Kornimate/medical-research-clean huggingface dataset:
a prospective multi-dose study of apixaban in subjects with nephrotic syndrome

Conditions: Nephrotic Syndrome; Membranous Nephropathy

Summary: this phase i study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (pk) and pharmacodynamics (pd) in subjects with nephrotic syndrome (ns) vs healthy control subjects. this study will enroll 20 subjects diagnosed with ns and 10 healthy control subjects. comparing differences in steady-state apixaban pk/pd parameters between subjects with ns and healthy volunteers will be essential to identifying a safe and effective apixaban dose and dose administration schedule for future randomized controlled trials (rcts).


Eligibility criteria:
inclusion criteria: study subjects * 18-79 years of age * confirmed diagnosis of ns, with at least one of the following (confirmed within 1 month prior to scheduled day 1 study visit): * nephrotic-range proteinuria, defined as \>3.0 g/24 hours * upc (ratio of protein to creatinine in random spot urine sample), defined as \>3.0 * hypoalbuminemia, defined as \<3.0 g/dl control subjects * 18-79 years of age * normal albumin levels (\>3.0 mg/dl) * no history of chronic kidney disease exclusion criteria: * age \<18 or ≥80 years old * serum creatinine (scr) ≥1.5 and weight ≤60kg (these subjects would receive a reduced apixaban dose, per drug labeling) * weight \>120 kg or body mass index (bmi) ≥40 kg/m\^2 * estimated glomerular filtration rate (egfr) \<15 ml/min or on dialysis * signs and symptoms of increased risk of bleeding, including but not limited to: frequent nosebleeds, unexplained or worsening bruising, blood in urine or stool * unwilling to avoid engaging in activities that may increase the risk of bleeding through body injury or bruising, during the study period (e.g., contact sports) * baseline prolonged inr, defined as inr \>1.4 * if inr is elevated, but pt and aptt are below the upper limit of normal (13.3 sec and 37.7 sec, respectively), then the subject may be cleared to receive the study drug at the discretion of one of the study physicians. * platelets \<100 x 109/l * history of stroke, or a history of gastrointestinal or intracranial bleeds * use of any prescription medications, over-the-counter (otc) medications, or herbal products that are strong inhibitors or inducers of cyp3a4 and/or p-gp within 14 days prior to study day 1 or anticipated need for such drugs during the study. examples included: * strong inducers of cyp3a4 (e.g., rifampin, carbamazepine, phenytoin, st. john's wort, etc.) * strong inhibitors of cyp3a4 (e.g., ketoconazole, ritonavir, clarithromycin, etc.) * antiplatelet and/or anticoagulant agents: heparin, aspirin\*\* (see below), clopidogrel, prasugrel, non-steroidal anti-inflammatory drugs (nsaids), warfarin, rivaroxaban, dabigatran, edoxaban * pregnancy or breastfeeding * liver disease with impaired synthetic function (inr \>1.4, total bilirubin \>1.2) * evidence of acute kidney disease by the kdigo criteria (\>1.5 x baseline scr, or \>0.3 mg/dl increase in scr, over past 48 hours * unwillingness to forgo drinking alcohol during the study period due to heightened bleeding risk.
reduction of corneal astigmatism with toric intraocular lens implantation in congenital cataract

Conditions: Congenital Cataract

Summary: this study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(iol) in congenital cataract.

this retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital cataract who had an astigmatism of 2.5 to 4.0 d prior to cataract surgery. review of preoperative and postoperative visual acuity (ucva), refraction, toric axis was performed.

Eligibility criteria:
inclusion criteria: * children less than 14 years * congenital cataract at initial visit * symmetrical keratometric astigmatism more than 2.0 d exclusion criteria: * microcornea (horizontal corneal diameter less than 9.5mm-asper that particular age) * corneal pathology * keratoconus * irregular astigmatism
comparing two ways to manage head and neck lymphedema

Conditions: Head and Neck Cancer; Lymphedema

Summary: this randomized clinical trial aims to compare clinic-based cdt and home-based (a hybrid model) cdt on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in hnc survivors with lymphedema.

primary aim: to compare the effects of clinic-based and home-based (a hybrid model) cdt on changes in the severity of lymphedema. secondary aim: to compare the effects of clinic-based and home-based (a hybrid model) cdt on symptom burden and functional status. exploratory aim: to compare the healthcare utilization between patients receiving clinic-based versus home-based (a hybrid model) cdt

