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At least 271 records · Page 15Linked to original sources
PubMed2004

Novel pharmacological therapies for the treatment of AIDS-related Kaposi's sarcoma.

Kaposi's sarcoma (KS) is the most common cancer associated with AIDS. KS aetiology and pathogenesis are still poorly defined and no definitive treatment has yet been identified. However, the introduction in 1996 of highly active antiretroviral therapy as a standard of care for those infected with HIV-1 determined a strong protection against the development of opportunistic infections, as well as a remission of pre-existing complications, including KS. Under highly active antiretroviral therapy, KS in particular has shown the highest clinical response rate reported to date among AIDS patients. Furthermore, recent insights into the pathogenetic mechanisms involved in KS development have provided new hope for a response and improved survival in patients with AIDS-related KS. This paper presents an overview of the current knowledge concerning pharmacological approaches to treating this disease. Newer treatments such as PEGylated liposomal anthracyclin, paclitaxel and pathogenesis-based strategies are also discussed.

AIDS-Related Opportunistic Infections↗
PubMed2001

The clinical potential of novel erythropoiesis stimulating protein.

Novel erythropoiesis stimulating protein (NESP) is a supersialylated analogue of endogenous erythropoietin or recombinant human erythropoietin (rhuEPO). It contains a total of five N-linked consensus carbohydrate binding sites in the native protein. NESP has a higher molecular weight due to an increased content of carbohydrates, which, however, has no meaningful influence on the binding to and activation of the erythropoietin receptor. The major difference in comparison to rhuEPO is the up to threefold increase of the terminal half-life of NESP, which allows for less frequent dosing of NESP. Several clinical studies have shown that NESP is as safe and efficient as rhuEPO in correcting renal anaemia and in the maintenance therapy of renal anaemia.

Adolescent↗
PubMed1995

Carbapenems in paediatrics.

Serious infections in paediatric patients pose some unique challenges to clinicians. Children represent a dynamic group of patients in whom there are age-related changes as well as age-related alterations in the biodisposition of various antimicrobial agents. In infants and children with serious infections multidrug therapy is generally employed. This occurs because most antibiotic therapy in these patients is initiated and continued on an empiric basis and few, if any, of the currently available agents may be employed confidently as monotherapy. When the agents currently available are compared on a pharmacokinetic and pharmacodynamic basis the carbapenems emerge as close to ideal for the treatment of serious infections in infants and children. Imipenem is the only member of this group currently available. It lacks paediatric labelling in the USA and its efficacy has not been compared directly with that of antibiotic regimens commonly employed in children. Meropenem is a new carbapenem currently under evaluation of the treatment of moderate to severe infections in children and adults. In 2 multicentre, randomised evaluations of the treatment of a variety of infections including lower respiratory tract infections, urinary tract infections, intra-abdominal infections, infections of the skin and skin structures, and septicaemia, the efficacy and safety of meropenem monotherapy were compared with those of cefotaxime-based regimens. Meropenem had an overall clinical efficacy rate of 98% compared with a rate of 95% for cefotaxime-based regimens. Neither regimen was associated with any significant clinical or laboratory adverse events. The carbapenem, meropenem, appears to be a reasonable choice for empiric therapy in infants and children with serious infections. Meropenem monotherapy has been evaluated and has been found to be as well tolerated and as effective as cefotaxime-based regimens in these patients.

Bacterial Infections↗
PubMed1993

["State of the art" of chemotherapy for lung cancer].

This paper reviews the recent clinical trials of chemotherapy and combined modality therapy in small-cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). 1) A meta-analysis has shown that survival is prolonged when radiotherapy is used in combination with chemotherapy in the treatment of limited-stage SCLC. A randomized trial comparing early radiotherapy (RT) with late RT has reported the survival advantage in the early RT. Recent pilot trials employing accelerated hyperfractionated RT with concurrent cisplatin (CDDP) and etoposide have shown encouraging survival results. 2) The approach to increasing dose intensity has been attempted in the treatment of extensive-stage (ES) SCLC. The most common approach is weekly chemotherapy. Results of pilot studies using this approach have shown the relatively high rate of complete response with an average of 36% and longer survival with a median of more than 10 months in ES-SCLC. 3) Combined modality treatment employing CDDP-containing chemotherapy or CDDP alone and radiotherapy have produced positive results in the treatment of locally advanced stage III A or III B NSCLC. In conclusion, despite the advances of treatment, the cure rate remains quite low in lung cancer. Further investigations are needed to improve the outcome with this disease.

Carcinoma, Non-Small-Cell Lung↗
PubMed2005

Methodological quality and reporting of ethical requirements in phase III cancer trials.

BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. CONCLUSION: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.

Clinical Trials, Phase III as Topic↗
PubMed1995

Retrieving research studies: a comparison of bibliographic and full-text versions of the New England Journal of Medicine.

It has been established that subject searches of medical full-text databases obtain higher recall than subject searches in a bibliographic database. In this study we attempted to determine if the same rule might apply when searching for a non-subject parameter such as study design. A simultaneous search of bibliographic and full-text records from the New England Journal of Medicine provided data on the number of items retrieved by each kind of search. Filtering strategies were created for 5 different study types: randomized controlled trials, other clinical trials and prospective studies, cohort studies, longitudinal and follow-up studies, and multicenter studies. The point of the study was to compare the numbers of items retrieved from the bibliographic database, MEDLINE, and those retrieved from the full-text version of NEJM, and to examine the unique access points available in each file. For all the study types the full-text file retrieved a larger number of records than MEDLINE, most of which were retrieved because of methodology terms found in the text but not in the title or abstract. In MEDLINE, descriptors and publication types, two value-added fields supplied by indexers, retrieved 11-89% more than title and abstract alone.

