Kornimate/medical-research-clean huggingface dataset:
garmin pact (physical activity tracking in type 1 diabetes using garmin vivosmart)

Conditions: Type 1 Diabetes

Summary: the goal of this observational study is to test the garmin vivosmart in children and youth (8-21) with type 1 diabetes (t1d) and their parents. the main questions it aims to answer are: * does the garmin vivosmart increase physical activity (pa)? * does the garmin vivosmart improve t1d status participants will: * wear the garmin vivosmart (4 or higher) for a year * complete surveys at the beginning, middle and end of participation asking about your t1d, t1d management, and pa * parents of children will also complete similar surveys about t1d


Eligibility criteria:
inclusion criteria: * participants aged 8-21 years of age and/or parent of participant aged 8-17 years of age * participants diagnosed with t1d greater than 6 months ago * participants must be patients at the children's mercy kansas city network exclusion criteria: * participants who do not meet age criteria above * participants who do not have t1d * participants who are unwilling to wear the device for at least 6 months
dosage and pd study of eftrenonacog-alfa

Conditions: Severe Haemophilia B

Summary: the purpose of this study is to evaluate the performance of different methods for measuring factor ix activity levels in haemophilia b patients treated with eftrenonacog-alfa and assess its pharmacodynamics (pd) in a real-life setting.

a recent european survey showed that increasing number of hemophilia b patients was switched from standard to extended half-life drugs. while some clinicians currently prefer to treat empirically rather than based on laboratory results, adoption of replacement therapy based on extended half-life products such as eftrenonacog-alfa may increase the interest in individualized pharmacokinetic assessments allowing the development of an initial dosing regimen. thus inaccurate fix activity measurements might be critical, especially when fix trough level is used to tailor patient dosing regimens. it is therefore important that fix activity levels are accurately determined allowing adequate recovery without increasing the cost of medical management of hemophilia b patients due to unnecessary dose corrections. with the expansion of the prescription of eftrenonacog-alfa, the problem of accurately measuring its recovery has risen within hemostasis laboratories. chronometric one-stage assays (osa) are currently the most widely performed tests for fix activity measurement. they are based on activated partial thromboplastin time (aptt) reagent and factor-deficient plasma. various aptt reagents are commercialized. they could lead to a substantial variability in fix results. chromogenic two-stage assays (csa) are less frequently used in clinical laboratories. they present fewer reagent choice compared to osa. several studies have evaluated osa and csa performances in samples spiked with eftrenonacog-alfa and have evidenced that some commonly used aptt reagents would not be suitable for accurately monitoring this product. whether these results are commutable to post-infusion samples collected from real-life patients remains unclear. unlike the measurement of a unique coagulation factor activity, thrombin generation assay (tga) is a dynamic global test that explores the coagulation cascade as well as the anticoagulant pathways. tga could be therefore a valuable tool to monitor replacement therapy in hemophilia b patients. hence the investigators sought in a real-life setting to compare 2 csa and 1 osa reagents to a product specific osa in severe hemophilia b patients supplemented with eftrenonacog-alfa. the investigators also aimed to evaluate the pharmacodynamics (pd) of eftrenonacog-alfa using tga.

Eligibility criteria:
inclusion criteria: * severe haemophilia b patients * treated with eftrenonacog-alfa exclusion criteria: * any other haemostatic or replacement therapy

Keywords: chromogenic assay extended half-life product fc fusion protein one-stage clotting assay pharmacodynamics
low energy dense, weight maintenance, risk of cardiovascular disease

Conditions: Body Weight Decreased

Summary: investigators presumed that low energy density (led) diet consumers will have lower risk of cardiovascular disease and are able to maintain their weight longer .

previous studies introduced different dietary interventions for weight loss maintenance. besides the debate on low fat or low carbohydrate diets, focusing on some food groups including fruits, vegetables and low fat dairies in the diet may be helpful for weight maintenance. however, energy intake is the key factor of weight maintenance. energy intake will decrease by reducing energy density (ed) of a diet without producing short-term calorie restriction or feeling hunger. there are several studies which showed the beneficial effects of low energy density diets on weight reduction. however, few studies discuses regarding the effects of such diets on weight maintenance.

