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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 199 records · Page 11Linked to original sources
PubMed2000

Psychotherapy adherence of therapists treating HIV-positive patients with depressive symptoms.

Adherence monitoring, a technology to specify research psychotherapies, was used in the NIMH Treatment of Depression Collaborative Research Program (TDCRP). The authors present adherence data from a similar randomized treatment trial of 56 depressed HIV-positive patients, comparing 16-week interventions with cognitive-behavioral therapy, interpersonal psychotherapy, and supportive psychotherapy alone or with imipramine. Therapists were certified in manualized treatments. Blind independent raters rated randomly selected taped sessions on an adaptation of the NIMH scale, yielding adherence scores for interventions and for therapist "facilitative conditions" (FC). All therapists were rated adherent. Interrater reliability was 0.89-0.99. The scale discriminated among the four treatments (P<0.0001), with each scoring highest on its own scale. FC, which might measure therapist competence independent of treatment technique, varied by intervention but did not predict treatment outcome. This study demonstrates the ability to reliably train adherence monitors and therapists able to deliver specified treatments. Its adherence findings provide the first replication of those from the landmark NIMH TDCRP study.

Analysis of Variance↗
PubMed2000

[Multicenter randomized trial of amnioinfusion].

Meconium staining of the amniotic fluid in labor is a frequent problem that is associated with an increase in the risk of neonatal and maternal morbidity. Amnioinfusion is a simple technique that is designed to prevent neonatal and maternal morbidity associated with meconium. Preliminary studies indicate that amnioinfusion is a promising approach to the prevention of such complications of labor. However, further research is required. The primary objective of this multi-centre randomized controlled study is to determine if amnioinfusion for thick meconium stained amniotic fluid results in a reduction in perinatal death or moderate to severe meconium aspiration syndrome. We will also assess the effects of amnioinfusion on other indicators of neonatal morbidity and on cesarean section. The study includes an evaluation of womens views on their childbirth experience and an economic evaluation of a policy of amnioinfusion The study will be achieved with the collaboration of approximately 50 obstetrical centres from across Canada, US, Europe, South America and South Africa. This multicentre trial will provide urgently needed information on the efficacy and effectiveness of amniofusion for the indication of meconium stained amniotic fluid.

Amniotic Fluid↗
PubMed2000

The role of underlying nephropathy in the progression of renal disease.

BACKGROUND: Disease-specific pathogenic mechanisms may be major determinants of the spontaneous rate of progression of chronic renal failure (CRF). To clarify the role of different underlying renal diseases, we examined the rate of CRF progression in 886 patients with chronic nephropathies. METHODS: Secondary analysis of two multicenter, prospective randomized trials: the Northern Italian Cooperative study (NIC) and the AIPRI study (ACE-Inhibition in Progressive Renal Insufficiency). Univariate and multivariate analyses of variance were used to select the covariates possibly related to CRF progression (estimated by means of the slope of the reciprocal of SCr against time), focusing on the contributory role of primary renal diseases. RESULTS: The overall rate of CRF progression was relatively low but there was a considerable difference in the slopes relating to the underlying nephropathy (particularly evident in the patients with chronic glomerulonephritis (CGN)). The median rate of CRF progression in both studies was more rapid in patients with polycystic kidney disease (PKD) and CGN than in those with other nephropathies. Multivariate analysis showed PKD as an independent predictor of the CRF progression rate only in the NIC Study (P < 0.0015); the selected variables in both studies predicted a variation of only 15-18% in the CRF progression rate. CONCLUSION: The underlying renal disease certainly plays a role in the natural history of CRF, but the variability of the CRF progression rates related to different renal diseases and between individuals with the same diagnosis underlines the need for caution in evaluating risk factors and predicting single patient outcomes.

Adult↗
PubMed2000

Prostate specific antigen testing and digital rectal examination before and during a randomized trial of screening for prostate cancer: European randomized study of screening for prostate cancer, Rotterdam.

