Kornimate/medical-research-clean huggingface dataset:
organization program of diabetes insulin management

Conditions: Type 2 Diabetes Mellitus

Summary: diabetes is a common, costly condition associated with significant morbidity and mortality. diabetes self-management education, the process of teaching individuals to manage their diabetes, has been considered an important part. the intensive education has the capacity to deliver effective interventions to a large number of people. the investigators may be able to redirect our efforts to diabetes care and education strategies that will have a positive impact on the optimization of glycemic control and the prevention of long-term complications of diabetes, reducing the subsequent human and health care costs.

this is a prospective, randomized, open-label, controlled clinical study. 1500 subjects with type 2 dm will be enrolled and be randomized into structured education group and conventional education group in 1:1 ratio. subjects in both of the groups will be treated with scilin®m30 twice daily (30 minutes before breakfast and dinner). all the previous oral antidiabetic drugs (oad(s)) will be discontinued except metformin and alpha-glucosidase inhibitors. the physician will determine the starting dose (0.3 iu/kg～0.4iu/kg), as well as later changes to dose according to insulin titration algorithm. the treatment duration will last 16 weeks.

Eligibility criteria:
inclusion criteria: * written informed consent obtained before any trial-related activities type 2 dm subjects; * age \> 18 years old,male or female; * continuous treated with two or more oral antidiabetic drugs (oads) for the last 3 months,and the current hba1c\>7.5%; * cooperative with structured management; exclusion criteria: * subjects with type 1 diabetes; * gestational diabetes mellitus and other specific types dm; * those who are unwilling to sign in icf; * subjects with repeated hypoglycemia; * subjects with bmi\>30kg/m2; * impaired liver function,defined as alanine aminotransferase (alat)\>= 2.5 or alkaline phosphatase (alp)\>= 2 times upper referenced limit times upper normal limit; * females of childbearing age who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial (adequate contraceptive measures as required by local law or practice); * mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation; * any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, myocardial infarction within the past 12 months; severe neurology or psychology or psychiatric diseases; serious infection; actively disseminated intravascular coagulation; * malignant neoplastic diseases (except carcinoma in situ); * current addiction to alcohol or other addictive substances;
comparative bioavailability study of eplerenone 50 mg tablets under fasting conditions

Conditions: Hypertension

Summary: the purpose of this study is to demonstrate the relative bioequivalence of eplerenone 50 mg er tablets under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
dietary oxalate and immune cell function

Conditions: Kidney Stone

Summary: the purpose of this study is to evaluate mitochondrial function in white blood cells and platelets from healthy individuals following dietary oxalate intake.

inflammation and dietary oxalate have been shown to play an important role in the development of kidney stones. oxalate is a small molecule found in plants and plant-derived food. individuals that have high oxalate intake have an increased risk of developing kidney stones. the co-investigators have previously shown that healthy subjects that consume dietary oxalate have increased plasma and urine oxalate. white blood cells are essential for the immune response and rely on the mitochondria to carry out important cell functions. the principal investigator's current research shows that patients with calcium oxalate kidney stones have decreased mitochondrial function in their immune cells. using the expertise of the investigators, this study will test whether oxalate has a direct effect on mitochondrial function in immune cells from healthy subjects. this information could help us understand the role of oxalate on the immune system during kidney stone pathogenesis.

Eligibility criteria:
inclusion criteria: * mentally competent adults who are able to read and comprehend the consent form, written in english * male or female * age 18 to 70 years * non-tobacco users * bmi between 19 and 27 * willingness to abstain from vigorous exercise during study period * normal blood comprehensive metabolic panel exclusion criteria: * mentally incompetent adults who are unable to read or comprehend the consent form, written in english * pregnant females * active medical problems * history of kidney stones * any medical disorder that could influence absorption or excretion of oxalate * bmi less than 19 or greater than 27 * tobacco users * current use of medications or dietary supplements

Keywords: dietary oxalate diet therapy
effects of hormone replacement therapy on arthralgia in postmenopausal women

Conditions: Arthralgia

Summary: arthralgia has been a common complaint in postmenopausal period which seems to be involved with estrogen depletion, although, its pathophysiology isn´t completely clarified. it seems to relate with the level of physical activity, climacteric symptoms and pain catastrophizing. in view of the multiple dimensions involved in arthralgia in postmenopausal women which characterize it as a complex phenomenon, this study aims to describe the effects of hormone replacement therapy in women aged between 45 and 55 years, considering estrogen as a possible anti-nociceptive factor.

