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NCT06966349
The CA-800 Corneal Analyzer (Visia Imaging S.R.L., Italy) is a device that can measure small imperfections in the tear film when the eyes are open. The goal of this study is to see if the device can detect changes in the tear film after instillation of an eye drop or when contact lenses are worn.
NCT03176927
There is a tremendous clinical need for a noninvasive technique that can assess gastric electrical activity and would be repeatable without any exposure to radiation. Investigators developed a new technique allowing to use noninvasive methods to assess bioelectrical activity in the gastrointestinal system. This has enabled to characterize the normal and pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG) records. Primary hypothesis for this proposal is that analysis of gastric slow wave uncoupling and propagation in multichannel MGG discriminates between normal and pathological gastric electrical activity. Eventually, investigators envision this research leading to new insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and chronic idiopathic nausea that would inform clinical management of these debilitating diseases.
NCT07015203
The project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic. The combined first trimester screening is aimed at predicting and detecting the most serious obstetric complications, such as the great obstetrical syndromes (preeclampsia, fetal growth restriction, preterm labor and intrauterine fetal demise "IUFD") and structural congenital defects (morphological and chromosomal). The primary objective of the project is to create a unified methodology for performing and evaluating the combined first trimester screening in connection with the National Health Information System (hereinafter referred to as "NHIS"), which will enable recording, providing analysis and linking recorded clinical parameters with data in the NHIS. The pilot project will also provide data for modeling appropriate mechanisms for reimbursement from public health insurance.
NCT07480239
This cross-sectional study aims to evaluate how interdental spacing and crown width discrepancies in primary dentition influence the perception of smile esthetics. Standardized smile photographs obtained from children with physiologic spacing patterns will be digitally modified to create different dental scenarios, including variations in interdental spacing, midline deviation, and crown width discrepancies. The images will be presented to adult participants, including dental students and parents, who will evaluate the esthetic appearance of each smile using a visual analog scale (VAS). The study seeks to determine how different spacing patterns and tooth size discrepancies affect the perception of smile esthetics in primary dentition.
NCT07504952
The goal of this clinical trial is to find out whether taking probiotics can improve thinking ability and gut (digestive) symptoms in healthy adults. The study will also explore whether probiotics affect mental health, alcohol cravings, and drinking and eating behaviours. The main questions it aims to answer are: * Do probiotics improve everyday thinking, attention, and memory? * Do probiotics reduce digestion issues or discomfort? * Do probiotics modulate alcohol cravings? * Do probiotics improve mood, stress, and anxiety levels? * Do probiotics influence drinking behaviour? * Do probiotics influence eating behaviour? Researchers will compare a probiotic supplement to a placebo (a look-alike product with no active ingredients) to see whether probiotics have real effects. Participants will be randomly assigned to one of these groups, and neither the participants nor the researchers will know who is receiving which treatment during the study. Participants will: * Take either a probiotic supplement or a placebo every day for 8 weeks * Complete online questionnaires about their mood, thinking, eating and drinking behaviours, and digestive health at the start and end of the study * Provide basic lifestyle and demographic information This study aims to better understand whether probiotics could be a simple and low-cost way to support cognitive function, digestive health and other wellbeing outcomes in generally healthy adults.