PURPOSE: Worldwide 2 large-scale randomized screening trials for prostate cancer have been initiated. Determining prostate specific antigen (PSA) involves a simple test that may influence the outcome of these trials if frequently done in the control arm or before study enrollment. We quantified PSA and digital rectal examination before and during the screening trial in Rotterdam, The Netherlands and in the general population. MATERIALS AND METHODS: Trial participants were administered study intake questionnaires on tests done before study participation. Data on PSA from the regional general practice laboratory were correlated with participant data. Various sources were used to quantify PSA tests and digital rectal examinations in the general population. RESULTS: Of men 55 to 74 years old 45% underwent digital rectal examination at 1 time and 13% reported that PSA was tested before trial participation. Each rate increased with age. No statistically significant effect of former PSA testing or digital rectal examination on the cancer detection rate was identified. The rate of PSA determination after initial screening and/or randomization in the control arm was 2-fold that in the screening arm (76 versus 33/1,000 person-years). PSA determination initially decreased in the screening arm but increased rapidly after some time. The number of PSA determinations in the general population was estimated to be 45/1,000 person-years at ages 55 to 69 years. CONCLUSIONS: PSA testing was moderate in the control arm but if different men undergo this test each year, the contamination rate may become rather high. In the final analysis of mortality PSA testing should be considered.

Adult↗
PubMedDate not supplied

Whole systems research: a discipline for studying complementary and alternative medicine.

The new discipline of whole systems research (WSR) targets the study of complex CAM therapies as system-level phenomena, as opposed to single-agent or uni-dimensional effects. This article describes the pre-defined goals, issues that were developed, and opportunities that were revealed in a workshop held in Vancouver BC, in which scientists, practitioners, and policy makers met to lay the foundations of WSR. Important issues were identified, such as treatment individualization, problems of diagnosis, patient-practitioner interaction, varying therapeutic contexts, and patient-determined outcome values. Research design issues that were addressed included a variety of challenges to the study of intact systems, in relation to both synergy and emergent behaviors, and the opportunities to innovate the conventional RCT. As the network of CAM scientists and practitioners engaged in WSR expands, a common nomenclature and body of techniques will help us to a better understanding of the ways in which whole systems affect healing.

British Columbia↗
PubMed2004

The use of polyhydroxy acids (PHAs) in photoaged skin.

The beneficial effects of alpha-hydroxyacids (AHAs) on skin were discovered by Drs. Van Scott and Yu in the early 1970s, including exfoliation, skin smoothing, and antiaging effects. A new generation of AHAs, called polyhydroxy acids (PHAs), was discovered that provide similar effects as AHAs but do not cause the sensory irritation responses that can limit the use of classical AHAs. PHAs have been found to be compatible with clinically sensitive skin, including rosacea and atopic dermatitis, and can be used after cosmetic procedures. PHAs provide additional humectant and moisturization properties compared with AHAs and can enhance stratum corneum barrier function, therefore increasing the skin's resistance to chemical challenge. Most PHAs also possess antioxidant properties. PHAs such as gluconolactone or lactobionic acid may be used in combination with other products, ingredients, or procedures such as laser and microdermabrasion to provide additional benefits to therapy or to enhance the therapeutic effect. Several studies were conducted in support of this, and methods and results are discussed. In summary, PHA-containing products were used in combination with retinoic acid in treating adult facial acne and were found to be well tolerated. PHAs plus retinyl acetate (pro-vitamin A) in a cream base exhibited significant antiaging skin benefits such as skin smoothing and plumping. PHAs plus hydroquinone showed excellent improvement in antiaging and skin lightening parameters. Finally, PHA-containing products were shown to be compatible with African American, Caucasian, and Hispanic/Asian skin and provided significant improvements in photoaging in these populations.

Acne Vulgaris↗
PubMed2000

Treatment of postherpetic neuralgia: an update.

