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NCT ID: NCT04916470 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

STEP HFpEF DM
Start date: June 15, 2021
Phase: Phase 3
Study type: Interventional

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle and physical activity. The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor. - At 6 of the visits participants will have blood samples taken. - At 5 of the visits participants will be asked to fill in a questionnaire - At 4 of the visits participants will have to do a 6-minute walking test - At 3 of the visits participants will have a test to check the heart. - participants will have their eyes checked before or at the start of the study and at the end of the study Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04915846 Recruiting - Clinical trials for X Linked Myotubular Myopathy

Tamoxifen Therapy for Myotubular Myopathy

TAM4MTM
Start date: December 18, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1 / 2, randomized, double-blinded, single cross-over study, with a washout period between treatment regimens, to test the efficacy and safety of tamoxifen therapy to improve motor and respiratory function in males with XLMTM.

NCT ID: NCT04915755 Active, not recruiting - Neoplasms, Breast Clinical Trials

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

ZEST
Start date: June 28, 2021
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy.

NCT ID: NCT04915300 Not yet recruiting - Clinical trials for Pulmonary Arterial Hypertension

Apabetalone for Pulmonary Arterial Hypertension

APPROACH-2
Start date: October 2023
Phase: Phase 2
Study type: Interventional

Throughout the past twenty years, numerous specific pharmacologic agents targeting the endothelial dysfunction associated with PAH have emerged. Short term placebo-controlled randomized trials assessing PAH-specific monotherapy with these molecules have reported improvements in pulmonary hemodynamics and exercise capacity. A recent meta-analysis also documented a reduction in short-term mortality of about ≈40% with such therapies. Several randomized clinical trials evaluating PAH-specific combination therapy have been conducted. Our recent meta-analysis showed that combination therapy was associated with a 35% risk reduction for the occurrence of clinical worsening compared to monotherapy. Nonetheless, the investigators also showed 17% of PAH patients receiving combination therapy still experienced clinical worsening over a median exposure of 16 weeks. Moreover, long-term survival on PAH-specific also therapy remains poor in the modern era, with a yearly mortality rate of 15 % in incident idiopathic PAH. The identification of innovative therapeutic targets and validation of these complementary therapeutic interventions are thus urgently needed in PAH. The investigators and others (K. Stenmark, University of Colorado and H. Bogaard, VU University Medical Center, Amsterdam, personal communications), have published strong evidence that BRD4 plays a key role in the pathological phenotype in PAH accounting for disease progression and showed that BRD4 inhibition can reverse PAH in several animal models. Intriguingly, coronary artery disease (CAD) and metabolic syndrome are more prevalent in PAH compared with the global population, suggesting a link between these diseases. Interestingly, BRD4 is also a trigger for calcification and remodeling processes and regulates transcription of lipoprotein and inflammatory factors, all of which are important in PAH and CAD. Apabetalone, an orally available BRD4 inhibitor, is now in a clinical development stage with a good safety profile. The overall objective of the study is to explore the efficacy and safety of apabetalone as an add-on therapy for adult PAH patients and to inform the conduct and the design of a Phase 3 trial. The primary objective of the study is to assess the efficacy of apabetalone as evaluated by the change in PVR over a period of 24 weeks compared to placebo in adult subjects with PAH on stable background therapy. Secondary objectives include changes at week 24 in 6MWD, plasma NT-proBNP concentration, WHO functional class, ESC/ERS risk stratification score, health-related quality of life and additional hemodynamic data from right heart. Exploratory objectives are to evaluate the effects of apabetalone compared to placebo in adult subjects with PAH on mortality and clinically relevant morbidity events, and on circulating levels and transcription changes in whole blood markers of metabolism, vascular calcification, inflammation, DNA damage and leucocyte expression of BMPR2.

NCT ID: NCT04915261 Recruiting - Clinical trials for Post-Op Complication

A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery

LENIENT
Start date: August 19, 2021
Phase: Phase 4
Study type: Interventional

The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery. Restrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices. Instructions within both arms of this study are considered within reasonable practice in Canada. All arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 7 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions. All patients are given standard of care instructions for follow up and complication assessment through our device clinic and 24/7 on call nursing program.

