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Months Duration (month + duration)
Kinds of Months Duration Selected AbstractsEvaluation of a Dialysis Sampler's Integrity in a Cold ClimateGROUND WATER MONITORING & REMEDIATION, Issue 1 2008O. Iwakun The use of a diffusion sampler made from regenerated cellulose dialysis membrane was investigated in this study to resolve issues from previous studies on the integrity of the sampler when deployed in the field. The dialysis samplers were deployed in monitoring wells at two upstream oil- and gas-contaminated sites. The average ambient temperature in the monitoring wells was 4 ± 1°C over the 6 month duration of the test. Burst pressure and tensile strength tests were used to determine the integrity of the samplers at two field sites over time. The test results showed no adverse impacts on the samplers' integrity after 6 months. Therefore, diffusion samplers from regenerated cellulose dialysis membrane show promising results when used for long-term monitoring associated with natural attenuation assessment under the conditions tested. [source] Community mental health nursing and early intervention in dementia: developing practice through a single case historyJOURNAL OF CLINICAL NURSING, Issue 2004John Keady PhD This paper reports on a single case history taken from the ,Dementia Action Research and Education' project, a 15-month primary care intervention study that was undertaken in North Wales in the early part of 2000. The study sought to address the meaning, context and diversity of early intervention in dementia care and employed a community mental health nurse and a psychiatric social worker to undertake early and psychosocial interventions with older people with dementia (aged 75 years and over) and their families. The workers tape-recorded, documented and analysed their interventions with 27 older people with dementia and their families over the 15-month duration of the study. Clinical supervision was also undertaken during the intervention phase. One case history is presented in this paper to illustrate the work of the community mental health nurse and to identify areas of practice development. Greater role transparency, collaborative working and improvement in educational preparation for practice are called for. [source] Lifestyle and medication interventions for the prevention or delay of type 2 diabetes mellitus in prediabetes: a systematic review of randomised controlled trialsAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 2 2010Agnes Yuen Abstract Objective: To assess lifestyle and pharmacological interventions aiming to delay type 2 diabetes mellitus (T2DM) in prediabetes. Methods: We searched the Cochrane Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, BIOSIS and LILACS databases, examined reference lists and contacted authors. We included randomised controlled trials (RCTs) on both lifestyle and medication interventions in prediabetes. These studies were at least 12 month duration and aimed to delay T2DM. Results: Four studies investigating lifestyle and medication with a total of 5,196 participants were identified. There was a high risk of bias in the studies and the interventions utilised varied considerably; thus, meta-analysis was not undertaken. The comparison between lifestyle and medication interventions was largely dependent on the intensity of the lifestyle program while we could not adequately assess their effects on cardiovascular morbidity. Adverse events with metformin and acarbose were common. Conclusion: There is substantial evidence that intensive lifestyle programs and medications delay T2DM in impaired glucose tolerance though it remains unclear which is more effective. Implications: Both interventions seem to be able to delay T2DM. However, both have issues with adherence and side effects and more RCTs are required. [source] Terazosin for treating symptomatic benign prostatic obstruction: a systematic review of efficacy and adverse effectsBJU INTERNATIONAL, Issue 3 2002T.J. Wilt Objective To systematically review and evaluate the effectiveness and adverse effects of the ,-antagonist, terazosin, for treating urinary symptoms associated with benign prostatic obstruction (BPO). Methods Studies were sought and included in the review if they were randomized trials of at least 1 month duration, involved men with symptomatic BPO and compared terazosin with placebo or active controls. The study, patient characteristics and outcome data were extracted in duplicate onto standardized forms using a prospectively developed protocol. Results Seventeen studies involving 5151 men met the inclusion criteria, i.e. placebo-controlled (10), ,-blockers (seven), finasteride alone or combined with terazosin and placebo (one), and microwave therapy (one). The study duration was 4,52 weeks; the mean age of the men was 65 years and 82% were white. Baseline urological symptom scale scores and flow rates showed that men had moderate BPO. Efficacy outcomes were rarely reported in a way that allowed for data pooling, but indicated that terazosin improved symptom scores and flow rates more than did placebo or finasteride, and similarly to other ,-antagonists. The pooled mean percentage improvement for the Boyarsky symptom score was 37% for terazosin and 15% for placebo (four studies). The mean percentage improvement for the American Urological Association symptom score was 38%, compared with 17% and 20% for placebo and finasteride, respectively (two studies). The pooled mean improvement in the International Prostate Symptom Score of 40% was similar to that with tamsulosin (43%). Peak urinary flow rates improved more with terazosin (22%) than with placebo (11%) and finasteride (15%), but did not differ significantly from the other ,-antagonists. The percentage of men discontinuing terazosin was comparable with those receiving placebo and finasteride, but greater than with other ,-antagonists. Adverse effects were greater than with placebo and included dizziness, asthenia, headache and postural hypotension. Conclusions The available evidence indicates that terazosin improves the symptoms and flow rates associated with BPO; it was more effective than placebo or finasteride and similar to other ,-antagonists. Adverse effects were generally mild but more frequent than with other ,-antagonists and associated with a two- to four-fold increase in treatment discontinuation. [source] Parents who quit smoking and their adult children's smoking cessation: a 20-year follow-up studyADDICTION, Issue 6 2009Jonathan B. Bricker ABSTRACT Aims Extending our earlier findings from a longitudinal cohort study, this study examines parents' early and late smoking cessation as predictors of their young adult children's smoking