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Results for “Controlled Clinical Trials as Topic”

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At least 91 records · Page 5Linked to original sources
PubMed1996

Growth hormone and fertility--clinical studies.

The linkage between the reproductive and somatotropic axes and the existence of a complex regulating system within the ovary involving growth factors and their binding proteins suggest that the ovary may be a target of growth hormone (GH) action. Clinical studies investigating possible applications of adjuvant GH treatment in ovulation induction and in vitro fertilization, mainly directed at poor responders to gonadotropin therapy, have shown that results are dependent on the hormonal status and 'ovarian age' of the subject. Additive GH is capable of increasing the sensitivity of ovaries to gonadotropins in those with a blatant or subtile lack of GH but not in those with a normal, saturated system. Improved pregnancy rates have not been convincingly forthcoming and more research is needed on the effect of GH and growth factors on the oocyte and endometrium. Disturbed GH kinetics in the polycystic ovary syndrome have prompted investigations of possible involvement of GH in the pathophysiology of this syndrome.

Anovulation↗
PubMed1999

The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force.

Clinical outcome assessment in Multiple Sclerosis (MS) is challenging due to the diversity and fluctuating nature of MS symptoms. Traditional clinical scales such as the EDSS are inadequate in their assessment of key clinical dimensions of MS (e.g. , cognitive function), and they have psychometric limitations as well. Based on analyses of pooled data from natural history studies and from placebo groups in clinical trials, the National MS Society's Clinical Outcomes Assessment Task Force recently proposed a new multidimensional clinical outcome measure, the MS Functional Composite (MSFC). The MSFC comprises quantitative functional measures of three key clinical dimensions of MS: leg function/ambulation, arm/hand function, and cognitive function. Scores on component measures are converted to standard scores (z-scores), which are averaged to form a single MSFC score. Preliminary analyses confirm that: (1) the three clinical dimensions of the MSFC are relatively independent; (2) the MSFC is sensitive to clinical changes over 1- and 2-year intervals; and (3) the MSFC has acceptable criterion validity (i.e., predicts both concurrent and subsequent EDSS change). The advantages and potential limitations of incorporating quantitative functional outcome measures such as the MSFC into collaborative databases are discussed.

Clinical Trials as Topic↗
PubMed2002

Outcomes studies of the gastrointestinal safety of cyclooxygenase-2 inhibitors.

Short-term endoscopic studies of the highly selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) rofecoxib and celecoxib have shown that these agents are well tolerated and have efficacy equivalent to nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) with fewer adverse effects on the upper gastrointestinal (GI) tract. These studies are limited, however, as the detection of endoscopic lesions is not well correlated with symptomatic ulcers and ulcer complications. Outcomes studies of the GI safety are, therefore, essential to understanding how coxibs are likely to perform in a clinical practice setting. Four large outcomes studies (Vioxx Gastrointestinal Outcomes Research, VIGOR; Assessment of Difference Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness trial, ADVANTAGE; Celecoxib Long-term Arthritis Safety Study, CLASS; and the Successive Celecoxib Efficacy and Safety Studies, SUCCESS) examined the GI safety of rofecoxib and celecoxib in over 39,000 patients with osteoarthritis or rheumatoid arthritis. Results of these studies showed that patients taking a supratherapeutic dose of rofecoxib or celecoxib had significantly lower rates of GI-related adverse events than those taking a nonselective NSAID (naproxen, ibuprofen, or diclofenac). Reduced risk of upper GI events was seen in patients with multiple risk factors and in patients using low-dose aspirin and corticosteroids concomitantly with a coxib. Results of large outcomes studies provide support for the COX-2 hypothesis and demonstrate the long-term safety and tolerability of coxibs.

Arthritis↗
PubMed1998

Mild to moderate hyperhomocysteinaemia in cardiovascular disease.

Elevated serum levels of homocysteine, a sulphur-containing amino acid, are increasingly recognized as an independent risk factor for atherosclerotic and thrombotic vascular disease. Presence of a thermolabile variant of methylenetetrahydrofolatereductase and an inadequate folate status are the most common causes of hyperhomocysteinaemia. Homocysteine damages the vessel wall mainly through generation of oxygen radicals and creates a prothrombotic environment. In the majority of cases, normalization of homocysteine levels can be achieved with administration of vitamins of the B-group. The effect of this treatment on cardiovascular outcome, however, remains undefined.

Arteriosclerosis↗
PubMed2000

[Radiotherapy and chemotherapy in the treatment of cancer of the rectum].

The North American consensus conference held in 1990 concluded that the best currently available adjuvant treatment for cancer of the rectum (T3, N1 to N3) was postoperative combination radiotherapy and chemotherapy. In 1994, the consensus conference held in Paris concluded that the benefit observed after preoperative irradiation warranted assessment of the effect of preoperative radiochemotherapy. To decide between these two consensus conclusions, it would be most logical to compare preoperative radiotherapy with postoperative radiochemotherapy in a group of patients with similar echo-endoscopic or imaging findings.

Antimetabolites, Antineoplastic↗
PubMed2001

Do some antidepressants work faster than others?

The clinical utility of antidepressant drugs is impaired by the delay in onset of their therapeutic action. It is becoming increasingly clear that differences exist between antidepressants with respect to this property, both within and between pharmacologic classes. Post hoc analyses of comparisons between selective serotonin reuptake inhibitors and dual-action antidepressants such as mirtazapine and venlafaxine indicate that the dual-action drugs may have a faster onset of action. At least in the case of mirtazapine, the earlier onset appears to be via a specific antidepressant effect and not an effect on sleep or other accessory symptoms. Studies that compare mirtazapine and venlafaxine are relatively rare and lack sufficient statistical power to determine a difference in the onset of action. Although these differences have been shown in clinical efficacy studies not specifically designed to detect differences in onset of action, a definitive demonstration of early onset of action awaits the results of appropriately designed and powered clinical studies currently planned or in progress.

Antidepressive Agents↗
PubMed2001

[Physical activity and health--recommendations].

BACKGROUND: The health consequences of physical inactivity and the health gains of regular physical activity are briefly summarized. We present physical activity recommendations based on a review of the literature for the general adult population. METHODS: This report employs recognised international standards for establishing causal relationships between physical activity and disease, distinguishing between four different levels: Convincing, probable, possible and insufficient evidence. Convincing or probable evidence have provided the basis for the recommendations given. RESULTS: The total amount of physical activity (a combination of intensity, duration and frequency) is related to a number of health variables in a dose-response relationship. The preventive effect (the health gain) increases with increasing activity level, but the relationship is not linear. The greatest health gains are attained by those who are least physically fit. This applies even in old age. The health gain seems primarily to be dependent on the total energy expenditure, and less on the intensity. The dose-response relationship between physical activity levels and health gains is a continuum that does not seem to have a lower limit. Thus, any activity can be said to be better than none. INTERPRETATION: We conclude that a minimum "target dose" that will yield substantial health gains for those who have been physically inactive for a long time, is activity of moderate intensity which corresponds to an energy expenditure of approximately 150 kcal (630 kJ) per day (or slightly more than 1,000 kcal (4.2 MJ) per week). This is equivalent to a daily walk of about 30 minutes. The activity can be divided into shorter intervals of physical activity during the course of the day, for instance intervals lasting 5-10 minutes. An increase in activity beyond this level will yield further health gains. The effect of exercise is just as good for older people as for younger people, and the same recommendations apply as to other adults.

Adult↗