Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of exenatide in patients with type 2 diabetes using metformin or sulfonylureas and metformin

Conditions: Type 2 Diabetes Mellitus

Summary: this study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (oad) agents and twice-daily placebo plus oad with respect to glycemic control.


Eligibility criteria:
inclusion criteria: * treated with a stable dose of one of the following for at least 3 months prior to screening: \* \>=1000 mg/day immediate-release metformin; or metformin \>=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy. * hba1c between 7.1% and 11.0%, inclusive. * body mass index (bmi) \>21 kg/m\^2 and \<35 kg/m\^2. exclusion criteria: * have participated in this study previously, or any other study using exenatide or glp-1 analogs. * have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening. * have characteristics contraindicating metformin or sulfonylurea use. * have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening. * have used drugs for weight loss within 1 month of screening.

Keywords: exenatide diabetes amylin lilly china
efficacy and safety of donepezil hydrochloride (aricept) in vascular dementia

Conditions: Vascular Dementia

Summary: the purpose of this study is to examine the efficacy and safety of cholinesterase inhibitor (donepezil hydrochloride) aricept in patients with vascular dementia (vad).

vascular dementia is a significant cause of intellectual and functional impairment in young patients consequent to cerebrovascular disease. post-mortem studies show that vad patients have a cholinergic deficiency like in alzheimer's disease (ad). cholinesterase inhibitors are now standard treatment for mild to moderate ad. this study aims to determine if donepezil, a cholinesterase inhibitor, would benefit patients with vad by decreasing their scores in the vadas-cog and improvement in their cibic rating over a period of 24-weeks treatment. adverse events will also be monitored.

Eligibility criteria:
inclusion criteria: the subjects eligible for this study are men and women outpatients, age 40-60 years old, who fulfill the criteria for vad according to the national institute of neurological disorders and stroke and the association internationale pour la recherche et l'enseignement en neurosciences international workshop (nincds-airen). subjects shall undergo extensive clinical examination by a stroke specialist and radiological examination (ct or mri) to document presence of cerebrovascular disease. the clinical diagnosis has to be relevant to the imaging findings. other inclusion criteria: subjects with clinically stable hypertension, diabetes mellitus, and cardiac disease for the last 3 months. subjects with history of recent stroke, who have not been hospitalized for stroke in the previous 3 months. subjects with depression controlled with medications. subjects should have no hearing or visual impairment and live with a reliable caregiver. exclusion criteria: subjects should have no radiological evidence of other brain disorders (subdural hematoma, post-traumatic / post-surgery) have no depression or other psychiatric disorders, infectious disorders, neoplastic condition, and metabolic and toxic encephalopathies, dementia due to ad or prior diagnosis of ad, and major depression or other psychiatric disorders. subjects with clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrine or other life threatening diseases; pregnancy, history of alcohol or drug abuse, and sensitivity to cholinesterase inhibitors; use of investigational agents, cholinomimetic and anticholinergic agents.

Keywords: vascular dementia
quality of vision and quality of life with lasik

Conditions: Myopia; Astigmatism; Quality of Lifte

Summary: the investigators are administering a validated questionnaire looking at patient reported quality of life and quality of vision after lasik surgery

the purpose of the study is to evaluate the prevalence of any functional limitations and their associated factors at one, three, six, and twelve months after lasik surgery and finally the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, six and twelve months following lasik surgery using two questionnaires.

Eligibility criteria:
inclusion criteria: * are aged 21 years or older. * have the ability to give informed consent. * speak and read english fluently. * have not previously had any form of refractive surgery, including prior lasik or cataract surgery. * may benefit from increased spectacle independence. * have been determined to be a good candidate for the lasik procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations. * have a treatment target of bilateral emmetropia. * express willingness and potential ability to return for all follow-up examinations through the 12-month follow-up exam under the care of the treating investigator. * are not enrolled in any other research study. exclusion criteria: * subjects under the age of 21. * patients with excessively thin corneas. * patients with topographic evidence of keratoconus. * patients with ectactic eye disorders. * patients with autoimmune diseases. * patients who are pregnant or nursing.