cessation. Design Parents' early smoking cessation status was assessed when their children were aged 8 years; parents' late smoking cessation was assessed when their children were aged 17 years. Young adult children's smoking cessation, of at least 6 months duration, was assessed at age 28 years. Setting Forty Washington State school districts. Participants and measurements Participants were 991 at least weekly smokers at age 17 whose parents were ever regular smokers and who also reported their smoking status at age 28. Questionnaire data were gathered on parents and their children (49% female and 91% Caucasian) in a longitudinal cohort (84% retention). Findings Among children who smoked daily at age 17, parents' quitting early (i.e. by the time their children were aged 8) was associated with a 1.7 times higher odds of these children quitting by age 28 compared to those whose parents did not quit [odds ratio (OR) 1.70; 95% confidence interval (CI) 1.23, 2.36]. Results were similar among children who smoked weekly at age 17 (OR 1.91; 95% CI 1.41, 2.58). There was a similar, but non-significant, pattern of results among those whose parents quit late. Conclusions Supporting our earlier findings, results suggest that parents' early smoking cessation has a long-term influence on their adult children's smoking cessation. Parents who smoke should be encouraged to quit when their children are young. [source] Long-term survey of laryngoplasty and ventriculocordectomy in an older, mixed-breed population of 200 horses.EQUINE VETERINARY JOURNAL, Issue 4 2003Part 1: Maintenance of surgical arytenoid abduction, complications of surgery Summary Reasons for performing study: Laryngoplasty (LP) is currently the most common surgical treatment for equine laryngeal paralysis, however, there have been no reports quantifying the degree of retention of arytenoid abduction following L P. ADitionally, the complications of LP have been poorly documented. Objectives: To record the degree of arytenoid abduction retention following LP and to accurately document all complications of surgery. Methods: A study (1986,1998) of 200 horses of mixed breed and workload, median age 6 years (prospective 136 cases and retrospective 64 cases) undergoing LP (using 2 stainless steel wires) and combined ventriculocordectomy was undertaken; 198 owners completed questionnaires, a median of 19 months following surgery. The degree of arytenoid abduction achieved was endoscopically, semi-quantitatively evaluated using a 5-grade system, at 1 day, 7 days, and 6 weeks after surgery. Results: On the day following LP, 62% of horses had good (median grade 2) arytenoid abduction, 10% had excessive (grade 1), and 5% had minimal (grade 4) abduction (overall - median grade 2). Due to progressive loss of abduction, moderate (median grade 3, range 1,5) abduction was present overall at 1 and 6 weeks after LP. Further surgery was required to re-tighten prostheses in 10% of cases with excessive loss of abduction, or to loosen prostheses in 7% of horses which had continuing high levels of LP abduction and significant post operative dysphagia. LP wound problems (mainly seromas and suture abscesses) were reported to last <2 weeks in 9% of cases, <4 weeks in 4% and >4 weeks in 4%. The (partially sutured) laryngotomy wounds discharged post operatively for <2 weeks in 22% of cases, <4 weeks in 7% and for >4 weeks in 2%. Coughing occurred at some stage post operatively in 43% of cases and its presence correlated significantly with the degree of surgical arytenoid abduction. This coughing occurred during eating in 24% of cases and was not associated with eating (or dysphagia) in the other 19% of cases. Chronic (>6 months duration) coughing occurred in 14% of cases, but appeared to be due to intercurrent pulmonary disease in half of these horses. Conclusions: Suturing the cricotracheal membrane allows most laryngotomy wounds to heal quickly. Laryngoplasty wound problems were of little long-term consequence when stainless steel wire prostheses were used. Potential relevance: A significant loss of LP abduction occurs in most horses in the 6 weeks following surgery and efforts should be made to find ways to prevent such loss. However, excessive LP abduction is associated with post operative dysphagia and coughing. [source] Low level laser therapy for healing acute and chronic wounds , the extendicare experienceINTERNATIONAL WOUND JOURNAL, Issue 2 2008Anita E Saltmarche Abstract The purpose of the study is to assess the effectiveness of low level laser therapy for wound healing when combined with the Extendicare Wound Prevention and Management Program. Sixteen residents at a Canadian Extendicare nursing home had a total of 27 sites treated consisting of 23 open wounds and 4 ,at risk' areas. Of the 23 open wounds, two wounds in between toes were not able to be ,traced' and deemed ,immeasurable' wounds, resulting in 21 open, measured wounds. The four ,at risk' (closed) areas were treated preventatively. Pressure, venous insufficiency and diabetic wounds were included. The majority (12/21) or 57·1%, of the wounds were chronic (,3 months duration) and 42·9% were acute (<3 months duration). The primary outcome measures included the PUSH Tool score, EZ GraphTM tracings and photographs. Secondary outcome measures were employed to better understand potential barriers to successful integration into clinical practice. Feedback on the effectiveness of low level laser therapy, the education program and determinations of hands-on relevance was sought from staff. At the end of the 9-week trial, the majority (61·9%) of the 21 wounds achieved significant improvement (,50% wound closure). Nine (42·8%) had 100% closure. Some improvement was seen in 14·3% and 23·8% of wounds demonstrated no change. Chronic and acute wounds had similar improvement. None of the wounds in this debilitated, frail population deteriorated during the study and no negative consequences of treatment were encountered. Without staff support, even if new technology has positive clinical outcomes, success would be limited. Staff rated low level laser, easy to learn and use, effective for the majority of their residents worth the additional time. Staff requested a continuation of low level laser even after study completion. [source] Evaluation of enamel matrix derivative as an adjunct to non-surgical periodontal therapyJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 8 2003Mauricio A. Gutierrez Abstract Objectives: The aim of this study was to evaluate the adjunctive use of enamel matrix derivative (EMD) on periodontal healing following nonsurgical periodontal therapy (scaling and root planing , SRP). Material and methods: The study was performed as an intraindividual, longitudinal trial of 