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NCT ID: NCT04965675 Recruiting - Clinical trials for Chronic Migraine in Children

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

PROSPECT-2
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

NCT ID: NCT04965493 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

BRUIN CLL-322
Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

NCT ID: NCT04964934 Recruiting - Clinical trials for ER-Positive HER2-Negative Breast Cancer

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

SERENA-6
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

NCT ID: NCT04964271 Recruiting - Prostatic Neoplasms Clinical Trials

Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants

Start date: September 9, 2021
Phase:
Study type: Observational

This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.

NCT ID: NCT04963647 Recruiting - Atrial Fibrillation Clinical Trials

7-day Holter Monitoring in Adult Patients With Recent IS or TIA, to Measure the Prevalence of Paroxysmal Atrial Fibrillation Including Episodes Less Than 30 Seconds: Transversal Study

MY-ATRIA
Start date: June 16, 2021
Phase:
Study type: Observational

The main outcome of this study will be to compare the prevalence of PA AF episodes longer than 30 seconds versus the prevalence of PA AF episodes including episodes shorter than 30 seconds, in adult patients who survived IS or TIA with no previous history of AF, after 7-day Holter monitoring. Based on the previous assumptions, the secondary objectives of the project will be: 1. To compare the prevalence of patients diagnosed with BAF after 24-hour, 72-hour, and 7-day Holter monitoring. 2. To study the feasibility of using information obtained from the ECG during sinus rhythm, for example the characteristics of the P-wave, to predict the presence of PA AF and BAF. 3. To Collect a new database of multi-monitored, high-resolution, long-term ECG signals. The data will be used by the My-Atria consortium for research purposes, for the development and validation of arrhythmia detection algorithms. The results of the study are intended to have an impact on how AF is screened, diagnosed, and treated. The results will also contribute to the choice of the most appropriate secondary stroke prevention modality, which therefore refers to the treatment of subjects who have already had an episode of IS or TIA.

NCT ID: NCT04963296 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

ALLEGORY
Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

NCT ID: NCT04963140 Recruiting - Asthma Clinical Trials

Self-Management Of Asthma By Forced Oscillation Technique

PIANOFORTE
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

Self-management strategies for asthma, including patients engagement and adherence to personalised action plans with advice on recognizing and responding to deterioration in control with effective treatments can improve asthma outcomes and possibly reduce the risk of future exacerbations. However, the real-life evidence is that asthma control remains sub-optimal in the majority of cases, thus increasing the related socio-economic costs worldwide. Because an increased variability of lung function remains a hallmark of poor asthma control and exacerbations, its assessment over time could contribute to the success of self-management plans. Previous studies have shown the potential of Forced Oscillation Technique (FOT) as a tool for monitoring increased variability of airway obstruction and for identifying the onset of acute deterioration of airway function. The aim of this study is to test the hypothesis that a personalised self-management plan including FOT improves asthma control and reduces number of days with increased symptoms compared to conventional asthma treatment.

NCT ID: NCT04962841 Recruiting - Frailty Clinical Trials

Nutraceuticals and Drug Treatment in Frail Older Adults

Start date: April 1, 2020
Phase:
Study type: Observational

Frailty is a multidimensional condition due to reserve loss leading to physical and cognitive impairment that is very common in older adults; in fact, its incidence increases with age. Frail older adults present a high risk of adverse events such as disability, hospitalization and mortality. It is very important to check comorbidities and complications to reduce the incidence of cognitive and physical impairment.

NCT ID: NCT04961996 Recruiting - Early Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.

NCT ID: NCT04961567 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

TOPAZ-2
Start date: July 16, 2021
Phase: Phase 3
Study type: Interventional

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.