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Published Clinical Trials (published + clinical_trials)
Selected AbstractsMonitoring asthma therapy using indirect bronchial provocation tests,THE CLINICAL RESPIRATORY JOURNAL, Issue 1 2007John D. Brannan Abstract Objectives:, Bronchial provocation tests that assess airway hyperresponsiveness (AHR) are known to be useful in assisting the diagnosis of asthma and in monitoring inhaled corticosteroid therapy. We reviewed the use of bronchial provocation tests that use stimuli that act indirectly for monitoring the benefits of inhaled corticosteroids. Data Source:, Published clinical trials investigating the effect of inhaled corticosteroids on bronchial hyperresponsiveness in persons with asthma were used for this review. Study Selection:, Studies using indirect stimuli to provoke airway narrowing such as exercise, eucapnic voluntary hyperventilation, cold air hyperventilation, hypertonic saline, mannitol, or adenosine monophosphate (AMP) to assess the effect of inhaled corticosteroids were selected. Results:, Stimuli acting indirectly result in the release of a variety of bronchoconstricting mediators such as leukotrienes, prostaglandins, and histamine, from cells such as mast cells and eosinophils. A positive response to indirect stimuli is suggestive of active inflammation and AHR that is consistent with a diagnosis of asthma. Persons with a positive response to indirect stimuli benefit from daily treatment with inhaled corticosteroids. Symptoms and lung function are not useful to predict the long-term success of inhaled corticosteroid dose as they usually resolve rapidly, and well before inflammation and AHR has resolved. Following treatment, AHR to indirect stimuli is attenuated. Further, during long-term treatment, asthmatics can become as non-responsive as non-asthmatic healthy persons, suggesting that asthma is not active. Conclusions:, Non-responsiveness to indirect bronchial provocation tests following inhaled corticosteroids occurs weeks to months following the resolution of symptoms and lung function. Non-responsiveness to indirect stimuli may provide a goal for adequate therapy with inhaled corticosteroids. Please cite this paper as: Brannan JD, Koskela H and Anderson SD. Monitoring asthma therapy using indirect bronchial provocation tests. The Clinical Respiratory Journal 2007;1:3,15. [source] Cosmeceuticals Containing Herbs: Fact, Fiction, and FutureDERMATOLOGIC SURGERY, Issue 2005Carl Thornfeldt MD Background. Modern medicine is rooted in ethnobotanical traditions using indigenous flora to treat symptoms of human diseases or to improve specific aspects of the body condition. Herbal medicine is now used by over half of the American population. Yet the American medical community generally lacks knowledge of the function, metabolism, interaction, adverse reactions, and preparation of herbal products. Objective. Because over 60 botanicals are marketed in cosmeceutical formulations, dermatologists need to obtain working knowledge of the major botanicals. The preparation, traditional uses, mechanisms of action, human clinical data, adverse reactions, and interactions all impact herbal efficacy and are discussed below. Method. English-language medical journal and symposium searches. Results. The most important botanicals pertaining to dermatologic uses, such as cosmeceuticals, include teas, soy, pomegranate, date, grape seed, Pycnogenol, horse chestnut, German chamomile, curcumin, comfrey, allantoin, and aloe. All are documented to treat dermatologic conditions. Only green and black tea, soy, pomegranate, and date have published clinical trials for the treatment of parameters of extrinsic aging. Conclusions. Preparation of botanical-based cosmeceuticals is complex. Very few of these products are supported by evidence-based science. CARL THORNFELDT, MD, FAAD, HAS INDICATED NO SIGNIFICANT INTEREST WITH COMMERCIAL SUPPORTERS. [source] Review of bupropion for smoking cessationDRUG AND ALCOHOL REVIEW, Issue 2 2003ROBYN RICHMOND Abstract The advent of bupropion hydrochloride sustained release (Zyban) has heralded a major change in the options available for smoking cessation pharmacotherapy. Bupropion is a selective re-uptake inhibitor of dopamine and noradrenalin which prevents or reduces cravings and other features of nicotine withdrawal. Bupropion is a useful oral and non-nicotine form of pharmacotherapy for smoking cessation. For this review a total of 221 papers were reviewed plus poster presentations. This review examines in detail original clinical trials on efficacy, categorised according to whether they were acute treatment trials in healthy smokers; studies in specific populations such as people with depression, chronic obstructive pulmonary disease (COPD) or cardiovascular disease; or relapse prevention studies. Overall, these studies in varying populations comprising over four thousand subjects, showed bupropion consistently produces a positive effect on smoking cessation outcomes. The evidence highlights the major public health role that bupropion has in smoking cessation. The methodological issues of published clinical trials reporting one year outcomes were examined in detail including: completeness of follow-up; loss to follow-up; intention to treat analysis; blindness of assessment; and validation of smoking status. The review discusses contraindications, adverse effects, dose and overdose, addictive potential, and the role of bupropion in reducing cessation-related weight gain. Bupropion combined with or compared to