Kornimate/medical-research-clean huggingface dataset:
comparison of surgical time and efficiency of total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: this study is designed to compare the surgical efficiency of trumatch® personalized solutions surgical technique compared to conventional surgical technique. specifically, the purpose of this study is to collect time data to enhance the existing economic model.

the study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of trumatch® personalized solutions surgical technique compared to conventional surgical technique.

Eligibility criteria:
inclusion criteria: * subject is male or female and between the ages of 18 and 80 years old, inclusive. * subject requires a primary total knee replacement and is considered by the investigator to be suitable for the specific knee prosthesis identified in the protocol. * subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to depuy * subject, in the opinion of the clinical investigator, is able to understand this clinical investigation, and co-operate with investigational procedures. * subject, who, in the opinion of the clinical investigator, are suitable for implantation using trumatch™ instrumentation. for example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause ct scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture are consistent with trumatch™ instrumentation. exclusion criteria: * the subject is a woman who is pregnant or lactating. * the subject has participated in a clinical investigation with an investigational product in the last 3 months. * the subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims. * the subject has previously had a prosthetic knee replacement device (any type) of the affected knee. * the subject requires simultaneous bilateral total knee replacements. * the subject had a contralateral tka and that knee was previously entered in the study. * subject in whom the surgeon intends to implant a knee prosthesis that is not in the pfc sigma primary knee system. * subject who has inflammatory arthritis. * subject who has a body mass index (bmi) of ≥ 40. (please see table 2-1: definition of terms, for bmi definition and calculation formulas).

Keywords: arthroplasties, knee replacement arthroplasties, replacement, knee arthroplasty, knee replacement knee replacement arthroplasties knee replacement arthroplasty knee replacement, total replacement arthroplasties, knee replacement arthroplasty, knee replacement, total knee total knee replacement
comparison of premixed insulin with basal-plus insulin in type 2 diabetes patients

Conditions: Diabetes

Summary: comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes

this is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 140 patients with type 2 diabetes from mackay memorial hospitals and mackay memorial hospital taitung branch. after enrollment, eligible patients will be randomized in a 1:1 ratio to either basal-plus therapy(bpt) or preprandial premix therapy(ppt). the effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. the safety will be followed during the 24-week study period. all study procedure will be conducted after obtaining informed consent.

Eligibility criteria:
inclusion criteria: * men and women with type 2 diabetes.(world health organization classification) \> 20 years of age. * patients who have received stable doses of any oads for at least 12 weeks prior to the screening visit. * treatment with basal insulin plus oads \>3 months with suboptimal glycemic control (hba1c \>7%) * fbg \ 0.7u/kg or had history of nocturnal hypoglycemia * patients who are willing and able to cooperate with study and give signed informed consent. exclusion criteria: * patients with type 1 diabetes. * history of severe hypoglycemia or hypoglycemia unawareness within prior 6 months. * patients who had received any investigational insulin for more than 3 months or who have received investigational insulin treatment within 4 weeks prior to screening visit. * patients hypersensitive with insulin analog or its excipients. * patients who are currently pregnant/lactating, or who are preparing for pregnancy or lactation. * renal dialysis patients, patients with severe liver disease or congestive heart failure * bmi \>40kg/m2 * excessive insulin resistance (total daily insulin dose\>2.0unit/kg)

Keywords: premix insuiln, basal-plus insulin
a trial to compare post prandial blood glucose control of biochaperone® combo with humalog® mix25 and with simultaneous injections of humalog® and lantus® in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of biochaperone® combo compared with humalog® mix25 and with simultaneous subcutaneous injections of humalog® and lantus® during three separate dosing visits.

this is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of biochaperone® combo compared with humalog® mix25 and with simultaneous subcutaneous injections of humalog® and lantus® during three separate dosing visits. furthermore, this study aims to compare the pharmacokinetic (pk) profiles of the three different study treatments. during each dosing visit, subjects will be given 3 doses of imp on three consecutive days (day 1, day 2 and day 3). dosing on day 2 and day 3 will be followed by a standardised solid meal test.

Eligibility criteria:
inclusion criteria: * male or female subject aged 18-70 years (both inclusive) * type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months * hba1c level between 7.5% and 9.5% (both inclusive) * body mass index between 20.0 and 40.0 kg/m2 (both inclusive) * treated with once daily injections with insulin glargine u-100 for ≥ 3 months prior to screening exclusion criteria: * type 1 diabetes mellitus * known or suspected allergy to the imps or related products * previous participation in this trial. participation is defined as randomised. * receipt of any medicinal product in clinical development within 60 days prior to this trial. * clinically significant abnormal haematology, biochemistry, urinalysis or coagulation screening tests, as judged by the investigator considering the underlying disease * supine blood pressure at screening outside the range of 90-160 mmhg for systolic or 50-95 mmhg for diastolic and/or resting supine heart rate outside the range 50-90 beats per minute. this exclusion criterion also pertains to subjects being on antihypertensives. * current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine u-100. the use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening. * use of glp-1 receptor agonists or oral antidiabetic drugs (oads) other than stable intake of metformin alone or metformin in combination with a dpp-4 inhibitor within 4 weeks prior to screening * women of child bearing potential not willing to use contraceptive methods.
comparative study of sitagliptin and gliclazide with metformin in type 2 diabetes patients with glucotoxicity

