Clinical Trials Logo

Filter by:
NCT ID: NCT05055154 Completed - Obesity Clinical Trials

Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD

Start date: June 14, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05054244 Active, not recruiting - Quality of Life Clinical Trials

Clinical Implications of Biofilm in Chronic Wound

Start date: July 1, 2021
Phase:
Study type: Observational

Chronic wounds are important economic and health-care problem. Biofilm has been recognized as a major factor in wound chronicity, delayed healing, and persistent infections, increasing the need for frequent dressing changes, painful debridement and systemic antimicrobial treatments influencing quality of life. In the presence of "un-cultivating" bacteria and limitations of clinical indicators of biofilm presence, there is a need for simple "screening" diagnostic method for biofilm detection. Chronic wounds of different etiology often associated with chronic pain reduce working abilities and cause restrictions in everyday living diminishing patient's quality of life. Efficacy of hyperbaric oxygenation therapy (HBOT) in treating chronic wound and associated infection has been suggested. This observational prospective cohort study will be conducted at the Department of undersea and hyperbaric medicine and Department of dermatovenereology, Clinical Hospital Center Rijeka during 3-year period from 2021. to 2024. including all patients treated due to chronic wound irrespective of the ethology. The patients will be evaluated upon enrolment, after 2, 4, 6 weeks, and 3, 6, 9, 12 months period, to clinically evaluate the wound characteristics, evaluate clinical healing rate, clinical indicators of biofilm and/or infection, need for additional diagnostic or treatment procedures. The patients in both groups (control and HBOT group) will be treated with standard treatment (dressings, debridement, antibiotics, infection control), in addition HBOT sessions will be performed (HBOT group). Impact of chronic wound and both treatment options to patient related outcome measures will be evaluated assessing intensity and pain characteristics, quality of life, depression, and anxiety by means of standardized questionnaires (visual analogue scale, McGill Pain questionnaire, Wound Quality of Life Index, Health Quality of Life Questionnaire, Beck depression and anxiety inventory). Microbiological analyses of swabs/biopsies will be evaluated to determine microbial profile and resistance. Detection and objectivization of biofilm will be evaluated by standard methods on microbiological isolates (Congo red agar, tube method, tissue culture plate method) and confocal scanning laser microscopy, and on clinical samples by light microscopy. Primary and secondary objective will be assessed after 1 year follow-up.

NCT ID: NCT05048225 Recruiting - Pregnancy Related Clinical Trials

Dietary Salt During Pregnancy and Maternal Vascular Function

Start date: September 1, 2021
Phase:
Study type: Observational

The main goal of this study is to investigate the association of dietary salt intake during pregnancy with systemic micro- and macrovascular reactivity and uteroplacental vascular function of the mother, and to examine the potential impact of elevated oxidative stress on this association. Also, the aim is to investigate whether there is an association between excessive salt intake during pregnancy and the outcome of pregnancy.

NCT ID: NCT05034406 Completed - Postoperative Pain Clinical Trials

The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05014542 Recruiting - Knee Osteoarthritis Clinical Trials

Needling Techniques for Knee Osteoarthritis

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

The purpose of this open-label, twenty-four 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 efficacy after nine weeks without treatment. 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 in advance determined acupuncture protocol for KOA since Traditional Chinese Medicine (TCM) theory connects KOA with Kidney deficiency syndrome. 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, which are three weeks long each, with treatment frequency three times weekly. It is to be expected that study design with twenty-seven acupuncture treatments of KOA in fifteen weeks achieves improvement with the KOA and Kidney deficiency symptoms, additionally. Also, treatment effectiveness is expected at the final assessment nine weeks after the last acupuncture treatment. That could confirm holistic aspect of TCM. Sixty-four patients with symptomatic KOA will be randomly allocated into the Acupuncture group or Control group (standard care) according to their permanent, unique, and coincidental Personal Identification Number which is given to all citizens in Croatia. Before experiment starts participant's demographic and disease parameters of both groups will be compared at baseline. Prescribed acupuncture protocol will be provided 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 as the final one. Subjective evaluation of symptoms intensity will be assessed by Western Ontario and McMaster University Arthritis Index (WOMAC) total score and subscales, Visual Analogue Scale (VAS), Kidney Deficiency Syndrome Questionnaire (KDSQ). Analgesics taken by participants for pain will be recorded. Hypothesis: Decrease in symptoms intensity could be achieved after treatment in experimental group compared to control.

NCT ID: NCT05008094 Enrolling by invitation - Parkinson Disease Clinical Trials

The Epidemiology of Parkinson's Disease in Croatia and the Influence of Genetic Factors and Microbiota on the Progression and Treatment Outcomes of the Disease (GiOPARK)

