Kornimate/medical-research-clean huggingface dataset:
bromfenac bid plus prednisolone acetate bid versus bromfenac bid plus prednisolone qid for the prevention of cystoid macular edema and retinal thickening

Conditions: Cystoid Macular Edema,; Retinal Thickening

Summary: the objective of this study is to determine if twice-daily dosing of prednisolone (pred forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (cme) when either regimen is used concomitantly with twice-daily bromfenac.


Eligibility criteria:
inclusion criteria: * · male or female \> 18 years of age scheduled to undergo cataract surgery * must be in good general health. patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams) * expected visual outcome of 20/25 or better. * ability to provide informed consent and likely to complete all study visits exclusion criteria: * · known contraindication to any study medication or any of their components * uncontrolled systemic disease * required use of ocular medications other than the study medications during the study * abnormal pre-operative octs * diabetic patients with a history of macular edema or diabetic retinopathy * amd, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease * only one eye of each patient can be enrolled
impact of electrolyte intake (sodium, phosphorus) on the growth of premature newborns

Conditions: Postnatal Growth Disorder

Summary: extrauterine growth restriction (eugr) is a common complication in the medical management of premature newborns. the long-term consequences of eugr are weight and height restriction, metabolic disorders, and neurodevelopmental disorders. the main risk factor for eugr is nutritional deficiency, particularly protein and energy. additionally, appropriate intakes of electrolytes, particularly sodium and phosphorus, are essential to promote harmonious growth. adequate sodium intake is essential to ensure satisfactory growth, especially in premature babies due to their higher body water content. adequate phosphorus intake is also essential because of its involvement in the formation of lean mass, with sufficient protein intake, and in phosphocalcic metabolism. at the regional university maternity of nancy, parenteral and enteral nutrition prescriptions for each premature newborn are made using the logipren® prescription assistance software, based on espghan recommendations. despite this theoretical security, it seems that they are not strictly respected. at the same time, premature newborns typically show weight loss often greater than -1 z-score. the objective of this research is to study the impact of electrolyte intake (sodium and phosphorus) on growth trajectories and the incidence of eugr in premature newborns discharged from the nancy maternity hospital in 2023. the secondary criteria are to describe sodium, phosphorus, protein and calorie intake and compliance with espghan recommendations; assess the true prevalence of stunting in our study population; and the impact of meeting electrolyte intake recommendations on children's growth trajectory, taking into account protein and calorie intake.


Eligibility criteria:
inclusion criteria: * neonates born between january 1st 2023 and december 31st 2023 * neonates born before 37 sa * neonates hospitalized at the nancy maternity hospital in neonatology exclusion criteria: * neonates transferred at the nancy maternity hospital after 48 first hours of life

Keywords: parenteral nutrition enteral nutrition electrolyte intake premature newborn growth trajectory
improvement of intraoperative behavior of staff to prevent postoperative complications

Conditions: Postoperative Complications

Summary: the aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. the intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.


Eligibility criteria:
inclusion criteria: * major patient * patient agreeing to participate in the study * patient who will benefit from orthopedic surgery for hip or knee arthroplasty with prosthesis placement non-inclusion criteria: * patient with previous history of surgical site infection

Keywords: behavior; operational block; monitoring; social sciences ; new technologies
functional and molecular characterisation of oesophageal distal epithelium: correlations with acid and non acid reflux

Conditions: Gastroesophageal Reflux

Summary: this study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with gord symptoms. in addition these patients will be characterized for their reflux especially by ph-impedancemetry, bilitec and oesophageal acid perfusion test. correlations between the characteristics of the reflux and the biological results will be calculated.

this study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with gord symptoms. in addition these patients will be characterized for their reflux especially by ph-impedancemetry, bilitec and oesophageal acid perfusion test. correlations between the characteristics of the reflux and the biological results will be calculated.

