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NCT ID: NCT06372145 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Start date: April 16, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]). SUBSTUDY: ToleDYNAMIC substudy

NCT ID: NCT06367582 Recruiting - Vertebral Fracture Clinical Trials

SPINE BONE CEMENTS OUTCOMES

Start date: September 4, 2019
Phase:
Study type: Observational

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels. TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.

NCT ID: NCT06302764 Recruiting - Stress Clinical Trials

Emergency Medical Staff Workload Analysis

Start date: October 1, 2023
Phase:
Study type: Observational

The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows: 1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms. 2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams. 3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols. 4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology. 5. Formation of an interdisciplinary international research team.

NCT ID: NCT06298955 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

Start date: February 19, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.

NCT ID: NCT06268873 Recruiting - Clinical trials for Chronic Kidney Disease and Hypertension

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.

NCT ID: NCT06244615 Recruiting - Clinical trials for Upper Respiratory Infection

Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.

NCT ID: NCT06112691 Recruiting - Clinical trials for Diabetic Retinopathy

ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY IN THE CHERNIVTSI REGION (Pilot Study)

AIMDR
Start date: February 1, 2022
Phase:
Study type: Observational

The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.

NCT ID: NCT06080048 Recruiting - Ulcerative Colitis Clinical Trials

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis

Start date: October 24, 2023
Phase: Phase 1
Study type: Interventional

SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).

NCT ID: NCT06028737 Recruiting - Gastric Cancer Clinical Trials

Total Neoadjuvant Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer

OCTASUR
Start date: August 25, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The main goal of this study is to investigate the histopathological regression rate in patients with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery: 1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT) followed by surgery. 2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.

NCT ID: NCT05951179 Recruiting - Clinical trials for Non-muscle Invasive Bladder Cancer

Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

ADVANCED-2
Start date: September 15, 2023
Phase: Phase 2
Study type: Interventional

TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: Cohort A: - Participants with CIS (± Ta/T1) who are BCG naive, or - Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: - Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)