this study is a randomized double-blind controlled clinical trial with postmenopausal women aged between 45 and 55 years with chronic arthralgia related to climacteric. they will be evaluated climacteric symptoms, pain intensity, level of physical activity, pain catastrophising, depression, anxiety, quality of sleep and quality of life. the volunteers will be randomized, in the proportion 1:1, to treatment with either 0,625 mg conjugated equine estrogen, via oral administration, for 12 weeks or placebo, via oral administration, for 12 weeks. the randomization will be performed by a computer-generated random numbers list. the investigators will be blinded until completion of 12 weeks. evaluation of climacteric symptoms, pain intensity, level of physical activity, pain catastrophising, depression, anxiety, quality of sleep and quality of life will be performed in the hospital at baseline, 1, 2, 3, 6 months and 15 days. in each visit, participants will be evaluated about adverse effects such as diarrhea, nausea and vomit.

Eligibility criteria:
inclusion criteria: * age between 45 and 55 years * chronic arthralgia related to climacteric * regular mammography and pap smear test in the last twelve months * availability to attend hormone replacement therapy * maximum of ten years of amenorrhea according to the criteria of stages of reproductive aging workshop (straw) * without use of hormone replacement therapy, at least, previous six months * no contraindication to hormone replacement therapy (current or past of breast and / or cervical cancer, severe current or recent heart disease, thromboembolism, hypertension with no control, metabolic diseases (but stable thyroid disease) and endometrial hyperplasia to be enlightened * informed consent exclusion criteria: * autoimmune diseases * visceral pain (chronic pelvic pain, dyspareunia, irritable bowel syndrome) * systemic diseases (rheumatic, neurological, oncology, sexually transmitted infection) * body mass index of 30 or greater * soy diet * abuse of alcohol and drugs * large surgeries
nasogastric tube securement comparison study

Conditions: Failure to Thrive; Nutritional Deficiency; Constipation; Bowel Obstruction; Feeding and Eating Disorders

Summary: this study evaluates the use of tape to secure nasogastric tubes compared to securement with a nasal bridle device.

patients who need to have a tube placed through their nose and into their stomach for medical treatments will sometimes have it accidentally removed. a nasal bridle is a device where a magnetic is used to attach a small piece of cloth tape that loops around the nasal septum bone and secures to the nasal gastric tube to prevent it from being pulled out accidentally.

Eligibility criteria:
inclusion criteria: 1. admitted to children's hospital colorado to: * 6th floor surgical inpatient unit, or * 8th floor medical inpatient unit, or * heart institute (cardiac intensive care unit or cardiac progressive care unit), or * interventional radiology. 2. require a nasogastric or transpyloric tube (corpak tube or clear feeding tube) for feeding or bowel cleanout. 3. predicted length of use is at least 48 hours. 4. newborn up to 21 years of age 5. have a completed consent for enrollment into the study. exclusion criteria: 1. burn patients because standard for placement is the nasal bridle; 2. patients with contraindications for bridle placement , such as * mechanical obstruction of the nasal airway * facial or nasal fractures * fracture of the anterior part of the cranium, or basilar skull fractures 3. any tubes placed for decompression (i.e. salem sump tubes) 4. nasally intubated, or 5. with cpap/bipap.

Keywords: nasogastric tube microbridle
clinical application of ultrasound in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: we hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound through submental area is different between normal control with those with obstructive sleep apnea syndrome who was comfirmed by polysomography.

patients with obstructive sleep apnea mainly due to upper airway narrowing are evaluated conventionaly by polysomography. recently, the magnetic resonace imaging has been well established in evaluating upper airway and correlating with the severity by tongue mass and the area of retropalatal airway. however, some drawbacks of mri includes expensiveness might lead its less use. as for ultrasound which is very popularly applied in medical illness, is more convenient and money saving than mri. we propose that ultrsound measuring the tongue volume and width of upper airway through submental area may be a alternative image for a upper airway measuring.

Eligibility criteria:
inclusion criteria: * group of sleep apnea: patients who have been diagnosed as having obstructive sleep apnea * control group: patients who have a negative polysomogrphy or a normal score of pittsburg sleep questionaire exclusion criteria: * less than 18-year-old * un-willing * not co-operated person
vascular reactivity in chronic kidney disease (ckd) patients receiving paricalcitol versus placebo

Conditions: Chronic Kidney Disease

Summary: this research is studying how vitamin d may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (ckd) patients. blood vessel health is worsened in ckd and some studies have shown that vitamin d improves blood vessel health. the type of vitamin d being used in this study (paricalcitol) is food and drug administration (fda) approved to treat high parathyroid hormone levels. the purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.


