Kornimate/medical-research-clean huggingface dataset:
effect of metformin on gut microbiota changes and glycemic control of newly diagnosed type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients.

this study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients. all the recurited patients were treated with metformin 1500-2000mg daily for 3 months. stool specimens and blood samples were collected at the beginning and 3 months later.

Eligibility criteria:
inclusion criteria: newly diagnosis type 2 diabetes ,hba1c \>7 % exclusion criteria: history of cardiovascular disease, hypertension, severe renal dysfunction defined as glomerular filtration rate \< 45 ml/min/1.73 m2; severe illness or diabetic ketoacidosis within 30 days, inability to tolerate ≥500 mg metformin twice per day and pregnancy.
ketamine for postoperative pain in bariatric surgery

Conditions: Pain, Postoperative; Bariatric Surgery Candidate

Summary: the aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. ketamine is an old general anaesthetic. low doses of it might be used as a adjunct in postoperative analgesia.the investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.

effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment. new analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects. one of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. to our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched. the investigators hypothesize that ketamine, acting through the n-methyl-d-aspartate receptor (nmda) and opioid receptors, provides favourable conditions for adequate post-operative pain management.

Eligibility criteria:
inclusion criteria: * ii or iii the american society of anesthesiologists (asa) physical status * age \> 18 years * bariatric surgery with general remifentanil anesthesia exclusion criteria: * anamnesis of using opioids for the treatment of chronic pain * opioid dependence * younger than 18 years
joint injections for osteoarthritic knee pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether prolotherapy (prt), a therapy based on injection of a sugar solution in and around the knee, can decrease pain and disability from knee osteoarthritis (oa).

oa is a common, debilitating condition for which there is no cure and no known cause. prolotherapy (prt) is an injection-based therapy for chronic musculoskeletal pain in which an irritant solution is injected at painful ligaments and tendons to produce stronger connective tissue and decrease pain. although limited studies suggest prt is effective may be effective for low back pain, its use has not been rigorously studied in human clinical trials for osteoarthritis. participants in this study will be randomly assigned to receive one of three treatments: standard prt, injections with a saline placebo, or a pamphlet with recommendations for home knee physical therapy. injections will be given at weeks 1, 5, and 9; injection group subjects will have the option to receive an additional 2 sets of injections. all participants will be assessed for a total of 1 year. a set of disease-specific and general quality-of-life questionnaires will be used to assess participants' outcomes . a randomized subset of participants (n=38)will receive magnetic resonance imaging (mri)of the knee at baseline and 52 weeks. at study completion, participants who did not receive prt will have the option to receive up to five sessions of prt at no cost. data will be collected for this group (minus mri) and will be analyzed separately. enrollment is limited to residents of southern wisconsin.

Eligibility criteria:
inclusion criteria: * pain from knee osteoarthritis that has impacted life for 3 months to 10 years * x-ray results indicating knee osteoarthritis exclusion criteria: * knee osteoarthritis surgical candidate * history of total knee joint repair * prior use of prt * prior fracture of the knee joint * joint injection of steroids or other drugs within the past 3 months * rheumatoid or inflammatory arthritis * chronic use of narcotic medication * other chronic pain diagnoses * diabetes mellitus * body mass index (bmi) greater than 45 * unresolved litigation * pregnancy * co-morbidity that may interfere with the study

Keywords: injection therapy
influence of obuvacaine hydrochloride eye drops on the comfort of meibomian gland massage patients

Conditions: Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland Dysfunction

Summary: in this study, there were differences in patients' demands for ephedrine during meibomian gland massage and whether it would affect patients' poor comfort. therefore, we needed to collect patients' pain grades during meibomian gland massage

meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. and meibomian gland massage is a very important step in the treatment. meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. and meibomian gland massage is a very important step in the treatment. meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. and meibomian gland massage is a very important step in the treatment. meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction. methods: we selected dry eye patients who visited dry eye clinic of aier eye hospital from june 2020 to march 2021 to conduct questionnaire survey and analysis with pain scalemethods: we selected dry eye patients who visited dry eye clinic of aier eye hospital from june 2020 to march 2021 to conduct questionnaire survey and analysis with pain scale group: divided into ephedrine drop group and artificial tear drop group research tool: pain rating scale

Eligibility criteria:
inclusion criteria: healthy people with no chronic disease exclusion criteria: people with chronic disease
coronary artery disease progression in patients with acute coronary syndromes and diabetes mellitus