other pharmacotherapies (nicotine patch; nortriptyline) is considered. Impressive evidence exists for the use of bupropion in smoking cessation among difficult patients who are hard-core smokers such as those with cardiovascular disease, chronic obstructive pulmonary disease (COPD) and depression. Bupropion reduces withdrawal symptoms as well as weight gain and is effective for smoking cessation for people with and without a history of depression or alcoholism. Serious side effects of bupropion use are rare. The major safety issue with bupropion is risk of seizures (estimated at approximately 0.1%) and it should not be prescribed to patients with a current seizure disorder or any history of seizures. In clinical trials of bupropion for smoking cessation no seizures were reported. Allergic reactions occur at a rate of approximately 3% and minor adverse effects are common including dry mouth and insomnia. [source] TOOTH WHITENING IN CHILDREN AND ADOLESCENTSJOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 6 2005Kevin J. Donly DDS The popularity of vital tooth whitening has increased significantly over the past two decades. Professionally supervised "in-office" and "at-home" tooth whitening methods have been documented in the literature with evidence of safety and effectiveness. Although the literature includes considerable information about vital tooth whitening in adults, minimal information is available concerning vital tooth whitening in children and adolescents. The need to provide vital tooth whitening for children might be infrequent owing to the natural whiteness of children's teeth. However, there are circumstances when tooth whitening can be desirable for children, such as fluorosis discoloration, generalized tooth darkening, post-traumatic injury discoloration, and postorthodontic tooth discoloration. Few well-controlled clinical trials evaluating the safety and effectiveness of vital tooth whitening in children are available in the literature, Furthermore, these published clinical trials were carried out by the same principal investigator. This review examines these trials and offers recommendations accordingly. [source] Offenders with intellectual disability: the size of the problem and therapeutic outcomesJOURNAL OF INTELLECTUAL DISABILITY RESEARCH, Issue 6 2002P. Barron Abstract Background People with intellectual disability (ID) who offend may be subject to a variety of disposals within the criminal justice system, or via diversion to health and social services in inpatient units or in community ID teams. Offenders with ID are a group with complex needs who may pose a recurrent risk to the public. Despite the significant number of offenders with ID, there is limited evidence on treatment effectiveness and outcomes. Methods A literature search of all electronic databases was undertaken, and journals were hand-searched for clinical trials or case studies of interventions for offenders with ID. The main outcome was recidivism rates. Results There were no published clinical trials of offenders with ID. A series of small-scale group cognitive-behavioural treatments for sex offenders offers the most persuasive evidence of success in reducing recidivism. Conclusion Offenders with ID often receive inadequate services as a result of poor identification through the criminal justice system and research into effective treatments is rudimentary. Further studies are necessary in order to improve treatment efficacy and service provision for a complex group of individuals. [source] Review article: gene therapy, recent developments and future prospects in gastrointestinal oncologyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2010Y. Touchefeu Aliment Pharmacol Ther 2010; 32: 953,968 Summary Background, Gene therapy consists of the introduction of genetic material into cells for a therapeutic purpose. A wide range of gene therapy vectors have been developed and used for applications in gastrointestinal oncology. Aim, To review recent developments and published clinical trials concerning the application of gene therapy in the treatment of liver, colon and pancreatic cancers. Methods, Search of the literature published in English using the PubMed database. Results, A large variety of therapeutic genes are under investigation, such as tumour suppressor, suicide, antiangiogenesis, inflammatory cytokine and micro-RNA genes. Recent progress concerns new vectors, such as oncolytic viruses, and the synergy between viral gene therapy, chemotherapy and radiation therapy. As evidence of these basic developments, recently published phase I and II clinical trials, using both single agents and combination strategies, in adjuvant or advanced disease settings, have shown encouraging results and good safety records. Conclusions, Cancer gene therapy is not yet indicated in clinical practice. However, basic and clinical advances have been reported and gene therapy is a promising, new therapeutic approach for the treatment of gastrointestinal tumours. [source] Review article: the role of rapid virological response in determining treatment duration for chronic hepatitis CALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2010F. F. POORDAD Aliment Pharmacol Ther,31, 1251,1267 Summary Background, For patients with chronic hepatitis C, attaining rapid virological response (RVR) is highly predictive of attaining SVR. Aim, To consider the predictive value of RVR in terms of SVR and relapse. Methods, Data were collected from published clinical trials to define the predictive value of RVR for SVR and evaluate