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NCT ID: NCT05760313 Recruiting - Clinical trials for Functional Constipation

A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

Start date: April 27, 2023
Phase: Phase 2
Study type: Interventional

Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 30 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at about 25 sites worldwide. Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05757869 Recruiting - Atrial Fibrillation Clinical Trials

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

LIBREXIA-AF
Start date: April 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.

NCT ID: NCT05754957 Recruiting - Clinical trials for Acute Coronary Syndrome

A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

LIBREXIA-ACS
Start date: April 7, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).

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: NCT05744635 Recruiting - Liver Failure Clinical Trials

Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients

LTA
Start date: May 10, 2023
Phase:
Study type: Observational

The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question[s] it aims to answer are: - Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C/D) - Changes in liver function parameters compared to baseline. - Change in the estimated glomerular filtration rate (eGFR) compared to baseline. - To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage) - Incidence of acute graft rejection during the study - Incidence of BK and cytomegalovirus (CMV) infection during the study - To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D) - To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record. Participants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care

NCT ID: NCT05743608 Recruiting - COPD Clinical Trials

NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients

RESPONSE
Start date: March 29, 2023
Phase:
Study type: Observational

The goal of this observational study is to measure improvement in health related quality of life in moderate to severe COPD patients treated with Trimbow inhalation powder. The main question[s] it aims to answer are: - Treatment's effect on quality of life - Treatment's effect on lung function Participants will be assessed according to routine clinica practice, without any additional intervention.

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: NCT05742607 Recruiting - Clinical trials for Non Small Cell Lung Cancer

IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)

Start date: June 23, 2023
Phase: Phase 2
Study type: Interventional

The study is intended to assess the safety and efficacy of neoadjuvant combination of IPH5201 and durvalumab in addition to standard chemotherapy and adjuvant combination of IPH5201 and durvalumab in untreated patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer (NSCLC).