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Phase II Trial of concurrent administration of intravesical BCG & Interferon in the treatment and prevention of recurrence of superficial transitional carcinoma of the urinary bladder.

Study Design: Cross-sectional comparison of the Self Regulatory Model (Leventhal, 1984) and The Health Belief Model (Rosenstock, 1966) by which the models will be used to predict and understand adherence to selfcare regimens of adolescents and young adults with food allergy. Proposed Sample Size / Power Calculations: The power calculation was based on multiple regression analysis for all predictor variables, 25 in total. To predict a minimum of 10% of the variance in adherence with an alpha=0.05 and power=0.90, a minimum proposed sample size of 275 participants will be needed. A 40% attrition rate has been anticipated due to the use of postal questionnaires and so a minimum of 459 participants will need to be recruited. Analyses Nonparametric item response theory analysis, univariate correlations and multiregressional analysis for predictor models will be conducted. Structural equation modelling will also be applied to assess the goodness of fit of the two social cognition models. Setting This study will be based in an outpatients setting and in the community. Participants will be identified and recruited from their hospital allergy clinic either whilst attending an appointment or from a hospital mail out. The third method of recruitment will involve participants from a convenience sample of the universities of Sussex and Brighton. Procedure Phase 1 Recruitment and consent The recruitment of study participants will involve three methods. The first method will involve recruiting participants in person from their hospital allergy clinic. Eligible individuals identified by clinic staff will be given a participant information leaflet and asked if they are interested in taking part in the study. Once verbal consent is given, participants will be directed to the chief investigator who will be present in clinic. Interested individuals would then have the opportunity to discuss the research with the chief investigator and/or the clinic staff. If still interested, individuals (aged 16-21 or parents of those aged 13-15) will be asked to sign two consent forms (one copy to keep for themselves) and be given a questionnaire. The participants will be given the opportunity to complete the questionnaire within the clinic, or take it home to complete. If the latter option is chosen, a freepost envelope addressed to the research team will be provided. Participants will also be given a correspondence slip on which to write their contact details to return separately to the research team if they are interested in receiving a summary of findings. The second method of recruitment will involve a patient database search by clinic staff and subsequent mail out to eligible individuals. Clinic staff will search their patient records for individuals who fit the inclusion criteria. The consultant in charge will confirm their eligibility and sign the invitation letter prepared on hospital headed paper. This will be put in an envelope together with the participant information leaflet, two consent forms (one copy for the participant to keep and the other to be returned), the questionnaire, future correspondence slip and freepost envelope addressed to the research team. The third method of recruitment will be a convenience sample through the Universities of Sussex and Brighton. A generic email will be sent to staff and students consisting of the participant information leaflet and detailing the main inclusion criteria. Individuals who are eligible and interested in taking part in the research will be asked to reply to the email with their contact details. Similarly to those recruited from the clinic mail out, these participants will be sent a pack containing another participant information leaflet, two consent forms, a questionnaire, a correspondence slip and a freepost envelope addressed to the research team. Phase 2 - Questionnaire In order to measure the models, carefully constructed and piloted questionnaires have been developed. Each participant will be asked to complete one questionnaire on one occasion. The questionnaire will collect demographic details, assess knowledge of how and when to use medication, confidence in the individual's own ability to use the medication, management of food allergy, the Revised Illness Perception Questionnaire (Moss-Morris et al., 2002) which is the validated questionnaire to measure items from the Self-Regulatory Model (Leventhal, 1984), items which relate to factors found within the Health Belief Model (Rosenstock, 1966) and finally the Revised Life Orientation Test (Scheier et al., 1994). The questionnaire completion time has been confirmed with individuals within the targeted age range and is expected to take no longer than 40 minutes to complete. In order to improve the response rate of questionnaires, a second mail out will be sent to all eligible participants one month after the initial mail out. Phase 3 - Feedback to participants Those participants who expressed an interest in receiving a summary of findings and provided contact details will be sent a summary document upon completion of the study. Measures Demographic/background Participants will be asked their age, gender, ethnicity, size of family, history of food allergy and anaphylaxis, use of the emergency medication autoinjectable epinephrine, membership of an allergy support group, possession of a management plan for their food allergy. Knowledge Knowledge about how and when to use an autoinjectable epinephrine device will be measured and the individuals confidence in their ability to do so correctly will also be looked at. This will enable us to explore whether underuse is as a result of poor knowledge or whether this can be better explained by other factors. Adherence Adherence will be measured by asking participants about their current methods of managing their food allergy. This will include questions on allergen avoidance and carrying emergency medication (auto-injectable epinephrine and additional medicines they may use to treat their food allergy). Revised Illness Perception Questionnaire (Moss-Morris et al., 2002), Health Belief Model (Rosenstock, 1966) items and the Revised Life Orientation Test (Scheier et al., 1994) The Revised Illness Perception Questionnaire (Moss-Morris et al., 2002) measures constructs from the Self-Regulatory Model (Leventhal, 1984) which include symptoms, the duration of food allergy, the consequences of having food allergy, the personal control an individual feels they have over their food allergy, the amount the individual feels the treatment can control their food allergy, emotions they associate with their food allergy, how much they comprehend their food allergy and what they believe are the causes. The Health Belief Model (Rosenstock, 1966) similarly looks at attitudes but in this case how susceptible and serious individuals feel suffering an allergic reaction would be, the barriers and benefits to following recommended advice and what prompts these individuals to follow this advice. The Revised Life Orientation Test (Scheier et al., 1994) will also be measured to determine levels of optimism which has been found in other studies to impact on the way participants respond to items on questionnaires. Anaphylaxis is a severe and potentially life threatening allergic reaction which can affect the airway, breathing and/or circulation. This reaction can be triggered by a number of different allergens but the most common are food, medications, insect venom and latex. Because these reactions occur suddenly and are potentially very serious, the best management lies in the correct use of the prescribed emergency medication. Epinephrine, or adrenaline as it is more commonly known, is the recommended drug for the treatment of anaphylaxis. Injecting the epinephrine into the outer thigh muscle is the preferred route of administration. For health professionals, patients and carers, this rapid administration is facilitated by the manufacture of preloaded syringes and autoinjectors. Despite the availability of these devices, a review of studies shows poor knowledge and skills amongst both health professionals and patients with regards to using autoinjectable epinephrine devices correctly. These studies found that as well as poor knowledge in using the autoinjectors, there was a lack of confidence amongst patients and an unwillingness to carry the device with them at all times. In other disease groups like asthma and diabetes, psychological models which involve asking people how they think about their illness and their related behaviours, have been found to help in the understanding of why some people follow or adhere to health professionals advice and why others do not. Based on these findings, this study will look at two appropriate psychological models and their ability to predict variation in adherence to self-care regimens in adolescents and young adults with food allergy related anaphylaxis.