3 months duration with a double-blinded, split-mouth, controlled, and randomized design. Twenty-two patients with moderate to severe chronic periodontitis were enrolled in the study. In each patient, two sites with pocket depths 5 mm and with radiographic angular bone defects >3 mm were selected. Baseline examination included measurement of probing pocket depth (PPD) and clinical attachment levels (CAL). The presence or absence of plaque and bleeding on probing at selected sites was also recorded. Following initial examination, full-mouth SRP was performed. Study sites were then treated with 24% EDTA for 2 min, followed by thorough irrigation with sterile saline. The sites were then randomized. The experimental site received subgingival application of enamel matrix derivative (Emdogain®, BIORA AB, Malmo, Sweden). The control site received no additional treatment. At 3 months, all sites were re-examined. The response to therapy in experimental and control sites was evaluated, using change in probing depth and CAL as the primary outcome variables. Statistical analysis (paired t -tests) was used to compare response to treatment in control versus experimental sites. Results: Statistically significant changes in PPD and CAL were seen in both treatment groups from baseline to 3 months. The mean PPD reduction was 2.3±0.5 mm for control sites and 2.0±0.3 mm for experimental sites. The mean CAL gain was 1.8±0.4 mm for control sites, and 1.4±0.3 mm for experimental sites. Statistical analysis, however, revealed no significant difference in PPD reduction or CAL gain between experimental and control groups (p>0.4). In addition, no difference was found between treatment groups in bleeding or plaque indices at 3 months. Conclusion: The findings from the present study do not support the use of EMD during routine, nonsurgical debridement of periodontal pockets as measured 3 months post SRP. Zusammenfassung Ziel: Das Ziel dieser Studie war die Evaluation eines adjunktiven Gebrauchs von Schmelzmatrixderivaten (EMD) auf die parodontale Heilung nach nicht chirurgischer parodontaler Therapie (Wurzelreinigung und ,glättung, scaling und root planing , SRP). Material und Methoden: Die Studie wurde als eine intraindividuelle, für 3 Monate longitudinale Studie mit einem doppelt blinden, split-mouth, kontrolliertem und randomisiertem Protokoll durchgeführt. 22 Patienten mit moderater bis schwerer chronischer Parodontitis wurden in die Studie einbezogen. Bei jedem Patient wurden zwei Flächen mit Sondierungstiefen5 mm und mit radiographisch feststellbaren angulären Knochendefekten>3 mm ausgesucht. Die Basisuntersuchung umfasste die Messung der Sondierungstiefen (PPD) und des klinischen Stützgewebeniveaus (CAL). Die An- oder Abwesenheit von Plaque und Provokationsblutung an den ausgesuchten Flächen wurden auch dokumentiert. Nach der anfänglichen Untersuchung wurde eine alle Zähne betreffende SRP durchgeführt. Die Studienflächen wurden dann mit 24% EDTA für zwei Minuten behandelt, gefolgt von einer sorgsamen Spülung mit steriler Kochsalzlösung. Die Flächen wurden dann randomisiert. Die experimentellen Flächen erhielten eine subgingivale Applikation von Schmelzmatrixderivaten (Emdogain®, BIORA AB, Malmö, Schweden). Die Kontrollflächen erhielten keine zusätzliche Behandlung. Zum dritten Monat wurden alle Flächen reexaminiert. Die Antwort auf die Therapie bei den experimentellen und Kontrollflächen wurden evaluiert in Hinsicht der Veränderung der Sondierungstiefe und CAL als die primären Ergebnisvariablen. Statistische Analysen (gepaarter t -Test) wurden für den Vergleich der Behandlung zwischen experimentellen und Kontrollflächen genutzt. Ergebnisse: Statistisch signifikante Veränderungen bei der PPD und dem CAL wurden in beiden Behandlungsgruppen zwischen Basis und 3 Monaten beobachtet. Die mittlere PPD Reduktion betrug 2.3±0.5 mm für die Kontrollflächen und 2.0±0.3 mm für die experimentellen Flächen. Der mittlere CAL Gewinn betrug 1.8±0.4 mm für die Kontrollflächen und 1.4±0.3 mm für die experimentellen Flächen. Die statistischen Analysen erbrachten jedoch keine signifikanten Differenzen für PPD Reduktion und CAL Gewinn zwischen den experimentellen und Kontrollgruppen (p>0.4). Es wurden auch keine Differenzen zwischen den Gruppen hinsichtlich Provokationsblutung und Plaqueindex zum dritten Monat beobachtet. Schlussfolgerung: Die Ergebnisse von der vorliegenden Studie unterstützen nicht die Anwendung von EMD während der routinemäßigen nicht chirurgischen Reinigung der parodontalen Taschen, wie die Messungen drei Monate nach SRP. Résumé Objectif: Le but de cette étude fut d'évaluer l'utilisation des dérivés de la matrice amellaire (EMD) sur la cicatrisation parodontale après un traitement parodontal non chirurgical (détartrage et surfaçage radiculaire). Matériel et méthodes: L'étude fut conçue en essai longitudinal intra-individuel d'une durée de 3 mois randomisée, contrôlée en double aveugle et en bouche croisée. 22 patients atteints de parodontites chroniques modérées ou sévères furent enrôlés. Pour chaque patient, 2 sites avec des profondeurs de poches5 mm et des lésions osseuses angulaires radiographiques>3 mm furent sélectionnés. L'examen initial comportait la mesure des profondeurs de poche au sondage (PPD) et les niveaux cliniques d'attache (CAL). La présence ou l'absence de plaque et de saignement au sondage sur les sites sélectionnés furent aussi enregistrées. Après l'examen initial, un détartrage et un surfaçage complet étaient réalisés. Les sites étudiés étaient alors traités par de l'EDTA à 24% pendant 2 minutes, puis fortement rinçés avec du serum physiologique. Les sites étaient alors répartis aléatoirement. Le site expérimental recevait une application sous gingivale d'EMD (Emdogain®, BIORA AB, Malmo, Sweden). Le site contrôle ne recevait pas de traitement supplémentaire. A 3 mois, les sites étaient réévalués. La réponse au traitement était évaluée par les modifications de profondeur de poches et de niveau d'attache comme variables primaires. L'analyse statistique (Test t apparié) permit de comparer la réponse au traitement. Résultats: Des modifications statistiquement significatives de PPD et de CAL ont été observées dans les deux groupes de traitement. La réduction de PPD moyenne était de 2.3±0.5 mm pour les sites contrôles et de 2.0±0.3 mm pour les sites expérimentaux. Le gain de CAL moyen était respectivement de 1.8±0.4 mm et de 1.4±0.3 mm.L'analyse statistique, cependant, ne révélait pas de différences significatives entre les deux groupes (p>0.4). De plus, aucune différence n'apparaissait entre les groupes pour le saignement et les indices de plaque au troisième mois. Conclusion: Les données de cette étude n'étayent pas l'utilisation routinière d' EMD lors du débridement non chirurgical