Clinical issues

Lawson, W. B. (1996). Clinical issues in the pharmacotherapy of African-Americans. Psychopharmacol. Bull, 32, 275-81. 

In general, the clinical presentation of the human diseases associated with the ingestion of marine seafood toxins is similar to that of any other food poisoning disease. However, a number of clinical issues make these diseases particularly difficult to diagnose and treat. For example, the neurotoxic syndromes associated with CFP, PSP, and NSP represent points along a continuum of disease severity rather than clinically exclusive diseases. Even if fish or other seafood is the suspected source of a disease outbreak, diarrhea associated with the outbreak could be misdiagnosed as originating from bacterial rather than from phycotoxin contamination. 

Biologicals and vaccines (including clinical issues for vaccines)... 

For patients with chronic CAD, nuclear imaging is essential for addressing the following major clinical issues (i) detection of ischemic myocardium, (ii) differentiation between viable hibernating or stunned myocardium and scar tissue in mechanically dysfunctional regions, and (ill) risk stratification for future major adverse events. Such information provides the basis for percutaneous coronary intervention (PCI) or coronary artery bypass (CAB) surgery and assessing their outcomes based on detection of residual ischemia and recovery of contractile function. 

Chester, K. Hawkins, R. (1995). Clinical issues in antibody design. Trends Biotechnol. 13, 294-300. 

The immune reconstitution inflammatory syndrome (IRIS) has emerged as an important clinical issue in the management of HIV-infected individuals on ART. IRIS is characterized by paradoxical worsening of symptoms and signs of inflammation in individual on ART (usually 2-6 months after ART initiation) related to the immunological gains of ART. 

CHMP (2006) Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance Non-CUnical and Clinical Issues ... 

With an estimated 3 million children and adolescents in the United States taking stimulants daily, the management of side effects is a significant clinical issue. Psychostimulant use is associated with several minor negative side effects in 10% to 15% of children treated that respond to adjustments in dose or in time of administration. Delay of sleep onset, reduced appetite, headache, and jitteriness are the most frequently cited stimulant-related side effects that have been identified in placebo-controlled trials Barkley et ah, 1990. No additional delay in sleep onset was seen after adding a third, mid-afternoon dose of MPH to standard bid dosing regimens (Kent et ah, 1995). Some children experience motor tics while on stimulants, but the mecha-... 

King, D.J. (1992) Benzodiazepines, amnesia and sedation theoretical and clinical issues and controversies. Hum Psychopharmacol 7 ... 

Kutcher, S. (2000) Practical clinical issues regarding child and adolescent psychopharmacology. Child Adolesc Clin North Am Psy-chopharmacol 9 245-260. 

Electroconvulsive therapy [ECT] is one of the oldest somatic treatments in psychiatry. The emergence of the field of psychopharmacology in the 1960s eclipsed advancement in ECT practice and research. To some extent, the pendulum has swung back in the past 15 years, as there has been intensive rediscovery of the basic science of ECT and an increase in its clinical use. Contemporary research has reexamined clinical issues, such as indications for treatment, response prediction, and relapse prevention, given the changing nature of psychiatric treatment and referral patterns. At the same time, more sophisticated approaches to treatment... 

Perhaps the most pressing clinical issue facing the field of ECT is the high rate of relapse following treatment. There has been very limited study of clinical or biological predictors of relapse (Nobler and Sackeim 1996). 

In one study [Mawson et al. 1982), the anti-OC effects of clomipramine were partially neutralized by instructing patients not to expose themselves to situations that would elicit OC symptoms. These antiexposure instructions contrast with the usual practice of advising patients to confront feared situations without performing compulsions. The impact of antiexposure instructions on outcome is more a theoretical than a clinical issue because most patients conduct self-exposure despite instructions to the contrary [Cottraux et al. 1989). 

Elphick M Clinical issues in the use of carbamazepine in psychiatry a review. Psychol Med 19 591-604, 1989a... 

Assessment of Drug Efficacy and Relevant Clinical Issues... 

Clinical issues and approaches should include the following ... 

Local legislation limits the availability and choice of opioids in many countries, but there can also be a reluctance to prescribe opioids for non-cancer pain due to the assumption that susceptible individuals may become addicted to these potent drugs through abuse. However, if opioids are prescribed on an individual basis with adequate support and education for the patients as well as their familes or carers, a great deal of unnecessary chronic pain and suffering can be prevented. But today there are still several unresolved clinical issues surrounding opioid use for which there is no data to construct a suitable policy. 

Schyve PM, Smithline F, Meltzer HY. Neuroleptic-induced prolactin level elevation and breast cancer an emerging clinical issue. Arch Gen Psychiatry 1978 35(11) 1291-301. 

Haddox, J. David. Legal and Clinical Issues In Prescribing Controlled Substance. 18 July 2002. . 

A number of other important research and clinical issues and questions have not been addressed for children and adolescents. How much napping occurs in school and out of bed What are the effects of sleep loss on metabolic processes, the immune system, and health outcomes in children and adolescents How do light exposure patterns affect sleep patterns and processes in children and adolescents How much and when do parents sleep and what role does a family s schedule of activities play in children s and adolescents sleep patterns What outcome measures have not been studied that are particularly important to parents and children What does sleep look like in underprivileged children and adolescents The list is long. 

Clinical Issues, Pharmacology, and Sleep Loss Effects... 

This series of monographs, Lung Biology in Health and Disease, includes a number of volumes on sleep, the first one having been published in 1984. Seven of these volumes have been exclusively about one or another aspect of sleep, and others, on different subjects, included components related to sleep. However, lack of sleep did not achieve stardom in this series until Dr. Clete Kushida from the world-famous Stanford Sleep Disorders Clinic and Research Center accepted the invitation to edit this volume on Sleep Deprivation Clinical Issues, Pharmacology, and Sleep Loss Effects. 

Committee for Proprietary Medicinal Products Guideline on Comparability of Medicinal Products Containing Biotech-nology-derived Proteins as Active Substance. Non-clinical and Clinical Issues. Evaluation of Medicines for Human Use, The European Agency for the Evaluation ofMedicinal Products, London (2003). 

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