Kornimate/medical-research-clean huggingface dataset:
amiodarone vs. catheter ablation for prevention of recurrent symptomatic atrial fibrillation

Conditions: Atrial Fibrillation

Summary: randomized trial of low-dose amiodarone therapy versus catheter ablation (ca) in older patients with persistent atrial fibrillation (af). primary objective: to compare amiodarone to catheter ablation in patients aged 50 to 80 years with symptomatic af for the composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia

this is a single centre vanguard phase prospective randomized open label study with blinded outcome adjudication. patients will be randomized by a central randomization system (1:1) to amiodarone or catheter ablation. 1. amiodarone will be started at a dose of 400 mg/day. after one month the dose will be lowered to 200 mg per day. patients will be seen every six months. at each visit the dose of amiodarone will be lowered by 100 mg per week if the patient is having a good clinical response to treatment. good clinical response will be a a clinical assessment that takes into account not only actual or possible arrhythmia recurrence but also side-effects and patient acceptability of treatment. a minimum dose of 700 mg/week will be allowed. if patient symptoms recur, the amiodarone dose may be increased but not above a dose of 200 mg/day . 2. catheter ablation of persistent af will be done within two months using pulmonary vein isolation in all subjects 3. patient not in sinus rhythm at time randomization will undergo dc cardioversion after at least 1 month of amiodarone rx or during ca. follow up: clinical assessment will include a medical history and physical examination to be performed at baseline, and every 3 months. this will also include 12-lead ecg. b. at 3, 6, 12, 18, and 24 months: qol questionnaire (afeqt- atrial fibrillation effect on quality of life) c. thyroid and liver function tests, chest x-ray will be obtained at regular intervals. d. arrhythmia will be monitored using a 2-week event monitors at 6, 12, 18, 24 months.

Eligibility criteria:
inclusion criteria: 1. recurrent symptomatic atrial fibrillation (af) 2. age 50-80 years with persistent af (≥1 of af episode lasting more than a week or requiring cardioversion) exclusion criteria: 1. permanent atrial fibrillation 2. prior continuous use of amiodarone of more than 2 weeks. 3. prior catheter ablation for af. 4. have a documented resting heart (while awake) of \< 50 beats per minute. 5. have a known severe liver disease. 6. are deemed not suitable for ca (la size, comorbidities...). 7. have a severe valvular disease or have a mechanical mitral prosthesis. 8. have a life-expectancy of less than 2 years.
essential tremor in children and adolescent

Conditions: Essential Tremor

Summary: essential tremor (te) is the most common abnormal movement of the adult. his diagnosis is based on a bundle of clinical arguments (movement disorders society, 1998). well characterized in the adult, little data is available concerning child. the objective of this work is (1) to define the demographic and clinical characteristics of the te of children and adolescents, (2) to determine the electrophysiological characteristics in the child, (3) evaluate the functional impact of te, and assess the functional impact of te, and assess the current management modalities of te in children and adolescent.

a multicenter, descriptive cross-sectional study will include children and adolescents whose diagnosis of te has been retained by an abnormal movement specialist before the age of 18 years. each child will benefit from an examination and a neurological and general clinical examination, a functional questionnaire, an electromyogram with accelerometer. will be determined: demographic characteristics (age, sex and ethnicity), family history of essential tremor, age of onset of tremor, tremor characteristics (location, occurrence conditions, aggravating or precipitating factors, scalability); additional examinations carried out and the treatments proposed or taken by the child as well as the functional repercussions of te in the child. patients with tremor who meet the inclusion and exclusion criteria will be selected retrospectively or prospectively from the active queue of patients at each center.

Eligibility criteria:
inclusion criteria: * subject whose age is between 3 and 18 years * subject affiliated to a social security scheme * parents or subjects who have been informed of the course and consequences of the study by an investigator and who have signed the informed consent form for prospective inclusion or who have given their non-opposition for retrospective inclusion. * diagnosis of essential tremor established according to the diagnostic criteria of the movement disorders society (1998), by a neuropediatrician or a neurologist, specialist in abnormal movements. the diagnosis is based on the presence of the following criteria: bilateral action tremor of the hands and forearms, absence of other neurological signs. * availability of an electromyogram for retrospective inclusions. exclusion criteria: * abnormal neurological examination outside tremor * family history or personal dysthyroidism * existence of a global psychomotor or motor developmental delay * taking medication that may induce tremor * known poisoning by heavy metals, bismuth, mercury, methyl bromide * severe appearance of the tremor * tremor suggestive of a psychogenic origin * abnormal or non-existent brain mri if family case
identification of epigenetic markers common to obesity and alzheimer's disease in women

