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NCT ID: NCT05521061 Recruiting - Diabetes Mellitus Clinical Trials

The Effect of Human Milk Oligosaccharides in Children With Type 1 Diabetes Mellitus

Start date: May 28, 2022
Phase: N/A
Study type: Interventional

Type 1 diabetes mellitus (DM) is an autoimmune disease characterized by absolute insulin deficiency, defined as insulin-dependent diabetes mellitus and develops due to autoimmune damage of beta cells in the pancreas. Approximately 425 million people worldwide are diabetic patients, 5% to 10% of whom are T1DM. In the majority of type 1 DM prevention studies, the main aim is to stop beta cell destruction. Primary prevention studies aim to prevent or alter exposure to environmental stimuli before autoimmunity is developed. Secondary prevention studies address interventions in the autoimmune processes that cause betacell destruction. Tertiary prevention studies include interventions to stop or reverse beta-cell destruction after clinical diagnosis of type 1 DM. Despite all technological advances, type1DM has not shown a permanent improvement in metabolic control over the last 5 years. Breast milk provides protection against Type 1 DM through the prevention of diabetogenic infections, delaying exposure to diet antigens including cow's milk, and the ability to produce healthy intestinal microbiota. Xiao et al. (2018) published in Nature, investigated the effect of human milk oligosaccharides on non-obese diabetic rats, where it was found that it improved intestinal flora and insulitis scores and brought the blood glucose level closer to the optimum level. This study is expected to fill the gap in the literature about dose-dependent efficacy and placebo of breastmilk oligosaccharides in diabetic humans. This project will investigate 1) the possible contribution of 2-FL oligosaccharides to the disease's metabolic control 2) their effects on beta-cell preservation in the pancreas 3)their effects on intestinal microbiota 4) whether there is a doseresponse relationship as compared to placebo among type 1 diabetic children. This project is designed as a double-blind randomized placebo-controlled experiment lasting for 36 months. The proposed research population consists of 111 children aged 4-16-year-old who were diagnosed with Type 1 DM at the Department of Pediatric Endocrinology of Ege University. The sample size was calculated as 111 with an effect size of 0.33, an error of 0.05 and a power of 80% using the F-test group (for a numerical variable such as blood glucose) for 3 groups. It is planned that the two intervention arms consist of 37 volunteers and the placebo group of 37 volunteers. In the research, 1.5 g/day of human milk oligosaccharides will be supplemented in the first intervention group and 3 g/day for the second intervention group. The placebo group will receive maltodextrin as a placebo at a dose with no effect on metabolic control. Patients included in the study will be provided human milk oligosaccharides for 3 months and will be under follow-up for 12 months. All variables, mainly C-peptide, HbA1c, immunoglobulins, lymphocytes and faecal analysis will be examined. The project aims to ameliorate the microbiota profile, optimize C-peptide levels, reduce exogenous insulin dependence through the provision of 2-FL from human milk oligosaccharides and develop a more applicable, acceptable and an innovative method in the metabolic control of the disease. It is believed that the psychosocial and economic burdens of the disease will be reduced by increasing the metabolic control of the disease.

NCT ID: NCT05521009 Recruiting - Infection Clinical Trials

Comparison of Adhesive and Non-adhesive Endotracheal Tube Holder Applied

Start date: February 7, 2023
Phase: N/A
Study type: Interventional

Mechanical ventilation is the continuation of respiratory function from outside by means of special devices until adequate oxygenation is provided by the patient's own respiratory functions in patients whose oxygenation is not sufficient for any reason. . Mechanical ventilation support is provided to patients with respiratory distress with a medical device called an endotracheal tube (ET) inserted through the mouth or nose. Endotracheal intubation is the most common access route for invasive mechanical ventilation (MV) in critical care areas such as the intensive care unit. As in the intensive care unit, as the tube insertion time increases, it becomes very important to fix the tube so that it does not come out. One of the most important and most common complications after ET placement is unplanned extubation. Correct tube detection is the best way to prevent unplanned extubation. In current clinical practice, there are several methods for securing ETs, including adhesive or cloth tapes and endotracheal tube attachment devices. Although there are many types of endotracheal tube holders today, the use of bandages or tapes is still the most commonly used method. Different endotracheal tube fixation techniques used have different advantages and complications. Skin injury and allergy due to adhesive tapes, which are frequently used in the detection of ET, are complications that can be seen in every patient and age group. Endotracheal tube fixation methods may increase the risk of infection due to the material from which they are produced.We planned this study to determine whether the endotracheal tube fixation tie or the gauze fixation from my tube fixation materials contains pathogens, and if so, the pathogen hosting rates.

