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NCT ID: NCT02571205 Completed - Clinical trials for Duchenne Muscular Dystrophy

Testosterone Therapy for Pubertal Delay in Duchenne Muscular Dystrophy

Start date: November 2015
Phase:
Study type: Observational

"Observational study of clinical outcomes for testosterone treatment of pubertal delay in Duchenne Muscular Dystrophy" is a single centre observational study that aims to follow the progress of 20 adolescents with Duchenne Muscular Dystrophy (DMD) and delayed puberty who are treated by the Newcastle muscle team, as they are treated with testosterone to induce puberty. The participants will all be treated with the standard stepwise regimen of testosterone injections every 4 weeks and data will be collected to help determine the effectiveness and tolerability of the current treatment regimen. The investigators will use the data to explore the effect of testosterone on pubertal development, growth, muscle strength and function, bone mineral density and body composition and characterise any side effects. Semi-structured interviews will also be carried out to learn the boys' views on the tolerability of the regimen. The study will last up to a maximum of 27 months in total for each participant, but may be less if they are happy with pubertal development before this time. It is important to do this study because from the investigator's limited experience in this group, testosterone treatment seems to be well liked and tolerated but the best treatment regimen to use remains unknown and there is no current consensus. It is not currently part of the standard of care in DMD but it would be important to include it if this study can show that it is an effective treatment for pubertal delay.

NCT ID: NCT02571036 Completed - Clinical trials for Gastrointestinal Stromal Tumors

A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies

Start date: November 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase, and an expansion phase. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.

NCT ID: NCT02570854 Completed - Clinical trials for Anemia, Iron-Deficiency

A Two-part Single- and Repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients

Start date: September 22, 2015
Phase: Phase 1
Study type: Interventional

The study will assess the safety, tolerability and efficacy of CSJ137 in chronic hemodialysis patients. It is hypothesized that treatment with CSJ137 may improve the level of hemoglobin in patients on chronic hemodialysis with iron-restricted anemia while reducing the need for dosing with erythropoietin and intravenous iron in these patients.

NCT ID: NCT02570308 Completed - Uveal Melanoma Clinical Trials

A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma

Start date: February 29, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation commenced at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter.

NCT ID: NCT02570126 Completed - Chickenpox Clinical Trials

A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.

Start date: November 13, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.

NCT ID: NCT02569983 Completed - Ovarian Neoplasms Clinical Trials

The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research

SOCQER-2
Start date: September 2015
Phase:
Study type: Observational

The primary aims of the SOCQER-2 study are to describe any impact on short (6 weeks), medium term (6, 12 months) and long term (18 months, 24 months) PRO/quality of life using validated questionnaires in patients undergoing standard or extensive surgery for suspected or confirmed Stage III/IV ovarian cancer and to describe progression free survival (PFS) in these patients.

NCT ID: NCT02569931 Completed - Clinical trials for Patellar Dislocation

The Unstable Kneecap - the Impact of Anatomy on Function

SPRING
Start date: December 2015
Phase: N/A
Study type: Interventional

The principal objective of the study is to find out which everyday activities make the kneecap unstable in people with patellofemoral instability. Analysing how a patient with an unstable kneecap walks will help us to determine if surgery is successful in these patients by seeing if better scores on patient questionnaires are found in patients following surgery and whether these patients also have a better pattern of walking. The investigators aim to use cameras and pressure pads to see how patients walk before and after surgery and see how this compares to patient scores on the questionnaires. If the investigators find that patients walk better after surgery they can justify that surgery is worthwhile for the patient and cost effective for the NHS.

NCT ID: NCT02569710 Completed - Chronic Hepatitis C Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

Start date: October 31, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.

NCT ID: NCT02569242 Completed - Esophageal Cancer Clinical Trials

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Start date: December 14, 2015
Phase: Phase 3
Study type: Interventional

The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.

NCT ID: NCT02569008 Completed - Clinical trials for Post Cardiac Surgery

Minimal Volume for Fluid Challenge in Post-operative Patients

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

This study evaluate the effect of different doses of crystalloids on the changes on cardiac output (CO) and on the proportion of responders and non-responders and aims to determine the minimal volume required to increase the mean systemic filling pressures (Pmsf) in post-cardiac surgical patients.