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NCT ID: NCT04978337 Terminated - Clinical trials for Respiratory Syncytial Virus

A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection

PRIMROSE
Start date: November 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.

NCT ID: NCT04972968 Terminated - Clinical trials for Polymyalgia Rheumatica

A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154

AIM-PMR
Start date: September 9, 2021
Phase: Phase 2
Study type: Interventional

Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide. The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04963790 Terminated - Covid19 Clinical Trials

Enabling Family Physicians to Reduce Vaccine Hesitancy and Increase Covid-19 Vaccine Uptake

Start date: November 14, 2021
Phase: N/A
Study type: Interventional

The approval and distribution of COVID-19 vaccines is an important milestone in the fight against the pandemic. However, although vaccines are widely recognized as a key public health measure to control infectious disease, there are still people who remain hesitant to get vaccinated. In Canada, 83% of Canadian adults have received or are willing to receive the vaccine. However, nearly 20% of adults and a larger proportion of parents of younger children remain concerned about receiving vaccines. In the context of a project to enable family physicians to identify vaccine-hesitant patients and deliver a tailored COVID-19 vaccination outreach campaign, the Canadian Practice Information Network, a tool for primary care providers to communicate with their patients, will be used to engage and address vaccination hesitancy in Canada. The study will identify information needs about COVID-19 vaccination among community-dwelling patients in three Canadian provinces and will assess the effectiveness of a tailored COVID-19 vaccine digital health communication strategy for primary care practices to address vaccination hesitancy and improve COVID-19 vaccination uptake. A two-arm cluster randomized trial design will be conducted in primary care practices in three Canadian provinces: Ontario, British Columbia, and New Brunswick. The study will use a convenience sample of primary care practice in these provinces. Recruited participants will be randomly allocated to the intervention and control groups. Patients assigned to the control group will receive health messages unrelated to the COVID-19. Participants in the intervention group will receive a series of tailored messages on COVID-19 vaccination targeting the main factors for hesitancy to address their concerns and persuade them to receive the COVID-19 vaccine. Aggregated survey responses across practices will be used to create segments of unvaccinated patients reflecting age, language, education level, rurality, sex, gender, ethnicity, and their attitudes or reasons for vaccine hesitancy or access barriers. Then, tailored messages will be created in a way that is meaningful to the recipients in the different segments. The primary outcome is the proportion of vaccine-hesitant individuals who receive a COVID-19 vaccine during the intervention period. The secondary outcome is the overall COVID-19 vaccine uptake.

NCT ID: NCT04961658 Terminated - Septic Shock Clinical Trials

Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients

AMETHYST
Start date: August 11, 2021
Phase: Phase 1
Study type: Interventional

Bacterial sepsis occurs in patients with severe infections. The condition is caused by toxic substances (toxins) released from bacteria and the patient's elevated inflammatory response to those toxins. In preclinical studies, human mesenchymal stromal cells (MSCs) have been proven to modulate host inflammation in infections, including sepsis. The purpose of the Phase I, open label, dose escalation safety trial is to determine whether escalating doses of enhanced MSCs (GEM00220) are safe and well tolerated in patients with septic shock.

NCT ID: NCT04956159 Terminated - Clinical trials for Inflammatory Bowel Diseases

TMS in Inflammatory Bowel Disease

Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

Transcranial magnetic stimulation (rTMS) has demonstrated diagnostic and therapeutic potential for a number of conditions and is an approved treatment for depression. Inflammatory Bowel Disease (IBD) has a significant impact on mental health, and comorbid maladaptive behaviors and pain are highly prevalent in patients with IBD and are often under-treated. The investigators predict TMS will improve comorbid maladaptive behavior (heightened interoceptive awareness, sleep, fatigue, catastrophizing, anxiety and depression), reduce pain and improve quality of life in persons with inflammatory bowel disease (IBD). Further, TMS benefits will be associated with changes in gut microbiome as measured by stool, blood and urine samples and normalization of IBD-associated changes in brain structure and/or function as measured by magnetic resonance imaging (MRI).

NCT ID: NCT04955990 Terminated - Clinical trials for Pulmonary Arterial Hypertension

A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants

CARE PAH
Start date: October 14, 2021
Phase: Phase 4
Study type: Interventional

This study is designed to describe pulmonary arterial hypertension (PAH) participants in terms of their clinical characteristics, therapies used, disease progression, and outcomes (example, death, hospitalization, risk category for predicted mortality risk, and patient-reported outcomes [PROs]) in real-world clinical practice. This study will collect high-quality real-world data that may be used as a stand-alone dataset or in combination with other studies to address relevant research questions (example, serve as an external control dataset to another study) to support development and access to PAH therapies, as well as to contribute to the knowledge base of PAH through publications.

NCT ID: NCT04948554 Terminated - Clinical trials for Systemic Sclerosis With and Without Interstitial Lung Disease

A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002)

Start date: March 10, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the MK-2225-002 (A1334-02) study is to evaluate the safety and tolerability of MK-2225 (ACE-1334) plus standard of care (SOC) in participants with Systemic Sclerosis (SSc) following multiple doses.

NCT ID: NCT04946318 Terminated - Asthma Clinical Trials

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma

Start date: September 8, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide safety and tolerability, pharmacokinetics and immunogenicity data for multiple CSJ117 doses inhaled once daily compared with placebo, in adult asthma participants treated with medium or high dose ICS plus LABA alone or with additional asthma controllers (additional controllers allowed: LTRA, LAMA, Theophylline and its derivatives), who have completed the prior phase llb study CCSJ117A12201C (NCT04410523).

NCT ID: NCT04944784 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

COURAGE-ALS
Start date: August 16, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

NCT ID: NCT04944758 Terminated - Clinical trials for Major Depression in Remission

Feasibility of Adherence to Light Therapy

Start date: April 21, 2022
Phase: N/A
Study type: Interventional

In this feasibility study, we propose an important question: What factors will affect participant adherence to the daily use of light therapy for maintenance treatment of depression? To answer this question, we will conduct a pilot study of open-label treatment with light therapy in a small sample (n=10) of participants meeting eligibility criteria to determine what factors will challenge or enhance adherence to a standard light therapy protocol.