Kornimate/medical-research-clean huggingface dataset:
bay94-8862 dose finding trial in subjects with chronic heart failure and mild (part a) or moderate (part b) chronic kidney disease

Conditions: Heart Failure

Summary: a placebo (part a) and placebo and active comparator controlled (part b), double-blind and randomized study to assess safety and tolerability of a new drug (bay94-8862) given orally


Eligibility criteria:
inclusion criteria: * men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy * clinical diagnosis of chf (chronic heart failure), either ischemic or non-ischemic, nyha (new york heart association) class ii - iii, treated with evidenced-based therapy for chf, e.g. beta-blockers and ace (angiotensin-converting enzyme) inhibitors or arb (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated * known kidney damage for \>/= 3 months, as defined by structural or functional abnormalities of the kidney, and * part a: 60 ml/min/1.73 m\*2 \</= egfr (estimated glomerular filtration rate) \< 90 ml/min/1.73 m\*2 (mdrd, modification of diet in renal disease) at the screening visit * part b: 30 ml/min/1.73 m\*2 \</= egfr \<= 60 ml/min/1.73 m\*2 (mdrd) at the screening visit * serum potassium \</= 4.8 mmol/l at the screening visit * systolic blood pressure \>/= 90 mmhg without signs or symptoms of hypotension at the screening visit exclusion criteria: * known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (part b only) * subjects with anuria, acute renal failure, or addison's disease * acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization * valvular heart disease requiring surgical intervention during the course of the study * history of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment

Keywords: chronic heart failure
comparing effectiveness of oral misoprostal for cervical priming in hysteroscopy

Conditions: Abnormal Uterine Bleeding; Chronic Pelvic Pain; Infertility, Female

Summary: research objective to compare effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy research hypothesis: null hypothesis effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo alternative hypothesis: : oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is better than placebo

research design randomized double-blinded placebo-controlled trial. the investigators who assess the outcomes and the participants do not know misoprostal group or control group. the patients are given the random concealed envelop which contains misoprostal or placebo to take before hysteroscopy. surgeon and the investigator whom assess patients do not know group allocation.

Eligibility criteria:
inclusion criteria: 1. premenopausal women 2. patients have following indication for diagnosis hysteroscopy * abnormal uterine bleeding * unexplained infertility * recurrent pregnancy loss * chronic pelvic pain * late postpartum hemorrhage 3. patients provided written informed consent exclusion criteria: 1. postmenopausal women 2. patients who have contraindication for misoprostal as following * allergic to misoprostal * medical illnesses such as cardiovascular diseases, asthma, renal disease 3. patients who have contraindication for hysteroscopoy as following * pregnant women * pelvic inflammatory disease * infection at cervix and vagina * cervical cancer

Keywords: cervical priming diagnosis hysteroscopy oral misoprostal premenopause
laboratory assessment of the concentration of direct oral anticoagulants in patients with atrial fibrillation

Conditions: Oral Anticoagulant; Atrial Fibrillation; Pharmacokinetics and Pharmacodynamics

Summary: the incidence of thromboembolic and bleeding event associated with catheter ablation for atrial fibrillation(caaf) varies from 0.9% to 5% during peri-operative period. direct oral anticoagulants (doac) (such as rivaroxaban, dabigatran and edoxaban) are gradually applied in clinical practice to prevent thrombosis events in patients with af, but studies have shown that doac are also affected by surgery, an invasive procedure, sub-therapeutic, food, renal function and age. however, the pharmacokinetic and pharmacodynamic of doac during the peri-operative period of caaf were lacking in china. the purpose of this study was to evaluate the pharmacokinetics and pharmacokinetics of doac in patients with peri-operative atrial fibrillation.


Eligibility criteria:
inclusion criteria: * patients with non-valvular atrial fibrillation(nvaf) undergoing catheter ablation * direct oral anticoagulants (rivaroxaban, edoxaban or dabigatran)are administered peri-operatively during catheter ablation. exclusion criteria: * patients who have taken direct oral anticoagulants or warfarin before admission. * cross-replacement of oral anticoagulants, such as taking dabigatran before surgery and replacing rivaroxaban after surgery. * abnormal coagulation tests (prothrombin time, partial thrombin time, thrombin time, antithrombin activity). * pregnant and lactating women.

