Kornimate/medical-research-clean huggingface dataset:
outcome of second generation drug-eluting stents in patients with diabetes mellitus

Conditions: Coronary Artery Disease; Diabetes Mellitus

Summary: design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (tlf) of second generation paclitaxel- versus abt578- versus everolimus- eluting stents study population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12. time course: initial enrollment: october 2010; end of the enrollment: december 2012 primary end-point: target lesion revascularization (tlf) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months. secondary end-points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin a1c ) on clinically-driven target lesion revascularization; 2)tlf and tlr within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (\> 12 months) of dual antiplatelet therapy

prospective, randomized, triple arm study. the study population will include all consecutive diabetic patients within 24 months undergoing elective second generation des implantation for de novo coronary artery disease. in the randomization process all participating centers will be equally stratified to avoid statistical unbalance.

Eligibility criteria:
inclusion criteria: 1. subject is \> 18 years old 2. presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent 3. subject and the treating physician agree that the subject will comply with all follow-up evaluations 4. subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the institutional review board/ethics committee of the respective clinical site exclusion criteria: 1. subject's age is \< 18 years and with acute myocardial infarction in the 48 prior to the procedure 2. the patient is pregnant or breastfeeding 3. known allergies to: aspirin, clopidogrel (plavix) and ticlopidine (tiklid), heparin, paclitaxel, everolimus, abt 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated) 4. a platelet count \ 700,000 cells/mm3 or a wbc \< 3,000 cells/mm3 5. subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints 6. prior participation in this study 7. active peptic ulcer or upper gi bleeding within the prior 3 months 8. subject has active sepsis 9. any lesion that is located in a saphenous vein graft 10. in the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study

Keywords: randomized controlled trial drug-eluting stent multicenter study
clinical study to evaluate the efficacy and safety of neuronox and botox with essential blepharospasm

Conditions: Essential Blepharospasm

Summary: this clinical study evaluates the efficacy and safety of neuronox compared with botox in adults with essential blepharospasm.

subjects are randomly assigned into the two groups at the ratio of 1:1. the purpose of study is to confirm the non-inferiority of neuronox to botox in terms of the efficacy and safety in subjects with essential blepharospasm.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 75 * subjects had to have a confirmed clinical diagnosis of essential blepharospasm requiring treatment by injection exclusion criteria: * subjects who underwent surgical operation * subjects with neuroleptic induced blepharospasm
hsv-2 shedding resolution after acyclovir treatment

Conditions: Genital Herpes

Summary: the purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.

the purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes. participants are asked to visit the university of washington virology research clinic for an initial screening appointment in which the clinician will ensure eligibility and informed consent will be obtained. participants who experience an outbreak during the next year will be asked to call the clinic at the beginning of their next outbreak. the clinician will arrange to admit the participant to the uw general clinical research center (gcrc) for a 5-day hospitalization stay. during hospitalization, participants will take acyclovir (400mg 3 times daily) and genital swabs will be collected every 2 hours during the day and every 4 hours at night for 5 days. after the last swab has been taken, the study nurse at the gcrc will do a final genital exam and the participant will be discharged. some participants will also be asked to enroll in a control arm during which the same procedures will be followed except they will not take acyclovir during the recurrence.

Eligibility criteria:
inclusion criteria: * age 18 years or older * history of clinically-evident genital herpes * 3 or more clinical genital herpes recurrences within the prior 12 months * hsv-2 seropositive by hsv western blot * willing and able to comply with study protocol exclusion criteria: * pregnancy * taking daily antiviral therapy for genital herpes * hiv seropositive or known immunocompromising medical condition * plan to move from the seattle area within the next year * hypersensitivity to or intolerance of acyclovir
safety study of memantine in pediatric patients with autism, asperger's disorder or pervasive developmental disorder not otherwise specified (pdd-nos)

Conditions: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Summary: the objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, asperger's disorder or pervasive developmental disorder not otherwise specified (pdd-nos).

