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Results for “Controlled Clinical Trials as Topic”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 73 records · Page 4Linked to original sources
PubMed1998

Blockade of glutamatergic transmission as treatment for dyskinesias and motor fluctuations in Parkinson's disease.

In animal models of Parkinson's disease (PD), glutamate antagonists diminish levodopa (LD)-associated motor fluctuations and dyskinesias. We sought to investigate if these preclinical observations can be extended to the human disease, by evaluating the effects of three non-competitive NMDA antagonists (dextrorphan, dextromethorphan and amantadine) on the motor response to LD in patients with advanced PD. In four separate trials, adjuvant therapy with these drugs reduced LD-induced dyskinesias and motor fluctuations. These findings support the view that drugs acting to inhibit glutamatergic transmission at the NMDA receptor can ameliorate LD associated motor response complications.

Amantadine↗
PubMed1996

Computer-administered clinical rating scales. A review.

While clinician-administered symptom rating scales are the most commonly used outcome measures in pharmaceutical research, error variance due to poor inter-rater reliability increases the risk of type II errors in multi-center clinical trials. Such error variance could obscure true differences between active drug and placebo, or between two comparator compounds. Computer-administered versions of symptom rating scales originally designed to be administered by trained clinicians offer a solution to this problem. This paper reviews the empirical data on the reliability, validity and equivalence of computer-administered rating scales. Computer-administered versions of clinician-administered scales are now available for the assessment of depression, anxiety, obsessive-compulsive disorder, and social phobia. Validation studies support the reliability, validity and equivalence of these scales. Patient reaction has been positive, with patients generally more honest with and often preferring the computer for assessing sensitive areas such as suicide, alcohol or drug abuse, sexual behavior, or HIV related symptoms. Applications using Interactive Voice Response (IVR) technology facilitate longitudinal monitoring of patients without requiring office visits to collect data, increase the accessibility of information to the clinician, and the quality of patient care through more informed decision making. When used in accordance with established ethical guidelines, computers offer a reliable, inexpensive, accessible, and time-efficient means of assessing psychiatric symptoms.

Clinical Trials as Topic↗
PubMed1994

The neglect of glucosamine as a treatment for osteoarthritis--a personal perspective.

Osteoarthritis results from progressive catabolic loss of cartilage proteoglycans, owing to an imbalance between synthesis and degradation. Standard drug therapy is only of palliative benefit and may exacerbate loss of cartilage. Glucosamine is an intermediate in mucopolysaccharide synthesis, and its availability in cartilage tissue culture can be rate-limiting for proteoglycan production. A number of double-blind studies dating from the early 1980s demonstrate that oral glucosamine decreases pain and improves mobility in osteoarthritis, without side effects. Nevertheless, medical researchers and physicians in the US have totally ignored this rational and safe therapeutic strategy. By mechanisms that are still unclear, the natural methyl donor S-adenosylmethionine also promotes production of cartilage proteoglycans, and is therapeutically beneficial in osteoarthritis in well-tolerated oral doses. These and other safe nutritional measures supporting proteoglycan synthesis, may offer a practical means of preventing or postponing the onset of osteoarthritis in older people or athletes.

Animals↗
PubMedDate not supplied

Vitamin D3 analogues.

Explore the source record for details and available documents.

Administration, Topical↗
PubMed2002

Pharmacologic management of childhood hypertension: current status, future challenges.

The treatment of childhood hypertension has been hampered by several factors, including a lack of extensive scientific data regarding drug efficacy and pharmacokinetics in children, a lack of manufacturer's recommendations for the use of antihypertensive agents in children, and a lack of age-appropriate drug formulations. These problems have forced clinicians either to rely on limited data from older studies of agents empirically no longer considered first-line choices for use in children, or to adapt agents studied in adults for pediatric use. Recent developments, including publication of single-center studies of newer agents and the proliferation of industry-sponsored trials spurred by the Food and Drug Administration Modernization Act, have increased the amount of data available. Investigators involved in such studies must ensure that the unique aspects of using antihypertensive drugs in children are adequately addressed.

Antihypertensive Agents↗
PubMed2003

[Hair loss].

Hair loss includes excessive shedding of hair (effluvium) and the alopecias, in which there is a decrease in the amount of hair. Both may occur diffusely, or in a circumscribed manner. The localization and pattern of circumscribed hair loss may give a clue to its cause. On the basis of morphologic criteria the alopecias are further classified into non-scarring and scarring types. Non-scarring alopecias (diffuse alopecia, androgenetic alopecia, alopecia areata) are essentially hair cycling disorders, while scarring alopecias result from irreversible destruction of the hair follicles with recognizable loss of follicular osita. Scalp biopsy should be an early step in the evaluation of any case of alopecia, in which scarring is suspected. Too little scalp hair is not a vital problem, but represents a major health care challenge. Only recently the psychological impact of hair loss has been appreciated by the medical community, though throughout history, too little hair has been a concern to mankind, and the object of cosmetic interest and quackery. Recent advances of the medical sciences have led to a better understanding of the underlying pathogenic processes and opened the venue to effective pharmacotherapy (minoxidil, finasteride) and technologies (autologous hair transplantation) for the treatment of the most common disorders. Together with the availability of such treatments, high technical standards for evaluating their efficacy have been developed and have become mandatory for appraisal of any hair growth promoting agent, both in clinical studies and in the individual patient.

Adult↗
PubMed2005

[Smoking cessation during treatment of alcohol dependence in drug and alcohol rehabilitation centres--a review].

