Kornimate/medical-research-clean huggingface dataset:
glucose metabolism, muscle mass/function and inflammation in the elderly

Conditions: Sarcopenia; Diabetes Mellitus

Summary: a thorough characterization of glucose metabolism and "inflammaging" in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. the investigators will correlate patterns of insulin secretion/sensitivity with "muscle "quality/quantity" in diabetic and non-diabetic elderlies (≥70 years old). by comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an "oxidative/inflammatory signature" (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. in all other patients, a diagnosis will be established according to the criteria of the american diabetes association * sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the european working group on sarcopenia in older people (ewgsop) * healthy volunteers: no diabetes, no sarcopenia and none of the exclusion criteria exclusion criteria (overall population): * acute diseases, * chronic obstructive pulmonary disease (copd) * conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer), * obesity (body mass index ≥30 kg/m2) * moderate-severe hepatic disease, * chronic kidney disease (estimated glomerular filtration rate \<30 ml/min per 1.73m2), * metal prostheses, * recent or ongoing infection, * inability or unwillingness to provide informed consent exclusion criteria (diabetic population): * type 1 diabetes, * hemoglobin a1c \>8.5% (69 mmol/mol), * basal-bolus insulin therapy, * insulin pump therapy, * proliferative diabetic retinopathy, * diabetic foot.

Keywords: inflammaging
patient-reported outcomes for sarecycline effectiveness and safety (proses)

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate the patient-reported outcomes (pros) in terms of health-related quality of life (hrqol) and signs of acne vulgaris (av) among patients with moderate to severe non-nodular av who are administered sarecycline (seysara®) in real-world community practice settings in the united states (u.s). investigator's global assessment (iga) of av and safety measures associated with use of sarecycline (seysara®) will be assessed over the study observation period of 12 weeks. clinicians will prescribe sarecycline (seyara®) as per their own clinical judgment and standard practice.


Eligibility criteria:
inclusion criteria: patient inclusion criteria: * male or female, aged 9 years and above * has facial non-nodular av with iga score of moderate or severe * considered as a potential candidate for sarecycline (seysara®) treatment, per clinician judgment caregiver inclusion criteria: * primary caregiver of the study-eligible patient * male or female, aged 18 years and above exclusion criteria: * patients with any known resistance to other tetracyclines * patients with any dermatological or physical condition of the face that could interfere with the av clinical evaluations. * patients with any history of allergy to tetracycline-class antibiotics, pseudomembranous colitis or antibiotic-associated colitis. * unable to comply with the requirements of the study or patients who in the opinion of the site investigator should not participate in the study other protocol defined inclusion/exclusion criteria may apply

Keywords: prospective non-nodular acne vulgaris perceptions health-related quality of life (hrqol) patient-reported outcomes (pros) signs & symptoms
comparative study of flecainide cr and placebo in the early treatment of atrial fibrillation.

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to assess the efficacy of flecainide controlled release (cr) in the prevention of recurrent af during 9 months of active treatment compared to placebo in patients with only one documented af episode.


Eligibility criteria:
inclusion criteria: * history of first symptomatic \& documented episode of af * lvef \> 40% and not on aad and in sinus rhythm at time of recruitment exclusion criteria: * history of more than 1 symptomatic documented af episode, persistent or permanent af. * history of ablation for previous af * reversible cause for af (e.g.thyroid, alcohol, pulmonary embolism, surgery * severe symptoms during af episode (e.g.syncope, chest pain) * all types of treated arrhythmias other than af * history of myocardial infarction (mi), coronary artery disease (cad), heart failure (i, ii, iii and iv of new york heart association -nyha- classification) or valvular diseases * left ventricular ejection fraction (lvef) ≤ 40% * bradycardia \ 240ms or qrs\> 120 ms or qtc\> 440 ms * brugada syndrome * conduction disturbances: complete bundle branch block (lbbb) or (rbbb), bifascicular block * 2nd or 3rd degree atrioventricular (av) block * sinus node dysfunction * severe hypertension with:systolic blood pressure ≥ 180 mmhg, and / or· diastolic blood pressure ≥ 100 mmhg * left ventricular hypertrophy (lvh) with septal thickness \> 14 mm on echocardiogram * implanted pacemaker * heart surgery within the last 6 months, or non-stable postoperative condition * renal failure: serum creatinine ≥ 150 µmol/l or creatinine clearance ≤ 50 ml/min (cockroft and gault formula * uncorrected electrolytic abnormalities * have used recently in the last 3 months prior to the inclusion any of the following treatments: oral amiodarone, treatments that lengthen qt interval (e.g.sultopride, drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, bupropion * anti-hypertensive drugs other than permitted in the study: ace-i, arb (sartans) and dhp from calcium channel blockers (ccb
placebo controlled study of 3 doses of rifaximin-eir tablet to treat moderate, active crohn's disease