this clinical study was a 48-week, multicenter, multinational, open-label extension study in pediatric outpatients with autism, asperger's disorder, or pdd-nos conducted at 106 study centers. patients were eligible for this long-term extension study if they had: * completed the open-label study mem md 67,or * completed the open-label study mem-md-91, or * completed the double-blind study mem-md-68, or * discontinued study mem-md-68 by meeting requirements for loss of therapeutic response the weight-based dose limits in this study were as follows: group a: ≥ 60 kg; maximum 15 mg/day group b: 40-59 kg; maximum 9 mg/day group c: 20-39 kg; maximum 6 mg/day group d: \< 20 kg; maximum 3 mg/day the decision to close the study early was based on data from 2 double-blind placebo-controlled studies (mem-md-57a and mem-md-68) that failed to demonstrate a statistically significant difference between memantine and placebo in the primary efficacy parameter based on social responsiveness scale (srs) total raw score.

Eligibility criteria:
inclusion criteria: * patients who completed study mem-md-67, mem-md-68, mem-md-91, or discontinued study mem-md-68 due to meeting the criterion for loss of therapeutic response. * having normal results from a physical examination and laboratory tests at visit 1 of this study (last visit of the preceding study). any abnormal findings must be deemed not clinically significant by the investigator and documented as such. * have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study exclusion criteria: * patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug * patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being * significant risk of suicidality based on the investigator's judgment, aberrant behavior checklist-irritability subscale (abc-i), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the children's columbia-suicide severity rating scale (c-ssrs) or any suicidal behavior

Keywords: autistic disorder asperger's disorder asperger's pediatric autism pervasive developmental disorder not otherwise specified (pdd-nos) pervasive child development disorder
assessment of urinary uromodulin and the corresponding gene expression as a biomarker of diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: detecting diabetes-related kidney diseases early is crucial to prevent end-stage renal disease (esrd). existing biomarkers' specificity and sensitivity vary, emphasizing the need for novel markers. this research assesses urinary uromodulin levels and its gene expression, aiming to identify a potential marker for early diabetic nephropathy (dn) detection in type 2 diabetes patients. uromodulin, encoded by the umod gene, is expressed mainly in the thick ascending limb of henle's loop epithelial cells, making it a promising candidate for early dn detection and progression towards esrd, potentially reducing chronic kidney disease prevalence.

introduction: diabetes mellitus (dm) is a metabolic disorder characterized by elevated blood glucose levels resulting from deficiencies in insulin secretion, insulin action, or both. prolonged hyperglycemia associated with diabetes can lead to lasting damage and dysfunction in various organs, including the eyes, kidneys, nerves, heart, and blood vessels (american diabetes association, 2008). among the complications of diabetes, diabetic nephropathy (dn) stands out as a significant contributor to chronic kidney disease (ckd) (macisaac et al., 2014). pathophysiologically, dn progresses from an early phase featuring glomerular hypertrophy, hyperfiltration, and microalbuminuria to an advanced phase marked by progressive glomerulosclerosis, increased urinary albumin excretion (uae), and impaired renal function (schrijvers et al., 2004). traditionally, dn severity is assessed by measuring urine albumin levels, with persistent microalbuminuria (30-300 mg/24 hr) or macroalbuminuria (\>300 mg/24 hr) serving as markers and predictors of dn and its progression to end-stage renal disease (adler et al., 2003). current practices in biomarker use for dn diagnosis show conflicting results regarding sensitivity and specificity in recent studies. therefore, it is imperative to identify novel biomarkers for early dn detection and progression to reduce the prevalence of chronic kidney diseases in the population (carole et al., 2017). uromodulin, also known as tamm-horsfall protein, is an 85 kda glycoprotein normally secreted by epithelial cells lining the thick ascending limb (tal) of henle's loop and early distal tubule. it is released through proteolytic cleavage of glycosylphosphatidylinositol (gpi)-anchored protein, primarily localized to the apical plasma membrane. uromodulin levels undergo significant changes in urinary excretion during pathological conditions, making it a valuable marker for renal disease

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients with not no album in ur is, micoalbuminuria and macroalbuminuria exclusion criteria:prescence of non diabetic or obstructive kidney disease,
osteogenic cell viability in bone graft

Conditions: Fractures, Closed

Summary: the purpose of this study is to find out if the cells in bone graft samples collected using a reamer are similar to the cells in bone graft samples collected using the iliac crest bone graft method.