des poches parodontales lorsqu'on en mesure les résultats 3 mois après détartrage et surfaçage radiculaire. [source] Pediatric primary cutaneous marginal zone lymphoma: in association with chronic antihistamine useJOURNAL OF CUTANEOUS PATHOLOGY, Issue 2006Novie Sroa There have been no prior reports of this lymphoma occurring in American children. We present a case of a 15-year-old male with a history of atopic diathesis and chronic use of antihistamine agents who presented with an asymptomatic lesion on his left forearm of 6 months duration. Because histopathological and immunohistochemical studies were compatible with marginal zone lymphoma, and the patient had no associated extracutaneous disease, the diagnosis of primary cutaneous marginal zone lymphoma was rendered. Based on the patient's past medical history prior to appearance of lesion, it was postulated that the development of lymphoma was associated with the ingestion of antihistamines and further propagated by his underlying atopic diathesis. [source] Primary Cutaneous Carcinosarcoma (PCCS0 Aka Metaplastic Carcinoma)JOURNAL OF CUTANEOUS PATHOLOGY, Issue 1 2005Ramin Ram We describe a case of PCCS in a 73 year-old male who presented with a rapidly growing tumor of 6 months duration on the right ear. Clinical examination revealed a 5 × 4 × 4-cm ulcerated, crusted, exophytic tumor on the superior aspect of the helix. Histologically, the mass revealed a biphasic tumor with malignant epithelial and mesenchymal components. The epithelial component consisted of a few foci of basal cell carcinoma (BCC). The majority of the tumor was composed of osteogenic sarcoma and malignant fibrous histiocytoma (MFH). An intricate transition of BCC into sarcoma was noted in a few foci. Atypical mitosis and necrosis were common. The BCC and tumor giant cells in the MFH area showed positive immunoreaction for cytokeratin and CD68 respectively. The tumor was negative for S-100 protein, HMB-45, muscle actins, chromogranin, and synaptophysin. In conclusion, a PCCS growing predominantly as osteosarcoma and MFH is reported. Although the exact histogenesis of PCCS is unknown, primitive mesenchymal cells of the dermis, surrounding the follicular units, are capable of pluripotent differentiation and are likely the source of origin of the sarcoma. The known aggressive biological behavior warrants wide excision and given the rare reports of metastasis and death, regular follow-up is required [source] Efficacy of Raloxifene for Treatment of Menopause: A Systematic ReviewJOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS, Issue 4 2002Mark Boyack MSN Purpose To critically appraise recent randomized controlled trials (RCT) of raloxifene and its effects on the long-term consequences of menopause. Data Sources All RCTs of greater than six months duration in post-menopausal women found in MEDLINE through July 2000. Conclusions Raloxifene lowered lipids, but estrogen had a more beneficial effect on HDL and fibrinolytic markers. Raloxifene had a more beneficial effect on triglycerides, inflammatory and thrombogenic markers. Compared to placebo, raloxifene reduced vertebral fractures but had a similar although lesser effect on bone mineral density and markers of bone turnover than estrogen. Estrogen receptor positive breast cancer was reduced by 90% with no increase in the incidence of endometrial cancer with raloxifene. The most serious side effect of raloxifene was an increased incidence of deep vein thromboses and pulmonary emboli. Implications Raloxifene has been shown to be beneficial using cardiovascular and osteoporosis endpoints in studies of short duration. More RCTs of longer duration with comparisons to other traditional treatments are needed before raloxifene becomes the treatment of choice. [source] On-demand requirements of patients with endoscopy-negative gastro-oesophageal reflux disease: H2-blocker vs. proton pump inhibitorALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2009P. JUUL-HANSEN Summary Background, It is questionable whether a symptomatic condition with few serious medical consequences requires proton pump inhibitor (PPI) treatment. If effective, a less-potent treatment may be preferable. Aim, To compare an H2-blocker in an effervescent formulation with a PPI in on-demand treatment of endoscopy-negative gastro-oesophageal reflux disease (GERD). Methods, Included were patients with heartburn and/or acid regurgitation for at least 3 months duration, a negative endoscopy and a positive response to 7 days of lansoprazole 60 mg daily. Following pH-metry, the patients were randomized to receive either ranitidine effervescent tablets 75 mg or lansoprazole capsules 15 mg to a maximum of four per day on-demand. The numbers taken were registered monthly for 6 months. If treatment was unsuccessful (lack of efficacy or side effects), patients were registered as failures. Results, One hundred and three patients were included and 63 were considered for statistical analysis; 32 on lansoprazole and 31 on ranitidine. Seventeen (55%) on ranitidine and four (13%) on lansoprazole failed. The average number of tablets per day was 1.2 in the lansoprazole group and 3.1 in the ranitidine group. Conclusions, On-demand treatment in patients with endoscopy-negative GERD gives a high success rate with a fairly low dose of PPI. The H2-blocker had significantly less success; nevertheless, almost half were satisfied with the treatment. [source] Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain,NEUROUROLOGY AND URODYNAMICS, Issue 1 2007Carolyn F. Langford Abstract Aims We conducted this study to examine the role of trigger point injections in females with chronic pelvic pain (CPP) of at least 6 months duration and specific levator ani trigger points. Methods This prospective study included 18 consecutive female patients with CPP and specific palpable levator ani trigger points. Pain was evaluated before and after trigger point injection on a Visual Analog Scale (VAS). Patient global satisfaction (PGS) and cure rates (PGC) were also measured by a VAS on a scale of 0,100%. The trigger points were identified manually by intravaginal palpation of the levator ani bilaterally. A mixture of 10 cc of 0.25% bupivacaine, 10 cc of 2% lidocaine and 1 cc (40 mg) of triamcinolone was used for injection of 5 cc per trigger point. A 5.5, Iowa trumpet pudendal needle guide was used for injection. All but one injection were performed in the office setting without sedation. Pelvic floor muscle exercises were taught for use after injection. Success was defined as a decrease in pain as measured by a VAS of 50% or more, as well as PGS and PGC scores of 60% or greater. There was a mean follow up of 3 months after trigger point injection. Results Thirteen of 18 women improved with the first trigger point injection resulting in a comprehensive success rate of 72%. Six (33%) of 18 women were completely pain free. Conclusion In the management of CPP, a non-surgical office-based therapy such as trigger point injections can be effective in selected patients. Neurourol. Urodynam. 