Conditions: Coronary Artery Disease; Diabetes Mellitus

Summary: a total of 100 patients with non-st-segment elevation acute coronary syndromes with or without diabetes mellitus will be included. all patients will undergo coronary angiography with identification of the infarct-related vessel and percutaneous revascularization with implantation of a stent/scaffold. after revascularization patients will undergo a combined positron emission tomography (pet)-coronary computed tomography (ct) protocol to quantify atherosclerotic burden (i.e. plaque volume) and activity (i.e. 18 fluorum-sodium-fluoride \[18fnaf\] uptake) in non-infarct related vessels, to assess calcium score (aim 1), and to quantify the acute results of pci in the infarct-related vessel (aim 2). at 12-month follow-up, all patients will repeat longitudinal 18fnaf pet-coronary ct evaluation to characterize progression of atherosclerosis in the non-infarct related vessels (aim 1) and to quantify neointimal suppression at the site of the treated coronary segment in the infarct-related vessel (aim 2). blood samples will be collected at baseline and 12 months for all patients. the aims of the study are: 1. to evaluate coronary artery disease progression in acute coronary syndromes patients with and without diabetes mellitus, and to investigate the predictive value of metabolic profiles, patterns of circulating mirnas and inflammatory mediators on coronary artery disease progression; 2. to evaluate the progression of disease within the infarct-related vessel treated with the use of bioresorbable stent/bioresorbable polymer stents in diabetic and non-diabetic patients with acute coronary syndromes.


Eligibility criteria:
inclusion criteria: * age \>18 and \<80 years, evidence of non-st-segment elevation acute coronary syndromes, ability to provide informed consent exclusion criteria: * st-segment elevation myocardial infarction, cardiogenic shock, suspected stent thrombosis, known allergy to aspirin or ticagrelor, childbearing potential, life expectancy \<1 year due to non-cardiac disease, severe chronic kidney disease.
mirnas evaluate the prognosis of sepsis by dynamic study

Conditions: Sepsis

Summary: sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. mirna is a post-transcriptional small rna which regulate mrna expression. the present study was designed to observe the selected mirna expression which evaluate the sepsis prognosis in the progression of sepsis in order to be a new target for the treatment of sepsis.

the study is a non-intervention observational study. purpose of this study is to observe some selected mirna expression which evaluate the sepsis prognosis in the progression of sepsis . the investigators will collect serum samples from patients with sepsis in sicu, ricu and eicu on the 1st、3rd、5th、7th、10th、14th day of 301 hospital since november 2011 , and then use mirvana paris kit extract total rna and use qrt-pcr detect mirnas expression in serum which can evaluate the prognosis of sepsis, and statistical analysis the mirnas expression correlation with sofa score.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sepsis * patients who agree with the study exclusion criteria: * aged \<18 years; * into the group who died within 24 hours; * agranulocytosis (\<0.5 × 109 / l); * combined hiv infection.

Keywords: sepsis mirna
neuroendocrine mechanisms of growth and body composition in preterm and term infants

Conditions: Premature Birth

Summary: the purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (adp) in rapidly growing, medically stable late gestation \[32-35 weeks post-menstrual age (pma)\] premature infants.

1. to assess the feasibility of measuring body fat deposition by adp in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth. 2. to test the relationship between %bf by adp to %bf by dxa, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, igf-1, igf binding proteins, adiponectin and leptin. 3. to perform inter- and intra-rater testing of anthropometric, ultrasound, and adp measurements. 4. compare growth, body composition and bone strength between infants born preterm to infants born full term.

Eligibility criteria:
inclusion criteria: * infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth * birth weight between the 5th and 95th percentile corrected for gestational age exclusion criteria: * chromosomal abnormalities * major congenital anomalies * major surgery * severe cns injury * inborn errors of metabolism * assisted ventilation * inability to start enteral feeds by 96 hours of age

Keywords: premature birth
ascending multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of evolocumab (amg 145) in adults with hyperlipidemia on stable doses of a statin

Conditions: Hyperlipidemia

Summary: the purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.

