Kornimate/medical-research-clean huggingface dataset:
mobility and voiding exercises in older women with urinary incontinence (moveonup)

Conditions: Urinary Incontinence, Urge

Summary: a prospective, two-arm randomized clinical trial utilizing a multidimensional intervention to reduce falls in older women with urinary urge incontinence. the intervention consist of general balance and strength training, bladder training and urge suppression, and home hazard assessments. the control group will receive informational booklets on fall prevention and behavioral treatment for urinary urge incontinence.


Eligibility criteria:
inclusion criteria: * female * 70 or older * living independently in the community * willingness to be randomized. * ability to read and understand english * be able to provide informed consent * low physical activity (physically active for 30 minutes or more less than or equal to 2 days per week on average over the past 6 months) per pas * ambulatory (defined as patient not confined to bed or wheelchair or ability to walk with or without an assistive device) * self-reported moderate to severe urge-predominant ui based on the iciq-sf \> 6 (q 1+2+3) * not planning to initiate new ui or overactive bladder (oab) treatment during the study duration * capable of participation in an exercise program without exacerbating any pre-existing condition(s), as determined by the study pi or designee exclusion criteria: * pelvic organ prolapse passed the hymen (per patient report) * undergoing active treatment for cancer (other than non-melanoma skin cancer) * uncorrected visual or hearing loss. * other urinary conditions or procedures that may affect continence status for example: urethral diverticulum, previous augmentation cystoplasty * progressive neurodegenerative disease e.g. parkinson's disease, multiple sclerosis per patient report * history of stroke or carotid sensitivity (i.e. syncopal falls) per patient report * unstable cardiac disease per patient report * fracture or joint replacement within the last six months per patient report * significant cognitive impairment (defined as a modified tics score of \< 27) * per pi discretion, participant cannot enroll in study
kogito: app to reduce perinatal psychosocial stress

Conditions: Psychological Stress; Perinatal Problems; Depression, Anxiety

Summary: the purpose of this research study is to test the efectivness of the remote solution for psychosocial stress in pregnant women and postpartum women. based on the connection of know-how in the field of social sciences and humanities (psychology, volunteer community and peer work with target group) and technological know-how (software design and development), investigators developed an interactive intervention software (kogito app) to reduce psychosocial stress in the target group.

this study examine the potential of kogito app in the delivery of mental and social support care to pregnant and postpartum women using psychometric methods. a) clinical efficacy of kogito app in a clinical cohort. sample: pregnant or postpartum women with who are being treated in the psychiatric perinatal outpatient clinic of the national institute of mental health, czech republic. the app will be tested as a add-on method of care. intervention group: kogito app is added to the usual care control group: usual care randomization: 1:1 participants in the intervention group will be asked to do following things: 1. complete survey questions at entrance into the study 2. use the kogito app 3. complete survey questions one month after study entrance participants in the control group will be asked to do following things: 1. complete survey questions at entrance into the study 2. complete survey questions one month after study entrance b) clinical efficacy of the kogito app in a general cohort. the app will be offered free of charge to users from the population of pregnant and postpartum women for the duration of the study. recruitment method: advertisements on social networks of national institute of mental health and other public media in czechia sample: pregnant or postpartum women from general population in czechia. the app will be tested using the waiting list as a control condition. intervention group: kogito app control group: one month waiting list randomization: 1:1 participants in the intervention group will be asked to do following things: 1. complete survey questions at entrance into the study 2. use the kogito app 3. complete survey questions one month after study entrance participants in the control group will be asked to do following things: 1. complete survey questions at entrance into the study 2. complete survey questions one month after study entrance

Eligibility criteria:
inclusion criteria: * age 18 or older * pregnant women to 1 year after childbirth * speak, read, and understand czech * signing of informed consent to the study and the gdpr form * participant owns a smart phone and has access to the internet access plus for the clinical group: * participant is undergoing the usual psychiatric care of the perinatal outpatient clinic of the national institute of mental health, czechia. exclusion criteria: * none
comparison of the efficacy and safety of immunoadsorption and plasma exchange for acute attack of refractory neuromyelitis optica spectrum disorders

