Clinical trials: in Romania
Prostate Cancer
Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option.
- Trial name
- PC-PEP (NCT04895839)
- Testing
- Patient Empowerment Program
- Where
- 16 sites in Belgium, Canada and 3 more
- Volunteers
- 2,130 people, healthy volunteers welcome
- Sponsor
- Gabriela Ilie
Sjogren Disease
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.
- Trial name
- EnVISage (NCT06928142)
- Testing
- Sibeprenlimab
- Where
- 64 sites in United States, Argentina and 6 more
- Volunteers
- 83 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)
The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and…
- Trial name
- NCT06726265
- Testing
- eftilagimod alfa, carboplatin plus paclitaxel, cisplatin or carboplatin + pemetrexed
- Where
- 147 sites in United States, Argentina and 25 more
- Volunteers
- 756 people
- Sponsor
- Immutep S.A.S.
Generalized Pustular Psoriasis
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
- Trial name
- GEMINI-1 (NCT05352893)
- Testing
- 750 mg Imsidolimab, 300 mg Imsidolimab
- Where
- 65 sites in United States, Australia and 13 more
- Volunteers
- 45 people
- Sponsor
- Vanda Pharmaceuticals
Scleroderma, Systemic
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis.
- Trial name
- VITALISScE™ (NCT05559580)
- Testing
- Avenciguat (BI 685509)
- Where
- 168 sites in United States, Argentina and 35 more
- Volunteers
- 214 people
- Sponsor
- Boehringer Ingelheim
Schizophrenia
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia
The primary objective of this study is to evaluate the efficacy of TV-44749 in adult participants with schizophrenia. A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in…
- Trial name
- SOLARIS (NCT05693935)
- Testing
- TV-44749
- Where
- 82 sites in United States, Bulgaria and 3 more
- Volunteers
- 675 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Inferior Turbinate Hypertrophy, Nasal Obstruction
Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy
The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction while minimizing side effects and complications.
- Conditions
- Inferior Turbinate Hypertrophy, Nasal Obstruction, Turbinate; Hypertrophy Mucous Membrane
- Trial name
- NCT06438185
- Testing
- IRE System
- Where
- 4 sites in Israel, Lithuania and 2 more
- Volunteers
- 48 people
- Sponsor
- ENTire Medical Ltd.
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)
Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer.
- Trial name
- NCT05624554
- Testing
- Nemtabrutinib, Fludarabine, Cyclophosphamide
- Where
- 97 sites in United States, Australia and 19 more
- Volunteers
- 300 people
- Sponsor
- Merck Sharp & Dohme LLC
Irritable Bowel Syndrome (IBS)
Synbiotic Supplement With Botanical Extracts for Gut Microbiota Balance in Irritable Bowel Syndrome
The goal of this clinical trial is to evaluate whether a synbiotic dietary supplement containing botanical extracts and multiple probiotic strains can improve gastrointestinal symptoms and modulate gut microbiota composition in…
- Trial name
- NCT07475299
- Testing
- Synbiotic supplement containing probiotic strains, botanical extracts, magnesium, vitamin B1, and L-theanine designed to support gut microbiota balance.
- Where
- Romania
- Volunteers
- 8 people
- Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
Thyroid Eye Disease
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease
This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with…
- Trial name
- UplighTED (NCT06307613)
- Testing
- Efgartigimod PH20 SC
- Where
- 77 sites in United States, Australia and 14 more
- Volunteers
- 102 people
- Sponsor
- argenx
Paediatric Asthma
Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
This study is to evaluate the efficacy of the digital health assistant (DHA) "Alex" in improving asthma control in asthmatic children and adolescents aged 10 to 19 compared to their baseline values.
