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NCT ID: NCT06159231 Recruiting - Clinical trials for Coronary Artery Disease

FAME II-10-year Follow-Up

FAME2-10yFU
Start date: April 25, 2023
Phase:
Study type: Observational

The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence. FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). Patients will have to sign a specific informed consent for the present 10-year follow-up. This study will be conducted for about approximately 6 months.

NCT ID: NCT06156904 Recruiting - Clinical trials for Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury

OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

OSsIRIS
Start date: January 31, 2024
Phase:
Study type: Observational

This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation. All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties. It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.

NCT ID: NCT06156579 Recruiting - AML Clinical Trials

Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML

VenSwitch
Start date: November 4, 2023
Phase: Phase 2
Study type: Interventional

The goal of this prospective, phase II single center, one arm, open label clinical trial is to test the efficacy and feasibility of a combination salvage therapy with Venetoclax and intensified Decitabine in patients with newly diagnosed AML (acute myeloid leukemia) and primary induction failure and patients with relapse of AML/MDS IB2 (myelodysplastic neoplasm with increased blasts 2) after chemotherapy. The primary endpoint is hematologic remission after treatment with Decitabine and Venetoclax. Participants eligible for the trial will receive a treatment of ten days of Decitabine and twenty-eight days of Venetoclax for one or two cycles, after which hematological remission will be assessed. Follow up will include the first one hundred days after end of treatment.

NCT ID: NCT06154785 Recruiting - Colorectal Surgery Clinical Trials

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

CROSS
Start date: December 15, 2023
Phase:
Study type: Observational [Patient Registry]

The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

NCT ID: NCT06154421 Recruiting - Clinical trials for Rheumatoid Arthritis Metacarpophalangeal Joint

Metacarpophalangeal Joint Prostheses in Hand Surgery.

FLEX
Start date: January 4, 2024
Phase:
Study type: Observational

The primary working hypothesis of this study is whether KeriFlex® metacarpophalangeal joint prostheses provide an equivalent result to Swanson finger joint implants in patients with rheumatoid arthritis or post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.

NCT ID: NCT06153693 Recruiting - Hypertension Clinical Trials

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

Start date: November 22, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

NCT ID: NCT06153251 Recruiting - Clinical trials for Relapsed and/or Refractory Multiple Myeloma

A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

Start date: January 23, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

NCT ID: NCT06152575 Recruiting - Multiple Myeloma Clinical Trials

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Start date: February 8, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: - Are 18 years of age or older and have MM. - Have received treatments before for MM. - Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: - a shot under the skin at the study clinic - through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

NCT ID: NCT06152445 Recruiting - Clinical trials for Non-celiac Gluten Sensitivity

Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

This study aims to assess the differences in tolerability of differently manufactured wheat breads in a target group of individuals with suspected wheat sensitivity. Additionally, it will be verified, if the absence of a response to oral exposure to defined bread types is associated with an absence of mucosal changes following CLE-assisted mucosal provocation with bread.

NCT ID: NCT06151964 Recruiting - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

A Trial to Learn How Safe AZD9550 is in People With Type 2 Diabetes Who Are Overweight or Obese

CONTEMPO
Start date: September 29, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

AZD9550 is in early development for the treatment of NASH, a type of liver disease that commonly affects overweight and obese patients who have T2DM. The purpose of this study is to investigate the safety, tolerability, and effects of increasing doses of AZD9550 in overweight and obese participants aged 18 through 65 years living with T2DM, and to investigate how AZD9550 is absorbed, distributed, and eliminated from the body.