Conditions: Type 2 Diabetes Mellitus; Glucotoxicity

Summary: this study compares the efficacy and safety of sitagliptin phosphate combined with gliclazide sustained-release tablets versus metformin in treatment-naïve patients with type 2 diabetes mellitus (t2dm) and glucotoxicity. the trial assesses glycemic control, patient compliance, and adverse events over a 12-week period using a randomized controlled design to determine the non-inferiority of the combined treatment.

in this single-center, prospective, randomized controlled non-inferiority study, treatment-naïve patients with t2dm and glucotoxicity were enrolled to evaluate the comparative efficacy and safety of two therapeutic regimens. the study investigates the combination of sitagliptin phosphate with gliclazide sustained-release tablets against metformin alone. participants were randomized and monitored for 12 weeks, with primary outcomes focusing on fasting plasma glucose (fpg) levels, body weight changes, and hypoglycemic events. the study also explores the impact of treatment on β-cell function and insulin sensitivity, utilizing pharmacogenomic analysis to evaluate genetic factors influencing treatment response.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus (t2dm) and glucotoxicity. * body mass index (bmi) between 18 and 30 kg/m². * fasting plasma glucose (fpg) levels ≥ 200 mg/dl and glycated hemoglobin (hba1c) ≥ 9.0%. * normal hepatic and renal functions (alt and ast ≤ 2.5 times the upper limit of normal; serum creatinine within normal limits). * capable of adhering to the prescribed anti-diabetic regimen and dietary guidelines. exclusion criteria: * diagnosis of type 1 diabetes mellitus. * hepatic or renal dysfunction (serum creatinine \> 1.2 times the upper limit of normal). * prior use of hypoglycemic medications before screening. * history of severe ketosis, ketoacidosis, or hyperosmolar hyperglycemic state. * current treatment with corticosteroids, immunosuppressive agents, or cytotoxic drugs. * major systemic diseases (e.g., cardiovascular, respiratory, neurological). * pregnant or breastfeeding women. * known allergies to sitagliptin or gliclazide. * poor compliance potential as assessed by the investigator.

Keywords: sitagliptin gliclazide metformin randomized controlled trial non-inferiority study glycemic control β-cell function
safety and efficacy of topical r333 in patients with discoid lupus erythematosus (dle) and systemic lupus erythematosus (sle) lesions

Conditions: Lupus Erythematosus, Discoid; Lupus Erythematosus, Systemic

Summary: the purpose of this study is to determine the safety, efficacy and tolerability of topical r333 ointment in discoid lupus erythematosus (dle) and systemic lupus erythematosus (sle) patients with active discoid lesions.

this is a phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the preliminary efficacy, safety, tolerability, and pharmacokinetics of topical r333 ointment formulated at 6% (60 mg/g) in dle and sle patients with active discoid lesions.

Eligibility criteria:
inclusion criteria: * diagnosis of sle or dle (dle confirmed histologically prior to randomization). * at least 2 active discoid lesions secondary to sle or dle prior to study entry, each with a minimum erythema rating score of ≥ 2. at least 1 of the active discoid lesions must have been present (by history) for ≥ 3 weeks prior to screening. * patients who are taking azathioprine, hydroxychloroquine, chloroquine, quinacrine, methotrexate, and/ or oral glucocorticoids, must be receiving a stable daily dose ≥ 4 weeks prior to randomization and must remain on the same dose throughout the study. azathioprine, hydroxychloroquine, chloroquine, quinacrine, or methotrexate must be initiated ≥ 8 weeks prior to randomization. exclusion criteria: * congenital or acquired immunodeficiency including: hiv infection, agammaglobulinemias, t cell deficiencies or htlv-1 infection at any time prior to the study. * lymphoproliferative disease or previous total lymphoid irradiation. * uncontrolled or poorly controlled hypertension. * history of psoriasis, eczema, or relevant atopy. * exposure to excessive or chronic uv radiation (e.g., tanning beds, sunbathing, solarium, phototherapy) within 2 weeks prior to randomization or during the study period.

