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Congenital Abnormalities clinical trials

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NCT ID: NCT04150120 Enrolling by invitation - Clinical trials for Congenital Heart Disease

eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness

eChildHealth
Start date: October 15, 2019
Phase: N/A
Study type: Interventional

The overall aim is twofold: 1) to stretch the borderline regarding the present knowledge of clinical and economic cost-effectiveness of eHealth as an aid for facilitating and supporting self-management in families with long-term childhood illness, and 2) to develop a sustainable multidisciplinary research environment for advancing, evaluating, and implementing models of eHealth to promote self-management for children and their families. A number of clinical studies are planned for, covering different parts of paediatric healthcare. The concept of child-centred care is essential. Experienced researchers from care science, medicine, economics, technology, and social science will collaborate around common issues. Expertise on IT technology will analyse the preconditions for using IT; economic evaluations will be performed alongside clinical studies; and cultural and implementation perspectives will be used to analyse the challenges that arise from the changes in relations among children, family and professionals, which may occur as a result of the introduction of eHealth. Child health is not only important in itself. Investments in child health may also generate significant future gains, such as improved educational and labour market performance. Six complex, long-term and costly challenges in paediatric healthcare are planned for, involving eHealth technology such as interactive video consultation, pictures, on-line monitoring, and textual communication. The research follows an international framework for developing and evaluating complex interventions in healthcare. End-users (families) and relevant care providers (professionals in health and social care) will participate throughout the research process. The overall aim is certainly to analyse eHealth as an aid for facilitating and supporting self-management. However, the plan also includes the research issue whether eHealth at the same time improves the allocation of scarce health care- and societal resources.

NCT ID: NCT04141605 Enrolling by invitation - Heart Failure Clinical Trials

Global Utilization And Registry Database for Improved heArt preservatioN

GUARDIAN
Start date: February 14, 2020
Phase:
Study type: Observational [Patient Registry]

The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.

NCT ID: NCT04138017 Enrolling by invitation - Ankle Arthritis Clinical Trials

ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

ViviGen
Start date: October 23, 2018
Phase: Phase 4
Study type: Interventional

To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.

NCT ID: NCT04106947 Enrolling by invitation - Quality of Life Clinical Trials

Transition of Care for Patients With Hirschsprung Disease and Anorectal Malformations

NOHARM
Start date: August 12, 2019
Phase:
Study type: Observational [Patient Registry]

Transition from paediatric to adult health care is crucial for preventing deterioration of chronic diseases. At present, transitional care (TC) is not established for patients with the Hirschsprung disease (H) and Anorectal Malformations (ARM). To set up a program for TC and to treat persisting symptoms in adults, data on outcome in adult patients are needed. At present such data are very limited. Therefore, we want to investigate clinical and PROM in H and ARM adolescents and adults. A cross sectional study in all H and ARM patients operated in Norway from 1970-2000 and in all adolescents operated at Oslo University Hospital from 2002-2006 will examine somatic, psychosocial and mental health, and quality of life (QoL). In children operated for H and ARM a large body of evidence shows that bowel problems, reduced QoL and impaired psychosocial and mental health are common. There are papers on sexual and urological impairment in these patients, but large studies on the topic is missing. It is a general assumption among paediatric surgeons that both somatic and mental health problems related to H and ARM improve during adolescence and adult life. Therefore, no standardized guidelines for TC in these patients have been established. Interestingly, very few studies have actually examined H and ARM patients beyond adolescence. Reports from patient organizations showing significant long-term sequels and inadequate understanding of the unique problems of H and ARM patients among health professionals treating adults. Hypothesis:H and ARM adults and adolescents have bowel, urinary and sexual difficulties and reduced QoL, psychosocial and mental health. H and ARM adults receive insufficient treatment of their chronic congenital disease. H and ARM patients with syndromes have particularly bad functional outcome. Anal dilatations and repeated rectal enemas have a negative impact on adolescent psychosocial and mental health. Main aim: Acquire knowledge about long-term bowel, urinary and sexual function, QoL and psychosocial and mental health in adult and adolescent H and ARM patients. Results: from this large study of H and ARM patients will have significant influence on treatment and follow-up, both nationally and internationally. Since very few countries except the Nordic countries have the possibility to follow patients with congenital malformations into adulthood, it is important that studies like this are done.

NCT ID: NCT03632044 Enrolling by invitation - Cleft Palate Clinical Trials

Evaluation of Trigeminal Nerve Blockade

Start date: November 20, 2018
Phase: Phase 4
Study type: Interventional

Cleft palate repair requires high doses of opioids for pain control postop. An alternative approach is placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve & covering the entire midface. Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve may provide effective analgesia for cleft lip repair, improving time to oral intake, pain control and time to hospital discharge.

NCT ID: NCT03523650 Enrolling by invitation - Clinical trials for Cavernous Malformations,Cerebral and/or Spinal

Oral Propanolol for Surgically Inaccessible Cavernous Malformations

Start date: February 7, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the role of propranolol as an alternative treatment for cavernous malformation in patients that may not be ideal candidates for surgery.

NCT ID: NCT03412760 Enrolling by invitation - Fetal Anomaly Clinical Trials

Hydrops: Diagnosing & Redefining Outcomes With Precision Study

HyDROPS
Start date: October 11, 2018
Phase: N/A
Study type: Interventional

This is a national, prospective study designed to investigate the genetic etiologies of non-immune hydrops fetalis (NIHF) and other birth defects. At least half of prenatally diagnosed NIHF cases remain of unknown etiology after standard work up, and a substantial proportion of other birth defects remain of unknown etiology as well. The investigators are performing exome sequencing (ES) for the affected fetus or neonate in unexplained cases, as well as enrolling cases with a genetic explanation to represent the full spectrum of diseases underlying NIHF and other birth defects.

NCT ID: NCT03022708 Enrolling by invitation - Clinical trials for Heart Defect, Congenital

Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

Xplore2
Start date: May 8, 2017
Phase: N/A
Study type: Interventional

This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.

NCT ID: NCT02920645 Enrolling by invitation - Clinical trials for Intracerebral Hemorrhage

Multicenter Validation of the AVICH Score

AVICH
Start date: September 2016
Phase: N/A
Study type: Observational

The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH. Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2) and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters, which are part of the AVICH score, will be compared between the 2 groups: ICH score including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young grade, including age, presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared. Multicentre validation study Key inclusion criteria: - All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage - Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria. Key exclusion criteria: - incomplete data set - AVM Patients with only subarachnoid hemorrhage (SAH) or IVH and no ICH

NCT ID: NCT00833599 Enrolling by invitation - Lymphedema Clinical Trials

Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

Start date: January 2009
Phase:
Study type: Observational

The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence imaging in subjects with acquired or hereditary lymphedema, in subjects with lipidema and other lymphovascular disorders and in normal health subjects; in order to attempt to correlate imaging phenotype(s) with genotype(s).