- Trial name
- ALEX (NCT07472283)
- Testing
- Phase I (months 1-3): DHA core functionality, Phase II (months 3-6): platform augmentation, Embedded qualitative study
- Where
- 5 sites in Romania
- Volunteers
- 42 people
- Sponsor
- University Children's Hospital Basel
Osteoarthritis
Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee
An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite…
- Trial name
- NCT05377489
- Testing
- RTX-GRT7039
- Where
- 96 sites in United States, Bulgaria and 5 more
- Volunteers
- 714 people
- Sponsor
- Grünenthal GmbH
Multi Drug Resistant Organisms
Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients
This study aims to evaluate the impact of digestive carriage of multidrug-resistant organisms (MDRO) on the risk of healthcare-associated infections in hospitalized adult patients.
- Trial name
- NCT07134270
- Testing
- MDRO Rectal Screening, 30-Day Telephone Follow-Up
- Where
- Romania
- Volunteers
- 400 people
- Sponsor
- Valeriu Gheorghita
Obesity, Overweight
AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes.
- Conditions
- Obesity, Overweight, Diabetes Mellitus, Type 2
- Trial name
- AMAZE 8 (NCT07400107)
- Testing
- NNC0487-0111, Semaglutide
- Where
- 120 sites in United States, Argentina and 12 more
- Volunteers
- 1,000 people
- Sponsor
- Novo Nordisk A/S
HIV Infection, HIV
#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.
The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV…
- Conditions
- HIV Infection, HIV, Stigma, Education
- Trial name
- #aware hiv (NCT06900829)
- Testing
- HIV team implementation
- Where
- 28 sites in Belgium, France and 8 more
- Volunteers
- 5,200 people, healthy volunteers welcome
- Sponsor
- Casper Rokx
Eosinophilic Fasciitis
EFESO: Study on Juvenile Onset Eosinophilic Fasciitis
Eosinophilic fasciitis is a connective tissue disorder characterized by inflammation of the muscle fasciae, which is very rare in children.
- Trial name
- NCT07348263
- Where
- 15 sites in United States, Croatia and 9 more
- Volunteers
- 20 people
- Sponsor
- Meyer Children's Hospital IRCCS
Edentulous; Alveolar Process, Atrophy, Healthy Adult Participants
Comparison of Nd Yag, Diode and Er:YAG Lasers vs Scalpel in Preprosthetic Vestibuloplasty: Vestibular Depth Gain
The aim of this study was to compare the clinical results obtained using the conventional approach versus the modern laser method, by recording postoperative results
- Conditions
- Edentulous; Alveolar Process, Atrophy, Healthy Adult Participants, Edentulous Alveolar Ridge With Labial Resorption
- Trial name
- 78/30102018 (NCT07462117)
- Testing
- vestibuloplasty for Nd-YAG group, diode vestibuloplasty, Er-YAG laser vestibuloplasty
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
Urinary Tract Infection, Acute Pyelonephritis
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication)…
- Trial name
- PIVOT-PO (NCT06059846)
- Testing
- TBP-PI-HBr, Imipenem-cilastatin, Dummy Infusion
- Where
- 85 sites in United States, Argentina and 17 more
- Volunteers
- 1,690 people
- Sponsor
- Spero Therapeutics
Chronic; Gastritis, Atrophic
Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis
This prospective multicenter study investigates the added benefit of incisura biopsy to correct identification of patients with high-risk chronic gastritis (OLGA stages III-IV).
- Trial name
- INCREASE (NCT05744596)
- Testing
- Incisura biopsy analysis
- Where
- 2 sites in Portugal, Romania
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Clinical Hospital Colentina
Carcinoma, Hepatocellular
Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7
REPLACE is a phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of regorafenib and pembrolizumab (Rego-Pembro) versus transarterial chemoembolization (TACE) or transarterial radioembolization…
- Trial name
- REPLACE (NCT04777851)
- Testing
- Regorafenib in combination with pembrolizumab, Loco-regional therapy
- Where
- 26 sites in United States, Belgium and 11 more
- Volunteers
- 45 people
- Sponsor
- Translational Research in Oncology
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