Kornimate/medical-research-clean huggingface dataset:
exercise training study of patients with claudicatio intermittens

Conditions: Claudication, Intermittent

Summary: the aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking.

patients with intermittent claudication will by a web-based program be randomized to either "five plus training" or walking at least 30 minutes three times per week. during the "five plus training" the participants are standing in front of a wall, which is used for support of the balance. the body is lifted with the calf musculature to the maximal height that the subject can achieve. this is repeated until pain is felt in the calf musculature. following the initiation of pain the subject performs five extra repetitions. the five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect. the patients are followed by absolute walking distance on a treadmill, quality of life questionnaire, and ankle-brachial index.

Eligibility criteria:
inclusion criteria: 1. pain in the calves after 300 m, or less measured on a treadmill 2. stable symptoms last 6 months or more 3. the pain must be gone within 5 minutes after the patients stop walking 4. ankle-brachial index at 0.7 or lower at rest 5. using statins and antiplatelet drugs since at least 3 months 6. age\> 18 years 7. signed consent exclusion criteria: 1. pain in the hips or elsewhere outside the calves while walking 2. remaining pain more than 5 minutes after stopped walking. 3. impossible to compress the arteries while measruing abi or abi lower than 0.4 4. use of statins and antiplatelet drugs less than 3 months 5. symptoms less than 6 months 6. diabetes measured with hba1c being over 48 mmol/mol (6%) 7. revascularisation the last 6 months 8. pain in the calves after longer than 300 m measured on a treadmill 9. reduced mobility in the ankles 10. reduced physical ability to perform a test on a treadmill. 11. age less than 18 years 12. general conditions that impairs the ability to take part in a training study including obesity, kols, heart disease, arthrosis, inflammatory joint diseases . 13. no signed consent
the effect of dual tasking on physical and cognitive functions in patients with parkinson disease

Conditions: Parkinson Disease

Summary: the ability of performing multi-tasking procedures is impaired in patients with parkinson's disease. in this study, our goal was to detect the effects of dual-task training with treadmill training on walking and balance and to compare its effects on quality of life, cognitive functions and risk of fall, to treadmill training alone.


Eligibility criteria:
inclusion criteria: the patients with idiopathic parkinson disease on medication who has * hoehn-yahr 1-3 * mini mental test score 20 and above * functional ambulation category 2 and above * no changes in medication in last 3 months * no rehabilitation programme in last 3 months exclusion criteria: * diagnosis of parkinsonism other than idiopathic parkinson disease * global aphasia * severe cognitive dysfunction * other neurologic/orthopedic diseases * limiting cardiovascular or pulmonary disease * visual impairment * hearing loss

Keywords: dual task, treadmill, cognitive rehabilitation
vitrectomy for branch retinal vein occlusion

Conditions: Vitrectomy

Summary: to evaluate the long term outcomes of pars plana vitrectomy (ppv), with and without internal limiting membrane (ilm) peeling, in eyes with persistent macular edema secondary to branch retinal vein occlusion (brvo). results suggest the following hypothesis: * ppv, with and without ilm peeling, appears to be beneficial in eyes with persistent macular edema due to brvo * effectiveness is maintained long term * ilm peeling does not significantly affect postoperative best corrected visual acuity (bcva)


Eligibility criteria:
inclusion criteria: * duration of symptoms lasting 27 weeks exclusion criteria: * vitreous hemorrhage * severe cataract * biomicroscopic vitreomacular traction and epiretinal membrane * previous vitreoretinal surgery * other ocular diseases that could contribute to visual loss. * patients with macular branch vein occlusion * patients with a history of previous grid laser photocoagulation

Keywords: branch retinal vein occlusion internal limiting membrane macular edema vitrectomy
valor: vaginal atrophy & long-term observation of recovery

Conditions: Atrophic Vaginitis; Vaginal Atrophy; Genitourinary Syndrome of Menopause; Lichen Sclerosus of Vulva; Lichen Planus of Vulva; Lichen Simplex of Vulva (Disorder)

Summary: vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.