Conditions: Crohn's Disease

Summary: this study aims to determine which of 3 doses of a non-absorbable antibiotic rifaximin is most effective in treating active moderate crohn's disease. rifaximin tablets are already marketed in some european countries and the usa to treat traveller's diarrhoea. a new gastro-resistant form of rifaximin called rifaximin-extended intestinal release (eir) will be used in this study. these tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver rifaximin directly to the site of the disease. rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease localised in the ileum and/or colon, documented either radiologically or endoscopically at least 3 months previously; * patients with a cdai of ≥ 220 to ≤ 400; * patients capable of and willing to conform to the study protocol; * patients who have provided signed and dated written informed consent. exclusion criteria: * patients potentially needing immediate surgery for crohn's disease, including patients with occlusive symptoms and/or stenotic tract with dilation above; * patients with active perianal crohn's disease; * patients with other infectious, ischemic, or immunological diseases with gastrointestinal involvement; * patients with symptoms attributed to short bowel syndrome or previous surgery; * patients with stoma; * patients affected by upper gastro-intestinal disease (gastro-duodenum-jejunum crohn's disease) alone or in combination with colitis or ileitis; * patients treated with: oral steroids and budesonide less than 30 days prior to screening; i.v. steroids less than 30 days prior to screening; antibiotics (such as metronidazole, tinidazole, ciprofloxacin, clarithromycin) less than 15 days prior to screening; * rectal steroids less than 30 days prior to the screening visit; * anti-tumour necrosis factor (anti-tnf) and other biological therapies less than 6 months prior to the screening visit; * pregnant women or nursing mothers; * females of childbearing age (unless surgically sterile) without a negative urine pregnancy test at screening and at enrolment; * patients with severe hepatic insufficiency (child c); * patients with severe cardiac insufficiency (nyha - new york heart association classes 3 - 4); * patients with known hypersensitivity to rifaximin; * any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, with immunological (including hiv infection), haematological or neoplastic disease; * withdrawal of informed consent; * patients who have used any investigational drug (except biological therapies) within 3 months prior to screening; * patients who have donated 250 ml or more of blood in the last 3 months.

Keywords: rifaximin-eir crohn's disease remission
paleo diet 8wk feasibility in overweight adults

Conditions: Overweight and Obesity

Summary: overweight, physically inactive but otherwise healthy adults habitually eating a traditional western diet will follow an ad libitum self-administered paleo diet for 8-weeks. blood and body composition will be measured before and after the intervention period.

the paleo diet is a dietary method that is gaining popularity among the general population due to potential weight loss and disease prevention benefits. the feasibility of the paleo diet and the effectiveness of self-administration in improving cardiometabolic disease risk factors remains uncertain. examination od cardiometabolic disease risk factors in overweight, physically inactive adults before and after 8-weeks of an ad libitum self-administered paleo dietary intervention. methods: overweight, physically inactive but otherwise healthy adults habitually eating a traditional western diet follow an ad libitum self-administered paleo diet for 8-weeks. blood samples were analyzed for fasting cardiometabolic disease biomarkers. participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the intervention to confirm western diet consumption at pre-, track compliance, and to assess dietary changes.

Eligibility criteria:
inclusion criteria: * age: 18-55 years * bmi \> 25 kg/m2 * currently consuming a typical western diet (high carbohydrate, low fat diet), which will be assessed using the 3-day dietary record (public domain) exclusion criteria: * known cardiovascular, metabolic (including type i or type ii diabetes), or respiratory disease * smoking and/or smokeless tobacco users * pregnancy
a prospective randomized trial of uncemented versus cemented hemiarthroplasty for displaced femoral neck fractures

