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NCT ID: NCT06363786 Not yet recruiting - Clinical trials for Incontinence-associated Dermatitis

Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and qPCR. In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of pathces. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with approproate statistical tests on 5% level for varaibles. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed.

NCT ID: NCT06363942 Not yet recruiting - Frailty Clinical Trials

A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.

NCT ID: NCT06364319 Not yet recruiting - cGVHD Clinical Trials

Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD

Start date: April 15, 2024
Phase: Phase 4
Study type: Interventional

The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.

NCT ID: NCT06364904 Not yet recruiting - Bladder Cancer Clinical Trials

An Phase III Study, Multicenter,Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.

Start date: April 15, 2024
Phase: Phase 3
Study type: Interventional

The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.

NCT ID: NCT06365346 Not yet recruiting - Resilience Clinical Trials

Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress.

NCT ID: NCT06365359 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique

LUNEK
Start date: April 15, 2024
Phase:
Study type: Observational

Chlordecone, an organochlorine pesticide, was widely used on banana farms in the French West Indies. Studies by Inserm and health authorities have confirmed the contamination of the food chain and the majority of the population of the French West Indies by chlordecone. Epidemiological studies conducted in the French West Indies have shown that exposure to chlordecone at the levels observed is associated with an increased risk of developing several diseases, including premature birth and prostate cancer. Many of the adverse effects associated with chlordecone could be explained by its estrogenic hormonal properties, and systemic lupus erythematosus (SLE) is an autoimmune disease whose sensitivity to estrogen is well known and is reflected by 1) its clear predominance in women, 2) its predominance in women of childbearing age, 3) its risk of exacerbation in the event of pregnancy. Chlordecone has the potential to modify the activity of SLE through mechanisms other than its pro-estrogenic effects. In rats, chlordecone was observed to induce alterations such as a reduction in lymphocyte count, thymic atrophy, and a decrease in splenic germinal centers and NK cells. In a mouse model of systemic lupus erythematosus (SLE), exposure to chlordecone results in increased production of immune complexes and anti-DNA antibodies, which are markers of disease activity and monitoring. Chlordecone also has a cellular effect that reduces the apoptosis of potentially auto-reactive lymphocytes and stimulates the production of GM-CSF, IL-2, TNF-alpha, and IFN-gamma. The latter is central to the pathophysiology of SLE. While experimental studies suggest a potential impact of chlordecone on SLE, no human studies have been conducted to date, and the chlordecone impregnation of lupus patients in Martinique remains unknown. The most serious and feared complication of SLE is kidney damage. Kidney damage from the disease and the necessary immunosuppressive treatments can lead to significant morbidity and mortality, including death and end-stage chronic renal failure. Therefore, it is important to manage the disease carefully. Suspected lupus nephritis is confirmed by a renal biopsy, which allows for formal diagnosis and categorization into several classes. Suspected cases are identified by a proteinuria to creatininuria ratio greater than 0.5 g/g (or 24-hour proteinuria greater than 0.5g). The objective of this project is to determine whether there is a positive association between lupus nephritis occurrence in patients followed by the internal medicine department of the Martinique University Hospital and organochlorine pesticide chlordecone impregnation.

NCT ID: NCT06365996 Not yet recruiting - Aging Clinical Trials

Development and Validation of the Polish Geriatric Core Set.

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

Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Proposed by the World Health Organisation (WHO), the geriatric core set is a set of categories of the International Classification of Functioning, Disability and Health (ICF) that allows for a comprehensive assessment of a person of geriatric age. In Poland, the geriatric core set has not yet been adapted and validated. Therefore, the aim of this study is the cultural adaptation and validation of the Polish version of the ICF-based categorical profile for the assessment of older people.

NCT ID: NCT06366087 Not yet recruiting - Clinical trials for Atropine Bioequivalence

Sublingual Atropine Bioequivalence by Route of Administration (SABER)

SABER
Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers.

NCT ID: NCT06366308 Not yet recruiting - Prostate Cancer Clinical Trials

Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population

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

Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field. Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations.

NCT ID: NCT06367790 Not yet recruiting - Basketball Players Clinical Trials

Plyometry and Tapping in the Functional Improvement of Non-professional Basketball Players

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Introduction. In basketball, the lower extremities have the highest prevalence of injury, regardless of gender and professional category. Objective. To analyse the efficacy of a physiotherapy intervention using a protocol of plyometric exercises and dry needling in non-professional basketball athletes. Methods. Randomised clinical study. 20 players will be randomised to an experimental group (plyometric exercises and dry needling of the gastrocnemius muscles) and a control group (plyometric exercises). The intervention will include 8 sessions over 4 weeks. The study variables will be: range of motion in dorsal flexion in loading (Leg Motion®) and unloading (goniometer) and vertical jump (MyJump2®). Expected results. An intervention of plyometric exercises and dry needling produces significant differences in range of motion and vertical jump in basketball players, compared to the isolated administration of plyometric exercises.