Eligibility criteria:
inclusion criteria: * who were on weight loss diet for the last one year and additionally, they did not want to lose more weight. * non-pregnant, non-lactaries and non-smokers aged 40-70 years included in the present study exclusion criteria: * dietary poor compliance

Keywords: overweight obesity low energy dense
using omnidirectional virtual reality and treadmill training for chronic stroke

Conditions: Stroke

Summary: the primary objective of this pilot randomized controlled trial (rct) is to test the feasibility (recruitment rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, sus) of omnidirectional treadmill virtual reality training (omni-vr) among chronic stroke survivors. our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-vr) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes. researchers will compare the intervention group and control group to evaluate the impact of omni-vr on cognition and physical function among stroke survivors. participants will: * undergo a 45-minute training session 3 times per week for 12 weeks * intervention group: omni-vr * control group: traditional exercise program (strengthening and walking activities)

mounting data indicates that cognition plays a role in complex walking and balance. however, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization. virtual reality or vr (a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the user's actions) has been introduced to neurorehabilitation to promote improvements in walking ability, balance, and cognition. it has also been demonstrated to be effective in improving motivation among stroke survivors and augmenting neuroplasticity. omnidirectional treadmill technology can be integrated with vr to allow for fully immersive rehabilitation. this novel and innovative technology mimics real-world environments and maximizes challenging cognitive and physical dual-tasking and balance activities while maintaining patient safety. however, no randomized trials have evaluated the impact of omnidirectional treadmill vr (omni-vr) on cognitive and physical function among stroke survivors. therefore, our study aims to test the feasibility and usability of the omni-vr. this pilot randomized control trial will also be the first study to test the feasibility and effect of a fully-immersive active omni-vr system among chronic stroke survivors

Eligibility criteria:
inclusion criteria: * stroke ≥ 6 months ago (per conventional stroke trials) * living within 50 km of halifax, nova scotia * functional ambulation category ≥ 3 * self-reported walking limitations (walk-12 score \> 20) * ability to exercise for ≥ 15 minutes * no visual deficits or hemispatial neglect * no other cardiovascular, orthopedic, or neurological diseases impacting walking or balance * montreal cognitive assessment (moca) scores \> 18 indicating moderate or severe cognitive impairment

Keywords: virtual reality stroke rehabilitation omnidirectional treadmill
a post-market clinical follow-up investigation to verify performance and safety of viiral®nasal spray in subjects with dry nose symptoms

Conditions: Rhinitis Sicca

Summary: a chronic irritation of the nasal mucosa can be painful and unpleasant for the individual. dry nasal mucosa with scabs is a common problem but not everyone seeks care. the causes can be several such as staying for long periods in dry and dusty air, hot rooms or hot environments, tobacco smoke, side effects of drugs and mechanical irritation (nasal congestion). the nasal spray contains salic acid (neuraminic acid). this substance is found naturally in humans in the nasal mucosa which keeps it moist. salic acid is also found, for example, in breast milk and is also found in food production. previous studies have shown that treatment with salic acid is gentle, relieves symptoms and has a soothing and moisturising effect. the purpose of the study is to evaluate whether the symptoms of dry nose can be improved with treatment with viiral®nasal spray and have a soothing and moisturising effect. the treatment also aims to prevent colds caused by viruses. as a control product in the study, a nasal spray with isotonic saline solution will be used. in this study, a total of 78 women and men who have been diagnosed with dry nose / rhinitis sicca will be included in the study. after the participants have given their consent to participate in the study, treatment with the study product or control product will begin. the treatment is started by the study participants themselves at home. two thirds will be treated with the study product and one third will be treated with a control product. clinic visits will be performed at three occasions after the screening/baseline visit, at day 14, day 28 and on day 56.


Eligibility criteria:
inclusion criteria: * signed informed consent form. * adult males and females ≥ 18 years old. * score of at least 10 as indication for application of moistening nasal sprays per investigator judgement, confirmed with a total rhinitis sicca symptom score (sensation of dry nose, nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, runny nose, thick nasal discharge, dry throat, impairment of smell and impairment of sleep) using a 5-point severity scale (0=none, 1=mild, 2=moderate, 3=strong, and 4 = very strong. * able to use the device independently. exclusion criteria: * antiallergy drugs and rhinitis medication, including rescue medication for symptom relief and anti-hyperactivity last week. * pregnancy or lactation at time of investigation participation. * physical or mental impairment affecting subjects' ability to use the device, per investigator judgement. * person not suitable for the investigation according to the investigator judgement.
between geriatric syndrome and chronic disease association and prevalence among nonagenarians

Conditions: The Study Addressed the Most Common Geriatric Syndromes and Chronic Diseases at Age 90 Years and Older and Their Association