Conditions: Obesity; Alzheimer's Disease

Summary: the purpose of this study is to compare average methylation of epigenetic markers on genomic dna and some genes (app, bace, lrp, sorl1) involved in cerebral amyloid homeostasis: * of obese young adults and healthy young adults * of obese young adults and individuals affected by alzheimer's disease (ad) having been obese at young adult age (\<50 years old) or individuals affected by alzheimer's disease (ad) having never been obese. the secondary purpose is to determine if there is an association between the frequency of these epigenetic markers and elements associated to the metabolic syndrome (lipidic and glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass, body mass index) in young adults.


Eligibility criteria:
inclusion criteria: group 1: * 18-50 year old women, age- (10 years) and sociocultural-matched with group 2 * non obese and never been obese * 18.5 \< bmi \< 25 * folstein mms \> 27 * informed consent * affiliation to social security plan group 2: * 18-50 year old women, age- (10 years) and sociocultural-matched with group 1 * waist size \> 88cm * 30 \< bmi \< 45 * insulin-resistant patients (insulin resistance index, homa-ir \> 3.8) * obesity onset during childhood (pre-puberty period) * folstein mms \> 27 * informed consent * affiliation to social security plan group 3: * \>60 year old women, age- (10 years) matched with group 4 * no obesity history (18.5 ≤ bmi \< 25 at adult age) * sporadic forms of mild to moderate ad with demonstration of ad physiopathologic process according to new recommendations of 2011 of national institute on aging and alzheimer's association on diagnostic guidelines for alzheimer's disease * 15\< folstein mms ≤ 26 * informed consent * affiliation to social security plan group 4: * \>60 year old women, age- (10 years) matched with group 3 * obesity history (bmi \> 30 at least one time at adult age) * sporadic forms of mild to moderate ad with demonstration of ad physiopathologic process according to new recommendations of 2011 of national institute on aging and alzheimer's association on diagnostic guidelines for alzheimer's disease * 15 \< folstein mms ≤ 26 * informed consent * affiliation to social security plan exclusion criteria: group 1: * \<18 * patient under guardianship, curatorship or judicial protection * folate supplementation * diabetic or glucose intolerant subjects * present participation to another study with neuropsychological evaluation and/or drug administration * pregnant women groups 2,3 and 4: * \<18 * patient under guardianship, curatorship or judicial protection * folate supplementation * present participation to another study with neuropsychological evaluation and/or drug administration group 2: - pregnant women group 4: - obese or overweight patients (bmi\>25)
exercise intolerance in non-obstructive hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: the excite-hcm study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of hcm-related symptoms and cardiac function. about 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, cardiac magnetic resonance, pet and cpet will be performed to evaluate their response to the intervention.


Eligibility criteria:
inclusion criteria: 1. patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2d echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result. 2. left ventricular outflow tract gradient \<30 mmhg at rest and with provocation. 3. left ventricular ejection fraction ≥ 50% by biplane simpson's method. 4. access to exercise equipment at home or at a fitness center. 5. ability to complete study related testing including online surveys and smart phone use 6. ability to perform 24 weeks of exercise training exclusion criteria: 1. history of exercise-induced syncope or ventricular arrhythmias 2. lvot obstruction being evaluated for septal reduction therapy; less than 3 months after 3. history of septal reduction therapy - surgery or ablation 4. history of icd placement in the previous 3 months 5. history of hypotensive response with exercise testing (\>20 mm hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure \>20 mm hg) 6. clinical decompensation in the previous 3 months, defined as new york heart association class iv congestive heart failure symptoms or canadian cardiovascular society class iv angina symptoms 7. left ventricular ejection fraction less than 50% by echocardiography 8. life expectancy less than 12 months 9. pregnant or planned pregnancy 10. inability to exercise owing to any medical or other limitations 11. unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group.
topical sevoflurane for treatment of chronic leg ulcers