Keywords: direct oral anticoagulants pharmacokinetics and pharmacodynamics atrial fibrillation rivaroxaban dabigatran edoxaban anti-fxa assays dilute thrombin time liquid-chromatography tandem mass spectrometry
built family lifestyle program for children with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the investigators have developed built in hopes of empowering families to adopt and sustain healthy food, sleep, and exercise routines that optimize child focus, attention, and behavior. over 6-weeks, the built program will explore what science says about the effects of sleep, nutrition, and exercise on brain development and behavior; investigate the food, sleep, and exercise routines of the world's best athletes and intellectuals; and experiment with home routines to find those that best fits with participating families. it is hypothesized that families participating in built (n=150) will show significant improvements in child health behaviors (sleep, nutrition, physical activity, recreational screen time), child mental health (adhd symptoms \[primary outcome\], child functional impairment), child physical literacy, and family dynamics (cohesion, structure, communication) from baseline to posttest.

families enrolled in chicago park district programs will be offered the opportunity to participate in the built family lifestyle program. using a single group design, measures will be taken within two weeks of program start and two weeks after completion. additional feasibility measures will be taken during the program itself to inform refinements across iterations. the built program will occur largely on-line and consist of weekly home challenges related to food, sleep, and exercise that add up to form a comprehensive home routine--the routine will optimize neurocognitive development and home structure. the program will be co-facilitated by uic students and chicago park district staff. for more information visit the program website: https://built.ahs.uic.edu.

Eligibility criteria:
inclusion criteria: * boys and girls ages 6 to 12 years old * parent orientation session summarizing activities * child free of conditions that preclude aerobic activity * child enrolled in chicago park district programming exclusion criteria: * boys and girls \ 12 years old * parent does not participate in orientation session summarizing activities * child has conditions that preclude aerobic activity * child not enrolled in chicago park district programming

Keywords: adhd lifestyle intervention routines behavior change community-engaged research
application of bioimpedance spectroscopy in taiwan dialysis patients

Conditions: Fluid Overload

Summary: a reasonable and simple algorithm was used to guide the dry weight determination with body composition monitor with the principle of bioimpedance spectroscopy (bcm-bis) and analyze the feasibility of this algorithm and evaluate the influence of bcm-bis-guided fluid management on the incidence of dialysis morbidities and clinical outcomes in maintenance hemodialysis (mhd) patients.

298 mhd patients in 6 hemodialysis centers in taiwan were enrolled in this randomized controlled study. all the participants were randomized into study group ( dry weight (dw) determined by bcm-bis) and control group ( dry weight determined by clinical symptoms) with stratification by diabetes mellitus and centers. body composition monitor based on bioimpedance spectroscopy (bcm-bis) was performed monthly and concomitant biochemical data and clinical outcomes were collected. intra-dialysis complications were recorded in every dialysis session. primary outcome was all-cause hospitalization. secondary outcomes included 1) complications during dw adjustment 2) intra-dialysis morbidities 3) hypertension 4) mortality 5) acute fluid overload (afo) or cardiovascular (cv)-related events. the clinical feasibility of the bcm-bis algorithm was also inspected. statistical methods: a software (sas) 9.3 was used for statistical analysis in this study. r 3.0 was used for graphic presentation of parts of the results. relative risk, incidence rate ratio and fisher's exact test were used to compare the discrete outcomes in both groups. survival analysis was used for time-related events. repeated-measured and longitudinal data were analyzed with the generalized linear mixed model (glmm) through the procedure for continuous variables (proc mixed) and for discrete variables (proc glimmix) in sas.

Eligibility criteria:
inclusion criteria: mhd patients with age ≥ 18 and dialysis vintage ≥ 3 months exclusion criteria: 1. coronary stents or pacemaker implantation 2. metallic devices in body, such as artificial joints or pins 3. contralateral or bilateral amputations 4. pregnancy

Keywords: hemodialysis body composition monitor
effect of a thin customized insole in ra

