Kornimate/medical-research-clean huggingface dataset:
efficacy study: darbepoetin alfa for the treatment of anemia in patients with chronic kidney disease

Conditions: Anemia; Kidney Disease

Summary: the purpose of this study is to evaluate whether the efficacy of darbepoetin alfa sf is equivalent to that of darbepoetin alfa rb for the treatment of anemia in patients with chronic kidney disease (ckd) receiving hemodialysis.


Eligibility criteria:
inclusion criteria: - diagnosis of ckd and receiving hemodialysis for greater than or equal to 3 months before enrollment - no prior exposure to eprex® or neorecorman® - baseline hemoglobin (hb) between 10 and 13 g/dl - on stable weekly or once every other week intravenous (iv) or subcutaneous (sc) darbepoetin therapy for at least 6 weeks prior to screening (stable is defined as less than 25% change in weekly dose and no change in frequency) - adequate iron stores (serum ferritin equal to or greater than 100 mg/l) - before any study-specific procedure, the appropriate written informed consent must be obtained exclusion criteria: - scheduled to receive a kidney transplant - uncontrolled hypertension, defined as a pre-dialysis systolic blood pressure (bp) greater than 180 and/or diastolic bp of greater than 110 - acute myocardial ischemia; hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, cerebrovascular event (stroke or transient ischemic attack) within 12 weeks before enrollment - parathyroid hormone (pth) level greater than 1500 pg/ml - major surgery within 12 weeks before enrollment (excluding vascular access surgery) - currently receiving antibiotic therapy for systemic infection - known positive hiv antibody or positive hepatitis b surface antigen - clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - red blood cell (rbc) transfusions within 8 weeks before enrollment - androgen therapy within 8 weeks before enrollment - systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy; myeloma; hemolytic anemia) - any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - pregnant or breast-feeding women. all subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. - treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - subject has known sensitivity to any of the products to be administered during dosing.

Keywords: hemodialysis darbepoetin alfa clinical trials nephrology amgen chronic kidney disease (ckd)
role of prophylactic biliary stent in reducing the recurrence of choledocholithiasis

Conditions: Choledocholithiasis

Summary: we planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance

patients with cholelithiasis can have presence of concomitant choledocholithiasis (cdl) in upto 30%. these stones may remain asymptomatic or cause obstructive jaundice and complications like cholangitis and pancreatitis. in situations where there is a failure of cdl clearance during endoscopic retrograde cholangiography (erc), biliary stenting is recommended to prevent complications. however, the role of prophylactic biliary stenting in situations where cdl clearance has been achieved, and the patient is awaiting cholecystectomy is debatable. one retrospective study showed benefit while a small prospective study and a retrospective study did not show benefit of prophylactic biliary stenting. moreover, a randomized controlled trial addressing this question is lacking. hence, we planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance.

Eligibility criteria:
inclusion criteria: * age between 18-80 years * cases of cholelithiasis with concomitant cdl in whom cbd clearance is achieved will be included. exclusion criteria: * informed consent not available * patients opting for single stage surgery * previous hepatobiliary surgery * failure to completely clear cdl on erc * concomitant benign biliary strictures (like chronic pancreatitis, portal cavernoma cholangiopathy, post cholecystectomy, primary biliary cholangitis related) * previous cholecystectomy patients * associated malignancy * coagulopathy(inr\>1.5, platlets\<1lac) * severe cholangitis
cognitive impairment and cerebral haemodynamics in individuals with symptomatic peripheral arterial disease

Conditions: Peripheral Arterial Disease; Cognitive Impairment

Summary: background: arterial disease of the legs causes symptoms such as pain when walking and may ultimately lead to a leg amputation. many older people with arterial disease of the legs also have problems with their thinking and memory. blood flow in the brain may be altered in these people and may be a cause for memory and thinking problems. aim: the aim of this project is to investigate whether people with arterial disease of the legs have altered blood flow in the brain causing problems with memory and thinking. research plan: twenty people with arterial disease of the legs causing pain while walking and twenty healthy people will have a series of non-invasive assessments. arterial disease in the legs will be measured using ankle blood pressures before and after walking. blood flow in the brain will be measured using ultrasound whilst performing memory and thinking tests. results will be compared between the people with arterial disease in the legs and the healthy people to see if there are any differences in blood flow to the brain and memory and thinking. benefits to society: this project will help determine if there is a link between arterial disease of the legs and memory and thinking problems caused by altered blood flow in the brain. it will enable future research in people with cognitive impairment caused by altered blood supply to the brain and to prevent confusion and further memory and thinking problems in people undergoing surgery for arterial disease of the legs.