Conditions: Leg Ulcer

Summary: patients with painful non-healing leg ulcer will be enrolled in the clinical single-blinded randomized study. the active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment, the control group will only have a standard rinse solution with cyteal tm (pierre fabre medicament, france). further treatment will then be carried out in the standard manner. the duration of the study will be 5 days; if the defect heals earlier, it will be terminated early. exclusion criteria: allergy to sevoflurane, inability to understand the questionnaire parameters to be monitored will be pain intensity, microbial colonization, appearance and size of the defect

a prospective single-blinded randomized study will be conducted in patients of the dermatovenereology clinic of the 3rd medical faculty of charles university (3lf uk) and the university hospital kralovske vinohrady (fnkv) with painful non-healing tibial ulcers. pain intensity on a numerical rating scale (nrs 0-10) must be nrs\>4. the envelope method will be used for randomization. to blind patients, therapy will be performed by separating patients with a drape from the treatment area of the body. as sevoflurane has a typical odor, it will only be used in the control group to soak up absorbent material held under the distal pole of the wound without skin contact. in the active treatment group, sevoflurane will be applied at the beginning of the wound treatment at approximately 1 ml/cm2 of the ulcer surface. the standard therapy used in the control group will use only cyteal tm lavage solution, which contains hexamidine diisetione 100 mg in 100 ml, chlorhexidine digluconate 20% solution 100 mg and chlorocresol 300 mg. the primary aim of the study will be pain relief after sevoflurane therapy. pain intensity will be measured by nrs at 1-hour intervals (excluding sleep); decrease of 2 point for at least 4 hours will be considered significant. secondary aim will be healing of ulcers. the effect will be controlled by elimination of pathologic microbial colonization, cleaning of the base of the wound and decreasing the size of the ulcer. microbial colonization will be measured by microbial swab culture before application, after the 1st application before dressing and on the 5th day after application), the appearance of the defect base will be assessed by the appearance of the surface, the size of the defect will be measured in cm2.

Eligibility criteria:
inclusion criteria: * patients with painful (pain intensity on the numerical scale nrs 0-10 is nrs\>4) non- healing tibial venous ulcers exclusion criteria: * allergy to sevoflurane * inability to understand the pain-intensity questionnaire

Keywords: leg ulcer sevoflurane pain healing ulcer microbial colonization
sass 2 : self assembled skin substitute for the autologous treatment of severe burn wounds in acute stage of burn trauma

Conditions: Burns

Summary: this clinical trial is designed to assess the safety, effectiveness and benefits of self assembled skin substitute sass grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.


Eligibility criteria:
inclusion criteria: * deep second degree burns or third degree burns over 50% tbsa (total body surface area) at time of recruitment or as determined by the surgeon; * limited availability of donor sites for autografts; * consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors. exclusion criteria: * skin grafting needed only on the face, hands, feet, ears or genital area; * connective tissue diseases; * hypersensitivity to bovine proteins; * coagulation disorders prior being burned; * immunodeficiency prior being burned; * uncontrolled diabetes prior being burned; * permanent wound coverage before sass grafts are ready;

Keywords: burn wounds burns skin substitute
delphinus softvue™ roc reader study

Conditions: Breast Cancer Detection; Dense Breast Parenchyma; Benign Breast Findings; Normal Breast Screening; Abnormal Breast Screening

Summary: the purpose of this multi-reader, multi-case (mrmc) reader study is to evaluate reader performance when softvue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. this reader study will include approximately 32 radiologist readers and a sample of approximately 200 breast screening cases to be selected from the library of images collected under delphinus protocol #dmt-2015.001 (nct03257839) arm 1 phases b, c, and d. the reader study image case set will be enriched with cancer cases.


Eligibility criteria:
radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. all readers must meet the following base inclusion criteria: * hold a current united states medical license * be american board of radiology certified * be mqsa-qualified * be experienced in reading dm images on a monitor * be experienced in reading breast ultrasound images on a monitor * have completed a financial disclosure showing no conflicts of interest * have provided a current curriculum vitae (cv) * have provided a signed readers' agreement * have provided written informed consent all qualified and confirmed readers will complete a multi-module softvue™ training program prior to their participation in a reading session for this study.

Keywords: breast screening breast imaging softvue mammography ultrasound reader study roc auc dense breasts breast density dense breast tissue breast neoplasms
evaluation of the in shape fitness intervention for adults with serious mental illness

Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder; Major Depressive Disorder

Summary: few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and non have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. the researchers sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the in shape program across urban community mental health organizations serving an ethnically diverse population.

in this randomized, controlled study, 133 adults age 21 and older with serious mental illness (smi) and poor physical fitness (bmi\>25, or \<10 minutes of exercise 2x over the past month) were randomized to either: a) in shape lifestyles (isl) intervention or b) health club membership and education (hcme): consisting of a ymca membership, educational materials on exercise and healthy diet, and an on-site introduction to the health club. the following three specific aims were addressed: 1) to compare isl and hcme with respect to: a) participation in regular exercise and dietary change; (b) participation in preventive health care; and (c) improved fitness and health; (2) to compare isl and hcme with respect to: (a) indicators of mental health and (b) personal self-efficacy; and (3) to explore differences in isl and hcme with respect to (a) selected physical, metabolic, dietary, and community functioning secondary outcomes; and (b) the relationship of demographic variables and readiness to change to outcomes. isl participants received a 6-month intensive program of one-to-one health mentoring, followed by a 3-month period of transitioning to self-directed individual and group programming, with assessments conducted at baseline, 3, 6, 9, and 12 months. if found to be effective, isl will provide a practical approach to improving health, independent functioning, and longevity in disabled persons with smi.

