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NCT ID: NCT05000697 Recruiting - Rectal Cancer Clinical Trials

Chemoradiation and Consolidation Chemotherapy With or Without Oxaliplatin for Distal Rectal Cancer and Watch and Wait

CCHOWW
Start date: July 14, 2021
Phase: N/A
Study type: Interventional

Background: Neoadjuvant chemoradiation (nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait - WW). Consolidation chemotherapy (cCT) regimens using fluoropyrimidine-based with or without oxaliplatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCt compared to fluoropyrimidine alone regimens in terms of primary tumor response remains unclear. Since oxaliplatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine+oxaliplatin) for patients with distal rectal cancer. Methods: In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine+oxaliplatin. Magnetic resonance (MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy (RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) will be enrolled in an organ-preservation program (WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion. Discussion: Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation.

NCT ID: NCT04994756 Recruiting - Stroke Clinical Trials

Stroke Thrombectomy and Aneurysm Registry

STAR
Start date: September 17, 2019
Phase:
Study type: Observational [Patient Registry]

This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes.

NCT ID: NCT04991935 Recruiting - Clinical trials for Eosinophilic Esophagitis

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.

NCT ID: NCT04988048 Recruiting - Covid19 Clinical Trials

Collaborative Study to Evaluate Heterologous Vaccination Against Covid-19 in Argentina

ECEHeVac
Start date: August 3, 2021
Phase: Phase 2
Study type: Interventional

Randomized, open, multicenter, collaborative and adaptive non-inferiority trial to evaluate the immunogenicity and reactogenicity of the heterologous vaccination schedules made up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca, Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity of heterologous and homologous vaccination schedules.

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.

NCT ID: NCT04983537 Recruiting - COVID-19 Vaccines Clinical Trials

Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes in an Elderly Population

Start date: July 26, 2021
Phase: Phase 2
Study type: Interventional

To determine whether a heterologous vaccination regimen in individuals with no known previous history of COVID-19 is non-inferior to that observed with counterpart regimens currently in use in Argentina among a population of persons aged 66 or above.

NCT ID: NCT04976920 Recruiting - Infertility Clinical Trials

Metabolomics Non Selection Study - Vitrolife Media

Start date: July 12, 2021
Phase:
Study type: Observational

In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. These analytes can be used to determine the implantation potential, and ploidy, of the embryo.

NCT ID: NCT04975997 Recruiting - Multiple Myeloma Clinical Trials

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

EXCALIBER-RRMM
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT04975308 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

EMBER-3
Start date: October 4, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

NCT ID: NCT04972721 Recruiting - Obesity Clinical Trials

SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial

SELECT-LIFE
Start date: September 1, 2023
Phase:
Study type: Observational

Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial. SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends. SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking. When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study. Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor. The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.