participants receiving low-to-moderate-dose statins were randomized in a 1:3 ratio to receive subcutaneous placebo or evolocumab and enrolled sequentially into one of 5 dose-escalation cohorts: 1. evolocumab 14 mg/placebo once weekly (qw) × 6 doses 2. evolocumab 35 mg/placebo once weekly (qw) × 6 doses 3. evolocumab 140 mg/placebo every 2 weeks (q2w) × 3 doses 4. evolocumab 280 mg/placebo every 2 weeks (q2w) × 3 doses 5. evolocumab 420 mg/placebo every 4 weeks (q2w) × 2 doses. participants receiving high-dose statins were randomized 1:3 to receive subcutaneous placebo or evolocumab 140 mg every 2 weeks × 3 doses (cohort 6). participants diagnosed with familial hypercholesterolemia (hefh) were randomized 1:2 to receive subcutaneous placebo or evolocumab 140 mg every 2 weeks × 3 doses (cohort 7).

Eligibility criteria:
inclusion criteria: * men and women ages 18 to 70 years (inclusive) at the time of screening with hyperlipidemia * body mass index (bmi) ≥18 and ≤ 35 kg/m\^2 at the time of screening * low-density lipoprotein cholesterol (ldl-c) level of 70-220 mg/dl (inclusive) at screening as measured by direct assay * for cohorts 1-5: on a stable dose of rosuvastatin (crestor) \< 40 mg/day, atorvastatin (lipitor) \< 80 mg/day, or simvastatin (zocor) 20-80 mg/day for ≥ 1 month prior to enrollment and expected to remain on this dose for the remainder of the study * for cohort 6: on a stable dose of rosuvastatin (crestor) 40 mg/day or atorvastatin (lipitor) 80 mg/day for ≥ 1 month prior to enrollment and expected to remain on this dose for the remainder of the study * for cohort 7: diagnosis of heterozygous familial hypercholesterolemia, based on a score of ≥ 9 points using the world health organization (who) criteria exclusion criteria: * diagnosis of homozygous familial hypercholesterolemia * history of heart failure, coronary artery bypass graft, or cardiac arrhythmia * history of acute coronary syndrome (e.g. myocardial infarction, hospitalization for unstable angina) or percutaneous coronary intervention, within 12 months prior to enrollment * planned cardiac surgery or revascularization * known aortic, peripheral vascular or cerebrovascular disease (including history of stroke or transient ischemic attack) * diabetes mellitus with any of the following: 1. known microvascular or macrovascular disease 2. hba1c \> 8.0% at screening 3. use of any hypoglycemic medication other than metformin * uncontrolled hypertension (systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 90 mmhg) either on or off therapy at screening or at baseline

Keywords: amg145 multiple dose statin ascending
determinants of quality of life related to health in alzheimer disease

Conditions: Alzheimer Disease

Summary: study the factors that explain health-related quality of life (hrql) in patients with alzheimer disease including: * the influence of the environment (physical and human) on health-related quality of life (hrql), * the influence of non-drug and drug treatments on health-related quality of life (hrql), * the influence of formal and informal help mobilized, * the influence of interactions "patient - caregiver" on health-related quality of life (hrql), * the influence of the ratio necessary cost on available resources on health-related quality of life (hrql)


Eligibility criteria:
inclusion criteria: * patients with alzheimer disease (dsm iv and nincds-adrda) * patients with mmse (mini mental state examination) \> or = 10 * out patients exclusion criteria: * severe sensory disturbances, * non french speaking

Keywords: dementia - alzheimer - quality of life
pharmacokinetic study of advate reconstituted in 2 ml sterile water for injection

Conditions: Hemophilia A

Summary: the purpose of this study is to determine the pharmacokinetics and safety of antihemophilic factor, recombinant, manufactured protein-free (rahf-pfm) reconstituted in 2 ml sterile water for injection (swfi) and compare with those of rahf-pfm reconstituted in 5 ml of swfi.


