Kornimate/medical-research-clean huggingface dataset:
effects of intensified sodium management in hemodialysis patients

Conditions: Renal Failure Chronic Requiring Hemodialysis

Summary: the primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.


Eligibility criteria:
inclusion criteria: * ambulatory, clinically stable maintenance hemodialysis patients on a thrice weekly hd regimen. * willing and able to provide written, signed informed consent after the nature of the study has been explained. * willing and able to comply with all study procedures. * age ≥18 years. exclusion criteria: * simultaneous participation in another clinical study except observational trials. * any psychological condition which could interfere with the patient's ability to comply with the study protocol. * pregnancy. * amputation of a limb. * pacemaker, implantable pump, artificial joint. * expectation that native kidney function will recover. * unable to verbally communicate in english or spanish. * scheduled for living donor kidney transplant, change to peritoneal dialysis, home hd or plans to relocate to another center within the next 14 months. * life expectancy \< 15 months

Keywords: sodium, hypertension, volume overload
hereditary angioedema kininogen assay

Conditions: Hereditary Angioedema

Summary: a multicenter epidemiological observational study aiming to explore the cleaved high-molecular weight kininogen (chmwk) including identification and characterization of other metabolite/biomarkers in hae type 1/2 patients

hereditary angioedema (hae) is a rare autosomal dominant genetic disorder characterized by recurrent tissue angioedema episodes, mainly caused by mutations in the serping1 gene that encodes c1 inhibitor (c1-inh), a protease involved in limiting bradykinin production. low levels of c1-inh (hae type 1) or dysfunctional c1-inh (hae type 2) lead to bradykinin accumulation, resulting in capillary leakage and tissue swelling. high molecular weight kininogen (hmwk) proteolysis, by active plasma kallikrein, results in bradykinin and chmwk generation. the goal of this study is to explore the chmwk concentrations in hae type 1/2 patients, as a biomarker for this disease. the haeka study is performed in collaboration with shire. shire is a wholly owned subsidiary of takeda pharmaceutical company limited.

Eligibility criteria:
inclusion criteria: * informed consent is obtained from the participant * the patient with diagnosis of hereditary angioedema (hae) type 1/2 based on international guidelines * the patient experienced ≥4 hae attacks within last 12 month before enrolment in the study * the participant is older than 18 years old exclusion criteria: * inability to provide informed consent * the patient is not diagnosed with hereditary angioedema (hae) type 1/2 * the patient experienced ˂ 4 hae attacks within last 12 month before enrolment in the study * the participant is younger than 18 years old

Keywords: hereditary angioedema cleaved high-molecular weight kininogen hereditary angioedema type i hereditary angioedema type ii
study comparing negative pressure dressing vs conventional in patients with resected sts after radiotherapy

Conditions: Soft Tissue Sarcoma

Summary: this is a randomized (1:1 ratio), prospective, comparative, controlled, open-label study. the aim is to compare the efficacy of negative pressure therapy (prevena™) versus standard postoperative wound management on the wound healing after surgery for previously irradiated soft tissue sarcoma (sts)

the gold standard treatment for primary non-metastatic sts is complete surgical resection. peri-operative radiation therapy (rt) has been proved to improve local control . nevertheless, the timing of rt, whether preoperative or postoperative, remains a debate. both have similar local control efficacy, but preoperative rt results in lower rates of long-term fibrosis and lymphedema and improved joint mobility than postoperative rt. on the other hand, the adverse effect of pre-operative rt is a higher rate of wound post-operative complications and re-operations. any effort to reduce the high rate of postoperative complications could offer the advantage of preoperative rt in terms of reduced long-term sequelae compared with postoperative rt without a higher wound complication rate postoperatively. short retrospective series of negative pressure wound therapy (npwt) after surgical resection of soft tissue sarcoma (sts) have reported very encouraging results in preventing wound complications: patients treated with npwt were less likely to develop wound complications than those who did not receive it. both groups did not report an increased rate of local recurrence. the use of npwt would also reduce the cost of care by avoiding complications. that's why the investigators propose this study comparing the use of a negative pressure dressing to a conventional dressing in patients with sts of the limbs or trunk resected after neo-adjuvant external radiotherapy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years at the day of consenting to the study * patients with primary sts of the limb or trunk treated with preoperative external radiation therapy (decided in multidisciplinary board) * intent to cure resection required for sts planned between 3 to 8 weeks after the end of rt * planned primary wound closure, including local or distant jambeau * ability to understand and willingness for follow-up visits * covered by a medical insurance * signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment. exclusion criteria: * known hypersensibility to silver * patients with a diagnosis of ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor * planned no wound-closure and skin graft after resection * patient requiring authorship or curators or patient deprived of liberty.

