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Inflammation clinical trials

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NCT ID: NCT06296238 Enrolling by invitation - Clinical trials for Prenatal Exposure Delayed Effects

Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia

Start date: February 15, 2023
Phase:
Study type: Observational

The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment. Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment. The main questions it aims to answer are: 1. What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes? 2. What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment? 3. What are the associations between maternal iodine status and thyroid function on infant neurodevelopment? We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age.

NCT ID: NCT06189599 Enrolling by invitation - Clinical trials for Chronic Inflammatory Small Bowel Disease

Modified antioxIdants Bacteria for Gut Inflammation

MOBIDIC
Start date: February 1, 2024
Phase:
Study type: Observational

Patients with IBD experience complex therapeutic pathways. The development of new treatments, more effective and free of side effects, is a therapeutic need. However, such therapeutic innovations can only be effective if they are accepted by the target populations. The objective of this study is to analyze, in patients with chronic inflammatory bowel diseases, the acceptability of 4 different treatments: chemically modified bacteria treatment, genetically modified bacteria treatment, probiotics, and fecal microbiota transplantation. The acceptability of the treatments, i.e. the patients' responses and their rationalizations, will constitute the evaluation criterion and the result of the research. This study will also allow us to evaluate the impact of IBD on quality of life and well-being. Research factors associated with quality of life and well-being, based on dedicated questions (scales validated and included in the questionnaire), evaluate the differential acceptability of the 4 treatments studied. Finally, cross-analyses between health, socio-demographic factors, quality of life and well-being will be performed.

NCT ID: NCT06188988 Enrolling by invitation - Clinical trials for Respiratory Viral Infection

Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis

Start date: November 1, 2023
Phase:
Study type: Observational [Patient Registry]

Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. Consequently, CF patients are not able to clear their lungs efficiently, and trapped bacteria can lead to chronic infection and inflammation of the lungs, and ultimately respiratory failure. CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF. Additionally, young children with CF suffer from viral infections as often as their healthy peers, but the episodes are more severe and often prolonged. Moreover, frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age. Although this link has been previously reported, the exact mechanisms by which this occurs need to be elucidated. A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms, general symptoms and a decline in lung function. Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed. Despite the current novel therapies in CF, treatment of respiratory infections stay relevant and is a greater challenge with increasing survival. The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF. About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of CF. There are no exclusion criteria. Duration of the study is 1 year to cover for seasonality of clinical symptoms. Study visits are scheduled at 3-month intervals corresponding with the regular follow up, or unscheduled during an acute pulmonary exacerbation. From all participants, two oropharyngeal swabs (for microbiome analysis and for immunological/mucin analysis) will be collected at set time points. For the linking of the laboratory data to the clinical characteristics, we will examine demographics, environmental exposures, and disease markers of CF. Next to the collection of the oropharyngeal swabs, a history, physical examination, and technical investigations will be performed at the study visits.

NCT ID: NCT06122961 Enrolling by invitation - Heart Failure Clinical Trials

Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)

POSEIDON
Start date: November 15, 2023
Phase:
Study type: Observational

This study will collect medical and background information from participants with diseases that affect the heart and blood vessels (cardiovascular disease). Participants will continue their normal care and will not get any treatment other than those the study doctor has prescribed.

NCT ID: NCT05945225 Enrolling by invitation - Pregnant Woman Clinical Trials

Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)

PRE-IOP
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Gingivitis in pregnant women is a common inflammatory periodontal disease that appears from the third month of pregnancy with an overall prevalence of 35 to 100%. This condition is induced by oral biofilm and exacerbated by increased levels of sex steroid hormones characteristic of pregnancy. Strict bacterial plaque control with both professional and home oral hygiene is essential. Manual toothbrushes require a more specific manual technique for women, while sonic electric toothbrushes, due to their ease of use, might be an excellent for oral individual prophylaxis. Therefore, the question of which type of manual or electric toothbrush might be more effective in reducing gingival inflammation in pregnant women is still unresolved. In literature there are a large number of in vitro clinical studies on this topic, there are currently no clinical studies investigating this long-term clinical comparison. In this context, this study is a randomized clinical trial consisting of a comparative evaluation between two manual and two sonic electric toothbrushes in the efficacy of the control of plaque in order to reduce gingivitis in women during the period of pregnancy.

NCT ID: NCT05932017 Enrolling by invitation - Surgery Clinical Trials

Comparison of Gingival Flap Procedure Using Conventional Surgical Loupes vs. Videoscope for Visualization

Start date: July 1, 2023
Phase:
Study type: Observational

This study is being performed to compare different methods of visualization during routine gum surgery. The gum surgery is standard of care. This study will compare the use of a small camera (videoscope) in conjunction with magnification glasses during surgery vs. surgery only using magnification glasses. Both methods are routinely used and are standard of care methods of visualization. The small camera (videoscope) is a device which allows us to see the area under high magnification and projects live video feed on a computer screen. The study is a split-mouth design pilot study. The patients are only receiving treatment that was previously diagnosed prior to entering the study. The treatment performed is standard treatment that fits in the routine standard of care. No interventional treatment is being performed. The only difference is the method of visualization/observation by the practitioner used during the surgical procedure. One side of the mouth will be treated with just loupes while the other side of the mouth will be treated with loupes and the videoscope.

NCT ID: NCT05896878 Enrolling by invitation - Opioid Use Clinical Trials

The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

This is a research study to evaluate the effectiveness of daily supplementation with Root.Health, a plant-based dietary supplement, on reducing levels of 11 abnormal urine biomarkers associated with chronic pain. Biomarkers are molecules found in blood, tissues, or other body fluids (such as urine) that indicate normal or abnormal processes.

NCT ID: NCT05799768 Enrolling by invitation - Obesity Clinical Trials

Ketogenic Diet in Rheumatoid Arthritis (RA)

KETORA
Start date: April 20, 2023
Phase: N/A
Study type: Interventional

This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.

NCT ID: NCT05744414 Enrolling by invitation - Clinical trials for Breast Implant; Complications, Infection or Inflammation

Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries

Start date: May 17, 2023
Phase:
Study type: Observational

The primary objective of this study is to histologically evaluate the incorporation of AlloMend® Acellular Dermal Matrix into surrounding native soft tissue. Adults 18 years of age or greater who have undergone a pre-pectoral placement of tissue expanders for breast reconstruction and will have a histological evaluation of the AlloMend® Acellular Dermal Matrix and native tissue at time of permanent breast implantation.

NCT ID: NCT05675241 Enrolling by invitation - Peri-Implantitis Clinical Trials

Characterizing the Inflammation Around Dental Implants

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

The use of titanium dental implants has become a common modern treatment to restore teeth. Although the success rate of dental implants is high, inflammation around the dental implant still occurs. The current study will investigate if the inflammation around the implant is due to bacterial infection, hypersensitivity or both. The goal of this cross-sectional study is to (1) Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection and hypersensitivity reaction; (2) Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis); (3) Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.