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In this trial, intravascular ultrasonography was used to compare the effects of atorvastatin versus rosuvastatin on regression of coronary atherosclerosis. Both statins led to regression in two thirds of patients, with no significant difference between their effects. Randomized clinical trials have consistently shown that inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase (statins) reduce cardiovascular event rates. 1 – 9 The favorable effects of statins extend across a range of levels of low-density lipoprotein (LDL) cholesterol, with no apparent lower threshold for a benefit. 3 , 9 , 10 In parallel, imaging trials have shown that intensive statin regimens slow the progression of coronary atherosclerosis and may even result in disease regression in some patients. 11 , 12 Accordingly, guidelines for cardiovascular disease prevention have increasingly emphasized that lowering LDL cholesterol levels with statins is the primary goal of lipid-modulating therapy. 13 , 14 Available statins differ considerably . . .

Wheezing is common among preschool children with an upper respiratory infection even when they do not have a clear predisposition to asthma. In this study, no benefit in the duration of in-hospital treatment was noted among children who received oral prednisolone, as compared with placebo; all children were treated with inhaled albuterol. No benefit in the duration of in-hospital treatment was noted among children who received oral prednisolone, as compared with placebo; all children were treated with inhaled albuterol. Attacks of wheezing that are induced by viral infections of the upper respiratory tract are common in children under the age of 6 years. 1 , 2 The majority of preschool children with virus-triggered wheezing have few or no interval respiratory symptoms and no chronic lower airway eosinophilia. 2 – 5 Furthermore, the propensity to wheeze with upper respiratory viral infections often resolves by school age. 6 , 7 National guidelines, which are based on the efficacy of systemic corticosteroids in reducing the duration of hospitalization in school-age children and adults with classic atopic asthma, 8 – 10 recommend the use of oral corticosteroids for preschool children with . . .

Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18–75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426. Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (−8·0 mm Hg [IQR –16·4 to 0·0] vs –3·0 mm Hg [–10·3 to 1·8]; median between-group difference –4·5 mm Hg [95% CI –8·5 to –0·3]; adjusted p=0·022); the median between-group difference was –5·8 mm Hg (95% CI –9·7 to –1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. ReCor Medical.

To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder. Pragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months. Six hospitals in Norway and Sweden. 220 adults with calcific tendinopathy of the shoulder, persistent for at least three months. Ultrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises. The primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated. Data from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval -2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (-0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid -1.8 (-4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported. This study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder. NCT02419040EudraCT 2015-002343-34; Ethical committee Norway 2015-002343-34; Ethical committee Sweden 2015/79-31; Clinicaltrials.gov NCT02419040.

Sodium-glucose co-transporters type 2 inhibitors (SLGT2i) are highly effective in controlling type 2 diabetes, but reported beneficial cardiovascular effects suggest broader actions on insulin resistance. Weight loss may be initially explained by glycosuria-induced net caloric output and secondary volumetric reduction, but its maintenance could be due to loss of visceral fat mass. Structured ultrasound (US) imaging of abdominal adipose tissue (“eco-obesity”) is a recently described methodology used to measure 5 consecutive layers of abdominal fat, not assessable by DEXA or CT scan: superficial subcutaneous (SS), deep subcutaneous (DS), preperitoneal (PP), omental (Om) and right perirenal (RK). PP, Om and RK are predictors of metabolic syndrome (MS) with defined cut-off points. To assess the effect of SLGT2i on every fat depot we enrolled 29 patients with type 2 Diabetes (HbA1c 6.5–9%) and Obesity (IMC > 30 kg/m 2 ) in an open-label, randomized, phase IV trial (EudraCT: 2019-000979-16): the Omendapa trial. Diabetes was diagnosed < 12 months before randomization and all patients were treatment naïve. 14 patients were treated with metformin alone (cohort A) and 15 were treated with metformin + dapaglifozin (cohort B). Anthropometric measures and laboratory tests for glucose, lipid profile, insulin, HOMA, leptin, ultrasensitive-CRP and microalbuminuria (MAL) were done at baseline, 3rd and 6th months. At 6th month, weight loss was −5.5 ± 5.2 kg (5.7% from initial weight) in cohort A and −8.4 ± 4.4 kg (8.6%) in cohort B. Abdominal circumference showed a −2.7 ± 3.1 cm and −5.4 ± 2.5 cm reduction, respectively ( p  = 0.011). Both Metformin alone (−19.4 ± 20.1 mm; −21.7%) or combined with Dapaglifozin (−20.5 ± 19.4 mm; −21.8%) induced significant Om fat reduction. 13.3% of cohort A patients and 21.4% of cohort’s B reached Om thickness below the cut-off for MS criteria. RK fat loss was significantly greater in cohort B group compared to cohort A, at both kidneys. Only in the Met + Dapa group, we observed correlations between Om fat with leptin/CRP/MAL and RK fat with HOMA-IR. US is a useful clinical tool to assess ectopic fat depots. Both Metformin and Dapaglifozin induce fat loss in layers involved with MS but combined treatment is particularly effective in perirenal fat layer reduction. Perirenal fat should be considered as a potential target for cardiovascular dapaglifozin beneficial effects.

