Kornimate/medical-research-clean huggingface dataset:
aqualase capsule wash for pediatric eyes

Conditions: Cataract; Pediatric Cataract

Summary: to determine whether aqualase capsule wash reduces posterior capsule opacification (pco) in pediatric eyes.

dramatic advances have occurred in the treatment of childhood cataracts in the last 10 years. intraocular lens (iol) implantation has been universally accepted as the standard of care for most children undergoing cataract surgery beyond infancy. despite advances in cataract surgery in children, pco remained a significant complication following pediatric cataract surgery. in addition to being visually disturbing, it also induces amblyopia in children and if not treated at the earliest, irreversible visual changes may occur. the younger the child, the more acute is the problem: pco occurs faster and the effect of amblyopia is more pronounced. to prevent opacification of the visual axis after cataract surgery, primary posterior capsulectomy and vitrectomy are routinely needed while managing pediatric cataract. this surgical step is not routinely used in adult cataract surgery, where we prefer an intact posterior capsule. researchers are constantly trying to find a way to avoid the need for invasive procedures like posterior capsulectomy and vitrectomy for pediatric eyes. use of aqualase technology has shown some capability in cleaning the capsular bag during cataract surgery. observations of this include anecdotal observation from users. aqualase for cataract removal with the infiniti vision system has been used since 2003, is registered, and the fda clearance is 510(k) number k980292. aqualase uses pulses of warmed balanced salt solution to gently emulsify and facilitate aspiration of cataracts. the device under evaluation falls under the same fda clearance. the unique aspect is the application tip which is intended to allow more thorough capsular bag cleaning or removal of more residual lens material than is currently being achieved. the energy source, controls, and materials are all identical to the currently marketed product. the difference is in the geometry of the distal most end of the application tip.

Eligibility criteria:
inclusion criteria: * bilateral cataract in a child aged 6-15 years old * informed consent from the parents/legal guardian. exclusion criteria: * traumatic cataract * fellow eye - visually not significant cataract * fellow eye surgery not scheduled within 3-month period after first eye surgery * dense posterior capsule plaque * preexisting posterior capsule defect * subluxated cataract * high myopia (defined as axial length \>24 mm) * child with multiple disability where it may not be feasible to perform yag laser capsulotomy in the office, if needed * participants with a strong likelihood of non-adherence (difficulties in adhering to follow-up schedule due to geographic distance from clinical center)

Keywords: pediatric eyes bilateral cataract iol implantation aqualase capsule wash posterior capsule opacification
strategies for improving proton pump inhibitors (ppis) prescription associated to non-steroidal anti-inflammatory drugs (nsaids)

Conditions: Adverse Events

Summary: background despite the low prevalence of serious complications associated with non-steroidal anti-inflammatory drugs (nsaids) use, there is a widespread use of gastroprotective proton pump inhibitors (ppis) in order to prevent adverse effects. inappropriate prescribing of ppis includes overprescribing for inappropriate indications and the misuse of first choice in their class in terms of efficacy, safety and cost. a series of recommendations, based on the best available scientific evidence, has been established to justify prophylaxis with ppis associated to nsaids. therefore, there is the need to encourage the incorporation of this knowledge to guide decisions of physicians with the objective of improving patient health and sustainability of the public health service. although since long ago there is a great concern regarding rational use of drugs, the available evidence for the most appropriate strategies to improve prescribing is scarce. passive dissemination of research findings are generally ineffective and at best result in small changes in practice. multifaceted intervention targeting different barriers to change are more likely to be effective than single intervention. objectives the objective of this study is to evaluate the effectiveness of two educational multifaceted strategies aimed at improving ppis prescription associated to nsaids use in primary care. we will also compare the cost-effectiveness of such strategies. hypothesis it is hypothesized that a quality improvement intervention directed to primary care physicians will decrease inappropriate ppis prescriptions associated to nsaids prescription. methodology a three-arm prospective quasi-randomized controlled trial will test the effectiveness of two strategies for improving ppi prescription associated to nsaid in primary care context. three of the canary islands will be selected and randomized to either a experimental multifaceted intervention (group education+audit-feedback+ccdss) group, a experimental multifaceted intervention (audit-feedback+ccdss) group, or a control group (usual intervention). from each of these islands, 6-8 primary care centers will be randomly selected to received the intervention practices. all family physicians working at each randomly selected primary care center were mandatorily included. primary outcome measure is reduction of inappropriate ppi prescription. the efficacy of the intervention will be examined within a 3, 6 and a 12 month follow up.


