Kornimate/medical-research-clean huggingface dataset:
super-dialysis-study: supera stent interventions in juxta-anastomotic (re)stenosis

Conditions: Stenosis of Arteriovenous Dialysis Fistula

Summary: the purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with supera stent by improving hemodynamic situation through obtuse shaping of the anastomosis.

up to 50 patients undergoing percutaneous intervention due to juxta-anastomotic (re-)stenosis of the av fistulas will be enrolled in this single-arm, prospective, multi-center ce marked study (iit). hemodialysis patients with failing radial-cephalic arteriovenous fistula (avf) will receive treatment with the supera stent and will be followed-up at 1, 3, 6 and 12 months after the procedure.

Eligibility criteria:
inclusion criteria: 1. patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy \> 12 months. 2. hemodialysis patients undergoing endovascular angioplasty due to a clinically symptomatic stenosis (de novo or restenosis) of the juxta-anastomotic radiocephalic avf with significant stenosis (lumen diameter \< 2.7mm) 3. patients with at least one previous endovascular intervention to restore avf function 4. the target lesion consists of one or more lesions with a target lesion length of less than or equal to 80 mm in the juxta-anastomotic segment of the radiocephalic avf 5. the target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation) 6. if there are other non-target lesions, then non-target lesions must be successfully cured with a balloon before treating the target lesion exclusion criteria: 1. patients with avf stenosis observed and estimated as nonsignificant (lumen diameter \> 2.7mm) or a vessel \ 7.5 mm in diameter by visual estimation 2. patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated. 3. patients with any contraindications as mentioned in the instructions for use (ifu) of the study device. 4. patients that are currently participating in another clinical trial involving any investigational drug or device that may potentially confound the results of the study, or that would limit the patient's compliance with the follow-up requirements of the study. 5. prior enrolment in this trial 6. women who are pregnant or lactating 7. patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study. 8. patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -

Keywords: juxta-anastomotic stenose of arteriovenous fistula
comparison of high-flow hemodialysis catheters placed from the left internal jugular vein(r12-022)

Conditions: End Stage Renal Disease on Dialysis (Diagnosis)

Summary: the patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (tdc) for hemodialysis access. the primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. this study will review and compare the complication rate and function of the three catheter designs.

the patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (tdc) for hemodialysis access. the primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. participants will be randomized to receive a split-tip, step-tip or symmetric tip catheter in a 1:1:1 ratio. all participants will be followed per their referring physician's standard of care. information regarding any patient complications will be obtained from dr. allon's dialysis patient database (vascular access in hemodialysis patients, irb # x980813005). this study will review and compare the complication rate and function of the three catheter designs. there are no studies to our knowledge that compared catheter designs placed specifically via the left internal jugular vein. the investigators hypothesize that because the left internal jugular vein is anatomically more complex than the right one, tunneled dialysis catheters with split-tip design may perform sub-optimally, compared to step-tip and symmetric tip designs, when placed via the left internal jugular vein. if this hypothesis is true, the results of the study may influence future clinical practice and reduce the rates of replacement of catheters placed through the left internal jugular vein, resulting in better patient care and significant cost-savings.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide a written informed consent 2. 19 years or older 3. hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein. 4. patent left internal jugular vein. 5. able to read and understand english. exclusion criteria: 1. previous enrollment in this trial 2. patients unable or unwilling to provide informed consent 3. prisoners or incarcerated individuals 4. women who are pregnant 5. patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated
hepatitis e virus infection in oncological patients

Conditions: Hepatitis E Infection; Hepatitis; Epidemic; Oncologic Disorders

Summary: the goal of this clinical trial is to investigate the prevalence of hepatitis e infection in oncological patients in a rural region of germany. consequently, we conducted prospective testing of blood samples from patients with haematological malignancies for evidence of hev infection using two distinct anti-hev igg and igm enzyme-linked immunosorbent assays (elisas). serum was taken from each patient before treatment initiation and during treatment follow-up. primary endpoint was determination of hev seroprevalence. a healthy cohort was established alongside a cohort of patients who had been hospitalised due to a diagnosis of sars-cov-2 infection. in addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for hev infection.