Conditions: Neuromyelitis Optica Spectrum Disorder

Summary: neuromyelitis optica spectrum disorder (nmosd) is one common demyelinating disease of the central nervous system in young adults, with high rate of disability and recurrence, and poor natural course, which can cause a serious burden on families and society. to today, there is still a lack of prospective, multi-center, large sample clinical trial evidence for the treatment and prognosis of acute attack of nmosd patients. this study will conduct a prospective, multi-center, single-blind, randomized controlled clinical trial of acute attacked nmosd patients in china. the researchers plan to collect 144 nmosd patients with acute attack in three research centers of guangzhou (the third affiliated hospital of sun yat-sen university, the zhongshan ophthalmic center of sun yat-sen university, and the guangdong 999 brain hospital), to study the safety and efficacy of immunoadsorption therapy. the subjects will be randomized into immunoadsorption group and plasma exchange group, and the following indicators will be evaluated: (1) changes in edss scores and visual acuity before and after treatment; (2) changes in aqp4-igg levels; (3) the safety of immunoadsorption treatment. this study is aimed to determine the efficacy and safety of immunoadsorption therapy for acute attack of refractory nmosd patients, and to provide more sufficient clinical evidence for the therapy selection for acute phase of nmosd patients.


Eligibility criteria:
inclusion criteria: 1. patients should meet the 2015 international nmosd with acute attacks diagnostic criteria (including first episodes and recurrences) 2. when nmosd patients with acute attacks undergo a course of hormone shock therapy (5-10g total methylprednisolone), edss ≥ 6.0 or visual acuity ≤ 20/200 3. serum aqp4-igg positive (cba test) exclusion criteria: 1. weight \<25kg 2. nursing or pregnant women 3. unable to establish a peripheral or central vascular access 4. the use of rituximab and gamma-ball shocks within 3 months prior to enrollment 5. using immunoadsorption and/or plasma exchange therapy within 3 months before enrollment 6. acei drugs must be taken within 1 week before the first treatment and during treatment and cannot be stopped

Keywords: neuromyelitis optica spectrum disorder immunoadsorption plasma exchange acute attack refractory
safety of mesentery-embedding surgery in patients with ileocolic crohn's disease on biotherapy

Conditions: Crohn Disease

Summary: 60% of patients with crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. this procedure is performed as close as possible to the gastrointestinal tract, but remaining mesenteric disease is a risk factor for recurrence. mesentery resection has encouraging results on recurrence requiring reoperation, with a reduction of over 30% in recurrences compared with the standard technique. the study authors wish to evaluate the safety of ileocolic resection surgery involving the mesentery in patients with crohn's disease treated with biotherapy. the study hypothesis is that mesentery surgery is no more risky than conventional (gold standard) surgery, and reduces the 6-month endoscopic recurrence rate in patients with ileocolic crohn's disease on biotherapy requiring ileocolic resection.


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * patient with histologically proven crohn's disease * patient who has undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat operation) * patient on anti-tnf α: infliximab or adalimumab (ecco 2014 recommendation), vedolizumab, ustkinumab, or other biotherapy (e.g. risankizumab) * patient able to understand, write and read french exclusion criteria: * the patient is participating in an interventional study * the patient is under safeguard of justice or state guardianship * medical treatment other than biotherapies including anti-tnf α (infliximab or adalimumab), vedolizumab, ustkinumab, risankinumab * contraindication to surgery, such as major cardiovascular comorbidities * pregnant, breast-feeding or parturient women
efficacy and safety of semaglutide injection vs ozempic® in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this is a 32-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and the active comparator in patients with type 2 diabetes mellitus who have inadequate glycemic control with metformin. eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or ozempic® injection abdominal subcutaneous injection will be given according to their groups weekly for 32 weeks. follow-up for 4 weeks after administration. trial product will be add-on to subject's stable pre-trial metformin. the study included a screening period (up to 2 weeks), run-in period（6 weeks），baseline, administration period(32 weeks), and a follow-up period (4 weeks). the duration of the study will be approximately 44 weeks for a participant.


Eligibility criteria:
inclusion criteria: 1. male or female, age 18-75 years (both inclusive) at the time of signing informed consent 2. subjects diagnosed with type 2 diabetes and on stable treatment in a period of 6 weeks prior to screening with metformin ≥ 1500 mg (or maximum tolerated dose ≥ 1000 mg) 3. hba1c 7.5 - 11.0 % (both inclusive) (screening) 4. hba1c 7.0 - 10.5 % (both inclusive) (randomisation) 5. bmi 18.5-35 kg/m2 (both inclusive) exclusion criteria: 1. other types of diabetes besides type 2 diabetes 2. a history of acute diabetes complications within 6 months before screening 3. a history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis 4. personal or family history of medullary thyroid cancer (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) 5. acute coronary or cerebrovascular event within 3 months before screening or randomisation 6. heart failure, new york heart association (nyha) class iv 7. treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 6 weeks before screening. an exception is short-term treatment (≤7 days in total) with insulin in connection with inter-current illness 8. fasting plasma glucose (fpg) ≥ 13.9mmol/l 9. screening calcitonin value ≥ 35 ng/l (pg/ml) 10. estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2 11. any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Keywords: glucagon-like peptide-1 receptor agonists semaglutide
evaluation of trc101 in subjects with metabolic acidosis associated with chronic kidney disease

Conditions: Metabolic Acidosis

Summary: this is a multicenter, double-blind, placebo-controlled, parallel-design study. the study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. the study dosing (trc101 or placebo) will continue for 12 weeks once daily. the maximum study duration is anticipated to be up to 16 weeks.