Eligibility criteria:
inclusion criteria: * diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus * continuous vulvovaginal symptoms * access to smartphone and tablet, laptop or computer * access to a valid email address exclusion criteria: * unable to provide informed consent * patient unable to apply topical device * allergy or intolerance to ingredients or excipients of the formulation of studied products * systemic hormonal therapy started less than 30 days before baseline * systemic corticosteroids ongoing treatment or used within the last 30 days before baseline * ongoing topical hrt or corticosteroid treatment for the indication under investigation * topical hrt or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline
deprescribing for older dialysis patients

Conditions: Kidney Failure, Chronic

Summary: aim 1 of the study is to identify the elements of a deprescribing intervention that address contextual factors specific to dialysis. aim 2 of the study, described in this record, is to determine the feasibility of a deprescribing intervention tailored for older dialysis patients. older adults receiving dialysis are often prescribed multiple medications. some of these medications are used to treat symptoms, but they also can increase the chance of significant health problems. the purpose of this study is to identify if it is feasible to reduce the use of medications that have been identified as causing an increased risk for health problems.


Eligibility criteria:
inclusion criteria (patients): * an adult receiving dialysis for at least 6 months * at least one active prescription for a potentially inappropriate medication (gabapentinoids, clonidine, alpha blockers, muscle relaxants, and z-drugs) exclusion criteria (patients): * advanced dementia * hospice care * non-english speaking inclusion criteria (providers): * must be employed by duke * must see patients at a duke affiliated davita hemodialysis (hd) clinic where duke nephrologists serve as medical directors and rounding physicians exclusion criteria (providers): none

Keywords: kidney failure, chronic renal dialysis aged inappropriate prescribing preliminary data
intranasal fentanyl for the treatment of acute severe pain on the pediatric emergency department of mercy hospital.

Conditions: Acute Pain

Summary: the treatment of acute severe pain in pediatric emergencies required a quick and effective therapeutic support. actually in france, only peripheral venous access or oral therapies with onset of action are commonly used and only few treatments can be used to manage the acute severe pain in children. in june 2017, an intranasal fentanyl use protocol has been established in the pediatric emergency department of mercy hospital-metz. the intranasal fentanyl treatment has proved his effectiveness and safe condition in many countries since few years even though has not yet obtained a marketing authorization for use in children in france. in view of the information, parental permission was obtained before the intranasal administration. the efficacy and surveillance data in all patient records of children who benefited this analgesic protocol were retrospectively collected between june 2017 and august 2018. this retrospective study wants to describe the efficacy and safety of intranasal fentanyl on the pediatric emergency department.


Eligibility criteria:
inclusion criteria: * all patients who received fentanyl intranasal between june 2017 and august 2018 exclusion criteria: * lack of surveillance data in the medical record of the patient

Keywords: pediatric fentanyl intranasal emergency
single dose pharmacokinetics of oral dextran sulfate (ua001) and intravenous dextran sulfate in healthy volunteers

Conditions: HIV Infections

Summary: to evaluate how the drug dextran sulfate (ds) is absorbed by the stomach and intestines when taken by mouth. to evaluate its effect on blood coagulation. ds has been reported to have anti-hiv activity. however, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when ds is taken by mouth.

ds has been reported to have anti-hiv activity. however, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when ds is taken by mouth. on 2nd day of hospitalization, each volunteer receives an oral dose of ds. over the next 24 hours, 15 blood samples are obtained (from 15 separate needle sticks). on 4th day, each volunteer is given an injection of ds into vein. 18 blood samples are obtained. blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion. all urine is collected.

Eligibility criteria:
exclusion criteria co-existing condition: volunteers with any of the following are excluded: * disorders of coagulation or disorders of plasma lipids. * allergy to dextran sulfate, other sulfates, other dextrans. concurrent medication: excluded: * volunteers who anticipate need for medication during study. volunteers with any of the following are excluded: * disorders of coagulation or disorders of plasma lipids. * allergy to dextran sulfate, other sulfates, other dextrans. prior medication: excluded within 2 weeks of study entry: * any medication. risk behavior: excluded: * ingestion of alcohol within 48 hours prior to study. * history of recent drug or alcohol abuse. * disorders of coagulation or disorders of plasma lipids. * allergy to dextran sulfate, other sulfates, other dextrans. volunteers selected are: * in good general health as determined by screening history, physical examination, and laboratory panel within established limits of normal for hospital laboratory. * consenting volunteers. * available for 6 days of continuous hospitalization.

Keywords: reference values infusions, intravenous intestinal absorption dextran sulfate administration, oral blood coagulation
lipid-lowering effect of plant stanol drink

Conditions: Hypercholesterolemia

Summary: to determine the effect of investigational products on serum ldl cholesterol.


