Clinical trials: in Romania
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.
- Trial name
- FORTITUDE-102 (NCT05111626)
- Testing
- Bemarituzumab, Nivolumab, Chemotherapy
- Where
- 348 sites in United States, Argentina and 27 more
- Volunteers
- 515 people
- Sponsor
- Amgen
Primary Sjögren's Syndrome
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).
- Trial name
- NCT06979531
- Testing
- IMVT-1402
- Where
- 96 sites in United States, Argentina and 11 more
- Volunteers
- 180 people
- Sponsor
- Immunovant Sciences GmbH
Intraoperative Hypotension, Jugular Veins
Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
This observational study aims to learn whether changes in the internal jugular vein during anesthesia induction can help predict low blood pressure and kidney injury after surgery. The main questions it aims to answer are: 1.
- Conditions
- Intraoperative Hypotension, Jugular Veins, Hypotension on Induction, General Anesthesia With Propofol
- Trial name
- PRO-JUGULAR (NCT07638306)
- Testing
- Internal Jugular Vein Ultrasound Assesment
- Where
- Romania
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Tîrgu Mureș Emergency Clinical County Hospital, Romania
Asthma
Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS).
The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication…
- Trial name
- TRECOS (NCT06264674)
- Testing
- CHF5993 200/6/12.5 μg pMDI HFA-152a, Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
- Where
- 118 sites in Bulgaria, Czechia and 12 more
- Volunteers
- 827 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Heart Failure, Acute Heart Failure
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
- Trial name
- REDEFINE-HF (NCT06008197)
- Testing
- Finerenone
- Where
- 356 sites in United States, Argentina and 24 more
- Volunteers
- 5,200 people
- Sponsor
- Colorado Prevention Center
Heart Failure (HF), Atrial Fibrillation (AF)
Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation
Heart failure and atrial fibrillation are two of the most common heart diseases globally. Nearly half of all patients with heart failure also have atrial fibrillation.
- Trial name
- HFcAF (NCT07436299)
- Where
- 15 sites in United States, Belgium and 8 more
- Volunteers
- 400 people
- Sponsor
- Oslo University Hospital
Non Squamous Non Small Cell Lung Cancer
A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with…
- Trial name
- NCT06687369
- Testing
- MB12 (Proposed Pembrolizumab Biosimilar), EU-sourced Keytruda®, US-sourced Keytruda®
- Where
- 173 sites in Armenia, Bosnia and Herzegovina and 22 more
- Volunteers
- 726 people
- Sponsor
- mAbxience Research S.L.
Haemophilia A, Haemophilia A With Inhibitors
A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A
This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes.
- Trial name
- FRONTIER4 (NCT05685238)
- Testing
- Mim8
- Where
- 141 sites in United States, Austria and 30 more
- Volunteers
- 451 people
- Sponsor
- Novo Nordisk A/S
Chronic Kidney Disease
A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on…
- Trial name
- Elevate-CKD (NCT07753993)
- Testing
- Elecoglipron
- Where
- 715 sites in United States, Argentina and 35 more
- Volunteers
- 7,000 people
- Sponsor
- AstraZeneca
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
CRS Questionnaire Validation Project
The 'CRS validation project' consists of a joint effort of 32 medical centers in Europe, the USA, and South Africa to carry out the validation of 2 novel questionnaires designated to measure self-perceived severity and control of…
- Trial name
- NCT06970977
- Where
- 32 sites in United States, Belgium and 9 more
- Volunteers
- 1,000 people
- Sponsor
- The European Forum for Research and Education in Allergy and Airway Diseases
Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).
- Trial name
- DeLLphi-312 (NCT07005128)
- Testing
- Tarlatamab, Durvalumab, Carboplatin
- Where
- 164 sites in United States, Argentina and 24 more
- Volunteers
- 350 people
- Sponsor
- Amgen
Acute Lymphoblastic Leukaemia
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than…
- Trial name
- NCT01949129
- Testing
- VP16, TBI, Thiotepa
- Where
- 119 sites in Argentina, Australia and 29 more
- Volunteers
- 1,800 people
- Sponsor
- St. Anna Kinderkrebsforschung
Primary Prevention of Atherosclerotic Cardiovascular Disease
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at…
- Trial name
- NCT05739383
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 983 sites in United States, Argentina and 40 more
- Volunteers
- 14,012 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab…
- Trial name
- Astefania (NCT04873362)
- Testing
- Atezolizumab, Trastuzumab Emtansine, Trastuzumab
- Where
- 238 sites in United States, Australia and 30 more
- Volunteers
- 1,188 people
- Sponsor
- Hoffmann-La Roche
Advanced Upper Gastrointestinal Tract Adenocarcinoma
A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body
This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell…
- Trial name
- STAR-221 (NCT05568095)
- Testing
- Domvanalimab, Zimberelimab, Capecitabine
- Where
- 168 sites in United States, Argentina and 27 more
- Volunteers
- 1,040 people
- Sponsor
- Arcus Biosciences, Inc.
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Evaluation of the Bifurcated Multilayer Flow Modulator for the Treatment of Abdominal Aortic Aneurysm
The study purpose is to determine the safety and efficacy of the BMFM used for the endovascular treatment of aortic aneurysm involving iliac arteries.
- Trial name
- STREAMLINER (NCT03024554)
- Testing
- Implantation of the Bifurcated Multilayer Flow Modulator
- Where
- 7 sites in Belgium, Bulgaria and 3 more
- Volunteers
- 42 people
- Sponsor
- Cardiatis
Metastatic Colorectal Cancer
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or…
- Trial name
- CodeBreaK 301 (NCT06252649)
- Testing
- FOLFIRI Regimen, Sotorasib, Panitumumab
- Where
- 291 sites in United States, Argentina and 33 more
- Volunteers
- 450 people
- Sponsor
- Amgen
Upper Urinary Tract Urothelial Carcinoma, Urothelial Carcinoma
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO [mitomycin] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of…
- Trial name
- NCT06774131
- Testing
- UGN-104
- Where
- 79 sites in United States, Bulgaria and 7 more
- Volunteers
- 70 people
- Sponsor
- UroGen Pharma Ltd.
Migraine
A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
- Trial name
- PIONEER-PEDS1 (NCT04396236)
- Testing
- Lasmiditan
- Where
- 152 sites in United States, Belgium and 13 more
- Volunteers
- 847 people
- Sponsor
- Eli Lilly and Company
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active…
- Trial name
- NCT06581198
- Testing
- rapcabtagene autoleucel
- Where
- 107 sites in United States, Argentina and 24 more
- Volunteers
- 179 people
- Sponsor
- Novartis Pharmaceuticals
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