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NCT ID: NCT02057705 Completed - Myotubular Myopathy Clinical Trials

Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Myotubular Myopathy (MTM)

MTM
Start date: February 2014
Phase:
Study type: Observational

This is a prospective, non-interventional, longitudinal study of the natural history and function of approximately 60 patients with MTM from the United States, Canada and Europe. The duration of the study, including the enrollment period, will be 36 months. Data from the study will be used to characterize the disease course of MTM and determine which outcome measures will be the best to assess the efficacy of potential therapies.

NCT ID: NCT02057484 Completed - Kidney Transplant Clinical Trials

A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

ADDRESS
Start date: March 3, 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

NCT ID: NCT02056990 Completed - Motor Activities Clinical Trials

Screening of Athletes

Start date: March 2014
Phase:
Study type: Observational [Patient Registry]

Athletes have to participate in screenings in order to reduce injuries. Up-to-now most screenings are purely clinically based. Literature, however, indicates the importance of knowledge on deviant movement patterns as possible risk factors for injuries. From this perspective, the current project aims to measure movement patterns, gait and running in young athletes to optimise training and prevent injuries. 2D- and 3d registration methods, force plate data and pressure plate data will be used to document the performance of the athletes.

NCT ID: NCT02056353 Completed - Critical Illness Clinical Trials

Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2)

LOGIC-2
Start date: February 2014
Phase: N/A
Study type: Interventional

Most critically ill patients are confronted with hyperglycaemia, which is associated with an increased mortality and morbidity risk. Normalising these elevated blood glucose levels by intensive insulin therapy may improve patient outcome, but is associated with an increased risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia) blood glucose control in critically ill patients than nurse-directed blood glucose control.

NCT ID: NCT02056236 Completed - Cardiac Arrest Clinical Trials

TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation

TELSTAR
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to estimate the effect of medical treatment of electro-encephalographic status epilepticus on neurological outcome of patients with postanoxic encephalopathy after cardiac arrest.

NCT ID: NCT02055066 Completed - Cancer Clinical Trials

A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.

NCT ID: NCT02055027 Completed - Clinical trials for Sleep Apnea, Obstructive

Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients.

Start date: February 2008
Phase: N/A
Study type: Observational

Prospective study designed to identify factors that would predict patient adherence to CPAP (Continuous Positive Airway Pressure) therapy.

NCT ID: NCT02054351 Completed - Ovarian Cancer Clinical Trials

Phase 1 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR)

OVAR
Start date: February 6, 2014
Phase: Phase 1
Study type: Interventional

Advanced ovarian cancer is a high medical need indication. Cure is not available to these patients and treatment has palliative intent. A proportion of advanced stage ovarian cancer expresses substantial levels of Claudin 6 (CLDN6), a carcino-embryonic transmembrane protein, which is absent from normal adult human tissue. IMAB027 is a monoclonal antibody that binds to CLDN6. Preclinically IMAB027 was shown to inhibit tumor growth and to kill cancer cells by antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. This trial is a first-in-human dose escalation and dose finding Phase 1 trial of IMAB027 in patients with recurrent advanced ovarian cancer to assess the safety and tolerability, the pharmacokinetics, the antitumoral activity and the immunogenicity of IMAB027.

NCT ID: NCT02054286 Completed - HIV Infection Clinical Trials

Safety, Tolerability and Immunogenicity Induced by the THV01 Treatment in Patients Infected With HIV-1 Clade B and Treated With Highly Active Antiretroviral Therapy (HAART).

Start date: December 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this Phase I/II trial is to evaluate the safety, tolerability and immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly active antiretroviral therapies). THV01 is composed of two vaccines that derived from the HIV (human immunodeficiency virus): lentiviral vectors. They are non-replicative and not infectious. They will be injected intramuscularly, eight weeks apart. Three doses will be assessed and compared to placebo. Eligible patients must have an undetectable viral load and must be treated by HAART for more than 12 months. They will be randomly allocated to one of the study group and will receive the experimental drugs at one of the three doses or a matching placebo. Their anti-HIV treatment will be alleviated around each experimental drugs' administration to enable THV01 efficacy. HAART will be resumed one week after the second injection. 15 weeks after resumption, HAART will be interrupted. Patients will then be monitored every 2 weeks for CD4+ T cell counts and viral load as well as for thorough assessment of the elicited immune response. Stringent anti-HIV treatments resumption criteria have been implemented, based on the CD4+ T cell counts and the viral load. 38 patients were enrolled in THV01-11-01 study and received the 2 injections. A long-term follow-up of all enrolled patients will be performed for 5 years post-prime administration. This will provide additional data on the safety and the potential long-term risks/benefits associated with THV01. The final study report will be written after the last patient last visit in the long-term follow-up.

NCT ID: NCT02053636 Completed - Breast Cancer Clinical Trials

A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

FINESSE
Start date: December 2013
Phase: Phase 2
Study type: Interventional

The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.