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Haematopoietic stem cell transplantation (HSCT) has been proposed for refractory autoimmune diseases, including systemic sclerosis (SSc). A sequential Bayesian phase I-II clinical trial was conducted in SSc patients to assess the feasibility, the tolerance and the efficacy of autologous HSCT. Peripheral blood stem cells (PBSC) were collected using(More)
OBJECTIVE Intravenous ibuprofen (IBU) has been found to be as effective as indomethacin for the treatment of patent ductus arteriosus (PDA) in preterm infants and has been associated with fewer adverse effects in comparative phase III studies. The dose regimen used (10-5-5 mg/kg/day) was based on limited pharmacokinetic data and no phase II study was(More)
Oligodeoxynucleotides containing CpG motifs (CpG ODNs) display a strong immunostimulating activity and drive the immune response toward the Th1 (T helper type 1) phenotype. These ODNs have shown promising efficacy in preclinical studies when injected locally in several cancer models. We conducted a phase 1 trial to define the safety profile of CpG-28, a(More)
The aim of phase II single-arm clinical trials of a new drug is to determine whether it has sufficient promising activity to warrant its further development. For the last several years Bayesian statistical methods have been proposed and used. Bayesian approaches are ideal for earlier phase trials as they take into account information that accrues during a(More)
We review the rationale behind the statistical design of dose-finding studies as used in phase I and phase I/II clinical trials. We underline what the objectives of such dose-finding studies should be and why the widely used standard design fails to meet any of these objectives. The standard design is a "memoryless" design and we discuss how this impacts on(More)
PURPOSE It is generally accepted that early visual deprivation from monocular enucleation (ME; the surgical removal of one eye) results in intact spatial vision. Yet, motion perception studies in this population yield inconsistent findings. Here, we investigated speed and luminance contrast perception in a group of ME individuals. METHODS Twelve ME(More)
The aim of a phase I oncology trial is to identify a dose with an acceptable safety profile. Most phase I designs use the dose-limiting toxicity, a binary endpoint, to assess the unacceptable level of toxicity. The dose-limiting toxicity might be incomplete for investigating molecularly targeted therapies as much useful toxicity information is discarded. In(More)
OBJECTIVE The aim of this study was to report our experience in the management of late morbidity after colonic interposition for caustic injury and to assess the influence of coloplasty dysfunction on patient outcome. SUMMARY BACKGROUND DATA Reports on coloplasty dysfunction after colon interposition for corrosive esophageal injuries are scarce in the(More)
BACKGROUND Surgery is the criterion standard for the treatment of severe burns and of late sequels after ingestion of corrosive agents, but long-term outcome is unknown. METHODS Patients who underwent surgery between 1987 and 2006, for the treatment of severe caustic burns (group I, n = 268) or of late sequels (group II, n = 79) were included in the(More)
OBJECTIVE The aim of this study was to describe the technique of colopharyngoplasty for the reconstruction of concomitant esophageal and pharyngeal caustic injuries and to evaluate the postoperative course and late functional outcomes. SUMMARY BACKGROUND DATA Surgical treatment of esophageal and pharyngeal strictures is a difficult challenge because(More)