Kornimate/medical-research-clean huggingface dataset:
effects of implementation of a self-measurement kiosk in the emergency department waiting room

Conditions: Emergencies

Summary: in this study the participant will be invited to be seated in the self-measurement kiosk after registration in the emergency department. in this kiosk, the participant will be measuring their own vitals and answering a short questionnaire regarding the reason for presentation. all these results are displayed on a screen for the triage nurse. based on the results, high-risk patients will be highlighted on the screen, so they may be seen faster.

the questionnaire entails questions which would otherwise be asked by the triage nurse, regarding reason for presentation, fever, pain and and possible allergies. this is done through a touch-screen. the vital signs and potential alarm symptoms from the (multilingual) questionnaire are being displayed with the pain score on a screen in the triage room and at the nurses desk. an adapted early warning score (aews - without respiratory rate) is calculated from the vital signs. abnormal results are being highlighted and carried up on the screen to the top position. this enables the triage nurse to pick up the sicker participants in the waiting room faster. the measurements are valid, so they do not have to be repeated by the triage nurse. users will be contacted afterwards regarding satisfaction of use

Eligibility criteria:
inclusion criteria: * all patients presenting ambulatory at the emergency department exclusion criteria: * patients presenting by ambulance / emergency medical services

Keywords: triage kiosk early warning score
directed use of remote patient management system amia to achieve prescribed dry weight

Conditions: Efficacy; Safety Issues

Summary: among ambulatory peritoneal dialysis patients, does use of the baxter amia peritoneal dialysis cycler with sharesource connectivity platform achieve dry weight targets better than use of the baxter home choice pro cycler.

the remote patient management system baxter amia automated peritoneal dialysis system with sharesource connectivity platform incorporates innovative technology (two-way remote connectivity, touch screen controls, voice guidance) to record patient treatments which are then able to be transmitted to their dialysis clinic for review and monitoring in near real-time. this has tremendous potential clinical utility given the struggles to achieve dry weights for most peritoneal dialysis patients using other systems, where typically, management regarding fluid balance is reviewed and revised only monthly. the new technology is the only device cleared in the us with patient-centric features. abstracts available have demonstrated that amia can improve efficiency of patient training and focus pd nursing time towards proactive tasks to help patients. there has also been insight into how remote patient management systems like amia can be used to objectively monitor patient compliance or catheter function above and beyond subjective endorsement from patients. however, with new technology comes new training for patient and staff (nurses, physicians) without understanding if interfacing with this new patient-centric featured technology improves patient-centric clinical outcomes. the new amia and sharesource programs may also require additional nurse and physician provider time to monitor data in real-time and to react to these data, which may incur additional expense to medical practices. thus, it is imperative to demonstrate the utility of the amia and sharesource programs for important improvement in patient management, which may ultimately translate into improved clinical outcomes (e.g. fewer hospital admissions, less heart failure, improved quality, and length of life).

Eligibility criteria:
inclusion criteria: * adults aged \> 21 years with esrd on peritoneal dialysis exclusion criteria: * unable to commit to 12 months of monitoring. * unable to stand safely on scale for weight * hospitalization for heart failure, volume overload, or cardiovascular disease within the last 3 months. * peritonitis within the past 3 months. * not responsible for self-care of peritoneal dialysis (proxy care will be excluded). * patients residing in a nursing home or other institutionalized individuals. * inability or unwillingness to provide informed consent (lacks decision making capacity) * alcohol, substance use, or other social conditions which preclude close follow-up and reliable participation, in the opinion of the primary nephrology physician or study investigator.

Keywords: estimated dry weight peritoneal dialysis amia sharesource ccpd peritoneal dialysis cycler homechoice pro
3d versus robot assisted laparoscopic prostatectomy.

Conditions: Prostate Cancer

Summary: a randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3d laparoscopic and robot assisted radical prostatectomy procedures.

the direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (ralp) are compared to those of 3d laparoscopic radical prostatectomy. the hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of rapl are significantly higher. a randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. the primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. secondary functional outcome measure is the preservation erectile function at 12 months post operatively. oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. the direct and indirect costs of both operative approaches are recorded.

