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NCT ID: NCT06081868 Not yet recruiting - Dental Caries Clinical Trials

RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Dental caries represents a challenge for Oral Health Services in several African Countries, like Uganda. Few studies have been reported the burden of oral health, its prevention and non-operative treatment among school children in African countries. Aim: To assess the prevalence and risk factors of dental caries and the effectiveness of strategies to prevent and treat dental caries using a non-operative approach among children in Gulu Municipality, Uganda. Methods: The proposal RCT is structured in three phases: 1. A descriptive cross-sectional survey to collect oral data among 610 school children selected using a multistage cluster sampling; 2. A randomized unblinded two-arm trial to assess the difference in the treatment/prevention of dental caries using non-operative means among school children in the Ugandian Gulu municipality; and 3. A comparison of oral health conditions between a group of children who will be given dental cleaning tools and followed up over time versus a control group. The oral health status of the participants will be assessed according to WHO and ICDAS guidelines. Stata 14.0. will be used for analysis; descriptive statistics will be carried out to analyze continuous and categorical variables and chi-square test as well as independent tests for bivariate analysis and modified poisson regression. In addition, the factors associated with dental caries will be determined by linear regression models using a statistical significance level of 5% (α = 0.05). Discussion: This trial will be the first trial conducted in Uganda assessing a school-based caries prevention programme using the WHO and ICDAS standardized international guidelines. The findings obtained will increase knowledge on oral health in Uganda school children and the effectiveness of community-based caries prevention programme in this population.

NCT ID: NCT06081179 Recruiting - Healthy Clinical Trials

Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans

Start date: October 24, 2023
Phase: Phase 1
Study type: Interventional

The study looks into whether administering psychedelic substances that stimulate the serotonin system influences pro-social behavior when compared to administering substances that stimulate the dopamine system in healthy individuals.

NCT ID: NCT06079970 Recruiting - Lung Cancer Clinical Trials

Confocal Laser Endomicroscopy VERification

CLEVER
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy. The main question[s] it aims to answer are: To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure). Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.

NCT ID: NCT06078345 Recruiting - Metabolic Disease Clinical Trials

Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis

BANDIT
Start date: October 12, 2023
Phase: N/A
Study type: Interventional

To test the hypothesis that active BAT improves metabolic health by buffering postprandial metabolites plasma metabolites and energy expenditure will be compared in volunteers with and without active BAT. Both groups will receive test meals with protein, fat and carbohydrates separately, so that the individual impacts of these macronutrients on diet induced thermogenesis and the buffering function of BAT can be derived. BAT biopsies will be taken before and after the test meals for molecular analysis.

NCT ID: NCT06076915 Completed - Healthy Clinical Trials

Usability and Feasibility of an Occupational Exergame-based Intervention

Senso@Work
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

High levels of sustained sedentary time in office workers are associated with non-communicable diseases as e.g. cardio-vascular diseases or diabetes. Moreover, recent evidence has further suggested a relationship between prolonged sitting periods and adverse mental health outcomes. Based on these facts, various types of occupational health-related interventions have already been undertaken, thereby mostly focusing on physical aspects. However, a promising intervention option that has only rarely been investigated in this context, are so-called exergames, which allow a combined physical and cognitive training in a motivating and time-efficient manner. This pilot trial aims to determine the usability and feasibility of an exergame-based intervention targeting occupational health aspects, whilst secondarily exploring potential effects on physical and cognitive functions. The study is planned for healthy (self-reported) office workers, aged between 18 and 65 years. Participants are asked to perform a minimum of 18 training sessions with a duration of 10-20 minutes during a period of six weeks. The design is planned as a two-arm crossover trial, where participants will randomly get allocated to a group, and either start with the training period or the control period (no training). After having completed the six-week training period, participants will evaluate the usability and report their experience with the exergame device. In terms of evaluation of the feasibility, adherence and attrition rates will be calculated at the end of the study. Before, after six weeks, as well as after 12 weeks, cognitive and physical assessments will be performed and questionnaires on behalf of stress experience and management will be elicited. The findings of this pilot trial will help to explore the possibilities of designing occupational health interventions by the implementation of motor-cognitive exergames. In addition, this trial offers the possibility of exploratorily analyzing the effects of exergame training in office-workers.

NCT ID: NCT06076902 Recruiting - Rotator Cuff Tears Clinical Trials

Patch Study (Patch-augmented Rotator Cuff Repair)

Start date: April 6, 2023
Phase: N/A
Study type: Interventional

This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.

NCT ID: NCT06075602 Recruiting - Clinical trials for Coronary Artery Disease

COMPLEX Registry - A Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting With compLEX and Calcified Coronary Artery Disease

COMPLEX
Start date: November 1, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and/ or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques/ devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

NCT ID: NCT06075147 Recruiting - Visual Impairment Clinical Trials

The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema

Start date: February 15, 2024
Phase:
Study type: Observational

This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors. In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied. Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg. The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have. The main information that researchers will collect: the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment. Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice. Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation. In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.

NCT ID: NCT06074744 Recruiting - Joint Diseases Clinical Trials

Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty

Start date: November 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare two different types of nerve blocks in patients undergoing surgery for primary Total Knee Arthroplasty. The main question aim to answer is: - is there a benefit in functional muscle power output of the leg? Participants will be randomized into either the intervention group or the control group and: - receive Subsartorial Saphenous Nerve Block (SSNB) + IPACK in intervention group (group 1) - receive Femoral Nerve Block (FNB) + IPACK in control group (group 2) Researchers will compare the 2 groups to see if there are differences in : - functional muscle power output of the leg? - muscle function, mobility, clinical and radiological results, ROM, pain control (NRS), opioid consumption, length of hospital stay, patient satisfaction, mobility, reduction of costs?

NCT ID: NCT06072417 Active, not recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level)

Start date: September 22, 2023
Phase: N/A
Study type: Interventional

To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on sleep disordered breathing