Twelve month studies

Twelve month studies may be more appropriate for chronically used drugs to be approved on the basis of short-term clinical trials employing efficacy surrogate markers where safety data from humans are limited to short-term exposure, such as some acquired immunodeficiency (AIDS) therapies. 

Twelve months studies may be more appropriate for new molecular entities acting at new molecular targets... 

Woody GE, Luborsky L, McLellan AT, et al Psychotherapy for opiate addicts does it help Arch Gen Psychiatry 40 639—645, 1983 Woody GE, McLellan AT, Luborsky L, et al Severity of psychiatric symptoms as a predictor of benefits from psychotherapy the Veterans Administration-Penn study. Am J Psychiatry 141 1172—1177, 1984 Woody GE, McLellan AT, Luborsky L, et al Twelve-month follow-up of psychotherapy for opiate dependence. Am J Psychiatry 144 590-596, 1987 Yabaluri N, Medzihradsky F Down-regulation of mu-opioid receptor by full but not partial agonists is independent of G protein coupling. Mol Pharmacol 52 896-902, 1997... 

Tttlane Medican. 1982b. Twelve month progress report on the studies of toluene diisocyanate irrduced pulmonary diseases. EPA/OTS Doc 86-870000688... 

The CLASS study published in fAMA in 2000 appeared to confirm the gastrointestinal protective effects of celecoxib (Celebrex ) over traditional NSAIDs after six months of treatment (Silverstein et al. 2000). However, material on the website of the FDA revealed a number of discrepancies between the data as published in fAMA and those submitted to the FDA. The published trial actually combined the results of two trials, one that continued for twelve months and the second which ran for 16 months. At 12-16 months there was no difference in gastrointestinal adverse effects between the celecoxib and traditional NSAID groups (Hrachovec and Mora 2001 Wright et al. 2001). 

Carbohydrate metabolic studies during twelve months of... 

The major findings of this study showed that patients treated with oral prednisone had a significant lower major adverse cardiac and cerebrovascular event (MACCE) (P = 0.0063), any target vessel revascularization (P = 0.001), and binary restenosis (P = 0.001) than those allocated in the placebo group. Twelve-month event-free survival rates were 93% and 65% in patients treated with prednisone and placebo, respectively (relative risk 0.18, 95% confidence intervals 0.05-0.61),... 

Recently there have been extensive studies on the structure and property of water. In December, 2004, upon assessing the major achievements of the past twelve months, Science declared that the study of water as one of the Breakthroughs of the Year. (Specifically, it was listed as No. 8.)... 

Four weekly versus daily (or event) sampling studies using the same type of samplers as in the present study have been reported. A Florida study (1) used three samplers monitoring on a daily, weekly and biweekly schedule for twelve months. All analyses were performed at the University of Central Florida within ten days of collection. 

Hesterberg TW, Axten C, McConnell EE, et al. 1997. Chronic inhalation study of fiberglass and amosite asbestos in hamsters Twelve-month preliminary results. Environ Health Perspect Suppl 105 1223-1229. 

Myllyla VV, Kultalahti ER, Haapaniemi H, Leinonen M FILOMEN Study Group. Twelve-month safety of entacapone in patients with Parkinson s disease. Eur J Neurol 2001 8(l) 53-60. 

Ramamoorthy R, Saraswathi TP, Kanaka TS. Carbohydrate metabolic studies during twelve months of treatment with a low-dose combination oral contraceptive. Contraception 1989 40(5) 563-9. 

Antidepressants generally produce effects within two to three weeks. Once therapeutic benefit has been obtained, it is important that the patient continue the medication for at least six months. Discontinuing in less than six months is likely to lead to relapse. In treating a patient s first depression, it is reasonable to gradually discontinue the medication after six to twelve months. If the patient has had two or more depressions, it is probably best to continue the medication because the likelihood of recurrence is significant (70 to 80 percent or more). Recent studies have also shown that subsequent depressive episodes may be less responsive to treatment. Therefore, in such cases the best treatment is to prevent relapse by continuation of medication. 

The primary effect of adding polymer to the aqueous solution Is that phase separation occurs In the salinity range of 0.8 to 2.0 gm/dl where a liquid crystalline phase exists in the polymer-free system. Phase separation does not occur immediately and may be very slow depending on the composition. Thus, a rather long time is required by the polymer-containing systems to come to equilibrium. The results of this study were obtained after more than twelve months of equilibration. Preliminary observations were reported earlier (30). 

D Amico DJ, Goldberg MF, Hudson H, et al. Anecortave Acetate Clinical Study Group. Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration twelve-month clinical outcomes. Ophthalmology 2003 110 2372-2383 Discussion 2384-2385. 

In previous years studies on the photoablation of polymers for etching purposes have been few. Over the last twelve months however, this area of work has expanded enormously and may be an indication of its commercial fruition. A dynamic model has been proposed for the laser ablation of polymer systems which implicates the successive absorption of two or more photons causing population to higher electronic excited states . In this work the excitation time of laser pulses was stepped and indicated that short-lived radicals play an important role in ablation. The wavelength of the... 

Twelve months after the last patient has had surgery, the study will be unblinded. The total duration of follow-up, however, is 24 months. Four more 2-day visits must be completed in the second year to ensure appropriate duration of safety assessments. 

A twelve-month selenium-supplementation trial in children with KBD in Tibet did not show any effect on the main symptoms and signs of the disease (Moreno-Reyes et al., 2003). But, in the same study, correction of iodine deficiency before the administration of selenium supplements induced partial recovery of growth retardation. Selenium had no additional effect on either growth or thyroid function, despite the normalization of serum-selenium levels. 

Studies on the diterpenoid alkaloids published during the past twelve months have provided much new structural and synthetic information on these complex plant bases. Twenty diterpenoid bases that are new or previously undetected in plant material have been reported from Aconitum and Delphinium species, and from Consolida ambigua and Garrya ovata. An extensive review of diterpenoid alkaloid chemistry has been published. ... 

Contamination of standard pH 2 nitric acid solution stored in soft glass (Kimble), boroslllcate glass (Pyrex, 774) and polethylene (Plax) containers for twelve months has been Investigated by Thiers (t6). The results of this study are shown in Table XXII. The polyethylene container was found to be the only one of the three that did not Introduce lead (as well as... 

Larsen M, Schmidt-Erfurth U, Lanzetta P, Wolf S, Simader C, Tokaji E, MONT BLANC Study Group, et al. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration twelve-month MONT BLANC study results. Ophthalmology May 2012 119(5) 992-1000. http //dx.doi.Org/10.1016/j.ophtha.2012.02.002. Epub 2012 March 17. PubMed PMID 22424834. 

Textile samples contained in one pot were exhumed on the first day of each month during the twelve month period of the study Fibers from each textile sample were permanently mounted on microscope slides for compara-... 

Verteporfin in Photodynamic Study Group, Verteporfin therapy of subfoveal choroidal neovascularization in pathologic myopia. Twelve month results of a randomized trial. Ophthalmology, 108, 841, 2001. 

There was also another reason for my decision. For too long, I had deferred taking the Specially Board Certification Exam in Psychiatry. Normally, this is something that clinicians try to get out of the way as soon as they become eligible - usually two years after completion of residency training. For almost twelve years, I had only occasionally done any clinical psychiatry. Without practicing a specialty, much of what one learns during residency rapidly fades away. I knew it would take several months of intense study to prepare for the written exam in May. 

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