Clinical Trials Logo

Filter by:
NCT ID: NCT05451277 Recruiting - Clinical trials for Cardiovascular Diseases

At the Heart of the Matter - Speckle Tracking Echocardiography in Lupus Mothers and Their Offspring

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

Women with systemic lupus erythematosus (SLE) have a high risk of placenta-mediated complications, which can lead to substantial cardiac morbidities in affected women and their offspring. In addition, maternal autoantibodies, which are actively transferred across the placenta during pregnancy, can affect the cardiovascular health of SLE offspring. Hydroxychloroquine (HCQ) is effective in preventing adverse pregnancy outcomes in SLE and might be beneficial in preventing fetal cardiovascular damage mediated by maternal autoantibodies. However, there are concerns that HCQ might cause maternal and neonatal cardiac toxicity. A novel imaging technique (i.e. speckle tracking echocardiography), which allows early identification of cardiac dysfunction, has proven superior to any other in assessing cardiac function in mothers and neonates experiencing placenta-mediated complications and in identifying drug cardiotoxicity. Yet, there has been no study using speckle tracking echocardiography to evaluate the cardiovascular health of pregnant SLE women and their offspring, as well as the potential adverse cardiac effect of HCQ. Moreover, due to unavailability of assays, HCQ dosing in SLE is generally done blindly, without checking drug levels. To fill these key knowledge gaps, the investigators aim to: 1) assess the impact of placenta-mediated complications on maternal and neonatal cardiac function, 2) evaluate if HCQ exposure (as measured by whole-blood levels) is associated with maternal and neonatal outcomes including cardiac toxicity, and 3) determine the effect of maternal autoantibodies on neonatal cardiac function. Ultimately, our proposal will help optimize reproductive and cardiovascular outcomes in lupus women and their offspring.

NCT ID: NCT05455398 Recruiting - Clinical trials for Hearing Loss, Sudden

Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections. The patients were randomly divided into a pilot group and a control group for a randomized controlled clinical study, with the pilot group receiving a round window niche enlargement via round window inner ear administration and the control group receiving regular intra-drum injection hormone therapy

NCT ID: NCT05470153 Recruiting - Clinical trials for Severe Asthma With Obstructive Sleep Apnea

The Efficacy of Continuous Positive Airway Pressure in Achieving Asthma Control in Patients With Severe Asthma and Obstructive Sleep Apnea

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Asthma is a common heterogeneous chronic disorder of the airways, characterized by variables, usually reversible and recurring symptoms related to one or more of airflow obstruction, bronchial hyper-responsiveness, and underlying inflammation. Approximately 5-10% of asthmatics have severe or difficult to treat asthma that remains problematic despite optimal treatment. Current asthma guideline recommend investigating the presence of OSA in the cases of severe or uncontrolled asthma. Obstructive sleep apnea (OSA) is a disease that characterized by frequent narrowing or collapsed of upper airways during sleep. Recent studies have shown an overlap between Asthma and Obstructive Sleep Apnea. The mechanism of interaction between OSA and asthma is complex. Moreover, the two diseases have common comorbid conditions such as GERD and obesity which negatively impact asthma control. Polysomnography is the study of sleep using different leads, heart rate and oxygen monitor to assess the architecture of the sleep. Abnormal obstructive breathing events during monitored sleep are described according to the latest recommendation of the American Academy of Sleep Medicine. For each patient with OSA, titration of CPAP pressure will be performed by conventional polysomnography or using auto-CPAP equipment using a validated protocol. The investigators aim in this study to examine the effect of CPAP treatment in severe asthma patient with concurrent moderate and severe OSA.

