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NCT ID: NCT05109611 Active, not recruiting - Clinical trials for SARS-CoV-2 Infection

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection

Start date: November 20, 2021
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individuals at risk of exposure to COVID-19 infection.

NCT ID: NCT05107609 Active, not recruiting - Stigma, Social Clinical Trials

Psychobiological Processes in Social Evaluation

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Higher-weight individuals face pervasive weight-related stigma and discrimination in their daily lives. There is conceptual and empirical evidence to suggest that weight stigma contributes to worse physical and psychological health outcomes, mediated by the deleterious psychobiological responses to psychosocial stress. Activating self-soothing emotional states (such as self-compassion) may protect against this psychobiological cascade, conferring resilience to negative social evaluation (such as weight stigma). This proof-of-concept study aims to establish the feasibility of an experimental protocol testing whether an acute self-compassion intervention can attenuate the psychobiological stress response to induced weight-based social-evaluative threat. Participants will be randomized into either self-compassion intervention or rest control groups. A standard body composition assessment will be used to induce weight stigma among young women who self-identify as "higher-weight." Stress-sensitive biomarkers (i.e., salivary cortisol and heart-rate variability) along with psychological indices of self-conscious emotions will be used to quantify the psychobiological stress response. This novel pilot study will contribute to efforts to understand the psychobiological processes by which self-compassion facilitates adaptive responding to acute stress, and will help inform future tests of interventions focused on mitigating the harmful health effects of social stigma.

NCT ID: NCT05104866 Active, not recruiting - Breast Cancer Clinical Trials

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Start date: October 18, 2021
Phase: Phase 3
Study type: Interventional

The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

NCT ID: NCT05103436 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Electrical Stimulation for Spasticity in Spinal Cord Injury

Start date: May 4, 2022
Phase: N/A
Study type: Interventional

This study examines the immediate and long-term effects of lumbosacral TENS on spasticity and residual voluntary force control in spinal cord injury in comparison to no TENS. Participants in the intervention group will receive 2 months of TENS. Participants in the control group will receive TENS after a 2-month delay. Modified Ashworth score and pendulum test will be used to assess spasticity and force control. Electrophysiological measures will be used to assess the activity profile of motorneurons.

NCT ID: NCT05103332 Active, not recruiting - Hypertension Clinical Trials

Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)

KARDIA-2
Start date: November 5, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of zilebesiran on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of zilebesiran as add-on therapy.

NCT ID: NCT05102591 Active, not recruiting - Migraine Disorders Clinical Trials

A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents

Start date: February 22, 2022
Phase: Phase 3
Study type: Interventional

Migraine is a neurological disease characterized by severe and recurrent headaches. Children and adolescents with migraine often present to the emergency department (ED) with acute attacks, where migraine accounts for up to ~30% of all pediatric ED visits for headache. Based on the limited evidence, many centers have adopted protocols whereby children and adolescents who visit the ED with acute attacks of migraine are treated with an IV neuroleptic (metoclopramide or prochlorperazine) and an IV non-steroidal anti-inflammatory (ketorolac). This combination of interventions is largely considered to be standard of care despite no rigorous evidence to support this practice. Side effect rates with the neuroleptics (metoclopramide or prochlorperazine) are considerable, and IV catheters are associated with high adverse event and failure rates in children and adolescents. Therefore, the current standard of care for managing children and adolescents visiting the ED with acute attacks of migraine poses concern to patients and is associated with significant pain and frequent side effects. Emerging neuromodulation devices show promise for expanding acute treatment options. Over the past few years, there has been a growth in research investigating the efficacy and safety of non-invasive neuromodulation, which delivers electrical or magnetic stimulation to nerves or neural tissue, for the management of acute attacks of migraine. At present, there are 3 commercially available, non-invasive neuromodulation devices that effectively and safely treat acute attacks of migraine in adults. Because none of these devices have a high level evidence in children, adolescents, nor in the ED setting, there is clinical equipoise as to which device would be most appropriate to study for treating children and adolescents visiting the ED with acute attacks. Throughout our patient engagement work, children and adolescents with migraine have identified that they are interested in trying remote electrical neuromodulation for treating migraine attacks in the ED. The investigators propose a pilot randomized controlled trial (RCT) that will determine the feasibility and acceptability of executing a phase III RCT, in which children and adolescents visiting the ED with acute attacks of migraine will be randomized to REN or standard of care IV treatment, and then crossed over to the other treatment arm if the initial intervention is not effective.

NCT ID: NCT05100225 Active, not recruiting - Clinical trials for Osteoarthritis, Knee

Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis

Start date: September 30, 2021
Phase: Phase 2
Study type: Interventional

Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).

NCT ID: NCT05097430 Active, not recruiting - Clinical trials for Hazardous Alcohol Use

PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)

Start date: September 28, 2021
Phase: N/A
Study type: Interventional

The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of HIV pre-exposure prophylaxis (PrEP) treatment.

NCT ID: NCT05095766 Active, not recruiting - Clinical trials for Brain Metastases, Adult

Comparaison Between MRI Alone or Combined With Positron Emission Tomography for Brain Metastasis Diagnosis

ITIRR
Start date: November 23, 2017
Phase:
Study type: Observational

During gamma scalpel treatment of brain tumors and metastases, a follow-up magnetic resonance imaging (MRI) scan is performed. The radiologist who reviews the MRI assesses whether there is an increase in signal at the tumor site. This increase potentially indicates that the treatment was not effective. However, in 25% of cases (one in four people), this signal enhancement is not due to ineffective treatment, but to inflammation (swelling/damage) and tissue death around the tumor. This is why when an increase in signal is detected, additional follow-up is essential. The standard additional follow-up has an accuracy of about 83%. This is an observational study on patients with brain metastatis comparing MRI alone or combined to PET-FET to improve accuracy of diagnosis of metastasis recurrence.

NCT ID: NCT05094609 Active, not recruiting - COVID-19 Clinical Trials

Phase 1 Trial of ChAd68 and Ad5 Adenovirus COVID-19 Vaccines Delivered by Aerosol

Start date: January 3, 2022
Phase: Phase 1
Study type: Interventional

This is a phase 1 study in healthy volunteers who have received at least three doses of an mRNA COVID-19 vaccine, to evaluate the safety and immune responses that develop in the blood and lungs following the administration by aerosol of either Ad5-triCoV/Mac or ChAd-triCoV/Mac, new experimental adenovirus-based vaccines expressing SARS-CoV-2 spike, nucleocapsid and RNA polymerase proteins.