[Drugs and teratogen monitoring. Experience in the Rhone-Alpes-Auvergne regions].
Explore the source record for details and available documents.
Abnormalities, Drug-Induced↗
Biomedical subjects
E Robert
Publications and source records attributed to E Robert.
[Bioethics and drug experimentation in hospitalized patients].
The authors discuss about clinical experimentation with drugs involving hospitalized subjects in consideration of four principles of Bioethics: Autonomy, Beneficence, Non Maleficence and Justice. This article explores also the problems linked to the application of good clinical practice according to the European and Italian recent rules. Human integrity, respect of patient's dignity, informed consent, correct methods, placebo, Ethics committees represent the essential basis for those researchers that intend conduct clinical trials really "with subject and not on the subject".
Clinical Trials as Topic↗
The epidemiology of orofacial clefts. 1. Some general epidemiological characteristics.
Using data from three registries of congenital anomalies based on a total of more than 5 million births, some epidemiological characteristics were studied for 8,315 infants with cleft lip and/or cleft palate. There was a racial variation in the rate of cleft lip/palate within the California program but also a marked difference in rate between the three programs-France, Sweden, and California-that is probably not mainly a result of variable ascertainment but of real differences between the populations. The main analysis was made on cases without a known chromosome anomaly. The classical sex distribution was found with an excess of males at cleft lip/ palate. The sex ratio was lower (= more normal) when associated nonfacial malformations existed. Pierre Robin type cleft palate had a near-normal sex distribution while other types of cleft palate had the usual excess of females. Twinning was increased for all facial clefts irrespective of type but was more common when nonfacial associated malformations were present than when the cleft was isolated. Among cases with isolated clefts, the total twin increase was not statistically significant but the proportion of monozygotic twins was increased. There was a U-shaped maternal age relationship for cleft lip/palate that was not seen for median cleft palate (although an indicated increased risk for infants of teen-age mothers existed). For all types of cleft, there was an increased risk at high parity also after standardization for maternal age.
California↗
The epidemiology of orofacial clefts. 2. Associated malformations.
Using data from a French, the Swedish, and the California registries of congenital anomalies based on a total of more than 5 million births, the presence of nonfacial malformations in infants with cleft lip or cleft palate was studied. Cleft lip was less often associated with chromosome anomalies than cleft lip with cleft palate, but when all cleft lip/palate infants were compared with all infants with median cleft palate, chromosome anomalies were equally common. Ascertainment of chromosome anomalies in infants with facial clefts varied among programs. One hundred and twenty-one infants with non-chromosomal syndromes were identified-also, for these a marked variability between programs existed. An analysis of the type of associated malformations was made, comparing cleft lip/palate and median cleft palate infants. Some associations specific for the cleft types were described but to a large extent similar associations were found irrespective of cleft type. This may indicate that under certain circumstance, the various cleft types may have similar causes.
Abnormalities, Multiple↗