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Candidate therapeutic see also Lammertse et al2 ; . A Phase 1 trial is specifically designed to evaluate the safety of the intervention and expose any adverse or toxic side effects, usually in small numbers of subjects with a simple open label design. Participant's who choose to take part in a Phase I trial may experience significant risks with a limited probability of receiving individual benefit. Preliminary Phase 2 proof of concept or evidence of activity ; data are sometimes collected during a Phase 1 trial, but only to develop a preliminary sense of potential efficacy and to assist in the identification of appropriate outcome measures to be used in subsequent properly powered Phase 2 or 3 trials. Many of the currently conceived therapeutics for the possible treatment of SCI involve an invasive intervention, such as the direct infusion of a drug or cellular transplant into, or around the injured spinal cord. As a consequence, healthy volunteers without SCI ; are unlikely to be recruited for a Phase 1 SCI clinical trial of this type. SCI is a heterogeneous disorder in terms of level of spinal injury, severity of injury and timing of treatments after injury. Some types of SCI eg central cord syndrome and cauda equina injuries ; have higher spontaneous rates of overall sensory and motor recovery. Thus, they may not be the best subjects to be included with other types of traumatic SCI during a Phase 1 or Phase 2 trial, as they could increase the variability of the outcome data. They may also be inappropriate, based on the proposed mechanism of action for the experimental intervention. Patients with complete ASIA A thoracic injuries are frequently suggested as being the `preferred' group of SCI participants for early phase SCI clinical trials. By confining the administration of the experimental therapeutic to the thoracic cord, it is probable that any adverse effects on spinal function would not seriously alter a person's functional capabilities ie not spread to more rostral cervical levels and compromise arm, hand or respiratory function ; . Complete ASIA A, thoracicinjured patients are a small proportion of total SCI cases, and there are, as yet, no validated outcome measures for changes in thoracic cord motor function although some are under development, see below ; . Sensory function can be evaluated using the ASIA examination or other measures. General Phase 1 trial safety outcome measures include: ongoing assessment of standard vital signs, physical examination data eg temperature, respiration, heart rate, and blood pressure ; , clinical laboratory tests eg hematology and urine analysis ; , as well as the appearance of any systemic adverse event observed or reported by a trial subject ; . Depending on the therapeutic drug or cell line being evaluated and the route of administration, other Phase 1 safety outcome measures may include the evaluation of unintended effects on the CNS or other body tissues, including infection, inflammation, or immune reactions. A more specific measure of neurological state is the ASIA assessment3 to determine whether there is any change in neurological level or any sensorimotor.
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Maureen Habel, RN, MA, a certified rehabilitation registered nurse, has been a director of nursing staff development and director of clinical nursing services and has taught health care management and leadership courses. She is an award-winning nursing writer in Long Beach, Calif. The author has declared no real or perceived conflicts of interest that relate to this educational activity. Buds Pricha Dhanmanonda. Patterns of bud development on imperata cylindrica rhizomes at Doi Pui. Bangkok : Kasetsart University, 1973. v, 39 p. R E4820 ; Buffaloes Apinun Suprasert. Histological and glycoconjugates histochemical studies on skin glands of the buffaloes glycoconjugates . Bangkok : Faculty of Veterinary Medicine, Kasetsart University, [1999]. 21 p. R E13211 ; Boonyern Sarikabhuti. Comparative study of the ATP level of swamp buffalo and cow red cells. Bangkok : Kasetsart University, 1987. vol. R E8650 ; Chollada Buranakarl. The Studies of renal function in relation to metabolic rate in the acute heat stressed swamp buffalo . Bangkok : Chulalongkorn University, 1987. 2 microfiches 108 fr. ; . T MF20482 ; Granum, Gina Margit. A comparative study on the effect of cassava hay supplementation in swamp buffaloes Bubalus bubalis ; and cattle Bos indicus ; . Khon Kaen : Khon Kaen University, 2003. 85 p. T E20675 ; Narongsak Chaiyabutr. Renal function studies in normal and heat stressed swamp buffalo. Bangkok : Chulalongkorn University, 1982. vii, 38 p. R E1266 ; Narongsak Chaiyabutr. Urea excretion in normal and heat stressed swamp buffalo . Bangkok : Chulalongkorn University, 1984. iv, 18 leaves. R E2441c.1; E2442c.2 ; Piboon Yutisri. Studies on strongyloidiasis of swamp buffaloes in Thailand. Japan : Azabu University, 1992. 52 p. T E6228 ; Buffaloes--Anatomy M. Liumsiricharoen. Anatomical study of corrosion cast kidney in swamp buffalo. Bangkok : Kasetsart University, [1997]. 17 p. R E11180 ; Buffaloes--Physiology Kalaya Youngsukying. Effects of heat stress on the renal electrolyte excretion related to body fluid of the swamp buffaloes. Bangkok : Chulalongkorn University, 1986. 2 microfiches 81 fr. ; . T MF20558 ; Buffaloes--Reproduction Rapee Boonplueang. Purification and property of swamp buffalo pituitary luteinizing hormone. Bangkok : Mahidol University, 1996. 85 p. T E10098 ; Buffer Varakorn Kasemsuwan. DC model of MOS transistor taking into account short channel effect emphasizing on the velocity overshoot and its application to the CMOS inverter delay model. Bangkok : Faculty of Engineering King Mongkut's Institute of Technology Ladkrabang, 2003. 64 p. R E20889 ; 25122 and fluticasone.
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Pregnant mothers are advised not to take any drugs or naturopathic remedies without first consulting with their physician. However, researchers are working to test many different drugs, including over-the-counter medications, prescribed drugs and naturopathic options. Access to research results gives doctors knowledge of the relative risks and benefits of any drug therapy, and studies have shown that many drugs are safe for use in pregnancy.25 The benefit of research into drugs and pregnancy is that health professionals can gain confidence in prescribing certain drugs when the benefits to the mother outweigh any unproven risks. Excellent information on this topic can be found at motherisk , a Canadian site and albenza. Symposium Perinatal Medicine. Flamish Society of Obstetrics and Gynecology, Knokke, Belgium Meeting European Association of Gynaecologists and Obstetricians, London, Great Britain Fortbildungstagung fr Fachrzte der Gynkologie und Geburtshilfe, Obergurgl, Austria V Barmbeker Gesprch : Geburtshilfe heute, Hamburg, D.D.R. Indonesian Society of Obstetrics and Gynecology, Semarang, Indonesia Congress "Childbirth the fetus in our hands", Toronto, Canada The third International Symposium : "The fetus as a Patient", Matsue, Japan XI European Congress of Perinatal Medicine, Rome, Italy XII World Congress of Gynecology and Obstetrics, Rio de Janeiro, Brasil XXVes Journes de Baudelocque : Buts et moyens de l'Osttrique moderne, Paris, France Postgraduate Course Continuous, pulsed and color Doppler in Obstetrics. Societa Italiana di Ginecologi e Ostetrica, Rome, Italy Opponent University of Iceland, Reykjavik. Ph.D. Thesis A. Dagbjartsson Advances in fetal surveillance. Workshop 200th anniversary of academic obstetrics in Bonn. University of Bonn Meeting European Committee "Doppler technology in Perinatal Medicine", Barcelona EEC Symposium "New methods for perinatal surveillance", Haarlem Schering Symposium "Kunstverlossingen", Berlijn Symposium Gynaecologische Chirurgie COBRA, Noordwijk John Patrick Memorial Symposium, London Ontario, Canada Symposium Foetale Bewaking, Utrecht 9.
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