Eligibility criteria:
inclusion criteria: * males or females ≥ 18 years of age at the start of screening * ckd with egfr 15-60 ml/min/1.73m2 by mdrd * not expected to start dialysis for 4 months * serum intact pth 70-200 pg/ml during screening period * on stable acei/arb regimen for 30 days prior to screening exclusion criteria: * history of any of the following diseases: * congestive heart failure * mi within the last 6 months * history of cerebrovascular accident * significant valvular disease * malignancy * currently taking any vitamin d products * mean systolic blood pressure values \> 190 or diastolic blood pressure values \> 100 mm/hg during the preceding 30 day period prior to screening * currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker * two consecutive serum calcium values greater than 10.2 mg/dl or ca x p \> 55 mg2/dl2 * currently receiving erythropoiesis stimulating agent or intravenous iron therapy * pregnant or breastfeeding

Keywords: chronic kidney disease vitamin d
pilot study of free from falls program in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this pilot study will compare how often people with multiple sclerosis (ms) fall before participating in the free from falls (fff) educational program, during the program, and for 8 weeks after the program. the protocol will also evaluate the accuracy, efficiency and convenience of an email survey to count how often people fall.

this pilot study will recruit people with ms who report falling at least twice in the previous 2 months to participate in the fff program. all subjects will record their falls and injurious falls on a daily basis for at least 3 weeks before the program, during the program and for 8 weeks after the program. the program will consist of a weekly 2 hour session. one hour of the session will be educational and one hour of the program will involve exercise. the outcome of this study will be change in fall rate between the periods before, during and after the program.

Eligibility criteria:
inclusion criteria: * ms of any type * age 18 years or older * able to walk at least 100 meters with intermittent or unilateral constant assistance (cane, crutch or braces) with or without resting * self-reported history of 2 or more falls in the previous 2 months * clinically stable ms with no relapses within 30 days * willing to provide informed consent * fluent in written and spoken english. * daily access to email and willing to respond to a daily email questionnaire exclusion criteria: * serious psychiatric or medical conditions that would preclude reliable participation in the study.

Keywords: accidental falls multiple sclerosis education exercise postural balance
clinical trial on anti-inflammatory effect of low-molecular weight heparin in pediatric cataract surgery

Conditions: Inflammation

Summary: the purpose of this study is to determine if intraocular infusion of low-molecular weight heparin (enoxaparin) influences postoperative inflammation following pediatric cataract surgery with intraocular lens (iol) implantation.

despite advances in cataract surgery in children, postoperative inflammation is a significant complication following pediatric cataract surgery. any drug that prevents or decreases this inflammation would be beneficial. heparin has anti-inflammatory and antiproliferative effects as well as anticoagulant properties. several studies on animal and adult human eyes show that adding heparin to the irrigating solution during cataract surgery results in less disturbance of the blood-aqueous barrier and helps prevent posterior capsule opacification (pco). a prospective, randomized, controlled and masked study is mandatory to evaluate the anti-inflammatory effect of low-molecular weight heparin for pediatric cataract surgery

Eligibility criteria:
inclusion criteria: * children (0-15 years) with congenital cataract scheduled for surgery with iol implantation and informed consent from the parents/legal guardian exclusion criteria: * preoperative: associated ocular anomalies (uveitis, microphthalmos, persistent fetal vasculature, aniridia, glaucoma, iris coloboma), traumatic cataract * intraoperative: inability to implant iol in the capsular bag, intraoperative complications- iris trauma, vitreous disturbance, descemet's detachment

Keywords: pediatric cataract surgery low-molecular weight heparin intraocular infusion anti-inflammatory effect
comparison of pain-related changes in cerebral blood volume in burn patients with neuropathic pain

Conditions: Neuropathic Pain

Summary: the investigators will observe increased or decreased cbv in patients with thermal injury compared with the cbv in healthy controls.

prevalence of chronic pain has been shown to be high after thermal injury. post-burn neuropathic pain causes chronic disabilities that is often difficult to treat effectively. to study changes in the pain network associated with neuropathic pain, magnetic resonance imaging(mri) will be used to evaluate cerebral blood volume(cbv) in patients who was injuried by burn. over the fifty participants will be recruited. the participants will be comprised 30 subjects with neuropathic pain caused by thermal injury and 20 healthy contols. the 30 patients with neuropathic pain will be comprised divided into 15 electrical injury group and 15 non-electrical burn injury group. the patients are included the patients with severe neuropathic pain that is rated at least 5 on the visual analogue scale (vas), despite treatments with gabapentin medication and other physical modalities. the intensity of neuropathic pain will be measured using the visual analogue scale(vas). depressive mood will be assessed using the beck depression scale. cbv maps will be compared between burn patients and controls. and the relationship between individual participant cbv(measured in voxels), bds and vas score will be also examined.

