Clinical trials: in Romania
Procedural Sedation, Gastrointestinal Endoscopy
Remimazolam-Propofol Combination Sedation for Gastrointestinal Endoscopy: A Prospective Observational Study
This prospective observational study evaluated the safety and efficacy of a remimazolam-propofol combination sedation protocol in adult patients undergoing elective gastrointestinal endoscopy at a tertiary care centre in Romania.
- Trial name
- NCT07604480
- Where
- Romania
- Volunteers
- 29 people
- Sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
Postoperative Pain, Postoperative Acute Pain
Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2%
The goal of this clinical trial is to evaluate whether the addition of a Transversus Abdominis Plane (TAP) block improves postoperative outcomes in women undergoing cesarean section.
- Trial name
- NCT07604376
- Testing
- Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side, Postoperative pain management using "traditional" analgesia iv regime
- Where
- Romania
- Volunteers
- 70 people
- Sponsor
- Matild Keresztes
Alcohol Use Disorder (AUD)
Multimodal Intervention for GGT Reduction in Alcohol Use Disorder (GGT-AUD)
The aim of this clinical trial is to evaluate whether a combined nutraceutical and psychological intervention can reduce gamma-glutamyl transferase (GGT) levels in individuals with Alcohol Use Disorder (AUD).
- Trial name
- GGT-AUD (NCT07603726)
- Testing
- Alcohol Reduction Counseling, Nutraceutical Treatment, Psychological Intervention
- Where
- Romania
- Volunteers
- 197 people
- Sponsor
- Medical Center TOPMED
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3…
- Trial name
- NCT06588478
- Testing
- Pirtobrutinib
- Where
- 131 sites in United States, Australia and 16 more
- Volunteers
- 249 people
- Sponsor
- Loxo Oncology, Inc.
Pulmonary Arterial Hypertension
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III.
- Trial name
- NCT05934526
- Testing
- Seralutinib, Generic Dry Powder Inhaler
- Where
- 166 sites in United States, Argentina and 29 more
- Volunteers
- 390 people
- Sponsor
- GB002, Inc.
Sjögren Syndrome
Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
- Trial name
- TWINSS (NCT03905525)
- Testing
- CFZ533
- Where
- 71 sites in United States, Argentina and 21 more
- Volunteers
- 273 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer
Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with…
- Trial name
- NCT03409614
- Testing
- REGN2810, REGN2810/chemo/ipi, Chemotherapy
- Where
- 133 sites in United States, Austria and 16 more
- Volunteers
- 789 people
- Sponsor
- Regeneron Pharmaceuticals
Non-small Cell Lung Cancer Metastatic
SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Primary Objectives: Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) Study…
- Trial name
- CARMEN-LC03 (NCT04154956)
- Testing
- SAR408701, Docetaxel
- Where
- 169 sites in United States, Argentina and 24 more
- Volunteers
- 389 people
- Sponsor
- Sanofi
Healthy Adult Participants
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
This study aims to explore the efficiency of a digital, Smartphone-delivered intervention for improving the quality of REM sleep on the mental health, emotion regulation and overall life quality of users.
- Trial name
- RESTWELL (NCT07589114)
- Testing
- Mobile smartwatch application.
- Where
- 2 sites in Romania
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell…
- Trial name
- NCT05239728
- Testing
- Belzutifan, Pembrolizumab
- Where
- 285 sites in United States, Australia and 30 more
- Volunteers
- 1,800 people
- Sponsor
- Merck Sharp & Dohme LLC
HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence.
- Trial name
- NCT04622319
- Testing
- DS-8201a, T-DM1
- Where
- 482 sites in United States, Argentina and 29 more
- Volunteers
- 1,600 people
- Sponsor
- Daiichi Sankyo
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2)…
- Trial name
- NCT04380636
- Testing
- Pembrolizumab, Olaparib, Etoposide
- Where
- 205 sites in United States, Argentina and 24 more
- Volunteers
- 870 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-Small Cell Lung Cancer
A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell…
- Trial name
- CheckMate-1533 (NCT06946797)
- Testing
- Nivolumab, Ipilimumab, Carboplatin
- Where
- 38 sites in United States, Brazil and 7 more
- Volunteers
- 76 people
- Sponsor
- Bristol-Myers Squibb
Dermatomyositis
A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis
The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis…
- Trial name
- GALARISSO (NCT05695950)
- Testing
- GLPG3667
- Where
- 54 sites in United States, Argentina and 13 more
- Volunteers
- 40 people
- Sponsor
- Lakefront Biotherapeutics NV
Healthy (For Part A), Chronic Myeloid Leukemia (for Part B and C)
Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
- Trial name
- NCT02629692
- Testing
- Vodobatinib (K0706) capsules
- Where
- 35 sites in United States, Belgium and 8 more
- Volunteers
- 124 people
- Sponsor
- Sun Pharma Advanced Research Company Limited
Ulcerative Colitis
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
- Trial name
- LUCENT 2 (NCT03524092)
- Testing
- Mirikizumab SC, Mirikizumab IV
- Where
- 385 sites in United States, Argentina and 32 more
- Volunteers
- 1,328 people
- Sponsor
- Eli Lilly and Company
Osteoporotic Fractures, Osteoporosis
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
This is an international multicenter prospective observational study. Patients with radiologically confirmed, symptomatic, single- or multilevel contiguous TL (from T1 to L5) fractures as a result of primary osteoporosis will be…
- Trial name
- NCT07027306
- Testing
- Posterior stabilization (pedicle screws)
- Where
- 15 sites in United States, Argentina and 12 more
- Volunteers
- 648 people
- Sponsor
- AO Foundation, AO Spine
Symptomatic Severe Aortic Stenosis
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
- Trial name
- START YOUNG (NCT06861361)
- Testing
- Myval balloon-expandable THV Series, Surgical bioprosthetic valve
- Where
- 49 sites in Austria, Estonia and 12 more
- Volunteers
- 1,180 people
- Sponsor
- Ceric Sàrl
B-Cell Non-Hodgkin Lymphoma (B-NHL)
A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to…
- Trial name
- OLYMPIA-4 (NCT06230224)
- Testing
- Odronextamab, Ifosfamide, Carboplatin
- Where
- 81 sites in Argentina, Australia and 12 more
- Volunteers
- 216 people
- Sponsor
- Regeneron Pharmaceuticals
Diabetes Mellitus, Type 2, Obesity
A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)
This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes.
- Trial name
- NCT05514535
- Testing
- Semaglutide, Insuline glargine U100 (reduced), Insuline glargine U100 (titrated)
- Where
- 239 sites in United States, Czechia and 10 more
- Volunteers
- 573 people
- Sponsor
- Novo Nordisk A/S
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