Kornimate/medical-research-clean huggingface dataset:
exercise, statins, and the metabolic syndrome

Conditions: Metabolic Syndrome; Obese; Sedentary

Summary: here we tested if statins or exercise plus statins had a greater capacity to lower metabolic syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk factors. we also examined if statins impacted exercise response for mitochondrial content in muscle or aerobic fitness.

objectives: determine if simvastatin impairs exercise training adaptations. background: statins are commonly prescribed in combination with therapeutic lifestyle changes, including exercise, to reduce cardiovascular disease risk in patients with the metabolic syndrome. statin use has been linked to skeletal muscle myopathy and impaired mitochondrial function, but it is unclear whether statin use alters adaptations to exercise training. methods: we examined the effects of simvastatin on changes in cardiorespiratory fitness and skeletal muscle mitochondrial content in response to aerobic exercise training. sedentary overweight or obese adults with at least 2 metabolic syndrome risk factors (defined according to national cholesterol education panel adult treatment panel iii criteria) were randomized to 12 weeks of aerobic exercise training or to exercise in combination with simvastatin (40 mg per day). the primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus lateralis) mitochondrial content (citrate synthase enzyme activity).

Eligibility criteria:
inclusion criteria: * sedentary metabolic syndrome subjects will be 25-59 y of age * overweight to class i or ii obese (bmi 25-39 kg/m2) men and women * 2 of 4 other characteristics of the metabolic syndrome including fasting glucose of 100 to 125 mg/dl; waist circumference greater than 102 cm in men and 88 cm in women, serum triglyceride concentration greater than 150 mg/dl, hdl-c concentrations less than 40 mg/dl in men and 50 mg/dl in women, and blood pressure greater than 130/85 mmhg * women must be taking birth control or be postmenopausal. exclusion criteria: * diagnosed cardiovascular disease or diabetes or disease * symptoms that could alter their ability to perform exercise * fasting blood glucose of greater than 126 mg/dl * smoking * taking any medications or supplements (e.g., statins, fibrates, metformin, thiazolidenediones, anti-hypertensives (ace-inhibitors and angiotensin blockers) which could affect blood lipids or insulin sensitivity. * women who are pregnant or plan to become pregnant during the duration of the study * individuals exercising regularly (more than one 30 min session per week) * individuals with an orthopedic limitations for walking. * report any allergies to the medications (statins, lidocaine)

Keywords: mitochondria fitness statins cholesterol metabolic syndrome
in situ remineralisation response of different artificial caries-like enamel lesions to home-care and professional fluoride treatments

Conditions: Dental Caries

Summary: this study mainly compared the response of the artificial carious enamel lesions to remineralisation in situ. the tested in vitro demineralising protocols were: mc gel, pa gel, mhdp and buffer solutions. the lesions were then remineralised in an in situ model, with crossover and double blind design. fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of each demineralising protocol during 3 experimental phases (3 days each). the experimental phases/treatments were: control (placebo dentifrice, saliva effect only), home-care (fluoride dentifrice, 1,100 ppm f, naf), and professional/home-care (varnish- 22,600 ppm f and dentifrice- 1,100 ppm f, naf). during the 3-day phase, the appliance was only removed during the main meals (four times a day, maximum 1 h duration each, interval between meals 2-3 h). immediately after the meals, before replacing the appliance in the mouth, the subjects were advised to perform oral hygiene using a soft end-rounded toothbrush (colgate® 360º sensitive pro-relief tm) and dentifrice (non-fluoridated from icefresh, bauru, sp, brazil or fluoridated dentifrice from crest procter \& gamble, cincinnati, oh, usa) according to the phase and dental floss (sanifill, são paulo, brazil). the remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of solution/specimen). thereafter, the appliance was replaced in the mouth and the subjects were advised to rinse with 10 ml of water for 5 s and to expectorate. in respect to professional/home-care phase, the varnish (duraphat, colgate, sp, brazil) was applied before the in situ study for 6h and then removed. the enamel remineralization was quantified using transverse microradiography (% mineral recovery and lesion depth, tmr), surface and cross-sectional hardness. the data were submitted to statistical analysis (p\<0.05).