NCT ID: NCT05520918 Completed - COVID-19 Pneumonia Clinical Trials

A Novel Parameter LIT/N That Predicts Survival in COVID-19 ICU Patients

Start date: March 30, 2021
Phase: N/A
Study type: Interventional

A brisk immune response can clear a pathogen but can cause extensive collateral damage to the host. It is known that coronavirus disease 2019 (COVID-19) infection triggers a multi system inflammatory disorder which can lead to a spectrum of clinical symptoms (Dhama et al. 2020). Severely ill patients maintain a sustained profile of high pro-inflammatory cytokines, (Lucas et al. 2020). Approximately 20% of patients display acute multi-system failure, including acute respiratory distress syndrome (ARDS), accompanied by an intense inflammatory process, which is life-threatening (Wang et al. 2020; Wu et al. 2020; Yang et al. 2020). However, in severe COVID-19, the lymphocyte count decreases progressively, while the neutrophil count gradually increases (Li et al. 2020). To date, four meta-analyses have reported that patients with severe COVID-19 infection have a higher Neutrophil/Lymphocyte ratio (NLR) than those with non-severe COVID-19 infection (Zheng et al. 2020, Chan & Rout. 2020; Ghahramani et al. 2020; Lagunas-Rangel et al. 2020). There is no absolute reported objective threshold level for when NLR progresses from near normal through moderate to severe. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for the clinician in monitoring changes to the patient status and to determine if interventions are having positive effect.

NCT ID: NCT05520684 Recruiting - Clinical trials for Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection

Asymptomatic Bacteriuria, Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors and UTI Risk

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

The SGLT2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. However, the association between SGLT2 inhibitors and urinary tract infection (UTI) risk is controversial. Moreover, it is not known whether asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors are risk factors for UTI in women. There is not enough data to recommend or not to recommend for performing urinalysis or urine culture test before initiation of SGLT2 inhibitors. The aim of the study is to investigate the effect of asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors on UTI risk in a prospective cohort of women with type 2 diabetes mellitus.

NCT ID: NCT05520554 Completed - Clinical trials for Neurological Disease

Development, Reliability and Validity of the Telerehabilitation Satisfaction Questionnaire- TrSQ

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

Parkinson's disease (PD), stroke, and Multiple Sclerosis (MS) are the most common neurological diseases. Today, physiotherapy and rehabilitation approaches together with optimal medical and surgical treatment form the basis of treatment for these diseases. Recently, it has been stated that various telerehabilitation interventions in the field of physiotherapy and rehabilitation may be an additional option to the rehabilitation approaches applied in the clinic. In addition, there are benefits such as continuity in patient education and rehabilitation, saving time and expenditure of individuals on the road. However, some problems arise in this form of treatment. Especially weak internet connection, sometimes requiring technical knowledge and expensive equipment can reduce the participation and satisfaction level of individuals. It is also important to evaluate the level of satisfaction in expanding the usability of telerehabilitation services and determining the best telerehabilitation service. For this reason, there is a need for questionnaires investigating the satisfaction level of physiotherapy and rehabilitation applied through telerehabilitation.

NCT ID: NCT05520541 Completed - Parkinson Disease Clinical Trials

The Effectiveness of LSVT-BIG Training in Improving Balance and Gait in Parkinson's Patients

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

Parkinson's disease (PD) is a chronic, progressive disease that causes motor and non-motor symptoms due to dopaminergic neuron loss. Today, the treatment of PD in addition to optimal medical and surgical treatments, physiotherapy and rehabilitation approaches have an important place in the treatment. Recently, it has been stated that intensive rehabilitation interventions in the field of physiotherapy and rehabilitation can be more effective than traditional rehabilitation approaches. Lee Silverman VoiceTreatment- BIG (LSVT-BIG) is a high-intensity exercise model aimed at improving bradykinesia and hypokinesia in PD. There are many studies showing improvements in balance, walking, motor performance, reaching ability, postural control, quality of life and cognitive status after LSVT-BIG training in PD. However, it is seen that there is no study investigating the effect of LSVT-BIG training directly by applying it as a home program. For this reason, there is a need for studies investigating whether this intensive treatment method can be an alternative to the clinical environment by applying it as a home program.

NCT ID: NCT05520502 Enrolling by invitation - Exercise Clinical Trials

The Effect of Pilates exercıses on Engine Performance and Body Composition ın Primary School Children

Start date: February 14, 2022
Phase:
Study type: Observational

In thıs study, planned for prımary chıldren between 7-11 years, pılates exercıses wıll be done wıth the chıldren who accept to partıcıpate ın the study wıth the accountance of the researcher and compared wıth the control group. Evaluatıon; parameters; engıne performance tests and body composıtıon analysıs.

NCT ID: NCT05520463 Completed - Back Pain Clinical Trials

Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

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

Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.

NCT ID: NCT05520216 Recruiting - Healthy Participant Clinical Trials

Effect of Rib Cage and Spine Mobility on Maximum Breath-Hold Time

Start date: September 20, 2022
Phase:
Study type: Observational

In this study, it was aimed to look at the effect of rib cage and spine mobility on maximum breath holding time. To determine the relationship between spine and rib cage mobility level and respiratory capacity.

NCT ID: NCT05520164 Completed - Pain Clinical Trials

Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.