Eligibility criteria:
inclusion criteria: * capacity to provide informed volunteer/patient consent * male or female, aged ≥50 years of age * able (in the investigator's opinion) and willing to comply with all study requirements * good understanding of written and verbal english peripheral arterial disease specific inclusion criteria: * clinical diagnosis of symptomatic pad (intermittent claudication) confirmed by positive haemodynamic tests (abpi \<0.90 in the symptomatic leg; and/or, * post-exercise \[walk test\] reduction in abpi of \>20% or post-exercise \[walk test\] reduction in absolute ankle pressure of \>30mmhg) exclusion criteria: * male or female, aged under 50 years * pregnant * unable (in the investigator's opinion) or unwilling to comply with any study requirements * major co-morbidity likely to affect cerebral autoregulation; severe respiratory disease, unilateral carotid artery stenosis (≥50%), atrial fibrillation, severe cardiac failure (left ventricular ejection fraction \<20%), or extreme frailty * history of significant diagnosed psychiatric disorder, learning disability (e.g. dyslexia) or neurological disorder (head injury, epilepsy, stroke and/or transient ischaemic attack \[tia\]) * diagnosis of dementia * uncorrected hearing impairment and/or significant visual impairment healthy control specific exclusion criteria * symptoms of intermittent claudication; and/or, * clinical diagnosis or history of pad
ambulatory management of moderate to high risk covid-19 (sars-cov-2) patients - the coronavirus related outpatient work navigators (crown) protocol

Conditions: Covid-19 (SARS-CoV-2)

Summary: descriptive report of the northwell crown program for ambulatory treatment of covid-19 (sars-cov-2) patients with moderate to high risk features

at the peak of the covid-19 (sars-cov-2) pandemic in new york city, there was a shortage of hospital resources as well as a fear among many new yorkers of going to the hospital. emergency services dead on arrival calls increased by as much as eight-fold.we created the crown program, a pulmonary physician guided home-care protocol to treat ambulatory covid-19 (sars-cov-2) patients with moderate to high risk features. this is a retrospective review of our crown program's patient characteristics, results and outcomes.

Eligibility criteria:
inclusion criteria: * covid-19 (sars-cov-2) infection ambulatory exclusion criteria: * need for hospital admission

Keywords: covid-19 (sars-cov-2) homecare ambulatory
comparisons of the impact of monotherapy with mirabegron or tolterodine versus combined treatment with mirabegron and tolterodine on autonomic function and bladder blow flow in women with overactive bladder syndrome: a randomized controlled study

Conditions: Female Patients With Overactive Bladder Syndrome

Summary: to evaluate the impact of combined therapy on the heart rate variability, compared with monotherapy in women with overactive bladder syndrome. secondary objective is to evaluate the impact of combined therapy on bladder blood perfusion.

patients and methods: we will conduct a prospective randomized controlled study in the outpatient clinic of department of obstetrics and gynecology of far eastern memorial hospital, and will recruit 150 female patients with overactive bladder syndrome. all female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the urgency severity score, the overactive bladder symptom score questionnaire, and the king's health questionnaire before taking the drug and four weeks and twelve weeks after taking the drug. in addition, measurement of heart rate variability and bladder blood perfusion will be performed. expected results: we will obtain the impact of monotherapy with tolterodine or mirabegron versus combined therapy on heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.