Eligibility criteria:
inclusion criteria: * localized prostate cancer undergoing radical prostatectomy * patient has to understand and be able to write and read finnish language * no prior head injury, dementia or parkinson's disease * no concomitant malignant illness * life expectancy of at least 10 years * 35-74 years of age exclusion criteria: * locally advanced prostate cancer (t4) * suspicion or documented metastases (m1) * serum psa \> 20 ng/ml * prior laparoscopic hernia surgery employing non resorbable mesh * prior pelvic irradiation or major surgery * prior malignant disease within prior 5 years excluding skin cancer (non-melanoma).

Keywords: radical prostatectomy laparoscopic prostatectomy robot assisted prostatectomy
efficacy and safety of naldemedine in treating opioid-induced constipation

Conditions: Opioid-induced Constipation

Summary: the purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (oic) in adults with non-malignant chronic pain who are not using laxatives.


Eligibility criteria:
inclusion criteria: * subjects aged 18 to 80 years inclusive at the time of informed consent * subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (oic) * subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate * subjects must not be currently using laxatives or must be willing to discontinue laxative use at screening and must be willing to use only the rescue laxatives provided throughout the study duration * subjects must meet opioid-induced constipation criteria based on the bowel movement and constipation assessment (bmca) diary exclusion criteria: * evidence of significant structural abnormalities of the gastrointestinal (gi) tract * evidence of active medical diseases affecting bowel transit * history or presence of pelvic disorders that may be a cause of constipation * surgery (except for minor procedures) within 60 days of screening * history of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical gi obstruction) * subjects who have never taken laxatives for the treatment of oic * history of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen \[nolvadex®\] and raloxifene \[evista®\] when being used for prevention of breast cancer * current use of any prohibited medication including opioid antagonists, partial agonists, or mixed agonists/antagonists

Keywords: opioid-induced constipation
cross-over study to prove bioequivalence between two brands of cefalexin suspension

Conditions: Anti-Infective Agents

Summary: a single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.


Eligibility criteria:
inclusion criteria: * healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ecg), blood chemistry, liver function profile and urinalysis exclusion criteria: * history of illnesses or any organic abnormalities that could affect the results of the study * history of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs * subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup
landmark vs ultrasound for combined spinal epidural

Conditions: Obesity (Body Mass Index &gt;30 kg/m2); Ultrasonography; Combined Spinal Epidural Anesthesia

Summary: a comparison of two different methods used in routine anesthesia practices will be made for the insertion of a catheter that will be placed at the waist for anesthesia in obese patients who will undergo orthopedic surgery. 60 obese patients aged 40-80, asa ii-iii, bmi\>30, who are planned to undergo elective orthopedic lower extremity surgery by placing a combined spinal epidural catheter at sakarya university medical faculty education and research hospital will be included in the study. general anesthesia or regional anesthesia techniques are routinely used in lower extremity surgery in our clinic. when placing a combined spinal epidural catheter, the entry site is determined by looking at anatomical landmarks or using ultrasound. patients will be divided into two different groups as anatomical marking or ultrasound. patients in the ultrasound group will be taken to the block room in our operating room before the operation and a location marking will be performed with ultrasound in the block room. patients in the anatomical marking group will be brought to a sitting position in the operating room in the operating room and a location marking will be performed by hand examination. after determining the needle entry site, patients in both groups will undergo the combined spinal epidural catheter placement procedure, which is performed routinely under sterile conditions, and the success rate at the first attempt, total success rates, number of needle redirections, and complications during the procedure will be compared.


Eligibility criteria:
inclusion criteria: * asa ii-iii * bmi\>30 * elective orthopedic lower extremity surgery * combined spinal epidural anesthesia (csea) exclusion criteria: * patients with csea contraindication * asa iv-v * diagnosed with scoliosis * patients with anatomical disorders * patients who did not agree to participate in the study * patients for whom follow-up conditions could not be met
effects of epicatechin on functional capacity, skeletal muscle structure and diastolic function in patients with heart failure with preserved ejection fraction (hfpef)

