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NCT ID: NCT05916742 Recruiting - Gingival Recession Clinical Trials

Biofunctionalization of a Volume-stable Collagen Matrix (VCMX) for the Treatment of Single Gingival Recession

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

The treatment of single gingival recessions comprises different well-established techniques, and the association between coronally advanced flap (CAF) and the subepithelial connective tissue graft is considered the gold standard. However, despite the excellent clinical results obtained, the use of subepithelial connective tissue graft is related to an increased risk of trans and postoperative bleeding, a longer duration of the surgical procedure and greater postoperative pain and morbidity. To overcome these limitations and increase patient acceptance, new biomaterials have been developed as possible alternatives to the use of connective tissue graft. Recently, tissue engineering has been investigating collagen matrices as carriers of biologically active substances. In vitro and in vivo studies have shown that the biofunctionalization of these matrices using injectable platelet rich-fibrin (i-PRF) can optimize the healing process of soft tissues using own's patient regenerative components. However, although it has promising potential, clinical studies evaluating the performance of functionalized collagen matrices are still scarce in the literature. Thus, the present study aims to evaluate the clinical, esthetic, patient-centered, immuno and microbiological results of the use of the biofunctionalized volume stable collagen matrix (VCMX) for the treatment of single gingival recessions RT1. For such purpose, a randomized controlled clinical trial of superiority, parallel and blind will be carried out. Seventy-five patients with RT1 single gingival recession will be selected, who will be randomly allocated to one of the following groups: CAF+VCMX+i-PRF (n = 25), coronally advanced flap associated with VCMX functionalized with i-PRF; CAF+VCMX (n=25), coronally advanced flap associated with VCMX; and CAF group (n = 25), coronally advanced flap alone (CAF). The groups will be compared regarding clinical, esthetic and patient-centered outcomes at the baseline, three and six months after the surgical procedure. The microbiological evaluation will be performed at baseline, three and six months after surgery and the concentration of inflammatory markers and growth factors will be assessed before the procedure and 3, 7, 14, 30 and 60 days after treatment.

NCT ID: NCT05957887 Recruiting - STEMI Clinical Trials

Short and Intermediate Term Effect of Dapagliflozin on Left Ventricular Remodeling in Anterior STEMI Patients

Start date: April 15, 2022
Phase: Phase 3
Study type: Interventional

Methodology This study will enroll (120) patients presenting with acute anterior STEMI who will undergo early reperfusion presenting at Helwan University Hospitals and Ain Shams University Hospitals. Diagnosis of STEMI will be based on: Sustained ST-segment elevation of at least 1 mm in at least 2 contiguous leads or new/presumably new left bundle branch block, plus >Typical anginal pain, or > diagnostic levels of serum cardiac biomarkers, or > imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. They will be subdivided into two (2) groups according to Dapagliflozin intake into: - Group A: Patients with diabetes mellitus (DM) (60) patients, they will be further subdivided into 2 subgroups: Group A1: 30 patients will receive Dapagliflozin in addition to standard anti-ischemic and anti-diabetic treatment. Group A2: 30 patients will receive standard anti-ischemic and antidiabetic treatment (Dapagliflozin not included). - Group B: Patients without DM (60) patients, subdivided to 2 subgroups: Group B1: 30 patients will receive standard anti-ischemic treatment. Group B2: 30 patients will receiv up e standard anti-ischemic treatment and Dapagliflozin. Methodology in details: The study patients will undergo early reperfusion according to the recent practice guidelines and the local hospital policy in managing ST elevation MI patients. Echocardiography will be performed twice: within 48 hours of admission and 3 months following the index event. Management: Twelve-lead electrocardiogram will be recorded at baseline and 30-min post-procedure. The ST-segment changes will be evaluated in the single lead with the most prominent ST-segment elevation before intervention. The ST-segment elevation will be measured to the nearest 0.5 mm at 60 ms after the J point. Significant ST segment resolution (STR) is defined as a reduction in ST-segment elevation of 50% after 30 min of infarct artery recanalization. Immediately before the procedure, patients will receive aspirin (300 mg), ticagrelor (180 mg) or clopidogrel (600 mg) depending on availability. Adjunctive pharmacological treatment during the procedure will include: 1. Unfractionated heparin as an initial bolus of 70 U/kg and additional boluses during the procedure to achieve an activated clotting time of 250 to 350 s (200 to 250 s if Glycoprotein IIb/IIIa (GPIIb/IIIa) antagonist is used). Heparin will be discontinued at the end of percutaneous coronary intervention. 2. The use of a GPIIb/IIIa antagonist during the procedure, primary PCI technique, indications, and methods of thrombectomy if indicated will be done under the regulations of the local hospital policy and the most recent practice guidelines.

NCT ID: NCT06004349 Recruiting - Autoimmune Disease Clinical Trials

Autoimmune and Autoinflammatory Genetics Study

Start date: April 15, 2022
Phase:
Study type: Observational

This is an exploratory natural history protocol that will enroll patients with known genetic diseases, such as VEXAS syndrome, or as yet undiagnosed disorders of inflammation with the goal of improving our understanding of disease processes. Blood, saliva, hair, nail, or buccal samples may be collected for genetic analysis, blood samples will be obtained for immunologic and other functional studies, and a small number of subjects may undergo skin biopsy.

NCT ID: NCT06197269 Recruiting - Clinical trials for Early-Onset Neonatal Sepsis

Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis

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

Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis.