Summary: objecti̇ve the world population is getting older. the most common condition in the aging population is comorbidity, which is a combination of more than one chronic disease or condition. contrary to the traditional view that specific symptoms are characteristic of a single disease, the coexistence of multiple diseases and other age-related conditions in elderly individuals leads to what is defined as geriatric syndromes. geriatric syndromes are quite common in the elderly population and are associated with poor quality of life, adverse health status, and increased cost. physicians who more frequently care and manage patients with comorbid diseases and geriatric syndrome can cope better with these conditions when faced with them. it is known that the frequency of comorbidity and geriatric syndrome increases especially in the elderly. however, in the oldest age group, which is showing the fastest increase in population, these rates are not clearly known. the aim of this study is to shed light on the management of elderly patients by identifying geriatric syndromes and comorbidity prevalence, as well as chronic diseases and common geriatric syndromes, in patients 90 years of age and older who applied to the geriatric outpatient clinic. method data of patients 90 years and older who applied to the geriatric outpatient clinic between november 2016 and january 2020 were retrospectively analyzed. the drugs used by the patients with their demographic characteristics such as age, gender, chronic diseases and geriatric syndromes were gathered. the drugs used were also obtained from the hospital-registered files and through the e-pulse health system. diabetes mellitus (dm), hypertension (ht), cardiovascular diseases (cvd), cerebrovascular occlusion (cvo), chronic obstructive pulmonary disease (copd), chronic kidney disease (ckd) were recorded as chronic diseases. mild cognitive impairment (mci), dementia, delirium, depression, fall, incontinence, malnutrition, sleep disorders, polypharmacy, and fall were recorded as geriatric syndrome. the modified charlson comorbidity index was used to calculate the comorbidity index.


Eligibility criteria:
inclusion criteria: * community-dwelling individuals aged 90 and over exclusion criteria: * patients with missing data were excluded from the study
cetrorelix (cet) pamoate regimens in patients with symptomatic benign prostatic hypertrophy (bph)

Conditions: Benign Prostatic Hypertrophy

Summary: benign prostatic hypertrophy (bph) is a common and bothersome condition of aging men. it is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. the aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of bph. current treatments of bph have a benefit / risk ratio which leaves room for improvement. for this study, study medication (cetrorelix pamoate or placebo) is administered by injection in the buttocks (intramuscular). all patients completing the double-blind portion (week 0 to 52) are eligible to receive the active drug during the open-label part of the study (week 52 to 90).

the objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in bph-related signs and symptoms. patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the international prostate symptom score (ipss). patients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion. patients will be administered an im injection of study drug at week 0, 2, 26 and 28 and will be followed up to week 52. then, in an open label fashion, patients will be administered an im injection of study drug at week 52, 54, 78 and 80 and will be followed up to week 90.

Eligibility criteria:
inclusion criteria: * benign prostatic hyperplasia, based on medical history * voiding symptoms exclusion criteria: * urgent need for prostate surgery or prior surgical treatment of the prostate or bladder * major organ dysfunction * eczema (atopic dermatitis) treated during the last 6 months * current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (botox) within the last 6 months prior randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization * urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy * history of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months

Keywords: cetrorelix
watchman for second prevention of stroke (wasps)

Conditions: Atrial Fibrillation; Stroke

Summary: to evaluate the effects of mechanical left atrial appendage (laa) closure for secondary prevention of stroke in the patients with nonvalvular atrial fibrillation

atrial fibrillation (af) is the most common sustained cardiac arrhythmia, affecting an estimated 5 million chinese. atrial fibrillation is the primary cardiac abnormality associated with embolic stroke; among patients with af, there is an annual stroke rate, about 5 times for the same age population in sinus rhythm. although warfarin therapy is effective at reducing the risk of stroke, chronic anticoagulation presents problems of safety and acceptability for many patients. drug and dietary interactions, frequent blood tests, and compliance issues all contribute to difficulties with chronic warfarin therapy. new oral anticoagulant compounds with better therapeutic range and without need for similar monitoring, such as dabigatran, rivaroxaban, apixaban and edoxaban,have been studied, but there is no direct comparison with left atrial appendage closure(laac). however,the left atrial appendage (laa) is the major location of thrombi in patients with af. in patients with nonrheumatic af and thrombus in the left atrium, the clot was located in the laa in 90%. and the watchman left atrial appendage system is a novel device designed to prevent the embolization of thrombi that may form in the laa. it is hypothesized that it may prevent ischemic stroke and systemic thromboembolism in patients with af.the protect-af and prevail trails confirmed this device's efficacy and safety, compared with warfarin, for preventing the combined outcome of stroke,systemic embolism, and cardiovascular death. and the device has been approved by china's fda. stroke is the primary cause of death in china, and recurrence of stroke remains a major public health issue. this cohort study is designed to evaluate the effects of mechanical left atrial appendage (laa) closure for secondary prevention of ischemic stroke in the patients with nonvalvular atrial fibrillation in china, compared with medicine approach (warfarin or noac),.