NCT07137442
Background: Tics are involuntary movements and vocalizations. Some tics are organic: They are related to diagnosed disorders. Sometimes tics have other causes, such as problems with how the brain and body send and receive messages. These are called functional tics. It can be difficult to tell the difference between these 2 types of tics. Doctors need to know more so they can make more accurate diagnoses. Objective: To learn more about the difference between functional and organic tics. Eligibility: Adults aged 18 to 80 years who have a tic that causes involuntary movements. Healthy volunteers with no tics are also needed. Design: Participants will have one 4-hour clinic visit. The visit may be done in 1 or 2 days. Participants will refrain from consuming alcohol or caffeine before the visit. They may have a physical exam. Participants will wear two types of sensors: Electromyography (EMG): Adhesive disks with sensors will be attached to the skin above some muscles. These disks will record electricity in the muscles as the participant moves. Electroencephalography (EEG): Sensors will be placed on the participant s scalp. The sensors may be adhered directly, or the participant may wear an electrode cap. The sensors will detect brain waves. Participants will rest while seated in a chair. Their involuntary tics will be monitored with the EMG and EEG. Then they will be asked to make movements to mimic their tics. Healthy volunteers will also rest; then they will be asked to perform movements that mimic tics. Participants will have their blink reflex tested. EMG sensors will be placed on the muscles near the eyes. Electrical pulses will be used to stimulate blinking. Participants will answer questionnaires about their tics and their health....
NCT07052162
Plasmodium vivax is the most geographically widespread malaria species and the second largest contributor to symptomatic malaria worldwide. It accounts for half of all malaria cases outside Africa, with an estimated 14.3 million clinical vivax malaria cases reported annually, contributing to an annual cost of US$359 million. Children are most vulnerable to infection, with P. vivax prevalence peaking between 2 to 6 years of age. In Papua New Guinea (PNG), there are \>1.5 million suspected P. vivax cases annually, and while P. falciparum infections are the most prevalent, P. vivax transmission is the most intense in the world. P. vivax in PNG provides a unique epidemiological setting in which to assess innovative treatments in children. The complex biology of P. vivax represents a challenge for malaria control and chemotherapy, especially dormant liver-stage parasites (hypnozoites) which can reactivate (relapse) and cause disease at a time remote from the primary infection. Hypnozoite relapse is the primary cause of vivax malaria in endemic regions and is resistant to most antimalarial drugs. Identifying effective treatments for radical cure, the complete elimination of parasites (both blood- and liver-stage), is therefore a priority. The World Health Organization (WHO) recommends a 14-day radical cure regimen for uncomplicated vivax malaria; comprised of blood stage treatment (chloroquine or artemisinin combination therapy (ACT)) and 14 days of the 8-aminoquinoline drug primaquine (PQ; 0.25-0.5 mg/kg/day) for liver-stage cure. More recently, the 8-aminoquinoline tafenoquine has garnered interest as an alternative radical cure agent to primaquine. However, there is limited data on the pharmacokinetics, tolerability and radical cure efficacy of tafenoquine in children. The overall aim of the study is to characterise the pharmacokinetic profile of tafenoquine (and primary metabolite) in Papua New Guinean children.
NCT07060404
In Papua New Guinea, administration of primaquine (PQ) or tafenoquine (TQ) to breastfeeding mothers is contraindicated during the first six months postpartum, when infants are recommended to be exclusively breastfed, because of a lack of comprehensive pharmacokinetic data on PQ/TQ neonatal and infant exposure via breast milk. The therapeutic restriction of PQ/TQ use in lactating women during the first six months postpartum effectively translates into \~10% of females being excluded from radical cure in endemic areas at any time. This is because many at risk women live in remote areas, are frequently lost to follow-up, or may have conceived again before they reattend. As a result, radical cure is rarely achieved and women are exposed to recurrent infections and cumulative risk of anaemia. Relapses may occur for years, placing subsequent pregnancies at risk and perpetuating intergenerational failure of fetal growth. They also contribute to malaria transmission, thus household and community exposure to vivax malaria. The goal of the present study is to determine how much PQ/TQ is transferred to a suckling baby, if a mother receives a treatment course of PQ/TQ at time of delivery. We also want to confirm that this treatment is safe and has no major side effects for babies in Papua New Guinea. The study Interventions areas follows: Group 1 - Participants receive PNG standard of care; PQ given 6-months postpartum; Group 2 - Participants receive a 14-day treatment regimen of PQ, at the standard dose prescribed in PNG for vivax radical cure (0.5 mg/kg/day for 14 days); Group 3 - Participants receive an accelerated high-dose 7-day treatment regimen of PQ, as per current WHO recommendations (1.0 mg/kg/day for 7 days); Group 4 - Participants receive a single dose of 300mg tafenoquine. All participants will be monitored for a total duration of 6 months, with the safety, tolerability, pharmacokinetics and preliminary relapse efficacy of PQ/TQ evaluated at standardised time points over this period (Day 0, 1, 3, 6, 8, 15, 20, 28, and Month 2, 3, 4, 5 and 6). At each of these time points, participants will be asked to describe any symptoms they may be experiencing, participate in a medical examination, and provide a blood and breast milk sample for drug analysis and safety (biochemistry and haematology testing). The investigators will also collect a small blood sample (heel prick) from the infant to measure drug concentrations and safety testing.
