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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.

We had shown Nw-hydroxy-l-arginine (NOHA) as a promising blood-based biomarker for estrogen-receptor-negative (ER−) breast cancer (BC) that differentiates ER− BC based on grade and molecular phenotype. In this in vitro study, we assessed the metabolic relevance for ER− BC-specific NOHA modulation and correlated them with NOHA regulatory responses. This study aids future NOHA clinical utility in ER− BC diagnosis and therapy management and would prove useful for potential drug discovery and development process.

In our prior study we identified N

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.

The aim was to evaluate the potential causes of dispensing-label errors at a hospital.The study took place at a 1200-bed NHS Foundation Trust with two main pharmacy dispensaries (one manual and one automated). Face-to-face interviews were conducted with staff involved in label-generation errors to obtain in-depth understanding of dispensing-label errors. Interviews were tape-recorded, transcribed and analysed with the aid of Nvivo into themes.Factors suggested as causing label-generation errors were illegible handwriting, lack of knowledge, hurrying through tasks, distractions, interruptions and the use of past medical records in generating labels. Self-checking every stage of the labelling process was suggested as the key to detecting and preventing errors.The study highlights the vulnerability of the label-generation process to errors, with potential causes linked to organisational, environmental, task, team and individual factors.

Chlamydia trachomatisis a major cause of bacterial sexually transmitted infections worldwide. In 2006, a new variant ofC. trachomatis(nvCT), carrying a 377 bp deletion within the plasmid, was reported in Sweden. This deletion included the targets used by the commercial diagnostic systems from Roche and Abbott. The nvCT is clonal (serovar/genovar E) and it spread rapidly in Sweden, undiagnosed by these systems. The degree of spread may also indicate an increased biological fitness of nvCT. The aims of this study were to describe the genome of nvCT, to compare the nvCT genome to all availableC. trachomatisgenome sequences and to investigate the biological properties of nvCT. An early nvCT isolate (Sweden2) was analysed by genome sequencing, growth kinetics, microscopy, cell tropism assay and antimicrobial susceptibility testing. It was compared with relevantC. trachomatisisolates, including a similar serovar EC. trachomatiswild-type strain that circulated in Sweden prior to the initially undetected expansion of nvCT. The nvCT genome does not contain any major genetic polymorphisms – the genes for central metabolism, development cycle and virulence are conserved – or phenotypic characteristics that indicate any altered biological fitness. This is supported by the observations that the nvCT and wild-typeC. trachomatisinfections are very similar in terms of epidemiological distribution, and that differences in clinical signs are only described, in one study, in women. In conclusion, the nvCT does not appear to have any altered biological fitness. Therefore, the rapid transmission of nvCT in Sweden was due to the strong diagnostic selective advantage and its introduction into a high-frequency transmitting population.

Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity. It is variable in both its surgical appearance and clinical manifestation, often with poor correlation between the two. Surgical treatment of endometriosis aims to remove visible areas of endometriosis and restore anatomy by the division of adhesions.To assess the efficacy of laparoscopic surgery in the treatment of subfertility associated with endometriosis. The review aims to compare outcomes of laparoscopic surgical interventions compared to no treatment or medical treatment with regard to improved fertility.We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of trials (June 2009), Cochrane Central Register of Controlled Trials (The Cochrane Library 2009, Issue 2), MEDLINE (1966 to June 2009), EMBASE (1980 to June 2009), and reference lists of articles.Trials were selected if they were randomised and compared the effectiveness of laparoscopic surgery in the treatment of subfertility associated with endometriosis versus other treatment modalities or placebo.Two studies were eligible for inclusion within the review. Both studies compared laparoscopic surgical treatment of minimal and mild endometriosis compared with diagnostic laparoscopy only. The recorded outcomes included live birth, pregnancy, fetal losses, and complications of surgery.When combining live birth rate and ongoing pregnancy after 20 weeks, meta-analysis demonstrated an advantage of laparoscopic surgery when compared to diagnostic laparoscopy only. The odds ratio (OR) was 1.64 (95% confidence interval (Cl) 1.05 to 2.57) in favour of laparoscopic surgery. Meta-analysis also demonstrated an advantage of laparoscopic surgery when compared to diagnostic laparoscopy only in terms of clinical pregnancy rates, with an OR of 1.66 (95% Cl 1.09 to 2.51) favouring laparoscopic surgery. The results still need to be interpreted with caution as Marcoux 1997 reported a large positive effect of surgery whereas Gruppo Italiano reported a small negative effect. When considering fetal losses, meta-analysis did not demonstrate an effect of laparoscopic surgery when compared to diagnostic laparoscopy only. The OR was 1.33 (95% Cl 0.60 to 2.94) favouring diagnostic laparoscopy only.The use of laparoscopic surgery in the treatment of subfertility related to minimal and mild endometriosis may improve future fertility.

Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity. It is variable in both its surgical appearance and clinical manifestation often with poor correlation between the two. Surgical treatment of endometriosis aims to remove visible areas of endometriosis and restore anatomy by division of adhesions and relieve painful symptoms.To assess the efficacy of laparoscopic surgery in the treatment of pelvic pain associated with endometriosis.For the update in July 2009 we searched the Cochrane Menstrual Disorders and Subfertility Group's specialised register of trials (searched July 2009), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 2, 2009), MEDLINE (1966 July 2009), EMBASE (1980 July 2009), and reference lists of articles.Randomised controlled trials were selected comparing the effectiveness of laparoscopic surgery used to treat pelvic pain associated with endometriosis, with other treatment modalities or diagnostic laparoscopy only.Assessment of trial quality and extraction of relevant data was performed independently by two reviewers.Five studies were included in the meta-analysis, including three full papers and two conference reports. All the randomised controlled trials with the exception of Lalchandani 2003 compared different laparoscopic surgical techniques with diagnotic laparoscopy only. Lalchandani 2003 compared laparoscopic coagulation therapy with diagnostic laparoscopy and medical treatment. Three studies (Abbott 2004; Sutton 1994; Tutunaru 2006) reported the pain scores six months post operatively. Meta-analysis demonstrated an advantage of laparoscopic surgery when compared to diagnostic laparoscopy only (OR of 5.72 95%Cl 3.09 to 10.60 ; 171 participants, three trials, Analysis 1.1). A single study (Tutunaru 2006) reported pain scores twelve months after the procedure. Analysis demonstrated an advantage of laparoscopic surgery when compared to diagnostic laparoscopy only (OR of 7.72 95%Cl 2.97 to 20.06 ; 33 participants, one trial, Analysis 1.1).Laparoscopic surgery results in improved pain outcomes when compared to diagnostic laparoscopy alone. There were few women diagnosed with severe endometriosis included in the meta-analysis and therefore any conclusions from this meta-analysis regarding treatment of severe endometriosis should be made with caution. It is not possible to draw conclusions from the meta-analysis which specific laparoscopic surgical intervention is most effective.

Instrumented helmets have been used to estimate impact acceleration imparted to the head during helmet impacts. These instrumented helmets may not accurately measure the actual amount of acceleration experienced by the head due to factors such as helmet-to-head fit.To determine if an accelerometer attached to a mouthpiece (MP) provides a more accurate representation of headform center of gravity (HFCOG) acceleration during impact than does an accelerometer attached to a helmet fitted on the headform.Single-factor research design in which the independent variable was accelerometer position (HFCOG, helmet, MP) and the dependent variables were g and Severity Index (SI).Independent impact research laboratory.The helmeted headform was dropped (n = 168) using a National Operating Committee on Standards for Athletic Equipment (NOCSAE) drop system from the standard heights and impact sites according to NOCSAE test standards. Peak g and SI were measured for each accelerometer position during impact.Upon impact, the peak g and SI were recorded for each accelerometer location.Strong relationships were noted for HFCOG and MP measures, and significant differences were seen between HFCOG and helmet g measures and HFCOG and helmet SI measures. No statistically significant differences were noted between HFCOG and MP g and SI measures. Regression analyses showed a significant relationship between HFCOG and MP measures but not between HFCOG and helmet measures.Upon impact, MP acceleration (g) and SI measurements were closely related to and more accurate in measuring HFCOG g and SI than helmet measurements. The MP accelerometer is a valid method for measuring head acceleration.

