Kornimate/medical-research-clean huggingface dataset:
synergy of exercise and nutrition in preventing and treating frailty

Conditions: Frail Elderly

Summary: the goal of this clinical study is to learn if combining a nutritional supplement with a multicomponent exercise program can help prevent and treat frailty in community dwelling older adults. the main questions it aims to answer is: does combining a nutritional supplement (meritene) with a multicomponent exercise program improve frailty and functionality in older adults? researchers will compare: * a group receiving both the nutritional supplement and the exercise program (intervention group) * a control group receiving neither (control group) participants: * take the nutritional supplement (meritene, 30g twice a day) for 180 days * attend (3days/week) supervised exercise sessions as part of the multicomponent program for 180 days (if assigned to the intervention group). * undergo regular clinical evaluations for frailty, nutritional status, cognitive function, emotional state, and quality of life. measurements will include: changes in frailty status, particularly gait speed, measured using share-fi criteria, nutritional assessment using the mini nutritional assessment (mna), physical and cognitive assessments, including edmonton frail scale, mmse, and short physical performance battery (sppb) and a complete biochemical and clinical blood analysis.


Eligibility criteria:
inclusion criteria: * i) men and women aged 70 years or older; ii) sedentary (less than three hours of weekly physical activity), iii) frail according to the survey of health, ageing and retirement in europe frailty index (share-fi); iv) gait speed lower or equal than 0.8 m/sec, v) community dwellers exclusion criteria: * i) life expectancy from the moment of selection lower than twelve months by any cause; ii) poorly controlled diabetes (glycated hemoglobin \> 9%); iii) cognitive impairment (score less than 17 in the mmse); iv) disability (score less than 50 points on barthel's scale); v) acute coronary event in the previous year; vi) hospital admission in the previous three months for any reason; vii) oncologic patient with active treatment with chemotherapy or radiotherapy; viii) major non-ambulatory surgery in the previous six months; ix) patient with a coronary event in the previous twelve months; x) institutionalized patient; xi) new york heart association class 3 to 4 baseline dyspnea; xii) lactose intolerance; xiii) being supplemented with a multivitamin or a protein-rich food; xiv) refusal to sign the informed consent.

Keywords: frailty malnutrition physical exercise program nutritional supplementation
local infiltration analgesia with ropivacaine versus placebo in caesarean section

Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting; Cesarean Section

Summary: the purpose of this study is to compare systematic local infiltration with ropivacaine 0.5 % versus ropivacaine 0.2 % versus placebo in patients undergoing elective caesarean section. the hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.


Eligibility criteria:
inclusion criteria: * eligible for elective caesarean section * able to speak and understand danish * able to give informed consent exclusion criteria: * alcohol or medical abuse * allergies to local anesthetics * age \< 18 years * intolerance to opioids
comparison of optical quality with different placement of refractive multifocal intraocular lens

Conditions: Cataract, Age-Related

Summary: the study aims to compare postoperative optical quality between two different implanting position of a rotationally asymmetric miol \[sbl-3 lenstec; +3.00 diopters (d)\], angle kappa based implantation and 0 to 180 degree implantation, in order to find out the optimal implantation position for sbl-3.

sbl-3 has been proved to provide patients with good near, intermediate and distant visual acuity, but there is not much study on the impact of sbl-3 position on postoperative visual acuity.the regional refractive design of sbl-3 means it could be affected by pupil center shift (described by angle kappa: the difference between visual axis and pupil axis), the investigators assume that maintaining the ideal ratio of distant and near segment(50% vs 42%) in the pupil center could yield both good distant and near postoperative visual acuity postoperatively. therefore, the investigators designed the implantation by placing the iol based on angle kappa to make sure the ratio of distant and near segment exposure in the pupil center close to 50:42. in this study, the investigators assessed the optical quality in patients with sbl-3 implantation based on angle kappa and 0 to 180 degree to provide surgeons with information for choosing appropriate implantation position for optimum postoperative satisfaction of sbl-3.

Eligibility criteria:
inclusion criteria: * age related cataract * underwent bilateral cataract surgery and sbl-3 implantation * corneal astigmatism \<1.5d exclusion criteria: * patients with active ocular inflammation * neuro-ophthalmic disease and macular disease * previous corneal or intraocular surgery, corneal opacities or disease * patients had surgical complications, pupillary trauma, inability to place the lens in the capsular bag * iol tilt or decentration deviated from intraoperative positioning * difficulties with examinations and follow-up

Keywords: multifocal intraocular lenses visual acuity kappa angle
efficacy and safety of ursodeoxycholic acid (udca) added to the dpp-4 inhibitor in people with type 2 diabetes and chronic liver diseases