Postherpetic neuralgia (PHN) is a chronic pain syndrome that is often refractory to treatment and can last for years, causing physical and social disability, psychological distress, and increased use of the healthcare system. In this paper we provide an update on recent developments in the treatment of PHN. We emphasise the results of recent studies that provide an evidence-based approach for treating PHN that was not available until very recently. In randomised, controlled clinical trials, the topical lidocaine patch, gabapentin, and controlled release oxycodone have been shown to provide superior pain relief in patients with PHN when compared with placebo. It has also recently been demonstrated that the tricyclic antidepressant nortriptyline provides equivalent analgesic benefit when compared with amitriptyline, but is better tolerated. Based on these results, nortriptyline can now be considered the preferred antidepressant for the treatment of PHN, although desipramine may be used if the patient experiences unacceptable sedation from nortriptyline. The topical lidocaine patch, gabapentin and controlled release oxycodone all appear to be as effective as tricyclic antidepressants in the treatment of patients with PHN, and the results of these recent studies suggest that each of these treatments should be considered early in the course of treatment. Additional controlled trials are needed to compare the efficacy and tolerability of these 4 treatments- tricyclic antidepressants, gabapentin, the topical lidocaine patch and controlled release opioid analgesics--used singly and in various combinations in the treatment of patients with PHN.

Herpes Zoster↗
PubMed2006

Longterm efficacy of topical nonsteroidal antiinflammatory drugs in knee osteoarthritis: metaanalysis of randomized placebo controlled clinical trials.

OBJECTIVE: To evaluate the longterm efficacy of topical therapies for pain control in primary knee osteoarthritis (OA). METHODS: Systematic literature search was carried out from January 1, 1966, to December 31, 2004, in Pubmed, Medline, Embase, and Cochrane database. Manual searches of related journals in the National Medical Library (New Delhi, India), the library of our institute, and conference abstracts were also carried out. We included randomized controlled clinical trials of 4 weeks or more comparing any topical nonsteroidal antiinflammatory drug (NSAID) with placebo or vehicle. Effect size for pain control was estimated. RESULTS: Out of 172 citations, 4 studies fulfilled all the specified criteria. Four of them compared topical NSAID with placebo or vehicle. Pooled effect of topical NSAID measured at 4 weeks or beyond was superior to placebo/vehicle in pain relief (mean effect size -0.28, 95% CI -0.42 to -0.14). CONCLUSION: Topical NSAID are effective for pain relief in knee OA for a longer duration; however, this may not hold true for all the preparations.

Administration, Topical↗
PubMed1990

Ketoconazole in the treatment of blepharitis.

A double masked, placebo controlled clinical trial, of topical 2% ketoconazole cream with lid hygiene, for the treatment of seborrhoeic and mixed seborrhoeic/staphylococcal blepharitis was conducted. Forty patients with symptomatic blepharitis, 20 randomly allocated to ketoconazole, 20 to placebo were entered. Treatment efficacy was assessed by improvement of symptoms using visual analogue scales, appearance of the eyelids and reduction in numbers of pityrosporum yeasts on the eyelids. Both groups showed a similar reduction in symptoms, and signs of inflammation. The overall clinical impression in the ketoconazole group was better at week five than in the placebo group. Sixty nine per cent were either normal or markedly improved, as compared to 42% in the placebo group, although this was not statistically significant (p less than 0.1, one-sided Mann-Whitney). Pityrosporum numbers were reduced significantly in both groups during the treatment period. Ketoconazole was no better than placebo at improving the symptoms of blepharitis. More ketoconazole treated patients had normal or markedly improved lids after treatment than the placebo group. Pityrosporum yeasts may play a role in blepharitis, and treatment with an antifungal has some advantages over conventional therapy.

Adult↗
PubMed1990

Topical anaesthesia of the normal tympanic membrane: a controlled clinical trial of different suspensions of lidocaine.

The purpose of this investigation was to find an effective method for topical lidocaine anaesthesia of the tympanic membrane for minor therapeutical procedures. Twelve subjects with healthy ears were tested in a randomized double-blind crossover trial. Xylocaine (lidocaine) aerosol 10%, lidocaine 4%, and lidocaine hydrochloride 5% were tested against placebo. Xylocaine aerosol was sprayed into a small container, shaken, and tempered. This made the application painless. The eardrum was stimulated by a point of a needle effective 25 min after application (p = 0.008 and p less than 0.05, respectively). Lidocaine hydrochloride showed no effect. No side effects were observed. The effectiveness seems to be dependent on the ionization of the drug, since the two effective drugs lidocaine and Xylocaine are un-ionized, whereas the ineffective lidocaine hydrochloride is ionized.