NCT ID: NCT05477043 Recruiting - Clinical trials for Surgery--Complications

Ureteral Patency After Uterosacral Ligaments Suspension

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

Uterosacral ligament suspension (USLS) is a commonly performed procedure used to correct prolapse of the vaginal apex. The procedure consists of approximating the vaginal apex to the uterosacral ligaments with a series of sutures placed bilaterally, and is most often performed from a transvaginal approach. USLS is associated with favorable outcomes and is overall safe. However, given the anatomical proximity of the uterosacral ligaments to the ureters, ureteral injury during suspension suture placement may occur. Ureteral occlusion in this setting occurs as a result of partial or complete ligation, kinking or anatomical distortion by the nearby sutures. As a measure for avoiding these undesired sequelae, cystoscopy is usually performed after suspension suture placement during USLS to ensure visualization of bilateral ureteral flow. Any interruption of ureteral flow is usually addressed by removal of the suspension sutures, ureteral stenting, and, rarely, surgical repair of the ureter if severe injury is sustained. Ultrasound can identify the ureteral jet of urine flowing into the bladder. Previous studies demonstrated ureteral jet asymmetry in case of obstruction, with an absent or weaker monolateral jet.

NCT ID: NCT05502497 Recruiting - Rehabilitation Clinical Trials

Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique on Fascia and Fat Tissue Thickness in Healthy Individuals.

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Instrument-assisted soft tissue mobilization (IASTM) technique can be used for non-pathological conditions as it has been shown in previous literature to affect flexibility and normal range of motion. The use of instrument-assisted soft tissue mobilization technique has been claimed to be an effective treatment in increasing tissue temperature, reducing adhesion to connective tissue and increasing collagen adaptation and increasing flexibility and normal range of motion. The instrument-assisted soft tissue mobilization technique works on the facial connective tissue in the body. This connective tissue contains "sheaths of collagen, which form the cavities and muscle divisions that mainly cover the organs." In some studies, they stated that instrument-assisted soft tissue mobilization increased perfusion, while in some studies they stated that instrument-assisted soft tissue mobilization increased blood circulation. The frequency of ultrasonography (USG) examinations for the musculoskeletal system has increased over time with technological developments and USG has entered daily use in the evaluation of various pathological conditions belonging to this system thanks to its comparable results with MR examinations. The unique advantages of USG such as low cost, easy availability, relatively short examination time, and dynamic real-time comparison with the contralateral side have made it easier to use for musculoskeletal examinations. The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization technique on strength, flexibility, balance, fascia and adipose tissue thickness in healthy individuals.

NCT ID: NCT05639439 Recruiting - Airway Management Clinical Trials

Comparative Evaluation of Periglottic Airway Devices With Performed Shape

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate four, most popular periglottic airway devices as regards to ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberscope).

NCT ID: NCT05662449 Recruiting - Ankle Fractures Clinical Trials

A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture

Synfix
Start date: April 1, 2021
Phase:
Study type: Observational

The investigators aim to evaluate the fixation of the ankle syndesmosis in appropriate ankle fractures with bioabsorbable screws. Ankle fractures are common, and a proportion of them involve both fracture of the bone and also disruption of the syndesmosis, a strong ligamentous complex connecting the distal fibula and tibia. If left without fixation this causes a high incidence of pain and early arthritis. The most common technique for fixation of this syndesmosis involves the use of the same type of metal screws used to fix the fractured bones. As the syndesmosis permits small degrees of movement in normal subjects, fixation of this with metal usually leads to screw breakage and, or pain. It is common practice to remove these screws after a period of time once the syndesmosis has healed in the correct position. Bioabsorbable screws have the advantage of allowing small increments of movement, and also resorb naturally therefore do not have to be removed with a second surgical procedure. They are used in other centres worldwide, and the investigators therefore seek to evaluate syndesmosis fixation with them in their unit. The investigators would aim to recruit patients who have a syndesmotic injury requiring fixation, and who can consent to participating. They would undergo an identical surgical procedure to the standard current practice, apart from using a bioabsorbable screw in exchange for the metallic screw for syndesmosis fixation. All other components would remain unchanged, as would post operative protocol and management. To evaluate the fixation the investigators would use a limited CT scan (equivalent of about 3 months background radiation) after the time of fixation and at one year. This will help to assess the maintenance of reduction of the syndesmosis with time. The investigators would also assess patient reported outcome measures and pain scores, length of procedure and intraoperative radiation levels, weight bearing distribution tests, as well as any complication that may arise.

