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At least 145 records · Page 8Linked to original sources
PubMed1993

Cisplatin and radiotherapy in the management of locally advanced head and neck cancer.

PURPOSE: This manuscript traces the results of combined modality head and neck cancer trials, with reference to survival and rates of local-regional control and distant metastases, that have led to current Phase III trials testing concomitant cisplatin and radiotherapy. METHODS AND MATERIALS: The toxicity, local control rates, and survival results of pilot trials and small randomized trials using concomitant cisplatin based chemotherapy and radiotherapy are reviewed. RESULTS: Enhanced mucosal toxicity and myelosuppression occur which affect patient compliance and tolerance of planned chemotherapy, but do not appear to affect delivery of standard fractionation radiotherapy. The encouraging results of single agent cisplatin and radiotherapy trials and those using cisplatin-5-FU and split course radiotherapy have led to the activation of three randomized Head and Neck Intergroup trials. These trials are for Stage III & IV carcinoma of the nasopharynx, Stage III & IV resectable carcinoma of the larynx (organ preservation) and Stage III & IV unresectable carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx. CONCLUSION: The three Intergroup study designs should allow for a definitive evaluation of concomitant treatment.

Cisplatin↗
PubMed2002

Double placebo design in a prevention trial for Alzheimer's disease.

The Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) is designed to compare two nonsteroidal anti-inflammatory agents against placebo. A placebo control for two active treatments can be achieved in several ways, each of which may have different implications for the logistics of drug supply, enrollment, adherence to treatment, and the validity of specific treatment comparisons. The authors outline the placebo designs considered in ADAPT, discuss their advantages and disadvantages, and provide their rationale for and the consequences of the selection of the double placebo design.

Aged↗
PubMed1989

Advanced cryptogenic fibrosing alveolitis: preliminary report on treatment with cyclosporin A.

Seven patients with fibrosing alveolitis who failed to respond to prednisolone and cyclophosphamide and were deteriorating, were treated with cyclosporin A. An initial favourable response was seen but was not maintained. When compared to a control population, matched for the extremely severe disease present in the treated group, survival was doubled from 2.5 to 5 months. With growing awareness of the possibility of heart-lung transplantation in this disease, even this trivial increase in survival may be of crucial importance in individual patients.

Cyclosporins↗
PubMed2000

Fatty acid composition of serum cholesterol esters as a reflector of low-saturated-fat, low-cholesterol diet in young children: the STRIP project. The Special Turku coronary Risk factor Intervention Project.

STRIP (the Special Turku coronary Risk factor Intervention Project) is an ongoing intervention trial which aims at a permanent reduction in the intake of saturated fat and cholesterol starting in childhood. A total of 75 intervention and 63 control children was studied consecutively at the ages of 7 and 13 mo, and 2, 3 and 5 y to evaluate the influence of such intervention on serum cholesterol ester (CE) fatty acid composition, a widely used biomarker of fatty acid intake. Analysis of 4-d food records showed that total intake of fat and of saturated fat increased with age in both groups of children but was constantly lower in intervention than in control children, e.g. at the age of 5 y the mean intakes of total fat and of saturated fatty acids were 31.1 E% and 33.9 E% and 12.1 E% and 14.6 E% in intervention and control children, respectively (p = 0.009 and 0.0001, respectively). Serum CE fatty acid compositions did not differ between the 2 groups at any age; the mean proportion of CE linoleic acid was 52.4% and 52.0% in 5-y-old intervention and control children, respectively. Correlation analysis showed, however, that the percentage of linoleic acid and of polyunsaturated fatty acids in CE reflected well the respective dietary intakes (r = 0.36; p = 0.0001 for both coefficients). In conclusion, CE fatty acid composition did not differ between the intervention and control groups, whereas CE linoleic and total polyunsaturated fatty acids reflected well the differences in their intakes at the individual level.

Child, Preschool↗
PubMed1992

Management of the non-descended testis: doubtful value of luteinizing-hormone-releasing-hormone (LHRH). A double-blind, placebo-controlled multicentre study.

In a double-blind, placebo-controlled multicentre study, the effect of luteinizing-hormone-releasing-hormone (LHRH) in 141 boys was analysed after 4-week treatment period with 0.4 mg LHRH nasal spray or placebo nasal spray three times daily. Data from 123 boys was analysed, with 62 boys in the treatment group and 61 in the placebo group. Full response i.e. the testis at the bottom of the scrotum on both sides in boys with bilaterally undescended testes, was found in six patients, one of them in the placebo group [Therapeutic gain of LHRH with 95% CI: 8.1% (0.1-16.6%, P = 0.12)]. Only in these boys could surgery be avoided. Considering the number of testes (and not the number of boys) a significant effect was found on at least one testis in 25% of boys with bilaterally undescended testes [Therapeutic gain with 95% CI: 24.0% (13.2-34.8%, P = 0.001)]. In unilateral undescended testes, the LHRH treatment showed no effect (P = 1.00). The inclusion of retractile testes did not affect our results. In our opinion LHRH has a limited place in treatment of the non-descended testis.

Administration, Inhalation↗
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↗
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↗
PubMed1996

Fluvastatin in combination with other lipid-lowering agents.

Fluvastatin, a new synthetic inhibitor of HMGCoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, has been studied in several models to examine its effects when used in combination with other lipid-modifying agents such as derivatives of fibric acid (bezafibrate), resins (cholestyramine), and niacin. The combination of fluvastatin with bezafibrate has been studied in a double-blind trial involving patients with well-documented familial hypercholesterolaemia. Fluvastatin 40 mg/day, combined with either bezafibrate 400 mg/day or cholestyramine 8 g/day, resulted in reductions in levels of low-density lipoprotein cholesterol (LDL-C), these being indistinguishable between the groups; however, significantly greater increases in levels of high-density lipoprotein cholesterol (21.3%) and reductions in levels of triglycerides (25.1%) were seen with the fluvastatin-bezafibrate combination. No notable increases were seen in levels of serum creatine kinase, aspartate aminotransferase, or alanine aminotransferase, and no cases of myopathy were observed. In a study model that examined low-dose combinations of fluvastatin with cholestyramine, reductions in levels of LDL-C of 15.8% and 19.3% were seen with fluvastatin 10 mg and 20 mg, respectively. After an 8-week interval in which a daily dosage of cholestyramine 8 g was added, from baseline, reductions of 26.3% in the 10 mg fluvastatin-cholestyramine group and 31.2% in the 20 mg fluvastatin-cholestyramine group were observed, whereas the placebo-cholestyramine group displayed a reduction of 14.9%. Doubling the resin dosage to 16 g/day for the final 8 weeks of the study provided little additional benefit. Myotoxicity has been observed when lovastatin is coadministered with niacin, and so the combination of niacin with fluvastatin has also been studied to examine the possibility of this effect occurring. Patients were randomised to either fluvastatin 20 mg or placebo for 6 weeks, after which time open-label niacin was administered to all patients and titrated to a final dosage of 3 g/day. After 6 weeks, fluvastatin produced a 20.8% reduction in LDL-C levels from baseline. When combined with niacin, a 43.7% reduction was noted at the week 15 endpoint, against the 26.5% reduction seen with niacin monotherapy. The combination was well tolerated, with no reports of myopathy or of significant elevations in creatine kinase or liver transaminase levels. Combinations of fluvastatin with a variety of other agents have been shown to have significant effects on lipid profiles, with no evidence to date of clinically remarkable safety findings. Thus, the use of combination therapies may result in optimal management of patients with moderately severe hypercholesterolaemia and mixed dyslipidaemic profiles.

Anticholesteremic Agents↗