Keywords: discoid lupus erythematosus systemic lupus erythematosus
noninvasive spinal cord stimulation for neurogenic and idiopathic overactive bladder

Conditions: Overactive Bladder; Incontinence, Urge; Neurogenic Bladder

Summary: overactive bladder (oab) affects 12-30% of the world's population. the accompanying urinary urgency, urinary frequency and incontinence can impair the ability to work, interact in social activities and can result in poor social functioning. multiple treatment modalities are available for overactive bladder. however, each therapy has drawbacks that limit its application in certain patient populations. for example, oral medications have significant side effects and suffer from poor adherence. botulinum toxin injection into the bladder wall is invasive, requires re-treatment on a regular basis and carries a risk of urinary retention. current neuromodulatory techniques are invasive and require highly-specialized care. therefore, a need exists for a non-invasive, well-tolerated and easily administered therapy for oab. transcutaneous spinal cord stimulation (tscs) has been developed and tested in able bodied individuals to initiate locomotor function as well as in the sci population for lower extremity and upper extremity function. more recently, we have tested this sci patients to enable lower urinary tract function and decrease detrusor overactivity, resulting in improved continence.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years 2. known diagnosis of overactive bladder, confirmed by: * presence of urinary frequency, urgency * frequent small-volume voids on frequency-volume chart * high score on iciq-oab, iciq-oabqol, and oab-q questionnaires exclusion criteria: 1. younger than 18 years of age 2. older than 80 years of age 3. presence of lower urinary tract symptoms suggestive of urinary retention or obstruction 4. finding of an elevated post-void residual (\>100 ml) on an ultrasonographic bladder scan 5. history of spinal cord injury, spina bifida or other neurological disease affecting the spinal cord 6. acute or current urinary tract infection 7. history of neuromodulation for overactive bladder (sacral nerve stimulation or peripheral tibial nerve stimulation) 8. current or planned pregnancy
laparoscopic dor versus toupet fundoplication for the treatment of idiopathic esophageal achalasia

Conditions: Esophageal Achalasia

Summary: the primary aim of this study is to test the hypothesis that heller myotomy and toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour ph testing when compared to heller myotomy and dor fundoplication.

idiopathic achalasia is an uncommon motor disorder of the esophagus which occasionally requires surgical intervention. although there are several controversial aspects of therapy for achalasia, laparoscopic myotomy is emerging as the procedure of choice. several studies report having good to excellent outcomes following a laparoscopic procedure in approximately 90% of patients. however, a main deterrent to long-term success is the development of gastroesophageal reflux disease (gerd) despite the use of an antireflux procedure. for this reason, most surgeons add a partial fundoplication to the myotomy. the gastric fundus can either be wrapped anterior to the esophagus (dor fundoplication), or posterior to the esophagus (toupet fundoplication). currently, the type of fundoplication is determined by surgeon's choice. there exists no systematic comparison of the two procedures. this multicenter, randomized study aims to evaluate patient outcomes following myotomy and dor versus toupet fundoplication.

Eligibility criteria:
inclusion criteria: * diagnosis of achalasia exclusion criteria: * prior heller myotomy

Keywords: heller dor heller toupet myotomy
study of psma-targeted 18f-dcfpyl pet/ct for the detection of clinically significant prostate cancer

Conditions: Prostate Cancer

Summary: this is a phase ii, single-center, open-label, trial to evaluate the diagnostic accuracy of psma-targeted 18f-dcfpyl pet/ct for detecting clinically significant prostate cancer in a screening population.

this is a phase ii, single-center, open-label, trial to evaluate the diagnostic accuracy of psma-targeted 18f-dcfpyl pet/ct for detecting clinically significant prostate cancer in a screening population. 150 biopsy-naïve patients with an elevated psa (2-10 ng/ml) will be enrolled in this study. within 28 days of informed consent, patients will undergo an 18f-dcfpyl pet/ct. all scans will be read by a single experienced radiologist who will identify regions of interest (roi) with discrete radiotracer uptake. the maximum suv value (suvmax) of each roi will be recorded. for patients without a detectable roi, the mean suv (suvmean) of a 1-2 cm volume of the prostate will instead be recorded. one to 28 days following pet/ct imaging, a systematic 12 to 14 core trus-guided prostate biopsy will be performed. immediately following completion of systematic trus biopsies, fusion-targeted biopsies of all pet and/or mri visible lesions will be performed, taking an additional 2 to 3 cores from each radiographic roi. all biopsy cores will be assessed for gleason score and percent cancer involvement.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * psa of 2-10 ng/ml * clinical stage t1c-t2a on digital rectal exam * elect to undergo trus-guided prostate biopsy as part of routine clinical care * willingness to sign informed consent and comply with all protocol requirements exclusion criteria: * history of prior prostate biopsy * administered a radioisotope ≤5 physical half-lives prior to the date of study pet/ct * administered iv x-ray contrast medium ≤24 hours prior to the date of study pet/ct * administered oral contrast medium ≤120 hours prior to the date of study pet/ct * any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives

Keywords: j17149 psma 18f-dcfpyl pet/ct
systemic, intrapulmonary and pleural inflammatory reaction in patients undergoing thoracic surgery

Conditions: Lung Neoplasms

Summary: inflammatory reaction in different compartments of the body may have a negative effect on outcome. this study assesses the inflammatory reaction systemically, intrapulmonary and intrapleural by measuring different cytokines. patients with lung cancer undergoing lobectomy or segmentectomy are included in the study. hypothesis: the inflammatory reaction in the pleural space is high compared to the systemic and intrapulmonary ones.