Eligibility criteria:
inclusion criteria: * age 21 or older * serious mental illness defined by an axis i diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia * persistent impairment in multiple areas of functioning (e.g., work, school, self-care) * body mass index (bmi) greater than 25 * able and willing to provide informed consent * on stable pharmacological treatment (same psychiatric medications over prior 2 months) exclusion criteria: * residing in a nursing home of other institution * diagnosis of dementia or significant cognitive impairment (mmse\<24) * unable to walk one city block * pregnant or planning to become pregnant within the next 18 months * unable to speak english * terminal illness with life expectancy \<1 year * current diagnosis of an active substance dependence disorder
post-operative cognitive dysfunction in normal aging patients undergoing elective orthopedic surgery

Conditions: Post Operative Cognitive Dysfunction

Summary: post-operative cognitive dysfunction (pocd) is a common concern for aging patients undergoing elective orthopedic surgery and significantly effects health outcomes. this study aims to evaluate the incidence of and risk factors associated with post-operative cognitive dysfunction in aging patients without prior history for mild cognitive impairment or dementia.


Eligibility criteria:
inclusion criteria: * age ≥50 and ≤90 * any patient undergoing elective orthopedic surgery for hip, knee, or shoulder replacement (as defined by diagnostic codes: m16.0, m16.12, m16.11, m17.0, m17.12, m17.11, m19.011, m19.012) exclusion criteria: * history of cognitive impairment of dementia * montreal cognitive assessment (moca) \<26 * history of parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, normal pressure hydrocephalus, huntington's disease, stroke, seizure disorder, brain tumor, or brain surgery * history of surgery requiring anesthesia within the past 3 months
sleep improvement intervention for hospitalized antepartum patients

Conditions: Sleep Disturbance in Hospitalized Antepartum Patients

Summary: this project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by lee and gay (2017).


Eligibility criteria:
inclusion criteria: * speak, read, and write english * medically stable * 20 weeks' gestation or greater * viable fetus * hospitalized at least 24 hours exclusion criteria: * do not speak, read, and write english * medically unstable * less than 20 weeks' gestation * nonviable fetus * hospitalized less than 24 hours
the effects of whole-body exercise to improve swallowing function in older adults with dementia

Conditions: Old Age; Dementia; Swallowing Disorder; Cough; Parkinson Disease; Neuro-Degenerative Disease

Summary: swallowing impairment (dysphagia) is extremely common in older adults living with dementia due to age-related changes in swallowing and other disease-specific impairments. dysphagia is commonly managed by modifying diet textures rather than engaging in rehabilitative swallowing therapy. this means that countless people with dementia are left to eat pureed foods and drink thickened liquids, which are unpalatable and lead to malnutrition. as the disease progresses, many are transferred to nursing homes. in canada, speech-language pathologists, who manage dysphagia, are consultants within nursing homes; therefore, swallowing therapy is non-existent. however, exercise therapy is more commonly available. rodent models have demonstrated that physical exercise strengthens tongue and vocal-fold musculature, which are critical components of swallowing. therefore, it is possible that whole-body physical exercise, which increases rate of respiration, will help to strengthen swallowing-related musculature in older adults with dementia. in this study, older adults (65+) with early-stage dementia will complete a 12-week physical exercise program to determine improvement of swallowing function.


Eligibility criteria:
inclusion criteria: * \> 59 years of age * able to walk independently with or without an assistive device for a distance of at least 10 meters * able to be active for 60 minutes with rest breaks * abe to independently follow directions * not involved in active rehabilitation * a diagnosis of a progressive neurologic disease * a maximum value for tongue strength \<40 kpa exclusion criteria: * neurological conditions other than a progressive neurologic disease * significant cardiovascular conditions * severe aphasia * pain, other medical conditions or behavioural issues that would limit safe participation in the exercise program * individuals with known structural causes of dysphagia * individuals with known allergies to latex * individuals receiving swallowing rehab

Keywords: dementia swallowing physical exercise parkinson disease