Eligibility criteria:
inclusion criteria: * a stimulated physiological salivary flow rate of \>1 ml.min-1 * a non-stimulated physiological salivary flow rate of \>0.25 ml.min-1 * good oral health (i.e. no cavities or significant gingivitis/periodontitis) exclusion criteria: * systemic illness * pregnancy or breastfeeding * use of fixed or removable orthodontic appliances * use of fluoride mouthrinse or professional fluoride application in the last 2 months.
feasibility of a new silicone hydrogel lens

Conditions: Myopia

Summary: the objective of this study is to determine the product feasibility of the investigational contact lens (test) when compared to the currently marketed acuvue oasys contact lens (control) and the air optix aqua contact lens (control) when worn by adapted wearers of soft contact lenses.


Eligibility criteria:
inclusion criteria: * participants must have clear central corneas and be free of any anterior segment disorders. * participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * participants must be myopic and require lens correction from -0.75 d to - 4.75d in each eye. exclusion criteria: * participants who have worn gas permeable (gp) contact lenses within the last 30 days or who have worn polymethylmethacrylate (pmma) lenses within the last three months. * participants with any systemic disease affecting ocular health. * participants using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * participants with an active ocular disease or are using any ocular medication. * participants who have had any corneal surgery (eg, refractive surgery). * participants who are allergic to any component in the study care products.

Keywords: contact lens
entecavir for biological agents associated hbv reactivation in inflammatory arthritis patients

Conditions: Rheumatoid Arthritis; Hepatitis B Reactivation; Exposure to Hepatitis B Virus

Summary: antiviral prophylaxis can prevent the risk of biologic agents-associated hbv reactivation in hepatitis b inactive carriers and patients with past hbv infection

the risk of hbv reactivation is associated with the intensity of immunosuppression. biological therapies block the action of biological products involved in immune-inflammatory pathogenesis of many diseases. however, these biologic agents induce a profound immunosuppression, and their use has been reported to be associated with hbv reactivation. currently, the actual incidence of hbv reactivation in inflammatory arthritis patients who underwent biologic treatments (tnf-α blockades) is unclear, especially in inflammatory arthritis (ia) patients with past hepatitis b infection. in this study, we plan to enroll ia patients who are inactive hbv carriers (hbsag-positive/ hbv viral loads \ 2,000 iu/ml for 2 consecutive visits of one month apart. the main goal of the study is to delineate the incidence of hbv reactivation during and after biologic treatment in ia patients who are inactive hbv carriers or have past hbv infection, and tries to define the optimal hbv monitoring and antiviral prophylactic strategy in ia patients.

Eligibility criteria:
inclusion criteria: 1. age : from 20 to 90 y/o. 2. hbsag-positive for more than 6 months and hbv dna \< 2000 iu/ml (subgroup 1）or hbsag-negative but anti-hbc positive with hbv dna \< 2000 iu/ml (subgroup 2）. 3. inflammatory arthritis patients who plan to treat with biological agents, including humira or enbrel or simponi or orencia or mabthera or actemra; as first line biologic treatment is indicated. exclusion criteria: 1. hcv, hiv, or hdv coinfection. 2. uncontrolled hcc or other malignancy within 3 years. 3. decompensated liver cirrhosis (ctp score ≥ 7). 4. uremia patients under hemodialysis or continuous ambulatory peritoneal dialysis or patients with ccr \< 50 ml/min 5. pregnant or breastfeeding women. 6. women of child-bearing potential (wocbp) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug.

Keywords: rheumatoid arthritis inactive hbv carrier resolved hepatitis b hbv reactivation anti-tumor necrotic factor-alfa
a multilevel intervention to increase colorectal cancer screening tests in patients with abnormal fecal immunochemical test results, proact trial

Conditions: Colorectal Carcinoma

Summary: this clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (crc) screening test results. the fecal immunochemical test (fit) is a non-invasive, stool-based, crc screening test. fits are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of crc screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. for fit-based crc screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. the multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a crc screening patient navigator, an educational video, and transportation assistance. the navigator provides patient support and assistance with colonoscopy scheduling. the educational video addresses identified patient fears around colonoscopies. transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal fit results.

outline: patients are randomized to 1 of 2 groups. group i: patients receive usual care from the crc screening program navigator which includes monthly phone calls with the crc screening program navigator, and assistance with colonoscopy scheduling. group ii: patients receive usual care as described in group i and additionally receive a quick response (qr) code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or ehr platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse. after completion of study intervention, patients are followed up for 18 months.

