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NCT ID: NCT05744921 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works.

ACCESS-EXT
Start date: March 7, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on patients with paroxysmal nocturnal hemoglobinuria (PNH). The aim of this study is to see how safe and effective the pozelimab + cemdisiran combination is for patients with PNH in the long term. The pozelimab + cemdisiran combination may be referred to as "study drugs" in this section. This study is looking at several other research questions, including: - How effective is the pozelimab + cemdisiran combination? - What side effects may happen from taking the study drugs? - How much of each study drug is in the blood at different times? - Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)

NCT ID: NCT05744596 Recruiting - Clinical trials for Chronic; Gastritis, Atrophic

Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis

INCREASE
Start date: March 23, 2023
Phase:
Study type: Observational

This prospective multicenter study investigates the added benefit of incisura biopsy to correct identification of patients with high-risk chronic gastritis (OLGA stages III-IV). It compares a biopsy protocol with and without a single incisura biopsy in a non-inferiority design.

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: NCT05740566 Recruiting - Clinical trials for Small Cell Lung Cancer (SCLC)

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

DeLLphi-304
Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

NCT ID: NCT05739383 Recruiting - Clinical trials for Primary Prevention of Atherosclerotic Cardiovascular Disease

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Start date: March 9, 2023
Phase: Phase 3
Study type: Interventional

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

NCT ID: NCT05738954 Recruiting - Clinical trials for Congenital Abnormalities

Pattern Recognition and Anomaly Detection in Fetal Morphology Using Deep Learning and Statistical Learning

PARADISE
Start date: May 4, 2022
Phase:
Study type: Observational

Congenital anomalies (CA) are the most encountered cause of fetal death, infant mortality and morbidity.7.9 million infants are born with CA yearly. Early detection of CA facilitates life-saving treatments and stops the progression of disabilities. CA can be diagnosed prenatally through Morphology Scan (MS). Discrepancies between pre and postnatal diagnosis of CA reach 29%. A correct interpretation of MS allows a detailed discussion regarding the prognosis with parents. The central feature of PARADISE is the development of a specialized intelligent system that embeds a committee of Deep Learning and Statistical Learning methods, which work together in a competitive/collaborative way to increase the performance of MS examinations by signaling CA. Using preclinical testing and clinical validation, the main goal will be the direct implementation into clinical practice. This multi-disciplinary project offers a unique integration of approaches, competences, breakthroughs in key applications in human, psychological, technological, and economical interest such as the 'smarter' healthcare system, opening new fields of research. PARADISE creates an environment that contributes significantly to the healthcare system, medical and pharma industries, scientific community, economy and ultimately to each individual. Its outcome will increase impact on the management of CA by enabling the establishment of detailed plans before birth, which will decrease morbidity and mortality in infants.

NCT ID: NCT05737927 Completed - Obese Clinical Trials

Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects

Start date: September 16, 2020
Phase: Phase 1
Study type: Interventional

The goal of this clinical study was to assess pharmacodynamics (PD) and pharmacokinetics (PK) of different Glucose beads formulations in obese healthy subjects under fasting condition. The study was designed in 2 parts. Part 1 (single-dose) of the study was randomized, open label, five-treatment, five-period, five-sequence, crossover and single-centric. Treatment arms were three dosages of a coated Glucose beads formulation (47% w/w glucose/bead; 8 g [T1], 12 g [T2] and 16 g glucose [T3]), one uncoated Glucose beads formulation (47% w/w glucose/bead; 12 g glucose [T4]) and one coated Glucose beads formulation (60% w/w glucose/bead;12 g glucose [T5]). Part 2 (multiple-dose) of the study was open label, one-treatment, one-period and single-centric. Treatment arm was coated Glucose beads formulation (12 g glucose [T2]).

NCT ID: NCT05729438 Recruiting - Cirrhosis, Liver Clinical Trials

Nutritional Assesment in Patients With Cirrhosis

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

This study aims to evaluated nutritional status in patiets with cirrhosis

NCT ID: NCT05728489 Recruiting - Psoriasis Clinical Trials

A Study to Test How Well Different Doses of BI 765250 Are Tolerated by People With a Skin Disease Called Plaque Psoriasis

Start date: March 9, 2023
Phase: Phase 1
Study type: Interventional

This study is open to adults with plaque psoriasis. The main purpose of this study is to find out whether people with plaque psoriasis can tolerate a medicine called BI 765250. Another purpose is to check whether BI 765250 can improve participants' skin condition. Participants are divided into 4 groups. Each group gets a different dose of BI 765250 or placebo as an infusion or injection. Placebo infusions and injections look like BI 765250 but do not contain any medicine. It is decided by chance, who gets BI 765250 and who gets placebo. During the first 2 weeks, participants get the study medicine as an infusion into a vein once a week. Afterwards, they get the study medicine as an injection under the skin every 2 weeks. In total, every participant gets 5 injections. Participants are in the study for about 8 months. During this time, they visit the study site 23 times. On 2 of the visits, participants stay overnight at the study site, once for 2 nights and once for 1 night. The doctors collect information on any health problems of the participants. They also regularly check participants' skin condition.

NCT ID: NCT05724199 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-SHUTTLE
Start date: February 21, 2023
Phase: Phase 3
Study type: Interventional

The coprimary objectives of the study are to: - evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-ADâ„¢). - evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).