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NCT ID: NCT05147220 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

REMODEL-1
Start date: December 16, 2021
Phase: Phase 3
Study type: Interventional

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

NCT ID: NCT05097287 Recruiting - Asthma Clinical Trials

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

ATLAS
Start date: December 16, 2021
Phase: Phase 4
Study type: Interventional

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

NCT ID: NCT05053282 Recruiting - Aging Clinical Trials

Long-life Endurance Exercise and Healthy Aging

CAA
Start date: September 1, 2020
Phase:
Study type: Observational

The project aims to explore the mechanisms by which lifelong exercise can promote healthy aging and slow down the negative impact of aging on the muscular system, immunity and the circadian system. The main goal of the project is to investigate the effect of lifelong endurance exercise on physical fitness, body composition, bone density and selected hormonal, biochemical, histological and molecular indicators of metabolic health and circadian clock function based on blood, immune cell and skeletal muscle tissue analyses in volunteers differentiated by age and weekly volume of physical activity. It is hypothesized that lifelong endurance exercise may have beneficial effects on the circadian system stability and many, but not all health outcomes. Osteopenia/osteoporosis and low-grade malnutrition may be more prevalent in the group of endurance-trained senior runners. In order to achieve the above research aims, sixty male subjects in total will be recruited according to inclusion and exclusion criteria. Four groups of subjects will differ according to their age and physical activity levels: - a group of endurance-trained seniors (age range 65 - 75 year old, n=15) ● a group of sedentary seniors (age range 65 - 75 year old, n=15) - a group of well endurance-trained young men (age range 20 - 30 year old, n=15) ● a group of sedentary young men (age range 20 - 30 year old, n=15). Subjects must meet the following inclusion criteria: 1. for athletes' groups: defined as more than 150 minutes of running activity per week; for young athletes at least 3 years and for master athletes at least 15 years history of running. 2. for groups less active than recommended: no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week. The standard inclusion criterion for every group will be body mass index (range 18.5-30 kg/m2). No experimental study has been published on the potential of life-long exercise to attenuate the aging-induced disorganization of the circadian system and thus to promote healthy aging. In this aspect, the proposed study is original and up-to-date. Moreover, also other aspects of the study, e.g. exercise and inflammaging or the risks (besides the benefits) of the long-life endurance training on bone tissue etc. have been studied only scarcely. Therefore, more scientific information is needed before it can be safely prescribed to the aging population

NCT ID: NCT05053139 Recruiting - Haemophilia A Clinical Trials

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Start date: December 2, 2021
Phase: Phase 3
Study type: Interventional

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

NCT ID: NCT05043090 Recruiting - Clinical trials for Papillary Renal Cell Carcinoma

Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

SAMETA
Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).

NCT ID: NCT05041881 Recruiting - Intraocular Lens Clinical Trials

Long-term Comparative Analysis of Visual Outcomes With 3 Intraocular Lenses: Monofocal, Trifocal and Accommodating

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

To compare visual outcomes, contrast sensitivity, glare occurrence, incidence of posterior capsule opacification (PCO) and subjective satisfaction in patients implanted with trifocal, accommodating and monofocal lens in long term period.

NCT ID: NCT05038735 Recruiting - Breast Cancer Clinical Trials

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

EPIK-B5
Start date: November 29, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.

NCT ID: NCT05021835 Recruiting - Inflammation Clinical Trials

ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

ZEUS
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

NCT ID: NCT04991116 Recruiting - Psoriatic Arthritis Clinical Trials

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

Start date: June 30, 2022
Phase: Phase 3
Study type: Interventional

An open label phase 3 study

NCT ID: NCT04987307 Recruiting - Ulcerative Colitis Clinical Trials

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: January 31, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.