26:59,62, 2007. © 2006 Wiley-Liss, Inc. [source] CONTROLLED-RELEASE OXYCODONE RELIEVES MODERATE TO SEVERE PAIN IN A 3-MONTH STUDY OF PERSISTENT MODERATE TO SEVERE BACK PAINPAIN MEDICINE, Issue 2 2002Article first published online: 4 JUL 200 Patricia Richards, MD, PhD; Pinggao Zhang, PhD; Michael Friedman, PhD; Rahul Dhanda, PhD. (Purdue Pharma L.P.) Introduction: Opioids are frequently prescribed for management of persistent low back pain, however, efficacy has not been well documented, and concerns are that opioids may impair physical functioning. Objective: To compare controlled-release oxycodone (CRO) with placebo in controlling pain and to observe the effect of CRO on quality of life and functionality. Methods: A double-blind, randomized, placebo-controlled, parallel-group study of 3 months duration was conducted in 110 subjects (49 males, 61 females), mean age 48 years (19,80 years). Subjects had a 3- to 12-month history of moderate to severe persistent low back pain and were previously unresponsive to therapeutic doses of NSAIDs, and/or low dose combination opioid analgesics. At baseline 4% of subjects were on opioids, 39% on NSAIDs, and 57% both NSAIDs and opioids. Subjects were treated with 10 mg CRO tablet or 10 mg oral placebo q12h, titrated to stable pain control. Existing treatment regimens of acetaminophen, NSAIDs, or oral steroids were allowed to continue. The Brief Pain Inventory (BPI), the Roland Morris Functionality Questionnaire, and the MOS 36-Item Short-Form Health Survey (SF-36) were the measures of pain intensity, functionality, and quality of life. Treatments were compared using repeated measures ANCOVA with baseline value as covariate. Results: CRO treatment was significantly superior to placebo on the BPI average pain intensity and average percent pain relief scores overall (4.6 vs 5.4, P = .03, and 47.2 vs 36.3, P = .05, respectively). Fewer CRO subjects discontinued because of inadequate pain control (P < .001). No significant differences between treatments were observed in either Roland Morris or SF-36 scores. Common adverse events for CRO were nausea, constipation, somnolence, headache, and pruritus, consistent with opioid use. Conclusions: Three-month treatment with CRO provides significant pain relief for subjects with persistent moderate to severe back pain, without significantly impairing functionality and quality of life. The support of Purdue Pharma L.P. for this research project is gratefully acknowledged. [source] Periradicular infiltration for sciatica: a randomized controlled trial. (University Hospital of Oulu, Helsinki, Finland).PAIN PRACTICE, Issue 4 2001Spine. In this study, 160 consecutive, eligible patients with sciatica who had unilateral symptoms of 1 to 6 months duration, and who never underwent surgery were randomized for a double-blinded injection with methylprednisolone bupivacaine combination or saline. Objective and self-reported outcome parameters and costs were recorded at baseline, at 2 and 4 weeks, at 3 and 6 months, and at 1 year. Recovery was better in the steroid group at 2 weeks for leg pain, straight leg raising, lumbar flexion, and patient satisfaction. Back pain was significantly lower in the saline group at 3 and 6 months. Sick leave and medical costs were similar for both treatments, except for cost of therapy visits and drugs at 4 weeks, which were in favor of the steroid injection. By 1 year, 18 patients in the steroid group and 15 in the saline group underwent surgery. Conclude improvement during the follow-up was found in both the methylprednisolone and saline groups. The combination of methylprednisolone and bupivacaine seems to have a short-term effect, but at 3 and 6 months, the steroid group seems to experience a "re-bound" phenomenon. [source] Hearing loss in chronic myeloid leukemiaPEDIATRIC BLOOD & CANCER, Issue 1 2005Rahul Naithani MBBS Abstract A 12-year-old girl presented with abdominal pain, fever, and hearing impairment of 6 months duration. She had massive hepatosplenomegaly and anemia. On the basis of her peripheral blood and bone marrow findings, she was diagnosed as chronic myeloid leukemia (CML) in chronic phase. Her hearing was assessed by brainstem evoked responses (BERA), which showed objective improvement in hearing with hydroxyurea. The rare occurrence of deafness in CML is reviewed and possible pathogenesis is discussed. Pediatr Blood Cancer 2005; 45: 54,56. © 2005 Wiley-Liss, Inc. [source] When thinking hurts: Attachment, rumination, and postrelationship adjustmentPERSONAL RELATIONSHIPS, Issue 3 2007COLLEEN SAFFREY The current study used an attachment framework to explore postrelationship rumination and adjustment. Young adults (N= 231) involved in a romantic relationship that (a) was of 3 months duration or longer and (b) ended in the last 12 months participated in the study. The study assessed rumination generally (brooding, regret, and reflection), and specifically concerning the ended relationship (relationship preoccupation and romantic regret). At the general level, brooding and regret were associated with more negative adjustment, whereas reflection was associated with more positive adjustment. At the relationship level, both relationship preoccupation and romantic regret were associated with more negative adjustment. Models tested indicated that rumination largely mediated the association between attachment anxiety and adjustment. [source] Improving the Sexual Quality of Life of Couples Affected by Erectile Dysfunction: A Double-Blind, Randomized, Placebo-Controlled Trial of VardenafilTHE JOURNAL OF SEXUAL MEDICINE, Issue 5 2005William A. Fisher PhD ABSTRACT Introduction., Erectile dysfunction (ED) has a dual negative impact on men and their female partners; both are likely to face a drop in sexual quality of life and challenges to their intimate relationship as couples' sexual activities are curtailed by the loss of erectile function. Aim., The primary objective of this study was to compare the efficacy of vardenafil vs. placebo in terms of success of maintenance of erection in men with ED and improvement of their female partner's sexual quality of life. Methods., This was a randomized, double-blind, multicenter, flexible-dose, parallel-group comparison of vardenafil vs. placebo for 12 weeks in men (,18 years) with ED of ,,6 months duration, and their female partners. Main Outcome Measures., Changes in patient's overall response rate to Sexual Encounter