Keywords: sts negative pressure wound therapy surgery with preoperative irradiation
risk factor and outcome of candidemia

Conditions: Candidemia

Summary: candidemia is the fourth leading cause of hospital-acquired infection in usa. in cmuh, it caused 9% hospital-acquired bloodstream infection in 2008 and 2009. in addition to increased mortality, candidemia also increased hospital stay and cost. there is a trend of increased cases of candidemia in recent years in cmuh. early empirical and target treatment can reduce mortality and shortened length of hospital stay. in the past, most prior studies in taiwan dealt with risk factors for mortality rather than for candidemia and also focused at in vitro susceptibility to antifungal agents. in this study, the investigators hope to analyze the candidemic cases from 2003 to 2009, estimated 1000 cases. there were some rare candida species. therefore, the investigators hope to do case study for these diseases to provide the epidemiology of candidemia in cmuh. the result can help clinician in predicting the disease and its outcome. besides, it also provides the epidemiology of candidemia in mid-taiwan.


Eligibility criteria:
inclusion criteria: * patient had candidemia from 2002-2010 exclusion criteria: * no

Keywords: risk outcome
retinal nerve fiber layer thickness and cerebrospinal fluid aβ/tau

Conditions: Alzheimer Disease

Summary: to test the hypothesis that retinal nerve fiber layer (rnfl) thickness is correlated with aβ and tau concentration of cerebrospinal fluid (csf) in an older population.

retinal nerve fiber layer (rnfl) thickness changing has been reported in alzheimer's disease (ad) patients at an early stage, and has been demonstrated as a potential biomarker able to predict cognitive deterioration (hinton dr et al., n engl j med 1986; london a et al. nat rev neurol 2013; chang ly et al., alzheimers dement 2014). however, whether rnfl thickness is correlated with cerebrospinal fluid (csf) features of ad pathogenesis (e.g., aβ and tau) remains unclear. the investigators thus conducted this observational cohort study to test the correlation between rnfl thickness changing and csf, to further validate rnfl as a potential ad biomarker.

Eligibility criteria:
inclusion criteria: 1. 50 years old or older; 2. five years or more of education and scores of mmse ≥ 24 points; 3. chinese as their first language; 4. having spinal anesthesia. exclusion criteria: 1. prior diagnoses of neurologic diseases, e.g., dementia, parkinson's diseases, multiple sclerosis or stroke according to dsm-iv; 2. history of mental disorders (e.g., major depressive disorder and schizophrenia) diagnosed according to dsm-iv; 3. known diseases contributing to the retina pathologies, e.g., diabetes, glaucoma or increased intraocular pressure (more than 22 mmhg), cataract, and macular degeneration and hypermyopia; 4. unwillingness to comply with the cognitive assessments; 5. ungradable images of oct.

Keywords: retinal nerve fiber layer cerebrospinal fluid aβ and tau
enhancing diagnosis and prevention of cardiovascular disease in newham by integrated use of electronic health records

Conditions: Cardiovascular Disease

Summary: the investigators will develop a "risk report" within the primary care electronic health record (emis) for patients attending for their national health service health check. the value of the report for reducing cardiovascular risk will be assessed qualitatively and also quantitatively in a non-randomised comparative trial.

the investigators will design a template within the primary care electronic health record (emis) that draws on health check data to provide a contemporary "risk report". included in the report will be clear description of life-time cardiovascular risks, the factors driving those risks and how risk might be reduced through life-style and risk factor modification. the investigators will evaluate the benefits of providing patients with a risk report qualitatively by patient and clinician interviews. quantitative analysis of the benefit of the risk report will be provided by a non-randomised comparative trial. first, a group of patients undergoing a conventional health check will be recalled after three months for a second health check, allowing measurement of the change in "heart age" - a convenient index of life-time cardiovascular risk. following introduction of the risk report the investigators will recall a further group of patients for a second health check, allowing measurement of the change in "heart age". the effect of the risk report will be determined by comparing the change in heart age between the two groups of patients.