Eligibility criteria:
inclusion criteria: * primary care physicians exclusion criteria: * participating as a subject in any other clinical research study * have received any other intervention on the subject within the last 6 months

Keywords: knowledge translation prescription primary care nsaid ppi gastrointestinal damage inappropriate prescription
metabolic impact of intermittent fasting in early type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: one known cause of type 2 diabetes (t2dm) is beta-cell dysfunction, which refers to the inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. unfortunately, no anti-diabetic medication or lifestyle intervention has been shown to prevent the worsening of beta-cell function over time. interestingly, however, intermittent fasting (if) - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. in individuals with t2dm, it is also been shown to improve glycemic control (i.e. reduce the sugar levels). while no research has studied whether if can improve pancreatic beta-cell function, the positive metabolic effects suggest that it could provide some benefit. the current study will evaluate whether if can improve pancreatic beta-cell function in individuals with early t2dm.


Eligibility criteria:
inclusion criteria: * men and women with type 2 diabetes mellitus diagnosed within preceding 10 years * age 20-70 years inclusive * body mass index ≥ 25 kg/m2 * diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (dpp-4) inhibitor either as monotherapy or in combination * hba1c value of 5.5 - 9.0% inclusive exclusion criteria: * current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter 2 (sglt-2) and/or sulfonylureas * involvements in any other clinical study on lifestyle intervention or requiring drug therapy * any history or eating disorder * renal dysfunction as evidenced by estimated glomerular filtration rate \<45 ml/min by modification of diet in renal disease (mdrd) formula * hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \>2.5x the upper limit of normal * malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer) * any other factor likely to limit adherence to the study, in the opinion of the investigators
a 6 month study comparing latanoprost with timolol in patients with open angle glaucoma or ocular hypertension

Conditions: Glaucoma; Open Angle Glaucoma; Ocular Hypertension

Summary: phxa41 is not inferior to timolol


Eligibility criteria:
inclusion criteria: * unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. * open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.) * iop of 22mmhg or higher obtained during the pre-study period. * patients currently not treated or on single-drug treatment for the elevated iop are eligible after a medication free period (wash-out) of: 1. 3 weeks for b-adrenergic antagonists 2. 2 weeks for adrenergic agonists 3. 5 days for cholinergics and oral carbonic anhydrase inhibitors. exclusion criteria: * history of acute angle closure. * severe trauma at any time. * intraocular surgery or argon laser trabeculoplasty within 6 months. * current use of contact lenses. * history of severe dry eye syndrome. * ocular inflammation/infection with three months of inclusion. * any condition preventing reliable applanation tonometry. * unacceptable finding at pre-study ocular examination as specified in the case report forms. * in investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status. * treatment of elevated iop with any topical b-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start. * cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block. * bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. * having participated in any other clinical study within the last month.

Keywords: open angle glaucoma ocular hypertension
monitoring of intracranial hemorrhage in non-severe head trauma patients hospitalized in the uhcd

Conditions: Head Trauma

Summary: the non-neurosurgical management of post-traumatic cerebral hemorrhagic lesions is currently poorly codified. it consists of neurological monitoring for 24 to 48 hours, and the performance of an almost systematic brain scan. anti-aggregation and anticoagulation treatments are stopped for 14 to 28 days and should be resumed according to the risk-benefit ratio and the advice of the patient's treating physicians and cardiologists. if the bleeding lesions do not progress, the patients are allowed to return home. if the lesions progress, the patients remain hospitalized for further monitoring, a new brain scan and neurosurgical advice. this study seeks to show that the performance of systematic brain imaging in the absence of clinical deterioration of patients admitted to the uhcd for post-traumatic intracranial hemorrhage could be avoided, and thus to administer an unnecessary dose of irradiation to the patients, and would also have a significant financial stake. several recent studies have shown that there is no need to perform a follow-up brain scan in the absence of neurological deterioration, even in anticoagulated patients or those on antiplatelet drugs. despite the growing number of articles, no recommendation or consensus has been proposed.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years old) * admitted to emergency department of the strasbourg university hospital during the year 2017 (from 01/01/2017 to 31/12/2017) * patient having given his consent to the reuse of his data for the purpose of this research * hospitalized at the university hospital for monitoring of a post-traumatic intracranial hemorrhage exclusion criteria: * patient having expressed opposition to participate in the study * non-isolated cranial trauma (mva, fall greater than 6 meters ..) * subject under court protection * subject under guardianship or curatorship

Keywords: head trauma intracranial hemorrhage cerebral hemorrhagic lesions neurological monitoring brain scan
added value of systemic lidocaine on postoperative pain, opiate use and nausea after knee arthroscopy

