Clinical trials

Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction. Objectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems. Methods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up. A cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.

The goal of this interventional clinical study is to learn if a Tinder fungus-based formulation -specifically a toothpaste and oral supplement powder-works as adjuncts to non-surgical periodontal therapy (NSPT) in patients with periodontitis. The main questions it aims to answer is: • Does the Tinder fungus-based formulation as an adjunct to NSPT reduce bleeding on probing more than a commercially available toothpaste as an adjunct to NSPT? Researchers will compare tinder fungus toothpaste and oral powder as an adjunct to NSPT to a commercially available toothpaste as an adjunct to NSPT to see if the Tinder fungus-based formulation works as adjuncts to NSPT in patients with periodontitis. Participants will: * Take tinder fungus toothpaste and oral powder or a commercially available toothpaste as an adjunct to NSPT twice daily for 30 consecutive days * Visit the clinic at least twice including a visit before and after the intervention * Keep a diary documenting their well-being and the number of times they used the toothpastes in the morning and evening.

The goal of this observational study is to learn how common Helicobacter pylori (H. pylori) infection is in adults without stomach or upper gastrointestinal symptoms who are having a preventive screening colonoscopy. Endoscopic screening of the stomach is yet not acceptet as a standard screening procedure in Western countries. However, Helicobacter pylori infection is known to increase the risk of developing gastric cancer. This study will look at the prevalence of Helicobacter pylori infection in asymptomatic patients who have an additional gastroscopy during the same session as their screening colonoscopy. It will also record other early tissue changes or risk factors for stomach cancer, such as intestinal metaplasia and Barrett's mucosa. The main questions this study aims to answer are: * How often is Helicobacter pylori found in adults without upper gastrointestinal symptoms by use of OGD? * Are there any correlations between H. pylori infection and other risk factors, such as BMI, smoking, alcohol consumption, or a family history of colorectal and/or stomach cancer? About 1000 participants are expected to take part. Adults undergoing a screening colonoscopy at a private endoscopy center will be offered the chance to have an additional gastroscopy if they meet the study's inclusion criteria (no previous Helicobacter pylori infection and no upper gastrointestinal symptoms). Small tissue samples (biopsies) will be taken from the stomach and lower esophagus during the gastroscopy. Biopsies will be checked histologically for the presence of Helicobacter pylori and early tissue changes. During the gastroscopy, no additional procedures or biopsies will be done beyond what is normally performed during a routine examination. Everything done during this procedure follows the standard steps of a regular gastroscopy. All data will be coded to protect participant privacy. Researchers will use statistical methods to find out how common Helicobacter pylori infection is and whether it is related to other lifestyle or family risk factors or tissue changes.

While the effectiveness of intravenous thrombolysis (IVT) decreases over time, patients show considerable variability in how quickly their ischemic core progresses. Quantitative net water uptake (NWU) has emerged as a biomarker indicating blood-brain barrier disruption and may better reflect the "tissue clock" than time alone. Low NWU is associated with favorable outcomes, whereas high NWU predicts poor outcomes and futile recanalization. The study aims to determine whether NWU measured on initial non-contrast CT is a treatment effect modifier for the IVT therapy.