Eligibility criteria:
inclusion criteria: * adults aged 40-74 years exclusion criteria: * prior diagnosis of heart disease, stroke, diabetes, kidney disease or dementia

Keywords: primary prevention national health service health check
comparison of insulin glargine against insulin aspart infused under the skin in patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this trial is conducted in europe. the objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes for more than 2 years * subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks * subjects currently treated with unchanged dose(s) for at least 1 month on one or two oral anti-diabetic drugs * bmi 25 - 40 kg/m2 * hba1c \< 9.5 % exclusion criteria: * known or suspected allergy to trial product(s) or related products * previous randomisation in this trial * pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods) * mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation. * any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by investigator * participation in other studies within the last three months
diffusion weighted magnetic resonance imaging and the optic nerve neuropathy.

Conditions: Ischemic Optic Neuropathy; Optic Neuritis; Compressive Optic Neuropathy; Traumatic Optic Neuropathy; Toxic Optic Neuropathy; Hereditary Optic Neuropathies

Summary: the aim of the project is to create a new, non-invasive and safe protocol for the early diagnosis of various types of optic neuropathies with the use of diffusion magnetic resonance imaging

in this study, it is planned to find twenty volunteers for each of the neuropathies and twenty healthy volunteers. each volunteer will undergo clinical tests such as visual acuity, color vision, intraocular pressure measurement, assessment of the anterior chamber and fundus using a slit lamp and volk lens, macular optical coherence tomography examination and examination of the optic nerve disc (oct), neurological field vision and visual evoked potential (vep) testing. each of the volunteers will undergo magnetic resonance imaging. during active scanning, patients will be asked for not blinking or moving their heads by staring at the red dot on the outside of the camera reflected in the coil mirror. the obtained diffusion tensor data will be used for further analysis.

Eligibility criteria:
inclusion criteria: optic neuropathy. exclusion criteria: common contraindications to mri (presence of pacemaker, non-mri-safety or claustrophobia)

Keywords: optic neuropathies visual evoked potential
study on skin microbiome of hfs

Conditions: Microbiota

Summary: to skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in china, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;finding markers for the treatment and prognosis of related diseases;identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy.

to skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in china, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;finding markers for the treatment and prognosis of related diseases;identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy

Eligibility criteria:
inclusion criteria: * age: 18-65 years old * advanced breast cancer patients * healthy volunteers exclusion criteria: * previous skin disease history, or other skin disease activity at present * various antibiotics, prebiotics, probiotics or lactic acid products used within three months; * having a history of alcoholism for more than 2 years and smoking for years; * pregnancy or lactation; * have oral, respiratory and gastrointestinal diseases; * other metabolic diseases, such as obesity, hypertension, diabetes, stones, and liver diseases; * other autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease; * history of gastrointestinal surgery; * family genetic history, history of mental illness, etc.; * the subject is participating in other research projects; * other reasons are not considered suitable for continued clinical trials.

Keywords: skin microbiota 16s rrna gene hand foot sysdom breast cancer chemotherapy
fluid-removal guided by vexus score with usual care in patients with acute kidney injury after cardiac surgery

Conditions: Acute Kidney Injury; Cardiac Surgery; Venous Congestion; Hemodynamic Stability

Summary: acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. there is a clinical continuum between acute kidney injury (transient if \ 48h), the development of acute kidney and chronic renal failure. each of these entities characterising renal recovery is associated with an increase in long-term morbidity and mortality. fluid management in patients with acute kidney injury is challenging, as both hypovolaemia and hypervolaemia are detrimental. venous congestion (reflecting intravascular hypervolaemia), is a well-established haemodynamic factor contributing to acute kidney injury after cardiac surgery. an ultrasound score, based on the venous doppler pattern explored in intra-abdominal organs, has recently been developed and is a better predictor of acute kidney injury than central venous pressure. whether using the vexus score to guide fluid removal in haemodynamically stabilised patients could promote renal recovery after acute kidney injury remains to be investigated. before designing a large randomised trial to test such a strategy, its feasibility in a pilot randomised trial is assessed.


