Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of atorvastatin + perindopril fixed-dose combination s05167 in adult patients with arterial hypertension and dyslipidemia

Conditions: Dyslipidemias; Hypertension

Summary: the purpose of this study is to demonstrate the superiority of atorvastatin/perindopril fixed dose combination (fdc) s05167 as compared to atorvastatin reference drug alone or perindopril drug alone on systolic blood pressure decrease and ldl cholesterol decrease respectively in patients presenting with hypertension and dyslipidemia after 8 weeks of treatment.


Eligibility criteria:
inclusion criteria: 1. men or women from 18 to 79 years old who can comply with the study requirements and timetable, 2. patients diagnosed with essential hypertension (as documented in patient's medical file). the diagnosis of hypertension should be based on at least two bp measurements on at least two visits. uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril) for combined systolic and diastolic hypertension (140 mmhg ≤ sbp \< 160 mmhg and 90 mmhg ≤ dbp \< 100 mmhg). or hypertensive patients naïve of treatment with 150 mmhg ≤ sbp \<160 mmhg and 90 mmhg ≤ dbp \< 100 mmhg. 3. dysplipidemic patients: naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 110 mg/ decilitre (dl) (or 2.84 millimole \[mmol\] /l) ≤ ldl-c \< 190 mg/dl (or 4.91 mmol/l) according to a previous laboratory result within 12 months. exclusion criteria: 1. unlikely to cooperate in the study, 2. pregnant and lactating women, 4. participation in another study at the same time or having participated in another study within 3 months before selection participation in noninterventional registries or epidemiological studies is allowed, 6.patients treated with \>1 anti-hypertensive drug or \>1 lipid lowering drug, 7.patients previously treated with atorvastatin and/or perindopril, 8.known resistance to ace inhibitors, 9.patients treated with beta-blockers or alpha-blockers, 10. patients with liver disease or renal impairment, 11.certain known cardiovascular diseases or cardiac rhythm disorders, 12.known or suspected symptomatic orthostatic hypotension, 13.familial hypercholesterolemia, 14.secondary hypertension or dyslipidemia, 15.patients who are hypersensitive to atorvastatin, perindopril or to any of the excipients of study drugs, 16.hypersensitivity to any other ace inhibitor, 17.history of angioedema associated with previous ace inhibitor therapy.

Keywords: dyslipidemia hypertension cardiovascular atorvastatin perindopril hmg-coa reductase inhibitor ace inhibitor fixed combination
evaluation of software for self-fitting of hearing aids by people with hearing loss

Conditions: Hearing Loss

Summary: the purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.

after being informed about the study and potential risks, clients giving written informed consent will be enrolled as participants. each participant will use the app to self-fit and fine-tune the study aids over 30 days. outcome measures include speech perception tests, questionnaires and the need for support with using the app. own-aid performance is the reference, while unaided performance is the baseline.

Eligibility criteria:
inclusion criteria: * online client * daily aid use * bilateral aid use * uses p70-r or p90-r aids (same model both ears) * does not use earmolds * uses same soft tip on both aids * owns iphone7/ios12 or later * willing to install prototype app on own phone and use it in study * willing to participate in study for 30 days exclusion criteria: * dexterity or cognitive issues that would be problematic for using the app in the study
follow-up of patients referred to unscheduled care centers by the emergency call center in the haut-rhin department, france

Conditions: Unscheduled Care

Summary: the objective of this study is to determine the follow-up of patients who were referred by the emergency call center of the haut-rhin department to an unscheduled care centers (ucc) and to determine whether they actuallly went to a ucc following their call, or if they were taken in charge by another care facility.

conduct of research: patients who contacted the emergency call center and were referred to an unscheduled care center in the haut-rhin will be contacted by mail in the first instance. ten to fifteen days after the call to the emergency call center, the investigator will contact the patient by phone, during which he/she will ask for the patient's oral consent to participate in the research and collect follow-up data using a standardized questionnaire. if the investigator is unable to reach the patient, further attempts will be made to call the patient up to 30 days after the initial call. if there is no response after this time, patients will not be included the study.

