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NCT ID: NCT01982045 Completed - Spinal Deformity Clinical Trials

RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion

AxA
Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.

NCT ID: NCT01981850 Completed - Clinical trials for Primary Myelofibrosis

A Phase 2 Study of RO7490677 In Participants With Myelofibrosis

Start date: October 1, 2013
Phase: Phase 2
Study type: Interventional

RO7490677 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue. The purpose of this study is to gather information on whether RO7490677 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated.

NCT ID: NCT01981590 Completed - Sleep Apnea Clinical Trials

Mapping for Acute Transvenous Phrenic Nerve Stimulation Study

MAPs
Start date: August 2013
Phase: N/A
Study type: Interventional

The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.

NCT ID: NCT01981005 Completed - Healthy Volunteer Clinical Trials

A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802

Start date: November 2013
Phase: Phase 1
Study type: Interventional

This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers

NCT ID: NCT01980290 Completed - Hepatitis, Chronic Clinical Trials

Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C

INTEGRATE
Start date: May 2013
Phase: N/A
Study type: Observational

The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.

NCT ID: NCT01978782 Completed - Depression Clinical Trials

Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL).

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

Depression is the most common mental health disorder among HIV-patients. Recognizing and treating depression is important in order to improve quality of life and health outcomes in those living with HIV. In clinical practice selective serotonin reuptake inhibitors (SSRIs) are used most frequently in HIV patients with depressive symptoms. A complicating factor in the concomitant use of antiretroviral agents and antidepressant therapy is the occurrence of drug-drug interactions. Citalopram can be seen as one of the preferred SSRIs in HIV-infected patients because citalopram has a relatively favourable drug interaction profile compared to other SSRIs. Raltegravir is an HIV-1 integrase inhibitor and is frequently being used as antiretroviral agent in combination with tenofovir/emtricitabine in HIV-patients. Raltegravir has shown sustained antiretroviral activity, is generally well tolerated and has little propensity to interact with other drugs because it does not inhibit or induce CYP450 enzymes. Theoretically, no clinically relevant drug interaction is expected between raltegravir and citalopram as raltegravir is not a CYP2D6 substrate and thus will not be affected by the possible inhibition of CYP2D6 by citalopram. Raltegravir is metabolized by UGT but citalopram is not known to influence UGT. A possible interaction may occur through inhibition of P-gp mediated transport of raltegravir by citalopram. However, even when no drug interaction is expected theoretically, it may be recommended to collect sufficient clinical evidence to support this hypothesis because unexpected interactions with raltegravir have been observed in the past. In order to be able to recommend raltegravir and citalopram concomitant use, a pharmacokinetic study in healthy volunteers is proposed.

NCT ID: NCT01978756 Completed - Breast Cancer Clinical Trials

Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.

Start date: March 2013
Phase: N/A
Study type: Observational

In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed. There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival. The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home. The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.

NCT ID: NCT01978548 Completed - Alzheimer Disease Clinical Trials

A Study to Evaluate the Effects of JNJ-54861911 on Amyloid Beta Processing in Cerebrospinal Fluid and Plasma in Patients With Prodromal Alzheimer's Disease

Start date: December 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-54861911 in patients with prodromal Alzheimer's disease (pAD).

NCT ID: NCT01978171 Completed - Breast Neoplasms Clinical Trials

Prediction of Everolimus-induced Interstitial Lung Disease

PREVENT
Start date: May 2014
Phase:
Study type: Observational

The investigators will determine which factors are predictive for the development and severity of everolimus-induced interstitial lung disease and will develop a prediction model based on these risk factors.

NCT ID: NCT01978158 Completed - Hypoxia Clinical Trials

Effects of Oxygen Status on Endotoxemia Induced Inflammation and Hypoxia Inducible Factor-1α

Start date: October 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Oxygen is a widely available gas that is cheap, easy to get and extensively used in medicine. From animal studies it has become apparent that increasing or lowering the degree of oxygen in the blood, the inflammatory response can be altered. We will investigate of this is also true in humans by increasing, lowering or keeping oxygen levels normal while giving healthy subjects a short inflammatory stimulus.