Keywords: lasik satisfaction
feasibility of an immediate preoperative chemotherapy before resection fo colorectal cancer

Conditions: Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated

Summary: the purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality


Eligibility criteria:
inclusion criteria: * colorectal metastatic adenocarcinoma (stage iv) with unresectables, measurables and visibles secondary lesions * primitive tumor must be operate * patient age between 18 and 70 * oms status performance \< 2 * life expectancy \> 12 weeks * hematologic function : pnn \>/= 1.5x10\^9/l, platelets \>/= 100x10\^9/l * hepatic function : bilirubin \</= 1.5xlsn, ast and alt \</= 3xlsn, alcalin phosphatasis \</= 3xlsn * plasmatimic creatin \</= 1.25xlsn * no previous chemotherapy or pelvic radiotherapy * men and women in age of procreate agreeing to use a contraception until 4 months after the end of treatment for women and until 6 months for men exclusion criteria: * nonmetastatic forms * colorectal tumor which requires preoperative radiotherapy * nonmeasurable metastasis based on recist criteria * previous chemotherapy for colorectal cancer * previous irradiation of the primitive tumour * specific indication against the treatment studied * patient considered as inoperable for physiological or carcinologic reasons * pregnant or breast feeding women
temporal relations and exercise interventions of various gait and cognitive domains in older adults

Conditions: Fallers; Mild Cognitive Impairment

Summary: the effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. third, whether changes in serum levels of the brain-derived neurotrophic factor (bdnf), insulin-like growth factor (igf)-1, and vascular endothelial growth factor (vegf) and expression of the apolipoprotein e (apoe) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.


Eligibility criteria:
inclusion criteria: * at least 65 years old * had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months) * can ambulate independently * has mild cognitive impairment exclusion criteria: * do not live in a community setting * cannot ambulate independently and communicate with researchers * have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia) * have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

Keywords: biomarker cognitive impairment gait abnormality older adults exercise
early goal directed sedation on microcirculation in septic shock

Conditions: Septic Shock

Summary: the investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients.

recent studies suggest that early goal directed sedation might improve the outcome of critically ill patients. the investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients with relative stable hemodynamics.

Eligibility criteria:
inclusion criteria: * septic shock patients despite early goal directed therapy * required sedation exclusion criteria: * age\< 18 * pregnancy * bradycardia (hr\<55bpm) * systolic blood pressure \< 80 mmhg / mean arterial pressure \< 50 mmhg on maximal support * death imminent * unlikely to survive 90 days * acute liver failure * dementia * high-grade block in the absence of a functioning pacemaker.

Keywords: septic shock sedation microcirculation
feasibility of ai-based classification of normal, wheeze and crackle sounds from stethoscope in clinical settings

Conditions: Respiratory; Lung

Summary: assessing the feasibility and testing the accuracy of the developed artificial intelligence algorithms for detection of wheezes and crackles in patients with lung pathologies in clinical settings on unseen local patient data acquired through three digital stethoscopes.


Eligibility criteria:
inclusion criteria: * ages all * written consent provided exclusion criteria: * subject condition unstable * chest wall deformity or wounds in adhesive application areas * written consent not provided
extension study of 1.0mg dose letrozole therapy in postmenopausal patients with breast cancer

Conditions: Postmenopausal Women With Advanced Breast Cancer

Summary: - to investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in japanese postmenopausal patients with advanced breast cancer which participated in double blind study.


Eligibility criteria:
inclusion criteria: - patients which participated in double blind study exclusion criteria: * patients with intolerable toxicity. * patients which confirmed progressive disease during double blind study. * patients which have received concurrent anti-cancer therapy during double blind study.

Keywords: aromatase inhibitor letrozole breast cancer
caffeine study for pain control following total joint replacement

Conditions: Pain, Postoperative

Summary: a prospective, double blinded, single center, randomized controlled study to evaluate the efficacy of caffeine in combination with acetyl salicylic acid (asa) in the management of postoperative pain in patients undergoing total joint arthroplasty.


Eligibility criteria:
inclusion criteria: * patient is older than 18 years old at the time of the surgery. * patient is treated by rothman orthopaedics institute and is scheduled for the surgical procedure at atlanticare regional medical center. * patient is undergoing total hip or total knee arthroplasty. * patient has the diagnosis of osteoarthritis of the hip or the knee, or other noninflammatory disease that results in joint damage to the hip or the knee. exclusion criteria: * patient has known history of opioid addiction and/or has taken opioids preoperatively. * patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal ekg. * patient has a known allergy to aspirin or caffeine. * patient has history of chronic pain that required the intervention of a pain management doctor. * patient has an active infection at the time of surgery (systemic or localized) or history of chronic infections that affected the lower extremities. * patient has history of cancer that would affect patient reported outcomes including pain. * patient has history of neuropathic pain or nerve degenerative disease. * patients undergoing revision surgery would be excluded. * patients who require alternate dtv prophylaxis other than asa.
evaluation of adult onset still disease classification criteria and differential diagnosis at eighteen months of follow-up