Eligibility criteria:
inclusion criteria: * call to the emergency call centre of the haut-rhin department by an adult (age ≥ 18 years) * referral to the unscheduled care center by the emergency call center non-inclusion criteria: * patient who does not answer phone within 30 days of call to the emergency call center * patient who refuses to participate in the study * call for someone other than him or herself (except when a parent calls for his or her minor child)
psychodynamic motivation and training program

Conditions: Coronary Heart Disease; Physical Activity

Summary: the purpose of this study is to examine the effectiveness of a psychodynamic motivation and training program (pmt) for the improvement of physical fitness in patients with stable coronary heart disease as compared to advice in exercise training or treatment as usual.

nonpharmacological secondary prevention of coronary heart disease is considered to be a safe and effective measure for reducing mortality substantially. major targets are the improvement of physical activity and dietary habits, smoking cessation and stress reduction. despite the effectiveness of life style changes, the compliance rate of patients is very low. to improve compliance with life style change programs psychotherapeutic interventions appear to have significant potential. against this background our study aims to examine the effectiveness of a psychodynamic motivation and training program (pmt) in addition to one session of advice in exercise training based on the results of spiroergometry (+ex) and usual cardiological care (tau). pmt will be compared with +ex and tau. n = 90 patients with stable coronary artery disease class, low physical activity, class i to iii angina pectoris will be randomly assigned to the three treatment conditions. the primary efficacy endpoint is change in the anaerobic threshold from baseline to 6 month follow-up. the results of the study will 1) help to determine the effectiveness of a psychodynamic life style change programs for the secondary prevention of cardiovascular disease and 2) will help to identify measures for designing specifically tailored interventions to improve compliance with cardiovascular prevention.

Eligibility criteria:
inclusion criteria: * stable coronary heart disease with ccs functional classification of angina class i-iii * low self rated physical activity * condition after percutaneous coronary intervention \> 4 weeks until \ 52 weeks after index percutaneous coronary intervention * residence \< 50 km radius of mainz * if treatment with betablockers or ivabradine then stable \> 4 weeks exclusion criteria: * acute coronary sydnrome or myocardial infarction \< 8 weeks * coronary stenosis of the dominant vessel \> 25% or high grade stenosis of the left coronary artery * heart failure with left ventricular ejection fraction \< 40% * nyha iii-iv * severe heart valve disorder * insulin dependent diabetes * orthopedic disorders or other disorders, which preclude regular physical activity * coronary artery bypass surgery \< 6 months before index pci * severe obesity (bmi ≥ 40) * need for systemic immunosuppression with cortisone or methotrexate * kidney failure with need for dialysis * intake of nitrates \< 12 hours

Keywords: psychodynamic psychotherapy coronary heart disease physical activity secondary prevention
a study of the effect of plasmaexchange in patients with acute liver failure

Conditions: Acute Liver Failure

Summary: the aim of this study is to examine if high-volume plasma exchange has a positive effect on mortality in patients with acute liver failure.


Eligibility criteria:
inclusion criteria: * patients with acute liver failure in encephalopathy grade 2-4 exclusion criteria: * alcoholic hepatitis * primary non function liver graft or graft dysfunction * known chronic liver disease * known malignancies * clinical suspicion of brain death
examining the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in crohn's disease

Conditions: Crohn's Disease

Summary: this is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (cdp870) in patients with moderate to severe crohn's disease previously enrolled in c87059 (cospar i, nct00349752).


Eligibility criteria:
inclusion criteria: * patients previously enrolled in c87059 (cospar i, nct00349752) exclusion criteria: * subject withdrawn or discontinued from c87059 (cospar i, nct00349752) study under specific conditions * subject who received treatment other than study medication and other than medications permitted in c87059 (cospar i, nct00349752) * subjects from countries where certolizumab pegol is authorized in crohn's disease treatment

Keywords: cdp870 certolizumab pegol crohn's disease
the effect of helicobacter pylori eradication on liver fat content in non-alcoholic fatty liver disease

Conditions: Fatty Liver; Liver Dysfunction; Insulin Resistance

Summary: the role of helicobacter pylori(hp)in the pathogenesis of non-alcoholic fatty liver disease (nafld) is controversial.

this randomized double blind clinical trial was performed in dyspeptic patients with positive antibody to hp and the evidence of fatty liver in ultrasonography. after excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have nafld. those with nafld liver fat score greater than (-0.64) and positive urea breath test (ubt) were enrolled. they were randomly assigned to lifestyle modification alone or lifestyle modification plus hp eradication groups. quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for hp eradication was performed in two weeks. hp eradication was documented by ubt. liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(homa-ir), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Eligibility criteria:
inclusion criteria: * dyspeptic patients with positive antibody to h.pylori and * persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic. exclusion criteria: * alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), * heart disease (ischemic or congestive), * hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), * renal disease (serum creatinine concentration of \> 1.5 mg/dl), * any severe systemic co-morbidities, neoplasm, * using any hepatotoxic medication during the past 3 months, * previous history of peptic ulcer, * previous history of h.pylori eradication, * existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and * pregnant or lactating women.