Eligibility criteria:
inclusion criteria: * \>18 years of age * \<=24 months post-hnc treatment * diagnosis of head and neck lymphedema and referral by their oncology providers * able to perform self-manual lymphatic drainage * having an electronic device (a computer, tablet, ipad, laptop, or smartphone) and internet access at home exclusion criteria: * active infection in soft tissues in the head and neck region * history of moderate or severe carotid artery occlusion * significantly severe lymphedema (e.g., severe periorbital swelling) * conditions impacting the safe delivery of lymphedema therapy
impact of madecassoside and 5 % panthenol cream in post photodynamic therapy for actinic keratosis

Conditions: Actinic Keratoses

Summary: premalignant aks are highly frequent in the light-skinned populations with an increasing incidence. pdt is considered a well-establish treatment for these lesions, and therefore it is essential to achieve an optimal and effective treatment as possible. the present study proposes a new post-treatment modality with application of an anti-inflammatory moisturizer cicaplast baume b5+ to the treated areas that may improve the overall patient satisfaction and minimize the local skin reactions. treatment regime consists of two daily applications of cicaplast baume b5+ for 14 days, and this regime is not associated with increased risk of systemic aes or serious events.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. \> 18 years of age or older at baseline 3. fitzpatrick skin type i-iii 4. clinical aks in two symmetrical areas on the face or on the chest, presented with at least ten aks 5. female subjects of childbearing potential must be confirmed not pregnant by negative pregnancy test prior to study inclusion and must use a safe contraceptive method during the study exclusion criteria: 1. previous exposure to pdt, energy-based devices, or ak treatment on the study areas within 3 months 2. pregnant or lactating women 3. patients with known allergy to mal or any ingredients in cicaplast, baume b5+ 4. concomitant treatment with immunosuppressant drugs 5. infiltrating tumors in the treatment areas 6. known porphyria 7. other skin diseases present in the test area at baseline 8. non-eligibility at the discretion of the investigator (e.g. non-compliance, unavailability or other reasons the subject is not believed to be able to comply with the clinical trial protocol)
protein s and myocardial infarction

Conditions: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction

Summary: to test the hypothesis that low levels of free protein s, a natural anticoagulant protein in plasma, were associated with an increased incidence of myocardial infarction in middle aged men and women.

background: free protein s (that portion of plasma protein s which is not in complex with c4b binding protein) is a cofactor for the anticoagulant effect of activated protein c. patients presenting with acute myocardial infarction have significantly reduced levels of free protein s. if the major hypothesis proved correct, patients at high risk of myocardial infarction could be identified and could be targeted for future studies to examine specific intervention therapy. design narrative: the blinded and prospective study began in 1992, although the grant was first awarded in 1983. the goal was to determine if low levels of free protein s were associated with an increased incidence of myocardial infarction. plasma samples were obtained yearly from 2,224 men aged 50-59 years who were participants in the second northwick park heart study sponsored by the british medical research council epidemiology and medical care unit. clinical endpoints for the study were documented fatal and non-fatal myocardial infarction. to prevent potential bias, this laboratory was blinded to the clinical endpoints until all samples had been collected and all causes of death in the study population had been adjudicated. ln addition to free protein s, total protein s and c4b binding protein were measured. the study design permitted the assessment of the temporal relationship between the development of low free protein s levels and the occurrence of myocardial infarction and the presence or absence of a biologic gradient (dose-response) between levels of free protein s and the frequency of infarction. these two analyses were important in assessing whether the observed association was causal or whether low protein s occured as a consequence of myocardial infarction. three levels of free protein s had been defined prior to initiating the study to determine if the frequency of myocardial infarction did follow a biologic gradient. the measurement of other potential markers of risk by other laboratories, such as prothrombin fragment fl+2 and factor x activation peptide, permitted a comprehensive evaluation of hemostatic risk factors in myocardial infarction. a second study was conducted in women to examine protein s as a risk factor for myocardial infarction. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
transcatheter aortic valve implantation in western norway

Conditions: Aortic Stenosis; Hypertension

Summary: a prospective study of 600 patients with severe aortic stenosis (as) and symptoms who underwent tavi at the haukeland university hospital, bergen, norway.