Adult↗
PubMed1999

Calcium antagonists in the post-myocardial infarction setting.

At present, the use of calcium antagonists for the secondary prevention of cardiac events following an acute myocardial infarction (MI) is not recommended. This advice is based on several large mortality studies using short-acting calcium antagonists in the absence of coronary reperfusion therapy. Even in these studies, discrepancies between the different pharmacological classes of calcium antagonists were recognised. When separated from the dihydropyridine calcium antagonists, the rate-lowering calcium antagonists, verapamil and diltiazem, do appear to provide some benefit in reduction of recurrent MI. Three large trials using verapamil post-MI demonstrated a significant reduction in reinfarction with a favourable trend towards reducing death as well. Similarly, the effects of diltiazem post-MI have been evaluated in 3 large trials. In 2 earlier trials, diltiazem lessened cardiac events in patients with nonQ-wave infarctions and those without pulmonary congestion upon presentation. Overall, there was a significant benefit in lessening reinfarction with no effect on mortality. The recently completed Incomplete Infarction Trial of European Research Collaborators Evaluating Prognosis Post-Infarction (INTERCEPT) trial found that sustained-release diltiazem given after thrombolytic therapy for acute MI lessened cardiac events by 23% (a nonsignificant difference) without worsening congestive symptoms. Overall, there is adequate data to support the use of heart-rate-lowering calcium antagonists for secondary prevention post-MI provided the patient is intolerant of beta-blocker therapy. These trials are reviewed in detail, and suggestions for clinical practice are provided in this article.

Animals↗
PubMed2002

A summary of the findings from the Post-CABG trial.

The Post-CABG trial was designed to assess the effects of 2 different lipid lowering strategies and low dose warfarin vs placebo (2 x 2 factorial) design on the progression of atherosclerosis in saphenous vein grafts. Atherosclerotic progression was determined by comparing baseline and follow-up angiograms (mean interval: 4.3 years) using quantitative angiography. Significant progression of disease in SVG's was reduced with the aggressive lipid lowering strategy compared to the moderate strategy; significant progression in SVG's was not altered by low dose warfarin. The beneficial effects on angiographic changes were demonstrated in multiple subgroups of participants in the trial. The composite clinical end point of death, MI, stroke, PTCA or repeat CABG was analyzed at the end of the trial and 3 years (extended follow-up) after closure of the angiographic trial. At the time of the extended follow-up the aggressive lipid strategy was associated with reduced clinical events; low dose warfarin was also associated with reduced clinical events.

Coronary Artery Bypass↗
PubMed1992

[Clinical experience with long-term administration of "essential" phospholipids in chronic active hepatitis. Review of 3 double-blind studies].

The results from three double-blind studies, obtained after a 12-month treatment with Essentiale or placebo in patients (n = 85) with HBsAg positive or HBsAg negative chronic active hepatitis provide evidence of the clear improvement of the clinical and histological picture in the majority of the patients treated with Essentiale forte.

Double-Blind Method↗
PubMed1996

Combined androgen blockade.

Combined androgen blockade (CAB), the addition of an antiandrogen to castration (medical or surgical), is becoming a well-established option for advanced prostate cancer. CAB with leuprolide and flutamide was found to improve both progression-free and overall survival, compared with leuprolide alone, particularly in patients with minimal metastatic disease. These findings have led to an intergroup study in more than 1,300 men, including 300 with minimal disease, of orchidectomy with flutamide versus orchidectomy with placebo, which will examine which patient subgroups benefit most from CAB. This intergroup study has already provided important information regarding prostate-specific antigen as a surrogate marker for response and progression. The success with CAB in lengthening survival and improving quality of life in metastatic prostate cancer has stimulated enthusiasm for broadening the base of clinical studies for the management of this disease.

Androgen Antagonists↗