Keywords: steatohepatitis helicobacter pylori alanine aminotransferase aspartate aminotransferase fatty liver liver diseases digestive system diseases
association of egg and dietary cholesterol consumption with mortality and diseases

Conditions: Mets; Death

Summary: to assess the associations between egg and dietary cholesterol consumption with mortality and metabolic syndrome (mets).

substitution models, sensitivity analyses, subgroup analyses and multiple linear regression analyses will be conducted to specifically estimate the hazard ratios and 95% confidence intervals of mortality and mets associated with egg and cholesterol consumption.

Eligibility criteria:
inclusion criteria: * participants aged ≥20 y exclusion criteria: * missing creatinine, age, cannot be linked to socio-demographic data; aged less than 20; without complete dietary data .
single-injection adductor canal block for total knee arthroplasty under spinal anesthesia

Conditions: Total Knee Arthroplasty

Summary: this study evaluates the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia.

this study aims to evaluate the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia. the effect of the single-injection adductor canal and continuous adductor canal block in patients receiving total knee arthroplasty under general anesthesia has been well established. however, due to the residual effect of spinal anesthesia, the effect of the single-injection adductor canal block needs to be determined. the investigators hypothesize that the single-injection adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.

Eligibility criteria:
inclusion criteria: * adult patients receiving total-knee arthroplasty under spinal anesthesia * asa class 1-3 exclusion criteria: * infection at the needle injection site * hard for pain evaluation * crps patient with lower extremity symptom * chronic opioid user * those with side effect to local anesthetics * those getting revision total-knee arthroplasty or with the previous operation at the same knee area * those getting the surgery under general anesthesia due to the failed spinal anesthesia
assisted movement neuro-rehabilitation: va multi-site clinical trial

Conditions: Cerebrovascular Disorders; Hemiplegia

Summary: the purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called mime. a control group receives additional occupational therapy without the use of mime.

this study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke. these hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with mime in the initial phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention. research plan - a multi-site clinical trial is in progress at the houston va medical center (vamc), the va greater los angeles health care system (glahcs), the va palo alto rehabilitation research and development center (rr\&dc), and the central texas veterans health care system (ctvhcs). ctvhcs serves as the coordinating site. the rr\&dc provides training and technical assistance for the other sites. methods - subjects with hemiparesis due to a stroke are randomly assigned to 3 groups. group 1 receives 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. group 2 receives a total of 2 hours/day of robot-assisted therapy. group 3 receives 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. outcome measures include assessment of strength, motor control, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. subjects are inpatients at one of the participating va hospitals. exclusion criteria: unable to follow instructions; medically unstable.

Keywords: rehabilitation robotics
added value of local clonidine for spine postoperative pain control, in addition to bupivacaine

Conditions: Post-operative Pain

Summary: the objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery.

patients candidates to posterior spine surgery (micro-discectomy, lumbar laminectomy with or without fusion, cervical laminectomy) are asked to participate to this prospective study. after verification of inclusion and exclusion criteria, patients consenting to enter the study are randomly assigned to one of the following subgroups: 1-pre-incisional wound infiltration with 20 ml of bupivacaine 0.25%. 2- pre-incisional wound infiltration with 150 μg of clonidine with 20 ml of bupivacaine 0.25%. demographic parameters, co-morbidities and other pre and per operative medical data are noted. in the post-operative period, patients received a standardized post-operative analgesic protocol (nsai and paracetamol). patients are asked to fill their pain diary using visual analog scale (vas) from day 0 till day 8 after surgery. morphine rescue consumption is noted. finally, the percentage of global subjective patient satisfaction regarding the post-operative wound pain is noted from 0 to 100.

Eligibility criteria:
inclusion criteria: * first (not recurrent) posterior spinal surgery at the operated site * american society of anesthesiologists class i or ii (operative risk) exclusion criteria: * allergy to local anesthetics or to clonidine * pregnancy * raynaud's syndrome * thromboangiitis obliterans * history of substance abuse * current treatment with corticosteroids

Keywords: clonidine bupivacaine post-operative pain arthrodesis discectomy local infiltration
evaluation of orientation and visual acuity of four toric soft contact lenses when head is tilted at 90 degrees

Conditions: Astigmatism

Summary: the purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.

non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, \~2 hour duration.