Conditions: Surgery; Pain, Postoperative; Nausea, Postoperative; Opioid Use

Summary: local intra-articular injection of anesthetics (lia) is increasingly used during knee arthroscopy for pain relief. the lia can only be performed at the end of surgery as the knee joint is continuously flushed during the arthroscopy. as a consequence, an optimal analgesic effect is only obtained one hour after surgery and opiates are typically used as pain relief in the immediate postoperative period. since these opiates have a number of side effects such as nausea, vomiting and drowsiness, other analgetic methods are desirable. intravenous administration of lidocaine, a safe, inexpensive analgesic, is already used in major (abdominal) surgeries and might also be a promising method for pain relief in the first hour after knee arthroscopy, in anticipation of the onset of the analgesic effect of the lia. the aim of this study is to verify if systemic administration of lidocaine has a beneficial effect on the pain immediately after knee arthroscopy. in addition, the effect of systemic lidocaine administration on postoperative nausea, vomiting and general patient comfort will be evaluated.

2x30 patients which are planned for elective knee arthroscopy are randomised: lidocaine-group and placebo-group. all patients receive standardised multimodal intravenous analgesia. after standardised induction of anesthesia, patient positioning and administration of basic analgetics paracetamol \& diclofenac, the patient is administered either linisol 2% (1.5 mg/kg) or placebo nacl 0.9% (0.075 ml/kg = equivalent volume). at the end of the procedure, linisol or placebo is readministered at the same dose. the surgeon and anesthesiologist are blinded for patient allocation. postoperative analgesic consumption, nausea and vomiting (ponv), general comfort and pain scores are recorded. visual analogue scores (vas) for knee pain are assessed before surgery, 1-15 minutes after awakening, at the moment of discharge from the post-anesthesia care unit (pacu) and at hospital discharge.

Eligibility criteria:
inclusion criteria: * signed informed consent * patients which are planned for elective knee arthroscopy * asa 1 and 2 * knee arthroscopy suitable for intra-articular injection of anesthetics exclusion criteria: * contra-indication for lidocaine, paracetamol or diclofenac * known history of severe post-operative nausea or vomiting * knee arthroscopy associated with anterior cruciate ligament reconstruction

Keywords: postoperative analgesia knee surgery intravenous lidocaine
mechanisms of dyspnea relief during exercise in copd patients following treatment with tiotropium (spiriva)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to explore the mechanisms of dyspnea relief during exercise in patients with copd following treatment with tiotropium bromide (spiriva)

this was a single-centre, randomised, double-blind, placebo-controlled, cross-over study. the duration of subject participation was 9 weeks. there was an initial screening period of up to 2 weeks. the first screening visit consisted of medical history, clinical assessment, chronic dyspnea evaluation, complete pulmonary function testing, and a symptom-limited maximal incremental cycle exercise test. a second visit during the screening period was intended as a training of the subject to the procedures to be performed in the study, with specific focus on familiarisation with the constant work rate exercise test. the screening period was followed by 2 x 7 day treatment periods (1 x tiotropium and 1 x placebo), separated by a 4 week washout period. on the last day of each treatment period, the subject visited the clinic to complete a series of trial related procedures, including lung function measurements and a constant work rate exercise test at 75% wcap to symptom limitation. testing consisted of pulmonary function testing, dyspnea evaluation, and symptom-limited constant-load cycle exercise tests with measurements of cardiopulmonary parameters, symptom intensity and pulmonary mechanics. \\ study hypothesis: dynamic hyperinflation restricts volume expansion during exercise and is suspected as a primary mechanism of dyspnea. the dissociation between drive or muscular effort to breathe and the mechanical response to increased volume (as reflected by an increased pes/pimax: vt/predicted vc ratio) correlates well with the intensity of inspiratory difficulty during exercise in copd. it was hypothesised that reduced borg ratings at a standardized exercise level after tiotropium would correlate strongly with reduced restricted volume expansion during exercise (i.e., increased vt/ic and eilv/tlc ratios, and decreased ic and irv). in other words, dyspnea and its predominant qualitative dimensions (i.e., inspiratory difficulty) result from patients being forced by dh to breathe at a high lung volume, at or above predicted tlc. comparison(s): tiotropium bromide (spiriva) vs. placebo

Eligibility criteria:
inclusion criteria: patients with chronic obstructive pulmonary disease (copd) with fev1 \ 120% predicted, a cigarette smoking history \> 20 pack-years, and moderate to severe chronic dyspnea exclusion criteria: patients with a history of asthma, allergic rhinitis or atopy; patients who participated in a rehabilitation program for copd within 6 weeks prior to screening
characterization of the facial and gut microbiome in rosacea

Conditions: Rosacea

Summary: questionnaires will be completed by each member of the twin set. a board-certified dermatologist will examine each member to categorize the type and severity of their rosacea. the facial and gut microbiome will be sampled and sent for microbial analysis.

