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Bèta-TCP (bèta-tricalcium phosphate) as a bone substitute in patients undergoing repair of the alveolar cleft in CLP(Cleft Lip Palate) patients.

This current study aims to investigate the use of Curios bèta-TCP, a synthetic tricalcium phosphate for repair of the alveolar cleft in patients with clefts of lip, alveolus and palate.The specific properties of Progentix TCP result in optimal and…

Taste, Speech and oro-facial relations following partial tongue reduction: A single-center, longitudinal, functional outcome study in patients with Beckwith-Wiedemann Syndrome that have undergone tongue reduction surgery

The aim of this study is to investigate the long-term outcomes in patients with BWS that have been surgically treated at our institution with the help of simple, non-invasive, objective study tools. We hope to gain valuable information regarding the…

Prospective study in congenital giant melanocytic naevi after curettage and laser ablation with the Erbium YAG laser (left-right comparison)

Proof that laser treatment will be better than the routine method using curettage. Besides it is claimed that laser treatment is less painfull.This will be assessed by photography, in which only black white (grey) evaluations are made. Colours are…

The use of β-TCP (bèta-tricalcium phosphate) as a filler of the autologous symphyseal bone graft harvest site in patients undergoing grafting of alveolar clefts in CLAP(Cleft Lip Alveolus Palate) patients

This current study aims to investigate the use of bèta-TCP, a synthetic tricalcium phosphate, as a filler of the autologous symphyseal bone graft harvest site in patients undergoing grafting of clefts of lip, alveolus and palate.The specific…

Optimal timing and technique for surgical correction of peri-orbital osseous deformities in congenital craniofacial disorders

Primary objective:To determine the most optimal technique and timing of surgery for correction of peri-orbital osseous deformities (hypertelorism, vertical orbital dystopia, and/or midface hypoplasia) for each specific condition (1. syndromic…

A three-part, open-label, randomized (Part 1) and fixed-sequence (Part 2 and Part 3) study to compare the pharmacokinetics of different ESB1609 Form A formulations to that of ESB1609 Form B (Part 1) and to investigate the effect of CYP2C9 inhibition and induction on the single dose pharmacokinetics of ESB1609 Form A (Part 2 and Part 3).

Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…

Phase 1/2 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-2002 in Adults with Hereditary Angioedema (HAE)

This study has been transitioned to CTIS with ID 2024-512317-40-00 check the CTIS register for the current data. Phase I Primary Objective• To evaluate the safety of NTLA-2002 and identify dose(s) for use in Phase 2Secondary Objectives• To evaluate…

Alveolar cleft repair using osteoinductive ceramics in children with unilateral cleft lip and palate

To provide for evidence that calcium phosphate based scaffolds generate equal amounts of residual bone volume compared to the use of autologous bone grafts in unilateral alveolar cleft grafting. A secondary objective is to prove that calcium…

Phase 1 Dose Escalation Study Assessing the Safety and Pharmacokinetics of PTC518 in Healthy Subjects

Primary ObjectivesPart 1:To characterize the safety and tolerability of single ascending doses of PTC518 in healthy subjects.Part 2:To characterize the safety and tolerability of PTC518 administered for 14 or up to 21 days in healthy subjects.Part 3…