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NCT ID: NCT02617901 Completed - Clinical trials for Bone Diseases, Developmental

Developing a COMputerised Bone Age Tool

COMBAT1
Start date: December 2014
Phase: N/A
Study type: Interventional

The Greulich and Pyle technique (G&P) is that most commonly used to assess bone age in children, particularly in the context of suspected skeletal dysplasia. However it has been shown not to be applicable to children of Asian and African ethnicity and may not be applicable to United Kingdom (UK) Caucasian children, who are now relatively more mature and larger than children of the mid 1930's (when G&P was developed). It is generally agreed that updated standards are required for rapid and reliable bone age assessment. The development of such standards requires irradiation of normal children. To do this ethically, radiation exposure must be kept as low as possible. Two recent studies suggest that bone age assessment can be reliably achieved from dual-energy x-ray absorptiometry (DXA) scans. As far as the investigators are aware, the Tanner & Whitehouse (TW3) method, which is preferred by some (e.g. endocrinologists and nutritionists), has not been assessed from dual-energy x-ray absorptiometry (DXA) scans - although not the main focus of this study, because of its popularity amongst certain specialties, the investigators shall be assessing the TW3 method also. Modern techniques should not only be available as textbooks, but should also be available in digital (on-line) format and where possible integrated with hospital PACS systems. The investigators believe that their team has the required experience and expertise to successfully carry out such a project. Before conducting the required large cross-sectional study, the investigators must first confirm that DXA can in fact replace radiographs for bone age assessment in children; which is the objective of this current study.

NCT ID: NCT02617589 Completed - Brain Cancer Clinical Trials

An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

CheckMate 498
Start date: March 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

NCT ID: NCT02616835 Completed - Healthy Volunteers Clinical Trials

Investigating the Physiology of Targeted Theta-burst Neuromodulation

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

This research seeks to study the physiological effects of theta-burst transcranial magnetic stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.

NCT ID: NCT02616783 Completed - HIV-1 Infection Clinical Trials

Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years

Start date: December 22, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.

NCT ID: NCT02615496 Completed - Clinical trials for Macular Degeneration

Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept

Start date: December 7, 2015
Phase: N/A
Study type: Observational

The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.

NCT ID: NCT02615080 Completed - Asthma Clinical Trials

Safety and Efficacy of CRD007 in Adult Asthma Subjects

Start date: November 30, 2015
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007 will be given as add on to a background of commonly used controller medication, i.e. inhaled corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing the background controller medication, the efficacy and safety of CRD007 will be evaluated on top of several dose levels of this medication.

NCT ID: NCT02614833 Completed - Clinical trials for Adenocarcinoma Breast Stage IV

IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

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

The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.

NCT ID: NCT02614794 Completed - Clinical trials for HER2 Positive Breast Cancer

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

HER2CLIMB
Start date: January 28, 2016
Phase: Phase 2
Study type: Interventional

This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.

NCT ID: NCT02614742 Completed - Clinical trials for Subarachnoid Hemorrhage, Spontaneous

SFX-01 After Subarachnoid Haemorrhage

SAS
Start date: April 2016
Phase: Phase 2
Study type: Interventional

This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.

NCT ID: NCT02614326 Completed - Clinical trials for Major Depressive Disorder

MemFlex to Prevent Depressive Relapse

Start date: January 2016
Phase: Phase 2
Study type: Interventional

A wealth of research has demonstrated that they way in which the investigators recall our personal, autobiographical memories is influential in the course of depression. Biases in the recall of autobiographical memory occur in the midst of a depressive episode, and are shown to prolong symptoms, however these biases also remain when depression remits, and may predispose the individual towards relapse. A novel cognitive intervention, MemFlex, aims to train individuals to be flexible in their retrieval of autobiographical memories, and thereby reduce depressive relapse. Changes in memory bias may also have an effect on intermediate processes that increase risk of depression, such as rumination, impaired problem solving, and cognitive avoidance. This feasibility trial compares the effects of MemFlex and Psychoeducation in their ability to reduce memory bias and intermediate cognitive risk factors, and thereby depressive relapse, in individuals remitted from Major Depressive Disorder. Clinical outcome and process measures will be assessed immediately following completion of the intervention, at 6 months post-intervention, and at 12 months post-intervention. If encouraging, the results of this pilot trial may provide a foundation for a later phase trial.