Eligibility criteria:
inclusion criteria: * patients: age \>= 45 years old and =\< 75 years old * patients: receives care at an harborview medical center (hmc) or university of washington-kent-des moines (uw-kdm) primary care clinic * patients: \>= 1 month from documented abnormal fit result * patients: has not received a colonoscopy between the abnormal fit and enrollment * clinic staff: hmc or uw-kdm physician or staff member who provides primary care or gastroenterology care * clinic staff: staff in the fred hutchinson (fred hutch)/uw medicine population health program that provide colorectal cancer screening and navigation
cope program , mental health, mother- infant interaction, sense of competence

Conditions: Empowerment; Competence; Outcome; Interaction

Summary: the aim of the study is to: - evaluate the effect of creating opportunities for parent empowerment program on maternal sense of competence, mental health outcome and mother-infant interaction. research hypotheses * mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high level of competence than those who don't. * mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit less stress level than those who don't. * mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high interaction than those who don't. the mothers of preterm neonates will be assigned into two equal groups as follows: * study group (group ii) mothers of preterm neonates who will receive cope program. * control group (group i) mothers of preterm neonates who will not receive cope program.

* research design: a quasi-experimental (pre-posttest) research design will be used. * setting: the study will be conducted at the neonatal intensive care unit at smouha specialty hospital in alexandria. * subjects: a convenience sampling of 60 mothers of preterm infants who admitted to the previously mentioned setting * during the 1st day of preterm admission to nicu data concerning characteristics of neonates and their mothers' in both groups will be obtained from medical records using tool i. * the pretest will be conducted to the mothers of neonates on the 1st day of admission in the nicu to assess mothers' sense of competence and perceived stress by interviewing them to collect data using tool ii, iii and mother infant interaction in both groups by observation using tool iv. * after completion of the pretest, the mothers in the study group will receive cope program, then at the 7th day of the study posttest will be done for both group

Eligibility criteria:
inclusion criteria: * the mother age more than 20 years, educated and has no experience of premature birth * the mother has no postpartum discomforts (such as, bleeding, depression or pain * premature neonates( gestational age 37 weeks) * birth weight \ 1500 g (lbw) * five-minute apgar score \> 7 * neonate not with any medically restricted conditions (e.g., intraventricular hemorrhage or intracerebral hemorrhage (grades iii and iv). * neonate not on ant ventilation assisted devices, such as ventilator or cpap exclusion criteria: -

Keywords: cope; maternal competence; maternal mental health; parent-infant interaction; preterm neonates
the correlation between clinical diagnosis of retained placenta and histology

Conditions: Retained Product of Pregnancy

Summary: the main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology. secondly, to assess different clinical parameters that are likely related to accuracy of the diagnosis of rpoc

background: retained products of conception (rpoc) are a common and treatable complication after delivery or termination of pregnancy. the reported incidence in the literature is around 1% of all pregnancies. most often, diagnoses are made on clinical basis and there is only scarce information available related to the correlation between the clinical and pathological diagnosis of rpoc. the gold standard for diagnosis of rpoc is based on histopathological confirmation of chorionic villi in tissue derived from the uterus. once rpoc is diagnosed on a clinical basis, several treatment options are available, including expectant management, pharmacological treatment, and surgical interventions. given the risks associated with surgical interventions, accurate diagnosis is vital. guidelines at maccabi health care organization mandate that hysteroscopic removal of suspected rpoc should be performed only after approval by a gynecological surgical preauthorization committee. based on the activity of this committee and starting 2011, maccabi has developed a database on certain gynecologic-surgical procedures including hysteroscopic removal of suspected rpoc. purpose of the study: the main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology. expected results: 70% correlation between the clinical and pathological diagnosis of rpoc. methods: establishing a dedicated database which includes demographic, clinical and histological data of women who have undergone hysteroscopic removal of suspected rpoc and statistical assessment of correlations. significance: determination of the correlation between clinical suspicion and histological diagnosis of retained placental tissue finding clinical parameters that may increase the accuracy of this diagnosis and will help to prevent unnecessary procedures.

Eligibility criteria:
inclusion criteria: * women who diagnosed clinically with rpoc * women who prefomed therapeutic hysteroscopy under the diagnosis of rpoc exclusion criteria: * women who underwent hysteroscopy presumptive diagnosis of rpoc without documentation of pathological results were excluded. * women who have not performed / recorded sonography test before the hysterocpy.