Conditions: Heart Failure

Summary: the major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the 1. structural and functional features of skeletal muscle (skm) 2. exercise capacity (as assessed by vo2 max) 3. parameters of diastolic heart function (as assessed by echocardiography) we propose that a 3 month treatment with epicatechin (through cocoavia® capsules) will lead to a significant improvement in exercise capacity and diastolic function.

patient inclusion/exclusion criteria: 1. new york heart association class ii/iii hf with preserved ejection fraction (ef) of \>50%. 2. nonsmokers 3. subject not taking coumadin, xarelto, prasugrel or pradaxa. patients on plavix for drug eluting stent will not be excluded. 4. ages between 40-65. we will exclude any women of child bearing potential

Eligibility criteria:
inclusion criteria: * medically diagnosed heart failure with ejection fraction of \>55% * bmi 27-32 * no significant hba1c fluctuations in past 6 months exclusion criteria: * smoking or quit smoking less than 1 year prior to enrollment * substance abuse * taking coudmadin or pradaxa

Keywords: with preserved ejection fraction of >55%
neutrophil gelatinase associated lipocalin (ngal) in urine: can this prove to be a biomarker for acute kidney injury in patients with sepsis?

Conditions: Severe Sepsis; Septic Shock; Acute Kidney Injury

Summary: patients with severe infection and sepsis are in high risk of hypo perfusion and therefore organ affection. temporary or permanent kidney failure is a common complication in these patients. today's golden standard for kidney failure detection is creatinine levels rising and / or oliguria. the investigators hypothesize that an even more sensitive biomarker; neutrophil gelatinase associated lipocalin(ngal) in urine can predict kidney injury before creatinine levels rise. in recent studies ngal in urine seem to be a sensitive biomarker in these patient to predict kidney injury, but the time factor for sampling optimally is not known. in this pilot study the investigators sample the urine at admission within the first hour of hospitalization to investigate if ngal can be used as a predictor in an emergency setting.


Eligibility criteria:
inclusion criteria: * severe sepsis * septic shock * patients must not be able to give consent exclusion criteria: * underaged (18 years ) * known kidney injury * fully alert patients that can give consent
role of the mespere venus 1000 in predicting heart failure hospital readmissions

Conditions: ADHF

Summary: the purpose of this study is to investigate the utility of venus 1000 in predicting 30-day hospital readmissions for acute decompensated heart failure. secondary outcomes will include correlation with nt-probnp and weight both at admission and discharge from hospital

rehospitalizations for heart failure have been linked to poor clinical outcomes, rates remain high despite different attempts to decrease them . clinical indicators of volume congestion at time of discharge are associated with increased rates of readmission . clinical evaluation of volume status remains the gold standard in determination of readiness and timing of hospital discharge, however identification of persistent congestion might prove difficult . assessment of the right atrial pressure can be done non-invasively at the bedside; however, precision and accuracy of this method are variable . echocardiography is a valuable tool in the estimation of elevated central pressure , this, however is time consuming and requires trained personnel. while invasive measurements provide accurate estimation of central venous pressure, it is an impractical approach in most patients, notwithstanding the risks associated with the insertion of a catheter into the central circulation . since a significant proportion of readmitted patients return to hospital with congestive symptoms, attempts have been made to improve our ability to assess volume status . current clinical evidence suggests that bnp-guided management of patients with congestive heart failure can decrease all-cause mortality and heart failure rehospitalization. however, biological variation for natriuretic peptides is high , and optimal targets are difficult to determine in individual patients. the mespere venus 1000 system is a non-invasive tool that has previously shown reliable correlation and accuracy with central venous pressure obtained invasively in the catheterization laboratory and good correlation with jugular venous pressure at the bedside.

Eligibility criteria:
inclusion criteria: * age 18 and older * patient admitted to st. michael's hospital with a main clinical diagnosis of decompensated heart failure. * signed informed consent exclusion criteria: * lack of patient consent. * presence of known av dialysis fistula. * allergy to adhesive tape from mespere venus 1000 system. * known central vein stenosis. * ongoing photodynamic therapy. * assisted ventilation. * associated acute coronary syndrome
using cannabis to treat restless legs syndrome

Conditions: Restless Leg Syndrome (RLS)

Summary: restless legs syndrome (rls) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. cannabis has been used by some rls patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with rls. a controlled trial is needed to establish how safe and feasible cannabis is as a treatment for rls. the investigators plan to randomize 30 participants with moderate-to-severe rls to receive either cannabis or placebo for 8 weeks. the investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. the investigators will also monitor patients for any adverse reactions to the study drug.