Eligibility criteria:
inclusion criteria: main inclusion criteria : * digestive symptoms suggestive of gord (heartburn, regurgitation, epigastric pain), or dyspeptic syndrome (nausea, belch, bloating, epigastric discomfort). * need of upper gi endoscopy and ph monitoring. * normal propagation of oesophageal persitaltic waves (manometry \< 6 months). * age 18 -70 yrs * signed informed consent * normal coagulation exclusion criteria: * barrett's oesophagus * previous oesophageal bleeding * need of nsaid treatment. * previous sus mesocolic surgery * alcool consumption \> 40g/d, smoking \> 10 cig/j * pregnancy or lack of contraceptive disposal, breast feeding. * allergy to xylocaïne

Keywords: gord - oesophageal sensitivity- oesophageal permeability
risk factors for barotrauma in covid-19

Conditions: Barotrauma; Covid19

Summary: barotrauma in mechanical ventilation (mv) is defined as lung damage attributable to the application of high airway pressure and is one of the potential mechanisms of ventilator-induced lung injury (vili). previous studies have shown an increased mortality in patients with barotrauma under mv; pneumothorax (ptx) being the most common presentation, but it can also present as pneumomediastinum (pm) with or without ptx, with extension to soft tissue as subcutaneous emphysema or even as pneumo-retroperitoneum and pneumo-scrotum. traditionally, underlying lung disease or age are known risk factors for non-trauma related barotrauma. however, in patients with novel coronavirus disease (covid-19), the incidence of this complication is more common than in non-infected patients, as recently reported. since little is known regarding which are the main risk factors for these events to develop, most pathophysiological mechanisms remain unexplained. the aim of this study was to determine the risk factors for developing barotrauma in patients under mv with covid-19 associated acute respiratory distress syndrome (ards). secondary objectives were to determine the incidence of barotrauma and its association with mortality.


Eligibility criteria:
inclusion criteria: * patients under mv fulfilling the berlin definition for ards, with positive sars-cov2 real time polymerase chain reaction exclusion criteria: * incomplete clinical records and other causes of extrapulmonary air

Keywords: barotrauma covid-19
effects of latin dancing on sleep quality in hispanic cancer survivors

Conditions: Cancer Survivorship; Sleep Disturbances

Summary: the primary objective is to assess the feasibility, acceptability and explore the impact of a culturally appropriate latin dance intervention vs. usual care on sleep quality for hispanic cancer survivors. secondary objectives are to examine the preliminary efficacy of a culturally appropriate latin dance intervention on secondary cancer- and treatment-related side effects (e.g., quality of life, distress, insomnia, fatigue).

in this feasibility randomized control trial (rct) study, the investigators will assess the feasibility, acceptability, and explore the impact of a latin dance intervention vs usual care on sleep quality among hispanic survivors. study aims: aim 1: develop a culturally appropriate latin dance intervention for hispanic cancer survivors using a bidirectional community engagement approach. using iterative qualitative feedback from hispanic cancer survivors, the investigators will develop a latin dance intervention for hispanic cancer survivors. aim 2: assess the feasibility and acceptability of a culturally appropriate latin dance intervention for hispanic cancer survivors. aim 3: provide preliminary evidence of the efficacy potential of a culturally appropriate latin dance intervention vs. usual care on subjective and objective sleep quality for hispanic survivors.

Eligibility criteria:
inclusion criteria: * be 18 years of age or older * self-identify as hispanic and/or latino(a) * have a confirmed diagnosis of a solid tumor or hematologic malignancy * must have completed primary cancer treatment 3+ months prior to enrollment (e.g., chemotherapy, surgery, and/or radiation therapy but may be on hormonal therapy and/or immunotherapy or other long-term therapies) * have sleep disturbance (indicated by a response of 3 or more on the md anderson symptom inventory sleep question by using an 11-point scale anchored by 0 \[no sleep disturbance\] and 10 \[worst possible sleep disturbance\] * be able to read and understand english and/or spanish * physically inactive (\<150 minutes of vigorous exercise/week within the past 3 months) exclusion criteria: * current regular latin dancing practice within the past year (2-3 times a week over a period of two months that is not interrupted). * inability to speak and read english or spanish proficiently * inability to understand informed consent * medical conditions that can cause sleep impairment: sleep apnea, restless leg syndrome, shift work * regular use of a walker or wheelchair * healing or unhealed fractures * heart failure * life expectancy \<12 months * unwilling to be randomized to study arms and/or commit to 8 weeks of classes and a follow-up assessment

Keywords: cancer cancer survivorship sleep disturbances hispanic cancer survivors latin dancing
novel multifocal soft contact lens study

Conditions: Myopia

Summary: a single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. habitual contact lens wearers will be asked to come to the study site for one visit. ocular health assessments and visual acuity will be completed with both the study lens and without.


