The effectiveness and cost-effectiveness of spinal cord stimulation for refractory angina (RASCAL study): study protocol for a pilot randomized controlled trial

This is the final version of the article. Available from the publisher via the DOI in this record.BACKGROUND: The RASCAL (Refractory Angina Spinal Cord stimulation and usuAL care) pilot study seeks to assess the feasibility of a definitive trial to assess if addition of spinal cord stimulation (SCS) to usual care is clinically superior and more cost-effective than usual care alone in patients with refractory angina. METHODS/DESIGN: This is an external pilot, patient-randomized controlled trial.The study will take place at three centers in the United Kingdom - South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital), Dudley Group of Hospitals NHS Foundation Trust, and Basildon and Thurrock University Hospitals NHS Foundation Trust.The subjects will be 45 adults with refractory angina, that is, limiting angina despite optimal anti-angina therapy, Canadian Cardiovascular Society Functional Classification Class III and IV, angiographically documented coronary artery disease not suitable for revascularization, satisfactory multidisciplinary assessment and demonstrable ischemia on functional testing.The study will be stratified by center, age and Canadian Cardiovascular Society Functional Classification.Interventions will involve spinal cord stimulation plus usual care ('SCS group') or usual care alone ('UC group'). Usual care received by both groups will include consideration of an education session with a pain consultant, trial of a transcutaneous electrical neurostimulation, serial thoracic sympathectomy and oral/systemic analgesics.Expected outcomes will be recruitment and retention rates; reasons for agreeing/declining participation; variability in primary and secondary outcomes (to inform power calculations for a definitive trial); and completion rates of outcome measures. Trial patient-related outcomes include disease-specific and generic health-related quality of life, angina exercise capacity, intake of angina medications, frequency of angina attacks, complications and adverse events, and satisfaction. DISCUSSION: The RASCAL pilot trial seeks to determine the feasibility and design of a definitive randomized controlled trial comparing the addition of spinal cord stimulation to usual care versus usual care alone for patients with refractory angina.Fifteen patients have been recruited since recruitment opened in October 2011. The trial was originally scheduled to end in April 2013 but due to slow recruitment may have to be extended to late 2013. TRIAL REGISTRATION: ISRCTN65254102.This article presents independent research funded by the National Institute of Health. Research (NIHR) under its Research for Patient Benefit (RfPB) program (grant reference: PB-PG-1208-18031)

The effectiveness and cost-effectiveness of spinal cord stimulation for refractory angina (RASCAL study): study protocol for a pilot randomized controlled trial

Background: The RASCAL (R efractory A ngina S pinal C ord stimulation and usuAL care) pilot study seeks to assess the feasibility of a definitive trial to assess if addition of spinal cord stimulation (SCS) to usual care is clinically superior and more cost-effective than usual care alone in patients with refractory angina. Methods/design: This is an external pilot, patient-randomized controlled trial. The study will take place at three centers in the United Kingdom - South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital), Dudley Group of Hospitals NHS Foundation Trust, and Basildon and Thurrock University Hospitals NHS Foundation Trust. The subjects will be 45 adults with refractory angina, that is, limiting angina despite optimal anti-angina therapy, Canadian Cardiovascular Society Functional Classification Class III and IV, angiographically documented coronary artery disease not suitable for revascularization, satisfactory multidisciplinary assessment and demonstrable ischemia on functional testing. The study will be stratified by center, age and Canadian Cardiovascular Society Functional Classification. Interventions will involve spinal cord stimulation plus usual care (‘SCS group’) or usual care alone (‘UC group’). Usual care received by both groups will include consideration of an education session with a pain consultant, trial of a transcutaneous electrical neurostimulation, serial thoracic sympathectomy and oral/systemic analgesics. Expected outcomes will be recruitment and retention rates; reasons for agreeing/declining participation; variability in primary and secondary outcomes (to inform power calculations for a definitive trial); and completion rates of outcome measures. Trial patient-related outcomes include disease-specific and generic health-related quality of life, angina exercise capacity, intake of angina medications, frequency of angina attacks, complications and adverse events, and satisfaction. Discussion: The RASCAL pilot trial seeks to determine the feasibility and design of a definitive randomized controlled trial comparing the addition of spinal cord stimulation to usual care versus usual care alone for patients with refractory angina. Fifteen patients have been recruited since recruitment opened in October 2011. The trial was originally scheduled to end in April 2013 but due to slow recruitment may have to be extended to late 2013

