Kornimate/medical-research-clean huggingface dataset:
clinical impact of the ibox as an early intervention tool

Conditions: Kidney Diseases; Kidney Disease, Chronic; Kidney Transplant Rejection; Kidney Transplant; Complications; Kidney Failure; Kidney Failure, Chronic; Kidney Dysfunction

Summary: international, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device predigraft, by showing that the use of predigraft could improve patient's follow-up.

the study aims to demonstrate improvement of the prevalence of biopsies leading to therapeutic change in the predigraft group compared to the standard of care group in kidney transplanted patients. it is hypothesized that using predigraft as a monitoring tool will help the physician detect earlier and more often abnormalities with the patient allograft. this should lead to an increased number of biopsies leading to therapeutic change. these biopsies should be performed earlier than without the ibox monitoring tool. this would improve long-term allograft function, kidney allograft and patient survival.

Eligibility criteria:
inclusion criteria: * men and women, age ≥ 18 years old at the time of consent. * patients receiving a living or deceased donor kidney allograft. * patients transplanted at least 3 months before inclusion. * patients who signed the informed consent form and are willing to comply with study procedures. exclusion criteria: * combined transplant (i.e. heart-kidney, liver-kidney). * patients who are unable or unwilling to comply with study procedures. * vulnerable patients (minors, protected adults, legally detained). * patients participating in other interventional studies.

Keywords: chronic kidney disease kidney transplant ibox predigraft kidney allograft prediction rejection allograft survival
methadone for postoperative pain

Conditions: Pain, Postoperative

Summary: the aim of this study is to compare the efficacy of methadone versus morphine in dealing with postoperative pain, in laparoscopic cholecystectomy under total intravenous anesthesia (tiva); efficacy is defined in terms of the difference of milligrams in morphine used as rescue analgesia postoperatively. our hypothesis is that methadone is more effective than morphine for postoperative pain treatment.

patients undergo laparoscopic cholecystectomy at almirante nef naval hospital will be recruited, between march and july 2013. the sample size was calculated to obtain an average difference of 4 mg of morphine (de 1.5) to 3 mg of morphine (de 1.5), with a power of 80% and a significance level of 0.05. this came down to 36 randomized patients into each group, so 86 patients will be recruited considering a 15% loss to follow up. before signing an informed consent, we will explain to them how to classify pain intensity numerical rating scale (nrs) and this will be evaluated periodically during the first 24 hours after surgery. general anesthesia will be based on remifentanil and propofol, titrated to achieve bispectral index (bis) between 40 and 60. patients will be randomized into methadone group (me) and morphine group (mo), they will receive 0.08 mg / kg bolus of methadone or 0.08 mg / kg bolus of morphine as applicable at the time of beginning surgery. postoperative analgesia will be standard for both groups. patient´s demographic data will be filed as well as surgical timings. all patients will remain in the anesthetic recovery room for the first two hours , to get a record taken of vital signs and measurement of nrs at 5, 15, 30, 60 and 120 minutes. if nrs is greater than or equal to 4, 1 mg of morphine ev will be used as analgesic rescue. in room measuring nrs continue hospitalized at 4, 8, 12 and 24 hours postoperatively and were used as rescue analgesia if ketorolac 30mg ev nrs is greater than or equal to 4. the amount of morphine is registered and ketorolac rescue of both groups as well as pain assessment scores. the occurrence of adverse effects such as nausea, vomiting, pruritus, urinary retention and respiratory depression is also recorded in both groups, to be compared later as a secondary objective.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic cholecystectomy in the almirante nef naval hospital * patients asa 1 or 2 exclusion criteria: * patients with renal insufficiency (creatinine\> 2.0 mg / dl) * patients with a history of liver failure * patients with bmi\> 35 kg/m2 * patients with hypersensitivity to the drugs in question * history of chronic use of opioids * need for conversion to open surgery

Keywords: pain, postoperative analgesics, opioid methadone morphine
retrospective study of the uni-graft® k dv patch in the clinical routine

Conditions: Femoral Artery Stenosis; Iliac Artery Stenosis; Carotid Artery Stenosis

Summary: uni-graft® k dv patch is marketed in europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020. previous studies focused on the clinical performance of different patch materials used for patch angioplasty in different indications, without specifying the product or manufacturer. thus, it is not surprising that there is a limited amount of published literature available describing the use of the uni-graft® k dv patch in the clinical routine. therefore, the aim of the present non-interventional study (nis) is to close this gap by collecting and evaluating existing safety and performance data documented in the clinical routine especially during the application of the uni-graft® k dv patch.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * written informed consent * treated with uni-graft® k dv patch for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery exclusion criteria: * use of the uni-graft® k dv patch if allergies to components of the patch are known * use of the uni-graft® k dv patch in case of a known hypersensitive reaction to the patch and / or its components (e.g. polyethylene terephthalate). * no use of uni-graft® k dv patch * use of uni-graft® k dv patch outside the intended use of the product at the date of application