Objective: To evaluate function and disability in patients with fibromyalgia before and after participation in a functionally oriented, multidisciplinary, 8-wk treatment program. Design: A total of 23 patients who met American College of Rheumatology criteria for the diagnosis of fibromyalgia were enrolled in the study. Outcome measures included: range of motion, 6-min walk test, a modified Fibromyalgia Impact Questionnaire, a modified SF-36 Physical Functioning Scale, and the Fibromyalgia Health Assessment Questionnaire. Pretreatment and posttreatment scores were analyzed using paired t tests. Results: All subjects completed the program, and there were no reported injuries. Three subjects failed to complete the survey instruments at the conclusion of the study. Intention to treat analysis including these subjects was carried out but did not significantly change results. For the remaining subjects (n = 20), a significant improvement was found on the Physical Functioning Scale (P = 0.01). Trends toward improvement on the Fibromyalgia Impact Questionnaire (P = 0.40) and Fibromyalgia Health Assessment Questionnaire (P = 0.14) were seen but did not achieve statistical significance. Range of motion testing revealed significant improvements in lumbar spine extension (P < 0.001), straight-leg raise (P < 0.001), cervical spine flexion (P < 0.01), cervical spine rotation (P < 0.05), and cervical spine side bending (P < 0.05). Distance traveled during the 6-min walk test increased significantly (P < 0.01), whereas perceived exertion as measured by the Borg scale did not change. There were no injuries or other adverse consequences of the program. Conclusions: This study utilized multiple functional outcome measures to demonstrate improved function and decreased disability in patients with fibromyalgia. Our patients reported significantly improved physical function after participation in the 8-wk intensive multidisciplinary treatment program. This progressive, functionally based exercise training program was well tolerated by all participants and outlines an effective exercise prescription for patients with fibromyalgia. Fibromyalgia patients in this study responded favorably to a treatment program that focused on function instead of pain.

Epidemiologic studies link Kaposi's sarcoma with a sexually transmitted agent. Human herpesvirus 8 (HHV-8) is likely to be that agent, but routes of transmission are poorly described. A seroepidemiologic study was conducted to determine whether HHV-8 is transmitted sexually between heterosexuals. Sera from 2718 patients attending a sexually transmitted disease (STD) clinic were tested for antibodies to HHV-8 and herpes simplex virus type 2 (HSV-2). Information on sex partners in the previous 12 months and past STDs were obtained by questionnaire. Relationships between possible risk factors and HHV-8 infection were assessed by logistic regression. Overall, seroprevalence of HHV-8 was 7.3%. Independent risk factors for HHV-8 in the whole group were homo/bisexuality and birth in Africa and, among homo/bisexual men, a history of syphilis and HSV-2 and human immunodeficiency virus seropositivity. Among heterosexuals there was no evidence for sexual transmission; the only independent risk factor for HHV-8 seropositivity was birth in Africa.

OBJECTIVE: To assess the degree of sexual mixing in a sexually transmitted disease clinic population stratified by country of birth. DESIGN: Prospective linked HIV serosurvey incorporating demographic and sexual risk data gathered by a doctor-administered questionnaire. SETTING: The Department of Genitourinary Medicine at St Thomas' Hospital, London, UK. SUBJECTS: Fifteen thousand eight hundred and seventy-eight heterosexuals who attended between April 1992 and February 1995. MAIN OUTCOME MEASURE: The degree of assortative (like-with-like) mixing, after stratification of the population by country of birth, of index patients, their parents and their sexual partners. RESULTS: Sexual mixing in this population of sexually transmitted disease clinic attenders is highly assortative when the CoB of parents (family origin) of index patients is taken into account. CONCLUSION: Our findings help to explain the low spread of heterosexual HIV infection in the UK to date, and may help future projections, and health targeting of those at risk. This model can be applied to other mixed population.

The study aimed to identify families with endometriosis and to document disease severity within the families and the clinical characteristics of the affected women.Two hundred and thirty women with surgically confirmed endometriosis in 100 families were identified. The families consisted of 19 mother-daughter pairs, 1 set of cousins and 56 sister pairs. There were 5 families with 3 affected sisters, 1 family with 5 affected sisters, and 18 families withor = 3 affected members in more than one generation. The mean age at the onset of symptoms and the mean age at surgical diagnosis was 22.1 +/- 8.8 SD (range 10-46) and 31.8 +/- 7.9 SD (range 15-56) years respectively. Seventy-nine women (34.3%) had revised AFS Stage I-II disease, and 151 (65.7%) had revised AFS Stage III-IV disease.The study confirms a familial tendency for endometriosis and supports the hypothesis that endometriosis has a genetic basis.

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.

(1) The cervico-ocular reflex (COR) in humans was measured while the subjects (n = 10) stood on a rotatable platform in a dark room with the head fixed by a stationary biteplate. Eye movements were measured in response to active and passive rotations about a vertical axis. (2) The COR gain (i.e., horizontal eye movement/amplitude of body rotation) was as great as 22% at low frequency of body rotation (0.025 Hz). With increasing frequency (e.g., at 0.4 Hz) the gain decreased to about 2%. (3) The phase angle of the eye movement ranged generally between -80 and -240 degrees with an average response around -180 degrees. (4) During active rotation, the COR response was similar to the responses measured during passive body rotation. (5) The principal conclusion drawn is that in normal adult humans the COR does not aid in stabilization of the image on the retina during passive or active body rotations. A theoretical function for the COR is presented and discussed.