Abstracting and Indexing↗
PubMed2000

How well are randomized controlled trials reported in the dermatology literature?

OBJECTIVE: To assess the methodological quality of the design and reporting of randomized controlled trials published in one major dermatology specialty journal. DESIGN AND DATA SOURCES: In a survey of all published parallel group randomized controlled trials, we found 73 reports with allocation described as randomized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997. MAIN OUTCOME MEASURES: Direct and indirect measures of the adequacy of randomization, trial sample size, baseline comparisons, and intention-to-treat analysis. RESULTS: Hand searching identified 73 randomized controlled trials, but only 31 of these were found by searching MEDLINE for the publication type clinical trials. Of the 73 randomized controlled trials, 68 contained sufficient information to include in the analysis. Only 1 study (1%) reported the method of random sequence generation, and only 5 studies (7%) reported adequate concealment of allocation. Among 38 trials that used simple randomization, the sample sizes in the comparison groups were identical in 22 occasions, raising the possibility that simple randomization might not have been adequately generated or concealed. Most trials (88%) excluded some randomized participants from their analysis. The median sample size was 23 per trial. Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis. CONCLUSIONS: Hand searching is important for locating all relevant trials. There is the need for higher methodological quality in clinical trial reporting in dermatology journals. The adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports.

Data Collection↗
PubMedDate not supplied

Improved glycaemic control in type 1 diabetes patients following participation per se in a clinical trial--mechanisms and implications.

The phenomenon of improved diabetes self-management following participation in a clinical trial, with subsequent improvement of glycaemic control, has been acknowledged in literature but has received little attention. Also, the potential implications of such a 'study effect' for clinical research are poorly explored. We review the literature and describe the effects on glycaemic and psychological outcomes in long-term poorly controlled type 1 diabetes patients participating in a qualification phase of a Good Clinical Practice (GCP) trial. Improved glycaemic control following participation in a clinical trial is best understood as the result of improved patients' instrumental coping behaviours, including increased self-monitoring of blood glucose (SMBG). Such improvement in self-care with ensuing improved glycaemic control has important consequences for trial design. Firstly, benefits seen in uncontrolled trials should be interpreted with extreme caution. Secondly, unspecific study effects and the effect of a given intervention may not simply be additive. Therefore, it is wise to include a run-in or qualification phase of adequate length before randomization in a clinical trial. A stable baseline HbA1c can thus be reached, upon which the specific effect of an intervention can be properly judged. Also, in a multi-centre trial, a qualification phase of sufficient length will help diminish differences in terms of intensity of care provided in participating centres.

Blood Glucose↗
PubMedDate not supplied

[Primary chemoprevention of tuberculosis in HIV-infected patients in non-industrialized countries].

In randomized placebo-controlled trials in Haïti, Zambia and Uganda, prophylactic use of isoniazid (INH) for 6 to 12 months reduced the annual incidence of tuberculosis in HIV-infected patients by more than 50 per cent. For several years, WHO, IUTATLD and CDC have recommended that HIV-positive patients testing positive in a PPD test should be treated with INH as a form of anti-tuberculosis chemoprophylaxis (ATC). Whilst these recommendations are easy to follow in industrialized countries, widespread use of ATC in developing countries remains problematic because: (i) It is unknown what proportion of patients are likely to be re-infected at the end of ATC in countries where TB is endemic; (ii) It is possible that resistant bacilli may be selected due to the incomplete exclusion from the ATC program of patients with active TB at enrollment; (iii) It is difficult to identify asymptomatic carriers of M. tuberculosis at enrollment; (iv) It is doubtful that all patients will comply with a treatment regime which lasts several months; (v) The cost of a widespread ATC program, whose full benefit remains to be evaluated, may be difficult to justify. This paper attempts to review these issues and demonstrates the need for more population-based clinical trials in the field.

AIDS-Related Opportunistic Infections↗
PubMed1997

The effects of dietary protein restriction on chronic progressive renal disease.

There have been a large number of clinical trials and two meta-analyses attempting to determine if dietary protein restriction retards the rate of renal disease progression. Indeed, in a systematic search of prospective, controlled trials examining the effects of protein restriction over at least 6 months, we located 23 published between 1980 and 1996. Only 12 of these trials were randomized and controlled. The results of the 23 studies were heterogeneous. Two meta-analyses combined the results of randomized, controlled trials. Although both meta-analyses concluded that dietary protein restriction significantly reduced the number of patients who died or required treatment for end-stage renal disease, the well-known effects of protein restriction on the signs and symptoms of uremia leave open the question of whether protein restriction had a substantial effect on renal disease progression per se. Adding to the uncertainty is the inconclusive result of the largest, best-designed clinical trial, the Modification of Diet in Renal Disease Study. In any case, the effect of protein restriction on the rate of decline in renal function is arguably modest, making it difficult to demonstrate statistical significance, even in large, well-designed clinical trials. All of these trials suggest that we need therapies that are more effective than dietary protein restriction to halt the progression of renal disease.

Chronic Disease↗