Eligibility criteria:
key inclusion criteria: * blood bicarbonate level of 12 to 20 meq/l. * estimated glomerular filtration rate (egfr) of 20 to 40 ml/min/1.73m2. * stable kidney function defined as \<=20% variability in egfr during screening period. key exclusion criteria: * any level of low blood bicarbonate during the screening period that in the opinion of the investigator, requires emergency intervention or evaluation for an acute acidotic process. * anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening. * heart failure with maximum new york heart association (nyha) class iv symptoms or that required hospitalization during the preceding 6 months. * heart or kidney transplant. * chronic obstructive pulmonary disease (copd) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months. * change in doses to alkali therapy in the 4 weeks prior to screening. * history or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers. * serum calcium \<= 8.0 mg/dl at screening. * planned initiation of renal replacement therapy within 12 weeks following randomization. * use of polymeric binder drugs within 14 days prior to screening.

Keywords: blood bicarbonate, kidney disease
music and physical activity in persons with dementia

Conditions: Dementia Frontal

Summary: fronto lobe dementia constitutes 10-20 % of dementia conditions within younger persons (\>65). people with neuronal degeneration in frontal and temporal lobes demonstrate a decline in social conduct, apathy, loss of insight that is gradual and progressive. family members often experience guilt and shame because of the patients' behavior before institutionalization, and different behavioral disorders will cause great challenges to family caregivers and to staff after institutionalization. preservation of dignity, both in regards to the person being affected, and their relatives, therefore seem highly relevant both before and after institutionalization.

the purpose of this study was to evaluate whether a combined intervention of physical activity and music therapy could reduce restlessness, irritability, and aggression among institutionalized people with severe dementia. an exploratory design was used to evaluate a combined intervention of physical activity, music therapy, and in- or outdoors walking daily, systematically implemented for eight weeks for persons with severe dementia in institutional care.

Eligibility criteria:
inclusion criteria:persons with dementia with symptoms of frontal lobe dementia, who had lived for at least 6 months in a unit special care dementia unit in a nursing home - exclusion criteria: -

Keywords: dignity music therapy physical activity
non-contrast enhanced peripheral magnetic resonance angiography

Conditions: Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Disease

Summary: to systematically develop, test, and refine peripheral vascular electrocardiography-gated fast spin echo magnetic resonance imaging for the accurate diagnosis of peripheral arterial disease without gadolinium contrast. to test prospectively the accuracy of fast spin echo in peripheral arterial disease patients, compared with bolus-chase and time-resolved gadolinium enhanced magnetic resonance angiography. additionally, as a substudy of this project, we will compare our fast spin echo approach with alternative non-contrast-enhanced magnetic resonance imaging methods such as time-of-flight and steady-state gradient echo imaging. the overarching goals of our research are to develop and validate a peripheral magnetic resonance imaging technique that accurately depicts anatomy and disease without exposing patients to exogenous contrast material and its associated risks.


Eligibility criteria:
inclusion criteria: * patients with known or suspected periphery arterial disease will be recruited. * in the initial sequence optimization stage, healthy volunteers will also be recruited for magnetic resonance angiography exclusion criteria: * patients with moderate to end stage renal disease (estimated glomerular filtration rate \< 30 ml/min/1.73m2). these patients will not be recruited as they will be unlikely to undergo routine contrast enhanced magnetic resonance angiography due to the risk of developing nephrogenic systemic fibrosis. * pregnant patients. gadolinium chelates are a fda category c drug, and therefore should be avoided in pregnancy. * claustrophobic healthy volunteers or any subject who is unable to lie flat for 60 minutes. * glomerular filtration rate \< 60ml/min/1.72m2 and coexisting history of pro inflammatory conditions such as recent surgery, sepsis or major infection, arterial or venous thrombosis. * any history of nephrogenic systemic fibrosis * unable/ unwilling to give informed consent * medical contra-indications to magnetic resonance imaging: e.g. pacemakers, implanted defibrillators, cochlear implants, aneurysm clips, and prior/ current metal workers. patients will be screened with a safety questionnaire. * clinically unstable patients * patients with newly placed stents will be excluded until 8 weeks post placement

Keywords: magnetic resonance imaging magnetic resonance angiography
cortical superficial siderosis and risk of recurrent intracerebral hemorrhage in cerebral amyloid angiopathy.