High-Speed Imaging of the First Kink Mode Instability in a Magnetoplasmadynamic Thruster

One of the biggest challenges to efficient magnetoplasmadynamic thruster (MPDT) operation is the onset of high-frequency voltage oscillations as the discharge current is increased above a threshold value. The onset regime is closely related to magnetohydrodynamic instabilities known as kink modes. This work documents direct observation of the formation and quasi-steady state behavior of an argon discharge plasma in a MPDT operating at discharge currents of 8 to 10 kA for a pulse length of approximately 4 ms. A high-speed camera images the quasi-steady-state operation of the thruster at 26,143 fps with a frame exposure time of 10 micro s. A 0.9 neutral density filter and 488-nm argon line filter with a 10-nm bandwidth are used on separate trials to capture the time evolution of the discharge plasma. Frame-by-frame analysis of the power flux incident on the CCD sensor shows both the initial discharge plasma formation process and the steady-state behavior of the discharge plasma. Light intensity levels on the order of 4-6 W/m2 indicate radial and azimuthal asymmetries in the concentration of argon plasma in the discharge channel. The plasma concentration exhibits characteristics that suggest the presence of a helical plasma column. This helical behavior has been observed in previous experiments that characterize plasma kink mode instabilities indirectly. Therefore, the direct imaging of these plasma kink modes further supports the link between MPDT onset behavior and the excitation of the magnetohydrodynamic instabilities

Natural history of irritable bowel syndrome

Producción CientíficaIBS). The aim of this study was to investigate the presence of chronic functional digestive symptoms in childhood, interviewing adult patients diagnosed with IBS, in an attempt to establish a relationship between them. METHODS: By means of a questionnaire, the history of colic, chronic diarrhea, functional abdominal pain, constipation and migraine in childhood, was analyzed in patients diagnosed with IBS according to the current Rome III criteria, and in control patients without known chronic digestive disorders. Fisher's exact test was used for comparison of frequencies. RESULTS: The IBS study group was made up of 40 patients (24 women; average age, 33.03 years), and the control group by 40 adults (22 women; average age, 29.62 years). IBS-diagnosed adults spoke about a significantly higher prevalence of chronic diarrhea (32.5/7.5%; odds ratio [OR], 7.01; 95% confidence interval [CI]: 26.84-1.80), and FAP (37.5/15%; OR, 4.30; 95%CI: 12.67-1.43) in their childhood, than the control group. There were no differences in the presence of other childhood functional symptoms. Interestingly, the present patients, when asked about the onset of symptoms that led to the diagnosis of IBS, referred to them mostly beginning in adulthood, not linking their current diagnosis of IBS with their background in childhood. In a proportion of adults with IBS the natural history of their symptoms probably began during their childhood.(IBS). The aim of this study was to investigate the presence of chronic functional digestive symptoms in childhood, interviewing adult patients diagnosed with IBS, in an attempt to establish a relationship between them. By means of a questionnaire, the history of colic, chronic diarrhea, functional abdominal pain, constipation and migraine in childhood, was analyzed in patients diagnosed with IBS according to the current Rome III criteria, and in control patients without known chronic digestive disorders. Fisher's exact test was used for comparison of frequencies. The IBS study group was made up of 40 patients (24 women; average age, 33.03 years), and the control group by 40 adults (22 women; average age, 29.62 years). IBS-diagnosed adults spoke about a significantly higher prevalence of chronic diarrhea (32.5/7.5%; odds ratio [OR], 7.01; 95% confidence interval [CI]: 26.84-1.80), and FAP (37.5/15%; OR, 4.30; 95%CI: 12.67-1.43) in their childhood, than the control group. There were no differences in the presence of other childhood functional symptoms. Interestingly, the present patients, when asked about the onset of symptoms that led to the diagnosis of IBS, referred to them mostly beginning in adulthood, not linking their current diagnosis of IBS with their background in childhood. In a proportion of adults with IBS the natural history of their symptoms probably began during their childhood