Conditions: Rheumatoid Arthritis

Summary: 50-90% of patients with ra reports foot problems and the metatarsophalangeal joints of the forefoot are most frequently afflicted. studies shows that foot problems can influence negatively on the walking function, physical activity and quality of life. different foot orthoses and insoles are used as an intervention. studies find that different insoles do have effect on pain, but there are no or minor effect on walking ability. the literature reports a further need for research and indicates the importance of studies on the effects of cost-effective insoles for patients with ra. custom-built insoles takes time and are often expensive, and many patients, especially women, do not wear them since they often do not fit the shoes they prefer to wear. in this study, a 4-mm thin, flat insole of a malleable plastic material (ci-core®) with synthetic textile material on the upper side is customized to provide support for the transverse and longitudinal arches of the foot to reduce pressure on painful joints. the insole is easily customized and ready for use the same day. the purpose of this study was to determine whether this insole can reduce foot pain and increase walking distance in patients with ra and forefoot pain. an experimental study was performed on patients with ra and forefoot pain in either one or both feet. the patients walked as fast as they could in 6 minutes (6mwt) with either insoles (situation a) and without insoles (situation b). the order of situation a and b was randomized, and the assessor was blinded for the order of the two situations. both tests were conducted the same day. after each test round, the patient was asked to register pain in the foot and perceived exertion. a telephone interview was conducted one year after the effect study to examine whether the insoles were still being used.


Eligibility criteria:
inclusion criteria: * diagnosis rheumatoid arthritis * foot pain while walking * positive gaenslens sign in forefoot * native norwegian speaking exclusion criteria: * cognitive dysfunction * problems reading * problems in walking due to problems han the foot such as in ankel, knee or hip

Keywords: ra insole forefoot walking ability pain
jet injection of 1% buffered lidocaine versus topical ela-max for anesthesia prior to intravenous (iv) catheterization in children

Conditions: Pain

Summary: this trial is a comparison of the anesthetic effectiveness of j-tip needle-free jet injection of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ela-max for peripheral intravenous catheter (piv) insertion. the researchers hypothesize that the jet injection of lidocaine will provide superior anesthesia to the ela-max prior to piv insertion.

a prospective, block-randomized, controlled trial comparing j-tip jet injection of 1% buffered lidocaine to a 30-minute application of 4% ela-max for topical anesthesia in children 8-15 years old presenting to a tertiary care pediatric emergency department for piv insertion. all subjects recorded self-reported visual analogue scale (vas) scores for pain at time of enrollment and pain of piv insertion. jet injection subjects also recorded pain of jet injection. subjects were videotaped during jet injection and piv insertion. videotapes were reviewed by a single blinded reviewer for observer-reported vas pain scores for jet injection and piv insertion.

Eligibility criteria:
inclusion criteria: * between the ages of 8-15 years requiring a piv as part of their management in the emergency department. exclusion criteria: * excluded from the study if they reported use of analgesic medication within 6 hours of enrollment, * had a glasgow coma score \< 15, * a baseline screening vas pain score \> 20 mm, or * a history of skin hypersensitivity or lidocaine allergy, * were incapable of self-reporting a pain score, * had a known neurological condition that alters pain perception, * had methemoglobinemia, or * did not speak or understand english.

Keywords: local anesthesia analgesia peripheral iv local anesthesia prior to peripheral iv insertion
chart review: central motor conduction time in neurological disorders

Conditions: Neurological Disorder

Summary: background: tms stands for transcranial magnetic stimulation. it is a non-invasive way to stimulate the brain. it helps researchers study the nervous system. tms can assess central motor conduction time (cmct). that can be used to diagnose some diseases. it can also show how well treatments are working. researchers want to study the records of people who have already had tms. they want to see how it relates to the results of diagnostic studies. objectives: to study the results of transcranial magnetic stimulation in certain neurological disorders. to create a descriptive analysis of the results. eligibility: records that are already in the ninds database design: the study will not enroll any participants. researchers will search the database for certain terms. these include tms, cmtc, and motor evoked potentials. this will identify records of people who had tms for diagnosis. using data from the records, researchers will calculate cmct. they will note other data that relate to cmct. researchers will analyze their findings. they will write a review article. personal data will be removed from all the records before the findings are analyzed.

objective- to retrospectively study the results of transcranial magnetic stimulation (tms) in various neurological disorders and create a descriptive analysis of the results. study population- existing records of patients within the ninds database who have had tms performed to measure central motor conduction time (cmct). design- * retrospective descriptive analysis. * the ninds emg database will be queried using terms such as tms, cmct, and mep (motor evoked potentials) to identify emg reports on patients who underwent tms for diagnosis * within these reports peripheral motor conduction time (pmct), the cortical motor evoked potential (mep) latency and amplitude will be used to calculate cmct, clinical patient factors pertinent to estimation of cmct as well clinically significant physical exam findings will be recorded as well. * clinical diagnoses and neurological exams will be extracted from medical records * patient identifiers will be de-linked after compiling data from medical records outcome measures - results of cmct using tms in different diagnoses will be summarized for different neurologic disorders and correlated to clinical exam measures documented in previous records

Eligibility criteria:
* inclusion criteria: 1. patients who were seen in the ninds emg section for diagnostic tms studies 2. patients tested between 1998 and 2017 3. greater than or equal to age 18.