Conditions: Adult Onset Still Disease

Summary: adult onset still disease (aosd) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. its diagnosis rely on sets of criteria, i.e. fautrel criteria and yamaguchi criteria. however, differential diagnosis might appear during follow-up of patients. the aim of this study is to assess diagnostic performance of fautral and yamaguchi criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.

adult onset still disease (aosd) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. other conditions such as cancer, infection or other inflammatory disease might mimick its symptoms. its diagnosis rely on sets of criteria, i.e. fautrel criteria and yamaguchi criteria. however, differential diagnosis might appear during follow-up after an initial diagnosis of aosd. the aim of this study is to assess diagnostic performance of fautral and yamaguchi criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.

Eligibility criteria:
inclusion criteria: * adults * with glycosylated ferritin dosage for suspected adult onset still disease * with at least 18 month of follow-up exclusion criteria: * known infectious disease * known cancer * known active connective tissue disease or vasculitis

Keywords: adult onset still disease differential diagnosis diagnosis performance
comparision of fibtem and blood-loss

Conditions: Sternotomy; Bleeding Test

Summary: correlation between fibtem and intraoperative blood loss


Eligibility criteria:
inclusion criteria: full sternotomy age \>18 inform consent signed exclusion criteria: hypofibrinogen

Keywords: 5 minute bleeding test swamb fibtem extem
diagnostic approach of deep vein thrombosis in primary care

Conditions: Thrombosis

Summary: to asses the cost-effectiveness of implementing different diagnostic strategies in patients with clinical assessment of suspected deep vein thrombosis (dvt) at first presentation in primary care. to evaluate the utility of using d dimer test to diagnose dvt in primary care. to describe the differential diagnosis and the strength of association between each outcome variable and the clinical prediction guide and the final diagnosis. it is a cross-sectional, multicentric study.

the participants are the patients referred from the 15 primary care centers (400.000 inhabitants) to the hospital de la santa creu i sant pau emergency department with suspected dvt. we will enter physical examination and anamnesis variables, wells and oudega's rules variables, d-dimer value and ultrasonography result. the outcome variables are the cost (€) of each possible way of diagnostic approach and the effectiveness will be measured by the ultrasonography result, which confirms or excludes the diagnosis. the sample will include 437 patients. a decision tree will be developed to analyze the different diagnostic options in dvt cases, using standard notation.

Eligibility criteria:
inclusion criteria: * patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of hospital santa creu i sant pau exclusion criteria: * anticoagulant treatment * patients who will not be able to follow control visit * patients with oncologic treatment

Keywords: deep vein thrombosis primary care diagnosis clinical model
hydroxyethyl starch and renal function after radical prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of this project is to investigate if hydroxyethyl starch (hes) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of hes during surgery.

hydroxyethyl starch (hes) is widely used in hospitals to maintain circulation in critically ill patients. in recent years studies have raised suspicion that hes is nephrotoxic. so far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine. the purpose of this project is to investigate hes's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of hes 130/0.4

Eligibility criteria:
inclusion criteria: * age \> 18 years * males * indication for radical prostatectomy exclusion criteria: * blood donation within the last month * lack of wish to participate * egfr\< 15ml/min
benlysta® special drug use investigation

Conditions: Systemic Lupus Erythematosus

Summary: the objective of this study is to collect and assess the information about long-term safety and effectiveness of benlysta for intravenous injection and benlysta for subcutaneous injection (hereinafter referred to as "benlysta") in daily clinical practice. the aim of conducting this drug use investigation (dui) in all subjects until data are accumulated from a certain number of subjects after benlysta being marketed, data will be collected on safety and effectiveness of benlysta in an early stage and thereby to take the necessary measures for proper use of benlysta. approximately 600 subjects will be enrolled in to this study. the observation period per subject will be 52 weeks from the start of benlysta administration. benlysta is the registered trademark of glaxosmithkline (gsk) group of companies.


