Clinical trials: in Romania
Melanoma, Stage II, Melanoma Stage III
Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients
Melanoma is a kind of skin cancer that starts in the melanocytes. Melanocytes are cells that make the pigment that gives skin its colour. 'Resected' means the melanoma has been completely removed with surgery.
- Trial name
- Dahlia (NCT06551064)
- Testing
- FYB206, Keytruda
- Where
- 17 sites in Bosnia and Herzegovina, Bulgaria and 9 more
- Volunteers
- 96 people
- Sponsor
- Formycon AG
Coronavirus Disease (COVID-19)
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms.
- Trial name
- MOVe-NOW (NCT06667700)
- Testing
- Molnupiravir
- Where
- 227 sites in United States, Argentina and 22 more
- Volunteers
- 3,082 people
- Sponsor
- Merck Sharp & Dohme LLC
Bipolar Disorder Type I With Mania or Mania With Mixed Features
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
- Trial name
- NCT06951711
- Testing
- KarXT
- Where
- 85 sites in United States, China and 9 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
Acute Respiratory Distress Syndrome, Infections
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS…
- Trial name
- NCT05947955
- Testing
- Rhu-pGSN, normal saline
- Where
- 65 sites in United States, Belgium and 11 more
- Volunteers
- 600 people
- Sponsor
- BioAegis Therapeutics Inc.
Transthyretin Amyloidosis With Cardiomyopathy
TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
The purpose of this study is to: Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events Evaluate the efficacy of nucresiran compared to placebo on additional…
- Trial name
- NCT07052903
- Testing
- Nucresiran, Sterile Normal Saline (0.9% NaCl)
- Where
- 266 sites in United States, Argentina and 34 more
- Volunteers
- 1,750 people
- Sponsor
- Alnylam Pharmaceuticals
Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate…
- Trial name
- NCT06136650
- Testing
- Opevesostat, Dexamethasone, Fludrocortisone acetate
- Where
- 330 sites in United States, Australia and 37 more
- Volunteers
- 1,314 people
- Sponsor
- Merck Sharp & Dohme LLC
Cutaneous Squamous Cell Carcinoma
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
- Trial name
- NCT05888844
- Testing
- INCB099280
- Where
- 77 sites in Australia, Brazil and 13 more
- Volunteers
- 63 people
- Sponsor
- Incyte Corporation
Primary Immune Thrombocytopenia
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP).
- Trial name
- ADVANCE SC+ (NCT04812925)
- Testing
- efgartigimod PH20 SC
- Where
- 83 sites in United States, Argentina and 23 more
- Volunteers
- 173 people
- Sponsor
- argenx
Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab…
- Trial name
- NCT07098988
- Testing
- Visugromab, Pembrolizumab 200 mg Q3W, Pemetrexed 500 mg/m^2
- Where
- 51 sites in United States, Germany and 5 more
- Volunteers
- 107 people
- Sponsor
- CatalYm GmbH
Myelodysplastic Syndrome, Anemia
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions
The main aim of this study is to assess how much elritercept reduces the need for RBC (red blood cell) transfusions and improves hemoglobin blood values in addition to how safe elritercept is when compared with epoetin alfa.
- Trial name
- ELRiSE MDS (NCT07422480)
- Testing
- Elritercept, Epoetin Alfa
- Where
- 162 sites in United States, Argentina and 26 more
- Volunteers
- 300 people
- Sponsor
- Takeda
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
This study aims to evaluate whether monitoring perioperative inflammatory and metabolic biomarkers can help identify postoperative complications early in adult patients undergoing colorectal or gastric cancer surgery.
- Trial name
- PERIO-BIO (NCT07881133)
- Testing
- Perioperative Biomarker-Guided Monitoring
- Where
- Romania
- Volunteers
- 320 people
- Sponsor
- Bucharest Emergency Hospital
Diabetes Mellitus, Type 2
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema.
- Trial name
- REIMAGINE 5 (NCT06534411)
- Testing
- Cagrilintide, Semaglutide, Tirzepatide
- Where
- 163 sites in United States, Argentina and 12 more
- Volunteers
- 1,023 people
- Sponsor
- Novo Nordisk A/S
Pancreatic Cancer, Chronic Pancreatitis
Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma
The goal of this prospective multicenter observational study is to evaluate the diagnostic accuracy of blood-based protein biomarkers for detecting pancreatic ductal adenocarcinoma (PDAC) in adults aged 18 years and older.
- Conditions
- Pancreatic Cancer, Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm
- Trial name
- NCT07875582
- Testing
- Blood-Based Protein Biomarker Assessment
- Where
- Romania
- Volunteers
- 100 people
- Sponsor
- Grigore T. Popa University of Medicine and Pharmacy
Chemotherapy-induced Thrombocytopenia
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy
- Trial name
- NCT03937154
- Testing
- Romiplostim
- Where
- 34 sites in United States, Argentina and 8 more
- Volunteers
- 145 people
- Sponsor
- Amgen
Systemic Sclerosis (SSc)
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis.
- Trial name
- eSScape (NCT06655155)
- Testing
- Efgartigimod PH20 SC
- Where
- 79 sites in United States, Argentina and 22 more
- Volunteers
- 87 people
- Sponsor
- argenx
Superficial Venous Insufficiency, Varicose Veins
Pilot Study: Evaluation of the Safety of the Application of Non-thermal HIFU for Varicose Veins Treatment of the Lower Limbs
EASY-VEIN NT is a pilot, prospective, single-center, non-randomized clinical investigation evaluating the safety and feasibility of the application of non-thermal high-intensity focused ultrasound (NT-HIFU) for the treatment of…
- Trial name
- EASY-VEIN NT (NCT07878767)
- Testing
- Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up
- Where
- Romania
- Volunteers
- 15 people
- Sponsor
- VeinSound
Moderately to Severely Active Crohns Disease
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with…
- Trial name
- SIBERITE-1 (NCT06819878)
- Testing
- Afimkibart
- Where
- 375 sites in United States, Argentina and 36 more
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Psoriatic Arthritis
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs.
- Trial name
- NCT04908202
- Testing
- Deucravacitinib
- Where
- 183 sites in United States, Argentina and 19 more
- Volunteers
- 670 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation
PulseSelect™ PFA Global Registry
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.
- Trial name
- NCT06393920
- Where
- 43 sites in Australia, Belgium and 14 more
- Volunteers
- 1,950 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Alzheimer Disease, Agitation
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in…
- Trial name
- NCT06937229
- Testing
- KarXT, KarX-EC
- Where
- 252 sites in United States, Argentina and 24 more
- Volunteers
- 650 people
- Sponsor
- Bristol-Myers Squibb
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