NCT06678737
Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth 1 and are associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, peer victimization, and a fourfold increased risk of suicide compared to the general population. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients. However, in these trials, only 52% of children and 38% of adults showed clinically meaningful tic improvement, meaning that 50-60% of patients do not benefit from CBIT. CBIT success relies on an ability to suppress tics that many youth lack. The central aim of CBIT is to enhance voluntary tic suppression. Better tic suppression ability drives CBIT improvement 10 and predicts lower tic burden over the course of illness. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. However, research shows that many youth lack this fundamental tic suppression ability that CBIT aspires to enhance. This study will examine the clinical and neural effects of a treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS) to the supplementary motor area (SMA) in young people with tic disorder.
NCT07120828
This study explores the long-term effects of dapagliflozin and empagliflozin on CYP8B1 gene expression and a range of metabolic, oxidative, and inflammatory biomarkers in obese patients with Type 2 Diabetes Mellitus (T2DM). Over a 6-month period, participants are assigned to three treatment arms: metformin (control), dapagliflozin, and empagliflozin. The study aims to determine how these medications influence bile acid metabolism, oxidative stress, leptin, GLP-1, IL-10, and IFN-γ, providing insight into the broader metabolic benefits of SGLT2 inhibitors
NCT07461649
Demographic data, medical and medication history, physical examination, 12-lead ECG, haematology, biochemistry, serology, urine routine analysis, additionally for females serum pregnancy test, hormone assay (FSH) will be done within 21 days and a chest X-ray within 06 months prior to check-in. In study period, each group subjects will be housed in the clinical facility for at least -60.00 hours pre-dose to 72.00 hours post-dose.
NCT07471373
This project PestiEndoMicro aims to provide an innovative approach, studying endometriosis under the genital and gut microbiota scope. To realize this project, the investigators are planning to dose cfDNA to assess the oxidative stress caused by endometriosis and study its epigenetics. At the same time, the investigators will take a pragmatic approach by assessing pesticide exposure in these patients and estimate the correlation between gut or genital dysbiosis and chemical agent exposure. Also, the investigators will take the initiative to use classic culture, qPCR techniques, and NGS to establish signatures in vaginal, endometrial and gut microbiota in patients with endometriosis. With these approaches, the goal is to gain more knowledge about endometriosis and optimize early diagnosis by establishing a signature in the genital and gut microbiota, but also by dosing the cfDNA. By doing so the investigators could open new opportunities to develop new therapeutic strategies for endometriosis.
NCT07031921
The study titled "Ultrasound Image Bank: Advancing Medical Research and Diagnostics", sponsored by the Fondazione Policlinico Universitario A. Gemelli IRCCS, aims to create a large-scale database of gynecological ultrasound images. These images will be collected during routine clinical care from both healthy patients and those with benign or malignant gynecological conditions. The goal is to support medical training, clinical research, and the development of artificial intelligence (AI) models for diagnostic purposes. This is a prospective, observational, single-center study, with an expected enrollment of approximately 25,000 patients over five years. The ultrasound images will be linked to histological outcomes (for those undergoing surgery within 3 months) or to follow-up scans at 1 year, to enhance early diagnosis and personalized treatment approaches.
