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NCT ID: NCT02413567 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

Start date: March 23, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.

NCT ID: NCT02413307 Completed - PTSD Clinical Trials

The Development and Evaluation of a Brief CFT Intervention for Trauma

Start date: February 2014
Phase: N/A
Study type: Interventional

**PLEASE NOTE** this study is currently open only to clients on the waiting list at the Centre for Trauma Resilience and Growth, UK. The project will involve adapting and implementing a five minute daily self-practice compassion-focused intervention and evaluate its impact on psychological and physiological factors associated with trauma. It aims to offer a novel intervention which may facilitate further benefits from trauma specific therapy. This would be a unique use of self-practice Compassion Focused Therapy (CFT) specifically for trauma clients. Previous research has found that many factors can impact on client's benefitting from therapy, including depression, anxiety and self-criticism. These things also get in the way of being compassionate towards oneself, and this can be a difficulty for people who have experienced traumatic events. Service users have identified that additional support before trauma specific therapy can be useful and this may offer a positive use of time whilst on therapy waiting lists. Hypotheses: i. A brief CFT intervention will decrease levels of depression, anxiety, stress and increase baseline Heart Rate Variability. ii. The compassion focused intervention will increase experiences of self-compassion, social safeness, and reduce levels of self-criticism. iii. High 'fear of compassion' will moderate the impact of the intervention and result in smaller changes in depression, anxiety, stress and post traumatic change. Clients of the Centre for trauma, resilience and growth will be approached to participate in the study. All participants will have experienced trauma for which they are seeking psychological support. The current compassion focused intervention will be offered to participants on the waiting list for trauma specific therapy at the trauma centre. Each participant will be asked to practice the intervention in their own time over a period of three weeks. There will be initial assessments, repeated assessments following the intervention, and repeated assessments pre and post trauma specific therapies engaged in.

NCT ID: NCT02412878 Completed - Multiple Myeloma Clinical Trials

Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma

ARROW
Start date: September 9, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the progression-free survival (PFS) of once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in adults with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).

NCT ID: NCT02412787 Completed - Hunter Syndrome Clinical Trials

Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094

Start date: April 14, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT treatment for those that did not receive idursulfase IT treatment in Study HGT-HIT-094.

NCT ID: NCT02412163 Completed - Osteoarthritis Clinical Trials

Ellipse Intramedullary Nail High Tibial Osteotomy Study

IM HTO
Start date: July 2015
Phase: N/A
Study type: Observational

This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will receive treatment with the Ellipse IM HTO Nail System and followed for six months.

NCT ID: NCT02412111 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor

Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.

NCT ID: NCT02412020 Completed - Clinical trials for Refractory Chronic Cough

Treatment of Refractory Chronic Cough With PA101

Start date: February 2015
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled, 2-period crossover, 2-cohort study in adult patients with refractory chronic cough. The purpose of the study is to assess the efficacy and safety of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating refractory chronic cough.

NCT ID: NCT02410889 Completed - Epilepsy Clinical Trials

EEG-fMRI: Towards a Useful Clinical Tool in Epilepsy

Start date: January 2007
Phase: N/A
Study type: Observational

The purpose of this project is to develop the method of combined recording of electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) in order to improve understanding of the relationship between electrical (EEG) and blood flow (fMRI) responses to epileptic discharges as a necessary step towards clinical use. One factor that currently limits the use of EEG−fMRI in patients with epilepsy is that a relatively large proportion of patients do not show any fMRI response despite epileptic activity having been detected on the EEG recorded during scanning. The reasons for this are unclear, which makes it difficult to predict in advance whether useful information will be gained from the scanning session. What is it about some epileptic discharges that results in a detectable change in the fMRI signal, while others which are no less obvious or frequent do not? This question will be addressed by determining the factors that are responsible for the occurrence of robust fMRI signal changes via detailed morphological, topographical and spectral analysis of the EEG signal on an event by event basis.

NCT ID: NCT02410837 Completed - Clinical trials for Lung Lesion(s) Requiring Evaluation

NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

Start date: April 16, 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.

NCT ID: NCT02410122 Completed - Stargardt Disease Clinical Trials

The Natural History of the Progression of Atrophy Secondary to Stargardt Disease Type 4: PROM1-Related Macular Dystrophy

ProgStar-4
Start date: December 2014
Phase:
Study type: Observational

While a fair amount of clinical data on Stargardt disease type 1 (STGD1) have been published, very little is known about Stargardt disease type 4 (STGD4). The ProgStar 04 study is an important opportunity to leverage the infrastructure, clinical trials sites, methods, and central reading center of the ProgStar program to investigate the progression of STGD4 and will help to establish patient cohorts worldwide for future clinical trials.