Keywords: retained placenta, surgical hysteroscopy, residua
standard total knee arthroplasty using platelet rich plasma (prp)

Conditions: Osteoarthritis

Summary: clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

the purpose of this study is to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

Eligibility criteria:
inclusion criteria: * patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later * patient agrees to be blinded to their treatment group assignment * patient is willing and able to return for follow-up over at least a six (6) month post-operative period although longer follow-up may be desired * patient agrees to participate by signing an irb approved informed consent form exclusion criteria: * patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery prp in * patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy) * patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products * patient has hemoglobin \< 12.0 (males), \< 11.0 (females) * patient has a clinically significant anxiety disorder * patient is on therapeutic anticoagulation medication and has an inr \> 1.3 * patient has a severe bleeding disorder * patient has a known addiction to drugs or alcohol, including, but not limited to: chronic daily use of narcotic medications for more than 90 days prior to surgery * patient is pregnant * patient is a prisoner * patient is involved in a personal litigation (e.g. worker's compensation) that relates to their knee surgery * patient is actively participating in another medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)

Keywords: prp, tka, pain scale, hemoglobin, hematocrit, narcotics
risk management plan (rmp) survey for purchasers of alli® (60 mg orlistat) in the european union.

Conditions: Weight Loss

Summary: following results from the first survey that forms part of the eu rmp for alli® (rmp survey 1; weusrtp3350), several amendments to the information included on the pack carton for alli® (orlistat 60 mg) were recommended. the main finding from rmp survey 1 was that a large proportion of alli® users had a body mass index (bmi) less than (\<)28 kg/m2 . (note: the european indication for alli® is adults 18 years and older with a bmi\<28 kg/m2.) the proportion of respondents overall who reported possible contraindications to alli® use was relatively low. the following changes to the pack labeling were agreed and have been implemented: : (1) a statement, highlighting the product is only for those with a bmi of 28 or above was added to the front of the pack; (2) wording of the bmi statement on the back of the pack was strengthened; (3) contraindications were highlighted in bold text; (4) the statement that alli® is not for use by those under 18 years of age was modified for clarity. in addition, a pharmacy reminder card was made available to retail pharmacists to improve awareness of the prescribing information for alli®. the survey will assess whether compliance with the authorized indication and contraindications among purchasers of alli® has been improved after one year of marketing the revised pack labeling.


Eligibility criteria:
inclusion criteria: * any individual who purchases alli from a pharmacy for their own personal use and provides consent. exclusion criteria: * no exclusion criteria.
japan-working groups of acute myocardial infarction for the reduction of necrotic damage by a k-atp

Conditions: Acute Myocardial Infarction

Summary: to evaluate whether nicorandil as an adjunctive therapy for ami reduces myocardial infarct size and improves regional wall motion

the benefits of percutaneous coronary intervention (pci) in acute myocardial infarction (ami) are limited by reperfusion injury. in animal models, nicorandil, a hybrid of an atp-sensitive k+ (katp) channel opener and nitrates, reduces infarct size, so the japan-working groups of acute myocardial infarction for the reduction of necrotic damage by a k-atp channel opener (j-wind-katp) designed a prospective, randomized, multicenter study to evaluate whether nicorandil reduces myocardial infarct size and improves regional wall motion when used as an adjunctive therapy for ami. twenty-six hospitals in japan are participating in the j-wind-katp study. patients with ami who are candidates for pci are randomly allocated to receive either intravenous nicorandil or placebo. the primary end-points are (1) estimated infarct size and (2) left ventricular function. single nucleotide polymorphisms (snps) that may be associated with the function of katp-channel and the susceptibility of ami to the drug will be examined. furthermore, a data mining method will be used to design the optimal combined therapy for post-myocardial infarction (mi) patients. it is intended that j-wind-katp will provide important data on the effects of nicorandil as an adjunct to pci for ami and that the snps information that will open the field of tailor-made therapy. the optimal therapeutic drug combination will also be determined for post-mi patients.

Eligibility criteria:
inclusion criteria: 1. age 20-79 years 2. chest pain of more than 30 min 3. 0.1 mv st-segment elevation in 2 contiguous ecg leads 4. admission to hospital within 12 h of symptom onset 5. first episode of ami 6. candidates for pci exclusion criteria: 1. history of old myocardial infarction 2. left main coronary artery stenosis 3. severe liver and/or kidney dysfunction 4. suspected aortic dissection 5. history of coronary artery bypass graft 6. history of allergic response to drugs 7. severe hypovolemia 8. right ventricular infarction

Keywords: acute myocardial infarction data mining nicorandil randomized clinical trial snps