although iliac crest bone grafting is the gold standard for autogenous bone grafting procedures, limited quantity in some individuals and donor site morbidity have lead surgeons to look for alternative harvest sites or sources such as allograft or osteobiologics. of these alternative harvest sites is the femoral shaft. intramedullary contents from reaming are composed of bone marrow, and blood and bone spicules. in this respect, the reamed contents are similar to the bone routinely harvested from the iliac crest. studies have shown that despite the reaming process using standard reamers, cells maintain their viability and are able to produce new bone. however, the addition of aspiration and irrigation used in the ria system could potentially compromise the harvested cell viability and limit their osteogenic potential. in addition, wenisch et al. have concluded that the harvested cells using standard intramedullary reamers not only proceed toward osteogenic differentiation, but also can be directed toward neurogenic differentiation. this suggests that reaming debris is a viable source of stem cells as well. ria allows for these cells to be harvested. it is our hypothesis that the intramedullary contents harvested using the ria system is similar to icbg in cell viability and osteogenic potential.

Eligibility criteria:
inclusion criteria: * subjects age 18 years or older * subjects undergoing a bone grafting procedure, either using an iliac crest or ria system harvesting technique, or * subjects undergoing reamed femoral intramedullary nailing using the ria reaming technique exclusion criteria: * subjects under age 18 * subjects with a history of: leukemia; cancer with bone metastases; renal failure, receiving dialysis; or on immunosuppressive medications

Keywords: iliac crest bone graft reamer irrigator aspirator
comparing hepatic intra-arterial injection of yttrium-90 microspheres versus fluorouracil (5fu) in colorectal cancer metastatic to the liver only

Conditions: Colorectal Neoplasm; Secondary Malignant Neoplasm of Liver

Summary: this is a phase iii trial comparing hepatic intra-arterial injection of yttrium-90 microspheres (selective internal radiation \[sir\] spheres) versus infusional intravenous (iv) 5fu in colorectal cancer metastatic to the liver only and refractory to standard iv chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically proven colorectal adenocarcinoma, metastatic to the liver only. * failure of prior chemotherapy for advanced colorectal cancer. * adequate laboratory values of hematologic, renal and liver function * world health organization (who) performance status (ps) \<= 2 * written consent exclusion criteria: * pregnant or lactating patients * other tumor type than adenocarcinoma (leiomyosarcoma; lymphoma). * patients with cirrhosis or other chronic liver disease * thrombosis of the hepatic main artery of the portal vein * lung shunting \> 20% as determined by nuclear medicine breakthrough scan * patients with serum bilirubin \> 1.0 x upper limit of normal (uln) or with ast and/or alt and/or alkaline phosphatase \> 5 x uln * patients with concurrent or within 4 week period administration of any other experimental drugs. * other serious illness or medical conditions.

Keywords: colorectal cancer liver metastasis intraarterial hepatic injection yttrium loaded microspheres colorectal neoplasm metastatic to the liver
subacromial impingement - the need of arthroscopic subacromial decompression after eccentric physical therapy exercises

Conditions: Subacromial Impingement Syndrome

Summary: objective: a randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (pt) for patients with subacromial impingement. hypothesis: h1 the exercises has a satisfactory effect and the need of an arthroscopic subacromial decompression can be reconsidered. h0 no difference between the two exercises (experimental and active control) and the patients still need surgery further the study objective is to evaluate predictors for a positive or negative treatment response after three months of rehabilitation as well as after 12 months. method: patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are offered a three month rehabilitation program during the waiting time for surgery which is approximately 4-6 months. all patients must have tried conservative treatments for at least 6 months in primary care with unsatisfactory results. the patients will be randomized to either the structured eccentric exercises tutored by a physical therapist or control exercises with general movements for the neck and shoulders. all patients has an equal number of sessions with the pt to offer similar attention. after three months the following key-question has to be answered: due to your current experience of your shoulder problems do you still need this surgical intervention? a blinded orthopedic surgeon evaluates the following outcomes at baseline and after three and twelve months. primary outcomes: constant-murley shoulder assessment, disabilities of the arm shoulder and hans and different aspects of pain. secondary outcomes; eq-5d, sick-leave and return to work. all patients are evaluated with a diagnostic ultrasound in order to reveal the condition of the rotator cuff. also long-term results in those who go thorough with the surgery and those who decline will be assessed after 12 months. importance of the study results: since there is no consensus about which intervention that should be preferred for patients with subacromial impingement the results of the current study is warranted. if this exercise program is successful it can be implemented into clinical practice. further, clinical characteristics of patients that really need an arthroscopic subacromial decompression can be identified.