Eligibility criteria:
inclusion criteria: * burn patients * severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (nrs). exclusion criteria: * cardiac arrest history * history of neurologic disease or brain surgery * unstable heart disease or presence of a cardiac pacemaker * psychiatric disorder * diabetes mellitus * abnormal renal function * contraindication for mri * pregnancy.

Keywords: burn neuropathic pain cerebral blood volume
tele-rehabilitation in chronic respiratory disease: an observational cohort study

Conditions: Chronic Respiratory Disease

Summary: pulmonary rehabilitation is a program that helps people with lung disease improve their function. it uses exercise, education, and self-management strategies to improve physical ability and quality of life. because some people are unable to visit west park healthcare centre, we established a remote supervised pulmonary rehabilitation program that patients can access via an electronic device (computer, tablet or smart phone). regular quality assurance is necessary to ensure that the program is effective. we plan to collect and summarize the program's results. the benefit of doing so is that it allows us to make any changes or improvements that may help patients with chronic respiratory conditions.


Eligibility criteria:
inclusion criteria: * stable chronic respiratory disease * qualified candidates for pulmonary rehabilitation, * current non-smoker; * primary diagnosis chronic respiratory disease limited by dyspnea (mmrc≥2); * free of exacerbation at the time of admission, and * stable co-existing conditions exclusion criteria: * completed pr within the previous 12 months of the current admission and * being unable to communicate with the treating team.
the influence of 5-httlpr and bdnf polymorphisms on anxiety and mood after acute exercise

Conditions: Polymorphisms; Exercise; Mood

Summary: the influence of 5-httlpr and bdnf polymorphisms on anxiety and mood after acute exercise. introduction: the 5-httlpr (slc6a4) and bdnf (val66met) polymorphism presents an action on the modulation of human behavior and has received great attention as a risk factor for several psychiatric disorders. in recent years, a growing number of studies have evaluated the association between these polymorphisms and personality traits related to anxiety and depression. objectives: to determine the frequencies of 5-httlpr and bdnf polymorphisms in a college students population; to determine the influence of 5-httlpr and bdnf polymorphisms on mood states and anxiety after acute physical exercise. material and methods: four hundred (400) college students will be assessed. in the first phase of the study, the following procedures will be performed: screening, aerobic fitness assessment (step test), questionnaires (par-q, habitual physical activity level, beck anxiety and depression scale, state-trait anxiety, and perceived stress scale), blood sample collection and genotyping. in the second phase of the study, two (2) groups with or without polymorphisms will be selected (for each gene). these groups will be submitted to four conditions (three experimental conditions and one control condition), carried out randomly and separated by an interval of 1 week. in the experimental conditions the volunteers will perform treadmill exercises sessions (30 minutes) in three different intensities (light, moderate and vigorous) and will respond to the borg scale at 10, 20 e 30 minutes. in the control condition the volunteers will be instructed to remain seated (quiet rest), relaxed and silent for 30 minutes. in both conditions, the volunteers will complete the profile of mood states (poms) and state-anxiety (stay), 05 (five) minutes before and, 5 (five) and 20 (twenty) minutes following the interventions.


Eligibility criteria:
inclusion criteria: * 18-30 years of age; * able to perform physical activities; non-inclusion criteria: * history of cardiovascular or respiratory diseases; * smoking; * use of psychiatric drugs; * psychotherapy treatment in the last six months.

Keywords: anxiety mood physical activity polymorphisms
effect of caffeine on heart function

Conditions: Fatigue; Tachycardia

Summary: * the primary objective of this study is to assess the effect of an energy drink on ventricular repolarization as measured by the interval between the cardiac q wave and the cardiac t wave (qt interval)obtained from the body surface ecg. * the secondary objective is to assess the effects of an energy drink on heart rate and blood pressure (hemodynamic effects). to place the observed changes in context, comparison will be made to a commonly consumed drink, coffee: starbuck's k-cup breakfast blend.

this study will assess cardiac repolarization before and after three conditions each of which will involve the subject drinking beverages of varying caffeine content.

Eligibility criteria:
inclusion criteria: * healthy * bmi between 24 - 29 exclusion criteria: * resting heart rate below 60 bpm * resting heart rate above 88 bpm * cardiovascular or metabolic disease

Keywords: heart rate blood pressure caffeine energy drink