Eligibility criteria:
inclusion criteria: * healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5 mmol/l) adults * signed written informed consent exclusion criteria: * participation in a clinical study within 30 days prior to screening visit and throughout the study * severe obesity * consumption of lipid/cholesterol lowering medication 1 month prior to the screening visit and throughout the study * consumption of plant stanol or plant sterol containing food products such as benecol or becel pro active 1 month prior to visit 2
a study with ipx056 in subjects with spasticity associated with multiple sclerosis

Conditions: Spasticity; Multiple Sclerosis

Summary: to explore the safety and efficacy of ipx056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (ms).

ipx056 was compared with commercially available tablets as it was designed to provide a prolonged duration of absorption to reduce dose frequency and/or to provide prolonged duration of antispasticity effect.

Eligibility criteria:
inclusion criteria: * male or female at least 18 years old. * agrees to use a medically acceptable method of contraception throughout the study * diagnosed with ms as defined by poser or mcdonald criteria. * receiving commercial baclofen tablets at a stable total daily dose ranging from 15 mg to 80 mg in a tid dosing regimen for at least 4 weeks prior to the screening visit that has resulted in improved spasticity. * willing to wash out and remain off other antispasticity medications during the study. exclusion criteria: * if female, the subject is pregnant, planning to become pregnant, or breastfeeding. * history of allergy or severe intolerance to baclofen. * did not respond to previous baclofen treatment in any formulation. * has experienced an exacerbation of ms within 1 month. * urinary tract infection (uti) within 2 weeks or two symptomatic utis within 6 months prior to the study. * subjects with clinically significant impairment of renal function * history of active seizure disorder or epilepsy, or currently taking an anticonvulsant for treatment or control of seizure. * other conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g. parkinson's disease). * treated with botulinum toxin type a or b within the previous 4 months, or with phenol or therapeutic alcohol nerve block within 12 months or planned use of these drugs during this study. * has clinically significant limitation of passive range of motion of lower extremities. * has had major surgery within 6 months prior to screening visit that may affect spasticity assessments such as abdominal surgery, back surgery, lower leg and knee surgeries.
shanghai cohort study of diabetic eye disease

Conditions: Diabetic Macular Edema of Both Eyes (Diagnosis); Diabetic Retinopathy Visually Threatening

Summary: to describe the design, methodology and baseline characteristics of the shanghai cohort study of diabetic eye disease (scode) study, a community-based study to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (dr), in adults with diabetes living in shanghai.

the shanghai cohort study of diabetic eye disease (scode) was a three-year community-based study to carry out a regular ocular health screening and epidemiological analysis for diabetic eye disease in the approximately 8,000 middle-aged and elderly people with diabetes in shanghai. through this study, we hope to understand the prevalence, epidemic trend and the features of risk factors distribution on diabetic eye disease, especially on dr. meanwhile, our aims also included estimating the ocular fundus changes and visual impairment associated with different grade of dr. furthermore, the aim of the present study was to investigate the association between serum and urine biochemical parameters and dr.

Eligibility criteria:
inclusion criteria: * adults with diabetes aged 35 years and above; under archives management; residing in shanghai. exclusion criteria: * all the study participants have difficulties of mobility or communication.
a study of subjects switched to lurasidone for the treatment of schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: lurasidone (lurasidone hcl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. switching between antipsychotic medications is common in the treatment of schizophrenia. the purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (d1050289-nct01143077).


Eligibility criteria:
inclusion criteria: * subject has completed 6 weeks of treatment and all required assessments on the final study visit (visit 8) of study d1050289 (nct01143077). exclusion criteria: * subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property. * subject has a body mass index (bmi) greater than 40 or less than 18 kg/m2 (see appendix 3 for bmi determination).

Keywords: schizophrenia lurasidone latuda
a 3 year follow-up prospective open randomized trial of tvt versus colposuspension for primary stress incontinence

Conditions: Urinary Incontinence

Summary: objective: to compare tvt with colposuspension (cs) as primary treatment for stress incontinence (sui). design: randomised, open, comparative trial 3-years follow-up. participants: 49 consecutive 35 to 70 years old women with urodynamic sui. setting: urology department of a district general hospital at leganés (madrid), spain. intervention: 24 patients randomised to tvt and 25 to cs.

background: evidence comparing effectiveness of tension-free vaginal tape (tvt) and burch's colposuspension (cs) in the long term follow-up is weak. objective: to compare tvt with cs as primary treatment for stress incontinence (sui). design: randomised, open, comparative trial 3-years follow-up. participants: 49 consecutive 35 to 70 years old women with urodynamic sui. setting: urology department of a district general hospital at leganés (madrid), spain. intervention: 24 patients randomised to tvt and 25 to cs. measurements: main outcome: assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the incontinence severity symptoms index (iss) and the incontinence impact symptoms index (iis) secondary outcome: 3 groups to asses cure rates: cured, improved and failure.

