Clinical Trials Logo

Filter by:
NCT ID: NCT03811561 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

FOCUS
Start date: May 8, 2019
Phase: Phase 3
Study type: Interventional

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

NCT ID: NCT03780504 Active, not recruiting - Psoriatic Arthritis Clinical Trials

Apremilast in Psoriatic Arthritis in Real-life Clinical Practice in Greece

APROACH
Start date: April 15, 2019
Phase:
Study type: Observational

Following the evidence from the controlled clinical trial setting on the significant clinical benefits of apremilast in the treatment of active PsA, there is a scarcity of real-life evidence on the effectiveness and the beneficial role of apremilast in PsA in routine clinical practice. The present study primarily aims to generate real-world evidence on the impact of apremilast treatment on a broad population of biologic-naïve PsA patients in terms of its clinical effectiveness across the wide spectrum of disease manifestations, as well as its impact on disease burden and HRQoL, in the routine primary care settings of Greece.

NCT ID: NCT03778931 Active, not recruiting - Breast Cancer Clinical Trials

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

EMERALD
Start date: May 10, 2019
Phase: Phase 3
Study type: Interventional

This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

NCT ID: NCT03771898 Active, not recruiting - Clinical trials for Metachromatic Leukodystrophy (MLD)

A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy

EMBOLDEN
Start date: May 13, 2019
Phase: Phase 2
Study type: Interventional

The main aim of the study is to determine if SHP611 given by injection into the spinal fluid that surrounds the brain and spinal cord (intrathecal; IT) prolongs the time for children with Metachromatic Leukodystrophy (MLD) to retain the ability to move from place to place. Other aims of the study are to determine the effects of intrathecal administration of SHP611 on movement and speech functions and to learn how well SHP611 injected in the spinal fluid that surrounds the brain and spinal cord is tolerated. Study participants will receive SHP611 for about 2 years with the possibility of an extended treatment period.

NCT ID: NCT03759496 Active, not recruiting - Bladder Cancer Clinical Trials

Efficacy of Durvalumab in Non-muscle-invasive Bladder Cancer

Start date: November 15, 2018
Phase: Phase 2
Study type: Interventional

Research Hypothesis Approximately 75% of patients with bladder cancer (BC) present with a disease confined to the mucosa (stage Ta, CIS) or submucosa (stage T1) (non-muscle invasive BC [NMIBC]). For high grade NMIBC, i.e. TaG3, T1G3 and CIS, intravesical bacillus Calmette-Guérin (BCG) immunotherapy is the treatment of choice, given that it prevents recurrence and reduces the odds of progression to MIBC. However, since initial BCG therapy fails in approximately 40% of patients over a 2-year period, new treatment options for these patients are of utmost importance. In that field of research durvalumab, a human monoclonal antibody that binds programmed cell death ligand-1 (PD-L1), demonstrated meaningful clinical activity as well as manageable safety profile in PD-L1-positive patients with BC, many of whom were heavily pretreated. Certain studies using systemic administration of anti-PD1 agents for BCG refractory NMIBC are ongoing. Nevertheless, intravesical administration may be advantageous, since selective bladder tumor uptake of monoclonal antibodies following intravesical administration, while this method results in negligible absorption in the circulation and, therefore, minimal risk of systemic toxicity. This notion is supported by the findings of a recent study of intravesical administration of recombinant adenovirus-mediated interferon-α2b gene therapy (rAd-IFNα), No rAd-IFNα DNA was detected in the blood. Furthermore, no systemic toxicity was reported in a phase II study using the same agent. The investigators, therefore, propose a phase II study of intravesical administration of durvalumab in patients with BCG refractory NMIBC. Since no safety or efficacy data specifically on intravesical administration of durvalumab exist, a run-in part will precede the main phase II, in order to confirm safety of the procedure and to reject a futility hypothesis, as described in the following sections of the protocol. Correlative studies of potential biomarkers in tumor tissue before and after durvalumab instillation are also proposed.

NCT ID: NCT03759379 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis

HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

Start date: February 14, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the 18 month Treatment Period. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all participants will be randomized to receive vutrisiran SC injection once every 6 months (q6M) or q3M in the Randomized Treatment Extension (RTE) Period.

NCT ID: NCT03754205 Active, not recruiting - Vaginal Atrophy Clinical Trials

Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

Start date: January 18, 2018
Phase: N/A
Study type: Interventional

This study evaluates the clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.

NCT ID: NCT03735121 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Start date: December 14, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

NCT ID: NCT03734029 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Start date: December 27, 2018
Phase: Phase 3
Study type: Interventional

This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body

NCT ID: NCT03727672 Active, not recruiting - Migraine Clinical Trials

Salivary Inflammatory Markers in Tension Type Headache and Migraine

SalHead
Start date: January 1, 2016
Phase:
Study type: Observational

Data role of salivary inflammatory markers in migraine and Tension Type headache (TTH) are lacking. Τhe investigators studied whether headache attacks are associated with changes in C reactive protein (CRP), Interleukin -1β and Interleukin -6 in saliva in patients with Tension Type Headache and Migraine and age matched healthy controls . Τhe investigators, also investigated whether these markers could be influenced by comorbidities such as depression and anxiety.