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New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590.Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups.In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Purpose We investigated Nw-hydroxy l -Arginine (NOHA) predictive response in serous ovarian carcinoma based on estrogen-hormone receptor expression status; and assessed the distinctive NOHA response between estrogen-receptor-negative (ER–) tumor subtypes of ovarian and breast cancer. Materials/methods Three-dimensional (3D) spheroids models of ER– and estrogen-receptor-positive (ER+) from breast and ovarian tumor, cultured for 9 weeks, were assayed for cellular levels of inducible nitric oxide synthase (NOS2), nitric oxide (as total nitrite) and l -Arginine, and compared to NOHA in culture medium. Statistical difference was set at p Results Nine-week in vitro studies showed a progressive NOHA reduction in culture medium by at least 0.4–0.8 fold, and 0.65–0.92 fold only in the ER– breast tumor and ER– ovarian tumor 3D spheroids, respectively; with increases in cellular NOS2 and nitric-oxide levels, by at least 1.0–2.45 fold in both ER– tumor subtype 3D spheroids (p l -Arginine to medium NOHA ratio was higher, and by at least 6.5–22.5 fold in ER– breast tumor 3D-spheroids, and at least 10–70 fold in ER– ovarian tumor 3D spheroids, than in ER+ and control conditions; and was ≥48% higher in ER– ovarian cancer than in ER– breast cancer 3D-spheroids. Conclusions The present study shows NOHA as a sensitive and selective indicator differentiating and distinguishing ER– subtypes based on the tumor grade.

This paper empirically examines the contribution of structural reforms to reducing inflation using a panel data-set of 25 transition economies. Two econometric methodologies are applied. First, the Blundell and Bond (1998) estimator for panel data incorporating lags of the dependent variable. Second, a panel logit estimator is employed to consider the likelihood of achieving low inflation. Results highlight the importance of price and trade liberalization and the reform of credit allocation for reducing inflation, the latter being especially important for bringing inflation below 10%.

In this paper, we examine the consequences of sequencing on the progress of reforms in transition economies. The paper uses panel logit models to determine whether or not progress in some reforms enhances the prospects for other reforms. We find that progress on small-scale privatization is associated with advances in several other reforms, perhaps because small-scale privatization creates lobbies for reform. Our estimations suggest that a comprehensive program of small-scale privatization is needed to stimulate large-scale privatization, trade, and banking reform in a country that has undertaken little reform. Moreover, if restructuring is to occur banking reform is necessary. We also find that relaxing the fiscal constraint stimulates large-scale privatization, restructuring, and trade reform. Finally, we find that negotiations about EU accession negotiations advance the transition but only in banking reform and competition policy. Journal of Comparative Economics 33 (4) (2005) 835–850.

The relationship from inflation and the real exchange rate to the rate of depreciation of the exchange rate for Hungary is investigated over 1991m6–2002m2. Evidence is found that prior to the adoption of the pre-announced crawl in 1995 depreciation responded to inflation. After the adoption of the crawl inflation is dominated by a trend that indicates the rate of depreciation to be diminishing over time. This trend is interpreted as being deterministic, as a consequence of the gradual reductions in the rate of official devaluations. In both periods depreciation was found to respond to the real exchange rate in ways that limited real appreciations of the currency.

Hormonal therapy (HT) is one of the most frequently prescribed drug regimens for women after the age of 50 years. HT has been developed progressively since the 1960s to provide estrogen to those women (a) who require relief of symptoms which have resulted from reduced circulating estrogen or (b) to act as an anti-resorptive agent to counteract the effect of the increased bone turnover which occurs with falling menopausal estrogen levels and which results in loss of bone mass leading to postmenopausal osteoporosis. However, a large number of women pass through the menopausal transition without experiencing distress as a result of the natural fall in estrogen hormone levels and since the introduction HT has been thought to be associated with a number of health benefits that have been tested in clinical trials but not substantiated. In women experiencing distressing climacteric symptoms double-blind randomised controlled clinical trials with a variety of HT regimens have shown that HT of any type provides symptom relief with no alternative treatment of similar effect. The dose and regimen of HT need to be individualised and in general the appropriate dose is dependent on the menopausal age. Women experiencing urogenital estrogen deficiency symptoms require long-term treatment which is most easily achieved with local estrogen. With the perspective provided by the most recent epidemiological findings not least from the estrogen only arm of the Women's Health Initiative Study (WHI) EMAS supports research activities generating HT with new compositions including lower doses and a wider range of progestins in order to positively affect the balance of clinical benefit and risk. Currently, however, individualized and appropriate prescription of the available HT products together with life-style management will sustain possibilities for beneficial effects on climacteric symptoms, quality of life and degenerative diseases after the menopause.

In places where the population has shrunk, the average mortality is high compared with places in which the population has grown. The correlation between population change and all-cause standardised mortality ratios was –0·62 (p

The phallometric test, which makes possible measurement of penile responses to various stimulus configurations, was originally devised as a volumetric method (description of details: Freund. 1965: Freund et al. , 1965). However. Bancroft et al. (1966) replaced volume measurement by circumference measurement, using basically a Whitney (1949) type strain gauge. A similar device for circumference measurement had already been used by Fisher et al. (1965) for the assessment of erectile activity cycles during sleep. Other strain gauges for penile circumference measurement have been designed by Jovanovic (1967a, b). Johnson and Kitching (1968) and Barlow et al. (1970) and with the exception of McConaghy (1967) and Barr (1973), apparently all the authors who currently work with the phallometric test of erotic preference use circumference measurement instead of volume measurement. This substitution seems to imply that penile volume changes are closely parallelled by circumference changes, an assumption which may be warranted for gross penile responses but which may not hold at all for responses in the range of mild sexual arousal. Under these circumstances direct comparison of both kinds of measurement appeared to be necessary.

The use of the condom by male patients attending a clinic specialising in sexually transmitted diseases has been assessed over a period of six months. Condom users were divided into those who used them properly and invariably, and those who did not. In the group studied, correct use of the condom was associated with a significantly lower probability of acquiring gonorrhoea (P less than 0-001) and a significantly higher chance of there being no sexually transmitted disease diagnosed (P less than 0-0005). The diagnosis-rate of non-specific urethritis, however, did not differ among the groups.