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Results for “Randomized Controlled Trials as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 253 records · Page 14Linked to original sources
PubMed2000

Prophylactic implantable cardioverter defibrillator trials: MUSTT, MADIT, and beyond. Multicenter Unsustained Tachycardia Trial. Multicenter Automatic Defibrillator Implantation Trial.

MUSTT and MADIT have clearly shown the survival benefit of an implantable cardioverter defibrillator (ICD) in patients with previous myocardial infarction, left ventricular ejection fraction < or = 0.40, and nonsustained ventricular tachycardia (VT), and who have had sustained VT induced at electrophysiology study. Progress in primary prevention of sudden cardiac death (SCD) depends on a concerted effort by clinicians to identify and appropriately treat MUSTT/MADIT-type patients; further research to more precisely define patient subgroups at risk for SCD and the willingness of industry to develop a lower priced ICD for prophylactic use are needed.

Clinical Trials as Topic↗
PubMed2001

Methodology of clinical trials focusing on the PC-Fix clinical trials.

Once development and mechanical and biological laboratory testing have been completed, new technologies to be used in orthopaedic and trauma surgery must be investigated in humans before they can be used routinely. Prospective clinical investigations with or without randomization to standard treatments conducted according to the current standards and guidelines for Good Clinical Practice must be performed to prove the safety and efficacy of the new device. Furthermore, these tests serve to determine the specific indications, contraindications, tips and tricks as well as the pitfalls and how to avoid them. Last, but not least, the study must result in improved teaching of the use of the device and in improved follow-up of patients. The basis of every conclusion drawn from such a study is the complete documentation of each single use of the new device. We present the modalities and methodology for conducting a prospective clinical multicentre investigation in trauma surgery, focusing on the clinical trials carried out on the Point Contact Fixator (PC-Fix), a device for the internal fixation of long bone fractures developed as part of the scientific evolution towards the Less Invasive Stabilization Systems (LISS) now being introduced into clinical practice. Four prospective multicentre clinical investigations with an overall number of 1,229 PC-Fixators implanted from October 1993 to May 1998 were performed. To our knowledge this is the largest prospective series ever reported in orthopaedic trauma surgery to test a new device before market introduction. Due to a special documentation and implant replacement procedure, every PC-Fix implantation was documented. Very few patients were lost to long-term follow-up due to the personal commitment of the study monitors. Regular personal visits of the study monitor to the investigating hospitals and close communication between the surgeons, the engineers responsible for development, the study monitor, and the study sponsor meant that problems were identified and dealt with professionally without compromising the health of the patient. Case report forms were concise and had to be transmitted without delay. Handling of radiographs has become easier thanks to the transmission of digital images to the study centre via the internet. There are some aspects specific to trauma surgery which require special consideration and planning is essential, but clinical trials can be performed effectively.

Clinical Trials as Topic↗
PubMed2001

Clinical trials of Herceptin(trastuzumab).

This report summarises the clinical efficacy and safety findings from clinical trials of the new anti-HER2 monoclonal antibody Herceptin(trastuzumab). Data from pivotal trials indicate that trastuzumab is active when added to chemotherapy in patients with advanced metastatic breast cancer. In particular, the combination significantly prolonged the median time to disease progression, increased the overall response rate, increased the duration of response, and improved median survival time by approximately 25% compared with chemotherapy alone. Furthermore, trastuzumab is active as a single agent in women with HER2-positive metastatic breast cancer, inducing durable objective tumour responses. In total, 15% of patients who had received extensive prior treatment for metastatic disease had an objective response. The median duration of response was 9.1 months following administration of single-agent trastuzumab. Notably, 2% of patients were free of disease progression at 6 months. The safety profile of trastuzumab either given alone or in combination was favourable.

Antibodies, Monoclonal↗
PubMed2003

[The Internet a good web for gathering data for clinical trials and registries. Traditional paper data forms are soon completely "out"].

With the development of the Internet technology, clinicians have got a valuable tool for solving some of the logistic problems affecting multicenter studies and registers. Web based solutions enhance efficiency and quality of multicenter studies. Data can be entered continuously without any time and geographical limitations. On-line connection to a central database improves involvement of participants, and information and alterations can easily be disseminated. The central database enables optimal randomization and stratification. Furthermore, web based IT solutions for studies and registers enable the patients to report their data directly into the database. Until now web based IT solutions have been rather expensive but may gradually come down in price.

Clinical Trials as Topic↗
PubMed2004

HepeX-C (XTL Biopharmaceuticals).

XTL Biopharmaceuticals is developing HepeX-C, a combination of two antibodies (HCV-AB68 and HCV-AB65) as a potential therapy for hepatitis C virus infection. By September 2003, phase II trials of HCV-AB68 alone had been conducted and XTL Biopharmaceuticals announced that it planned to conduct a phase I study of the antibody combination.