NCT ID: NCT05736913 Recruiting - COVID-19 Clinical Trials

Intradermal COVID-19 Vaccination in the Immunocompromised

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

COVID-19 is an infectious disease caused by SARS-CoV-2 virus, causing millions of deaths around the globe since the beginning of the pandemic. COVID-19 vaccination was proven to be effective at reducing both mortality and development of severe COVID-19 after infection. Vaccine-elicited protection is particularly important for immunocompromised patients, as they are more susceptible to infections with their defective immune response, for instance, previous review had suggested that patients with malignancies and recipients of solid organ transplants may be at increased risk of developing severe COVID-19 disease and even death. To further complicate the scenario, there are two obstacles: firstly, immunocompromised individuals may have suboptimal response from vaccinations, as studies have shown that recipients of solid organ transplant have suboptimal or even are seronegative after the fourth dose booster vaccination . Secondly, with constant mutation of the SARS-CoV-2 viruses, new variants evolve over time, leading to reduction in vaccine efficacy and breakthrough infection in healthy individuals. Therefore, novel vaccine strategy should be considered to enhance the vaccine response in these immunocompromised individuals. In this study, intradermal injection instead of intramuscular injection for vaccine delivery is proposed, as the investigators have observed improved immunogenicity and few adverse events from previous experience of influenza vaccination. The study aims to evaluate the immunogenicity, safety and tolerability of intradermal COVID-19 vaccination in immunocompromised patients.

NCT ID: NCT05739968 Recruiting - Quality of Life Clinical Trials

Impacts and Testing of the "Multi-domains Active-living Program" in Operable Non-Muscle Invasive Bladder Cancer Patients

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Among bladder cancer, the majority of them (70%) are non-muscle-invasive bladder cancer (NMIBC). The survival time is even longer in NMIBC. Patients with NMIBC receive surgery or transurethral resection of bladder tumor (TURBT). However, patients with NMIBC need to receive a three-month repeatedly intrusive cystoscope from diagnosis for the first year. Furthermore, following each cystoscope, patients will receive 3 to 6 times bladder BCG (Bacille Calmette Guérin) or chemotherapy. These repeatedly intrusive cystoscopes, TURBT, and intensive bladder treatments might cause impacts on patients' life. The investigator aims to (1) construct a Multi-domains Active-living Program (MAP) with e-health enhanced intervention; and (2) compare the effects of the MAP with oncology case manager (OCM) care (experimental group) and OCM care only (control group) on the indicators and quality of life. Intervention study is a 12-month two-group randomized trial, including OCM care only (control), Vs. MAP+OCM program (experimental group). MAP will be constructed based on literature review and preliminary results. Main contents of MAP are to (a) cope multi-domain of distress, and (b) develop an active life style to handle their life after cancer, including effective coping, relaxation, regular physical activities, and balance nutrition. Four face-to face interventions will be delivered, including: day before hospital discharge post-operation, before the last weekly instillations of induction therapy (around 6±2 weeks post operation), 2nd-time cystoscopy and before 1st maintenance therapy (around 3- month post operation) and 3rd-time cystoscopy which before the second cycle of maintenance therapy (around 6- month post operation) [section 1-4], respectively. A brief and automatic app reminder (before) and side-effect follow-up (after) from 2nd section of face-to face intervention will be sent. Boosting health education will also be provided by app/ phone calls or in person around 2 to 4 weeks after discharge. Patients in the MAP+OCM group also can raise their questions through APP to receive brief intervention. The outcomes will be assessed at 5 time points: time before first intervention, before 2nd to 4th interventions, and 12 months, T1-T5, respectively. We will use Generalized Estimated Equation (GEE) to analyze the data with total 120 subjects (60 Vs 60 estimated).

NCT ID: NCT05758623 Recruiting - Bone Deformity Clinical Trials

Mg-containing Biodegradable Polymer Bone Repair Material

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The subjects of this study are patients with non-load-bearing bone defects of the extremities who need bone grafting surgery. The patients was treated with bone graft using magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd.. Three follow-up visits were performed at the 12th, 24th and 36th weeks after bone grafting, the clinical role for bone will be assessed.