This is a phase II study using the combination of bortezomib, rituximab, fludarabine, mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition each patient will receive Pneumocystis carinii Pneumonia (PCP) prophylaxis with Trimethoprim/sulfamethoxazole (TMP/Sulfa) or equivalent agent. On day 4 the physician has the option of starting granulocyte colony-stimulating factor (GCSF), granulocyte macrophage colony-stimulating factor (GMCSF), or pegylated GCSF. All patients who receive at least one dose of the drug will be evaluated for toxicity. Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response. The chemotherapy dosing will continue until there is evidence of disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses of therapy. The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.

Patients with refractory pulmonary sarcoidosis will be eligible for participation in this open label trial of Rituximab as additional therapy. The study will evaluate the efficacy of rituximab in improving the symptoms and functional capacity in patients with chronic sarcoidosis with pulmonary involvement who are symptomatic despite current treatment. Sarcoidosis is a inflammatory disease affecting many parts of the body, especially the lungs. While most patients do well, there is a group of patients who require continuous doses of prednisone or other drugs. The current study will determine the role of Rituximab as new agent for patients with refractory disease.

During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.

INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years postprocedure. Up to 25 sites in Europe may participate. Subjects will be enrolled and followed at 1 month and 6 month post-procedure and annually up to 5 years. INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years postprocedure. Up to 25 sites in Europe may participate.

WHO has urged all developing countries to develop programmes to improve complementary-feeding (CF) practices because of their importance for optimal growth, development and health of infants and young children While supplementation programmes and/or highly-fortified "super-foods" have limited success in improving CF-practices in disadvantaged environments, population-specific food-based dietary guidelines (FBDG), based on locally-available foods and requires minimal changes to local food pattern, will enhance the chances of programme success. Our previous study was able to identify the need for, potential and finally develop FBDG for CF of 6-8mo and 9-11mo infants using combined linear-and-goal programming approach (LP approach). This research is therefore being made to support the next phase of the study i.e. to assess the efficacy of FBDG, for improving CF/dietary-practices and growth in <24mo children (window of opportunity). As growth and development is inter-related, home-based stimulation will be included in this trial to see the effect on child development. While studies have shown that stimulation at early age benefits children through their late adolescence; evidence from Indonesia is lacking. This study therefore aims to see the effect on growth and development of community trial using food-based dietary guideline and stimulation. It is expected that findings from this study will provide scientific evidence as the basis for program formulation.

The primary purpose of this study is to compare the effectiveness on the disability of low back pain patients of The Back Book, The Back Guide, and a control intervention (generic recommendations on general health). Patients are divided into 3 groups:those who receive The Back Book (classic education), those who receive The Back Guide (cognitive behavioral education) and the control group). They are patients who consult a physician at the primary care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.

The aim of this study is to compare the effects of thoracic epidural analgesia and rectus sheath blockade on postoperative pulmonary functions, pain scores, duration of analgesia, sedation scores, patients' satisfaction and adverse effects. FEV1, FEV1/FVC ratio will be measured by a bed side spirometer. - Induction of anesthesia: propofol 1.5-2.5 mg kg-1. - Muscle Relaxants: rocuronium 0.6 mg kg-1 for induction. - Maintenance: Sevoflurane 0.7-1.5 MAC vaporized in air-oxygen (40% inspired fraction). Radial artery catheterization: under complete aseptic conditions 20G cannula will be inserted into the radial artery of non-dominant hand after performing modified Allen`s test and local infiltration of 0.5ml xylocaine 2% . Thoracic epidural catheter will be inserted before induction of general anaesthesia under aseptic insertion conditions and using loss of resistance to air technique with the patient in the sitting position at T9- T11 interspaces. The Rectus sheath catheters will be inserted bilaterally using ultrasound (SonoSite M-Turbo®, Sonosite , USA) guidance as described by Webster after induction of general anaesthesia. Pulmonary complications are among the most important postoperative complications after midline incisions, for which different analgesic modalities have been tried. Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery owing to the proved superior analgesia, reduction of opioid related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility However, it is not without complications. Rectus sheath block provides several advantages over epidural anesthesia. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for somatic analgesia after major abdominal surgeries. Although patients with rectus sheath block may experience some visceral pain, it is usually minimal by 24 hours after surgery.

Domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. It has been shown to safely increase the milk supply of lactating women. To date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. However, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk. The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.