Eligibility criteria:
inclusion criteria: 1. ability to give informed consent 2. any gender 3. any racial or ethnic origin 4. 18 - 40 years of age 5. distance visual acuity with best corrected visual acuity of 20/25 with each eye 6. habitual soft contact lens wearer with myopia 7. good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the investigator). exclusion criteria: 1. current or active ocular inflammation or infection as determined by the investigator. 2. astigmatism \> 0.75 d in either eye 3. history of previous eye surgery 4. demonstration or history of corneal ectasia or keratoconus. 5. pregnant or lactating.
the site study - dexamethasone ophthalmic insert in or on day of surgery versus in-office post-op day 1

Conditions: Cataract

Summary: to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (iol) compared to insertion 1-day post-op.

this is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (iol) compared to insertion 1-day post-op. there will be approximately 50 eyes with two groups: group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the or. group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the hopd. each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: baseline (screening visit), operative visit/insertion day (day 0), day 1, day 7 and day 30.

Eligibility criteria:
inclusion criteria: * subjects will be eligible for study participation if they: are an adult subject aged 65 years or older are planning to undergo non-complicated cci ce/pciol in one or both eyes are willing and able to comply with clinic visits and study related procedures are willing and able to sign the informed consent form exclusion criteria: * subjects are not eligible for study participation if they: have active infectious systemic disease have active infectious ocular or extraocular disease have unobstructed nasolacrimal duct in the study eye(s) have known hypersensitivity to dexamethasone or are a known steroid responder have a history of ocular inflammation or macular edema are currently being treated with immunomodulating agents in the study eye(s) are currently being treated with immunosuppressants and/or oral steroids are currently being treated with corticosteroid implant (i.e. ozurdex) have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye have a history of complete punctal occlusion in one or both punctum currently use topical ophthalmic steroid medications are unwilling or unable to comply with the study protocol are determined by the investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
a prospective study on uss assessment of pelvic structures in 3rd trimester of pregnancy versus delivery outcome

Conditions: Pelvic Floor Disorders; Pregnancy

Summary: the proposed study is to evaluate if there are specific factors in the pelvic floor functional anatomy which can predict the ability of having a vaginal birth after caesarean section. physical characteristics of the soft tissue in the female pelvis play an important role in successful vaginal delivery. a "tight" or less distensible pelvic floor muscles may influence mode of delivery, leading to poor labour progression and by compressing foetal head produce ctg abnormality such as decelerations, both resulting in caesarean delivery. one of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the passage of fetal head through the birth canal by stretching and distending. therefore distensibility of the female pelvic floor influences mode of delivery. three hundred patients, in the third trimester of pregnancy, will be recruited via the antenatal clinics to minimize any disruption in their pregnancy care provision. eligible participants are pregnant women who had either one or no vaginal births, or one caesarean section and who can give an informed consent and maintain their autonomy regarding mode of delivery with understanding of the forthcoming study results. participants will be excluded if they sustain any obstetric complications that may impede on time and mode of delivery including an emergency prelabour caesarean section. ultrasonographic assessment of the differences in the pelvic characteristics of these women will be used to predict a successful of trial of vaginal delivery after caesarean section (vbac) in subsequent pregnancies. the results will be used to better inform whether there is a simple (single ultrasound assessment) that can be used to help inform women's choice regarding mode of delivery. results from this research could be a pioneering blueprint for further studies, as there is very little known about this topic.


Eligibility criteria:
inclusion criteria: 1. english speaking women 2. over 16 years old women 3. women willing to provide written informed consent 4. women who had either prior vaginal delivery or caesarean section or no prior birth experience exclusion criteria: 1. women who cannot give an informed consent, 2. under the age of consent, 3. any participants whose pregnancies complicated during the antenatal period that may influence decision on time and mode of delivery that is anyone who has to undergo an emergency prelabour lscs, 4. nonenglish speaking women 5. less than 16 years old women
metabolic aspects of citrate anticoagulation in renal replacement therapy

Conditions: Acute Renal Failure; Critical Illness

Summary: citrate anticoagulation is associated with metabolic side effects which are linked to a portion of citrate reaching systemic circulation. data on significance of systemic gain of citrate and its relationship to method configuration are missing. patient might also receive certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution is used. the authors test variable methods of indirect estimate of systemic dose of citrate which would allow to quantify the metabolic input without mostly unavailable measurements of citrate levels.


