Clinical trials: in Slovenia
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.
- Trial name
- NCT04153149
- Testing
- Vutrisiran, Sterile Normal Saline (0.9% NaCl)
- Where
- 121 sites in United States, Argentina and 31 more
- Volunteers
- 655 people
- Sponsor
- Alnylam Pharmaceuticals
Nutritional Status, Nutrient Deficiency
Dietary Challenges in the Population of Nursing Homes' Residents
To obtain up-to-date data on nutritional status of older adults, a national dietary survey will be conducted in 2022/2023, providing data on the consumption of foods and enabling the assessment intakes of energy and specific…
- Conditions
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency, Vitamin D Deficiency
- Trial name
- NUTRICARE (NCT05389618)
- Testing
- Diagnostic Tests
- Where
- Slovenia
- Volunteers
- 387 people
- Sponsor
- Institute of Nutrition, Slovenia (Nutris)
Type 1 Diabetes Mellitus
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on…
- Trial name
- FABULINUS (NCT06111586)
- Testing
- Frexalimab, Insulin
- Where
- 79 sites in United States, Austria and 14 more
- Volunteers
- 197 people
- Sponsor
- Sanofi
Periodontal Diseases
Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
Minimally invasive non-surgical therapy (MINST) is a new approach towards regeneration of deep periodontal defects. Important part of MINST procedure, besides usage of magnification loupes and piezo-electric devices seems to be…
- Trial name
- MINST (NCT04036513)
- Testing
- MINST, Conventional SRP
- Where
- Slovenia
- Volunteers
- 20 people
- Sponsor
- University of Ljubljana
Amputation, Gait Disorders, Neurologic
Usability of the Smart Hallway System in Clinical Setting
The aim of the study is to examine suitability of data and processed reports acquired from the Smart Hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.
- Trial name
- SmartHallway (NCT06645054)
- Testing
- Standard rehabilitation, Lower-limb prosthesis, Lower-limb orthosis
- Where
- Slovenia
- Volunteers
- 100 people
- Sponsor
- University Rehabilitation Institute, Republic of Slovenia
Relapsing-Remitting Multiple Sclerosis
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-naive, switching…
- Trial name
- SONATA-MS (NCT07827586)
- Testing
- Ocrelizumab
- Where
- 2 sites in Czechia, Slovenia
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
Foramen Ovale, Patent, Echocardiography
Long-term Outcomes After Percutaneous Closure of PFO
International medical centre Medicor from Slovenia has reported 363 successful percutaneous closures of patent foramen ovale (PFO) from October 2006 till October 2023.
- Conditions
- Foramen Ovale, Patent, Echocardiography, Embolic Stroke, Atrial Fibrillation
- Trial name
- NCT05558774
- Where
- Slovenia
- Volunteers
- 364 people
- Sponsor
- MC Medicor
Erythema, Telangiectasis
The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters
The aim of this study is to compare the effects of 16 weeks of daily dietary supplementation with two investigational products containing collagen, methylsulfonylmethane (MSM), and vitamin C on skin parameters in comparison to a…
- Conditions
- Erythema, Telangiectasis, Skin Redness
- Trial name
- TO-COSKIN4 (NCT07345195)
- Testing
- CPMSM-HD, CPMSM-LD
- Where
- Slovenia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- VIST - Faculty of Applied Sciences
Acute Kidney Injury, Fluid Overload
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
There is a growing focus on short- and long-term kidney health in neonates, including those with acute kidney injury (AKI). AKI occurs commonly in the Neonatal Intensive Care Unit (NICU) and is associated with adverse outcomes.
- Conditions
- Acute Kidney Injury, Fluid Overload, Prematurity Complications, Risk Factors
- Trial name
- AWAKEN 2 (NCT06823115)
- Where
- 125 sites in United States, Argentina and 31 more
- Volunteers
- 8,000 people
- Sponsor
- Indiana University
Heart Failure
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more.