Eligibility criteria:
inclusion criteria: * \>20 years old . * female patients with overactive bladder syndrome exclusion criteria: * cases of hypersensitivity to mirabegron or tolterodine. * betanley is contraindicated in the following patients: uncontrolled severe hypertension. * dexotol is contraindicated in the following patients: known urethral diverticulum, known bladder malignancy, patients with urinary retention and gastric retention, patients with uncontrolled narrow-angle glaucoma, patients with renal dialysis, severe renal dysfunction (ie inulin clearance rate (gfr\<30 ml/min) or liver dysfunction (i.e. liver cirrhosis), use strong cyp3a4 inhibitors such as ketoconazole. * patients with myasthenia gravis. * the patient is taking drugs that interact with tolterodine or mirabegron.
families preventing diabetes together

Conditions: Type 2 Diabetes; Pediatric Obesity

Summary: the current study proposes to study the feasibility and acceptability of the families preventing diabetes together intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

the current study is a randomized controlled trial with 40 families. twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through fairview health services. an additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from fairview health services for the parent with diabetes. parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program. adult patients and their families will be recruited in two ways: 1. from fairview health service's clinics in the north metropolitan area with the assistance of fairview health service diabetes educators, and 2. through mychart messages informing them about the study. adults between the ages of 25 and 55 years who have a diagnosis of type 2 diabetes, who have participated in at least some diabetes education through fairview health services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

Eligibility criteria:
inclusion criteria: * parent with type 2 diabetes * at least 1 child between the ages of 7-12 * parent has completed at least some diabetes education through fairview health system exclusion criteria: * parent with type 2 diabetes does not speak or read in english * no parents with type 2 diabetes or no children ages 7-12 years * parent with type 2 diabetes has not completed at least some diabetes education
impact of semi-automated proposal and optimization of diagnoses and surgical procedures for precoding: a randomized controlled trial

Conditions: Diagnosis-Related Groups; Healthcare Common Procedure Coding System

Summary: the hypothesis of present study is that the daily monitoring and optimization of drg coding is associated with higher reimbursement. therefore, the primary objective is to determine if the daily monitoring and optimization of drg coding of individual cases leads to better proceeds per day.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery as inpatients (at least one night stay) * treated at the kantonsspital st. gallen, st. gallen site exclusion criteria: * surgery as outpatients * surgery at the rorschach and flawil sites * patients operated on by the department of surgery, but hospitalized at another department of the hospital

Keywords: drg diagnosis-related groups icd reimbursement
zinc supplement in regorafenib treated mcrc patient

Conditions: Colorectal Cancer Metastatic

Summary: phase ii randomized trial to investigate whether supplementation of zinc decreases the incidence of hfsr that occurs after treatment of tyrosine kinase inhibitor, regorafenib.

this study is aimed to investigate the effect of zinc supplementation on improving regorafenib treatment safety and efficacy in patients with metastatic colorectal cancer (mcrc). the difference in grade 2 or worse hand-foot skin reaction (hfsr) incidence within the first 8 weeks of regorafenib treatment between two arms will be examined as the primary objective.

Eligibility criteria:
inclusion criteria: * patients diagnosed with mcrc who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib * ability to understand and willingness to sign written informed consent form (icf) exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice * patients with baseline zinc level above 120 ug/dl * patients with known allergy to zinc supplementation * pregnancy * patients who are unsuitable for study participation, based on investigator's discretion
family based mindfulness intervention

Conditions: Parental Stress; Parent and Child Stress; Parental and Child Obesity; Child Obesity

Summary: the goal of the proposed interdisciplinary study is to assess feasibility of recruiting a pilot sample of parents of toddlers and engaging them in a pilot study to test a version of mindfulness-based intervention for parenting stress reduction (pmh), an empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling for parents of preschoolers (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy eating and physical activity in parent and child; and prevent overweight and obesity in preschoolers with an obese parent.

this project was a preliminary feasibility and pilot efficacy study to assess stressed low income parents of toddlers who were obese to assess whether a mindfulness based parenting intervention (pmh) can reduce their stress, increase parenting and improve family healthy food and physical activity choices. parents and toddlers also participated in a toy wait task, a behavioral assay of parenting.the empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling (control) for parents of preschoolers (aged 2-5) was compared to a nutrition and physical activity counseling alone condition to assess whether pmh improved toddler weight, physical activity and parent emotion regulation and healthy eating.