Eligibility criteria:
inclusion criteria: * intensive care unit admission within 72 hours of cardiac surgery with extracorporeal circulation * acute kidney injury defined by kdigo criteria * vasoactive inotropic score \<45 and capillary refill time \<3s * informed written consent exclusion criteria: * hypokalaemia \<3.5mmol/l * hyponatremia\<125mmol/l * hypernatremia \>145mmol/l * metabolic alkalosis with ph \>7.50 * impossibility to measure capillary refill time * chronic liver disease * cirrhosis with portal hypertension * known thrombus of the inferior vena cava * mechanical circulatory assistance (ecmo or mono left ventricular assistance) * severe pre-operative chronic kidney disease (gfr \< 30ml/min/1.73m2) * need for renal replacement therapy anticipated by the attending physician within 24 hours * known hypersensitivity to furosemide and/or hydrochlorothiazide * severe allergy to wheat * patient already included in another interventional study with an exclusion period still in progress * pregnant, breast-feeding or women of childbearing age without suitable contraception * patients under guardianship, curatorship or safeguard of justice * patients under psychiatric care * patients not affiliated to a social security scheme or beneficiaries of a similar scheme

Keywords: acute kidney injury cardiac surgery venous congestion vexus score diuretic fluid removal
motivational interview and nomophobia

Conditions: Nomophobia; Smartphone Addiction

Summary: a preparation session and a motivational interview consisting of 4 sessions will be applied to nursing students. data collection tools will be applied before, after and at 3 months.


Eligibility criteria:
inclusion criteria: * being over 18 years of age * being a first-year nursing student * agreeing to participate in the research exclusion criteria: * having problems understanding and speaking turkish * having visual or hearing impairment * having a neuropsychiatric disease

Keywords: nursing student smartphone addiction nomophobia motivational interview
polymorphisms at distinct genetic loci affect response to anti-cd20 monoclonal antibody therapies

Conditions: Lymphoma

Summary: this is a non-interventional, r01-funded pilot study that will identify serum and cellular markers in patients' blood samples that can be used as short-term biomarkers of rituximab response. we hypothesize that serum complement levels, activation of natural killer cells, and clearance of peripheral b-cells will be accurate biomarkers of rituximab response, and may be correlated with long-term outcomes.

this study does not involve the administration of study drug. this study will only require additional blood draws to identify how patients respond to rituximab and other anti-cd20 antibody therapy. it is expected that blood draws will occur on the same day in which an iv is placed to dose you with the anti-cd20 antibody or for other bloodwork being performed in order to avoid extra sticks. if you take part in this study, you will have additional blood drawn at the following time-points surround anti-cd20 antibody therapy: pre dose, cycle 1 * two 7.5 ml tubes (two teaspoons) of blood will be taken along with your other pre-chemotherapy bloodwork post dose, cycle 1 * two 5 ml tubes (three teaspoons) of blood will be taken pre dose, cycle 2 * two 5 ml tubes (two teaspoons) of blood will be taken post dose, cycle 2 * two 5 ml tubes (two teaspoons) of blood will be taken pre dose, cycle 6 * two 10 ml tubes (four teaspoons) of blood will be taken post dose, cycle 6 * two 10 ml tubes (four teaspoons) of blood will be taken note: two tubes will be taken at each draw. if no blood was drawn in the prior 8 weeks, 10 ml of blood will be taken per tube. for the first 4 draws (at cycle 1 and cycle 2, pre- and post-), the amount of blood being taken is to ensure that the patient does not have more than 50 ml of blood taken within an 8 week period.

Eligibility criteria:
inclusion criteria: 1. any adult patient who has not received rituximab or other anti-cd20 antibody within the past year who is initiating rituximab or other anti-cd20 antibody treatment. 2. treatment plan that includes at least two doses of anti-cd20 antibody and longitudinal follow up over at least a one-month time span. exclusion criteria: 1. hgb less than 8.0 g/dl or hct less than 25% (transfusions or growth factors are permissible). 2. treatment with any anti-cd20 antibody within the past 12 months.