Eligibility criteria:
inclusion criteria: * women between the ages of 35 and 70 who had completed their family with a clinical (booney test positive) and urodynamic diagnosis of stress urinary incontinence * previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm h2o or residual volume greater than 100 ml) * cystocele over grade i * previous hysterectomy * body mass index (bmi) of 40 or more * uncontrolled diabetes * neurological disease * recurrent urinary tract infections * genital atrophy precluding vaginal surgery * known bleeding diathesis or current anticoagulant therapy

Keywords: stress urinary incontinence female incontinence surgical treatment female stress urinary incontinence
home-based transitional telerehabilitation in cardiac recovery

Conditions: Coronary Artery Disease; Cardiac Rehabilitation

Summary: the main aim is to determine the impact of home video-based cardiac rehabilitation program on elderly patients' health-related quality of life and therapeutic self-care post-coronary revascularization

over the past decade, the efficacy of coronary artery bypass graft (cabg) surgery in treating coronary artery disease (cad) has significantly advanced, particularly in improving symptom relief and survival rates among older adults. remarkably, cad stands as the foremost cause of global mortality, contributing to a staggering 16% of all deaths, with a notable surge of more than 2 million additional fatalities recorded in 2019, reaching a total of 8.9 million. this escalating incidence is particularly pronounced in the middle east and north africa, where cad has witnessed a 160% increase, signifying a critical healthcare concern with a mortality rate of 120 per 100,000 individuals. in the realm of cardiovascular diseases, individuals aged 75 years and above face substantial threats, with cad posing a significant threat to both morbidity and mortality. despite the acknowledged benefits of cabg, older adults' post-cabg commonly grapple with a spectrum of musculoskeletal and neurological challenges stemming from the surgical procedure. this encompasses incisional sternotomy pain, respiratory issues, weakness, leg swelling, sleeping difficulties, wound healing complications, poor appetite, dissatisfaction with postoperative supportive care, and difficulties with eating. psycho-socially, these individuals often experience distress, depression, a sense of loss of control, concerns about surgery success, social dysfunction, and fear of death. the postoperative period necessitates an in-hospital stay of approximately one week, with depressed functional capacity immediately following cabg, potentially linked to fear of activity and pain exacerbated by movement. this is followed by a convalescence period of 2 to 6 weeks for recovery after discharge and the resumption of daily activities. the healing process for chest and leg wounds typically spans 4 to 6 weeks, with pulmonary function and lung capacity decreasing one week following cabg up to 4-6 months after surgery compared to pre-surgery levels.

Eligibility criteria:
inclusion criteria: * aged 60 years or older * diagnosed with cad and were recommended to undergo elective cabg by a cardiologist * intact cognitive function * agree to be visited by the researchers at home * didn't have previous experiences with cabg. exclusion criteria: * have an experience with cabg * demonstrates cognitive dysfunctions.
persistence of immune response after vaccination with influenza vaccine

Conditions: Influenza, Human; Immunisation Reaction

Summary: this clinical study will be performed in subjects aged 12-60 years old enrolled in nct01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the immune response of influenza vaccine up to 24 months after vaccination.

subjects were previously vaccinated at 12 to 60 years of age with 2010 seasonal influenza vaccine.the persistence phase starts 24 months after the primary vaccination and blood samples will be taken at 6, 12, 18 and 24 months after primary vaccination. subjects whose antibody titer less than 1:40 at 6 months after primary vaccination will receive a booster dose of influenza vaccine.

Eligibility criteria:
inclusion criteria: * aged 12-60 years old * male or non-pregnant female * volunteers received 2010 seasonal influenza vaccine * clinically healthy as determined by: medical history inquiring and physical examination * provide written informed consents before joining the trial exclusion criteria: * without history of 2010 seasonal influenza vaccine administration, * allergic to any ingredient of vaccine, * autoimmune disease or immunodeficiency, * severe adverse reaction after vaccination, such as allergies, hives, breathing difficulties, angioedema or abdominal pain, * severe acute and chronic diseases * axillary temperature over 37.0℃ at the time of vaccination.

Keywords: influenza vaccine immune response persistence