Intraluminal tracheal lipoma as a rare cause of dyspnoea in a dog

Background: Tracheal tumors are rarely diagnosed in veterinary medicine and the majority of tracheal neoplasia reported in adult dogs are malignant. Intratracheal lipoma has not been previously reported in the veterinary literature. Case presentation: A 7-year-old Briard dog was evaluated for inspiratory dyspnoea and an inspiratory wheeze. Cervical radiographs and tracheoscopic examination revealed an intratracheal mass that was surgically removed. The dog has been asymptomatic after the surgery. Conclusions: Based on histopathology, the mass was diagnosed as lipoma. To the authors' knowledge, this is the first published report of an intratracheal lipoma in the veterinary literature.Peer reviewe

Can We Do Away With PTBD?

Percutaneous Transhepatic Biliary Drainage (PTBD) is performed in surgical jaundice to decompress the biliary tree and improve hepatic functions. However, the risk of sepsis is high in these patients due to immunosuppression and surgical outcome remains poor. This raises a question—can we do away with PTBD? To answer this query a study was carried out in 4 groups of patients bearing in mind the high incidence of sepsis and our earlier studies, which have demonstrated immunotherapeutic potential of Tinospora cordifolia (TC): (A) those undergoing surgery without PTBD (n = 14), (B) those undergoing surgery after PTBD (n = 13). The mortality was 57.14% in Group A as compared to 61.54% in Group B. Serial estimations of bilirubin levels carried out during the course of drainage (3 Wks) revealed a gradual and significant decrease from 12.52 ± 8.3 mg% to 5.85 ± 3.0 mg%. Antipyrine half-life did not change significantly (18.35 ± 4.2 hrs compared to basal values 21.96 ± 3.78 hrs). The phagocytic and intracellular killing (ICK) capacities of PMN remained suppressed (Basal: 22.13 ± 3.68% phago, and 19.1 ± 4.49% ICK; Post drainage: 20 ± 8.48% Phago and 11.15 ± 3.05% ICK). Thus PTBD did not improve the metabolic capacity ofthe liver and mortality was higher due to sepsis. Group (C) patientg received TC during PTBD (n = 16) and Group (D) patients received TC without PTBD (n = 14). A significant improvement in PMN functions occurred by 3 weeks in both groups (30.29 ± 4.68% phago, 30 ± 4.84% ICK in Group C and 30.4 ± 2.99% phago, 27.15 ± 6.19% ICK in Group D). The mortality in Groups C and D was 25% and 14.2% respectively during the preoperative period. There was no mortality after surgery. It appears from this study that host defenses as reflected by PMN functions play an important role in influencing prognosis. Further decompression of the biliary tree by PTBD seems unwarranted

Management of Multiple Primary Lung Cancer in Patients with Centrally Located Early Cancer Lesions

BackgroundPatients with centrally located early lung cancer (CLELC) are often heavy smokers with a considerably high risk of multiple primary lung cancer (MPLC) lesions; treatment strategies for such patients must preserve the cardiopulmonary function.MethodsBetween July 2004 and July 2008, patients with CLELC underwent photodynamic therapy (PDT) using NPe6, second-generation photosensitizer at Tokyo Medical University Hospital. Among these patients, we retrospectively analyzed MPLC, which was treated by surgery plus PDT or PDT alone and examined the effectiveness of PDT, and we propose a treatment strategy for patients with MPLC.ResultsA total of 64 patients with CLECL received NPe6-PDT, and MPLCs were found in 22 patients (34.4%) using sputum cytology and a bronchoscopical examination using autofluorescence bronchoscopy. Among these 22 patients, 10 patients underwent surgery for primary lung cancer and underwent NPe6-PDT for the treatment of secondary primary CLELC, one patient underwent PDT for CLELC as a primary lesion followed by an operation for peripheral-type lung cancer as a secondary primary lesion, and 11 patients underwent PDT alone for MPLC lesions (28 lesions) that were roentgenographically occult lung cancers. Among these 22 patients with MPLC including peripheral-type lung cancers, which were resected by surgery, all 39 CLELC lesions exhibited a complete response after PDT, and all patients were alive.ConclusionsFor patients with lung cancer with a long-term history of smoking, careful follow-up examinations after surgical resection are needed considering the incidence of metachronous primary lung cancers. PDT can play an important role for the treatment strategy for MPLC