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NCT ID: NCT01825512 Completed - Clinical trials for Chronic Iron Overload

Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients

Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

Multicentre, randomised, open label, non-inferiority active-controlled trial to evaluate efficacy and safety of a 12-months treatment with deferiprone (DFP) at dose of 75-100 mg/kg/day versus deferasirox (DFX) at dose of 20-40 mg/kg/day in paediatric patients (1 month < 18 years old) affected by hereditary haemoglobinopathies and requiring frequent transfusions and chelation.

NCT ID: NCT01751893 Completed - Clinical trials for Palmar-plantar Erythrodysesthesia (PPE)

Testing the Effectiveness of Henna on Managing PPE

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants special attention because it is the most common dose-limiting toxicity. this study is designed to test the effectiveness of a henna treatment protocol in the management of capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar erythrodysesthesia.

NCT ID: NCT01740713 Completed - Clinical trials for Chronic Iron Overload

Pharmacokinetic Study of Deferiprone in Paediatric Patients

DEEP-1
Start date: December 2012
Phase: Phase 2
Study type: Interventional

Deferiprone (DFP) is the most extensively studied oral iron chelator to date. It has been authorised in Europe in 1999 for the treatment of iron overload in patients with beta-thalassaemia major when DFO is contraindicated or inadequate. Despite a wide experience of DFP there are limited experimental data available on DFP in children and no pharmacokinetic data in children under 6 years of age. On the basis of the existing data in adults and adolescent, in the DEEP-1 trial a pharmacokinetic bridging model will be developed to support the dose selection in children aged less than 6 years. The study will consist of two phases, namely an experimental phase, during which patients will receive a single dose and a modeling phase, during which PK data obtained after single dose in patients < 6 years of age will be analysed in conjunction with historical PK data in adults and older children and adolescents. The model-based analysis of the data obtained after single dose will enable the assessment of the dosing regimen required for the purpose of accurate pharmacokinetic bridging. The ratio between the predicted systemic exposure parameters (AUC and Cmax) in the target population and reference group will be used as basis for recommendation of the dose in the target population.

NCT ID: NCT01739764 Completed - Neoplasms Clinical Trials

An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

Start date: February 19, 2013
Phase: Phase 4
Study type: Interventional

This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.

NCT ID: NCT01728675 Completed - Aging Clinical Trials

Eccentric Exercise and Oxidative Stress

Start date: May 2012
Phase: N/A
Study type: Interventional

The purpose of the present investigation is to compare the responses and adaptations of young and elderly individuals to repeated eccentric exercise in regards to muscle function and redox homeostasis in a side-by-side comparison.

NCT ID: NCT01723969 Completed - Colorectal Cancer Clinical Trials

Screening Platform for Clinical Trials in Advanced Colorectal Cancer

SPECTAcolor
Start date: September 2013
Phase:
Study type: Observational

The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials. Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients. A major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients. The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.

NCT ID: NCT01694745 Completed - Pain Clinical Trials

EUROpean Pain Audit In Neonates

EUROPAINsurvey
Start date: October 2012
Phase: N/A
Study type: Observational

EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study. The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries. The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes. The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception. The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.

NCT ID: NCT01673958 Completed - Heart Failure Clinical Trials

Stair Descending vs. Stair Ascending Exercise

Start date: February 2012
Phase: N/A
Study type: Interventional

The aim of the present project is to compare the acute and chronic effect of stair descending versus stair ascending exercise on muscle damage and performance in elderly males with chronic heart failure.

NCT ID: NCT01590524 Completed - Anxiety Clinical Trials

Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer

Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Guided Imagery and Progressive Muscle relaxation are effective as stress reducing techniques in parents of hospitalized children with cancer.

NCT ID: NCT01465308 Completed - Clinical trials for Head and Neck Cancer

The Effect of Honey on Xerostomia and Oral Mucositis

AC-H
Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the use of pure honey will help in the treatment of radiation induced xerostomia and oral mucositis (symptom management)