Conditions: Femoral Neck Fractures

Summary: there is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly no definite conclusions have been made in regards to what kind of arthroplasty is favourable cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality. cementless implants are associated with increased postoperative pain and decreased walking ability. this study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. previous studies have mostly used uncemented stems with different designs. null hypothesis: no (less than 10 points) difference in hhs between groups at 1 year and 5 years

inclusion criteria: dislocated intracapsular femoral neck fracture in patients ≥ 70 years old exclusion criteria: pathological fracture, systemic or local infection, short life expectancy/not mobile at all, symptomatic coxarthrosis. null hypothesis: no (less than 10 points) difference in hhs between groups at 1 year (sd of hhs is 15 points) power: 95% significance: 0.05 60 patients in each group needed. to compensate for high mortality and drop-out: 200 patients, 100 in each group randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent. recorded after surgery: operating time arthroplasty components used need of blood transfusion blood loss size of incision recorded at discharge, 3 months, 1 year and 5 years: x-ray of pelvis and hip harris hip score barthels adl-index quality of life (eq-5d) use of analgetics use of walking aids publication: international orthopaedic journal.

Eligibility criteria:
inclusion criteria: * dislocated intracapsular femoral neck fracture * ≥ 70 years old exclusion criteria: * pathological fracture * systemic or local infection * short life expectancy/not mobile at all * symptomatic coxarthrosis

Keywords: fracture femoral neck arthroplasty
assessment of visual performance in patients with low levels of astigmatism

Conditions: Cataract Extraction; Corneal Astigmatism

Summary: to assess visual performance in patients with low levels (0.5-0.75 diopters) of corneal astigmatism.


Eligibility criteria:
inclusion criteria: * 50-75 years of age * proof of eye exam within the last 12 months * operated for uncomplicated, age-related cataracts \>3 months * corneal astigmatism of 0.5-0.75 diopter exclusion criteria: * previous ocular or refractive surgery/trauma * clinically severe corneal dystrophy * amblyopia * degenerative visual disorders

Keywords: corneal astigmatism post-cataract surgery visual performance corneal astigmatism 0.5-0.75 diopter
evaluation of inner ear and brain structures with contrast-enhanced mri in patients with meniere's disease

Conditions: Meniere's Disease

Summary: * this prospective study aims to better characterize inner ear's perilymphatic structures with magnetic resonance imaging using contrast media and delayed injection in patient's with meniere's disease. * mr perfusion imaging will be assess in both cochlea as well * primary auditory brain pathways will be evaluated through mr diffusion imaging


Eligibility criteria:
inclusion criteria: * major subjects of over 40 years (mean age of meniere's disease 40 to 50 years) * informed consent signed * medical examination performed prior to participation in research * patients with clinical criteria of meniere's disease according to the classification of the american association of otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation) * recipient of a french social security scheme exclusion criteria: * patients minors * patients on a legal protection regime type guardianship * respiratory pathologies, cardiovascular, renal, diabetes * claustrophobia * contraindications to exposure to a magnetic field * contraindications to injecting dotarem ®
preservative-free mk2452 (tafluprost) for open-angle glaucoma/ocular hypertension (mk2452-001)(completed)

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: this study was to compare the safety and efficacy of the preservative-free formulation of 0.0015% mk2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with open-angle glaucoma and ocular hypertension. this study was to demonstrate that the preservative-free formulation of 0.0015% tafluprost is non-inferior to preservative-free 0.5% timolol maleate.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension * patient has a mean (or median) iop of \>=23 and =\<36 in at least one eye at the 0800 hours time point at the baseline visit. * patient has \<5 mmhg difference in mean (or median) iop between eyes at each time point (0800 hours, 1000 hours, and 1600 hours) at baseline. * patient is currently using a prescribed ocular hypotensive medication and has been on a stable dose for 30 days prior to screening, or patient is drug-naive (those who have never used or who have not used ocular hypotensive medication for at least 4 weeks prior to screening) * patient is able to safely discontinue current ocular hypotensive medication during up to the 4-week washout period * patient has vision corrected to 20/80 or better in each eye * patient is willing and able to avoid wearing contact lenses from 4 weeks prior to dosing through 24 hour after final dosing * patient is willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications * patient is not pregnant and not planning to become pregnant during the study * patient is male or female ≥18 of age on the day of signing the informed consent exclusion criteria: * patient is unable to use study medication in the affected eye(s) * patient has a history of inflammatory ocular surface disease or anterior or posterior uveitis in either eye * patient has a history of retinal detachment, diabetic retinopathy, or other progressive retinal disease * patient has experienced significant visual field loss within the last year * patient has had intraocular surgery in either eye in the last 4 months * patient has a history of glaucoma surgery or refractive surgery in either eye * patient is currently taking two or more anti-glaucoma medications (except cosopt™ or its generic formulation) * patient has previously used tafluprost * patient has a history of cardiovascular disorder within 6 months prior to screening * patient has a history of bronchial asthma, wheezing, pneumonia, copd, other pulmonary disease, or abnormal chest x-ray * patient has a mean (or median) iop \>36 mmhg in either eye at the screening visit or at any time point (0800 hours, 1000 hours, and 1600 hours) of the baseline visit.
appropriate oxygen levels for extremely preterm infants: a prospective meta-analysis

