There are about 1447 clinical studies being (or have been) conducted in Croatia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The most common cause of lumbar radicular pain is intervertebral disc herniation with or without pressure on the nerve root, which leads to inflammation and pain. Just as the mechanical component is important, so is the inflammatory component in the etiology of lumbar radicular pain. Numerous pro-inflammatory and anti-inflammatory proteins were found in serum, cerebrospinal fluid and disc biopsies from patients with lumbar radicular pain. Interleukin(IL)-1β, IL-6, IL-8, and tumor necrosis factor TNF-α are the most frequently investigated (8, 9). Elevated levels of IL-6 and TNF-α were found in patients with lumbar pain caused by intervertebral disc herniation. In order to avoid systemic and unwanted effects of analgesics, undergoing anesthesia and long-term and extensive operations, minimally invasive procedures are increasingly used in the treatment of lumbar radicular pain. Epidural administration of steroids and local anesthetic through a transforaminal approach (ESI TF) and percutaneous laser disc decompression (PLDD) are some of these methods. Lumbar radicular pain occurs due to inflammation and/or disc-radicular contact. Corticosteroids interrupt the inflammatory process, the transmission of pain signals via nociceptive C fibers and reduce capillary permeability. Along with the corticosteroid, a local anesthetic is also applied, which leads to immediate analgesia by blocking the conduction of painful impulses by blocking sodium channels. Percutaneous laser disc decompression (PLDD) is a minimally invasive method of treating lumbar radicular pain performed under local anesthesia under fluoroscopic control. The laser energy leads to the heating of the tissue of the nucleus pulposus, which leads to the evaporation of a small volume of water inside the disc. Viewing the disc as a closed hydraulic system, a small decrease in the water content within the disc leads to a disproportionate decrease in intradiscal pressure, which results in retraction of the herniated disc. Thermal energy leads to protein denaturation, which causes structural changes and thus prevents further retention of water in the disc, and a stable scar is created at the point of laser action. On the basis of current knowledge, an attempt is made to establish a link between inflammatory parameters as predictive and prognostic biomarkers in the treatment of patients with lumbar radicular pain caused by intervertebral disc herniation.
The remarkable therapeutic anticaries effect of fluoride is well recognized, but in recent years, toxic effects on the oral mucosa have been discussed. So far, many in vivo studies examining the genotoxic and cytotoxic effect of fluoride in human cells (lymphocytes, bone marrow, germ cells) have been carried out, but there are no studies examining the effect of fluoride on cells of the buccal mucosa. In vitro studies have shown that sodium fluoride can be toxic to fibroblasts of the oral mucosa by inhibiting protein synthesis, suppressing mitochondrial function and consequently reducing the amount of intracellular ATP. The study would include 80 participants, aged between 18 and 75. All subjects would use the same toothpaste without fluoride for the first month, and then they would be randomly divided into four groups, where three groups would receive a toothpaste with fluoride with one of the active substances (sodium fluoride, sodium monofluorophosphate, amine fluoride) for the next 60 days, while the control group would continue to use the toothpaste without fluorine. Swabs of the buccal mucosa would be taken at 0 (before the start of use) and 30, 45 and 60 days after the start of using the tested toothpastes. The aim of this research would be to examine the cytotoxic and genotoxic effect of toothpastes containing fluoride with different active substances and to compare their effect. As a measure of genotoxicity and cytotoxicity in cells, the micronucleus test will be used.
Previous studies have shown that application of hyaluronic acid preparations to wounds of the skin and mucosa have a beneficial effect. There is a lack of studies showing the effect of applying hyaluronic acid preparations to treat damaged nipple skin in breastfeeding mothers. This study aims to determine the effect of applying a hyaluronic acid preparation to damaged nipple skin in breastfeeding women.
The goal of this observational study is to evaluate the cortical silent period (cSP) in cricothyroid muscle (CT) in laryngeal dystonia and control healthy subjects. The study will provide norms related to latency and amplitude of motor evoked potentials (MEPs) and duration of cSP in CT muscle in laryngeal dystonia and control healthy subjects. Findings may give a baseline in comparison to findings in laryngeal diseases and insight into maladaptive cortical control function during phonation in laryngeal diseases like laryngeal dystonia.
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Therapy of advanced cancer of the larynx includes excision of the entire larynx. After the removal of the larynx, the pharyngoesophageal segment (PES) is created by reconstruction of the soft tissue of the pharynx and oesophagus, and its vibration creates a replacement voice. High-speed video endoscopy (HSV) is the only method that visualizes and measures vibration of pharyngoesophageal mucosa (PEM) after laryngectomy. Acoustic characteristics of three forms of the rehabilitated voice of laryngectomized persons (oesophageal voice, tracheoesophageal voice using a speech prosthesis and electrolarynx) have been satisfactorily described but, the interdependence of acoustic and visual representations of the phonatory movement of the PES is still insufficiently investigated. In recent years, the development of biomechanical models is created to analyse the vibration of the PES, but still no uniform results have been achieved that would explain whether the parameters obtained from the analysis of the waveform of the PES can be compared with the parameters obtained from the acoustic analysis of the voice of a laryngectomized patients
Contrast sensitivity (CS) and tear film (TF) changes are noted in late postoperative period after upper blepharoplasty (UB), while the same was rarely investigated in the early postoperative period. The reason for aforementioned improvement of vision quality is unclear. Suggested explanations include changes in higher-order aberrations, elimination of the overlay effect created by excess skin on the upper eyelids and/or eyelashes directed toward the eyelid, or changes in corneal topography (CT) and keratometry. Furthermore, there is no consensus on the best technique for UB. Due not only to different surgical techniques, but also to different methods of measuring the tear film quality, it is very difficult to quantify the aforementioned studies. While changes in tear volume parameters and changes in tear film (TF) rupture have been investigated in detail, changes in the lipid layer have rarely been investigated. According to previous studies, there are different findings about changes in CT after UB. The aim of the research is to determine whether there are anatomical (CT) and functional (TF and CS) changes in subjects with functional dermatochalasis before the procedure and in a month-long postoperative period. The research is conducted on examinees diagnosed by clinical examination with functional dermatochalasis with the exclusion of examinees with ocular or systemic conditions affecting TF, best corrected visual acuity or CT. Detailed medical history and ophthalmologic examination will be performed with grading of the external appearance of the upper eyelids. All diseases and conditions that can lead to changes in CS, TF or corneal defects will be noted. Preoperatively all subjects will have CS recorded in photopic conditions, TF analysis and CT (Keratograph 5M, OCULUS Optikgeraete GmbH, Wetzlar, Germany). UB will be performed in the operating room at the UED. At first (seven days postoperatively) and second (one month postoperative) check-up a CS check will be performed at the UED and TF analysis and CT at Lens LTD.
This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.
Orthodontic appliances can affect changes in the relationships of members of the oral microbiome. Microbiome imbalance can result in oral infections and complicate treatment. The focus is on the microbiological profile of dental biofilm and its control. The effects of metals released by corrosion of alloys for oral use on the microbiome and the extent to which they modify the effectiveness of gingivitis therapy by mechanical and chemical control of biofilm will be investigated. Early and late colonizers of the tooth surface will be analyzed. The condition of gingiva will be assessed, and the results will show the specifics of biofilm and gingiva exposed and unexposed, and differences in the response of individual bacteria to therapy. Molecular biology techniques will be used to quantify the total bacterial biomass (16s rRNA) and the proportion of specific bacterial species within the dental biofilm.
This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.