Kornimate/medical-research-clean huggingface dataset:
efficacy study of triamcinolone and bevacizumab intravitreal for treatment of diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: triamcinolone and bevacizumab intravitreal for treatment of diabetic macular edema

efficacy study of triamcinolone and bevacizumab intravitreal for treatment of diabetic macular edema

Eligibility criteria:
inclusion criteria: * 18 years of age at least * diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present: * current regular use of insulin for the treatment of diabetes * current regular use of oral hypoglycemic agents for the treatment of diabetes * diabetes as defined by american diabetes association (ada) * symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eighth-hour fasting plasma glucose \> 126 mg/dl * diabetic macular edema clinically observable associated with diabetic retinopathy: * without prior foveal treatment with laser therapy * if photocoagulation or peripherical or macular laser, at least 3 months * absence of macular ischemia by fluorescein angiography on baseline visit * bcva score between 20 letters (20/400 etdrs)e 70 letters (20/40 etdrs) in the study eye measured by the etdrs method at qualification/baseline visit * retinal thickness \> 275um by oct * one eye per patient will be chosen for the study. in case of both eye eligible, it will be chosen an eye to be treated with study medication and another eye treated with laser * taught hyaloid syndrome exclusion criteria: * uncontrolled systemic disease * initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit * renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit * any ocular condition in the study eye that in the opinion of the investigator would prevent a 2 lines improvement of visual acuity (e.g. severe macular ischemia) * presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema * presence of an epiretinal membrane in the study eye * history of iop elevation in response to steroid treatment in either eye * history of glaucoma or optic nerve head change consistent with glaucoma damage * ocular hypertension requiring more than 1 anti-glaucoma medication to maintain iop \< 11mmhg at qualification visit * presence of anterior chamber intraocular lens in the study eye * active optic disc or retinal neovascularization in the study eye at qualification visit * active or history of choroidal neovascularization in the study eye

Keywords: avastin bevacizumab triamcinolone diabetic macular edema macular edema intravitreal injection
a multiple centre, cohort study of new crrt membranes oxiris for patients with septic shock

Conditions: Acute Kidney Injury Due to Sepsis (Disorder)

Summary: the objectives of this study are to determine whether continuous renal replacement therapy (crrt) with oxiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (sofa) , hemodynamic, mortality compared crrt with conventional membrane.

sepsis is the leading cause of death in icu, resulting in multi-organ failure in critically ill patients. patients with septic shock combined sepsis-associated acute kidney injury (aki)have even poorer outcome. endotoxin activity, inflammation and immune dysfunction, have been consider relevant to their pathogenesis of sepsis. high levels of inflammation are associated with worse clinical outcomes. however, all studies of anti-inflammation treatment in sepsis patient are failed and anti-inflammation treatment of sepsis still remains controversial. oxiris is a new filter with adsorptive membrane, which removes endotoxin and inflammatory mediator from plasma. but current evidence of oxiris is limited, and only some small sample studies have proved that it can improve the haemodynamics and the sepsis-related organ failure assessment(sofa) score. our hypothesis was that oxiris would be associated with better clinical outcomes, such as decreased sofa score, improved survival rate, better hemodynamic, and improved of organ function.

Eligibility criteria:
inclusion criteria: * \>18 years * treated by crrt using oxiris or conventional membrane * sofa cardiovascular score ≥ 3 * septic shock due to abdominal or pneumonia( gram-negative bacterial infection or suspected gnb infection) * written informed consent exclusion criteria: * chronic kidney disease * renal replacement therapy (rrt) in the last 30 days * pregnancy * immunosuppressive treatment or steroids (prednisone \> 0.5 mg/kg/day or equivalent). * autoimmune disorder. * transplant receptor. * inclusion in other ongoing studies within the last 30 days. * coexisting illness with a high probability of death

Keywords: septic shock, aki, crrt
resection of pulmonary metastasis in clear cell renal cell carcinoma +/-adjuvant sunitinib therapy (smat)

Conditions: Renal Cell Carcinoma; Pulmonary Metastases

Summary: the aim ist to identify biomarkers in the blood, to indicate early response or early treatment resistance.