Eligibility criteria:
inclusion criteria: * elective lobectomy * elective segmentectomy * 20-90 years * informed consent given exclusion criteria: * emergency operations * pneumonectomy

Keywords: lobectomy inflammatory reaction intrapulmonary intrapleural
technology assisted physical activity among hospitalised patients with respiratory disease

Conditions: Respiratory Disease

Summary: the aim of this study is to investigate if patients hospitalised for medical disease will increase their time spent out of bed during hospitalisation through simple feedback about physical activities from a mobile device. physical activity is measured by means of a pair of accelerometers embedded in band aids placed on the thigh and on the chest. the measurement is continuous and data is uploaded to a secure internet-server. summaries of physical activity (bedrest, sitting, standing, walking) is computed and can be displayed on a mobile device (tablet) through a dedicated application. the study will be conducted as a controlled cohort study in a large tertiary public hospital in copenhagen, denmark. patients admitted to department of respiratory medicine will be included and will have their physical activity measured during hospitalisation. half of the cohort will receive visual feedback about the amount of physical activity from a mobile device placed on the bed table. a total of 108 patients will be included resulting in 6 periods of 18 patients each.


Eligibility criteria:
inclusion criteria: 1. is admitted to the department of respiratory medicine 2. has signed informed consent 3. reads and speaks danish exclusion criteria: 1. any condition that, in the opinion of the investigator, makes the person unfit for participation 2. has allergy towards band aid
retrospective analysis assessing clinical risk factors for cardiovascular events and mortality and development of a risk calculator in chronic kidney disease stage 5 on dialysis

Conditions: Chronic Kidney Disease (CKD)

Summary: the purpose of this study is to evaluate which clinical and laboratory factors are associated with major adverse cardiovascular event (mace) in chronic kidney disease (ckd) patients on dialysis. the study will also establish a cardiovascular (cv) risk equation appropriate for this dialysis population.

this study is a retrospective analysis of dialysis dependent ckd patients participating in aurora. the retrospective analysis will be performed using the aurora study database. aurora was a prospective clinical trial in which dialysis patients were randomly assigned to rosuvastatin or placebo, sponsored by astrazeneca. patients included in the aurora study who had end stage renal disease (esrd) and had been treated with regular hemodialysis or hemofiltration for at least 3 months. patients were recruited from approximately 300 centers in 25 countries. the clinical study data is held by astrazeneca ab, sweden. no formal sample size calculation was performed. the sample size is based on the available data from the aurora study.

Eligibility criteria:
inclusion criteria: * patients who participated in the aurora study. in brief, men and women who had esrd and had been treated with regular hemodialysis or hemofiltration for at least 3 months (patients were recruited from 280 centers in 25 countries). exclusion criteria: * the major exclusion criteria in aurora were statin therapy within the previous 6 months, expected kidney transplantation within 1 year, and serious hematologic, neoplastic, gastrointestinal, infectious, or metabolic disease (excluding diabetes) that was predicted to limit life expectancy to less than 1 year. * other exclusion criteria were a history of a malignant condition, active liver disease (indicated by an alanine aminotransferase level that was more than three times the upper limit of the normal range), uncontrolled hypothyroidism, and an unexplained elevation in the creatine kinase level to more than three times the upper limit of the normal range.

Keywords: aurora cardiovascular events chronic kidney disease
cpap in diabetes type 2 patients with sleep apnea

Conditions: Diabetes; Sleep Apnea

Summary: aim: to assess if six months of treatment with cpap associated with conventional drug therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome sahs)

main objective: to assess the effect of 6 months of cpap treatment associated with conventional drug therapy on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (sahs)

Eligibility criteria:
inclusion criteria: * subjects 18 to 75 years old; diagnosis of type 2 diabetes mellitus; treatment with diet; oral antidiabetics or insulin stable in the last month; levels of hba1c\> 7.5% (if not supported clinic two controls to confirm with a difference not exceeding 0.5%); overweight or obese (bmi ≥ 25 kg/m2) exclusion criteria: * professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (epworth scale\> 18); morbid obesity (bmi\> 40 kg/m2); cpap treatment

Keywords: diabetes apnea- hypopnea syndrome glycemic control prevalence sahs life quality