GiOPARK
Start date: May 1, 2020
Phase:
Study type: Observational

Parkinson's disease (PD) is the second most common neurodegenerative disease, which affects 2-3% of the general population above 65 years. There are significant differences in incidence depending on geographical location, race, and ethnicity. The exact cause of the disease is still unknown, but the role of genetic and environmental factors has already been established. Certain genetic forms of the disease make up for a small percentage, so it is thought that environmental factors have a more significant impact on the development of the disease. The incidence of PD is higher in people exposed to significant quantities of pesticides and traumatic brain injury, while there is a smaller incidence in smokers and people consuming more significant quantities of caffeine. The project will finish in four years, with the first 20 months dedicated to the first phase (genetic-epidemiological research), and the entirety of the 48 months for the second phase of the project (prospective clinical research). The main goal of the first phase of the project is to determine which genetic mutations are the ones most represented in the Croatian population afflicted with the familial form of PD. In the second phase the main goal is to determine the influence of genetic factors and microbiological factors on the disease's progression as well as on the treatment outcomes. Specific goals of this part of the project are to determine how many patients in the general population of PD patients present with a genetic disorder and which genes have a role in that disorder, as well as determine the composition of intestinal and oral microbiota both in the patient test group and the healthy control group. Furthermore, specific goals are to evaluate the effects of standard PD treatment on the composition of microbiota, neurodegeneration progression and the activity of neuroinflammation in the central nervous system (CNS) and to examine whether there is a link between the physiological and the pathophysiological function of microbiota, using markers of disease progression and glial activity. Last specific goal is to analyze potential pathological conformation protein forms that could be used as a biomarker in early stages of the disease and a biomarker of disease progression. The first phase of the study will provide the first epidemiologic data on the familial form of PD, as well as the mutations most represented in patients with PD in Croatia. Additionally, the prospective clinical study will contribute to enlightening the intertwined effects of genetic and environmental factors in the emergence and progression of the disease, as well as their effect on treatment outcome. Intestinal and oral microbiota composition analysis will determine whether there is a difference between PD and the healthy population while using the short-chain fatty acid profile will determine the metabolic differences between the two groups. Analyzing the markers of CNS homeostasis, inflammation, and neuroglial function will determine the progression of the disease and also correlate them to genetic factors as well as the microbiota function and composition. Analyzing the pathological conformation forms of alpha-synuclein could lead to the discovery of novel biomarkers in the early stages of the disease, as well as to follow the progression of the disease

NCT ID: NCT05007171 Completed - Obesity Clinical Trials

Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients

Start date: June 14, 2019
Phase: N/A
Study type: Interventional

Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions disturb redox system by generating excessive reactive oxygen species (ROS) and causing oxidative stress (OS) leading to DNA damage. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, inflammation and OS. The aim of study is to test the influence of 3-weeks VLCD on anthropometric, biochemical and genomic parameters in class II and III obesity patients.

NCT ID: NCT05000385 Recruiting - Clinical trials for Mastication Disorder

Masticatory Efficiency in Children

Start date: May 1, 2021
Phase:
Study type: Observational

This study aims to evaluate the association of masticatory efficiency with different conditions of the stomatognathic system (transitioning from primary to secondary dentition, dental caries, malocclusion, tooth loss, prosthodontic treatment) in the paediatric population. Also, to assess the correlation between masticatory efficiency and nutritional status. The study will be conducted on children between 3 and 14 years of age. Masticatory efficiency will be evaluated by the optical scanning method. Participants will chew a standardized silicone tablet controlled by the examiner for 20 masticatory strokes. By scanning the comminuted particles, data on each particle's size will be obtained. Enhanced masticatory performance is presented by a decrease in the chewed particle areas and an increase in the number of chewed particles.

NCT ID: NCT04997460 Recruiting - Hypoglycemia Clinical Trials

Diabetes Type One in Pregnancy and Continuos Glucose Monitoring

DIP1/CRO
Start date: January 11, 2021
Phase:
Study type: Observational

Type I diabetes mellitus (T1DM) affects about 0.1-0.2% of all pregnancies. T1DM in pregnancy increases the risk of maternal and neonatal complications. Continuous glucose monitoring systems (CGM) provide a continuous display of measured glucose. Studies have shown improved pregnancy outcomes for patients with T1DM using CGM when compared to capillary blood glucose measurements. This prospective observational study analyses impact of glycemic variability on development of large-for-gestational-age neonates and effects of hypoglycemia during pregnancy on pregnancy outcomes. Furthermore, overall glycemic regulation, different insulin metrics and C-peptide concentration during pregnancy will also be assesed.

NCT ID: NCT04988802 Not yet recruiting - Clinical trials for Hypothyroidism Primary

The Effect of Dietary Supplements for Pregnant Women on Levothyroxine Absorption

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

Hypothyroidism is a common disease that is successfully treated with the replacement of thyroid hormones in the form of levothyroxine. Levothyroxine is drug used in the first line of substitution therapy because it appropriately mimics physiological secretion of thyroxine (T4) and its peripheral conversion to triiodothyronine (T3). However, due to its narrow therapeutic index, and because it is administered at very low doses (micrograms - μg), it is particularly sensitive to the absorption phase interactions, which are due to its narrow therapeutic index, mainly clinically significant. In pregnancy, one of the goals is to maintain the values of thyroid stimulating hormone (TSH) in the lower part of the reference interval (below 2,5 milli-International units - mIU/L) for a proper child development. Also, due to increased nutritional needs during pregnancy, nutritional supplements are commonly used by pregnant women on their own initiative, but also often recommended by healthcare personnel. Reviewing the literature, we did not find high quality evidence to suggest the existence or to refute the interaction between dietary supplements for pregnant women and the absorption of levothyroxine. The aim of this study is to investigate this potential interaction between dietary supplements used in pregnancy and levothyroxine absorption in order to test the safety of the use of these preparations in pregnant women who are on replacement therapy with levothyroxine.