Eligibility criteria:
inclusion criteria: * different hemato-oncological entities without age restriction exclusion criteria: * patients already receiving antineoplastic therapies * not given written consent
functional efficiency of self-sufficiency test

Conditions: Stroke/Brain Attack

Summary: the aim of this study is to design and validate new tool for evaluation of self-sufficiency in post-acute stroke patients. and further identify the factors influencing changes in the functional efficiency of self-sufficiency test (fest) in post-acute rehabilitation care.

the research included the development of the fest and its validation and the determination of the influence of selected factors on the change in functional self-sufficiency assessed by fest. the fest consists of nine assessed categories (mobility, stability, locomotion, dressing, hygiene, eating, household care, communication, finances), which allow a comprehensive assessment of the current status of post-acute stroke patients. patients meeting inclusion criteria are screened: 1/ diagnosed with ischemic or haemorrhagic stroke in the post-acute stage; 2/ aged ≥18 years; 3/ stable vital functions; 4/ rehabilitation load of 4 hours per day; 5/ maintained swallowing functions. exclusion criteria: 1/ tracheostomy; 2/ not recommended by psychotherapist due to cognitive deficit and unwillingness; 3/ severe sensory deficit (hearing, vision). patients are tested at the beginning (first measurement) and at the end of the post-acute rehabilitation care (second measurement) at the rehabilitation institute. the battery of tests included fest, bi, the action research arm test (arat). descriptive statistics will use for the basic statistical analysis. cronbach's alpha will use to assess reliability. the correlation between variables will calculate using spearman's and pearson's correlation coefficients and the biserial correlation coefficient. construct validity will assess using factor analysis. the difference between independent samples will verify by two-sample t-test. the effect of baseline demographic characteristics (age, gender), and ua functional status on the improvement in the level of self-sufficiency measured by fest will verify by multivariate linear regression. all tests will perform at a significance level of 0.05. ibm spss statistics for windows (version 23.0) statistical software will use for statistical processing (armonk, ny: ibm corp).

Eligibility criteria:
inclusion criteria: * diagnosed with ischemic or haemorrhagic stroke in the post-acute stage; aged ≥18 years; stable vital functions; rehabilitation load of 4 hours per day; maintained swallowing functions. exclusion criteria: * tracheostomy; not recommended by psychotherapist due to cognitive deficit and unwillingness; severe sensory deficit (hearing, vision).
far infrared irradiation for the management, control and treatment of frontotemporal dementia

Conditions: Pick Disease of the Brain

Summary: pick's disease, also known as pick disease,or ftd is a rare fronto-temporal neurodegenerative disease. this study will investigate the use of far infrared radiation for the control, management and treatment of pick's disease.

this disorder causes progressive destruction of nerve cells in the brain and causes tau proteins to accumulate into the "pick bodies" that are a defining characteristic of the disease. tau proteins are microtubule-associated proteins that are abundant in neurons in the central nervous system and are less common elsewhere. observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells. it is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have ftd.

Eligibility criteria:
inclusion criteria: * people with pick's disease exclusion criteria: * none

Keywords: brain atrophy, circumscribed lobar circumscribed lobar atrophy of the brain lobar atrophy (brain) pick disease pick's disease picks disease of brain
ultrasound measurement of rijv in patients between 0-2 years

Conditions: Anatomic Abnormality; Internal Jugular Vein; Neonates; Infants, Premature; Children

Summary: after obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. the patients for whom central venous catheterization is indicated will be included. the success rates and outcomes of catheterization will be recorded.


