Clinical trials: in Romania
Triple Negative Breast Cancer, PD-L1 Negative
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally…
- Trial name
- ASCENT-03 (NCT05382299)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, nab-Paclitaxel
- Where
- 363 sites in United States, Argentina and 28 more
- Volunteers
- 623 people
- Sponsor
- Gilead Sciences
Tooth Impaction, Impacted Canine, Dental Anomalies
This Systematic Review Aims to Synthesize Available Evidence Regarding the Prevalence, Anatomical Distribution, Etiological Determinants, and Diagnostic Assessment of Permanent Canine Impaction. A Systematic Search of PubMed, PubMed Central, and ScienceDirect Was Conducted for Studies Published Betw
This systematic review aimed to synthesize current evidence regarding the prevalence, anatomical distribution, etiological determinants, and diagnostic assessment of permanent canine impaction.
- Trial name
- PCI (NCT07509320)
- Where
- Romania
- Sponsor
- Dimitrie Cantemir University
Breast Neoplasms
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2…
- Trial name
- EMBER-4 (NCT05514054)
- Testing
- Imlunestrant, Tamoxifen, Anastrozole
- Where
- 672 sites in United States, Argentina and 29 more
- Volunteers
- 8,000 people
- Sponsor
- Eli Lilly and Company
Sjögren's Syndrome
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
- Trial name
- POETYK SjS-1 (NCT05946941)
- Testing
- Deucravacitinib
- Where
- 199 sites in United States, Argentina and 31 more
- Volunteers
- 774 people
- Sponsor
- Bristol-Myers Squibb
Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.
- Trial name
- Eucalyptus (NCT06430866)
- Testing
- ABP 234, Pembrolizumab
- Where
- 128 sites in Argentina, Bulgaria and 16 more
- Volunteers
- 163 people
- Sponsor
- Amgen
Diffuse Large B-cell Lymphoma
Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP…
- Trial name
- frontMIND (NCT04824092)
- Testing
- Tafasitamab, Lenalidomide, Rituximab
- Where
- 307 sites in United States, Argentina and 27 more
- Volunteers
- 899 people
- Sponsor
- Incyte Corporation
Migraine
Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.
- Trial name
- EMBRACE (NCT04252742)
- Testing
- Erenumab
- Where
- 91 sites in United States, Bulgaria and 7 more
- Volunteers
- 512 people
- Sponsor
- Amgen
Brain Injury Traumatic Mild
Using Routine Inflammatory and Metabolic Blood Tests (Bedside Included) to Predict Brain Injury in Children After Minor Head Trauma
Traumatic brain injury (TBI) poses significant strains on the paediatric population, for which the possible side effects of diagnostic imagistics could induce life-altering conditions.
- Trial name
- paeds_mTBI_Bio (NCT07397091)
- Where
- 7 sites in Romania
- Volunteers
- 800 people
- Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
Symptomatic Knee Osteoarthritis
Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis
This was a double-blinded, two-arm, phase 2a study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.
- Trial name
- NCT04886258
- Testing
- DFV890
- Where
- 31 sites in United States, Argentina and 6 more
- Volunteers
- 115 people
- Sponsor
- Novartis Pharmaceuticals
Generalized Pustular Psoriasis
Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
- Trial name
- GEMINI-2 (NCT05366855)
- Testing
- Double-blind 200 mg imsidolimab, Open-label 200 mg imsidolimab, Standard of Care (SOC)
- Where
- 65 sites in United States, Australia and 13 more
- Volunteers
- 42 people
- Sponsor
- Vanda Pharmaceuticals
Liver Cirrhosis
Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).
- Trial name
- NCT06478602
- Testing
- Fecal microbiota transplantation
- Where
- Romania
- Volunteers
- 19 people
- Sponsor
- Cristian Ichim
White Spot Lesion
Clinical Evaluation of an Experimental Remineralization Product
The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another…
- Trial name
- NCT06166849
- Testing
- Experimental Fluoride Application
- Where
- Romania
- Volunteers
- 43 people
- Sponsor
- Ivoclar Vivadent AG
Systemic Lupus Erythematosus
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Trial name
- NCT07011043
- Testing
- Budoprutug
- Where
- 18 sites in United States, Bulgaria and 6 more
- Volunteers
- 30 people
- Sponsor
- Climb Bio, Inc.
Melanoma
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
- Trial name
- NCT05907122
- Testing
- ABP 206, FDA-licensed Nivolumab, EU-authorized Nivolumab
- Where
- 76 sites in United States, Argentina and 20 more
- Volunteers
- 256 people
- Sponsor
- Amgen
Idiopathic Pulmonary Fibrosis
MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
The study will evaluate the efficacy and safety of axatilimab in participants with IPF.
- Trial name
- NCT06132256
- Testing
- Axatilimab
- Where
- 78 sites in Australia, Belgium and 11 more
- Volunteers
- 145 people
- Sponsor
- Syndax Pharmaceuticals
Retinopathy of Prematurity
Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)
Primary objectives of the study are: To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP).
- Trial name
- NCT04515524
- Testing
- Non-Interventional
- Where
- 30 sites in United States, Bulgaria and 8 more
- Volunteers
- 100 people
- Sponsor
- Regeneron Pharmaceuticals
HEPATITIS B CHRONIC, Hepatitis D
Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D
Periodontal disease is a chronic inflammatory condition associated with systemic diseases, highlighting the concept of periodontal medicine.
- Conditions
- HEPATITIS B CHRONIC, Hepatitis D, Periodontitis
- Trial name
- NCT07491848
- Testing
- Bulevirtide, No intervention
- Where
- 2 sites in Romania
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Research Center of Periodontal-Systemic Interactions
Pancreatoduodenectomy, Pain Management
Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy
The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy.
- Conditions
- Pancreatoduodenectomy, Pain Management, Opioid Analgesia, Multimodal Analgesia
- Trial name
- NCT07423650
- Testing
- Nefopam 120mg/day infusion, Lidocaine Infusion, Peridural
- Where
- Romania
- Volunteers
- 93 people
- Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
Obesity
Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities
The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability.
- Trial name
- ZUPREME (NCT06662539)
- Testing
- Petrelintide
- Where
- 32 sites in United States, Poland and 1 more
- Volunteers
- 493 people
- Sponsor
- Zealand Pharma
Systemic Lupus Erythematosus
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT03920267
- Testing
- BMS-986165
- Where
- 98 sites in United States, Argentina and 12 more
- Volunteers
- 261 people
- Sponsor
- Bristol-Myers Squibb