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Phase II clinical trials are performed to investigate whether a novel treatment shows sufficient promise of efficacy to justify its evaluation in a subsequent definitive phase III trial, and they are often also used to select the dose to take forward. In this paper we discuss different design proposals for a phase II trial in which three active treatment doses and a placebo control are to be compared in terms of a single‐ordered categorical endpoint. The sample size requirements for one‐stage and two‐stage designs are derived, based on an approach similar to that of Dunnett. Detailed computations are prepared for an illustrative example concerning a study in stroke. Allowance for early stopping for futility is made. Simulations are used to verify that the specified type I error and power requirements are valid, despite certain approximations used in the derivation of sample size. The advantages and disadvantages of the different designs are discussed, and the scope for extending the approach to different forms of endpoint is considered. Copyright © 2008 John Wiley & Sons, Ltd. 相似文献
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Michael L. Graham Jonathan J. Shuster Barton A. Kamen David L. Cheo Matthew P. Harrison Brigid G. Leventhal D. Jeanette Pullen V. Michael Whitehead 《Cancer chemotherapy and pharmacology》1992,31(3):217-222
Summary We enrolled children with acute lymphoblastic leukemia (ALL) in a Pediatric Oncology Group (POG) pilot study to monitor erythrocyte (RBC) methotrexate (MTX) and folate (F) levels before and during treatment. The mean value for RBCF at diagnosis was 0.86±0.46 nmol/ml RBC in the 214 patients who achieved remission and 1.21±0.74 nmol/ml RBC in the 10 patients who did not (P=0.020). Folate levels tended to increase during remission induction, but they dropped following an intensive consolidation with methotrexate to levels that were sustained throughout chemotherapy treatment. Methotrexate levels reached mean values of approximately 0.15 nmol/ml RBC at the end of an intensive methotrexate consolidation, then fell to levels that were sustained throughout maintenance therapy. There was a weak correlation between improved event-free survival and higher RBCMTX levels after consolidation, but no correlation was found between improved survival and the level of RBCMTX or RBCF during maintenance therapy. A larger study with more complete data is needed to determine whether RBCMTX or RBCF might be useful in predicting event-free survival in patients with ALL.This work was supported in part by grants from the National Cancer Institute and the National Institute of Health (CA-30969, CA-28476, CA29139, CA-159-89, and CA-33587) 相似文献
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Smoking in Pregnancy and Parenthood: What is the Role of Depression, Anxiety and Nicotine Addiction?
Leona Bull Ronan Burke Siobhan Walsh Emma Whitehead 《Early child development and care》2003,173(2):349-356
This paper presents some of the findings from the Smoking in Pregnancy study of attitudes towards smoking among pregnant women, mothers of young children and their partners in East Surrey. As part of the study, respondents completed a General Health Questionnaire to identify mental health difficulties and, if they were smoking at the time of the study, they also completed the Fagerstrom nicotine addiction test. Eleven female respondents had high scores on the General Health Questionnaire, suggesting symptoms of depression, anxiety and/or social dysfunction for these women. There was no evidence that smokers were suffering from greater mental health difficulties than ex-smokers or non-smokers. However, the General Health Questionnaire scores of smokers were positively associated with their level of nicotine dependence. Furthermore, when General Health Questionnaire scores of all respondents were compared with self-reported health status there was a marked discrepancy suggesting under-reporting of symptoms by women. 相似文献
7.
A. A. Paul A. E. Black J. Evans T. J. Cole R. G. Whitehead 《Journal of human nutrition and dietetics》1988,1(6):437-450
Longitudinal measurements of breastmilk intake in 48 Cambridge infants showed that intake reached a peak of 824 g/24 h in boys and 741 g/24 h in girls in the third and fourth months, respectively. Regression analysis demonstrated that, in the early months, the infants' weight accounted for a major part of the variance in breastmilk intake. Infants in non-manual social classes received more breastmilk and started solids later than those in manual groups. In the early months weight gain showed a relative increase compared to growth standards, but later infancy was characterized by a progressive deceleration in weight and length gain. Adiposity, as measured by triceps skinfold thickness differed most markedly from growth charts and was only equivalent to the tenth standard centile at all ages. The lower skinfold thickness measurements are considered to be more appropriate to breastfed infants in general. 相似文献
8.