Few studies were performed to compare ultrasound guided brachial plexus block with procedural sedation for reduction of shoulder dislocations in the Emergency Department (ED). This study was done to provide further evidence regarding this comparison. This was a randomized clinical trial performed on patients presenting with anterior shoulder dislocations to the emergency department of an academic level 2 trauma center. Exclusion criteria were any contraindications to the drugs used, any patient which may not be potentially assigned into both groups because of an underlying medical condition, presence of neurovascular compromise related to the dislocation, presence of concomitant fractures, and patient refusal to participate in the study. Patients were randomly assigned into the Procedural Sedation and Analgesia (PSA) group with propofol and fentanyl or ultrasound guided Inter-Scalene Brachial Plexus Block (ISBPB) with lidocaine and epinephrine. A total of 60 patients (30 in each group) were included in the study. The emergency room length of stay was significantly lower in the ISBPB group, with mean (SD) values of 108.6 (42.1) vs. 80.2 (25.2) minutes (p=0.005). However, pain scores in the PSA group during reduction showed advantage over ISBPB [0.38 vs. 3.43 (p<0.001)]. Moreover, patient satisfaction was higher with PSA (p<0.001). Using ISBPB for reduction of anterior shoulder dislocations takes less time to discharge and may make it more feasible in conditions mandating faster discharge of the patient. However, since pain scores may be lower using PSA, this method may be preferred by many physicians in some other situations.

In this randomized, placebo-controlled trial, otherwise healthy preterm infants received injections of palivizumab, a monoclonal antibody against respiratory syncytial virus, or placebo. Infants receiving the antibody had fewer episodes of wheezing. Illness of the lower respiratory tract that is caused by respiratory syncytial virus (RSV) is the most common cause of hospital admission in the winter season during the first year of life. 1 Severe RSV bronchiolitis has been associated with an increase in subsequent rates of early wheezing, 2 , 3 asthma, and possibly allergic sensitization later in life. 4 – 7 Early childhood wheeze after RSV infection has a high prevalence, influences quality of life, and generates substantial health care costs. 8 – 11 The pathogenesis of recurrent wheeze after RSV infection is still poorly understood. Gern and Busse distinguished two nonexclusive relationships between RSV infection . . .

In this clinical trial of hospitalized medically ill patients, extended thromboprophylaxis (30 days) with apixaban had similar efficacy to that of a shorter course (6 to 14 days) of subcutaneous enoxaparin. There was more bleeding with apixaban. Venous thromboembolism is a common and potentially fatal complication in hospitalized surgical patients and acutely ill medical patients. 1 The benefits of providing pharmacologic thromboprophylaxis over the entire course of the hospital stay have been validated, with efficacy and safety shown in both populations. 2 – 5 Among high-risk surgical patients, such as those undergoing total hip replacement, extended thromboprophylaxis in the period after hospital discharge has reduced the rate of both asymptomatic and symptomatic venous thromboembolism. 6 On the basis of these findings, current practice guidelines recommend extended thromboprophylaxis in such patients. 7 One study (the Extended Prophylaxis for Venous Thromboembolism in Acutely Ill . . .

The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m2vs ≥35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024. Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54–0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53–0·95; p=0·021). We found no difference in incidence of adverse events between the study groups. Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery. UK National Institute for Health Research Health Technology Assessment Programme.