PURPOSE: Review of the international literature on smoking cessation with smokers having a concurrent alcohol abuse disorder. The three aims are: 1. discussion of the pros and cons of concurrent smoking cessation and treatment of alcohol use disorder, 2. smoking cessation strategies and 3. description of national and international studies evaluating smoking cessation interventions with patients who are at the same time treated for their alcohol abuse disorder. METHOD: The results are collected on the basis of an extensive literature research in PsychInfo, Science Direct and Medicine. RESULTS: Considering the pros and cons, it can be concluded that smoking cessation should be offered to this subgroup of high risk smokers. The open question is which kind of interventions are effective. Intervention strategies should consist of a multi-level approach including structural as well as person-specific components. Evaluation studies show that a 12% abstinence rate at one year follow-up can be achieved in case of an intensive intervention in combination with a restrictive tobacco policy. Alcohol abstinence is not jeopardised by a concurrent smoking cessation, when smoking cessation is voluntary. CONCLUSIONS: On the basis of empiric research the common arguments against smoking cessation within the subgroup of alcohol-addicted smokers cannot be maintained on the basis of empiric research. Rehabilitation centres treating substance abuse disorders provide an excellent setting for the treatment of nicotine dependence. Interventions should include structural as well as subgroup-specific components.

Alcoholism↗
PubMed1994

The natural history of disc herniation and the influence of intervention.

The natural history of lumbar disc herniation must be considered when evaluating the influence and outcome of intervention. The combination of clinical signs and symptoms and corresponding radiologic findings permits a more certain diagnostic conclusion compared with many other obscure back disorders. The relationship between low back pain and a herniated disc is unclear. Mechanical compression and chemical changes may be the source of nerve root symptoms. Studies have shown that the natural course of acute radiculopathy has a good prognosis. Bed rest, information, and analgesics usually are sufficient therapeutic measures. Prolongation of symptoms requires radiologic examination. The decision regarding continued conservative therapy versus surgical intervention must be evaluated. Chemonucleolysis and percutaneous nucleotomy are being used, but the indications are uncertain.

Adult↗
PubMed2000

Interim analysis and sample size reassessment.

This article deals with sample size reassessment for adaptive two-stage designs based on conditional power arguments utilizing the variability observed at the first stage. Fisher's product test for the p-values from the disjoint samples at the two stages is considered in detail for the comparison of the means of two normal populations. We show that stopping rules allowing for the early acceptance of the null hypothesis that are optimal with respect to the average sample size may lead to a severe decrease of the overall power if the sample size is a priori underestimated. This problem can be overcome by choosing designs with low probabilities of early acceptance or by midtrial adaptations of the early acceptance boundary using the variability observed in the first stage. This modified procedure is negligibly anticonservative and preserves the power.

Animals↗
PubMed1995

The role of proton pump inhibitors in the treatment of gastro-oesophageal reflux disease.

Efficacy (healing, symptom relief) and cost-effectiveness are the principal reasons for the rapidly increasing use of proton pump inhibitors (PPIs) for the management of gastro-oesophageal reflux disease. EFFICACY: Mean healing rates pooled from clinical trials are as follows: on omeprazole (OME) 20 mg vs. H2-receptor antagonist. H2RA (cimetidine (CIM) 1.6 g or ranitidine (RAN) 300 mg) (eight studies) at 4 weeks, 67% vs. 37%: at 8 weeks, 81% vs. 49%: on lansoprazole (LAN) 30 mg vs. H2RA (three studies), 83% vs. 47% and 91% vs. 63% at 4 and 8 weeks, respectively. The benefit is greatest in severe disease because the H2RAs are disproportionately less effective. Heartburn is more rapidly relieved and in a higher proportion: at 4 weeks, on OME 20 mg vs. H2RA. 77% vs. 47% and on LAN 30 mg vs. H2RA, 81% vs. 46%. Both PPIs are effective in H2RA-refractory disease, approximately 80% healing occurring in 8 weeks. Relapse rates after healing vary from 25% to 85% at 6 months. Maintenance therapy sustains remissions: relapse at 1 year is, on OME 20 mg vs. RAN 300 mg (2 studies), 12% vs. 79%, and 28% vs. 55% (and 38% on OME 10 mg); on LAN 30 mg vs. 10 mg vs. RAN 600 mg, 20% vs. 31% vs. 68%. The effectiveness of the lower dose allows for dose titration. COST EFFECTIVENESS: The higher drug costs for the PPIs are offset by their higher efficacy, making their use cost effective, particularly in severe disease. Efficacy and cost effectiveness are likely to further expand the use of PPIs at the expense of H2RAs as increasing numbers of patients with milder disease are treated.

Anti-Ulcer Agents↗
PubMed2001

Defining benefits and risks for SERMs in clinical trials and clinical practice.

Differences between clinical trials and clinical practice with respect to defining benefits and benefit/risk ratios for SERMs are discussed. These differences stem from the perception that there is discordance between the statistical significance and the "clinical meaningfulness" of research data in the minds of the practitioner and patient. One way that we can obtain data that are more clinically meaningful is to solicit input in the planning stages of clinical trials from practicing community clinicians and their patients. However, there are drawbacks to community input, such as potentially unrealistic expectations. A further issue is the need to characterize clinically meaningful drug benefits and acceptable benefit/risk ratios for a drug. Individual patients have differences regarding their views of optimal benefits and acceptable risks, so a method or tool for determining what is clinically meaningful would be helpful in presenting comprehensive information to the patient. To present useful information to clinicians, head-to-head comparisons of a new drug with a standard agent should be undertaken. NIH's support in this area of comparator trials is critical to their implementation. Estrogen has been considered the standard for comparison of agents for conditions associated with menopause in clinical trials. Estrogen has been the "gold standard" in clinical practice as well. In fact, challenging the position of estrogen, even where scientifically supported, has proven to be an uphill battle. In the practice setting, we elaborate the challenges of keeping up with the scientific literature and of then communicating this information in a fashion that is relevant to the individual patient.

Clinical Trials as Topic↗