Kaufmann SJ; Sharif K; Sharma V; McVerry BA 《Human reproduction (Oxford, England)》1998,13(2):498-499
The patient was diagnosed in childhood as having severe congenital
neutropenia and had recurrent admissions with severe infections. In 1987,
prior to getting married, she was sterilized. She continued to require i.v.
antibiotics when she contracted a severe infection. On one occasion, she
was treated with growth colony stimulating factor (G- CSF). Her increased
neutrophil count was sustained following this treatment. In June 1993, she
wished to start a family and underwent in- vitro fertilization (IVF)
treatment. G-CSF was given prior to oocyte retrieval. She conceived on her
first cycle and an ultrasound scan revealed a singleton pregnancy.
Throughout the course of the pregnancy, her white cell count was monitored
closely and remained at <1.0x10(9)/l. The pregnancy progressed
uneventfully and at 37 weeks gestation she was admitted for G-CSF
injections. At 38 weeks she was delivered of a boy weighing 3350 g, by
elective Caesarean section. His white cell count was normal. This is the
first case of G-CSF being used before conception and during pregnancy in a
patient with congenital neutropenia. It shows that advances in cytokine
therapy and close interdisciplinary liaison can lead to a successful
outcome and help patients, who would otherwise remain childless, to achieve
a family.
相似文献
9.
C Whitehead BA L D Sanders PhD M Rosen CBE FCAnaes J O Robinson PhD 《International journal of clinical practice》1991,45(4):263-264
SUMMARY In order to assess the reliability of drug information supplied by day-stay cases, 85 consecutive patients were interviewed. A comparison of the interview answers with the details previously volunteered during the admission procedure showed an increase of 80% in the information given by the patient. While the detailed interviewing technique is time-consuming and may not be infallible, this substantial increase in information highlights problems in the current routine. 相似文献
10.
Silber SJ; Nagy Z; Devroey P; Tournaye H; Van Steirteghem AC 《Human reproduction (Oxford, England)》1997,12(11):2422-2428
The aim of the study was to determine whether a prior diagnostic testicle
biopsy can predict success or failure of testicular sperm extraction (TESE)
with intracytoplasmic sperm injection (ICSI) in patients with
non-obstructive azoospermia caused by testicular failure, and what is the
minimum threshold of sperm production in the testis which must be surpassed
for spermatozoa to reach the ejaculate. Forty- five patients with
non-obstructive azoospermia caused by testicular failure underwent
diagnostic testicle biopsy prior to a planned future TESE-ICSI procedure.
The diagnostic testicle biopsy was analysed quantitatively, and correlated
with the quantitative findings of spermatogenesis in patients with normal
spermatogenesis, as well as with the results of subsequent attempts at
TESE-ICSI. Men with non- obstructive azoospermia caused by germinal failure
had a mean of 0-6 mature spermatids/seminiferous tubule seen on a
diagnostic testicle biopsy, compared to 17-35 mature spermatids/tubule in
men with normal spermatogenesis and obstructive azoospermia. These findings
were the same for all types of testicular failure whether Sertoli cell
only, maturation arrest, cryptorchidism, or post-chemotherapy azoospermia.
Twenty-two of 26 men with mature spermatids found in the prior testis
biopsy had successful retrieval of spermatozoa for ICSI, 12 of their
partners became pregnant, and are either ongoing or delivered. The study
suggests that 4-6 mature spermatids/tubule must be present in the testis
biopsy for any spermatozoa to reach the ejaculate. More than half of
azoospermic patients with germinal failure have minute foci of
spermatogenesis which are insufficient to produce spermatozoa in the
ejaculate. Prior diagnostic testicle biopsy analysed quantitatively (for
the presence of mature spermatids) can predict subsequent success or
failure with TESE-ICSI. Incomplete testicular failure may involve a sparse
multi-focal distribution of spermatogenesis throughout the entire testicle,
rather than a regional distribution. Therefore, it is possible that massive
testicular sampling from many different regions of the testes may not be
necessary for successful TESE-ICSI.
相似文献