Keywords: reconstructive interventions vascular patch polyethylene terephthalate
double-dose rabeprazole accelerates and sustains the control of symptoms in patients with nerd

Conditions: Gastroesophageal Reflux Disease

Summary: to the best of our knowledge, there has been no randomized controlled trial to compare double dose ppi therapy with standard one dose ppi therapy for nerd patients. thus, we hypothesize that a double dose ppi would accelerate and sustain the control of symptom in nerd patients.

in asian, the majority of gerd cases are cases of nonerosive reflux esophagitis(nerd). nerd is a difficult -to-treat acid reflux condition even with ppi compared to reflux esophagitis(re). in addition, the quality of life of nerd patients is quite low, nerd patients need quicker and more effective treatment options. at present, ppi-based step-down treatment is recommended for gerd patients. doubling th ppi dose has become a commonly practiced therapeutic strategy in patients with gerd who failed ppi once daily. in patients with symptomatic gerd who failed the one dose ppi can increase the rate of overall symptom improvement by 22-26%. there are various mechanisms for standard dose ppi failure in gerd patients. esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients. patients with the sensitive esophagus (normal endoscopy and ph test but positive symptom index) were more likely to respond to ppi twice a day. it is thus of clinical interest to determine whether an increased dosage of ppi can achieve rapidly the control of symptoms for patient with nerd patients.

Eligibility criteria:
inclusion criteria: * heartburn and/or reflux at least twice weekly in the absence of visible esophageal mucosal breaks at endoscopy exclusion criteria: * pregnancy * lactation * hx of gastric surgery * hx of gastric cancer or peptic ulcer * major medical problems (including chf, renal failure, copd, asthma, liver cirrhosis) * severe systemic illness * hx of malignancy, allergy hx to rabeprazole * patients who had taken antibiotics * antisecretory agents including h2-blocker * ppi within 4 weeks before endoscopy * current usage of steroids, nsaids, aspirin, anticoagulant medication

Keywords: gastroesophageal reflux disease proton pump inhibitor standard dose double dose
effect of dietary sodium intake on vascular endothelium

Conditions: Postural Tachycardia Syndrome (POTS)

Summary: the investigators will test the hypothesis that markers of vascular endothelial dysfunction will be exaggerated acutely with an extreme high sodium diet compared to an extreme low-sodium diet. the investigators will compare patients with postural orthostatic tachycardia (pots) to healthy control subjects.

the study will involve a crossover design in which each subject will be assessed (as below) while on a very low-sodium (10 meq/day) diet compared with a very high-sodium diet. these acute dietary interventions will be part of the parent study ("dietary salt in postural tachcyardia syndrome" funded by r01 hl102387) for 4-5 days at the time of the study. dietary success will be assessed using a 24h urine for sodium and creatinine as a part of the parent study. blood will be drawn and collected in a fasting state for future assay and analysis of the following tests: * glucose, insulin (glucose impairment, insulin resistance) * fasting lipid profile * c-reactive protein (hscrp) (inflammatory state) * inflammatory cytokines (inflammatory state) * aliquots (future analysis) pulsitile arterial tonometry (pat) protocol calf blood flow in reactive hyperemia (cbf-rh) - venous occlusion plethysmography evaluation of forearm-mediated dilation

Eligibility criteria:
inclusion criteria: * subjects will be enrolled in the parent study "dietary salt in postural tachcyardia syndrome" funded by r01 hl102387 postural tachycardia syndrome * diagnosed with postural tachycardia syndrome by the vanderbilt autonomic dysfunction center * subjects will be enrolled in the parent study "dietary salt in postural tachcyardia syndrome" funded by r01 hl102387 * postural tachycardia syndrome * diagnosed with postural tachycardia syndrome by the vanderbilt autonomic dysfunction center * increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes) * chronic symptoms consistent with pots that are worse when upright and get better with recumbence control subjects * healthy, non-obese, non-smokers without orthostatic tachycardia * selected to match profiles of pots patients (gender, age) * not using vasoactive medication * age between 18-60 years * male and female subjects are eligible. * able and willing to provide informed consent exclusion criteria: * overt cause for postural tachycardia (such as acute dehydration) * inability to give, or withdrawal of, informed consent * pregnant * other factors which in the investigator's opinion would prevent the subject from completing the protocol.