Eligibility criteria:
inclusion criteria: 1. be at least 18 and less than or equal to 50 years of age 2. be able and willing to adhere to the instructions set forth in the protocol. 3. have a distance spherical component between -1.00 d and -6.00d with cylinder in the range of 0.75 d to 1.75d 4. sign the statement of informed consent. 5. have normal, healthy eyes exclusion criteria: 1. the presence of ocular or systemic disease or need for medication which might interfere with contact lens wear. 2. pre-existing ocular disease precluding contact lens fitting. 3. insufficient lacrimal secretions 4. aphakia, keratoconus or a highly irregular cornea 5. previous eye surgery involving the anterior segment 6. current pregnancy or lactation (to the best of the subject's knowledge). 7. use of concurrent ocular medication 8. active participation in another clinical study at any time during this study.-

Keywords: astigmatism orientation visual acuity contact lenses
compare of surgical condition and complications with moderate and deep nm block

Conditions: Neuromuscular Blockade

Summary: this study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.the explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.

neuromuscular blocking agents (nmbas) are frequently using during anesthesia to facilitate tracheal intubation and to improve surgical conditions. in an adequately anesthetized and monitored patient, the presence of one or two responses in the train-of-four (tof) pattern normally indicates sufficient relaxation for most surgical procedures in general practices. it has been called moderate neuromuscular blockade (mnmb) condition. nowadays, laparoscopic surgeries have expanded impressively into various areas of surgeries, both in scope and volume. if any hypothetical advantages of deep neuromuscular blockade (dnmb) during laparoscopic surgery turned out to be realized in practice with sufficient supporting evidence, it would become an important anesthetic option for better patient outcomes.

Eligibility criteria:
inclusion criteria: * all adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent. exclusion criteria: * known allergy to rocuronuim, cisatracurium or sugammadex * significant liver or kidney dysfunction * any neuromuscular disease * pregnant or breast feeding * indication for rapid sequence induction * inability to give informed consent * patients taking any medication with potential interference with neuromuscular transmission

Keywords: deep nm block surgeon's satisfaction bridion
accel-loading-acs study

Conditions: Platelet Aggregation Inhibitors; Anti-inflammatory Agent; Myocardial Reperfusion Injury

Summary: the purpose of this study is to determine whether adjunctive cilostazol loading/maintenance to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients with non-st-elevation acute coronary syndrome (acs)undergoing percutaneous coronary intervention (pci).

in acs patients, platelet activation, inflammation, and ischemia-reperfusion injury can be closely associated with the risk of post-pci myonecrosis and ischemic events occurrence. in the accel-ami (adjunctive cilostazol versus high maintenance-dose clopidogrel in patients with acute myocardial infarction)study, adjunctive cilostazol increased platelet inhibition compared with double-dose clopidogrel. meanwhile, statins can reduce the extent of myonecrosis via limiting inflammation and myocardial infarct size by activating phosphatidylinositol-3-kinase (pi3k), ecto-5'-nucleotidase, akt/endothelial nitric oxide synthase (enos), and the downstream effectors inducible nitric oxide synthase (inos) and cyclooxygenase-2 (cox-2). inhibition of pi3k, adenosine receptors, enos, inos, or cox-2 abrogates the protective effects of statins. in animal study, the combination of low-dose statin with cilostazol synergistically limits infarct size. multiple studies have shown that cilostazol can influence inflammation and risk pathway using the similar pathway with statin. this study will be performed to evaluate the role of adjunctive cilostazol in platelet inhibition, inflammation, and myonecrosis compared with standard treatment.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * non-st-elevation acs patients undergoing pci within 48 hours after hospitalization exclusion criteria: * st segment elevation acute myocardial infarction * nste acs with high-risk features warranting emergency coronary angiography * oral anticoagulation therapy with warfarin * use of pre-procedural glycoprotein iib/iiia inhibitor * contraindication to antiplatelet therapy * ast or alt ≥ 3 times upper normal * left ventricular ejection fraction \< 30% * wbc \< 3,000/mm3, platelet \< 100,000/mm3 * creatinine ≥ 3 mg/dl * stroke within 3 months

Keywords: cilostazol platelet inflammation myonecrosis