Eligibility criteria:
inclusion criteria: * age 18 years or older; * a history of stroke/transient ischemic attack(tia) over 3 months; * paroxysmal, persistent, or permanent nonvalvular af; * 4.2 or more cha2ds2-vasc risk factors * eligibility for long-term anticoagulation with warfarin or new oral anticoagulants. exclusion criteria: * patent foramen ovale with atrial septal aneurysm * an atrial septal defect * mechanical valve prosthesis * left ventricular ejection fraction less than 30% * mobile aortic atheromata * symptomatic carotid disease
assessment of heart and heart-lung transplant patient outcomes following pulmonary rehabilitation

Conditions: Emphysema; Alveolitis, Fibrosing; Cystic Fibrosis; Bronchiectasis; Lung Diseases

Summary: at present, a specific community based rehabilitation programme for lung or heart-lung transplant recipients does not exist. 160 hospitals throughout the united kingdom (uk) offer pulmonary rehabilitation programmes. the programmes operate under evidence-based guidelines as outlined by the chartered society of physiotherapy. increasing evidence shows that rehabilitation programmes help improve performance, exercise endurance, and quality of life; and reduce symptoms and demand on health-care resources. this study proposes to compare the outcomes of lung and heart-lung transplant patients attending local pulmonary rehabilitation against others receiving the trust's current document-based programme. the study is a randomized controlled trial: * control arm: those patients randomized to the 'control' arm will receive the trust's standard rehabilitation programme that consists of an information pack supplied upon discharge. they will then complete and undertake the following tests: short-form 36 (sf 36; version 2) questionnaire, chronic respiratory questionnaire (crq-sr), incremental shuttle walk test and spirometry forced expiratory volume in 1 second (fev1) and forced vital capacity (fvc). the patient will follow the information contained in the information pack and the above tests and questionnaires will be repeated 6 months post discharge. * experimental arm: a patient who is randomized to the 'experimental' arm will be asked to complete the following tests upon discharge: short-form 36 (sf 36; version 2) questionnaire, chronic respiratory questionnaire (crq-sr), incremental shuttle walk test and spirometry fev1 and fvc. three months post discharge, the patient will be enrolled into a local pulmonary rehabilitation programme. the programme is typically structured to last 6-12 weeks. the above tests and questionnaires will be repeated 6 months post discharge. to measure the effectiveness of either the information pack or the rehabilitation programme the following endpoints will be subjected to analysis in both the experimental and the control group: * short-form 36 questionnaire; * chronic respiratory questionnaire; * incremental shuttle walk test; * borg scale; * spirometry fev1 and fvc; * hospital re-admission rates and mortality rates. the undertaking of a multidisciplinary-led programme of rehabilitation facilitates a better quality of life than a document-based rehabilitation programme in lung and or heart-lung transplant out-patients. the aim of the study is to construct an optimal programme of rehabilitation in lung or heart-lung patients.


Eligibility criteria:
inclusion criteria: * all patients who have undergone either a lung or heart-lung transplant. * fit for discharge from the transplant unit's intensive care unit. * \> 18 years of age. exclusion criteria: * patients under 18 years of age. * patients unable to understand or comprehend the study.

Keywords: end stage fibrotic lung disease
to evaluate sarilumab - sar153191 (regn88) - auto-injector device in patients with rheumatoid arthritis

Conditions: RA

Summary: primary objective: to collect real-use data of the sarilumab auto-injector device (aid) used by rheumatoid arthritis (ra) participants. secondary objective: to compare the pharmacokinetic (pk) exposure of sarilumab administered by aid versus prefilled syringes (pfs).

total study duration up to 74 weeks: screening up to 4 weeks, aid assessment phase of 12 weeks, extension phase of 52 weeks and post-treatment follow-up of 6 weeks. for participants not entering the extension phase, total study duration up to 22 weeks (screening, aid assessment phase and follow-up).

Eligibility criteria:
inclusion criteria: * diagnosis of ra, ≥3 months disease duration; * participant willing and able to self-inject; * continuous treatment with 1 or a combination of non-biologic disease modifying antirheumatic drugs (dmards) (except leflunomide in combination with methotrexate); * moderate-to-severely active ra. exclusion criteria: * participants \<18 years; * prior treatment with anti-interleukin 6 (il-6) or il-6 receptor (il-6r) antagonists; * treatment with tumor necrosis factor (tnf) antagonists; * treatment with ra-directed biologic agents other than with a tnf-α antagonist mechanism as follows: anakinra, abatacept, rituximab or other cell-depleting agent; * prior treatment with a janus kinase inhibitor. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.