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Hypertrophy clinical trials

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NCT ID: NCT05572242 Recruiting - Clinical trials for Alveolar Ridge Enlargement

Leukocyte-platelet Rich Fibrin for Alveolar Ridge Preservation

L-PRF
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

After tooth extraction, there is a subsequent bone loss as a part of the natural healing of the tissue. Up to 50% of bone loss occurs during the first three months after extraction, jeopardizing a possible implant treatment. Alveolar ridge preservation techniques reduce bone loss, allowing a future implant treatment. Different bone filling materials have been used with good clinical results. The second-generation platelet concentrates (L-PRF) have recently been shown to induce bone regeneration when filling the socket after extraction, with significant biological and economic advantages. The hypothesis of this study is to test whether or not the use of L-PRF in alveolar ridge preservation results in a non-inferior horizontal radiographic change compared with the combination of a xenogeneic bone substitute with a collagen matrix.

NCT ID: NCT05569382 Recruiting - Clinical trials for Non-obstructive Hypertrophic Cardiomyopathy

Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy

TEMPO II
Start date: August 10, 2022
Phase: Phase 4
Study type: Interventional

Aim: to compare the treatment effects of Bisoprolol (beta 1 receptor specific beta blocker (BB)) and Verapamil (cardio-specific calcium channel blockers (CCB)) in patients with non-obstructive hypertrophic cardiomyopathy (HCM). Background: Hypertrophic cardiomyopathy (HCM) is characterized by hypertrophy of the left ventricular wall and a hypercontracted state of the sarcomeres. This narrows the left ventricular cavity, but though the left ejection fraction is increased the stroke volume and the cardiac output cannot be fully compensated. The disease manifestations can be mild or develop into severe functional limitations and devastating complications at early age. Dyspnea, chest pain, palpitations and syncope are the most common symptoms, and patients are at risk of supraventricular and ventricular arrhythmias. Arrhythmias and sudden cardiac deaths may precede heart failure symptoms. Patients with symptomatic HCM are treated initially with beta blockers and calcium channel blockers. However, there is limited evidence supporting the effectiveness of this guideline-recommended treatment in HCM. Methods: The study is a multicenter, double-blinded, randomized, placebo-controlled cross-over trial. Patients are randomized in to three 35-days treatment periods with Bisoprolol, Verapamil and Placebo. Each treatment period includes a 7-days up titration period, a 21-days target dose period and a 7-days down titration period. Between treatment periods 45 days treatment pause is allowed. End point will be evaluated at day 21 (- 4 days). Patients will be evaluated by cardiopulmonary exercise test, echocardiography, 7 day Holter-monitoring, biomarkers and the Kansas City Cardiomyopathy Questionnaire (KCCQ). A subgroup of patients will also be evaluated with cardiac magnetic resonance imaging. Hypotheses: Three separate phases each with one primary effect parameters will be analyzed between treatment with Bisoprolol and Verapamil: Phase 1: The maximal oxygen consumption (VO2 max) is different (ΔVO2 max ≥1 ml/kg/min) between treatments in non-obstructive HCM patients Phase 2: The left ventricular enddiastolic volume (LVvol) is different (ΔLVvol ≥3 ml) between treatments in non-obstructive HCM patients. Phase 3: The incidence of non-sustained ventricular tachycardia (NSVT) is different (Hazard ratio ≥ 0.5) between treatments in non-obstructive HCM patients. The trial will be performed and analyzed in three phases, and each phase may be unblinded and analyzed separately.

NCT ID: NCT05556343 Active, not recruiting - Clinical trials for Cardiomyopathy, Hypertrophic

A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

MERCUTIO
Start date: January 18, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MYK-224 in participants with obstructive Hypertrophic Cardiomyopathy (oHCM)

NCT ID: NCT05550584 Completed - Anesthesia Clinical Trials

High Flow Oxygen During Operative Hysteroscopy.

HOPE
Start date: June 17, 2022
Phase: N/A
Study type: Interventional

High-flow nasal cannula (HFNC) oxygen therapy represents an open circuit ventilation system that uses flows up to 70 L/min of 100% oxygen through the Optiflow THRIVETM device (Fisher and Paykel Healthcare Ltd, Auckland, New Zealand). Compared to conventional oxygen therapy systems, the heating and humidification of the flows facilitate tolerability by the patient, allow to reach higher and more stable inspiratory fractions of oxygen, produce a flow-dependent effect of continuous positive airway pressure and by reducing dead space, have the potential to increase alveolar volume and improve gas exchanges. The use of HFNC is increased in anesthesia as the only airways management technique during short-term procedures under procedural sedation or general anesthesia. Operative hysteroscopy is a short-term procedure (<30 minutes), usually performed in a day-hospital regimen, under procedural sedation. In case of apnea and/or hypoventilation, or for long and complex hysteroscopic procedures, the patient can be ventilated through facial or laryngeal masks. The primary objective of this prospective randomized controlled trial is to compare the rate of success of ventilation using the THRIVE device to laryngeal mask ventilation during operative hysteroscopies under procedural sedation. Secondary objectives will be the comparison of the percentage of complications in terms of inability to manage the airways, episodes of hypotension, cardiac arrhythmias, post-operative nausea and vomiting, degree of dyspnea and comfort of the patient in the Post-Anesthesia Care Unit between the two methods.