Eligibility criteria:
inclusion criteria: 1. between ages 18-70 years; 2. able to read and write (parent) 3. family with a child between 2-5 years old 4. bmi of parent in obese category 5. high parenting stress (mean score of \>=3 on 3 questions from parenting stress index) exclusion criteria: 1. any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation 2. diagnosis of mental retardation, autism or other pervasive developmental disorder for child 3. inability to give informed consent 4. current serious medical disorder precluding participation in physical activity
feasibility of a postpartum lifestyle intervention on the cardiometabolic risk profile of gdm women

Conditions: Dietary Modification; Weight Loss; Physical Activity; Breastfeeding

Summary: the goal of the study is to investigate the effect of a lifestyle intervention program (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on minimizing postpartum weight retention among women with recent gdm.

women with a history of gestational diabetes (gdm) are characterized by increased risk for subsequent type 2 diabetes (t2d) and cardiovascular disease (cvd). these women are also characterized by higher body mass index (bmi) and waist circumference compared to women without prior gdm. failure to lose the weight gained during pregnancy can lead to increased bmi for subsequent pregnancies. as such, the childbearing-age period has been described as a potential period of weight gain and represents a critical window for the development of obesity, t2d and cvd. therefore, strategies aiming at preventing postpartum weight retention (wr) and early cardiometabolic alterations in women with a history of gdm are of paramount importance. principal investigator have shown that a low diet quality score was associated with greater adiposity and lower insulin sensitivity in women with prior gdm. furthermore, less than 10% of women with prior gdm met the recommendations for breastfeeding, nutrition, and physical activity. investigators have shown that attitude and perceived behavioral control were significant predictors of the intention to adopt healthy eating. for those who did engage in healthy behaviors, lower prevalence of cardiometabolic alterations was observed, providing supportive evidence that the adoption of healthy behaviors may be key to prevent the progression to an altered cardiometabolic profile.

Eligibility criteria:
inclusion criteria: * pregnant women diagnosed with gdm * fluent in french * had a singleton pregnancy * at least 18 yrs old * with a reported pre-pregnancy bmi ≥18.5 kg/m2 exclusion criteria: * women who had bariatric surgery * women who plan another pregnancy in the following year * women with a history of type 1 or type 2 diabetes * women with a multiple pregnancy

Keywords: gestational diabetes dietary modification weight loss physical activity breastfeeding
efficacy of structured exercise-nutritional intervention on sarcopenia in patients with osteoporosis

Conditions: Sarcopenia; Osteoporosis

Summary: this is a prospective parallel group, double-blinded randomized controlled trial. subjects are randomized into two groups - the intervention group and waitlist control group. subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (hmb). the intervention group would first receive the intervention during the 12-week study period. meanwhile, the waitlist control group would receive 12 weeks of conventional care. after the study period, they would receive the same intervention.


Eligibility criteria:
inclusion criteria: 1. diagnosis of sarcopenia: * low hand grip strength (male: \<28 kg, female: \<18 kg) and * low appendicular skeletal mass by bioimpedance analysis (male: \<7.0 kg/m2 female: \<5.7 kg/m2) 2. diagnosed with osteoporosis by: * fragility fracture or * t-score ≤-2.5 sds at any site based upon bmd measurement by dual energy x-ray absorptiometry (dxa) scan exclusion criteria: 1. incompetent in giving consent or following commands 2. non-ambulatory subject 3. unstable medical conditions contributing to sarcopenia, for example but not limited to: 1. end stage organ failure 2. unstable cardiovascular, respiratory, gastrointestinal and endocrine conditions 3. active malignancy 4. chronic kidney disease stage iv or above or with hyperkalaemia 5. diabetes mellitus on medications or with unstable control 6. terminal illness 7. obese subjects (bmi ≥ 25.0) 8. self-reported allergy to the ingredients of the nutrition supplement 9. patients with metallic implants 10. any orthopaedic pathologies affecting the strength of bilateral upper limbs 11. any hereditary or acquired muscular diseases 12. participation in other regular exercise programme