Eligibility criteria:
inclusion criteria: * the subject or subject's legally authorized representative has provided written informed consent * the subject has severe hemophilia a as defined by a baseline fviii activity \<= 1% of normal; tested at screening * the adolescent/adult subject has a documented history of at least 150 exposure days to fviii concentrates (either plasma-derived or recombinant), and the pediatric subject has at least 50 exposure days * the subject is \>= 12 to \ = 2 to \ 60 * the subject is human immunodeficiency virus negative (hiv-) or hiv+ with stable cd4 count \>= 200 cells/mm³ (cd4 count determined at screening, if necessary) exclusion criteria: * the subject has a known hypersensitivity to mouse or hamster proteins or to fviii concentrates * the subject has a history of fviii inhibitors with titer \>= 0. 5 bu (bethesda assay) or \>= 0.4 bu (nijmegen modification of the bethesda assay) any time prior to screening * the subject has a detectable fviii inhibitor at screening, \>= 0.4 bu (nijmegen modification of the bethesda assay), in the central laboratory * the subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: international normalized ratio (inr) \> 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices * the subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia a (e.g. qualitative platelet defect or von willebrand disease) * the subject has received another investigational product within 30 days of enrollment * the subject's clinical condition may require major or moderate surgery (estimated blood loss \> 500 ml) during the period of participation in the study * subjects with clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance * the subject is a female of childbearing potential with a positive pregnancy test at screening
real world experiences of the inap® lite in osa adults in taiwan

Conditions: Obstructive Sleep Apnea of Adult

Summary: a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the inap® lite sleep therapy system in adults with obstructive sleep apnea

obstructive sleep apnea (osa) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat osa. to this end, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the inap® lite sleep therapy system (inap® lite), a tongue and soft palate retaining intraoral device, in adults with osa.

Eligibility criteria:
inclusion criteria: * diagnosed with osa with ahi\>5 exclusion criteria: * patients with central sleep apnea (csa). * patients with have severe respiratory disorders such as pulmonary diseases, pneumothorax, etc. * patients with loose teeth or advanced periodontal disease. * patients with pathologically low blood pressure.
care pathway for children with autism spectrum disorder included in the elena cohort

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (dsm 5). in france, national guidelines about practices recommends early and specific interventions but care pathway are not well described for asd children. the national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the french population. in addition, the elena cohort is a large cohort of children with asd followed for 6 years. data collected include clinical characteristics of children (iq, severity of asd...) and parents (educational level, professional status...). the first objective of this project is to identify patterns of care trajectories using data from elena cohort matched to data from national health insurance information system. secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.


Eligibility criteria:
inclusion criteria: - included in elena cohort exclusion criteria: - opposable to reuse data

Keywords: care pathway health administrative database
effect of exercise on endothelial injury in hypertensive patients

Conditions: Hypertension; Healthy

Summary: introduction: endothelial dysfunction precedes atherosclerosis being evidenced in patients with hypertension. increasing physical activity levels and/or physical exercise are part of the recommendations of antihypertensive therapy. however, the effects of oscillations and/or increase the systemic blood pressure induced by exercise session on endothelial function has not been studied. objective: to evaluate the effect of aerobic exercise, resistance exercise and combined exercise on endothelial injury levels in patients with hypertension. methodology: hypertensive (n = 51) and healthy subjects (n = 30) (30-59 years old) will perform at random 40 minutes of aerobic exercise (50-60% of heart rate reserve) or 40 minutes of resistance exercise (4 x 12 repetitions of exercises for lower limbs, 60-70% of one repetition maximum and 60-90 second interval) or 40 minutes of combined exercise (20 minutes of resistance exercise and 20 minutes of aerobic exercise, in that order). blood will be collected 10 minutes before, 10 and 60 minutes after intervention for the quantification of endothelial microparticles (mpe) circulating (induced endothelial lesion) and endothelial progenitor cells (epc) circulating (endothelial recovery capacity) by flow cytometry. ambulatory blood pressure monitoring (abpm) will be held before and after the intervention. ultrasonography is used to measure the flow-mediated dilation of the brachial artery 10 minutes before, 10, 30 and 60 minutes after the intervention. statistics: generalized estimating equation (gee) for repeated measurements and person correlation, being significant p \< 0.05. it is expected to show results to ensure cardiovascular protection in patients with hypertension caused by different types of exercise and consequent endothelial injury and release induced regenerative factors. knowledge of the magnitude of injury and endothelial recovery provided by different types of exercise can contribute scientifically to health professionals aimed at prescribing exercise with a vascular protective vision in patients with hypertension.


Eligibility criteria:
inclusion criteria: * adults with hypertension; * 30 to 59 years old. exclusion criteria: * diabetes; * heart disease; * participating in any regular exercise program over the last six months; * orthopedic impairments or any physical or mental limitation that prevents - achievement of physical exercise; * body mass index in class ii obesity or more (bmi ≥ 35 kg / m2); * smoking.

Keywords: exercise endothelium hypertension endothelial progenitor cell endothelial microparticle