There are about 1441 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.
Acute appendicitis (AA) is a disease of younger age, but it occurs in 1 out of 500-2000 pregnancies. The current treatment of choice for AA in pregnancy is surgical. Even with standard clinical examination, serum inflammatory markers, and transabdominal ultrasound, the decision on surgical treatment of acute appendicitis (AA) and the rate of negative appendectomy in pregnancy are still unsatisfactory. There are several scoring systems (Alvarado, Tzanakis) that help making decision on operating more easier, however their specificity is either high with low sensitivity, or the other way around. In addition, all scores are based on adult non-pregnant population. We are making an observational study to develop a scoring system that would include ultrasonic imaging with clinical-biochemical parameters while not compromising sensitivity and specificity.
This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.
This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder. Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change. The doctors also regularly check participants' health and take note of any unwanted effects.
The aim of this study was to evaluate the value and safety of discharge of a child to home care within 24 hours after laparoscopic appendectomy for uncomplicated appendicitis to reduce the impact on the child's psyche and need for hospitalisation. Baseline demographic data and intraoperative finding will be recorded. Parents are given a two-page questionnaire that is completed in three cycles (immediately after discharge, daily until the first control and immediately before the first control). All data will be statistically processed using descriptive statistics.
World increase in mortality from consequences of antimicrobial resistance (AMR) represents a significant public health problem. Irrational prescribing of antimicrobial drugs (AMD) in general population is one of the main causes of development AMR. This is also contributed by fact that up to 90% of total antimicrobial consumption in Europe is related to the general population. Problem of AMR has been recognized by World Health Organization and Council of European Union, which support the establishment of the antimicrobial stewardship team (A-team). A-team provides co-ordinated interventions that promote rational use of AMD. To date, no study has been carried out in which A-team from hospital environment goes to primary health care for the purpose of rationalization prescribing of AMD by primary health care practitioners. Project for implementation of hospital A-team in primary health care in Koprivnica-Križevci County was initiated using academic detailing method aimed at rationalization of the consumption of AMD.
Hospital Acquired and Ventilator Associated Pneumonia (HAP/VAP) pose a significant burden to patients admitted to the Intensive Care Unit (ICU). Reported incidence ranges from 10-16% in all ICU patients (including HAP and VAP) and around 20-30% in ventilated patients (VAP). Patients with HAP/VAP have a high mortality rate. The estimated attributable mortality of VAP is 6-13%. Randomized Controlled Trials (RCTs) are the gold standard for evaluating medical interventions, but are difficult to perform in this population. Several preventive and therapeutic treatment options are being developed that will require evaluation in phase-III trials. These trials are challenging due to the relatively low incidence of the outcome (e.g. HAP/VAP) or of the domain under study (e.g. specific antibiotic resistant infections) and the requirement of informed consent in critically ill patients. There is a need for a well-organized and well-trained international RCT network that enables efficient execution of a series of RCTs in this population. The aim of the current study is to set up an infrastructure to prospectively enroll patients at risk of HAP/VAP in ICUs in several European countries. Site personnel will be trained to obtain a GCP (Good Clinical Practice) certification (if not already done), to timely identify and enroll patients at risk of HAP/VAP, to timely identify occurrence of HAP/VAP, collect informed consent forms, collect source data, enter data into a clinical database, and use a dedicated system to reply to queries. Site sample collection, processing, identifying the causative organism, and antibiotic susceptibility testing will be validated and adapted if required where possible. Where site infrastructure and regulations allow, the possibility of automated data collection of included participants will be explored to ensure sustainability of the future platform. Furthermore, collected data will be used to inform future diagnostic, preventive and therapeutic trials. E.g. they may support assumptions in sample size calculations and expected number of enrolled participants, they may help in prioritizing interventions, or they may be used in simulations of adaptive trials to optimize decision rules.
Obesity leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, insulin resistance, inflammation and OS. The aim of this study is to determine the effect of a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with BMI ≥ 35kg/m2.
Aim of this study is to examine the effects of subcutaneously applied local anesthetics at trocar site in combination with intraoperative intraperitoneal analgesia on duration and character of pain in pediatric patients undergoing laparoscopic varicocelectomy.
The purpose of this open-label, thirty-nine weeks-long clinical study is to investigate the efficacy of acupuncture for Knee Osteoarthritis (KOA) as adjunctive therapy to conventional treatment in comparison to conventional therapy alone and assessment of its eventual prolonged effectiveness after nine and twenty-four weeks without treatment. The long-term effects of acupuncture on KOA are not yet confirmed. A safety assessment will be done. It will be interesting to find possible additional benefits of acupuncture while treating knee/s with an advance determined acupuncture protocol for KOA and Kidney Deficiency Syndrome (KDS) since Traditional Chinese Medicine (TCM) theory connects KOA with KDS. Acupuncture treatment point prescription will use local points for KOA and non-local points with their influence on KOA through Kidney deficiency as a root cause. The deep layered chronic pathological condition like KOA requires a higher number of acupuncture treatments. This study will provide three cycles of acupuncture treatments to participants of the Acupuncture (A) group, which are three weeks long each, with treatment frequency three times weekly. It is expected that the study design with twenty-seven acupuncture treatments of KOA in fifteen weeks achieves improvement with the KOA and Kidney Deficiency Syndrome (KDS), additionally. Also, treatment effectiveness on KOA and KDS is expected to persist at the final assessment nine weeks after the last acupuncture treatment. That could confirm the holistic aspect of TCM. Sixty-four patients with symptomatic KOA will be randomly allocated into the A group or C group (standard care) according to their permanent, unique, and coincidental Personal Identification Number which is randomly given to all citizens in Croatia. Before the experiment starts participant's demographic and disease parameters of both groups will be compared at baseline. Prescribed acupuncture protocol will be provided firstly to the Acupuncture group. Objective assessments of therapeutic efficacy will be done by a physiatrist at three time-points: baseline, after final acupuncture treatment (15th Week), and at the 24th Week. Subjective evaluation of symptoms intensity, by participants, will be assessed by Western Ontario and McMaster University Arthritis Index (WOMAC) total score and subscales, Visual Analogue Scale (VAS), and Kidney Deficiency Syndrome Questionnaire (KDSQ) every three weeks till the 24th week (nine assessments with baseline one). Analgesics taken by participants in the last three days before every assessment will be recorded. Participants from the study were promised to receive equal acupuncture treatment after completion of the experiment and belonging assessments if they were randomised into the non-acupuncture group (Control). So, the participants of the C group cross over and after the 24th week of this study start with the identical acupuncture treatment protocol. This study added later the 10th identical assessment to both groups of participants to estimate the within-subject C group effect of the acupuncture treatment protocol and to estimate the duration of treatment effect in the A group 24 weeks after the last acupuncture treatment. Also, in the 24th week was added the Lequesne index, as a more objective and clearer measure of symptomatic and functional improvement of the knees. Participants were asked to fill out the questionnaire according to the actual condition and according to a memory of "how it was before the experiment start". Hypothesis: A decrease in symptom intensity could be achieved after treatment in the experimental group compared to the control.