prospective randomized multi-center phase ii trial for resection of metastases from pulmonary metastases (poor prognosis) in clear cell renal cell carcinoma + / - adjuvant sunitinib therapy over one year

Eligibility criteria:
inclusion criteria: * \>/= 2 synchronous or within 24 months after nephrectomy occured pulmonary metastases. patients in whom more back than 2 years of a solitary lung metastasis, bone metastasis or brain metastasis was resected, may also be included in the study. * aged 18 to 75 years * functionally acceptable surgical risk * women in conceptional age: negative pregnancy test and adequate contraception * adequate hematologic, renal, hepatic and coagulation-physiological functions * amylase/ lipase \< 1,5 x upper limit of normal * informing the patient about the study and the present written consent to participate after clarification in accordance with the stipulations of amg(german drug law), and the principles of gcp ("informed consent") * patient compliance and geographic proximity to allow adequate follow-up exclusion criteria: * presence of other metastases outside the lung * progress in the 12-week sunitinib therapy before resection of metastases * r1 or r2-finding in resection of metastases * dialysis after nephrectomy * previous or existing serious cardiovascular (grade iii - iv according to nyha(new york heart association)) disease, active angina pectoris or ischemia, myocardial infarction within previous 6 months , uncontrolled hypertension(rr diastolic 120 mmhg(millimeters of mercury)) * serious hematopoetic (e.g. serious bone marrow aplasia), pulmonary, hepatic or renal disease * stroke within the previous six months * patients with poorly controlled diabetes mellitus * serious bacterial or fungal infections * chronic hepatitis b or c, hiv(human immunodeficiency virus) infection * autoimmune disease * prior organ transplantation * prior autologous bone marrow transplant or stem cell transferred within the last 4 months before study * neuropsychiatric diseases that affect patient compliance * manifesto, second malignancy or other malignancy within the past 5 years (except basal cell carcinoma, carcinoma in situ of the cervix, incidental prostate carcinoma, superficial urothelial ca ptag1-2 and pt1g1) * therapy with immunotherapeutic agents including monoclonal antibodies, cytotoxic drugs or hormones (other than bisphosphonates and oral contraceptives) within the last 4 weeks prior to enrollment. previous use of inhibitors of ras/raf-, mek kinase, akt kinase and mtor inhibitors or induction of farnesyltransferase * previous use of angiogenesis inhibitors such as vegf / vegfr, pdgf / pdgfr and other key molecules of angiogenesis * parallel treatment with rifampicin * participation in other treatment studies in the last 4 weeks

Keywords: carcinoma metastases renal lung
skin traction versus position splint in patients with hip fracture

Conditions: Hip Fractures; Complication of Traction Procedure; Pain; Splints

Summary: the aim of this prospective, randomized controlled trial is to compare the effects of preoperative skin traction and position splint on pain, comfort, complications, difficulty level of nursing interventions, satisfaction from treatment and nursing care in patients with hip fracture. the sample is comprised of 34 patients with hip fracture in each group, totally 68 patients. skin traction and position splint were applied after block randomization. data regarding pain, comfort, satisfaction from care, immobilization comfort, complications, time of operation and hospitalization time were collected after intervention.


Eligibility criteria:
inclusion criteria: * being inpatient who were planned the surgery due to the hip fracture (caput femur fracture, collum femur fracture, femur intertrochanteric fracture and subtrochanteric fracture) diagnosis in the orthopedics and traumatology clinic * being 50 years old or more * patients who speak and literate in turkish * patients who gave informed consent to participate in the study exclusion criteria: * any condition that emerges an obstacle for verbal and written interaction during data collection phase * unable to perform written or verbal communication in turkish * withdrawal from the study due to medical reasons or death, at his/her will prior to preoperative data collection * urgent non-elective surgery * physician decision that do accept the method of immobilization assigned to the patient as appropriate

Keywords: comfort satisfaction
placebo controlled dose-response study of rivoglitazone in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess the efficacy response of rivoglitazone hcl on the change in hba1c after 12 weeks of treatment in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * hba1c \>6.5% and \<10% * fpg \>126 mg/dl (7mmol/l) and \<270 mg/dl (15 mmol/l) exclusion criteria: * history of type 1 diabetes * history of ketoacidosis * current insulin therapy * c-peptide \<0.5ng/ml * impaired hepatic function * chf or history of chf (nyha stage i - iv) * uncontrolled hypertension