NCT05989802
Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years. The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies seek to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests for use in children.
NCT03269058
This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca. The information will: * reveal what is not working properly * make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning This biomedical research will take place at the University Hospitals of DIJON and NANTES. * 28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo. * The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months. * Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose. * Participation in the study will last 6 months and include 4 protocol visits.
NCT05539872
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
NCT07441551
Musculoskeletal disorders (MSDs) are among the most common occupational health problems and are closely associated with ergonomic risk factors in the workplace. Different occupational roles expose workers to distinct biomechanical and postural demands, which may influence musculoskeletal health in different ways. Field-based (blue-collar) work is typically characterized by physical workload and repetitive movements, whereas office-based (white-collar) work mainly involves prolonged sitting and static postures. This cross-sectional comparative study aims to evaluate and compare musculoskeletal characteristics and ergonomic risk levels between blue-collar and white-collar workers employed in the same industrial setting. Full-time employees aged 18-65 years who have been working in the same factory for at least two years are included. Outcomes include muscle strength, joint range of motion, ergonomic risk assessed using the Rapid Entire Body Assessment (REBA), musculoskeletal complaints, body awareness, health-related quality of life, and anxiety levels. Objective measurements and validated self-report questionnaires are used. Following baseline assessment, individualized ergonomic and exercise-based recommendations are provided as part of a workplace health promotion approach. Participant satisfaction and perceived ergonomic awareness are descriptively evaluated after eight weeks. The findings aim to support occupation-specific ergonomic risk assessment and preventive strategies in industrial work environments.
NCT05966649
Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated. Previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth. Infections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation). Synbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.
NCT07432763
The goal of this clinical study is to learn if Pomegranate Seed Oil supplementation works to combat urinary tract infections, recurrenturinary tract infections, or pneumonia and contributes to the tapering or discontinuation of antipsychotics in palliative care patients withadvanced dementia. The main questions it aims to answer are: * Does Pomegranate Seed Oil supplementation reduce the likelihood of developing a urinary tract infection? * Does Pomegranate Seed Oil supplementation prevent UTI reinfection? * Does Pomegranate Seed Oil supplementation reduce the likelihood of pneumonia? * Does Pomegranate Seed Oil supplementation contribute to the tapering or discontinuation of antipsychotics? Researchers will compare Pomegranate Seed Oil to care-as-usual to see if Pomegranate Seed Oil supplementation can increase quality of care in palliative care patients with advanced dementia.
NCT07161973
Diminished use of skeletal muscle, such as occurs with many chronic diseases (e.g., heart failure or cancer cachexia), denervation, bedrest, immobilization (e.g., limb casting or bracing), etc., is a common clinical condition affecting untold millions of individuals each year. Such disuse leads to a rapid decline in muscle fiber area and hence whole muscle size, contributing to a decrease in strength, speed, and power as well as alterations in energy metabolism. Collectively, these changes lead to reduced physical function and contribute to the seriousness of any disease, illness (e.g., pneumonia), surgery (e.g., joint replacement), or injury (e.g., broken bone) accompanied by decreased muscular activity. Currently, there are no effective pharmacological treatments to prevent disuse-associated muscle wasting in humans. The above-described effects of disuse appear to be due, at least in part, to a decrease in nitric oxide (NO) bioavailability. Reduced synthesis of NO and/or increased NO destruction (due to increased production of oxygen free radicals) likely contributes to the mitochondrial changes, energetic abnormalities, and muscle atrophy resulting from immobilization. The objective of this study is to investigate the potential benefits of dietary nitrate supplementation on immobilization-induced changes in muscle contractile function and mitochondrial respiratory capacity in young healthy men. Our disuse-induced muscle atrophy model will involve wearing a knee brace for a period of 14 d.