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NCT ID: NCT06172010 Recruiting - Clinical trials for Prosthetic-joint Infection

Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection

RiCOTTA
Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

In this Dutch multicenter clinical trial, patients with a staphylococcal prosthetic joint infection, will, in the oral antibiotic treatment phase, be randomized between clindamycin monotherapy and rifampicin / levofloxacin combination therapy. The clinical endpoint will be treatment success one year after finishing antimicrobial treatment.

NCT ID: NCT06177314 Recruiting - Contact Dermatitis Clinical Trials

Molecular Diagnosis of Allergic Contact Dermatitis

MODAL
Start date: April 1, 2023
Phase:
Study type: Observational

Allergic contact dermatitis (ACD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries. ACD typically presents as a severe skin inflammation with redness, edema, oozing and crusting. It is characterized by a delayed type IV hypersensitivity response mediated by allergen-specific T cells in sensitized individuals. Current diagnosis relies on clinical investigations by diagnostic patch testing with suspected allergenic chemicals. The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. This is a time consuming and costly process. It requires experienced medical staff to read the reaction, and is only performed by a limited number of expert dermato-allergologists across Europe (which limits the accessibility of suspected ACD patients to diagnosis). Finally, if the robustness of the patch-test method is undisputable, it cannot be neglected that patch-test results are sometimes false positive or non-relevant, which leads to non-appropriate disease management. Therefore, there is today an urgent need for the availability of new ex vivo/in vitro tools based on the modern understanding of the immune mechanisms of ACD to enhance the current diagnostic procedure, and open new avenues for a personalized diagnosis of skin ACD. In this context, the team "Epidermal Immunity and Allergy" (CIRI, Inserm U1111) recently characterized the molecular signatures of ACD (using microarrays), based on positive patch-test reactions to reference chemical allergens or non-allergenic irritants. It was shown that there are unique molecular profiles and signaling pathways characterizing each inflammation. Machine learning methods were then developed to identify and validate classification algorithms based on the expression levels of a minimum set of biomarkers (n=12), enabling very good discrimination between allergen-induced and irritant-induced patch-test inflammation (which was confirmed by complementary quantitative RT-PCR analyses). Finally, some patients with weak positive patch-test reactions to allergens show no/low marks of allergy molecular signature, questioning about the reliability/relevance of their patch-tests results. Our results therefore stress the value of molecular profiling of patch-test reactions to improve/reinforce clinical ACD diagnosis, and to help the dermatologist to discriminate true versus false positive patch test reactions. Importantly, those results also open new avenues for the development of a future point care diagnosis. Indeed, it is currently is estimated that only 20% of patients being sent for allergology work-ups suffer from true skin allergy (i.e. patients with positive patch-tests, combined with relevant clinical history and confirmatory use tests). Most of the patients (80%) are in fact suffering from skin irritation. Therefore, the detection of ACD biomarkers in active eczema lesions could provide the dermatologist with major information to improve and accelerate its clinical diagnosis. This could also prevent numerous patients (negative for ACD biomarkers) being sent for unnecessary allergology work-ups. However, to date, it remains to be demonstrated that (i) the same panel of ACD biomarkers is expressed both in acute eczema lesions and positive patch-test reactions, and that (ii) the detection of these biomarkers allows for a sensitive and reliable diagnosis of skin allergy. The main objective of the study will be to make the proof of concept that the expression of allergy biomarkers correlates with patients suffering from true ACD (i.e. patients with high biomarker expression in acute lesions, positive patch-tests and relevant clinical history), versus those developing skin irritation (no/low biomarker expression in acute lesions, negative patch-tests, and lack of clinical history).

NCT ID: NCT06184932 Recruiting - Clinical trials for Traumatic Brain Injury

TeleRehab to Restore Upper Limb Function in People With Chronic TBI

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The study aims to inform the subsequent large-scale clinical trial focused on using telerehabilitation techniques and technologies to improve upper limb function and quality of life.

NCT ID: NCT06187987 Recruiting - Pulmonary Embolism Clinical Trials

Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism - a Retrospective Analysis

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

International guidelines recommend intravenous thrombolysis (IVT) for high-risk pulmonary embolism (PE). In high-risk PE where IVT is contraindicated or has failed, surgical embolectomy or catheter-directed intervention (CDI) is recommended. CDI is also recommended as an alternative in patients with intermediate-risk PE with haemodynamic deterioration during anticoagulation treatment. Although there is a lack of randomized studies comparing CDI to anticoagulation or systemic thrombolysis in PE, several studies and recent meta-analyses have shown that CDI is an effective treatment that is associated with fewer complications than IVT, especially bleeding.