Keywords: transcranial magnetic stimulation (tms) electrophysiology
stellate ganglion block as novel treatment for heart failure patients

Conditions: Stellate Ganglion Block

Summary: stellate ganglion block as novel treatment for heart failure patients

stellate ganglion block as novel treatment for heart failure patients

Eligibility criteria:
inclusion criteria: * age 18 : 70 years old. * nyha class iii-iv heart failure. * heart failure with a reduced ejection fraction (hfref) lvef ≤ 40% calculated using 2d echocardiography and biplane simpson's . * optimal tolerated medical therapy for heart failure. exclusion criteria: * active malignancy. * acute heart failure including pulmonary edema or cardiogenic shock. * severe, life-threatening non-cardiac disease. * pregnancy. * localized infection. * coagulopathy or anticoagulated patients. * refused this procedure.
non-operative treatment versus volar locking plate in treatment of distal radius fracture in patients over 65 years

Conditions: Distal Radius Fracture

Summary: the present collaboration study on the treatment of distal radius fractures is aimed to: (i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with prwe (ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with prwe (iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture (iv) to assess the effect of pain catastrophizing score (pcs) on the functional outcome of non-operatively and operatively treated distal radius fracture (v) to assess the association between physical activity and the number of wrist movements measured with axivity accelerometer and functional outcome measured with proms of non-operatively and operatively treated distal radius fractures (vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome (vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (ewc) with functional outcome measured with prwe and pass


Eligibility criteria:
inclusion criteria: * low energy intra or extra-articular dorsally displaced distal radius fracture within 3 cm of the radiocarpal joint, diagnosed with lateral and posterior-anterior radiographs in er * \>10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in the radiograph exclusion criteria: * refuse to participate the study * open fracture more than gustilo 1 gradus * age under 65 years * chauffeure's or barton´s fracture * smith´s fracture (volar angulation of the fracture) * does not understand written and spoken guidance in local languages * pathological fracture or previous fracture in the same wrist or forearm
the analgesia effect of electroacupuncture battlefield acupuncture versus sham electroakupuncture post surgery

Conditions: Percutaneous Nephrolithotomy

Summary: the goal of this clinical trial is to learn the effect of ear electroacupuncture bfa therapy in reducing pain, analgesic dose, and improving patient quality of live post percutaneous nephrolithotomy surgery. the main questions it aims to answer are: * does bfa ear electroacupuncture reduce postoperative pain of percutaneous nephrolithotomy surgery better than sham electroacupuncture group? * does bfa ear electroacupuncture reduce postoperative analgesic dose of percutaneous nephrolithotomy surgery better than sham electroacupuncture group? * does bfa ear electroacupuncture improve postoperative quality of life of percutaneous nephrolithotomy surgery better than sham electroacupuncture group? researchers will compare ear electroacupuncture bfa to sham electroacupuncture to see the different analgesia effect between these groups. participants will: * get ear electroacupuncture bfa or sham electroacupuncture therapy, 2 hours before surgery for 30 minutes * take drug paracetamol 1000 mg intravenous after surgery according to the needs of the patient's pain complaints after surgery in both groups


Eligibility criteria:
inclusion criteria: * men or women aged 18-65 years * patients who have been diagnosed with kidney stones measuring \> 2 cm and will undergo pcnl surgery * vas score \<7, assessed 2 hours before pcnl surgery * receive standard analgesic therapy * willing to participate in this study until completion and sign an informed consent. exclusion criteria: * kidney anatomical abnormalities * ear deformities (microtia) * patients with cognitive impairment, uncooperative (receiving antidepressants or strong opioid or narcotic analgesics) * tumors, wounds or skin infections in the needling area. * heart rhythm disorder, unstable hemodynamics that require intensive care including extremely high body temperature and using a pacemaker. * allergy to acupuncture needles or certain metals * patients who have had a dj stent or nephrostomy before pcnl * history of metal implants in the body except amalgam