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NCT ID: NCT03604185 Terminated - Aging Clinical Trials

Effects of Short-term Choir Participation on Auditory Perception in Hearing-aided Older Adults.

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

Hearing loss has been associated with decreased emotional wellbeing and reduced quality of life in aging adults. Although hearing aids can target aspects of peripheral hearing loss, persistent perceptual deficits are widely reported. One prevalent example is the loss of the ability to perceive speech in a noisy environment, which severely impacts quality of life and goes relatively unremediated by hearing aids. Musicianship has been shown to improve aspects of auditory processing, but has not been studied as a short-term intervention for improving these abilities in older adults with hearing aids. The current study investigates whether short-term choir participation can improve three aspects of auditory processing: perception of speech in noise, pitch discrimination, and the neural response to brief auditory stimuli (frequency following response; FFR). Sixty hearing aided older adults (aged 50+) recruited from the Greater Toronto Area will be randomly assigned to one of three conditions: a choir singing class (n=20), a music appreciation class (n=20), and a do-nothing control group (n=20). Choir participants will take part in a singing class for 14 weeks, during which they will take part in group singing (2 hours/week) supported by individual online musical training (1 hour/week). Participants will undergo pre- and post-training assessments, conducted during the first week of the choir class and again after the last week. Participants in the music appreciation class will be involved in 14 weeks of music listening classes, and the do-nothing control group will not engaged in an active intervention. All participants will undergo the same battery of assessments, measured before and after the 14-week time frame. Auditory assessments (speech perception in noise and pitch discrimination tests) will be administered electronically, and the FFR will be obtained using electroencephalography (EEG). Each of the four assessment sessions (two pre-training, two post-training) will last approximately 1.5 hours, for a total of 6 hours of data collection. The goal of this research is to investigate whether short-term musical training will result in improved auditory outcomes for older adults with hearing aids. It is predicted that the choir singing group will demonstrate the greatest improvements across all auditory measures, and that both the choir singing and musical appreciation groups will experience greater improvements than the do-nothing control group.

NCT ID: NCT03603964 Terminated - Clinical trials for Acute Myeloid Leukemia

Guadecitabine Extension Study

Start date: July 18, 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label extension study for participants who participated in a previous Astex-sponsored guadecitabine clinical study [including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)].

NCT ID: NCT03603522 Completed - Atopic Asthma Clinical Trials

Probiotics and Capsaicin Evoked Coughs

PCEC
Start date: July 16, 2019
Phase: N/A
Study type: Interventional

Cough in asthma is a very common and troublesome symptom in asthma, which predicts severity and poor prognosis. Previous studies have shown that asthmatics have an exaggerated cough response to capsaicin. Currently available asthma treatment is not designed to target the cough reflex directly, so this presents an unmet need for patients. The treatment being tested in this study is the commercially available over the counter oral probiotic BioGaia® DSM17938. Based on clinical and pre-clinical evidence, it is hypothesized that TRPV1 antagonism with BioGaia® DSM17938 will result in a reduction in capsaicin evoked coughs in patients with asthma.

NCT ID: NCT03603314 Completed - Clinical trials for Severe Sudden Sensorineural Hearing Loss

Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

AUDIBLE-S
Start date: February 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period

NCT ID: NCT03602859 Active, not recruiting - Ovarian Neoplasms Clinical Trials

A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

FIRST
Start date: October 11, 2018
Phase: Phase 3
Study type: Interventional

Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated both in the PD-L1 positive and overall population of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.

NCT ID: NCT03602781 Withdrawn - Clinical trials for Pulmonary Arterial Hypertension

Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric

Start date: August 2018
Phase: Phase 3
Study type: Interventional

Study of PAH Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide

NCT ID: NCT03602768 Completed - Aging Clinical Trials

Evaluation of the Online Memory & Aging Program and Online Goal Management Training

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

The current study is designed to test the effectiveness of online programs for memory and executive functions in healthy aging. The investigators are testing online adaptations of two cognitive interventions that have been extensively studied, validated, and implemented in clinical settings: The Memory & Aging Program (MAP) targets normal memory change in healthy aging, and Goal Management Training (GMT) targets executive functioning deficits in a variety of cognitive and neurological conditions including healthy aging. Both programs combine psycho-education, targeted skills training and clinical support to empower participants with knowledge and strategies to harness their cognitive faculties. These programs are being tested against a waitlist control as well as against a commercial/research brain training platform (Cambridge Brain Sciences) in a design comparing performance on memory and executive functioning measures before and after the interventions/controls. The main hypothesis is that MAP will lead to memory-specific improvements above control conditions, whereas GMT will lead to greater improvements in measures of executive functions relative to controls.

NCT ID: NCT03602560 Completed - Clinical trials for Primary Biliary Cholangitis

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

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

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

NCT ID: NCT03601845 Completed - Clinical trials for Diffuse and Focal Liver Diseases, Cerebral Function

MRE-IA in Liver Disease and Neurovascular Imaging

MRE-IA
Start date: January 31, 2019
Phase: N/A
Study type: Interventional

The objective of this research project is to develop Magnetic Resonance Elastography by Intrinsic Activation (MRE-IA) imaging methods at two imaging centers (CRCHUS and CRCHUM) for use in ongoing studies in liver disease and neurovascular imaging. MRE is a developing MR imaging modality that provides detailed maps of tissue's mechanical properties, based on displacement measurements made during the propagation of low amplitude vibrations through the region of interest. MRE-IA uses the pressure pulses of the cardiac cycle to induce the vibrations needed for MRE image reconstruction. MRE-IA has already been demonstrated based on the use of existing, clinically approved MR imaging sequences, and once this capability has been established at the two centers, initial trials will be done to demonstrate the method's potential in liver and neurovascular imaging. In the case of the liver, this pilot project funding will be used to perform MRE-IA imaging in patients with chronic liver disease and focal liver lesions. Results will be analyzed to establish the relationship between the mechanical properties mentioned above and disease stage. In the neurovascular case, imaging will be conducted under basic visual and motor stimulus conditions in healthy subjects, and results compared non-stimulus control images to determine changes in the above properties based on brain function. In addition, MRE-IA images will be compared with BOLD imaging to investigate the role of fluid conductivity in fMRI results.

NCT ID: NCT03601793 Completed - Alcohol Problem Clinical Trials

An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator

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

The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.