NCT ID: NCT06190327 Recruiting - Depressive Symptoms Clinical Trials

Effects of a Blended Indoor and Outdoor Physical Exercise Program on Depressive Symptoms in Hong Kong Older Adults

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Depression is a mental health problem often occurring in the elderly. Performing physical exercise is a key element in decreasing depressive symptoms in older adults. Most studies investigating depression and physical exercise have focused on structured exercise comprise of one or two exercise components and based on the clinical patients associated with major depression. There is limited research combining multicomponent (aerobic+resistance+balance) in an exercise program and targeting non-clinical adults with depressive symptoms, with even less available for older adults. More attention has been paid to the role of outdoor exercise on human health. Exercise in a natural environment may provide greater physiological and psychological benefits compared to indoor exercise. Findings demonstrated that green exercise provides double the beneficial effect on improving depression among adults. Although green exercise shows effects on the improvement of depression, recently a review has indicated that structured exercise programs in older adults with depressive symptoms were mainly conducted in the indoor environment. Compared with outdoor exercise which is easily influenced by the weather and with low access of available facilities, indoor exercise is more comfortable, quiet, and convenient to operate especially for older adults. Considering the high relevance between nature and mental health, the combination of indoor and outdoor exercise programs might be able to maximize intervention effectiveness while maintaining the benefits for each type of intervention.Therefore, more rigorous RCT studies in this field are needed, particularly for non-clinical older adults with depressive symptoms.

NCT ID: NCT06191276 Recruiting - Frailty Clinical Trials

Combating Hospital-related Function Decline Among Prefrail Older Adults: A Pilot Study

STEP@Home
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This study focuses on the "Strength-based Tailored-Exercise Program at Home (STEP@Home)" aimed at improving health outcomes for geriatric patients at risk of hospitalization-associated functional decline. It is a sequential mixed-method study that combines quantitative and qualitative approaches.

NCT ID: NCT06205511 Recruiting - Clinical trials for Human Immunodeficiency Virus

The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV

SWISH
Start date: April 1, 2023
Phase:
Study type: Observational

The study will evaluate 300 people living with HIV that attend the Vivent Clinic for HIV care. We will characterize our population and include age, race/ethnicity, sex at birth, tobacco use, alcohol use, other comorbidities, HPV vaccination status, other HPV disease, and lab values such as CD4 count and HIV viral load. We will compare results between participants who are HPV positive and negative. We will also evaluate the relationship between HPV oral infections and lesions and the variables above to better understand possible predictors of HPV infections and lesions.

NCT ID: NCT06207396 Recruiting - Intoxication Clinical Trials

Characteristics of Spiking in Ghent: a Multicentric Prospective Observational Study..

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

This study aims to document the incidence and characteristics of spiking in the Ghent region, both anamnestically and by toxicological analysis. Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent;

NCT ID: NCT06218043 Recruiting - Nutrition, Healthy Clinical Trials

An Iodine Balance Study to Investigate the Recommended Iodine Intake in an Elderly Population

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Current Chinese dietary iodine reference intake (DRIs) standards lack direct data on recommended iodine intake (RNI) in the elderly. The elderly have a high prevalence of thyroid diseases. The risk threshold of iodine intake in the elderly is unknown. Identifying the appropriate iodine intake for the elderly to maintain optimal thyroid function to reduce the burden on medical resources is a public health issue requiring high attention. The iodine balance study is an important method for exploring physiological iodine requirements. Few iodine balance studies have been conducted in the elderly. This study aimed to conduct an iodine balance study and provide information on the appropriate iodine intake level for elderly people.

NCT ID: NCT06223685 Recruiting - Clinical trials for Irritable Bowel Syndrome

The Efficacy of Probiotics as an Adjunct to Treatment of SIBO With Rifaximin

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effectiveness of probiotic bacterial supplements as an additional therapeutic modality in patients with small intestine bacterial overgrowth who receive oral antibiotic treatment (rifaximin) The main questions it aims to answer are: 1 To evaluate the effectiveness of a dietary intervention using pro-biotic bacterial strains as an adjunct to treatment of SIBO with rifaximin. 2. Evaluation of ultrasonographic imaging of mesenteric lymph nodes in patients with SIBO. 3. Evaluation of the effect of rifaximin treatment and dietary intervention on non-alcoholic fatty liver disease activity parameters in patients with coexisting NAFLD and SIBO. According to the study schedule, a total of 3 visits will be made within 3 months. Visit 1, after 6 weeks Visit 2 and after another 6 weeks, Visit 3. Patients will also be invited to a follow-up Visit 4, three months after completing participation in the study. All study participants will receive treatment recommendations for SIBO in accordance with standard practice - a 14-day antibiotic treatment with Rifaximin. In addition, a randomly selected half of the study participants will receive probiotic therapy and half a placebo. - An ultrasound examination of the mesenteric root lymph nodes will be performed at each visit, - followed by a lier steatosis/fibrosis assessment using SWE elastography or FibroScan. - Blood sampling is required on each visit. All study participants will receive detailed guidelines during dietary consultations at each visit for the use of a low FODMAP diet. - Each participant will receive a paper diary on how to assess the severity of bloating and evaluate bowel movements, which must be filled out daily. - In addition, at the visits the patient will be asked to fill out an additional questionnaire on other gastrointestinal complaints and mental health.