Clinical trials: in Romania
Asthma
A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment…
- Trial name
- NCT01867125
- Testing
- Lebrikizumab
- Where
- 181 sites in United States, Argentina and 24 more
- Volunteers
- 1,081 people
- Sponsor
- Hoffmann-La Roche
Asthma
A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA)…
- Trial name
- NCT02104674
- Testing
- Lebrikizumab, Montelukast
- Where
- 82 sites in United States, Brazil and 9 more
- Volunteers
- 313 people
- Sponsor
- Hoffmann-La Roche
Glioma
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
- Trial name
- NCT06413706
- Testing
- Abemaciclib, Temozolomide
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 45 people
- Sponsor
- Eli Lilly and Company
Atopic Dermatitis
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
- Trial name
- ROCKET-ASCEND (NCT05882877)
- Testing
- Rocatinlimab
- Where
- 547 sites in United States, Argentina and 40 more
- Volunteers
- 2,621 people
- Sponsor
- Amgen
Bladder Cancer
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current…
- Trial name
- KEYNOTE-B15 (NCT04700124)
- Testing
- Pembrolizumab, Enfortumab vedotin (EV), RC + PLND
- Where
- 188 sites in United States, Argentina and 27 more
- Volunteers
- 808 people
- Sponsor
- Merck Sharp & Dohme LLC
Small Cell Lung Carcinoma Extensive Disease
Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab…
- Trial name
- CASPIAN (NCT03043872)
- Testing
- Durvalumab, Tremelimumab, Carboplatin
- Where
- 207 sites in United States, Argentina and 21 more
- Volunteers
- 987 people
- Sponsor
- AstraZeneca
Knee Injuries, Joint Surface Knee Lesions
A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee
The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data.
- Trial name
- NCT06916728
- Testing
- Marketed Product - MP01, Surgical Standard of Care
- Where
- 8 sites in United States, Belgium and 4 more
- Volunteers
- 170 people
- Sponsor
- Smith & Nephew, Inc.
Periodontal Diseases, Dental Plaque
Marginal Biofilm Distribution and Periodontal Response to Supragingival and Juxtagingival Aligner Designs
This prospective, longitudinal, within-person (split-mouth) clinical study evaluates the influence of two clear aligner trimming-line designs on marginal soft-tissue biofilm distribution and periodontal tissue response over a…
- Conditions
- Periodontal Diseases, Dental Plaque, Gingivitis
- Trial name
- BIOFILM-ALIGN (NCT07642037)
- Testing
- Supragingival aligner trimming-line, Juxtagingival festooned aligner trimming-line
- Where
- Romania
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Myeloproliferative Disorders, Myelofibrosis
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions
The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus…
- Conditions
- Myeloproliferative Disorders, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis
- Trial name
- INDEPENDENCE (NCT04717414)
- Testing
- ACE-536
- Where
- 185 sites in United States, Argentina and 24 more
- Volunteers
- 313 people
- Sponsor
- Celgene
Relapsing-remitting Multiple Sclerosis
A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and < 18 years over a flexible duration.
- Trial name
- Operetta 2 (NCT05123703)
- Testing
- Ocrelizumab, Fingolimod
- Where
- 71 sites in United States, Argentina and 23 more
- Volunteers
- 188 people
- Sponsor
- Hoffmann-La Roche
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Viral Hepatitis
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
- Trial name
- NCT07128550
- Testing
- Tobevibart, Elebsiran, Bulevirtide
- Where
- 38 sites in Austria, France and 5 more
- Volunteers
- 150 people
- Sponsor
- Vir Biotechnology, Inc.
Cardiovascular-Kidney-Metabolic Syndrome, Atrial Cardiomyopathy
Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization
Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan…
- Conditions
- Cardiovascular-Kidney-Metabolic Syndrome, Atrial Cardiomyopathy, Atrial Fibrillation, Chronic Kidney Disease
- Trial name
- ATRIO-CKM (NCT07697469)
- Where
- Romania
- Volunteers
- 200 people
- Sponsor
- Grigore T. Popa University of Medicine and Pharmacy
Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy
This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1…
- Trial name
- LATIFY (NCT05450692)
- Testing
- Ceralasertib, Durvalumab, Docetaxel
- Where
- 191 sites in United States, Argentina and 21 more
- Volunteers
- 594 people
- Sponsor
- AstraZeneca
Surgical Site Infection, Colon Surgery
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- D-PLEX312 (NCT04411199)
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 58 sites in United States, Bosnia and Herzegovina and 11 more
- Volunteers
- 975 people
- Sponsor
- PolyPid Ltd.
Atrial Fibrillation (AF)
Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their…
- Trial name
- LILAC-TIMI 76 (NCT05712200)
- Testing
- Abelacimab
- Where
- 789 sites in United States, Argentina and 33 more
- Volunteers
- 2,500 people
- Sponsor
- Anthos Therapeutics, Inc.
Depression, Anxiety
Group Cognitive Evolutionary Therapy for Depression
The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health, especially on depressive symptoms and anxiety.
- Trial name
- GRCET (NCT06359769)
- Testing
- Group Cognitive Evolutionary Therapy
- Where
- Romania
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- University of Bucharest
Primary Biliary Cholangitis
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
- Trial name
- ELSPIRE (NCT06383403)
- Testing
- Elafibranor
- Where
- 60 sites in United States, Czechia and 8 more
- Volunteers
- 92 people
- Sponsor
- Ipsen
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer…
- Trial name
- OASIS-4 (NCT05587296)
- Testing
- Elinzanetant (BAY3427080)
- Where
- 102 sites in Austria, Belgium and 14 more
- Volunteers
- 474 people
- Sponsor
- Bayer
Overweight, Obesity
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe.
- Trial name
- NCT07357766
- Testing
- Cagrisema
- Where
- 116 sites in United States, Bulgaria and 12 more
- Sponsor
- Novo Nordisk A/S
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