NCT ID: NCT04915144 Withdrawn - Clinical trials for Neuroendocrine Tumors

177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs

Start date: January 15, 2023
Phase: Phase 2
Study type: Interventional

This study is to assess if personalized peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATOC results in fewer adverse events than standard PRRT. Subjects will be randomized to either receive personalized or standard PRRT. Personalized PRRT will be determined based on dosimetry calculations after the first cycle. In addition comparisons, will be made with progression-free survival, serial CT imaging, ctDNA, and quality of life questionnaires. Subjects will be followed for 5 years or until they have progression and are switched to another systemic treatment (not including treatment with somatostatin analogues).

NCT ID: NCT04914923 Recruiting - Clinical trials for Obsessive-Compulsive Disorder

Mindfulness-Based Interventions for OCD

MindOC
Start date: November 9, 2021
Phase: N/A
Study type: Interventional

Obsessive-compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting about 2% of the population. It is characterized by the presence of recurrent obsessions and/or compulsions that are time consuming and cause marked distress and/or impairment. Untreated, OCD runs a chronic and deteriorating course. According to the World Health Organization, OCD is among the top 10 leading causes of disability worldwide. Examination of non-medicinal treatments for OCD has focused on two distinct treatments: exposure and response prevention (ERP) and cognitive therapy (CT), often combined into an integrated cognitive-behavioural treatment (CBT). CBT is considered the first line psychological treatment for OCD, with estimates of response rates of between 70-80%. However, there are a significant number of treatment non-responders and the majority of responders are still left with impairing residual symptoms. One area of investigation that has shown potential benefit for general mood and anxiety disorders has been mindfulness-based interventions (MBIs), yet the potential benefits of MBIs in OCD has been largely unexamined, except for several small preliminary studies that show clinical promise. The purpose of this study is to examine the clinical benefits of a standardized MBI treatment for OCD in a large-scale, multi-site randomized controlled trial. The results of this study will directly determine whether Mindfulness can be considered an effective treatment for OCD. If this study can demonstrate that a short-term mindfulness intervention can significantly reduce the suffering associated with OCD, then the findings could easily be translated into routine clinical care in and out of hospital settings. Results of this study will also potentially add to our understanding of the mechanisms that drive OCD symptoms, improve our knowledge of psychological treatment mechanisms, and elucidate how biological factors influence psychological treatment outcomes.

NCT ID: NCT04914507 Recruiting - Clinical trials for Scoliosis Idiopathic

A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

Start date: September 9, 2021
Phase: N/A
Study type: Interventional

Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device

NCT ID: NCT04914481 Recruiting - Clinical trials for Low-Flow, Low-Gradient Aortic Stenosis

Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI

ATLAS TAVI
Start date: April 1, 2021
Phase:
Study type: Observational

The ATLAS TAVI Registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent Transcatheter Aortic Valve Implantation (TAVI) for classical or paradoxical low-flow, low-gradient aortic stenosis (LFLG AS) with available non-contrast MSCT data on aortic valve calcification (AVC). The main objective of this study is the assessment of outcome after TAVI according to AVC density severity in patients with LFLG AS.

NCT ID: NCT04913948 Completed - Covid19 Clinical Trials

Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario, Canada

COPE
Start date: April 30, 2020
Phase:
Study type: Observational

In order to assess the mother-to-infant and potential vertical transmission of SARS-CoV-2 infection in pregnant women, maternal and neonatal biological samples will be prospectively collected from women with confirmed or suspected COVID-19 at participating hospitals across Ontario. Samples will be tested for the SARS-CoV-2 serology and viral load. Outcomes for the study objective will be ascertained through the collection and testing of biological samples from the mother and/or infant. Specifically the investigators will: 1. Assess maternal nasopharyngeal or oropharyngeal swab, vaginal mucosa, ano-rectal swab, amniotic fluid, placenta (including subamniotic swab), breastmilk, cord blood and neonatal nasopharyngeal swab for RNA particles of coronavirus, by ddPCR. 2. Assess maternal serum for anti-coronavirus antibodies, by immunoassay. 3. Examine the impact of coronavirus on the neonate with respect to serology and viral load, in addition to placenta pathology findings and ddPCR. 4. Assess vertical transmission and the effect of coronavirus through placental pathology examination using placental pathology synoptic report.