Keywords: pots endothelial function high salt vs low salt diet pat protocol calf blood flow forearm mediated dilation
comparison of volar locking plate fixation alone and volar locking plate fixation plus calcium phosphate bone cement augmentation for distal radius fractures patients aged more than 65

Conditions: Distal Radius Fracture

Summary: the incidence of distal radius fracture (drf) increases with age, and thus, because of improving life expectancies, these fractures are set to become more common. fractures of the distal radial metaphysis are known to be strongly related to osteoporosis, and as a result, the management of distal radius fractures in elderly patients is beset with difficulties. recently, more aggressive fracture fixation in the elderly has become a topic of interest, in the hope of increasing the rate of recovery to preserve the ability to live independently. many elderly patients remain active well into their eighth and ninth decades, for example, some pursue activities, such as, golf and tennis, on a daily basis. the introduction of volar locking plating system has increased this interest. this system, which uses a fixed angle principle, has been proposed to be effective at maintaining good anatomic reduction, even in the elderly. however, there is a still concern about remaining metaphyseal defect after reduction of the osteoporotic drf. injectable calcium phosphate bone cement (cpc) has been used to augment the remaining metaphyseal defect after fracture reduction including drf, specially in osteoporotic old patients. the purpose of this randomized, prospective study was to investigate that additional cpc augmentation has any benefit over volar locking plate fixation in unstable drf patient who is older than 65. the null hypothesis is that there is no difference of wrist functional outcomes, radiographic outcomes, and complications between treatment of volar locking plate alone and calcium phosphate bone cement as well as volar locking plate in unstable drf patient who is older than 65.


Eligibility criteria:
inclusion criteria: * all patients older than 65 years old with an acute drf were considered for inclusion for this study. inclusion criterion of this study was an unacceptable closed reduction after one attempt of closed reduction. the criteria of unacceptable closed reduction included dorsal angulation of \> 100, volar angulation of \> 200, an articular gap or step off of \>2 mm, radial inclination of \ 5mm. exclusion criteria: * a preexisting severe illness * an ipsilateral upper extremity injury * a previous wrist injury * surgical delay of more than 2 weeks * a concomitant ulnar neck fracture.
a new tool for automatic ovarian follicle count and it abilities to evaluate ovarian reserve

Conditions: Infertility

Summary: the ultrasound unit in meir medical center developed new software to automated ovarian follicle count on the basis of 3d us. the investigators intent to evaluate this software at two steps: * to compared the abilities of the software to physician follicle count. * to evaluate with the software the antral follicle count, as expression to ovarian reserve at 3 different time of the month. the investigators believe that the software measurement of the small follicle can be better than the common antral follicle count that is use today, and by this accurate evaluation of the small follicle the investigators can evaluate the ovarian reserve at any time of the mount, and not only at the early follicular phase that use today.

antral follicle count (afc) is one of the methods to evaluate ovarian reserve. but this method is not that straightforward with a lot of inter and intra observe variation. in attempt to overcome this problems we going the verified a new software for automated afc. at the first step we will compare the human count and the software count of the afc in 150 exams of ovaries at 3d us. at the second step we will use the software to evaluate ovarian reserve at 50 women before fertility treatment. this woman will be questioned about epidemiologic data (age, ethnicity, medical history) and evaluate at the early follicular phase with blood test for follicle stimulating hormone, luteinizing hormone , e2, anti-mullerian hormone , prolactin, thyroid-stimulating hormone, testosterone, progesterone, 17-hydroxyprogesterone, dehydroepiandrosterone-sulphate. the evaluation of the afc by us will be at early follicular phase, late follicular phase and mid luteal phase

Eligibility criteria:
inclusion criteria: * woman under age 40 years all * woman at evaluation before beginning of fertility treatment * woman with regular menstrual cycle exclusion criteria: * woman who treat with ovulation induction

Keywords: antral follicle count automated antral follicle count ovarian reserve
epidemiology of acute respiratory distress syndrome in chinese icus

Conditions: Acute Respiratory Distress Syndrome

Summary: the acute respiratory distress syndrome(ards)has a high morbidity and mortality in patients admitted to intensive care units(icus). it represents a significant public health issue. no large nationwide, multicenters study of ards has been conducted in china. the purposes of this study are to analyse: 1)the incidence and outcomes of ards in icu; 2) factors associated the mortality ; and 3) risk factors for development of ards .

all patients admitted to the participating icus during a 6-month period(from january 1, 2015 to july 1,2015 ) will be screened at icu admission and daily for the occurrence of ards ( aecc criteria) for a maximum of 28 days after icu admission. data collection: 1. for all patients, demographic characteristics, admission category, the patient source intervention during icu , apacheii , sofa score and discharge information will be collected 2. for patients with ards, data about abg , parameters of mv, hemodynamic on day0 to day7 and last day of mv will be collected. 3. for patients without ards at icu admission, data about risk factor for ards ,such as lips score, parameters of mv , and fluid balance on icu day0 to day7 will be collected.