Conditions: Type 2 Diabetes Mellitus; Chronic Liver Disease

Summary: 1. objectives 1. to test whether ursodeoxycholic acid (udca) increases glucagon-like peptide-1 (glp-1) response to nutrients and improves glycemic control in people with type 2 diabetes. 2. to test whether sitagliptin enhances udca-induced beneficial effect in glp-1 levels and glycemic control. 3. to test safety of combination therapy of sitagliptin and udca in people with type 2 diabetes. 2. clinical hypothesis. 1. udca increases glp-1 response to nutrients via provoking bile acids excretion from the liver to the intestine/colon. 2. udca improves glycemic control in people with type 2 diabetes. 3. sitagliptin enhances udca-induced response of glp-1 to nutrients. 4. sitagliptin has additive beneficial effects with udca in glycemic control in people with type 2 diabetes. 5. combination therapy of sitagliptin and udca is safe and well-tolerated in people with type 2 diabetes. 6. the combination therapy may loose weight by unique mechanisms of each agent; glp-1 inhibits appetite by acting on cns and gastrointestinal motility, whereas udca-enhanced circulating primary bile acids increases energy expenditure through the pathway involving g protein-coupled bile acid receptor 1 (gpbar1, or m-bar, tgr-5) and subsequent activation of type 2 iodothyronine deiodinase (d2) in brown adipose and muscle tissues, as reported previously.


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. hba1c \>=6.5% during 8 weeks prior to the study 3. treated with none or single oral hypoglycemic agent(oha: sulfonyl ureas, biguanides, or thiazolidinediones) over 12 weeks prior to the study exclusion criteria: 1. non-type 2 diabetes 2. medical history and/or complication of diabetic ketoacidosis 3. medical history and/or complication of severe hypoglycemia 4. insulin treatment within 16 weeks prior to the study 5. treatment with alpha-glucosidase inhibitors or sitagliptin within 12 weeks prior to the study 6. treatment with glucocorticoid 7. unstable glycemic control 8. hypersensitivity to or contraindication of sitagliptin and voglibose 9. aspartate transaminase (ast) or alanine transaminase (alt) \>=2.5 time of institutional upper normal limit 10. uncontrolled hypertension (systolic blood pressure \>160mmhg or diastolic blood pressure \>100mmhg) 11. severe health problems not suitable for the study 12. pregnant or lactating women 13. hepatitis b or c

Keywords: ursodeoxycholic acid sitagliptin bile acids glp-1
effectiveness of lumbar traction in lumbar disk herniation

Conditions: Lumbar Disk Herniation

Summary: the purpose of this study is to compare the clinical outcome of medical treatment associated with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.

this is a prospective and randomized study. medical treatment = anti-inflammatory therapy and epidural medical treatment associated with lumbar traction medical treatment = + 5 lumbar traction sessions.

Eligibility criteria:
inclusion : * patient with lumbar disc herniation with radiculopathy, over 18 years and consenting exclusion : * sciatic complicated (motor deficit or cauda equina syndrome), against indication for medical treatment and / or lumbar traction * previous lumbar surgery * sciatica without disc herniation
acute heart graft rejection screening by cardiac magnetic resonance imaging

Conditions: Cardiac Graft

Summary: acute heart allograft rejection is a common complication after orthotopic heart transplantation. primary objective of this study is to assess cardiac mri as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.

acute heart allograft rejection is a common complication after orthotopic heart transplantation. it can lead to multiple cardiac injuries and sometimes to patient's death. currently, acute heart graft rejection screening is based on invasive strategies. gold standard is represented by endomyocardial biopsies which provide side effects risk, rare but potentially fatal for the recipient. cardiac mri is an imaging tool recently used in cardiology. it is a non-invasive without any x-ray exposition method well adapted to assess cardiac function and cardiac muscle composition. cardiac mri is probably a great tool to help the screening of acute heart allograft rejection, by detecting changes in myocardium structure. mri validation as a screening tool for heart allograft rejection detection could help to reduce endomyocardial biopsies realised after orthotopic heart transplantation.

Eligibility criteria:
inclusion criteria: * orthotopic heart transplantation patients * endomyocardial biopsies \< 72h * estimated glomerular filtration ratio \>30ml/min (calculated by cockcroft formula for patients age \ 65 ans) * patients affiliated to french national health insurance * for pre-menopausal female patients, negative pregnancy test * patient's consent form signature * patient with correct french writing and speaking comprehension exclusion criteria: * endomyocardial biopsies showing acute cellular rejection grade 1r or antibodies mediated rejection pamr1 * patient in need of renal dialysis * past history of allergic reaction or side effects after gadolinium infusion * hemodynamical instability * mri contra-indication (claustrophobia, ocular metallic objects, non mri compatible cardiac device, neurological non rmi compatible device, osteosynthesis prosthesis older than 1980) * pregnant or breast feeding woman * patient participating to another clinical trial
neutralizing antibody seroprevalence study with a retrospective component in participants with late-onset pompe disease