Profile question 3 (SEP3) "Did your erection last long enough for you to have sexual intercourse?" and female partner's response to the quality of life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL) at last observation carried forward (LOCF) were considered the primary efficacy measures. In addition, patient's response to SEP2 "Were you able to insert your penis into your partner's vagina?," the erectile function domain of the International Index of Erectile Function (IIEF-EF) and patient's mSLQQ-QOL score were also assessed. Results., Compared with placebo, vardenafil significantly improved overall least square (LS) mean per-patient SEP3 success rate (28% vs. 68%; P < 0.0001) and partner's LS mean (standard error [SE]) mSLQQ-QOL score at LOCF (32.14 [3.24] vs. 65.80 [3.10]; P < 0.0001). In addition, compared with placebo, vardenafil also improved overall LS mean per-patient SEP2 success rate (47% vs. 80%; P < 0.0001), LS mean (SE) IIEF-EF scores at LOCF (12.7 [0.8] vs. 22.8 [0.8]; P < 0.0001) and patient's LS mean (SE) mSLQQ-QOL (28.37 [3.46] vs. 63.85 [3.28]; P < 0.0001) at LOCF. Conclusions., Vardenafil improved erectile function in men with ED and improved the sexual quality of life of the couple. Fisher WA, Rosen RC, Mollen M, Brock G, Karlin G, Pommerville P, Goldstein I, Bangerter K, Bandel T-J, Derogatis LR, and Sand M for the Vardenafil Study Group. Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil. J Sex Med 2005;2:699,708. [source] A self-sustaining climate mode in the tropical atlantic, 1995,97: Observations and modellingTHE QUARTERLY JOURNAL OF THE ROYAL METEOROLOGICAL SOCIETY, Issue 564 2000Itsuki C. Handoh Abstract An anomalous climatic event in the tropical Atlantic, starting in autumn 1995 and continuing into the autumn of 1997, is investigated. Using remotely sensed datasets and a reduced-gravity model, it is shown that this event contained both a warm and a cold phase, each of roughly 12 months duration. The propagating signal within each phase is identified in the sea surface height and temperature signatures as both equatorial and off-equatorial waves in the ocean, with coupling to atmospheric convection. The strength, geographical pattern and timing of the anomalous period is consistent with it being the first observed example of a coupled mode of interaction between the ocean and atmosphere found in two previous coupled ocean-atmosphere models of the tropics. This interpretation means that the two-phased climate event, which we will call the Equatorial Atlantic Oscillation (EAO), was associated with purely internal atmospheric and oceanographic variability within the Atlantic basin and hence was independent of the Pacific climate. It can also be inferred, from long-term monthly sea surface temperature and sea-level pressure datasets, that there were potentially several previous EAO events during the past century. [source] Surgical removal of an ovarian tumour in a koi carp (Cyprinus carpio)AUSTRALIAN VETERINARY JOURNAL, Issue 5 2006SR RAIDAL Ultrasonography, radiography and exploratory coeliotomy were used to diagnose and treat a large intracoelomic neoplasm from a female koi carp (Cyprinus carpio) presented for abdominal enlargement of several months duration. Feed was withheld for 1 week immediately prior to surgery and the fish was sedated with isoeugenol (AQUI-S®) at a dose rate of 10 mL/L to facilitate diagnostic imaging techniques. Surgical anaesthesia was induced by adding tricaine (MS-222) 50 mg/L to the water and an exploratory coeliotomy and tumour removal was performed. The fish was allowed to recover in fresh water at 18°C and salt was added slowly to the water over a period of 1 hour to a concentration of 5 g/L This concentration was maintained in a recovery pond for 1 week postoperatively. Enrofloxacin was administered intramuscularly (10 mg/kg) immediately, 3 days and 1 week postoperatively. A diagnosis of undifferentiated ovarian carcinoma was made on the basis of the histological appearance of the neoplasm and immunohistochemical staining. [source] The Industry View on Long-Term Toxicology Testing in Drug Development of Human PharmaceuticalsBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 2000Herman Van Cauteren The 1990's have seen a general acceptance that studies with a maximal duration of 6 months in rodents are all that is required for adequate safety assessment of developmental pharmaceutical agents. However, controversy has arisen concerning the most appropriate duration for chronic toxicity testing in non-rodents. Initial suggestions that 6 months duration was sufficient have been countered by findings noted in 12-month studies that were not seen in shorter-term studies. Retrospective analysis of available data eventually lead to a subsequent ICH recommendation that studies of 9 months duration would be now acceptable. However, until recently the FDA position on this recommendation was unclear and an analysis of industry practices since the ICH recommendation was made in 1997 has shown that the 9-month guideline is not widely applied. Recent clarification by the FDA will probably result in a continued but limited use of this alternative. An industry view on the future of chronic toxicology testing in rodents and non-rodents is presented. [source] There is no clear association between low serum ferritin and chronic diffuse telogen hair lossBRITISH JOURNAL OF DERMATOLOGY, Issue 5 2002R. Sinclair SummaryBackground Low iron stores are considered a possible cause of chronic diffuse telogen hair loss in women. Estimation of serum ferritin is recommended as part of the initial assessment when women present with chronic diffuse telogen hair loss, and iron supplementation therapy is commonly recommended for those found to have low iron stores. Objectives To evaluate the relationship between low serum ferritin (,20 µg L,1) and chronic diffuse telogen hair loss in women. Methods Between 1997 and 1999, 194 consecutive women who presented to a specialist hair clinic were assessed for diffuse telogen hair loss of greater than 6 months duration. All underwent biochemical investigations that included serum ferritin and had two 4-mm punch biopsies taken from the vertex of the scalp. One biopsy was sectioned horizontally and the other vertically. Results Twelve women were found to have a serum ferritin of 20 µg L,1 or less (6·2%). Androgenetic alopecia was found on scalp biopsy in seven of these 12 women, while the other five women had normal histology. The five women with low iron stores and normal histology were treated with iron supplementation alone. This was continued until the serum ferritin was > 20 µg L,1. Cessation or reversal of hair loss was not seen in any of these women. Conclusions No direct relationship