the proposed continuum linking RVR to relapse. Results, These data support a 24-week regimen among genotype (G)1 patients who attain RVR with positive predictive values (PPVs) of 77.8% and 85.7% in patients with G1 infection treated for 24 and 48 weeks. Conversely, failure to attain RVR among G1 patients should not be viewed as a criterion for extending treatment duration beyond 48 weeks: negative predictive values (NPVs) were 60.9% and 52.7% in G1 patients without RVR treated for 48 and 72 weeks. Among G2/3 patients, RVR has a high PPV; however, the NPV varied with treatment duration indicating that a 24-week treatment regimen is warranted in G2/3 patients who fail to attain RVR. Conclusions, The present analysis confirms RVR as a strong predictor of SVR that can be used to tailor treatment duration, but which also should be appreciated in the context of treatment duration and regimen. [source] Health-economic analysis: cost-effectiveness of scheduled maintenance treatment with infliximab for Crohn's disease , modelling outcomes in active luminal and fistulizing disease in adultsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2008J. LINDSAY Summary Background, Infliximab has been shown to be efficacious in moderate-to-severe Crohn's disease (CD). Aim, To evaluate the cost-effectiveness of scheduled maintenance treatment with infliximab in luminal and fistulizing CD patients. Methods, Markov models were constructed to simulate the progression of adult CD patients with and without fistulae during treatment with infliximab (5 mg/kg). Transitions were estimated from published clinical trials of infliximab. Standard care, comprising immunomodulators and/or corticosteroids was used as a comparator. An average weight of 60 kg was used to estimate the dose of infliximab. The costs and outcomes were discounted at 3.5% over 5 years. The primary effectiveness measurement was quality-adjusted life years (QALYs) estimated using EQ-5D. One-way and probabilistic sensitivity analyses were performed by varying the infliximab efficacy estimates, costs and utilities. Results, The incremental cost per QALY gained was £26 128 in luminal CD and £29 752 in fistulizing CD at 5 years. Results were robust and remained in the range of £23 752,£38 848 for luminal CD and £27 047,£44 206 for fistulizing CD. Patient body weight was the most important factor affecting cost-effectiveness. Conclusion, Eight-week scheduled maintenance treatment with infliximab is a cost-effective treatment for adult patients suffering from active luminal or fistulizing CD. [source] Review article: current management of metastatic colorectal cancer , the evolving impact of targeted drug therapiesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2008T. YAU Summary Background, The field of colorectal cancer chemotherapy has been transformed by the advent of molecule-specific drugs. Combined use of such drugs enhances tumour response rates, but controlled data quantifying the relative efficacy and cost-effectiveness of different drug combinations on overall survival remain scarce. Aim, To conduct an overview of published clinical trials in advanced colorectal cancer, with the objective of framing provisional approaches to current management. Methods, An NCBI/PubMed search was performed using the strings, ,colorectal cancer' (,metastatic' or ,advanced' or ,palliative') and (,chemotherapy' or ,drug therapy' or ,targeted' or ,target-specific' or ,molecularly-targeted'). Results, Combinations of target-specific drugs (with or without the DNA-alkylating agent oxaliplatin) have substantially enhanced colorectal cancer time to progression over the last decade and have also expedited surgical resection of liver metastases. Disease-free survival, overall survival and quality of life are favourably influenced. Conclusions, Target-specific drugs improve palliative efficacy in the setting of advanced colorectal cancer. However, key issues persist as to the cost-effectiveness of these newer drug treatments, and further controlled trials are needed to resolve this important debate. [source] A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myelomaBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2006Axel Glasmacher Summary The activity of thalidomide in relapsed or refractory multiple myeloma is widely accepted but not yet demonstrated in a randomised-controlled trial. A systematic review of the published clinical trials of these patients could reduce the possible bias of single phase-II studies. A systematic search identified 42 communications reporting on 1674 patients. Thirty-two trials used an escalating dosing regimen and four a fixed dose regimen (one dose with 50 mg/d, three doses with 200 mg/d). The target dose in the dose escalating trials was 800 mg/d in 17 trials, 400,600 mg/d in 10 and 200 mg/d in one trial. The intention-to-treat population for efficacy was 1629 patients with a median age of 62 years. The complete and partial (>50% reduction in monoclonal protein) response rate was 29·4% (95%-confidence interval, 27,32%). The rates for minor responses or stable disease were 13·8% (12,16%) and 11·0% (9,13%). Progressive disease was reported in 9·9% (8,11%). The median overall survival from all trials was reported at 14 months. Severe adverse events (grade III,IV) included somnolence 11%, constipation 16%, neuropathy 6%, rash 3%, thrombo-embolism 3%, cardiac 2%. In conclusion, thalidomide monotherapy achieved complete and partial responses in 29·4% of patients with relapsed or refractory multiple myeloma. [source] | ||||||||||