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NCT ID: NCT05250388 Recruiting - Clinical trials for Shoulder Dislocation

The Effect of Arthroscopic Bankart Repair on Anterior-posterior Glenohumeral Translation and Shoulder Proprioception in Patients With Traumatic Anterior Shoulder Instability: a Prospective Cohort Study

Start date: April 1, 2022
Phase:
Study type: Observational

The purpose of the study is to investigate biomechanical and proprioceptive conditions in patients with symptomatic traumatic anterior shoulder instability undergoing arthroscopic Bankart repair. To determine these, non-invasive and non-irradiating examination methods that have been proven valid and reliable will be used in a combination that has not been reported before. The objective is to determine whether the anatomical reconstruction affects biomechanical and proprioceptive measures in the traumatic unstable shoulder. The study will also investigate patient-reported and clinical outcomes. The hypotheses are that the intervention improves biomechanical and proprioceptive conditions to the near-normal state, as measured after both 6 and 12 months. Further, hypotheses are that the intervention leads to improved patient-reported and clinical outcomes.

NCT ID: NCT05252923 Recruiting - COVID-19 Clinical Trials

Endothelial Protection in Convalescent COVID-19 Patients

Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

This pilot open-label randomized controlled trial aims to assess if treatment with sulodexide may improve the endothelial status and inflammatory response in post-COVID-19 patients. Survived inpatients with severe-to-critical COVID-19 within 14 days after discharge are randomized to receive sulodexide 250 LSU 1 oral capsule twice daily or no treatment for 8 weeks. Biomarkers of endothelial dysfunction, inflammation, and prothrombotic changes are assessed at 0, 4, and 8 weeks. The hypothesis is that affected endothelial function, pro-inflammatory, and pro-thrombotic changes could be improved with sulodexide treatment in convalescent COVID-19 patients who suffered a severe-to-critical clinical presentation and have chronic comorbidities of high risk for endothelial dysfunction.

NCT ID: NCT05253352 Recruiting - Lymphatic System Clinical Trials

Mapping and Quantifying Lymphatic Drainage of the Arm's Alternate Pathway

Start date: April 1, 2022
Phase:
Study type: Observational

Using indocyanine green (ICG) lymphography and lymphoscintigraphy with SPECT/CT imaging, the aim is to evaluate the anatomy of the lymphatic system pathway in two separate populations: healthy female volunteers and women with a history of breast cancer who did not develop lymphedema.

NCT ID: NCT05253677 Recruiting - Clinical trials for Coronary Artery Disease

Precise Procedural and PCI Plan (P4)

P4
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Computed tomography (CT) has become an established tool in the diagnostic workup of patients with suspected coronary artery disease (CAD). The availability of coronary CT angiography (CCTA) before the invasive procedure allows stratifying case complexity and can be used to improve patient selection for PCI, to plan and guide therapeutic interventions. Beyond the diagnostic and therapeutic phase, it helps to better organize the catheterization laboratory workflow. The P4 study is an investigator-initiated, multicenter, randomized study with a non-inferiority design of patients with an indication for PCI aiming at comparing clinical outcomes between two imaging strategies to guide PCI, being coronary CT-guided PCI strategy (investigational technology) and IVUS-guided PCI strategy (comparator). After identifying the presence of a significant coronary stenosis, the patient will be randomized either to CT- or IVUS-guided PCI groups. Both CT and IVUS-guided PCI will be performed following the P4 trial protocol. When the procedure is completed, post-PCI FFR will be measured. All patients will be followed in hospital, at 30 days (±15 days), 12 months (±1 month) and yearly until 5 year.

NCT ID: NCT05254431 Recruiting - COPD Clinical Trials

The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The term "Overlap Syndrome" (OS) is used to describe the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single patient. Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population. The International Classification of Functioning, Disability and Health (ICF) evaluates functional status in chronic pulmonary disease globally in 5 domains. The investigators propose to study validated outcomes in 3 of these domains: 1) participation in life situations; 2) physical activity; and 3) cardiovascular health. The investigators long-term goal is to develop an exercise strategy tailored to Veterans with OS which will reduce the risk of functional decline through increased PA.

NCT ID: NCT05260619 Recruiting - Clinical trials for Central Nervous System Lymphoma

Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma

PCNSL-LEM
Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

The study will include 28 patients with primary CNS DLBCL who are ineligible with autologous hematopoietic stem cell transplantation or whole brain radiation therapy as consolidation therapy. Induction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent). Patients with MRI documented response CR or PR after induction chemotherapy will enter the study protocol of lenalidomide maintenance (at a dose of 15 mg per day, on days 1 to 21 of each 28-day cycle) for a maximum of 12 cycles, withdrew consent, the disease progressed, or unacceptable toxic effects occurred.