NCT ID: NCT05544955 Not yet recruiting - Clinical trials for Physical Performance

Protein Ingestion Timing on Body Composition and Biochemical Markers in Resistance-trained Males

Start date: September 17, 2022
Phase: N/A
Study type: Interventional

Protein ingestion timing is an important component for muscle accretion. We hypothesized that protein ingestion timing could affect muscular adaptations and performance in resistance-trained men.

NCT ID: NCT05532228 Completed - Infections Clinical Trials

Evaluation of the Functional Impact of Adenotonsilectomy

Start date: August 20, 2020
Phase:
Study type: Observational

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

NCT ID: NCT05510180 Completed - Clinical trials for Hypertrophic Cardiomyopathy

CVD Risk Profile in Children With HCM

Start date: May 21, 2019
Phase:
Study type: Observational

Hypertrophic cardiomyopathy is a disease of the heart muscle that causes the heart to become thicker and this thickness places children at risk of heart rhythm problems, heart failure and sudden death.To decrease the risk of sudden death, health care providers generally counsel that the patient should stop all intense physical activity. While this recommendation may decrease the risk of sudden death it is unclear what the long term impact of reduced physical activity is on cardiovascular health in children with HCM. Cardiovascular (CV) disease is a disease of the heart and blood vessels and is the cause of heart attacks in adults. There are many risk factors for the development of CV disease including genetics, medical conditions and lifestyle choices. While some studies in adults suggest that patients with HCM are at higher risk of poor cardiovascular health, this has not yet been assessed in children. Although, CV disease is generally thought of to be a disease of adults, there is a lot of information that suggests the development of CV disease starts early in life and therefore by promoting heart healthy lifestyles in children, it is possible that these children will becomes healthier adults. The goal of this project is to assess risk factors for CV disease in a population of children with HCM at the two largest pediatric cardiac programs in Canada. This assessment will be to look at factors we can measure (e.g., weight, cholesterol levels) and patients' and families' perceptions of what it means to be heart healthy. It is hoped that through this project risk factors for heart disease, and poor "heart healthy" lifestyles choices, will be identified in order to develop strategies to decrease these risk factors in patients with HCM. With a better understanding of the families' perceptions of heart healthy behaviours, educational tools and resources for cardiovascular health promotion in patients with HCM can be developed.

NCT ID: NCT05489705 Recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive HCM)

DISCOVER-HCM
Start date: August 16, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) treated in the real-world setting. The registry study also provide a real-world understanding of the current obstructive HCM patient population, treatment patterns, and clinical relevant outcomes for patients with symptomatic obstructive HCM in the US.

NCT ID: NCT05461157 Enrolling by invitation - Wound Heal Clinical Trials

Preoperative Silicone Ointment and Wound Healing

Start date: November 14, 2022
Phase: N/A
Study type: Interventional

Optimal scar healing is of great importance to patients, especially following surgery of the head and neck. This study evaluates the effectiveness of preoperative silicone ointment in wound healing in head and neck surgeries.

NCT ID: NCT05459935 Recruiting - Clinical trials for Obstructive Sleep Apnea

Photobiomodulation for Pediatric Hypertrophic Tonsils

Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Pediatric obstructive sleep apnea is a medical condition where a child has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which the primary treatment is usually a surgery targeted towards removing swollen tonsils and adenoids. However, surgical removal of tonsils and adenoids comes with its own risks of complications during and after surgery including secondary hemorrhage and long term increased risks for respiratory and infectious diseases. Perhaps more importantly, surgical removal of swollen tonsils and adenoids does not guarantee successful treatment of a child's obstructive sleep apnea. The use of laser light therapy in a non-cutting manner (known as photobiomodulation and abbreviated as PBM) has been a relatively new development within medicine. Recently, dentists have begun to use PBM as a method to treat adult snoring and, with lesser success, adult obstructive sleep apnea. To date, there are no known side effects to the use of PBM for the treatment of any sleep breathing disorders. However, no research has been published on the use of PBM for the treatment of pediatric obstructive sleep apnea or swollen tonsils in children The purpose of this project is to determine whether photobiomodulation can provide a beneficial effect on pediatric hypertrophic tonsils and pediatric obstructive sleep apnea and, if it does, to create the appropriate workflow, referral pathways, and treatment parameters for clinicians to provide this treatment as a multidisciplinary approach in a clinical setting. The investigators hypothesize that photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea and will also result in improved AHI scores (be able to breath significantly better when sleeping) in these children.