a prospective study of 600 patients with severe aortic stenosis (as) and symptoms who underwent tavi at the haukeland university hospital, bergen, norway between january 2012 and july 2019. demographics, clinical data including cardiovascular risk factors, arterial and echocardiographic parameters were prospectively collected. the data on all-cause mortality will be collected. echocardiograms (immediate before tavi, at discharge after tavi and at 6-12 months follow-up) will be analyzed. the main scientific objectives are: to assess survival benefits of tavi according to baseline risk profile. to determine the echocardiographic predictors of left ventricular mass regression and left ventricular function recovery. to evaluate global lv load (zva=valvular-arterial impedance) following tavi. to assess the impact of various types of blood pressure responses immediately after tavi on clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. hemodynamically severe aortic stenosis and symptoms 2. a decision of tavi by heart team 3. patients undergoing tavi (transcatheter aortic valve implantation) 4. life expectancy \> 1-2 years exclusion criteria: 1. sever frailty 2. severly reduced cognitive function 3. multiple comorbid conditions 4. technically not suited for tavi

Keywords: aortic stenosis echocardiography transcutaneous aortic valve implantation left ventricular dysfunction left ventricular hypertrophy mortality
evaluation of transforaminal epidural steroid injection in radicular low back pain according to msu classification

Conditions: Radiculopathy Lumbar; Low Back Pain; Disc Herniation; Injections, Epidural

Summary: low back pain is a common disease in all ages and it effects seriously quality of life. medical treatment,interventional methods and surgery are the treatment options. transforaminal epidural steroid injections (tfsi) is one of the interventional method for radiculopathy with low back pain. michigan state university(msu) classification is a mri based disc herniation classification. it helps to classified disc herniation in types, places and sizes. the aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone tfsi according to msu classification.


Eligibility criteria:
inclusion criteria: * between the ages of 18-65 * after outpatient evaluation, a decision was made to perform transforaminal steroid injection, * low back pain of more than 6 on a numeric rating scale (nrs) * radiculopathy for more than 4 weeks and less than one year and straight leg raising \<45 * disc herniation at the l4-l5 or l5-s1 level on mri * failure to respond to medical treatment for at least one month exclusion criteria: * neurological deficit, * bleeding problems, * localized infection, * spinal pathologies (such as tumors), * fractures, * severe stenosis, * uncontrolled diabetes, * pregnancy, * red flag symptoms (such as motor and/or sphincter dysfunction) * patient reluctance, * computed tomography (ct) and mri findings in favor of sequestrated fragments from herniated disc, * sphincteric disorders, * previous spine surgeries
the peripheral intravenous catheterisation

Conditions: Pain

Summary: pain management during medical care is considered to be a basic human right and also affects patient satisfaction. in addition, effective management of acute pain contributes to improved patient outcomes. patient satisfaction is a subjective state that indicates whether the healthcare provided has met the patient's needs and expectations. many nurse theorists, including florence nightingale, have expressed the importance of providing comfort and relief for patients. in fact, comfort has been a crucial aspect of patient care since nightingale's days, and has been considered an indispensable constituent of integrated nursing care. studies to improve comfort may contribute to improving individuals' health outcomes, enforcing health-improvement behaviors, and improving healthcare quality as well as satisfaction and contentment of the individual and the nurse in the process of administering healthcare. in the literature, although the efficacy of various pharmacological methods for reducing pain associated with the insertion of pic has been evaluated in adults, studies on nonpharmacological methods are limited. however, most of the studies were performed in healthy adults. easy, inexpensive, and fast methods with unlikely side effects are needed to control pain and distress due to the pic insertion in adults. therefore, this study was performed to evaluate the effectiveness of distraction methods.