Conditions: Cerebral Amyloid Angiopathy

Summary: cerebral amyloid angiopathy (caa) is a major cause of lobar intracerebral hemorrhage (ich) in the elderly with high risk of recurrence. the investigators aim to determine the relationship between cortical superficial siderosis (css), a mri hemorrhagic marker of caa and the risk of symptomatic ich recurrence in a multicentric prospective cohort of patients with acute lobar ich related to caa. the investigators hypothesize that patients with css have an increased risk of recurrent symptomatic ich relative to those without css.

patients with acute lobar ich fulfilling the boston criteria for probable or possible caa will be enrolled within 30 days after ich onset. brain mri performed at baseline will be analyzed blinded to clinical data. patients with presence of css will be compared with those without css. during a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and mri evaluation. the investigators will compare the rate of recurrent symptomatic ich at 24 months in patients with vs. without css.

Eligibility criteria:
inclusion criteria: * lobar ich within 30 days after onset * available brain mri sequences of adequate quality including fluid-attenuated inversion recovery (flair) and t2\*-weighted gradient-recalled echo (t2\*-gre) sequences. * modified boston criteria for probable or possible caa * age ≥ 55 years * written consent exclusion criteria: * secondary brain hemorrhage : vascular malformation (arteriovenous malformation, aneurysm, cavernous); cerebral veinous thrombosis; brain tumor; coagulopathy; vasculitis; hemorrhagic infarction, * infratentorial siderosis * contraindications to mri * neurosurgical intervention before inclusion, * progressive neoplasm * patient without affiliation to the french social security * patient under guardianship

Keywords: intracerebral hemorrhage cerebral amyloid angiopathy cortical superficial siderosis magnetic resonance imaging
sedative-anxiolytic effects on simulated driving performance

Conditions: Psychomotor Impairment

Summary: this study evaluates the effect of anxiety drugs taken at night on the ability to drive a car the next day. participants will receive alprazolam, placebo, or zolpidem at night before bed or in the morning before using a driving simulator to assess impairment.


Eligibility criteria:
inclusion criteria: * valid driver's license * english-speaking and literate exclusion criteria: * using daily medication for chronic condition * acute narrow angle glaucoma * previous adverse experience with study drugs * experiences motion sickness in response to driving simulator * bmi \> 30 * women who are pregnant, lactating, or planning on becoming pregnant * regular use of tobacco products * current substance use disorder * clinically significant ecg * current ongoing psychiatric disorder
cervical cancer screening project part c

Conditions: Cervical Cancer

Summary: this proposal has been developed through collaboration between the university of minnesota and new american community services (nacs), and the research design is based on a needs assessment conducted by the community partner. the investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based pap test. all participants will be given identical education materials on cervical cancer screening and hpv, currently in use by the minnesota sage program.

the trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (hpv) testing for cervical cancer screening. the main objective is to estimate the successful screening completion rate among a sample of somali women who have not undergone cervical cancer screening for three or more years. women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based pap test.

Eligibility criteria:
inclusion criteria: * somali female age 25-70 years * have lived in the u.s. 10 years or less * have not had a pap test (by self report) in the last 3 years exclusion criteria: * women with a self reported past history of any of the following will not be eligible: * total hysterectomy * cervical cancer * active history of cervical dysplasia

Keywords: pap test hpv testing cervical cancer
a study to evaluate efficacy and safety of cs-3150 in japanese hypertensive subjects

Conditions: Essential Hypertension

Summary: this study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of cs-3150 compared to placebo in japanese hypertensive subjects. primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 20 years or older at informed consent * subjects with essential hypertension (sitting sbp ≥ 140 mmhg and \< 180 mmhg, sitting dbp ≥ 90 mmhg and \< 110 mmhg,and 24h-hr blood pressure more than 130 mmhg in sbp and 80 mmhg in dbp) exclusion criteria: * secondary hypertension or malignant hypertension * diabetes mellitus with albuminuria * serum potassium level \< 3.5 or ≥ 5.1 meq/l * reversed day-night life cycle including overnight workers * egfr \< 60 ml/min/1.73 m\^2

Keywords: essential hypertension mineralocorticoid receptor antagonist cs-3150 japanese