Clinical trials: in Romania
Multiple Myeloma
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who…
- Trial name
- KarMMa-9 (NCT06045806)
- Testing
- idecabtagene vicleucel, Lenalidomide, Fludarabine
- Where
- 101 sites in United States, Australia and 16 more
- Volunteers
- 79 people
- Sponsor
- Celgene
Frailty Syndrome, Dementia
The Impact of Transcutaneous Vagal Nerve Stimulation on Frailty Syndrome in Older Adults
This clinical study, conducted at the Techirghiol Balneary and Rehabilitation Sanatorium, aims to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in improving clinical and biological…
- Trial name
- NCT07416708
- Testing
- Transcutaneous Auricular Vagus Nerve Stimulation, Physiotherapy
- Where
- Romania
- Volunteers
- 80 people
- Sponsor
- Balnear and Rehabilitation Sanatorium Techirghiol
Carcinoma, Non-Small-Cell Lung
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had…
- Trial name
- LIBRETTO-432 (NCT04819100)
- Testing
- Selpercatinib
- Where
- 211 sites in United States, Australia and 30 more
- Volunteers
- 152 people
- Sponsor
- Eli Lilly and Company
Sepsis Abdominal
Perioperative Sepsis. An Epigenetic Perspective
This single-center, prospective, observational study evaluates the impact of perioperative sepsis on inflammatory response, coagulation abnormalities, cardiac dysfunction, and microRNA expression in adult patients undergoing…
- Trial name
- PESE (NCT07442552)
- Testing
- • Presepsin • C-reactive protein (CRP) • Fibrinogen • Aspartate aminotransferase (AST) • Alanine aminotransferase (ALT) • Creatinine • Urea • Creatine kinase (CK) • Creatine kinase-MB (CK-MB) • NT-pro
- Where
- Romania
- Volunteers
- 40 people
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Hormone Receptor Positive Breast Cancer
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal…
- Trial name
- FALCON (NCT01602380)
- Testing
- faslodex 500mg, arimidex 1mg, faslodex dummy
- Where
- 118 sites in United States, Argentina and 18 more
- Volunteers
- 462 people
- Sponsor
- AstraZeneca
Liver Cirrhosis With Acute Decompensation
Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures
Patients with liver cirrhosis have historically received prophylactic transfusions before invasive procedures with high risk of bleeding.
- Trial name
- PROTECT-CIRR (NCT07437755)
- Testing
- Blood Products transfusion
- Where
- Romania
- Volunteers
- 116 people
- Sponsor
- Grigore T. Popa University of Medicine and Pharmacy
Gastroesophageal-junction Cancer, Monoclonal Antibody
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with…
- Conditions
- Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT06532006
- Testing
- HLX22, Pembrolizumab, Trastuzumab
- Where
- 208 sites in United States, Argentina and 15 more
- Volunteers
- 550 people
- Sponsor
- Shanghai Henlius Biotech
Muscular Dystrophy, Duchenne
A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)
Part 1 (dose escalation) will evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram [mg/kg] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will…
- Trial name
- MIS51ON (NCT03992430)
- Testing
- Eteplirsen
- Where
- 59 sites in United States, Colombia and 24 more
- Volunteers
- 160 people
- Sponsor
- Sarepta Therapeutics, Inc.
Mucopolysaccharidosis I (MPS I)
Mucopolysaccharidosis I (MPS I) Registry
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I.
- Trial name
- NCT00144794
- Where
- 141 sites in United States, Argentina and 35 more
- Volunteers
- 1,406 people
- Sponsor
- Genzyme, a Sanofi Company
Carcinoma, Squamous Cell, Non-small-cell Lung
A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1.
- Trial name
- NCT03976362
- Testing
- Pembrolizumab, Carboplatin, Paclitaxel
- Where
- 178 sites in United States, Argentina and 18 more
- Volunteers
- 851 people
- Sponsor
- Merck Sharp & Dohme LLC
Hereditary Angioedema, Pediatric
Berotralstat Treatment in Children With Hereditary Angioedema
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and effectiveness of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to < 12 years of age for prophylactic…
- Trial name
- APeX-P (NCT05453968)
- Testing
- Berotralstat
- Where
- 15 sites in Austria, Canada and 8 more
- Volunteers
- 29 people
- Sponsor
- BioCryst Pharmaceuticals
Advanced Melanoma
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
- Trial name
- PRISM-MEL-301 (NCT06112314)
- Testing
- Brenetafusp, Nivolumab, Nivolumab + Relatlimab
- Where
- 211 sites in United States, Argentina and 24 more
- Volunteers
- 680 people
- Sponsor
- Immunocore Ltd
Muscular Dystrophy, Duchenne
Registry of Translarna (Ataluren) in Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)
This study is being performed as a post-approval safety study (PASS), per the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to gather data on Translarna (ataluren) safety…
- Trial name
- NCT02369731
- Where
- 71 sites in Austria, Brazil and 14 more
- Volunteers
- 316 people
- Sponsor
- PTC Therapeutics
Giant Cell Arteritis (GCA)
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper…
- Trial name
- SELECT-GCA (NCT03725202)
- Testing
- Upadacitinib, Corticosteroid (CS)
- Where
- 172 sites in United States, Australia and 22 more
- Volunteers
- 429 people
- Sponsor
- AbbVie
Multiple Sclerosis, Primary Progressive
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course.
- Trial name
- O'HAND (NCT04035005)
- Testing
- Ocrelizumab
- Where
- 155 sites in United States, Australia and 21 more
- Volunteers
- 1,013 people
- Sponsor
- Hoffmann-La Roche
Relapsing Forms of Multiple Sclerosis
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)
In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study.
- Trial name
- FUSION (NCT05798520)
- Testing
- BIIB091, DRF
- Where
- 77 sites in United States, Bulgaria and 8 more
- Volunteers
- 127 people
- Sponsor
- Biogen
Head and Neck Cancer
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)
The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell…
- Trial name
- NCT05386550
- Testing
- Xevinapant, IMRT
- Where
- 206 sites in United States, Argentina and 24 more
- Volunteers
- 166 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Multiple Myeloma, Secondary Immunodeficiency (SID)
Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic's standard practice.
- Trial name
- NCT05879757
- Testing
- No Intervention
- Where
- 27 sites in Argentina, Czechia and 9 more
- Volunteers
- 75 people
- Sponsor
- Takeda
Type 1 Diabetes, Obesity
A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.
- Conditions
- Type 1 Diabetes, Obesity, Overweight
- Trial name
- SURPASS-T1D-2 (NCT06962280)
- Testing
- Tirzepatide
- Where
- 79 sites in United States, Argentina and 8 more
- Volunteers
- 465 people
- Sponsor
- Eli Lilly and Company
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