Eligibility criteria:
inclusion criteria: * patients who ranked 4 (less urgent) and 5 (non-urgent) based on canadian emergency department triage * patients who had no visual, audial, or lingual disabilities, and no mental disorder. exclusion criteria: * patients who planned to have pic insertion and were suitable for having a peripheral intravenous catheter insertion at their antecubital location using 20 gauge (pink) cannula were eligible. * patients who refused to participate in the study, * patients who were not eligible for a 20 g peripheral intravenous catheter insertion, * patients who could not be inserted a peripheral intravenous catheter at the first time
post-activation performance enhancement in single and multi-joint exercises with bfr and ems in male volleyball players

Conditions: Volleyball Players; Post Activation Potentiation; Muscle Strength

Summary: investigators used a randomized controlled crossover design to compare the effect of blood flow restriction (bfr) and electrical muscle stimulation (ems) protocols on post-activation performance enhancement (pape) in multi-joint versus single-joint exercises. participants took part in six test sessions 72 hours apart. in the bfr group, 50% of the arterial occlusion pressure (aop) was used. in the ems group, a 75 hz current was applied. in the low resistance exercise group, only exercise was performed without any condition. bench press (multi-joint) and triceps push-down (single-joint) exercises were used in the conditions.

participants took part in six test sessions 72 hours apart. all tests were performed between 2 and 4 pm to reduce the influence of circadian rhythms or fatigue on performance. anthropometric measurements, 1 rm test, and grip strength and serving speed tests were determined before the practice session on the first day as a control condition. on the other six experimental days, players were randomly assigned to protocols (bfr, ems, and low-load) using software (http://www.randomizer.org). in the bfr group, 50% of the arterial occlusion pressure (aop) was used. in the ems group, a 75 hz current was applied. in the low resistance exercise group, only exercise was performed without any condition. bench press (multi-joint) and triceps push-down (single-joint) exercises were used in the conditions. in all protocols, participants performed a standardized warm-up protocol consisting of a 5-minute run at 9 km/h on a treadmill and a general warm-up consisting of 3 minutes of whole-body light stretching exercises. following the warm-up and pre-exercise protocols, grip strength and service speed tests were performed with rest periods.

Eligibility criteria:
inclusion criteria: * being healthy * male volleyball athletes * willing to maintain the intervention for all sessions exclusion criteria: * being under 18 years old * having a chronic disease * contraindication for electromyostimulation (ems) * contraindication for blood flow restriction (bfr) * contraindications for exercise

Keywords: post-activation performance blood flow restriction exercise volleyball hand grip strength service speed
efficacy and safety of aclidinium bromide 400 µg compared to placebo and to tiotropium bromide in patients with stable moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: * adult male and female patients aged ≥40 with stable moderate to severe copd (gold guidelines). * post-salbutamol (fev1) \< 80% and ≥ 30% of predicted normal value and post-salbutamol fev1/fvc \< 70%. * current or ex-smokers of 10 ≥pack-years. exclusion criteria: * patients with no history or current diagnosis of asthma. * no evidence of an exacerbation within 6 weeks prior to the screening visit. * no evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities. * no contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Keywords: copd antimuscarinic
stopping cardiovascular treatments and mortality in a micu

Conditions: Critical Care; Medication; Cardiovascular Diseases; Outcome, Fatal

Summary: cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. however, following icu admission, such treatments are frequently interrupted and/or modified. the question of the study is to investigate wether such treatment interruption might be responsible for prognosis modifications.

cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. however, following icu admission, such treatments are frequently interrupted and/or modified. few studies have investigated the outcome impact of medications interruption and/or modifications following hospital admission. we did consider that it might be interesting to study whether treatment continuation, interruption, and/or re-introduction following icu admission may modify patients' outcome either in the icu or following hospital discharge (at 3,6 and 12 months).

Eligibility criteria:
inclusion criteria: * all patients with cardiovascular treatment prior to icu admission exclusion criteria: * data unavailability * consent withdrawal following information
study evaluating dvs-233 sr in elderly outpatients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to evaluate the overall safety and tolerability profile of two dose levels of dvs-233 sr during 6 months of open-label treatment in elderly outpatients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * outpatients men and women aged 65 years or older. * mini mental state examination score of 24 or above. * subjects must have a primary diagnosis of mdd based on the criteria in the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv), single or recurrent episode, without psychotic features, on study day 1, if depressive symptoms for at least 30 days prior to screening visit and minimum screening and study day -1 (baseline) scores of 16 on the hamilton psychiatric rating scale for depression (ham-d17). exclusion criteria: * significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention. * current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified mini international neuropsychiatric interview (mini). current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified mini and considered by the investigator to be primary, causing a higher degree of distress or impairment than mdd. presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic). presence of dementia. * depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder. other exclusion applies.

Keywords: depression