men ≥ 90 cm women ≥ 85 cm), plasma triglycerides ≥ 150 mg/dl hdl cholesterol men < 40 mg/dl, women < 50 mg/dl, blood pressure ≥130/85 mm hg (or treatment for hypertension), fasting plasma glucose ≥ 100 mg/dl
activities of daily living (adl) virtual reality (vr) for acquired brain injury (abi) upper-limb rehabilitation

Conditions: Upper Limb Rehabilitation; Stroke

Summary: acquired brain injury (abi) individuals have shown greater engagement and functional recovery when trained in virtual reality (vr)-assisted rehabilitation therapies. after developing an activities of daily living (adl)-focused vr system in a prior study, this related follow-up study aims to test the efficacy and impact of this vr system on upper-limb rehabilitation outcomes of abi individuals when routinely integrated into treatment plans.

after completion of informed consent, patients will undergo screening assessments to determine eligibility for study participation. all eligible participants integrate vr into rehabilitation treatment plans twice per week for 12 weeks. graphical complexity increases progressively throughout the study: "simple" in weeks 1-4, "standard" in weeks 5-8, and "complex" in weeks 9-12. assessments are conducted at pre-intervention and post-intervention.

Eligibility criteria:
inclusion criteria: * acquired brain injury with upper extremity impairment * fugl-meyer assessment of upper extremity (fma-ue) score of 20 points or more * able to follow commands and instructions * least 2 months post-stroke, in the subacute or chronic recovery phase exclusion criteria: - contraindications that increase susceptibility to vr-related adverse events and/or prevent completion of training tasks, such as seizures, epilepsy, visual acuity deficits (besides glasses), vertigo, nystagmus, motion sensitivity, or other non-abi conditions that impede upper limb movement
a study on probiotic formula in autistic children

Conditions: Autism Spectrum Disorder

Summary: a randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in autistic children with gastrointestinal symptoms.

autism spectrum disorder (asd) is a neurodevelopmental disorder of children with estimated prevalence of near 1% by who in 2022. to date, the cause and etiology of asd is still unknown, and there is no proven effective pharmacological treatment for asd. the gut microbiota has been proved to have great impact on neurological development, in this study, we aim to explore the effectiveness of safety of probiotic formula on asd children, by comparing with placebo and fecal microbiota transplantation (fmt). this study will be a randomized, double-blind, placebo-controlled trial. totally, 156 autistic children with gastrointestinal symptoms will be enrolled and randomly allocated into three groups: probiotic formula group, fecal microbiota transplantation (fmt) group and placebo group. participants are treated with 4 probiotic formula/fmt/placebo capsules each day, for 84 days. participants would be followed up at the 4th, 8th, 12th and 24th week after enrollment by simple physical examination, relevant scale questionaire (including autism behavior checklist(abc),childhood autism rating scale(cars),gastrointestinal symptom rating scale(gsrs),social responsiveness scale(srs),self-rating anxiety scale(sas) and autism diagnostic observation schedule(ados)), and blood and fecal samples collection.

Eligibility criteria:
inclusion criteria: * children and adolescents aged 3-11 years old * clinical diagnosis of asd, based on the diagnostic and statistical manual of mental disorders (dsm-v) * associated with gastrointestinal symptoms for at least 14 days (diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances) * with guardians who can fully understand the informed consent and voluntarily sign the written informed consent exclusion criteria: * antibiotics or probiotics used within 1 mont * serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding * medications related to mental disorders or depression * relying on tube feeding * swallowing dysfunction that unable to take capsules * history of severe allergies * paticipation in other clinical studies within 4 weeks * poor compliance and have difficulty in completing follow-up.

Keywords: autism spectrum disorder gut microbiota
tolcapone in obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the proposed study will consist of a 5-week double-blind cross-over study trial of tolcapone in 20 people (ages 18-65). the study will be divided into an initial 2 week phase and a second 2 week phase, with one of the 2 week phases consisting of active treatment with tolcapone, and the other 2 week phase consisting of inactive placebo treatment. there will be a one-week wash-out phase between the 2-week treatment phases. participants will be randomized to receive either tolcapone or placebo during the first 2 week phase on a 1:1 basis. this blinding will be maintained by the ids pharmacy at the university of chicago.

the goal of the proposed study is to evaluate the efficacy and safety of tolcapone in adults with obsessive compulsive disorder (ocd). the hypothesis to be tested is that tolcapone will be more effective and well tolerated in adults with ocd compared to placebo. the proposed study will provide needed data on the treatment of a disabling disorder where current treatments are often ineffective. the primary aim of this application is to conduct a randomized placebo-controlled pharmacotherapy trial using tolcapone in 20 participants with ocd. the study will consist of two phases: a 2 week active treatment phase with tolcapone, a one-week wash-out phase, and a 2 week placebo phase. the subjects will be randomized to either receive tolcapone or placebo treatment in the first 2 weeks, and the other during the remaining 2 week phase. this will be one of few studies assessing the use of pharmacotherapy for the treatment of ocd in adults. assessing the efficacy and safety of tolcapone will help inform clinicians about additional treatment options for adults suffering from this disorder.

Eligibility criteria:
inclusion criteria: 1. males and females age 18-65; 2. diagnosis of current ocd based on dsm-5 criteria and confirmed using the clinician-administered structured clinical interview for dsm-5 (scid); 3. able and willing to provide written consent for participation. exclusion criteria: 1. unstable medical illness, including liver disease, as determined by the investigator; 2. history of seizures; 3. clinically significant suicidality (defined by the columbia suicide severity rating scale); 4. baseline score of ≥17 on the hamilton depression rating scale (17-item hdrs); 5. lifetime history of bipolar disorder type i or ii, schizophrenia, autism, any psychotic disorder, or any substance use disorder; 6. initiation of psychotherapy or behavior therapy within 3 months prior to study baseline; 7. previous treatment with tolcapone; 8. any history of psychiatric hospitalization in the past year; 9. currently pregnant (confirmed by urine pregnancy test)