Eligibility criteria:
inclusion criteria: * ≥25 years of age * diagnosis of rls based on the international rls study group criteria * refractory rls symptoms despite use of dopaminergic and/or alpha-2-delta ligand therapy * onset of rls at least 6 months before screening exclusion criteria: * sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of \>15) * cannabis use within 4 weeks of study enrollment * known allergy to cannabis, cannabinoids or palm/coconut oil * currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment evaluation) * active substance abuse * ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled hypertension * serious liver disease * history of schizophrenia or any other psychotic disorder
study to evaluate the efficacy and safety of intra-articular da-5202 in patients with osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: this phase ii clinical study is to evaluate the efficacy and safety of da-5202 in patients with osteoarthritis of the knee.

eligible subjects are randomly assigned to receive da-5202 high dose(20mg) or da-5202 low dose(10mg) or na hyaluronate once a week intra-articular injection for 3 weeks.

Eligibility criteria:
inclusion criteria: * male and female patients between 20 and 80 y old * primary knee osteoarthritis confirmed clinically and radiologically according to american college of rheumatology criteria and have following 3 items 1. knee joint pain 2. have any of the following 1. males and females more than 50 y 2. morning stiffness within 30 minutes 3. crepitus 3. presence of spur on radiological evidence * kellgren-lawrence grade ⅰ to ⅲ confirmed radiologically * knee pain under weight-bearing greater than 40/100mm-vas(visual analogue scale) at randomization visit * patients willing and able to provide signed informed consent after the nature of the study has been explained exclusion criteria: * bmi(body mass index) \> 32 * complete obliteration of femoropatellar joint space on x-ray * kellgren-lawrence grade iv * knee surgery within a year * history of fracture, rheumatoid arthritis or other inflammatory arthritis in knee articular cavity * intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months * skin diseases or infection overlying the joint * history of severe drug allergy or hypersensitivity to drugs(piroxicam, hyaluronic acid) * history of allergy, asthma, rhinitis, angioedema, rash to aspirin or other nsaids (including cox-2 inhibitor) * treatment with anticoagulants such as heparin or coumarins (warfarin etc.) * history of gi diseases such as peptic ulcer, bleeding, perforation, ulcerative colitis, crohn's disease within 1 year * severe hypertension * patients with psychiatric disorder, alcoholism, drug addiction * presence of severe concomitant diseases or malignancy within 5 years * have participated in another clinical trial 4 weeks prior to the study * women of child-bearing potential who are not using \*adequate means of contraception (\*adequate means of contraception: condom, oral contraception, barrier methods using spermicide, intrauterine devices etc.) * any condition that, in the view of the investigator, would interfere with study participation
paleolithic diet in the treatment of diabetes type 2 in primary health care

Conditions: Diabetes Mellitus, Type 2

Summary: there is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. this study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. the basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a palaeolithic ("old stone age") diet which is free from food items produced in agriculture or the food industry. our study hypothesis is that a palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2. fifteen patients with diabetes type 2 have been randomized to 1. a palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts 2. a standard diabetes diet as recommended by national health authorities. the patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. the study is conducted in primary health care stations.


Eligibility criteria:
inclusion criteria: * adults with capacity to perform study * diabetes mellitus type 2 * c-peptide \> 0 * hba1c \>5.5 * unchanged diabetes treatment during last 3 months * weight and hba1c varied less than 5% during last 3 months * no acute heart disease during last 6 months * unchanged treatment with betablocker last 6 months * unchanged treatment with thyroid hormone substitution last 6 months exclusion criteria: * treatment with insulin * chronic treatment with steroids (not inhaled) * treatment with waran (anticoagulant cumarin type) * creatinin \> 130 micromol/l * elevated liver enzymes (alat,asat,alp or gt \> 4 x upper reference value) * acute heart disease * changed treatment with betablocker or thyroid hormone substitution