Eligibility criteria:
inclusion criteria: 0-2 years elective surgery requirement for central venous cannulation exclusion criteria: congenital cardiovascular anomalies emergency surgeries previous cannulation or any intervention on the neck

Keywords: central venous catheter, pediatrics, ultrasound imaging
kidney allograft dysfunction without reversible causes

Conditions: Kidney Graft Dysfunction

Summary: the purpose of this study is to learn the best way to prolong kidney life in patients exposed to calcineurin inhibitors, who already have evidence of damage possibly caused by the calcineurin inhibitor on kidney biopsy.


Eligibility criteria:
inclusion criteria: 1. serum creatinine increased greater than or equal to 25% over baseline with no acute or reversible cause clinically evident. although egfr is arguably better for estimating kidney allograft function than serum creatinine, pragmatics dictate the use of a change in serum creatinine in the initial selection of patients. these criteria are currently used by transplant coordinators for selection of patients for the kidney biopsy as a part of large on-going study at our center. 2. adequate (greater than or equal to 8 glomeruli) biopsy showing chronic allograft injury reported as mild/moderate can or cni toxicity based on the previously used banff 97 classification and no potentially reversible causes of graft dysfunction, e.g. acute rejection or treatable recurrent disease. patients with histological evidence of mild recurrent disease that does not appear to be severe enough to explain the deterioration in function, e.g. iga on immunofluorescence, or changes consistent with early diabetic nephropathy, will not be excluded. 3. receiving csa (trough level concentration 75-125 ng/ml) or tacrolimus(trough level concentration 6-12 ng/ml) plus mmf (or aza) with (or without) prednisone. 4. able to give informed consent. exclusion criteria: 1. urine total protein excretion \>500 mg/g creatinine. 2. egfr (estimated by mdrd) \<40 ml/min/1.73 m2 3. triglycerides \>400 mg/dl or total cholesterol \>300 mg/dl 4. allergy to macrolide antibiotic or rapamycin 5. women of child-bearing potential not using effective contraception 6. treated for acute rejection within the past 2 months 7. \<12 months after transplantation 8. potentially treatable cause(s) of allograft dysfunction, including acute rejection, dehydration, and congestive heart failure. 9. recurrent or de novo kidney disease that is histologically severe enough to be causing graft dysfunction 10. polyoma virus (bk) nephropathy, or serum positive for bk by polymerase chain reaction 11. a second, functioning organ transplant. 12. receiving sirolimus. 13. patients with any past or present malignancy (other than non-melanoma skin cancer)
wright foot & ankle post-market observational study

Conditions: Arthritis; Rheumatoid Arthritis; Fracture; Trauma Injury; Fusion of Joint

Summary: wright foot \& ankle post-market observational study, multi-year, multi-site, multi-device, post-market observational study, 10 sites, a minimum of 40 patients per device

the selected design is a global, multi-center, non-randomized, prospective observational study. the study subjects included are those treated with one or more approved or cleared wright medical products included in this study.

Eligibility criteria:
inclusion criteria: * willing and able to consent to participate (written, informed consent); * willing and able to attend/complete the requested follow-up visits; * considered for treatment with one or more approved or cleared wright medical products included in this study exclusion criteria: * subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated; * unable to consent to participate (written, informed consent); * unable to attend/complete the requested follow-up visits
optimized strategy for diabetic patients with critical limb ischemia(part ii) (dcli-ii)

Conditions: Vascular Diseases; Diabetes

Summary: the purpose of this trial is to find out the appropriate way to treat dm patients with critical limb ischemia. this trial includes two parts. part i focuses on the treatment of femoral arterial lesion and part ii focuses on the treatment of below-knee arterial lesion.

the trial includes two parts and here is part ii. this part is a multi-center, prospective, registration study which focuses on the treatment of below-knee arterial lesion. totally 130 patients will be entered into this part. they should suffer ischemic symptom with rutherford 3-6 for the occlusion of the below-knee arteries(anterior tibial、posterior tibial or peroneal artery). according to the lesion length, the patients will accept transluminal angioplasty or below-knee arterial bypass. they will be followed up for 3 years. study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.

