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NCT ID: NCT06139328 Recruiting - Clinical trials for Myocardial Infarction

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack

IRI-EXPLORE
Start date: November 24, 2023
Phase: Phase 2
Study type: Interventional

This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack. Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 4 times as likely to receive BI 765845 than placebo. Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT06139237 Not yet recruiting - Healthy Clinical Trials

Factors That Determine the Responses to Food Ingestion: Protein Load

Start date: November 2023
Phase: N/A
Study type: Interventional

Aim: to determine to what extent meal composition influences postprandial sensations. Experimental design: randomized cross-ower study comparing the responses to a high protein (47.3% protein, 39.4% carbohydrates, 13.3% lipids) versus a balanced (22.2% protein, 67.85% carbohydrates, 9.95% lipids). In each participant the meals (both containing 20.8 g protein and diluted to a volume of 200 mL) will be tested on separate days. Healthy, non-obese participants (8 men and 8 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion, at 10 min intervals up to 60 min after the meal and at 30 min up to 120 min after ingestion. Blood samples for biochemical and hormonal determinations will be taken before and after ingestion.

NCT ID: NCT06138808 Enrolling by invitation - Clinical trials for Epilepsy Intractable

5-SENSE Score Validation Study

Start date: January 9, 2024
Phase:
Study type: Observational

The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.

NCT ID: NCT06138158 Recruiting - Clinical trials for Non Specific Low Back Pain

Improvement of Fear-avoidance Beliefs in Patients With Chronic Low Back Pain

Start date: November 11, 2023
Phase: N/A
Study type: Interventional

Non-specific chronic low back pain is the main cause of public spending on health care and labor, with a prevalence of 10.2%. Its therapeutic management is difficult, with moderate levels of pain and persistent disability over time, influenced by psychosocial factors, such as "fear-avoidance" beliefs. The supervised therapeutic exercise program associated with an educational component is one of the most effective interventions to reduce pain and disability in these patients, but its efficacy seems to be less if there are erroneous beliefs, avoidance attitudes, or fear of physical activity, since it makes it difficult to follow the recommendations. The Back School would address this problem, seeking to improve pain, disability and increase quality of life.

NCT ID: NCT06137716 Completed - Clinical trials for Post-acute Covid-19 Syndrome

Robotic Assisted Hand Rehabilitation Outcomes in Adults After COVID-19

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Therefore, assessing the efficacy of robotic-assisted rehabilitation is crucial for post-COVID-19 fatigue syndrome patients, aiming to improve motor function and overall recovery. The study focuses on evaluating rehabilitation effectiveness in individuals with upper-extremity impairment using a hand exoskeleton-based robotic system.

NCT ID: NCT06137170 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment

RegoSeq
Start date: March 1, 2024
Phase:
Study type: Observational

This is an observational study in which data already collected from people with metastatic colorectal cancer will be studied. Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus). Cancer is considered metastatic if it spreads to other parts of the body. The study drug, regorafenib, is already approved for doctors to prescribe to people with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. Other approved treatments for mCRC include TAS and bevacizumab. The combination of the anti-cancer drugs trifluridine and tipiracil is called TAS. Both TAS and bevacizumab prevent cancer cells from growing and multiplying. Some studies have shown that people with mCRC who took TAS along with bevacizumab, lived longer than when TAS was taken alone. This may be especially beneficial for patients who have tried other treatments before. However, there is limited knowledge about how and in which order these drugs are given. To better understand the impact of the order of taking regorafenib and TAS, with or without bevacizumab, more knowledge is needed about how well these treatments work in people with mCRC in European countries. The main purpose of this study is to learn more about the effects of treatment in people with mCRC who have already received regorafenib and TAS, with or without bevacizumab, one after the other (also called sequential treatment) in a different order. To do this, researchers will collect the following information: - how long participants received sequential treatment for mCRC - number of participants receiving further treatment for mCRC after the sequential treatment - number and type of further treatments for mCRC - how long did participants live (also called overall survival). The data will come from the participants' information stored in health records from 4 centers in 3 European countries including France, Italy, and Spain. The data will be from people with mCRC who started sequential treatment between January 2013 and December 2022 or until the most recent date that allows researchers to assess the participants' health for at least 3 months. In this study, only available data from routine care are collected. No visits or tests will be required as part of this study.

NCT ID: NCT06137144 Recruiting - Lymphoma Clinical Trials

AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.

PRIMAVERA
Start date: January 23, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

NCT ID: NCT06137118 Recruiting - Clinical trials for B-cell Acute Lymphoblastic Leukemia (B-ALL)

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

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

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

NCT ID: NCT06136741 Recruiting - Clinical trials for Moderate to Severe Atopic Dermatitis

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

REZOLVE-AD
Start date: October 23, 2023
Phase: Phase 2
Study type: Interventional

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 15-35 days for screening and then up to approximately day 378 (last dose on day 280 + 98 days safety follow-up) for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.

NCT ID: NCT06136650 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Start date: December 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.