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NCT ID: NCT03794544 Completed - NSCLC Clinical Trials

Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

Start date: March 8, 2019
Phase: Phase 2
Study type: Interventional

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).

NCT ID: NCT03793608 Completed - Peanut Allergy Clinical Trials

Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Start date: March 12, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24. The secondary objectives are: - To determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC - To evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients - To evaluate the effects of dupilumab treatment on the levels of peanut-specific Immunoglobulin E (IgE) - To evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations - To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time

NCT ID: NCT03792841 Completed - Prostate Cancer Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC

Start date: February 5, 2019
Phase: Phase 1
Study type: Interventional

A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of prostate specific membrane antigen half-life extended bispecific T-cell engager acapatamab in subjects with metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

NCT ID: NCT03790709 Completed - Alzheimer Disease Clinical Trials

ANAVEX2-73 for Treatment of Early Alzheimer's Disease

Start date: July 3, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73.

NCT ID: NCT03790644 Completed - Clinical trials for Lung Disease Chronic

Powered Assist to Improve Ambulation in Severe Lung Disease

REVIVE
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.

NCT ID: NCT03789032 Completed - Pharmacokinetics Clinical Trials

Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat

Start date: October 3, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, fixed sequence, open-label study to evaluate the effect of multiple oral doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat 300 mg in healthy male and female subjects.

NCT ID: NCT03788434 Completed - Clinical trials for Clostridium Difficile Infection

Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

CONSORTIUM
Start date: February 8, 2019
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).

NCT ID: NCT03787836 Completed - Clinical trials for Diabetes Mellitus, Type 2

Improving Individual Glycemic Response With Exercise Intensity

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

Large interindividual variability exists in the glycemic response to exercise program, resulting in a subset of individuals known as exercise non-responders (NRs). Increasing the intensity of an exercise intervention has been proposed as one method for rescuing NRs by producing beneficial changes. However, this theory has not been tested on NRs classified using glycemic outcomes. This study will evaluate if increasing the intensity of an exercise intervention will elicit a response within previous exercise NRs.

NCT ID: NCT03787719 Completed - Clinical trials for End Stage Renal Disease

Dialysis-Less Frequently In The Elderly

D-LITE
Start date: June 27, 2018
Phase: N/A
Study type: Interventional

Thrice-weekly dialysis is the accepted standard of care for hemodialysis (HD) patients. Observational studies suggest that elderly HD patients do as well and have better quality of life with less dialysis (ie twice-weekly). We propose a single-center pilot study of 40 patients to determine the feasibility of a large randomized controlled trial (RCT) designed to determine the impact of HD frequency on well-being in new HD patients above the age of 70. The primary outcomes will be metrics of feasibility and safety. We hypothesize that an adequately powered RCT that will determine whether elderly patients who dialyze twice weekly have improved well-being compared to thrice-weekly is feasible

NCT ID: NCT03786770 Completed - Frown Lines Clinical Trials

Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)

Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.