between low serum ferritin and hair loss can be established. The usefulness of serum ferritin in the routine investigation of women with chronic diffuse telogen hair loss is unclear, as is the role of iron supplementation therapy in the management of hair loss. [source] Analyses of mortality risk in patients with dementia treated with galantamineACTA NEUROLOGICA SCANDINAVICA, Issue 1 2009H. H. Feldman Objective,,, To analyze mortality data from patients with Alzheimer's disease (AD), Alzheimer's plus cerebrovascular disease (AD + CVD) or vascular dementia (VaD). Methods,,, (1) Meta-analysis of mortality data from double-blind, placebo-controlled, randomized trials; and (2) recontact study to collect additional longer term mortality data from previous galantamine trial participants. Results (meta-analysis),,, Across 12 trials (,6 months duration), there was no increased risk of mortality associated with the use of galantamine (n = 4116) compared with that of placebo (n = 2386) (OR galantamine/placebo: 0.67, 95% CI 0.41,1.10). Results (recontact study),,, Median survival was 79 months for patients with AD (n = 478) and 59 months for patients with AD + CVD (n = 180) or VaD (n = 145). Prolonged galantamine treatment (> vs ,6 months) was not associated with decreased survival time (75 vs 61 months respectively; P = 0.02). Cox regression analyses were consistent with the Kaplan,Meier analyses. Conclusions,,, We found no short-term or longer term evidence of increased risk of mortality associated with the use of galantamine in patients with AD, AD + CVD or VaD. [source] Phase II study of daily oral perifosine in patients with advanced soft tissue sarcoma,CANCER, Issue 10 2006Howard H. Bailey MD Abstract BACKGROUND. A multicenter Phase II study was performed to evaluate the clinical activity of an initial loading (150 mg every 6 hours × 4 doses) dose followed by continuous daily oral dosing (100 mg/day) of perifosine in patients with advanced soft tissue sarcomas (STSs). METHODS. Patients with measurable metastatic STS received perifosine as first-, second-, or third-line treatment and underwent disease assessment every 8 weeks until disease progression, excessive toxicity, or patient refusal. RESULTS. Twenty-three patients received 66 cycles (1 cycle = 4 weeks) of perifosine. One partial response of 9 months duration was observed. The overall 3 and 6 month progression-free survival was 22% and 9%. NCI CTC (v2.0) Grade 1 to 2 gastrointestinal toxicity or fatigue were the most common (>50% of subjects) toxicities observed. The steady-state plasma perifosine levels (Css) were similar to prior experience (mean 6 ,g/mL). Patients with Css levels >6 ,g/mL appeared more likely to remain on study past 2 months than those with levels <6 ,g/mL. CONCLUSIONS. Despite not achieving the primary objective of ,40% 6-month progression-free survival rate, optimism remains for this agent in STS patients. Prolonged responses in heavily pretreated STS patients continue to be observed with perifosine treatment. Continued assessment of perifosine in STS appears warranted, with special attention to specific histologies or tumor characteristics that might identify a more sensitive population and achieving perifosine Css levels >6 ,g/mL. Cancer 2006 © 2006 American Cancer Society. [source] The role of atopy in Maltese patients with chronic rhinitisCLINICAL OTOLARYNGOLOGY, Issue 3 2004A.M. Agius The global prevalence of allergic rhinitis has been on the increase and recent clinical experience in Malta has shown a similar trend. The aim of this study was to investigate the role of atopy in 415 patients presenting with rhinitis of at least 3 months duration, and to identify the common allergens responsible. Presenting clinical features, past and family history of seasonal allergic symptoms, exposure to cigarette smoking, pet ownership and occupation were analysed. All patients were skin tested for common allergens. Fifty-five per cent of patients were atopic, the main allergens responsible being house dust mite, cat dander and grass pollen. Rhinorrhoea and sneezing were significantly more common in atopic patients, who were more likely to have a past history and family history of seasonal asthma, eczema or rhinoconjunctivitis. Skin test-negative patients with idiopathic rhinitis were mostly females and tended to present a decade later. Differentiation between atopic and idiopathic chronic rhinitis may be helpful in the clinical setting in order to help predict response to treatment. [source] Tales from the frontline: the colorectal battle against SARSCOLORECTAL DISEASE, Issue 2 2004I. M. J. Bradford Abstract Objective The recent worldwide epidemic of Severe Acute Respiratory Disease (SARS) caused over 800 deaths and had a major impact on the health services in affected communities. The impact of SARS on colorectal surgery, particularly service provision and training, is unknown. This paper reports these changes from a single colorectal unit at the centre of the outbreak. Patients and methods Hospital databases and electronic patient records covering the 4 months duration of the SARS epidemic and an equivalent period preceding SARS were compared. Data was collected for inpatient admissions, outpatient consultations, operative surgery, colonoscopy and waiting times for appointments or surgery. Results The SARS epidemic resulted in reductions of 52% for new outpatient attendances, 59% for review attendances, 51% for admissions, 32% for surgical procedures and 48% for colonoscopies. Major emergency procedures, cancer resections and complex major procedures were unaffected. Operative procedures by trainees reduced by 48% and procedures by specialists reduced by 21%. Patients awaiting early or urgent outpatient appointments rose by 200% with waiting times for colonoscopy increased by a median 3, 5 or 9 weeks for outpatient, inpatient or non-urgent cases, respectively. The waiting time for minor elective colorectal surgery was extended by 5 months. Conclusion SARS resulted in a major reduction in the colorectal surgical caseload. The consequences were evidenced by a detrimental effect on waiting times and colorectal training. However, serious pathology requiring emergency or complex surgery was still possible within these constraints. [source] Self-monitoring of blood glucose in type-2 diabetes: what is the evidence?DIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 6 2007Grace McGeoch Abstract Background There is a controversy about self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes who are not using insulin. Randomized trials are limited in duration, size, and validity. Methods Systematic search for randomized trials and observational studies published since 1990. For inclusion studies had to report