Rationale and Relevance: Branch Atheromatous Disease (BAD) describes an atherosclerotic occlusion of one of the deep penetrating cerebral arteries, including the lenticulostriate artery (LSA), paramedian pontine artery (PPA), and anterior choroidal artery (ACHA). BAD is frequently associated with early neurological deterioration (END), particularly progressive motor deficits that contribute to increased disability. Despite its clinical relevance, BAD remains underrepresented in major radiomorphological classification systems such as TOAST, which has led to limited evidence and unclear treatment strategies. Previous studies suggest that the efficacy of intravenous thrombolysis (IVT) may be reduced in BAD compared to other stroke etiologies. Objectives: The primary objective of this study is to evaluate the efficacy and safety of IVT compared with single antiplatelet therapy (SAPT) and dual antiplatelet therapy (DAPT) in patients with BAD-related stroke. A secondary objective is to examine the impact of acute-phase blood pressure fluctuations on END and functional neurological outcomes. Design and Methods: This international multicenter study will be conducted retrospectively according to the STROBE guidelines. Eligible patients include those with BAD-related stroke treated at one of the participating centers between 2010 and 2025. Inclusion criteria comprise characteristic diffusion-weighted MRI patterns in predefined vascular territories (LSA, PPA, ACHA) and a symptom onset ≤24 hours before admission. Patients with typical lacunar infarcts or with other identified stroke etiologies will be excluded. Endpoints: Primary endpoints include functional outcome at three months, defined as a favorable outcome with a modified Rankin Scale score of 0-1; occurrence of END, defined as a ≥4-point worsening on the NIHSS within 24-48 hours; and symptomatic intracerebral hemorrhage. Collected data include clinical, imaging, and therapeutic variables, as well as blood pressure trajectories and pre-stroke treatments (as detailed in the study protocol). Statistical Analysis: Analyses will be performed using SPSS and R. Descriptive statistics, univariate analyses, and multivariable models (IPTW and Poisson regression) will be applied. Results will be reported as adjusted relative risks with 95% confidence intervals. Significance: This study will provide the first comprehensive evaluation of IVT versus SAPT/DAPT in BAD-related stroke, and will investigate the clinical impact of blood pressure changes in this specific stroke subtype. The findings aim to support evidence-based treatment recommendations for a currently underrecognized and poorly understood stroke etiology.

Plastic particles known as microplastics are now a ubiquitous part of the environment. Human exposure to microplastics occurs through the consumption of contaminated food and polluted air, which affect the intestinal system. Several studies have detected the presence of microplastics in various parts of the human digestive system, e.g., in feces. Unfortunately, little is known about the presence of microplastics in the mouth as the primary part of the digestive system. Periodontal pockets can be considered an ideal deposition site for microplastics. Since microplastics are suspected of being an immunomodulatory factor, there is great interest in their presence in subgingival plaque and their possible exacerbation of chronic inflammatory diseases such as periodontitis. The following study aims to clarify the presence, classification, and concentration of microplastics in subgingival plaque. No comparable study has been identified to date.

The goal of this clinical trial is to learn if the reduction of the noises (through head phones with music and noise cancelling) that occur during wisdom teeth removal, leads to a significant reduction in fear levels in patients compared to patients who do not have any noise reduction. The main questions it aims to answer are: Do music and noise cancelling help patients to have less fear during wisdom teeth removal surgery by reducing the sounds of the surgery? Is there a difference between just the noise cancelling function or is it better to combine noise cancelling and music together? Participants will: Just come to their regular appointment (wisdom teeth removal) to our clinic, no follow ups needed. All participants will answer one questionnaire before and one after the surgery. All of them will have their rate of heartbeat measured for three times (before, during and after surgery, measured by a puls oximeter on the finger). They will be allocated to one of the three study groups (no headphones, headphones with noise cancelling or headphones with noise cancelling and music).

Preserving the ridge dimension after tooth extraction aims to avoid the need for bone augmentation procedures before implant placement. This study aims to show that socket preservation procedure is a safe, easy and predictable method that stabilizes the bone situation when late implantation is planned.

Dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. The variety of treatment options and products on the market might seem overwhelming. This study aims to show that laser treatments are efficient in reducing pain scores compared to a desensitizing agent (Gluma). 80 patients with at least two hypersensitive teeth will be enrolled in this study. Patients will be divided randomly into four groups (control group (Gluma), laser group 1 (2.94 µm wavelength), laser group 2 (1064 nm wavelength), laser group 3 (970 nm wavelength)). Visual Analog Scale will be measured before treatment, right after treatment, one week after treatment, one month after treatment, three months after treatment. Mixed Anova's and descriptive analysis will be used for statistical evaluation.