Conditions: Pompe Disease; Pompe Disease (Late-onset); Glycogen Storage Disease Type 2; LOPD; Lysosomal Storage Diseases; Acid Maltase Deficiency

Summary: the purpose of this study is to obtain information pertaining to the occurrence of antibodies to investigational spk-3006 capsid and gaa, gaa activity and gaa antigen levels in the usual care setting of late-onset pompe disease (lopd) participants on an enzyme replacement regimen. additionally, a careful evaluation of laboratory and functional testing in patients with lopd may provide information to better understand the disease features and better drive the design of a future interventional investigational gene therapy trial. an understanding of the underlying status of liver and muscle health in individuals with lopd may also inform best surveillance during the conduct of gene therapy trials.


Eligibility criteria:
inclusion criteria: * provide written informed consent and authorization to use protected health information in accordance with national and local privacy regulations * male or females ≥18 years of age * currently on ert using regular recombinant human gaa infusions for at least 18 months prior to screening * documented history of clinically moderate late-onset pompe disease. exclusion criteria: * history of hiv infection * requires any invasive ventilation (other than bipap at night) or noninvasive ventilation while awake and upright * previously received spk-3006 * previously dosed with any investigational or approved gene therapy product at any time or treated with an investigational drug within the last 12 weeks (vaccination studies are accepted) * any concurrent clinically significant condition that would not allow the potential participant to complete the day 1 examinations, or other condition that, in the opinion of the investigator and/or sponsor, makes the subject unsuitable for participation in the study * unable or unwilling to comply with the schedule of visits and/or study assessments described in the clinical protocol.
a study to evaluate the safety, tolerability, pharmacokinetics and efficacy of asc30 tablets and asc30 tablets a1 in participants with obesity

Conditions: Weight Management

Summary: this is a phase i, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of asc30 tablets or asc30 tablets a1 in participants with obesity.


Eligibility criteria:
inclusion criteria: 1. have provided informed consent before initiation of any study-specific procedures. 2. male or female participants, non-smokers, between 18 and 65 years of age (both inclusive). 3. no clinically significant findings from medical history, physical examination, 12-lead ecg, vital signs measurements, and other screening procedures. exclusion criteria: 1. have evidence of any clinically significant active or chronic disease. 2. have any prior diagnosis of diabetes mellitus (t1dm or t2dm), or rare forms of diabetes mellitus. 3. have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. 4. have a history of acute or chronic pancreatitis. 5. participants with a known clinically significant gastric emptying abnormality. 6. have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy. 7. have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol.
pharmacokinetics and pharmacodynamics of anthocyanins

Conditions: Gout

Summary: the purpose of the study is to establish the pharmacokinetic parameters of cherry juice concentrate and identify its potential to alter inflammatory markers in gout patients.


Eligibility criteria:
inclusion criteria: * diagnosis of gout exclusion criteria: * allergy to cherries or cherry products * any history of malignancy * history of any pancreatic or biliary tract disease * significant anemia * history of significant renal (scr \> 1.5 mg/dl) * hepatic disease (liver enzymes 3 times upper limit of normal) * any active gastrointestinal condition * history of large bowel resection for any reason * use of cherry juice concentrate or consumption of cherries within 14 days * personal or inherited bleeding disorders or currently on anticoagulation * women of childbearing age not on oral contraceptives * women who are pregnant or nursing

Keywords: gout tart cherry pharmacokinetics
comparison of endoscopy and diffusion-weighted enterography-mri for the diagnosis of crohn's disease recurrence following ileocolic resection: a pilot study

Conditions: Crohn's Disease

Summary: nearly three-quarters of patients with crohn's disease have small bowel involvement and 80% of them will have complications that will require a surgical procedure, usually an ileocolonic resection with ileocolonic anastomosis. the rate of recurrence at the anastomosis site and in the ileum after surgery, whether symptomatic or not, is high, at least 60% in one year and 80% within three years. the gold standard for monitoring being ileocolonoscopy, endoscopic surveillance is recommended in these patients, once between 6 to 12 months after surgery and then every 2 years. the mri enterography is a validated technique for the assessment of small bowel crohn's disease. the enterography mri is a validated technique for the assessment of small bowel crohn's disease. the mri enteroclysis was evaluated in two studies compared to endoscopy, with excellent performance in terms of recurrence detection sensitivity and suggested as an alternative to it to avoid an invasive procedure repeated in these patients. the mri enterography (without enteroclysis) does not provide as good distension of the bowel loops as mri enteroclysis because it relies on the principle of oral ingestion prior to the examination of large amounts of liquid. however, it is much better tolerated by the patient, does not involve radiation that exists with enteroclysis, is much simpler to use and requires no special equipment to magnetic fields.

determine the diagnostic performances of mri enterography for the diagnosis of recurrence at the anastomosis site and in the ileum in patients with crohn's disease who have had ileocolonic resection. assess the value of diffusion sequences of mri enterography for the diagnosis of recurrence at the anastomosis site and in the ileum in patients with crohn's disease who have had ileocolonic resection.