- Trial name
- NCT06424288
- Testing
- vicadrostat, empagliflozin
- Where
- 671 sites in United States, Argentina and 28 more
- Volunteers
- 6,712 people
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or…
- Trial name
- FIBRONEER™-ON (NCT06238622)
- Testing
- Nerandomilast
- Where
- 375 sites in United States, Argentina and 42 more
- Volunteers
- 1,666 people
- Sponsor
- Boehringer Ingelheim
Traumatic Brain Injury, Intracranial Hemorrhages
Andexanet Alfa for Reversal of Factor Xa Inhibitors in Traumatic Brain Injury: A Retrospective Single-Centre Study
Elderly patients on direct oral anticoagulants (DOACs), specifically factor Xa (FXa) inhibitors such as apixaban and rivaroxaban are at elevated risk of haematoma expansion following traumatic brain injury (TBI).
- Trial name
- AA-TBI (NCT07898982)
- Where
- Slovenia
- Volunteers
- 34 people
- Sponsor
- University Medical Centre Ljubljana
Cervical Vertebral Disc Degeneration, Intervertebral Disc Displacement
Cervical Movement Control Before and After Anterior Cervical Discectomy and Fusion
Degenerative cervical disc disease can cause neck pain, nerve symptoms, dizziness, and problems with balance and head movement control.
- Trial name
- MOVE-ACDF (NCT07425613)
- Testing
- Anterior Cervical Discectomy and Fusion
- Where
- Slovenia
- Volunteers
- 50 people
- Sponsor
- University of Ljubljana
Periodontitis
Probiotics as Adjunct to Nonsurgical Periodontal Treatment
ProlacSan probiotic lozenges and gels contain L. plantarum and L. brevis strains with proven in vitro antimicrobial activity against P. gingivalis.
- Trial name
- NCT04137419
- Testing
- Probiotic lozenges
- Where
- Slovenia
- Volunteers
- 40 people
- Sponsor
- University of Ljubljana
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Most patients resuscitated from out-of-hospital cardiac arrest (OHCA) remain comatose on hospital admission and are routinely managed with continuous sedation.
- Conditions
- Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury, Post-Cardiac Arrest Syndrome
- Trial name
- NCT07895771
- Testing
- Minimal sedation, Standard continuous sedation
- Where
- Slovenia
- Volunteers
- 100 people
- Sponsor
- University Medical Centre Ljubljana
Sleep Onset Latency, Sleep Quality
Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
single-center, randomized, cross over, double-blind, placebo controlled intervention study
- Trial name
- NutriSom-01A (NCT06600633)
- Testing
- 14 days of intervention with Active Control (AC), 14 days of intervention with Test Product (TP)
- Where
- Slovenia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Institute of Nutrition, Slovenia (Nutris)
B-Cell Acute Lymphoblastic Leukaemia
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
The IntReALL BCP 2020 study aims to review recent developments and findings regarding chemoimmunotherapy with inotuzumab and immunotherapy with blinatumomab and to increase the use of promising new immunotherapeutic drugs as…
- Trial name
- NCT07476729
- Testing
- Inotuzumab ozogamicin (INO), Blinatumomab
- Where
- 21 sites in Austria, Belgium and 19 more
- Volunteers
- 750 people
- Sponsor
- Charite University, Berlin, Germany
Growth Hormone Deficiency in Children
A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).
- Trial name
- REAL4 (NCT03811535)
- Testing
- Somapacitan, Norditropin®
- Where
- 139 sites in United States, Algeria and 24 more
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Atrial Fibrillation (AF)
Assessment of Catheter Tissue Contact in PFA
Pulmonary vein isolation remains the cornerstone of invasive treatment for atrial fibrlllation. Despite recent technological advances in the field of pulsed field ablation (PFA) pulmonary vein isolation durability and arrhythmia…
- Trial name
- ASSESS PFA (NCT07721948)
- Testing
- Electrode tissue contact assessment during pulsed field ablation
- Where
- Slovenia
- Volunteers
- 60 people
- Sponsor
- University Medical Centre Ljubljana
Colon Polyp, Adenoma
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
The study will compare the use of a 6-month follow-up vs a 12-month follow-up after the removal of a large non-pedunculated polyp 20-50mm in size and without high grade dysplasia.
- Conditions
- Colon Polyp, Adenoma, Serrated Polyp, Recurrence, Local Neoplasm
- Trial name
- STARLING (NCT07198945)
- Testing
- 6-month follow-up, 12-month follow-up
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 546 people
- Sponsor
- Indiana University
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