Eligibility criteria:
inclusion criteria: all patients age \>18 yrs admitted to 24 participating icus exclusion criteria: no patients should be excluded (regardless of age, underlying disease, life expectancy, etc).
balance effects of morton´s extension in flat foot

Conditions: Healthy Subjects

Summary: the aim of this study is to simulate the orthopedic treatment called morton's extension on flat foot patients to check balance effects in standing position.

the objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on flat foot patients to verify the balance with stabilometry study.

Eligibility criteria:
inclusion criteria: * women and men aged 18 to 30 with flexible flat feet. exclusion criteria: * participants who have had any previous limb surgery, and/or previous lower limb trauma within the last year * uncorrected hearing or visual impairment. * lumbar pathology with radicular involvement. * pregnancy. * healthy participants performing strenuous exercise. * diagnosed active or inactive rheumatic or inflammatory disease. * participants consuming alcohol within 24 hours prior to recording or stimulants 6 hours prior to testing (e.g. caffeine). * participants who have a history of injury with residual lower extremity symptoms within the past year. * participants with evidence of a leg length discrepancy (difference in distance from the anterior superior iliac spine to the superior iliac spine at the surface of the most prominent aspect of the medial malleolus) of more than 1 cm 19 * having at least 15 degrees of ankle dorsiflexion. * participants with evidence of balance deficit, as determined through oral questioning about falls and by use of the balance evaluation systems test (bestest). * participants with neurological pathology with lower limb deformities, sensory-motor disturbances, neuromuscular pathology, or neurovascular disease.

Keywords: balance foot orthopedics
impact of work environment absent of natural light on vitamin d levels

Conditions: Vitamin D Deficiency

Summary: three types of workers exposed to different levels of natural sunlight will be tested for vitamin d blood level, pth, ca, p, albumin and alkaline phosphatase. in addition, each tested worker will be asked to fill a questionnaire for demographic, medical and personal habit information.


Eligibility criteria:
inclusion criteria: * people employed in their current work place at least 6 months, exclusion criteria: * people who consume food additives containing vitamin d. * people who have a chronic illness which harms the vitamin d absorption, such as celiac, chronic pancreatitis, cystic fibrosis and ibs. * people who have a chronic illness which harms vitamin d metabolism, such as chronic hepatitis, kidney insufficiency and nephrotic syndrome. * pregnant women. * people who require prescribed medicine like steroids, anti-convulsion, and hiv treatments.

Keywords: vitamin d sunlight deficiency
lllt of trophic ulcers of lower extremities and chronic venous insufficiency

Conditions: Trophic Ulcers; Chronic Venous Insufficiency

Summary: the aim of this study was to evaluate comparatively the efficiency of traditional treatment methods in patients with chronic venous diseases of c6 class, and a new combined low level laser therapy (lllt) by lasmik device. the results of outpatient examination and treatment of patients with venous trophic ulcers, observed in the city polyclinic of "tula municipal clinical hospital №2" were analyzed.

during a longitudinal study, a group of patients was followed up in the period of complete or partial recovery. international classification of lower extremity chronic venous disorders сеар was used as a clinical classification of chronic venous insufficiency (cvi). depending on the applied treatment method, patients were divided into 2 groups: 1. (n=34) conventional treatment 2. (n=34) conventional treatment + combined lllt, including external exposure with 635nm wavelength + intravenous laser blood illumination (ilbi) with 365-405nm (uv-spectrum) and 520-525nm (green spectrum) wavelength alternately, according to the special scheme

Eligibility criteria:
inclusion criteria: * over 18 years of age, * cvi stage 6 (s6) in compliance with сеар exclusion criteria: * hemorrhagic syndrome, * neoplastic syndrome, * hyperthermic syndrome (fever, patient body temperature over 38°c), * syndrome of systemic (cardiac, vascular, respiratory, renal and hepatic) and multiple organ failure (general severe illness), * cachexic syndrome (severe general exhaustion), * epileptic syndrome, * hysterical syndrome, * convulsive syndrome

Keywords: trophic ulcer; low level laser therapy; chronic venous insufficiency
bone marrow aspirate concentrate (bmac) vs corticosteroid injection

Conditions: Osteoarthritis of the Knee

Summary: prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of bmac on patient-reported outcomes (pros) in patients with primary knee osteoarthritis.

the purpose of this study is to examine the influence of bmac on patient-reported outcomes (pros) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up. all patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. this study will aim to recruit and enroll a total of 100 patients (50 per group). treatment arms include bmac injections (arm1) and corticosteroid injections (arm 2). patients in the corticosteroid injection group (arm 2) will receive a sham incision. follow-up will be up to six months (12-months if crossover (arm 3)).

Eligibility criteria:
inclusion criteria: * patients between the ages of 18-70 * long standing knee pain from osteoarthritis (kl grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks * 7-day average pain score of at least 4 on vas scale exclusion criteria: * systemic diseases (diabetes, malignancies, infections, etc.) * post-traumatic arthritis * patient had intra-articular injection on affected knee in last three months