Animals↗
PubMed1994

Current status of neoadjuvant therapy for non-small cell lung cancer.

Any program of therapy for clinically advanced non-small cell lung cancer (NSCLC) that would increase the incidence of local tumor control and decrease the likelihood of distant metastatic disease would be of obvious benefit. The objective of neoadjuvant therapy is to eradicate the primary tumor and micrometastatic disease. In the past 10 years, many trials have been completed to evaluate neoadjuvant therapy and they have included sequential chemoradiotherapy, concurrent chemoradiotherapy, chemotherapy/surgery, and chemoradiation/surgery. These trials have predominately been phase 2 trials and have demonstrated that chemotherapy is generally well tolerated, surgery is technically feasible, and operative morbidity and mortality are not excessive. Long-term survival for patients with clinically advanced NSCLC is improved when compared with historic controls. These trials have demonstrated a greater than 50% clinical response rate and in approximately 20% of patients who have undergone resections, the tumor is sterilized. This latter group of patients demonstrate significantly improved survival. Cost-benefit ratios and quality of life have yet to be evaluated. Final determination of the effectiveness of neoadjuvant therapy for NSCLC awaits completion of phase 3 trials.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1997

Updated results of the trials of screening mammography.

Most analysts agree that screening women for breast cancer can reduce the death rate by at least 25% to 30%. In 1993 the National Cancer Institute created a great deal of confusion among women and their physicians by withdrawing support for screening women aged 40 to 49 years. The controversy arose as a result of the inappropriate and scientifically insupportable analysis of data from the early results from the randomized controlled trials of screening. Despite that the trials were not designed to evaluate women aged 40 to 49 years as a separate subgroup and that they lacked the statistical power to permit legitimate analysis of this subgroup, women aged 40 to 49 years were analyzed separately, and erroneous conclusions were drawn. In an effort to justify these conclusions, other data have been analyzed improperly to try to suggest that significant screening parameters change at menopause or at the age of 50, whereas the facts do not support any abrupt change. There are no parameters such as breast density, cancer detection rate, or positive predictive value that change abruptly at age 50 or any other age. With longer follow-up of the screening trial data and the commensurately greater statistical power, the most recent meta-analyses provide statistically significant proof that screening can reduce the death rate from breast cancer for women aged 40 to 49 years by at least 24%.

Adult↗
PubMed2000

An easily customized, random allocation system using the minimization method for multi-institutional clinical trials.

In a randomized clinical trial, random allocation of patients to treatment groups should be done to balance in the distribution of prognostic factors. Random allocation in a multi-institutional randomized clinical trial is conducted by a coordinating center, independent of the medical institution the attending doctor uses for his/her practice. This study provides a sophisticated system for doing an exact random allocation of patients to treatment groups. The minimization method proposed by Pocock was applied to this system to balance the distribution of prognostic factors between two treatment groups, even when the number of registered patients is relatively small (S.J. Pocock, Allocation of patients to treatment in clinical trial, Biometrics 35 (1979) 183-197). Furthermore, Zelen's method is used to balance the number of patients allocated to the two groups within each institution (M. Zelen, The randomization and stratification of patients to clinical trials, J. Chron. Dis. 27 (1974) 365-375.). This system was created by the 'PERL&RSQUO; language for writing common gateway interface (CGI) script, and can therefore, be easily extended to include data entry function by attending doctors as well as the random allocation function. This system is being used effectively in thirteen multi-institutional randomized clinical trials for stomach, colon-rectum and breast cancers in Japan.

Clinical Trials as Topic↗
PubMed2005

Cocaine Rapid Efficacy Screening Trials (CREST): lessons learned.

AIMS: The Cocaine Rapid Efficacy Screening Trials (CREST) were designed by the National Institute on Drug Abuse Division of Treatment Research and Development (NIDA, DT R&D) to rapidly screen a number of medications potentially useful for the treatment of cocaine dependence. DESIGN: Each CREST trial was designed to compare several medications in a single trial against an unmatched placebo. The placebo group was included in each trial to avoid the nearly universal positive response to medications seen in open-label trials. In addition, a common set of procedures and outcome measures were employed throughout to increase comparability of results obtained from different trials and from different times. PARTICIPANTS: In all, 18 medications were screened in seven different trials, conducted in four different sites throughout the United States involving 398 cocaine-dependent patients. FINDINGS: Three medications were found to be promising enough to include in subsequent larger trials. Common statistical procedures for evaluating medications were developed to facilitate comparisons across sites and across time. A portion of the data were pooled and analyzed, which yielded some useful insights into cocaine dependence and its treatment. Finally, a review of individual trials together with the pooled analysis revealed several potential improvements for future screening trials. CONCLUSIONS: Overall, the CREST trials proved to be useful for rapidly screening medications for treatment of cocaine dependence, but several modifications in design should be made before this framework is applied further.

Clinical Trials as Topic↗
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↗