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NCT ID: NCT05673304 Recruiting - Breast Cancer Clinical Trials

Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pathological complete response (pCR) in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC). As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.

NCT ID: NCT05673252 Recruiting - Cervical Cancer Clinical Trials

CERvical Cancer The InFlammatory Index (CERTIFIKO)

CERTIFIKO
Start date: November 18, 2022
Phase:
Study type: Observational

Although significant advances in screening and treatment , cervical cancer is the fifth most common female cancer in Europe. Major prognostic factors for oncological outcome are used to categorise patients at high, intermediate and low risk groups and to define the type of radical hysterectomy according "Querleu-Morrow classification". The goal of this prospective observational study is to evaluate the association between several inflammatory markers and risk groups according European guidelines in women with cervical cancer Human Papillomavirus (HPV)-associated, in order to optimize the treatment.

NCT ID: NCT05673187 Recruiting - NSCLC Stage IV Clinical Trials

Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status

ADEPPT
Start date: June 12, 2023
Phase: Phase 2
Study type: Interventional

ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).

NCT ID: NCT05672602 Recruiting - Long COVID Clinical Trials

Biomarkers of LONG COVID (LONG COVID_LCM)

LONG COVID_LCM
Start date: July 20, 2022
Phase:
Study type: Observational

This observational prospective study is aimed to investigate noncoding RNAs (ncRNAs) such as microRNAs (miRNAs) and long noncoding RNAs (lncRNAs) as potential peripheral blood biomarkers of severity and poor prognosis in COVID-19 patients. Patients with intermittent or permanent symptoms after COVID-19 at the moment of the recruitment were considered affected by LONG COVID disease. In particular, the aim is to clarify if COVID-19 biomarkers remain deregulated similarly in LONG COVID patients. To this purpose, plasma and peripheral blood mononuclear cells (PBMCs) will be collected and patients will be compared to individuals who have never been affected by COVID-19 or asymptomatic LONG COVID patients.

NCT ID: NCT05671744 Recruiting - Pregnancy Related Clinical Trials

Fetal Cell Analysis From Maternal Blood

Start date: November 22, 2021
Phase: N/A
Study type: Interventional

The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.

NCT ID: NCT05671510 Recruiting - Clinical trials for Non Small Cell Lung Cancer

ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

PRESERVE-003
Start date: June 28, 2023
Phase: Phase 3
Study type: Interventional

The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

NCT ID: NCT05670327 Completed - Weakness, Muscle Clinical Trials

Diaphragmatic Ultrasound and Weaning After Lung Transplant.

Start date: June 22, 2021
Phase:
Study type: Observational

The prevalence and adverse effect of diaphragm dysfunction (DD) after bilateral-lung transplant (LT) are still unclear, despite a well-known negative impact on weaning and outcome in other cohorts of critically ill and surgical patients. Objects: The primary aim is investigating the prevalence of DD, assessed using point-of-care ultrasound and defined as diaphragm thickening fraction (TFdi) < 29%, at the first weaning trial after LT. Secondary aims are investigating the impact of DD on weaning (defined success or failure according to pre-defined criteria, neuroventilatory efficiency (EAdi or NVE), perioperative (14-day) pneumonia, ICU length of stay (LOS), in-hospital mortality, and identifying potential risk factors for DD. Moreover, we aim to study the correlation between TFdi versus EAdi/NVE and the rapid shallow breathing index (RSBI), respectively.

NCT ID: NCT05669989 Recruiting - Plasma Cell Myeloma Clinical Trials

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Start date: April 5, 2023
Phase: Phase 2
Study type: Interventional

- This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. - This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. - The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

NCT ID: NCT05669755 Recruiting - Clinical trials for Cardiovascular Disease

REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

REDEFINE 3
Start date: March 1, 2023
Phase: Phase 3
Study type: Interventional

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

NCT ID: NCT05669014 Recruiting - Clinical trials for Idiopathic Inflammatory Myositis

A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)

Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. 2. To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24. 3. To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24. Other secondary objectives include: 1. To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants. 2. To evaluate the safety and tolerability of daxdilimab in participants.