Conditions: Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Retinopathy of Prematurity; Infant, Newborn, Diseases; Infant, Very Low Birth Weight

Summary: the primary question to be addressed by this study is: compared with a functional oxygen saturation level (spo2) of 91-95%, does targeting spo2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?

oxygen has been used in the care of small and sick newborn babies for over 60 years. however, to date there has been no reliable evidence to guide clinicians regarding what is the best level to target oxygen saturation in preterm infants to balance the four competing risks of mortality, lung disease, eye damage and developmental disability. five high quality randomised controlled trials are now underway assessing two different levels of oxygen saturation targeting (usa - support; australia - boost ii; new zealand - boost nz; uk - boost ii uk; canada - cot). the value of these gold-standard trials can be further enhanced when, with careful planning, they are synthesised into a prospective meta-analysis (pma). a pma is one where trials are identified for inclusion in the analysis before any of the individual results are known. we have established the neonatal oxygenation prospective meta-analysis (neoprom) collaboration, comprising the investigators of these five trials and a methodology team. the trials are sufficiently similar with respect to design, participants and intervention and, with planning, will have enough common outcome measures to enable their results to be prospectively meta-analysed. together they have a combined sample size of almost 5000 enrolled infants.

Eligibility criteria:
inclusion criteria: * infants \< 28wks gestation exclusion criteria: * infants \> 28wks gestation

Keywords: prospective meta-analysis preterm infant pulse oximetry oxygen saturation
role of beta-blockers in the prevention on the arisen of a severe sepsis (tess)

Conditions: Community-Acquired Infections

Summary: the severe sepsis (ss) and toxic shock (ts) are both frequent and severe complications of infectious diseases. they are one of the top ten causes of death in industrialized countries. but an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence on a community infection has never been studied. the objective of this study is to evaluate this role.

the severe sepsis (ss) and toxic shock (ts) are both frequent and severe complications of infectious diseases. they are one of the top ten causes of death in industrialized countries. the adrenergic system is heavily involved in this pathological/physiological context. if the effect of various therapeutic strategies allowing the care of the ss/ts was widely estimated, the impact, positive or negative, therapeutic prescribed in the long term or more punctually - but be that as it may before the arisen of the sepsis - on the evolution of a community acute infectious pathology towards the ss/ts, had only little studied. the main objective of this study is to estimate the possible protective role of a long-term prescription of a beta-blocker on the arisen of the ss/ts in patients having an acute infectious pathology of community origin. the secondary objective will be to estimate, at the patients having developed a ss/ts, the impact of this long-term prescription of beta-blockers on the mortality in intensive care unit (icu).

Eligibility criteria:
inclusion criteria: * common characteristics of cases and controls: * patients aged of more than 18 years old * hospitalized patients, during the period of study, via the icu of the participating hospital center, for a community infectious pathology: * lower respiratory infections (pneumonia) * intra-abdominal infections (cholangitis, diverticulitis, peritonitis) * urinary parenchymal infection (pyelonephritis complicated or without abscess, prostatitis, orchitis, epididymitis) * infections of skin and soft tissue infections (cellulitis, fasciitis) * meningitis, endocarditis, osteo-articular infections, salpingitis definition of cases: * patient included in the study and admitted to the emergency service either directly from icu or after a hospitalization in a specialty for severe sepsis or septic shock on their infectious disease community. definition of controls: * patient included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before being released from the hospital. non inclusion criteria: * opposition of the patient to the it processing of its data within the framework of this observational study. * exclusion criteria: occurrence, during hospitalization, a severe sepsis or septic shock associated with a nosocomial superinfection.

Keywords: severe sepsis toxic shock