Eligibility criteria:
inclusion criteria: * patients with crohn's disease * patients with ileocolonic resection more than 6 months ago and less than 4 years ago * patients with indication of ileocolonoscopy * patient consenting to participate to the study * patient enrolled in the national healthcare insurance program * patient older than 18 years exclusion criteria: * patients with contraindications for mri
refining treatment options for trichomonas vaginalis infection: a comparative analysis of metronidazole and secnidazole

Conditions: Trichomonas Vaginitis; Bacterial Vaginitis

Summary: this is a multi-centered, randomized, open-label, parallel, phase iv clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (mtz) and oral single-dose secnidazole (sec) for the treatment of trichomonas vaginalis in both women and men.

this is a multi-centered, randomized, open-label, parallel, phase iv clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (mtz) and oral single-dose secnidazole (sec) for the treatment of trichomonas vaginalis in both women and men. the goal is to refine t. vaginalis treatment for women and men by examining the effectiveness (aim 1) and cost-effectiveness (aim 2) of multi-dose oral mtz versus single-dose oral sec. the investigators have several secondary analyses for aim 1 including to examine if bacterial vaginosis (bv) interferes with t. vaginalis treatment, to explore preferences for follow-up visits, and to examine the natural history of t. vaginalis infection in both sexes. if single-dose oral sec is found to be superior to multi-dose oral mtz, this could potentially result in an estimated 280,000 people in the u.s./year receiving better care, having fewer adverse sexual and reproductive health outcomes, and having a reduced risk for hiv acquisition. it will also provide patients with a single-dose oral treatment option that will be particularly attractive for subjects with concomitant t. vaginalis and bv.

Eligibility criteria:
inclusion criteria: * women and men aged 18 years or older of any race/ethnicity will be included in the study. * participants must have either a positive t. vaginalis rapid antigen test (osom), or wet mount microscopy with motile trichomonads, or nucleic acid amplification test (naat) urinalysis or pap smear positive for tv within two weeks of available results (and have not yet been treated) that is confirmed by repeat t. vaginalis naat testing at study enrollment, * willing and able to provide and understand informed consent to comply with the study protocol, * have a method of contact (either phone, email or social media), * be willing to be randomized. exclusion criteria: * pregnant/lactating or seeking to be pregnant * have been treated for with a 5-nitroimidazole (i.e. metronidazole (mtz), tinidazole (tdz), or secnidazole \[sec\]) in the last 28 days * used intravaginal boric acid or any other intravaginal treatment for t. vaginalis in the last 14 days * have a history of a type 1 hypersensitivity reaction to 5-nitroimidazole medications * are taking phenytoin (dilantin) and/or warfarin (coumadin) due to drug-drug interactions with oral mtz * use of medications which may alter the metabolism of mtz including lithium and barbiturates (amobarbital, butalbital, methohexital, phenobarbital, pentobarbital, primidone, secobarbital) * have been previously enrolled in the study
zinc supplementation in very low birth weight infants-a randomised controlled trial

Conditions: Preterm Infant; Effect of Drugs; Zinc Deficiency Disease

Summary: * zinc (zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems. * due to many reasons, preterm infants are generally believed to be naturally in a negative zn balance during the early periods of life. * regulation of intestinal zn absorption of preterms is unrelated to infant's zn status. * there still is a lack of knowledge in the possible relation of zn deficiency and development of nec and/or feeding intolerance in preterm infants. * even if zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

background and objectives: preterm infants have high zinc (zn) requirements and are generally believed to be in a negative zn balance in the early period of life. in this study, we aimed to investigate the effect of high dose zn supplementation in very low birth weight (vlbw) infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (nec), late-onset sepsis (los). methods: this is a prospective randomized trial. vlbw preterm infants with gestational age of \<32 weeks were randomly allocated on the seventh day of life to receive extra amount of supplemental zinc along with the enteral feedings or not, besides regular low dose supplementation, from enrollment until discharge. outcome measures were feeding intolerance, nec (stage≥2), los and mortality.

Eligibility criteria:
inclusion criteria: * \< 32 weeks gestational age and/or \<1500 gr birth weight * born in the study hospital * being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient exclusion criteria: * major congenital malformations and/or critical congenital heart defects * born in another hospital * severe birth asphyxia * severe sepsis * previous early-onset nec history * infants on the intervention arm who did not continue zinc supplementation during the study period * hemodynamically unstability * infants nil per os * no consent from the family * death before the 7th day of life