NCT ID: NCT05262686 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study was to explore the clinical and immunological efficacy of belimumab plus low dose IL-2 in systemic lupus erythematosus.

NCT ID: NCT05263089 Recruiting - Clinical trials for Proximal Cavities of Posterior Teeth

Clinical Performance of Injectable Universal Flowable Composite in Proximal Cavities of Posterior Teeth.

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the clinical performance of injectable universal flowable composite vs conventional resin composite restorations in proximal cavities of posterior teeth. The null hypothesis is proposed that there will be no difference in the clinical performance of injectable universal flowable composite versus conventional resin composite restorations in proximal cavities of posterior teeth. The design for this randomized controlled clinical trial is a superiority framework with parallel groups with equal allocation ratios. The patients are randomly divided into two groups where one group will receive conventional resin composite and the other group will receive injectable universal flowable resin composite. The restorations will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria at baseline, 3, 6, 12 month.

NCT ID: NCT05263297 Recruiting - Pain, Acute Clinical Trials

The Effect of Two Different Cognitive-Behavioral Combined Programs in Blood Collection

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of two different cognitive-behavioral combined programs, including video games or kaleidoscope, on the pain, fear and anxiety experienced by children who apply for therapeutic or diagnostic venous blood collection, and their parents' satisfaction levels. In addition, this research aims to create a holistic approach to child health due to the evaluation of both children and parents. The population of the research will be children aged 8-10 who come to the Children's Blood Collection Unit of Karaman Training and Research Hospital between February 2022 and March 2022. The sample of the study will consist of 96 children and their parents who applied to the Blood Collection Unit on the specified dates, met the inclusion criteria and agreed to participate in the study. The pediatric blood collection unit provides service between 08:00 and 16:00 on weekdays. In order to determine the number of samples, power analysis was performed using the G*Power (v3.1.9) program. It was planned to carry out the research with a total of 96 children and their parents, 32 in each group, considering possible case losses during the research period. Evaluation of the data will be done in the computer environment with the SPSS (Statistical Package for Social Sciences) 22.0 package program. Percentage distributions, mean, standard deviation, chi-square test, analysis of variance will be used in the analysis of the data. In addition, the variance of the groups will be examined with the Levene test in order to make further analysis. In cases where the variance is equal, Bonferroni analysis will be used in post hoc advanced analyses, and Dunnett T3 analysis will be used in cases where the variance is not equal. The research findings will be evaluated at the 95% confidence interval, at the p<0.05 significance level.

NCT ID: NCT05264142 Recruiting - Healthy Clinical Trials

Risk of CYP2C19 Phenoconversion in Healthy Volunteers With Rapid, Normal, and Intermediate Predicted Metabolizers' Status

Switch19
Start date: April 1, 2022
Phase: Phase 1
Study type: Interventional

CYP2C19 is responsible for the metabolism of approximately 10% of drugs currently on the market, including several proton pump inhibitors, clopidogrel, benzodiazepines and some tricyclic antidepressants, including amitriptyline. It is a cytochrome whose activity is characterized by a great variability in the general population. This variability can be explained, in part, by genetic and environmental factors The classification of phenotypes associated with CYP2C19 has evolved over time. Today, five distinct phenotypes are used to characterize this variability: the slow metabolizer (SM) phenotype, the intermediate metabolizer (IM) phenotype, the normal metabolizer (NM) phenotype, the fast metabolizer (RM) phenotype and finally the ultra-fast metabolizer (UM) phenotype. (UM) phenotype. Although directly measurable with test substances, CYP2C19 phenotypes are often assigned on the basis of genotype. They may be impacted by intrinsic (e.g., comorbidities) or extrinsic (e.g., co-medications) factors. Phenoconversion or phenotypic change is the phenomenon by which an individual switches from one phenotype to another due to an environmental influence such as a drug interaction. However, genotype is likely to influence the degree of response to a drug interaction. Vulnerability to phenoconversion therefore differs according to the genotype of the individual. The purpose of our study is to determine whether individuals genetically MR, NM and IM have the same vulnerability to phenoconversion. Thus, the magnitude of the response to CYP2C19 inhibition will be studied in these 3 groups of individuals (NM:*1/*1, RM:*1/*17 and IM:*1/*2-*2/*17). Inhibition will be studied in two steps, using a strong (fluvoxamine) and a weak (voriconazole) inhibitor of CYP2C19.