NCT ID: NCT06294782 Recruiting - Clinical trials for Refractory Ventricular Tachycardia

PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia

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

This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized.

NCT ID: NCT04287192 Recruiting - Clinical trials for Older Adults With Complex Care Needs

Digital Bridge: Using Technology to Support Patient-centered Care Transitions From Hospital to Home

DB
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

Older adults who live with multiple chronic conditions are more likely to experience frequent admissions and discharges from hospital. These transitions are often challenging and leave people at risk of readmission. Appropriate, timely and person-centred communication across all health care providers involved in transitions (in and out of hospital) as well as with patients and their families is critical to ensure a smooth and effective transition process. Digital health technologies can play an important role in improving person-centred communication across clinical settings and clinicians. This project will develop and test a Digital Bridge by connecting communication technologies already in use in hospital and primary care/community settings to improve communication between providers in hospital and in primary care, patients and family caregivers from admission to 6 months post-discharge. The investigators will engage with all the technology users to co-design the Digital Bridge, ensuring that how the investigators connect the existing technologies and adopt them into practice will meet the needs of providers, patients and their caregivers. Next hospital partners will adopt the technology into general medicine and rehabilitation services in hospital systems in Toronto (Sinai Health System) and Mississauga (Trillium Health Partners). The investigators will evaluate the Digital Bridge through a pre-post pragmatic trial, assessing impact on patient experience (quality of transition), patient outcomes (quality of life), transition processes (provider communication and teamwork), and system costs (economic evaluation). This project adopts an implementation science lens, allowing the investigators to collect qualitative data on enablers and barriers to adopting the Digital Bridge to help inform development of a scale and spread strategy.

NCT ID: NCT04536480 Recruiting - Type 2 Diabetes Clinical Trials

Impact of Meal Timing on Glycemic Profiles in Adolescents With Type 2 Diabetes

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

Because of its simplicity, TLE may represent a more feasible approach for adolescents than other caloric restriction regimens based on macronutrient composition and kilocalories. Our preliminary data support TLE feasibility, acceptability, and safety in adolescents with obesity, with and without T2D. However, no trial to date has studied the effects of TLE on glycemic control and body composition in adolescents with T2D. Our long-term goal is to determine whether TLE is a beneficial as part of the medical regimen early in diagnosis in adolescents living with T2D, and if so, to identify: 1) participant characteristics associated with positive response, 2) mechanisms by which TLE operates, and 2) the best methods to administer TLE to maximally harness its effects. Therefore, the aim of this study will be to compare cardiometabolic effects of TLE (8-hr eating period/16-hr of daily fasting) versus a prolonged eating period (12+hour eating period) in a randomized pilot study with careful control of timely compliance, dietary composition, calorie intake, and physical activity to accurately capture the dosage of the intervention received. We hypothesize that TLE will minimize glycemic excursions, delay β-cell deterioration, and reduce body fat mass in adolescents with T2D when compared to prolonged eating periods. One-hundred adolescents with T2D will be recruited. All participants will be randomized to one of two meal-timing schedules to be followed for 12 weeks: (1) Control: >12-hour eating period or (2) TLE.

NCT ID: NCT04952077 Recruiting - Clinical trials for Ischemic Stroke, Acute

MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation

MR-Reperfusion
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

Cerebral infarction by proximal occlusion of the anterior circulation is common with major personal and societal consequences. MRI is the gold standard for exploring stroke, especially ischemic, and a number of biomarkers on initial MRI (before reperfusion) are predictive of neurological prognosis. However, their spatiotemporal evolution in the suites of reperfusion is unclear. Close monitoring by MRI would make it possible to precisely know the tissue, vascular and microvascular evolution of the infarct area and the penumbra after reperfusion, and thus to characterize MRI biomarkers associated with efficient tissue reperfusion. The aim of the MR-Reperfusion study is to characterize new MRI biomarkers of efficient tissue reperfusion.

NCT ID: NCT05084300 Recruiting - Fibromyalgia Clinical Trials

Effectiveness Pain Neuroscience Education In The Executive Functions In Patients With Fibromyalgia

PNE
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

Fibromyalgia (FM) is a chronic, complex and disabling clinical entity that has an average global prevalence of 2.7%. It occurs mainly in women in a 3: 1 ratio. It is characterized by persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous systemic symptoms such as dizziness, migraine, digestive alterations or sensory intolerances. At present there is no pharmacological treatment with specific indication for FM. Usually, non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality. Many studies have shown cognitive impairment in FM patients compared to control groups, and FM patients mainly show problems with working memory processes and / or in their attentional and executive domains, as well as in speed of speech. processing (BD Dick, Verrier, Harker, & Rashiq, 2008; Glass, 2009; Tesio et al., 2015; Williams, Clauw, & Glass, 2011). Many patients with FM have little understanding of their condition, leading to maladaptive pain cognitions and coping strategies. Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia. This study aimed to explore the effectiveness of pain neuroscience education in patients with FM. Therefore, this research aims to analyze the effectiveness of the neuroscience education program on pain in executive functions and the intensity of pain in patients with FM.

NCT ID: NCT05229055 Recruiting - Acute Pain Clinical Trials

Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Post-traumatic Acute Pain in the Emergency Department ( INVESCK )

Start date: April 15, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Pain is the most common complaint for emergency department (ED) visit. Intranasal ketamine has been shown to provide rapid, well-tolerated, effective analgesia to emergency department (ED) patients with acute pain. few trials have studied ketamine infusion subcutaneously for pain management in trauma patients.