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NCT ID: NCT05814523 Not yet recruiting - Clinical trials for Refractory Status Epilepticus

To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

Start date: February 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.

NCT ID: NCT05421286 Not yet recruiting - Inflammation Clinical Trials

The MISTRAL Study: Gut Microbiome Correlates of Serious AIDS and Non-AIDS Events

MISTRAL
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

MISTRAL (Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination) is a 5-year EU Horizon 2020 project, running from 1/1/2020 - 31/12/2024. The project is led by Fundacio Privada Institut de Recerca de la Sida-Caixa CAIXA in Barcelona and aims to explore the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies. If successful, MISTRAL will benefit millions of human beings living with, or at risk of acquiring HIV-1 infection, and will produce novel concepts and technical innovations applicable to other human diseases. By doing that, MISTRAL will help to unlock the full clinical potential of the human microbiome to stratify patient outcomes and will irreversibly bring microbiome science closer to clinical practice

NCT ID: NCT05202600 Not yet recruiting - Appendix Tumor Clinical Trials

Justification of Incidental Appendectomy With Respect to Pathohistological Findings

Start date: February 1, 2022
Phase:
Study type: Observational

This study seeks to justify performing an incidental appendectomy according to the following hypotheses: 1. The frequency of neoplasms in pathohistological (PHD) findings of incidental appendectomy (IA) is significantly higher than in PHD findings in appendectomies for acute appendcitis (AA) 2. The number needed to treat (NNT) for appendiceal tumors in the elderly is less than 500. 3. The rate of complicated AA in the elderly population is significantly higher than in the younger age group 4. NNT IA for complicated appendicitis in the elderly is less than 300. 5. NNT IA for potential death due to AA in the elderly is less than 500.

NCT ID: NCT04865328 Not yet recruiting - Overactive Bladder Clinical Trials

Impact of OAB Symptoms on Quality of Life in Croatia

OAB-CRO
Start date: May 10, 2021
Phase:
Study type: Observational

Overactive bladder (OAB) has a negative impact on the daily activities of affected individuals. OAB affects an estimated 12-17% of adults and has a similar reported prevalence in men and women. It has the potential to impair multiple domains of quality of life, including restriction of social and work life, while also resulting in higher healthcare resource use and costs. The primary objective of the present study was to evaluate, in a Croatian population reporting symptoms of OAB, the effect on work productivity and treatment behaviors (treatment seeking, receiving treatment, treatment dissatisfaction and treatment discontinuation).

NCT ID: NCT04709458 Not yet recruiting - Clinical trials for Acute Myelogenous Leukemia

Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis

Start date: September 1, 2022
Phase: Phase 1
Study type: Interventional

This is a study of allogeneic stem cell transplantation with TBX-2400 in adult subjects with Acute Myelogenous Leukemia (AML) or Myelofibrosis (MF). The donor cells are exposed to a protein that has been shown in the laboratory to improve the ability of the donor cells to make blood and immune cells after transplant. Exposure of the donor cells to this protein does not modify the genes in the cells in any way. This study has two goals. The first goal is to find out if transplant with TBX-2400 is safe. The second goal is to find out what effects TBX-2400 stem cells have on time to engraftment in adult subjects with AML or MF. The study hypothesis is that TBX-2400 cells will shorten the time to immune reconstitution after transplant.

NCT ID: NCT04564690 Not yet recruiting - Selenium Clinical Trials

Enriched QUARTET® Hen Eggs and Cardiovascular Function

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Role of oxidative stress in the development of cardiovascular diseases is well known and extensively investigated, because of its direct effects on vascular function, but also on the activation of the immune response. Thus, food products that could increase the antioxidant capacity of the vascular system would also act protective against cardiovascular diseases. However, we lack systematic clinical and pre-clinical research with food products instead of food supplements, which would result in consistent and repeatable results. Many studies have proven the effectiveness of n-3 polyunsaturated fatty acids (n-3 PUFA) in improvement of endothelial function, improvement of elasticity of the vascular wall and the anti-inflammatory effects in patients with chronic diseases, such as metabolic syndrome, if they are taken as an pharmacological preparation. Our research group recently reported that favorable anti-inflammatory properties of n-3 PUFA enriched hen eggs potentially contribute to the improvement of microvascular endothelium-dependent vasodilation in healthy individuals. In addition, this study aimed to determine the effect of QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein; QUARTET No. 012743696, 2014.) consumption on cardiovascular function in both healthy individuals and cardiovascular patients.

NCT ID: NCT04491305 Not yet recruiting - Quality of Life Clinical Trials

EHP-5 in Preoperative Assessment in Women With Endometriosis

EHP-5CRO
Start date: August 1, 2020
Phase:
Study type: Observational

There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. After validation, we will prospectively follow women with endometriosis through whole process - pre- and postoperatively.

NCT ID: NCT04304573 Not yet recruiting - Clinical trials for Postoperative Complications

Is Correcting Total Serum Calcium Levels Important After Thyroidectomy

Start date: June 9, 2020
Phase:
Study type: Observational

This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020. The aim of this study is to determine whether total serum calcium level should be corrected for serum albumin in assessing symptomatic hypocalcemia after total thyroidectomy and which variable (total serum calcium, ionized calcium, corrected serum calcium for albumin with Payne's formula or early PTH) is the most valuable predictor of symptomatic hypocalcemia after total thyroidectomy.

NCT ID: NCT03779165 Not yet recruiting - Clinical trials for Tachycardia, Ventricular

R Wave Sensing After VT Ablation

RASA-VT
Start date: December 2018
Phase:
Study type: Observational [Patient Registry]

Sustained, monomorphic ventricular tachycardia (VT) is most commonly encountered in patients with structural heart disease, usually with ischemic aetiology. It has been proven that repeated episodes of sustained VT contribute to the mortality of patients with structural heart disease. These patients are usually implanted with implantable cardioverter defibrillator without (ICD) or with cardiac resynchronisation therapy (CRT-D). According to the current guidelines 3D mapping with radiofrequency (RF) ablation of the tachycardia substrate is an established therapeutic option. As part of the clinical follow-up of patients implanted with cardiac implantable electronic devices (CIED), CIED function parameters are monitored every 6 months, which is always done before and after any procedure involving RF ablation. Furthermore, a transient drop of R wave sensing has been demonstrated after the atrioventricular (AV) node ablation in patients with single-chamber pacemakers and fast atrial fibrillation. The aim of this study is to assess the change in R wave sensing after the RF ablation of VT substrate. This study will be performed as a clinical, prospective, multi-centre, observational cohort study with a structured follow-up period of 12 months. All consecutive patients with sustained VT implanted with ICD or CRT-D undergoing RF ablation procedure of myocardial substrate, who are able to understand and sign informed consent, will be enrolled. Primary objective is a R wave sensing drop > 30% after VT substrate ablation procedure. Recruiting should not exceed 12 months with the minimal follow-up period of 12 months (24 months in total). Standardized statistical methods and test will be done using SPSS Software Version 22.0 or newer. This unique study offers the possibility to show the impact of RF ablation on short-term and long-term R wave sensing change assessed by ICD or CRT-D's ventricle electrode in patients with sustained VT and structural heart disease undergoing ablation procedure. This observational data is needed to further refine the treatment of these patients and to prevent possible ICD/CRT-D dysfunction which could endanger this patient population.

NCT ID: NCT03632460 Not yet recruiting - Pain, Postoperative Clinical Trials

Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery