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NCT ID: NCT03877237 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction (HFrEF)

DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced Ejection Fraction

Start date: April 12, 2019
Phase: Phase 3
Study type: Interventional

International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Reduced Ejection Fraction (HFrEF)

NCT ID: NCT03877224 Not yet recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction (HFpEF)

DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction

Start date: April 5, 2019
Phase: Phase 3
Study type: Interventional

International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)

NCT ID: NCT03875846 Recruiting - Blood Pressure Clinical Trials

Intraoperative Simultaneous Pressure Guided Revascularization Study

INSTANT
Start date: October 1, 2018
Phase:
Study type: Observational

This study aims to determine whether intraoperative physiologic measurements of blood flow to the leg during endovascular treatment of Peripheral Arterial Disease (PAD) can predict future clinical outcomes.

NCT ID: NCT03875534 Not yet recruiting - Achondroplasia Clinical Trials

A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia

Start date: March 2019
Phase:
Study type: Observational

This is a long-term, multi-center, longitudinal, observational study in children with achondroplasia (ACH). The aim is to study height velocity and comorbidities in children with ACH. This is a natural history study and no study medication will be administered.

NCT ID: NCT03875079 Not yet recruiting - Metastatic Melanoma Clinical Trials

A Phase IB Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant Targeting Fibroblast Activation Protein-Α, In Combination With Pembrolizumab (Anti-Pd-1), In Participants With Previously Untreated Advanced And/Or Metastatic Melanoma

Start date: April 10, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 2 parts: a safety run-in (Part I) and an expansion (Part II). Part II will start once all participants in Part I have completed the observation period.

NCT ID: NCT03873870 Not yet recruiting - Clinical trials for Neuroendocrine Tumors

68Ga-DOTATATE PET for Management of Neuroendocrine Tumors

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This is a research study to collect information regarding usefulness of positron emission tomography (PET) scans using a special dye called 68Ga-DOTATATE for patients with neuroendocrine tumours by determining the number of of patients whose clinical management was changed as a result of the scans.

NCT ID: NCT03873441 Not yet recruiting - Cerebral Palsy Clinical Trials

Innovative Game-Aided Rehabilitation Platform for Rehabilitation of Balance in Children With Cerebral Palsy

Start date: July 2019
Phase: N/A
Study type: Interventional

The research project focuses on the evaluation of an engaging computer game-aided rehabilitation platform for use in rehabilitation of young children with cerebral palsy. The goal of this research program is to produce high quality therapeutic point-of-care approaches and cost-effective delivery systems leading to better long-term health outcomes. At present, the challenges entailed in providing therapy services continue to put identified children at risk of missing opportunities to maximize the neurodevelopmental capacities, sustain any behavioral recovery and prevent future complications.The program is grounded on the technological developments and on current research documenting the benefits of computer-aided learning tools, exercise gaming applications in rehabilitation and principles of adaptive learning and neuroplasticity. A randomized controlled trial (RCT) will be conducted to study the feasibility and effectiveness of a computer game-aided rehabilitation platform (CGR) for a repetitive task practice (RTP) protocol designed for training of balance in young children with Cerebral Palsy (CP).

NCT ID: NCT03872349 Not yet recruiting - Metabolic Syndrome Clinical Trials

Effects of Monounsaturated Fatty Acids on Intestinal Lipid Metabolism in Insulin Resistant Subjects (MUFA )

Start date: August 19, 2019
Phase: N/A
Study type: Interventional

The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins à (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with insulin-resistance. In this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (SFAs) by monounsaturated fatty acids (MUFAs) reduces CVD risk in the general population. Although the beneficial impact of PUFAs on CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels, recent data suggest that chronic MUFA consumption may also exert beneficial effects on CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by MUFAs on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal TRLs represent a large proportion of the atherogenic lipoproteins. The general objective of the proposed research is to investigate how dietary MUFAs in place of SFAs modify intestinal lipoprotein metabolism in men and women with dyslipidemia associated with insulin-resistance. The investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins will be lower following a diet rich in MUFAs than after consuming a diet rich in SFAs. The investigators also hypothesize that substitution of SFAs by MUFAs will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.

NCT ID: NCT03871829 Not yet recruiting - Multiple Myeloma Clinical Trials

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.

NCT ID: NCT03871530 Not yet recruiting - Labor Pain Clinical Trials

A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia

Start date: March 15, 2019
Phase: N/A
Study type: Interventional

Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to be programmed to deliver small amounts of the local anesthetic and opioid solution at regularly timed intervals. However, little evidence is available to guide optimal settings for PIEB. The gaps in evidence include: (1) programmed timing for the first PIEB bolus (referred to as the "NEXT bolus") (2) determination of PIEB bolus volume (3) the interval for subsequent doses (PIEB interval). Response Surface Methodology will be utilized to best estimate the optimal PIEB settings (NEXT bolus interval, PIEB interval time, PIEB volume) by using the following clinical primary outcome measures: maternal satisfaction score, need for a clinician administered rescue bolus, and the ratio of PCEA boluses requested/delivered.