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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Prednisone Administration in Quiescent COPD Patients to Determine the Effect on Gene Expression

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Chronic Obstructive Pulmonary Disease
    Chronic Obstructive Pulmonary Disease
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: Prednisone

Eligibility
  • Ages: 19 to 95 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Prednisone

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

St. Paul's Hospital, Vancouver, British Columbia, Canada

Brief Summary

In this study, prednisone dose, day/time administration will be controlled in a stable COPD patient population to determine its effect on peripheral whole blood gene expression. This data has never been collected in a COPD population using the investigators' chosen platform for gene expression (Affymetrix Human Gene 1.1 ST). Conducting this experiment is essential for achieving the broader aims of an already existing and related study titled "Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management" study. As part of this existing study, blood is being collected from hospitalized and non-hospitalized COPD patients in order to develop a blood-based biomarker test for the diagnosis and prediction of acute exacerbation of COPD (AECOPD). The majority of these patients were administered prednisone as part of standard care for the treatment of AECOPD. As such, the effect of prednisone on gene expression needs to be ruled out.

Assessment of Metoprolol in the Prevention of Vasovagal Syncope in Aging Subjects

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Vasovagal Syncope
    Vasovagal Syncope
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: Metoprolol, Drug: Matching Placebo

Eligibility
  • Ages: 40 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Metoprolol, Drug: Matching Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

St. Boniface General, Winnipeg, Manitoba, Canada

Brief Summary

Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and probably is responsible for CDN $250 million in health care spending each year. It is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. The most common cause is vasovagal syncope. This occurs in people of all ages, and is a lifelong predilection. While the median number of faints in the population is 2, those who come to the investigators care have a median 10-15 lifetime spells, and have an increased frequency in the year before presentation. Vasovagal syncope is due to abrupt hypotension and transient bradycardia, which cause cerebral hypoperfusion. The pathophysiology may be either failure of venous return or progressive vasodilation, both due to inappropriately low sympathetic outflow. Sympathetic stimulation might be involved early in the reflex cascade. There is no known medical treatment for frequent fainting. The investigators performed the pivotal CIHR-funded randomized trials that showed that neither permanent pacing, beta blockers, nor fludrocortisone help the majority of patients. However 3 observational studies suggested that beta blockers prevent syncope in older subjects, and the Prevention of Syncope Trial (POST1) showed in a prespecified, -stratified analysis that patients ≥42 years tended to benefit. The investigators recent meta-analysis showed a benefit from metoprolol in these patients, with a hazard ratio of 0.52 (CI 0.27 to 1.01), and an age-specific response to beta blockers (p = 0.007). These results suggest the need for a randomized clinical trial of metoprolol for the prevention of vasovagal syncope in older subjects. Accordingly,the investigators conducted a poll of 48 cardiologists and neurologists in Canada and abroad: 98% stated that a randomized trial was necessary, and 92% agreed to participate in such a trial. Separately, this study emerged as the first choice for syncope randomized trials after consultation with Canadian and international experts. Objective: To determine if treatment with metoprolol in patients ≥40 years old with moderate to severely frequent vasovagal syncope will better suppress syncope recurrences than placebo. Methods: This will be a longitudinal, prospective, parallel design, placebo-controlled, randomized clinical trial. Patients will be enrolled during a recruitment period of 4 years and followed for a fixed period of 1 year. Subjects will have had ≥1 faint in the previous year, and a diagnosis of vasovagal syncope based on a quantitative diagnostic score. They will be randomized to receive either metoprolol or placebo at an initial dose of 50 mg bid. Dose adjustments will be made according to treating physician discretion to optimize tolerance and compliance while maximizing dose. The primary outcome measure will be the time to the first recurrence of syncope (after a 2 week dose titration wash-in period) over the 1-year observation period. The primary analysis will be performed on an intention-to-treat basis. Secondary analyses will include an on-treatment analysis, as well as analyses comparing syncope and presyncope frequency, number needed to treat, quality of life, impact of syncope on daily living, and cost from the perspective of the publicly funded health care system. The investigators will enroll 248 patients to have an 85% power to detect a reduction (p<0.05) in the primary outcome from 50% (placebo group) to 30% (midodrine group), a 40% relative risk reduction. This sample size also allows for a 11% rate of subject dropout with loss to follow-up before a syncopal event. The University of Calgary Syncope Clinic has a well-functioning clinical trial apparatus that successfully completed the randomized, multicenter Prevention of Syncope Trials (POST1: metoprolol for vasovagal syncope; POST2: fludrocortisone for vasovagal syncope) and SIRCAT (Statin-Induced Reduction of Cardiomyopathy Trial). Enrolment is underway in the CIHR-funded POST3 (pacing versus loop recorders in syncope patients with bifascicular block) and POST4 (midodrine for vasovagal syncope). Study centres that were highly productive in POST1-4 have agreed to participate. The investigators therefore will have ample syncope enrolling centres. Relevance: This study will provide evidence to inform the use of metoprolol in the treatment of moderate to severely frequent syncope in older patients with vasovagal syncope. Given the lack of any other conventional medical therapy the investigators expect it to have rapid impact on care.

Saxenda in Obesity Services (STRIVE Study)

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Obesity, Weight Loss, Diabetes Mellitus
    Obesity, Weight Loss, Diabetes Mellitus
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: Saxenda, Other: Specialist Obesity Management Services

Eligibility
  • Ages: 18 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Saxenda, Other: Specialist Obesity Management Services

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

St Vincent's University Hospital, Dublin, Ireland

Brief Summary

A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg [LIRA 3mg] with pre-specified stopping rules for the medication). The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.

Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Diabetes Mellitus, Type 2
    Diabetes Mellitus, Type 2
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: Diabetes mellitus Type 2 De-escalation treatment (DET)

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Diabetes mellitus Type 2 De-escalation treatment (DET)

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

NYC Research, Inc., New York, New York, United States

Brief Summary

This phase IV study is a prospective open-label multi-center study to investigate the effect of a temporary individualized poly-pharmaceutical De-escalation treatment with the target to regenerate ß-cell function over 12 weeks on the disease stage and glycemic control in patients with type 2 diabetes. This is an uncontrolled pilot study to collect data for later confirmatory trials.

ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD)

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Hypertension
    Hypertension
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: ACEI/CCB, Drug: ACEI/DIU

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: ACEI/CCB, Drug: ACEI/DIU

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Brief Summary

Study name: ACEI/CCB versus ACEI/DIU combination antihypertensive therapy in Chinese hypertensive patients (ACvAD) Rationale:Most current hypertension guidelines recommend the combination therapy of an angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) with a calcium antagonists (CCB) or thiazide diuretics (DIU). However, whether the two combination treatments have similar antihypertensive effects in Chinese hypertensive patients is still lack of clinical evidence, especially randomized controlled trials using ambulatory or home blood pressure measurement as the main evaluation method. Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: ACEI/CCB group and ACEI/DIU group. Study population: Men or women over 18 years (n=580) meeting the inclusion/exclusion criteria. Randomization and treatment: Potentially eligible patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers and whether receive antihypertensive treatment, eligible patients will be randomly divided into two groups, taking benazepril 10 mg/amlodipine besylate 5mg fixed-dose combination (1 tablet once a day) or benazepril 10 mg/hydrochlorothiazide 12.5 mg fixed-dose combination (1 tablet once a day). Follow up: All patients should sign an informed consent form before entering the study. The follow-up period is 6 months. Sample size estimation: a total of 580 patients should be enrolled in this study.

Second-generation Drug-eluting Stents in Diabetes

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Coronary Artery Disease, Diabetes Mellitus
    Coronary Artery Disease, Diabetes Mellitus
  • Phase Phase 4
    Phase 4
INTERVENTION

Device: Polymer-free amphilimus-eluting stents, Device: Biolinx Polymer-based zotarolimus-eluting stents

Eligibility
  • Ages: 18 to 100 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Device: Polymer-free amphilimus-eluting stents, Device: Biolinx Polymer-based zotarolimus-eluting stents

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

Brief Summary

This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology. It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design. The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).

Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Atopic Dermatitis
    Atopic Dermatitis
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: Crisaborole 2% Top Oint

Eligibility
  • Ages: 2 Years and older (Child, Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Crisaborole 2% Top Oint

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

MGH Clinical Unit for Research Trials in Skin (CURTIS), Boston, Massachusetts, United States

Brief Summary

The purpose of this study is to document the timing of improvement in atopic dermatitis symptoms and severity following the application of crisaborole ointment 2% in patients 2 years or older with mild to moderate atopic dermatitis. Crisaborole ointment 2% will be applied topically twice daily for four weeks and progress will be assessed by photography and patient-reports.

Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Vaccination
    Vaccination
  • Phase Phase 4
    Phase 4
INTERVENTION

Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun, Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang, Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS

Eligibility
  • Ages: 18 to 24 Months (Child)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun, Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang, Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Yangxian Center for Disease Control and Prevention, Hanzhong, Shaanxi, China

Brief Summary

Subjects will be recruited and divided into 3 groups: Hepatitis A(Live)Vaccine,Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd Hepatitis A(Live)Vaccine,Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd., and Hepatitis A(Live)Vaccine,Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. After immunization, the immunogenicity and safety of three different manufacturers will be compared and the data will be analyzed.

Low-dose Glucocorticoid Vasculitis Induction Study

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Wegener Granulomatosis, Microscopic Polyangiitis, Anti-Neutrophil...
    Wegener Granulomatosis, Microscopic Polyangiitis, Anti-Neutrophil...
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: Rituximab, Drug: Glucocorticoids

Eligibility
  • Ages: 20 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Rituximab, Drug: Glucocorticoids

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Asahi General Hospital, Asahi, Chiba, Japan

Brief Summary

Previous reports suggested conventional immunosuppressants such as cyclophosphamide could not reduce glucocorticoid dose in remission induction in ANCA-associated vasculitis because of lower remission rate and higher relapse rate. However those reports didn't include rituximab. B cell depletion therapy by rituximab is a new strategy for remission induction in ANCA-associated vasculitis. The RAVE and RITUXVAS trial (NEJM 2010, both) showed high-dose glucocorticoid plus rituximab had roughly the same efficacy and safety as high-dose glucocorticoid plus IV-cyclophosphamide. In addition, recent retrospective observational studies reported low-dose glucocorticoid plus rituximab led to re-induction in severe relapsing ANCA-associated vasculitis. Thus, the investigators aim to investigate whether rituximab can reduce glucocorticoid dose in induction remission in ANCA-associated vasculitis (to show non-inferiority for efficacy between low-dose and high-dose glucocorticoid plus rituximab). Participants will be randomised to the "low-dose glucocorticoid plus rituximab" or the high-dose glucocorticoid plus rituximab" groups. Primary endpoint is proportion of remission at 6 months, then data regarding relapse and long-term safety will be collected until 24 months. The study has been designed by the principal and coordinating investigators. It will include 140 participants from 18 hospitals in Japan. It is funded by Chiba University Hospital and Chiba East Hospital.

Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Spinal Cord Injury
    Spinal Cord Injury
  • Phase Phase 4
    Phase 4
INTERVENTION

Drug: NeuroAiD

Eligibility
  • Ages: 18 to 65 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: NeuroAiD

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia

Brief Summary

SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and will provide important information on the feasibility of conducting larger controlled trials.