on SMBG in type 2 diabetes managed with oral hypoglycaemic agents and/or diet alone, HbA1c or clinical outcome, have at least 50 patients and be of at least 6 months' duration. Results Three randomized trials with 1000 patients were included, though all had interventions differing in the amount of education on SMBG, and in the population studied. The two larger studies had statistically significantly lower HbA1c levels with SMBG. Thirteen observational studies had information on over 60 000 patients. Smaller studies had lower initial HbA1c and showed no association between SMBG and laboratory or clinical improvement. Larger studies tended to have higher initial HbA1c and did show an association between SMBG and laboratory or clinical improvement. Overall, improvement in glycaemic control with SMBG tended to be seen in studies with initial HbA1c above 8%. Conclusions It is likely that SMBG is beneficial in some circumstances, for example as an educational tool, for patients with type 2 diabetes not using insulin who have poor glycaemic control. More information is needed at the level of the individual patient, rather than group means, and about timing and frequency of monitoring, response to those results, what constitutes effective patient education, and long-term clinical outcomes. Copyright © 2007 John Wiley & Sons, Ltd. [source] Use of Percutaneous Electrical Nerve Stimulation (PENS) in the Short-term Management of HeadacheHEADACHE, Issue 4 2000Hesham E. Ahmed MD Objective.,To evaluate the short-term effects of percutaneous electrical nerve stimulation (PENS) in the management of three types of chronic headache. Background.,Traditional electroanalgesic therapies have been reported to be effective in the management of acute headache symptoms. However, no controlled studies have been performed in patients with chronic headache. Methods.,Thirty patients with either tension headache, migraine, or posttraumatic headache symptoms of at least 6 months' duration were randomized to receive PENS (needles with electricity) or "needles alone" according to a crossover study design. All treatments were administered for 30 minutes, three times a week for 2 consecutive weeks with 1 week off between the two different treatments. For the PENS treatments, an alternating electrical stimulation frequency of 15 and 30 Hz was used. Pain, activity, and sleep scores were assessed using a 10-cm visual analog scale, with 0 corresponding to the best and 10 to the worst, during the 48-hour period prior to the beginning of the two treatments, immediately before and after each treatment session, and 48 hours after completing each treatment modality. Results.,Compared with the needles alone, PENS therapy was significantly more effective in decreasing the overall VAS pain scores for tension-type headache, migraine and posttraumatic headache (58%, 59%, and 52% versus 20%, 15%, and 20%, respectively). Similarly, PENS therapy produced greater improvement in the patients' physical activity (41% to 58% for PENS versus 11% to 21% for needles only) and quality of sleep (41% to 48% for PENS versus 12% to 20% for needles only). However, there were no differences in the pattern of the response to PENS therapy among the three headache groups. Conclusions.,Percutaneous electrical nerve stimulation appears to be a useful complementary therapy to analgesic and antimigraine drugs for the short-term management of headache. Interestingly, the analgesic response to PENS therapy appears to be independent of the origin of the headache symptoms. [source] Polymorphisms in PTGS1, PTGS2 and IL-10 do not influence colorectal adenoma recurrence in the context of a randomized aspirin intervention trialINTERNATIONAL JOURNAL OF CANCER, Issue 9 2007Richard A. Hubner Abstract Regular use of aspirin and other nonsteroidal antiinflammatory drugs reduces both the development of colorectal neoplasia and recurrence of colorectal adenoma (CRA). Modulation of the effects of aspirin by genetic factors has been reported, potentially allowing targeting of treatment to individuals most likely to gain benefit. Prostaglandin H synthase 1 (PTGS1) and PTGS2 are key enzymes in prostaglandin synthesis and are inhibited by aspirin, whilst interleukin-10 (IL-10) is an important antiinflammatory cytokine. We investigated whether functional genetic polymorphisms in the PTGS1, PTGS2 and IL-10 genes influence CRA recurrence in individuals participating in a randomized aspirin intervention trial. DNA was available for genotyping from 546 patients who received aspirin (300 mg daily) or placebo for a mean 41-months' duration. Homozygote carriers of variant alleles for the PTGS1 50C>T, PTGS2 ,765G>C and IL-10 ,592C>A polymorphisms did not have a significantly altered risk of CRA recurrence (relative risk [RR] = 0.91; 95% confidence interval [CI]: 0.14,6.07, RR = 1.32; 95%CI: 0.66,2.62 and RR = 1.24; 95% CI: 0.74,2.07, respectively). There were also no significant interactions between aspirin intervention and genotype in determining recurrence risk. These data indicate that these polymorphisms are unlikely to influence CRA recurrence and cannot be used to identify individuals who derive benefit from aspirin intervention. © 2007 Wiley-Liss, Inc. [source] Trospium chloride once-daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome: an integrated analysis of two randomised, phase III trialsINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 12 2009D. R. Staskin Summary Background:, Trospium chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose:, We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of trospium chloride (trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods:, Adults with OAB of , 6 months' duration with urinary urgency, frequency and , 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results:, In total, 1165 subjects were randomised (trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (,1.9 vs. ,2.7; p < 0.001) and UUI episodes/day (,1.8 vs. ,2.4; p < 0.001) at week 12. The most frequent AEs considered possibly related to study treatment were dry mouth (trospium XR, 10.7%; placebo, 3.7%) and constipation (trospium XR, 8.5%; placebo, 1.5%). Notably, rates of central nervous system (CNS) AEs were lower with trospium XR vs. placebo (dizziness: 0.2% vs. 1.0%; headache: 1.4% vs. 2.4%). Conclusions:, Treatment with trospium XR resulted in statistically significant improvements in both of the dual primary and all of the secondary outcome variables. Trospium XR demonstrated favourable rates of AEs, particularly CNS AEs (numerically lower than with placebo) and dry mouth (lower than previously reported with trospium immediate-release, although not compared in a head-to-head study). [source] | |||||||||||||||||||||||||||||||