Eligibility criteria:
inclusion criteria: * the study will include all subjects to whom benlysta is administered. in addition, among subjects who start administration after launch, those to whom benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well. exclusion criteria: * n/a

Keywords: benlysta, systemic lupus erythematosus, safety, efficacy
comparison of glargine and oral antidiabetic drugs (oads) in newly diagnosed type 2 diabetes

Conditions: Diabetes

Summary: the investigators designed this prospective, randomized control study to compare the efficacy and safety between the basal insulin glargine therapy and metformin-based oads after correction of the glucose toxicity with a short period of intensive insulin therapy.

detailed description: objective-type 2 diabetes is associated with defects in insulin secretion and insulin sensitivity. hyperglycemia may aggravate these defects, a feature known as glucose toxicity. previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. the current study attempts to identify whether basal insulin glargine or metformin-based oads for further management would have a long-term benefit in newly diagnosed type 2 diabetes after short-term intensive insulin therapy. research design and methods-newly diagnosed type 2 diabetic patients (fasting blood glucose \>200 mg/dl or random blood glucose \>300 mg/dl) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. hba1c were measured before intensive insulin injection. after discharge, patients will be randomized to receive basal insulin injection or metformin-based oads for further management. patients will be followed in our clinics and adjust their medication according to their blood glucose levels. hba1c were measured 6 months later.after the six-month intervention, these patients were continually followed up for another six months. subjects received an oral glucose tolerance test (ogtt) after the intensive insulin therapy and at the end of the 6th and 12th month. expected results-we will expect that basal insulin glargine,compared with metformin-based oad treatment,could more effectively maintain adequate glycemic control in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed type 2 diabetic patients. 2. drug naïve, with severe hyperglycemia (fasting plasma glucose\>11.1mmol/l or random plasma glucose \>16.7mmol/l) 3. those who age between 30 and 70 years old and can inject insulin by themselves. exclusion criteria: 1. established type 1 diabetes or positive anti-glutamic acid decarboxylase antibody; 2. malignancy, pregnancy or lactating; 3. history of ketoacidosis; 4. hepatic dysfunction with alanine aminotransferase 2.5 times higher than the upper limit of normal; serum creatinine \>2 mg/dl; 5. poor blood pressure control (sbp\>180mmhg or dbp \>110mmhg); 6. definite coronary artery disease, heart failure, left ventricular hypertrophy; 7. severe anemia; acute or severe chronic diabetes complications; 8. bmi\<18 kg/m2 or ≥41kg/m2; 9. history of alcohol abuse or drug abuse; 10. mental disorder and other endocrine disorders; dysfunction of digestion and absorption; 11. chronic diseases need long-term glucocorticoid treatment.
the korean titration study: comparison of the self-titration methods for glargine-300

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to demonstrate efficacy and safety of self-titration algorithm with gla-300 using the insight algorithm (once daily by 1 unit) and the edition algorithm (once weekly by 3 units) in korean patients with t2d.

the primary objective of this study is to obtain efficacy and safety descriptive data on two different titration algorithms: the insight titration algorithm (self-titration of 1 unit/day) and the edition trial algorithm with insulin glargine 300 units/ml (gla-300) when given as basal insulin in uncontrolled t2dm patients on basal insulin with or without non-insulin anti-hyperglycemic agent (niaha) or in insulin naïve patients. in a korean, single-center, type 2 diabetes patients with basal insulin therapy will be enrolled. they will be randomly assigned to either titration algorithm for gla-300. after 12 weeks, the glycemic control, patients' satisfaction to the titration methods and healthcare providers' satisfaction to titration methods will be assessed.

Eligibility criteria:
inclusion criteria: * aged ≥ 19 years * treated for t2d for at least 6 months * uncontrolled t2d * use of smpg * hba1c \> 7% and ≤ 10% in patients with a basal insulin (gla-100, gla-300, neutral protamine hagedorn (nph), and detemir) or hba1c \> 7% and ≤ 11% in insulin naive patients * signed informed consent exclusion criteria: * type 1 diabetes mellitus * pregnancy or lactation * night-shift worker * unwilling to inject insulin or perform smpg * treated with insulin other than basal insulin within the previous 3 months * not on stable dose of basal insulin (±20%) in the last 3 months * initiation or change in dose of oral anti-hyperglycemic agents in the last 3 months * history of alcohol or drug abuse * active cancer or other significant comorbidities which the investigator would make the patients unsuitable for participating in the study * any clinically significant laboratory finding which the which the investigator would make the patients unsuitable for participating in the study * known drug allergy to insulin * not signed informed consent * incompletion of the study * participating in another clinical trial

Keywords: insulin