Eligibility criteria:
inclusion criteria: * the patients volunteer to join the trial and sign the formal consent. * the patients are ≥55 year-old and ≤75 year-old. * the patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. * obvious stenosis or occlusion in below-knee popliteal artery * no obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured. * no surgical contraindications;no infection in operation region. * be diagnosed with dm for at least 1 year. exclusion criteria: * refuse random treatment. * previous operations on the target artery. * acute lower extremity arterial thrombosis. * serious major organ failure. * allergic to the contrast agent or has contrast nephropathy. * no clinical compliance or unfit to join the trial

Keywords: critical limb ischemia diabetes mellitus diabetes foot
aspire pilot: comparing self-collected hpv testing with visual inspection with acetic acid screening for cervical cancer

Conditions: Cervical Cancer

Summary: cervical cancer remains a public health burden, particularly in developing countries such as sub-saharan africa where the infrastructure for organized screening programs does not exist. as a result, other screening modalities (visual inspection with acetic acid) are the standard of care in such regions. it is now known, persistent infection with an oncogenic human papillomavirus (hpv) type is a necessary precursor of cervical cancer and evidence is showing hpv testing is a potential, safe and effective alternative to cytology testing (the pap smear). this study is evaluating the feasibility and acceptance of hpv self-collection vs. via in a cohort of women from kisenyi, uganda.


Eligibility criteria:
inclusion criteria: * aged 30-65yrs * living or working in community of kisenyi, uganda * access to mobile telephone * fluent in luganda, somali or english * competent to provide informed consent exclusion criteria: * known to be pregnant at study entry (self-reported) * complete hysterectomy * prior diagnosis or treatment of cervical dysplasia or cervical cancer

Keywords: cervical cancer cervical cancer screening low resource setting hpv self-collection via
the influence of high heeled shoes on the sagittal balance of the spine and whole body

Conditions: Back Pain

Summary: the purpose of this study is to investigate the influence of high heeled shoes on the sagittal balance of the spine and the whole body. the investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity. this would be an explanation for the increased prevalence of back pain in individuals frequently wearing high heels. in order to assess these changes, differences in the two following outcome parameters will be measured on a standing lateral eos-radiograph of the whole body - barefoot and with high heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .

female volunteers (age ≥ 21 years) that are not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels \> 3 cm) will be included. exclusion criteria are osseous metastases, missing written informed consent, cognitive inability to consent on their own, and pregnancy. based on own preliminary studies, a sample size of 19 (+3 to anticipate drop outs) patients is aimed for. after obtaining informed consent, the participants will be interviewed with special regard to their age, gender, height, weight, shoe size, past medical history, occupational and recreational activities, and duration and frequency of wearing high heeled shoes. a clinical examination of the spine and pelvis will be performed as well as a pregnancy urine test. standing lateral eos-radiographs (http://www.eos-imaging.com/) of the whole body will be taken - once barefoot and once with high heeled shoes (heel height 9 cm). all data acquisition is going to be performed during a single session, participants will not be followed up. the following parameters will be assessed on the radiographs: presence and number of (healed) fractures, osseous metastases, sagittal c7 plumb line, meatus plumb line, cervical lordosis, thoracic kyphosis, lumbar lordosis, spino- sacral angle as described by roussouly et al. (2006), pelvic incidence, pelvic tilt. for statistical analysis, all data will be collected in a statistic software file (spss. 21.0, spss inc, chicago, illinois). after testing for normal distribution, these differences in means of the primary and secondary outcome parameters between the barefoot and the high heeled radiograph will be assessed using a paired student's t-test or non-parametric tests. the level of significance is p \< 0.05.

Eligibility criteria:
inclusion criteria: * not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels \> 3 cm) exclusion criteria: * osseous metastases * missing written informed consent * cognitive inability to consent on their own * pregnancy

Keywords: sagittal balance posture lumbar lordosis high heeled shoes