Eligibility criteria:
inclusion criteria: * acute renal failure on continuous renal replacement therapy for more than 24 hours (cvvh or cvvhdf). exclusion criteria: * absence of consent.

Keywords: acute renal failure anticoagulation citrate haemodiafiltration haemofiltration renal replacement therapy
special drug use surveillance for entresto tablets

Conditions: Chronic Heart Failure

Summary: this is a single arm, multicenter, observational study in japanese chronic heart failure patients.

this study is a special drug use surveillance to evaluate the safety and efficacy of entresto tablets (hereafter called entresto) clinically administered in japanese patients for the newly approved indication of "chronic heart failure" and to be conducted as one of the rmp-specified additional pharmacovigilance activities.

Eligibility criteria:
inclusion criteria: * patients must provide written consent to cooperate in this study before the start of entresto * patients using entresto for the first time for the following indication indication: chronic heart failure patients on standard of care for chronic heart failure exclusion criteria: * patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as entresto * the following patients for whom entresto is contraindicated in the package insert patients with a history of hypersensitivity to any of the entresto ingredients patients with a history of angioedema (angiotensin ii receptor blockers or angiotensin converting enzyme inhibitors-induced angioedema, hereditary angioedema, acquired angioedema, idiopathic angioedema etc.) diabetic patients on aliskiren fumarate patients with severe hepatic impairment (child-pugh class c) pregnant or possibly pregnant women

Keywords: chronic heart failure entresto japan sacubitril/valsartan sacubitril valsartan sodium hydrate
efficacy and safety of remibrutinib after switching from ocrelizumab in participants living with relapsing multiple sclerosis.

Conditions: Relapsing Multiple Sclerosis

Summary: the purpose of this phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwrms).

the study is a randomized, open-label, non-inferiority multi-center, phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwrms. this study consists of an initial core part (cp) (maximum duration per participant of up to 24 months), followed by an extension part (ep) (of up to 24 months duration) for eligible participants. all participants completing the 24-month treatment of the core part of the study are eligible to continue in the extension part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months.

Eligibility criteria:
key inclusion criteria: * male or female 40 years of age or older * diagnosis of rms according to the 2017 mcdonald diagnostic criteria * treated with ocrelizumab according to routine clinical practice and at standard dose * neurologically stable within 30 days * suitable to be switched to remibrutinib based on physician judgement or patient preference key exclusion criteria: * diagnosis of primary progressive multiple sclerosis (ppms) according to the revised 2017 mcdonald criteria * history of clinically significant central nervous system disease or neurological disorders * history of confirmed progressive multifocal leukoencephalopathy or neurological symptoms consistent * active clinically significant systemic bacterial, viral, parasitic or fungal infections * active, chronic disease of the immune system other than ms * severe cardiac disease or significant findings on the ecg * participant who is unable to undergo mri scans * history of life-threatening infusion or injection reaction related to ocrelizumab other inclusion and exclusion criteria may apply

Keywords: ms rms remibrutinib lou064 ocrelizumab age mri t2 lesions neda-3
rct of uniport vats for lung cancer

Conditions: Single-port Video-assisted Thoracoscopic Surgery

Summary: video-assisted thoracoscopic surgery (vats) has been widely used for non-small cell lung cancer (nsclc) for nearly two decades. usually, it was applied through three ports with at least one drainage after surgery, which often lead to acute chest pain. therefore, fewer, smaller ports, and wider intercostal space for surgery has been required. uniport vats became a feasible option with the development of surgical techniques and instruments, with potentially less postoperative pain and shorter hospital stays. however, there may be some complications, or with a longer time of operation, even more difficult in lymph nodes resection during learning curve. in our study, a randomized controlled trial was designed to study the operation time, perioperative blood loss, conversion rate, duration of postoperative drainage, length of hospital stay, visual analogue score of postoperative pain, complications, and survival.


Eligibility criteria:
inclusion criteria: patients with ct1-3n0-1m0 nsclc; good cardiopulmonary function; prepared to undergo radical resection; exclusion criteria: patients with n3 or m1 nsclc; poor cardiopulmonary function; not be prepared to undergo radical resection;

Keywords: non small cell lung cancer perioperative efficacy multi-port