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NCT ID: NCT05750173 Recruiting - Clinical trials for Transcatheter Aortic Valve Implantation (TAVI)

The EASE-IT CT Registry

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.

NCT ID: NCT05748483 Recruiting - Migraine Clinical Trials

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

TEMPLE
Start date: October 7, 2023
Phase: Phase 3
Study type: Interventional

A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

NCT ID: NCT05748171 Recruiting - Clinical trials for ACUTE LYMPHOBLASTIC LEUKEMIA

A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

Start date: May 17, 2023
Phase: Phase 2
Study type: Interventional

This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.

NCT ID: NCT05746559 Recruiting - Clinical trials for Chronic Kidney Disease

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

ARTEMIS
Start date: April 6, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

NCT ID: NCT05744401 Recruiting - Alzheimer's Disease Clinical Trials

A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease

Start date: January 4, 2023
Phase: Phase 2
Study type: Interventional

A long-term extension study to evaluate the safety, tolerability, and efficacy of AL002 in participants with Early Alzheimer's Disease.

NCT ID: NCT05743036 Recruiting - Clinical trials for Metastatic Colorectal Cancer

ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

Start date: February 27, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and potential clinical benefits of ZN-c3 administered in combination with encorafenib and cetuximab in adult participants with metastatic BRAF V600E mutant colorectal cancer previously treated with one or two treatment regimens.

NCT ID: NCT05742802 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

PROSPERO
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.

NCT ID: NCT05741476 Recruiting - Allergy, Peanut Clinical Trials

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

VITESSE
Start date: February 21, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.

NCT ID: NCT05741385 Recruiting - Liver Cirrhosis Clinical Trials

A Study to Compare How Different Substances (Caffeine, Warfarin, Omeprazole, Metoprolol, and Midazolam) Are Handled by the Body of Healthy People and People With Liver Cirrhosis

Start date: April 25, 2023
Phase: N/A
Study type: Interventional

The main trial objective is to ascertain whether the metabolism activity of selected cytochrome (CYP) isozymes caffeine (CYP1A2 probe drug), S-warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug), metopolol (CYP2D6 probe drug), and midazolam (CYP3A probe drug) are similar or different in F4 liver cirrhosis patients on standard therapy compared to healthy subjects.

NCT ID: NCT05741372 Recruiting - Liver Cirrhosis Clinical Trials

A Study to Compare How Different Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Handled by the Body of Healthy People and People With Liver Cirrhosis

Start date: April 25, 2023
Phase: N/A
Study type: Interventional

The main trial objective, is to ascertain whether the transport activity, given by the maximum concentration (Cmax) and the area under the curve (AUC0-24) values for the different components in the transporter cocktail are similar or different in F4 liver cirrhosis patients on standard therapy compared to healthy subjects.