1. twin set subjects will be administered a questionnaire regarding demographics (age, gender, state of residence, time lived together, birth order), rosacea duration, prior rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and symptoms suggestive of cardiovascular or gastrointestinal disease/disorder. 2. subjects will be examined by a board-certified dermatologist and global assessment, inflammatory counts and clinician's erythema score will be performed. eyes will be examined for signs of ocular rosacea. 3. facial microbiome sampling will be performed on-site utilizing a kit manufactured by ubiome. the skin with active rosacea will be swabbed and the swab immediately placed in sample medium. the tube is then shipped to the manufacturer for 16s rrna shotgun metagenomics to identify resident bacterial genera and species. (16) this can be compared to their extensive library of normal controls, to the other member of the twin set and to acne subjects. 4. subjects will be given a fecal microbiome kit for home sampling. feces obtained from toilet paper is collected and placed in the sample medium. subjects can either ship directly or return to the study site for shipping.

Eligibility criteria:
inclusion criteria: 1. presenting with monozygotic or dizygotic twin 2. one or both twins with facial rosacea 3. willingness to allow facial and fecal samples to be analyzed - exclusion criteria: 1. non-twin siblings 2. absence of facial rosacea in both twins -
effect of verbal instruction on pelvic floor muscle contraction in post stroke patients

Conditions: Pelvic Floor Muscle Weakness

Summary: the aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles in post stroke patients. pelvic floor muscle contraction will be evaluated via transabdominal ultrasound. ultrasound.

sub-acute stroke patients during the rehabilitation period in the rehabilitation hospital will be examined. each participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating". those who will not be able to contract will be taught by the ultrasound as a biofeedback. the assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. a curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. an on screen caliper and measurement tool will be used to measure bladder displacement.

Eligibility criteria:
inclusion criteria: * one to 6 months post first stroke * understand the language and simple instruction * willing to participate in the study * mini mental assessment \>21 exclusion criteria: * aphasia * side neglect * active urinary tract infection * has been treated before for pelvic floor rehabilitation

Keywords: verbal cue, pelvic diaphragm, stroke
impact of telehealth on engagement in psychotherapy and/or medication treatment

Conditions: Psychiatric Diagnosis

Summary: in the present study, investigators aim to (1) adapt the making connections intervention (mci) as an intervention to address telehealth engagement and examine whether this targeted intervention can improve youth engagement in telehealth treatment; and (2) assess attitudes towards help-seeking and therapeutic alliance from both the youth and clinician viewpoint to examine the impact of these factors on engagement in telemental health treatment. forty adolescent participants ages 12-18 will be randomized to either telehealth treatment as usual (tau) plus the telehealth making connections intervention (mci-t) engagement session or telehealth tau alone and followed for 12 weeks from baseline assessment. all clinicians will receive training in the mci-t intervention and provide either mci-t + usual care or usual care only depending on the condition to which the adolescents are randomized. all evaluations and therapy sessions will be done over telehealth platform.

clinicians who participate in the study may be assigned more than one study case, and therefore will complete measures on each study case. all of the clinicians will receive training in the making connections intervention-telehealth (mci-t) intervention. the clinicians will deliver the intervention based on the random assignment of the adolescent participants to a treatment arm. when clinicians provide care to adolescents randomized to the mci-t condition, they will participate in a monthly consultation over telehealth to review cases to promote adherence and fidelity to the treatment.

Eligibility criteria:
inclusion criteria: youth sample 1. youth ages 12-18 years of age receiving an evaluation in the diagnostic evaluation service, the diagnostic evaluation and stabilization clinic (desc), or another clinical service in the outpatient child behavioral health service at newyork presbyterian (nyp) - morgan stanley children's hospital (msch)/ nyp-msch. 2. english speaking exclusion criteria: youth sample 1. active suicidal ideation with current plan and/or intent that requires a higher level of care than outpatient treatment or treatment in desc 2. diagnosis of intellectual disability inclusion criteria: clinician sample 1. work as a clinician in any msch outpatient behavioral health service or desc 2. clinician consent 3. english or bilingual in english and spanish exclusion criteria: clinician sample 1. none

Keywords: anxiety depression telehealth behavioral problems