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NCT ID: NCT03349801 Active, not recruiting - Clinical trials for Age Related Macular Degeneration (AMD)

Development of Novel Clinical Endpoints in Intermediate AMD

MACUSTAR
Start date: March 26, 2018
Phase:
Study type: Observational

Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR

NCT ID: NCT03345823 Active, not recruiting - Crohn's Disease Clinical Trials

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

U-ENDURE
Start date: March 21, 2018
Phase: Phase 3
Study type: Interventional

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

NCT ID: NCT03339635 Active, not recruiting - Testicular Cancer Clinical Trials

Short-term Testosterone Replacement in Testicular Cancer Survivors

Start date: December 21, 2018
Phase: Phase 2
Study type: Interventional

To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome. A randomized double-blind placebo controlled intervention study, followed by an open-label treatment phase. Results of this pilot study will be used to design a multicenter randomized controlled study in a large group of TC survivors

NCT ID: NCT03337360 Active, not recruiting - Male Subfertility Clinical Trials

The Impact of a Nutritional Supplement (Impryl®) on Male Fertility

SUMMER
Start date: April 23, 2018
Phase: N/A
Study type: Interventional

Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples a male factor is involved. Male infertility is of multifactorial origin. In the past decade, the role of oxidative stress on sperm has been researched thoroughly and found to be the problem in 30% to 80% of male infertility cases. Impryl® is a nutritional supplement mainly consisting of vitamin B, which works on the metabolic system by activating the one carbon cycle and recycling of homocysteine without the use of any direct strong antioxidants. In this study the investigators want to determine the effectiveness of nutritional supplement Impryl® in men of infertile couples on ongoing pregnancy rate, with or without assisted reproduction technology (ART).

NCT ID: NCT03330847 Active, not recruiting - Clinical trials for Metastatic Triple Negative Breast Cancer

To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.

Start date: March 7, 2018
Phase: Phase 2
Study type: Interventional

This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and olaparib monotherapy versus olaparib in combination with an inhibitor of WEE1 (adavosertib [AZD1775]) in second or third line setting in patients with Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment arms are olaparib monotherapy, olaparib+ Ceralasertib and olaparib+adavosertib. The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different schedules of administration of each of the treatment options as well as their different toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the option of consenting to the main part of the study within the 28-day screening period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the total number of patients randomised will be lower (approximately 350 patients). Approximately 300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being discontinued.

NCT ID: NCT03327948 Active, not recruiting - Clinical trials for Urinary Incontinence, Urge

Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

ARTISAN-SNM
Start date: November 21, 2017
Phase: N/A
Study type: Interventional

The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.

NCT ID: NCT03321552 Active, not recruiting - Clinical trials for Critical Limb Ischemia

PROMISE International

Start date: December 15, 2017
Phase: N/A
Study type: Interventional

The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

NCT ID: NCT03315221 Active, not recruiting - Safety Clinical Trials

Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.

Renoir
Start date: March 8, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment. Preterm infants have much higher nutrient requirements than term infants. The preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants. Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. The current Nutricia HMF (control product) has been available in its current composition since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in accordance with the ESPGHAN recommendations. Recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development. The Renoir study will investigate the difference between both HMFs with regards to the growth velocity as well as the safety and tolerance of the new HMF.

NCT ID: NCT03313921 Active, not recruiting - Myopia Clinical Trials

The MORE Study: Manifest vs. Online Refraction Evaluation

MORE
Start date: January 4, 2018
Phase: N/A
Study type: Interventional

The assessment of the refractive state of the eye is a fundamental and important part of ophthalmic and optometric clinical practice. The development of an unsupervised online subjective refraction method makes a refraction more accessible and can be quite cost-saving. In this study, the investigators want to validate an online refraction method which was recently created in the Netherlands. The study comprises two different set of participants: Part one contains fifty healthy volunteers, 18-40 years of age, with a refractive error and no other ophthalmic pathology. Part two contains fifty patients with an ophthalmic pathology. The online refraction outcomes will be compared to a manifest refraction and automated refraction in a cross-sectional study design.

NCT ID: NCT03304223 Active, not recruiting - Clinical trials for Kidney Transplant Rejection

IL2 Imaging in Renal Transplantation

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection. However, this is an intervention associated with complications like bleeding, patient discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false negative results. So, the introduction of a new non-invasive diagnostic tool for allograft rejection could have major implications for the care of renal transplant recipients. For the purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET), the tracer 18-Fluor-Interleukin-2 ([18F]FB-IL2) has been developed. The investigators hypothesized that a high correlation exists between [18F]FB-IL2 uptake and the extend of T cell infiltration into renal transplants with signs of rejection