Eligibility criteria:
inclusion criteria: * subacromial impingement verified with neer impingement injection test * at least 6 months duration * treated in primary care without satisfactory result for at least 6 months three of these five must be positive: * neer impingement sign * hawkins-kennedy impingement sign * jobe supraspinatus test * patte maneuver * typical history and pain location (c5 dermatome) exclusion criteria: * radiological finding of malignancy, osteoarthritis, fractures * polyarthritis or fibromyalgia * pathological hyper-laxity or dislocation of the any of the shoulder joints * cervical spine pathology * lack of communication skills that prevent the use of outcome measures
diabetes outcomes and unmet resources

Conditions: Diabetes

Summary: this study will refine and test the effectiveness of careavenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.


Eligibility criteria:
inclusion criteria: * be 18-75 years of age * be diagnosed with type 1 or type 2 diabetes with prescribed anti-hyperglycemic medication * have a most recent hemoglobin a1c(hba1c) level within the past 6 months of ≥7.5% for individuals ≤70 years and \>8.0% for individuals between 70-75 years in age * have access to a telephone that can receive and send text messages * not participating in another diabetes intervention research study exclusion criteria: * significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.

Keywords: diabetes self-management adherence social determinants of health social risk factors
pharmacokinetics of amikacin and cefuroxime in critically ill patients.

Conditions: Sepsis; Septic Shock; Infection, Bacterial; Critically Ill

Summary: infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. since critically ill patients often have altered pharmacokinetics (pk) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the icu or the ed. to prevent the risk of inadequate dosing in icu patients, it is important to fully understand the pk of antibiotics in this vulnerable group in order to optimize the dosing regimens. with this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in icu and ed patients. a heterogeneous population of icu and ed patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. by using population modeling the investigators will simulate different dosing regimens and mic values and compare probability of target attainment between each of these dose and mic combinations. this will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.


Eligibility criteria:
inclusion criteria: 1. the patient is admitted to the icu or ed; 2. the patient is at least 18 years of age on the day of inclusion; 3. is managed with a central venous catheter or arterial line; 4. is treated with amikacin and/or cefuroxime as standard care. exclusion criteria: 1. has previously participated in this study.

Keywords: sepsis septic shock infection critically ill
vascular health and exercise performance of overweight children

Conditions: Patient Compliance

Summary: the purpose of this study is to assess exercise performance in 20 healthy children 10-19 years of age with a body mass index greater than 85th percentile and to evaluate the effect of dietary and exercise intervention over 12 weeks.

our hypothesis is that the vascular health in these children will improve at the end of intervention. the results of this study will help us in our long-term objective of improving vascular health of children with congenital/acquired heart disease, a group particularly at risk for premature atherosclerosis.

Eligibility criteria:
inclusion criteria: * 10-19 years old * overweight (bmi \> 85 percentile) * interested in a 12 week ¬home exercise \& nutrition program * have computer \& internet access * can come to lucile packard children's hospital at stanford for a 3-hour test at the start \& end of the study (so only twice!) * are able to come to testing after fasting overnight * do not smoke * do not take any medications exclusion criteria: * non-overweight adolescents
effectiveness and safety of bulkamid® as bulking agent for the treatment of female urinary incontinence

Conditions: Urinary Incontinence

Summary: to assess effectiveness of bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period


Eligibility criteria:
inclusion criteria: * informed consent * symptomatic stress or mixed urinary incontinence for at least 12 months * having at least 1 incontinence episode per day over three days exclusion criteria: * regular or intermittent users of an urethral catheter * pregnant women * suffer from severe allergies or anaphylaxis * suffer from autoimmune diseases or any unstable or sever cardio-vascular disease * history of any cancer within the last 5 years * previous surgery for the treatment of urinary incontinence, including bulking

Keywords: urinary incontinence bulkamid