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NCT ID: NCT02090959 Terminated - Clinical trials for Nervous System Diseases

An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy

Start date: March 20, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren [PTC124-GD-020-DMD {NCT01826487}]) to augment the overall safety database. Screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (PTC124-GD-020-DMD) and this extension study. This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (DMD) is discontinued.

NCT ID: NCT02088151 Terminated - Clinical trials for Age-related Macular Degeneration

Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina

Start date: June 2010
Phase: N/A
Study type: Interventional

Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects. In this study, patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration will be treated with SRT. Patients will be assessed 1, 3 and 6 months after treatment.

NCT ID: NCT02082522 Terminated - Clinical trials for Hilar Cholangiocarcinoma

Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)

Start date: November 12, 2014
Phase: Phase 3
Study type: Interventional

Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction. This research study will evaluate the efficacy and safety of PDT with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts. It will involve 200 patients across North America and Europe. Other countries may participate if needed. Participation will last at least 18 months.

NCT ID: NCT02080039 Terminated - Spinal Cord Injury Clinical Trials

Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

Start date: September 2012
Phase: N/A
Study type: Interventional

In this study the following hypotheses will be tested: Electrical stimulation of the gluteal muscle (buttocks) leads to 1. an increase in the thickness of the gluteal muscle 2. a decrease in the thickness of the fat of the buttock area 3. a change in the distribution of the middle and maximal seating pressure to a more consistent pressure 4. an increase in well-being of the patients.

NCT ID: NCT02078843 Terminated - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumors

Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors

GaIN
Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher diagnostic value in the detection of neuroendocrine tumors than the established imaging method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the investigators will compare the diagnostic performance of both methods.

NCT ID: NCT02072057 Terminated - Cancer Cachexia Clinical Trials

Study of Ruxolitinib in the Treatment of Cachexia in Patients With Tumor-Associated Chronic Wasting Diseases.

Start date: April 20, 2014
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the effects and safety of Ruxolitinib, a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) inhibitor for the treatment of tumor-associated cachexia in chronic wasting diseases.

NCT ID: NCT02069860 Terminated - Clinical trials for Hemodialysis Access Failure (Disorder)

BONE ANCHORED PORT for Hemodialysis Treatment

BAP
Start date: April 4, 2016
Phase: N/A
Study type: Interventional

A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear, connected with a double lumen central venous catheter inserted in the jugular vein, and will be used in conjunction with an adapter as a permanent vascular access for hemodialysis treatment.

NCT ID: NCT02068625 Terminated - Retinal Detachment Clinical Trials

Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment

Start date: September 2010
Phase: Phase 4
Study type: Interventional

This randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. Based on results from a study in mice suffering from retinal degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a second-generation propargylamine with neuroprotective properties modulating the caspase-dependent pathway of programmed cell death.

NCT ID: NCT02067741 Terminated - Breast Cancer Clinical Trials

CR1447 in Endocrine Responsive-HER2neg and TN-ARpos Breast Cancer

Start date: June 14, 2016
Phase: Phase 2
Study type: Interventional

SAKK 21/12 is a stratified, multicenter Phase II first in-human trial with transdermal CR1447 (4-OH-testosterone) and is directed to patients with endocrine responsive-HER2neg and TN-ARpos metastatic or locally advanced breast cancer. The trial will be conducted in Switzerland with max. 90 patients. CR1447 has a very good safety and tolerability profile and combines two mechanisms of action, interaction with the AR and the aromatase enzyme may have a higher activity than drugs with a single mechanism and might offer the possibility of non-chemotherapy based endocrine therapy to the limited treatment options in TN-ARpos BC. Transdermal application of CR1447 might have the advantage to continuously release of 4-OHT into the blood stream, thus omitting a first pass effect. In Phase II the main objective is to assess activity and to determine the efficacy and tolerability of CR1447. Phase II will consist of two strata, into which patients will be stratified according to their hormonal receptor status: Stratum A for patients with endocrine responsive-HER2neg disease, regardless of their AR status and Stratum B for patients with triple-negative and determined ARpos disease. Patients with triple-negative disease tested negative for AR will be excluded from the trial. In both strata patients will be treated with 400 mg of CR1447 until disease progression, patients' wish or physicians' decision to end treatment. Biopsies of one defined metastatic lesion in those patients who gave informed consent will be performed at baseline and within the third week of treatment with CR1447. Measurement of AR expression, expression of downstream targets of ERα, ERβ, PR, AR, angiogenesis and other translational studies as described in this protocol should help confirming the hypothesis of an increased benefit of CR1447 due to its dual action, efficacy of topical application, tolerability and in deciding whether one should proceed to a large randomized trial.

NCT ID: NCT02064868 Terminated - Clinical trials for Acute Heart Failure (AHF)

Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

RELAX-AHF-EU
Start date: January 31, 2014
Phase: Phase 3
Study type: Interventional

This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).