Keywords: rivoglitazone hcl thiazolidinedione peroxisome proliferator-activated receptor gamma (ppargamma) diabetes mellitus, type 2
preserve-hd: observational study of the merit hero® graft and super hero® in patients on hemodialysis

Conditions: End Stage Renal Disease; Hemodialysis Access Failure

Summary: the goal of this observational study is to increase the understanding of the safety and performance of merit medical's hero graft system (hero) and super hero adaptor and support seal system (super hero) devices. this study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. if participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.


Eligibility criteria:
key inclusion criteria: * subject provides written informed consent * subject is ≥ 18 years * subject is end-stage renal disease patient on hemodialysis. * subject is treated with hero graft or super hero system in accordance with device instructions for use (ifu) key exclusion criteria: * subject has a previously placed hero or super hero device that is undergoing revision or replacement * subject has a topical or subcutaneous infection associated with the implantation site * subject has known or suspected systemic infection, bacteremia or septicemia

Keywords: hero
a phase 2 study of brivanib in chinese patients with previously treated advanced hcc

Conditions: Hepatocellular Carcinoma (HCC)

Summary: this is a phase 2, open-label, randomized, multicenter study to investigate the efficacy, safety, and pharmacokinetics of brivanib in patients with previously treated advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * 18-75 years, male or female * histologically or cytologically confirmed or the clinical diagnosis standard confirmed hepatocellular carcinoma (hcc) patients * failure or intolerance to prior treatment with chemotherapy and/or targeted therapy * liver function status child-pugh class a or b (score≤7) * ecog performance status score 0 or 1 * patients must have adequate bone marrow, renal and hepatic function exclusion criteria: * known history or symptomatic metastatic brain * uncontrolled moderate and severe ascites * with bleeding tendency and thrombosis history * known history of severe cardiovascular disease * uncontrollable active infections (≥ctcae grade 2) * pregnant or breastfeeding women

Keywords: hepatocellular carcinoma hcc brivanib
tocopherols and alpha lipoic acid treatment chronic kidney disease (talat)

Conditions: Chronic Kidney Disease

Summary: oxidative stress and acute phase inflammation are now recognized to be highly prevalent in both the chronic kidney disease (ckd; pre-dialysis) and end stage renal disease (esrd; on hemodialysis) populations, and several lines of evidence point to their contribution in the development of atherosclerosis. biomarkers of the inflammatory state such as c-reactive protein (crp) and interleukin-6 are robust predictors of cardiovascular events and death in these two populations. the uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. it has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. in this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress in patients with stage iii and iv ckd.


Eligibility criteria:
inclusion criteria: 1. patients with stage iii-iv chronic kidney disease measured by mdrd formula. 2. age \> 18 or \< 75 years. 3. life expectancy greater than one year. 4. ability to understand and provide informed consent for participation in the study exclusion criteria: 1. aids (hiv seropositivity is not an exclusion criteria) 2. active hepatitis c or b 3. active gout 4. other active inflammatory diseases. 5. active malignancy excluding basal or squamous cell carcinoma of the skin. 6. gastrointestinal dysfunction requiring parental nutrition. 7. history of functional kidney transplant \< 6 months prior to study entry. 8. anticipated live donor kidney transplant over study duration. 9. prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations. 10. patients taking vitamin e supplements \> 60 iu/day, vitamin c\> 500mg/day over the past 30days. 11. patients taking anti-inflammatory medication except aspirin \< 325mg/day over the past 30 days. 12. patient taking any prednisone therapy. 13. more than two hospitalizations within the last 90 days or one hospitalization within the last 30 days. 14. on experimental drug protocols. 15. hypersensitivity to organic nitrates, isosorbide, or nitroglycerin. 16. hypersensitivity to vitamin e or alpha lipoic acid. 17. pregnant women
a phase 3 lot-consistency clinical trial of live attenuated varicella vaccine

Conditions: Varicella

Summary: the purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.

the study is a single-center, double-blind, randomized, bridging clinical trial. the purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .

Eligibility criteria:
inclusion criteria: * healthy volunteer between 1-3 years old; * legal identity; * guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study. exclusion criteria: * prior vaccination with varicella vaccine or with history of varicella infection; * axillaty temperature \> 37.0 °c before vaccination; * history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; * epilepsy (except febrile seizures), history of seizures or convulsions, a family history of mental illness, autoimmune disease, or immunodeficiency; * severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases; * acute disease or acute stage of chronic disease within 7 days prior to study entry; * receipt of any blood product, immunosuppressant, hormone, other investigational medicine(s) within 30 days prior to study entry; * receipt of any live attenuated vaccine within 1 month prior to study entry, or receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry; * any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx; * based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded.

Keywords: live attenuated varicella vaccine consistency immunogenicity safety children
to improve the ability of early screening and diagnosis in patients with diabetic nephropathy

Conditions: Diabetic Kidney Disease

Summary: this is a large-scale, multi-center, observational study. it is planned to establish a large database of 10,000 patients with type 2 diabetes mellitus to investigate the prevalence, awareness and screening rates of diabetes kidney disease (dkd), and provide real-world data on the efficacy and safety of sodium glucose cotransporter 2 inhibitors (sglt2i) in patients with type 2 diabetes mellitus (t2dm).

among the various complications of diabetes mellitus, dkd is considered as a major threat and is one of the manifestations of diabetic microangiopathy. it is one of the main causes of death for patients with t2dm. albuminuria is the earliest manifestation of dkd, which is mostly asymptomatic at the early stage, if the albuminuria is poorly controlled, it may develop into clinical dkd. therefore, it is very important to improve the patients' awareness of dkd, regularly screen early kidney diseases and use drugs rationally. in order to promote the standardization of diagnosis and treatment of patients with dkd, improve the knowledge and screening rate of patients with dkd, help the formation of health literacy, healthy behavior and lifestyle, the investigators planned the study. study objectives: 1. to understand the epidemiological disease burden of dkd in china, and to investigate the prevalence rate, awareness rate and screening rate of dkd; 2. to understand the treatment status of patients with dkd in china; 3. to provide real-world data on the efficacy and safety of sglt2i in the treatment of dkd in china;

Eligibility criteria:
inclusion criteria: * it is known that patients with t2dm has a history of more than 12 months (the who1999 standard) and is treated with at least one anti-diabetic agent. * gender and age: men and women who are at least 18 years old with informed consent. * patients are willing and able to provide written informed consent before participating in this study. exclusion criteria: * type 1 diabetes mellitus (dm) * patients with severe ketosis, diabetic coma, severe infection or severe trauma * perioperative patients * patients with severe renal impairment and advanced nephropathy (egfr \< 45 ml/min/1.73m2) * renal transplant patients * patients are participating in or have participated in any other clinical trials in the past 3 months * any disease with a life expectancy of less than 2 years according to the clinical judgment of the investigator * pregnant or lactating women * patients judged by the investigator to be unsuitable for participating in the study.

Keywords: sglt2 inhibitors diabetic kidney disease albuminuria
the effectiveness of health promotion programs on the pre-frail individuals

Conditions: Older Adults

Summary: this pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the coronavirus disease 2019.

this pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the coronavirus disease 2019. design: a two-arm parallel cluster randomized controlled trial. older adults ≥60 years old were recruited from eight community units in northern taiwan. one-hundred and sixty-seven eligible subjects consented to participate in the study. community units were randomly assigned to either an intervention arm (n=82) or a control arm (n=87). the intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. the control arm received an education leaflet. assessments were performed at baseline and 16 weeks for physical activity, physical performance, and pre-frailty rate. analysis of covariance or chi-square test adjusted for pretest evaluated the differences between the two study arms.

Eligibility criteria:
inclusion criteria: * older adult with age ≥ 60 years * community-dwelling * no hearing and visual acuity difficulties exclusion criteria: * unconscious * cognitive impairment or dementia

Keywords: multicomponent exercise training older adults physical activity physical performance pre-frailty coronavirus disease 2019 pandemic