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NCT ID: NCT06405841 Not yet recruiting - Rib Fractures Clinical Trials

Costal Fracture Assessment for Relief and Enhancement of Quality of Life

CARE
Start date: June 2024
Phase:
Study type: Observational

This study explores the impact of rib fractures on patient well-being and quality of life, aiming to identify effective interventions for pain relief and functional improvement. It investigates the long-term outcomes of conservative treatment for rib fractures, analyzing factors such as analgesic therapy, hospitalization duration, and respiratory infection rates. Anticipated results include a comprehensive assessment of patient quality of life and the potential translational implications for healthcare practice. Furthermore, the study aims to inform healthcare resource optimization, potentially guiding treatment decisions and improving patient outcomes within the National Health Service.

NCT ID: NCT06405152 Recruiting - Clinical trials for Macrophage Activation Syndrome

Assessment of Macrophage Activation syndromE in STill's Disease

AMETHYST
Start date: September 27, 2023
Phase:
Study type: Observational

Assessment of Macrophage activation syndrome in STill's disease: retrospective chart analysis of patient History, Symptom resolution and Treatment characteristics

NCT ID: NCT06405035 Recruiting - Adenocarcinoma Clinical Trials

Dissecting the Role of MIcrobioMe in gastroEsophageal Tumor: a multIdisCiplinary Longitudinal Study

MIMETIC
Start date: March 8, 2022
Phase:
Study type: Observational

Gastric cancer (GC) is the second leading cause of cancer mortality and remains the fourth common cancer worldwide. Gastric and esophageal cancers treated with curative intent both have a poor prognosis with five-year survival rate varying between 30% and 40% [Hagen]. Therefore, even in the localized or locally advanced (LA) disease, relapse-related death remains a major challenge for curative treatment. Currently, there are several strategies for the curative treatment of GC including perioperative chemotherapy (peri-Op cht), adjuvant chemotherapy and adjuvant chemoradiotherapy. Despite the therapeutic management of localized or LA GC is well established, there is uncertainty about the power of prognostic and predictive factors to tailor anticancer treatments. In addition to that, further investigation is needed to investigate if pre-existing environment factors may act on carcinogenesis and to explore the molecular mechanisms that underlying cancer growth and invasiveness.

NCT ID: NCT06404853 Completed - Clinical trials for Constipation - Functional

Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation

MANNAPED
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

Functional constipation is a widely prevalent pediatric issue, with a prevalence in some studies as high as 32.2%. Treatment consists of a combination of behavioral and pharmacological interventions (mainly, administration of polyethylene glycol laxatives or the use of enemas). Glucomannan (GNN) is a polysaccharide of 1,4-D-glucose and D-mannose found in the soluble fiber of some plants. While studies available in the literature to date agree that mannite is a dietary supplement with safe use, the usefulness of this compound remains controversial.

NCT ID: NCT06404489 Not yet recruiting - Major Surgery Clinical Trials

Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)

PROGRESS
Start date: May 2024
Phase: N/A
Study type: Interventional

The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period constitutes a unique opportunity to address comorbidities and modifiable risk factors, improve functional capacity and address deficiencies in physiologic reserve, which might otherwise preclude surgery or significantly impede recovery. Therefore, the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery. The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group.

NCT ID: NCT06404021 Active, not recruiting - Heart Failure Clinical Trials

Electronic Device Implantation Through Remote Guidance

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

Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants are limited by availability and costs of field clinical specialist (FCS) bioengineers. This study explores feasibility of remotely supported implantations through an internet based platform, aiming at enhancing efficiency and overcoming geographical or pandemic related barriers. The first phase of the study included programming and phantom assessments in 20 cases followed by 10 remote guided CRT-D and ICD implantations in additional heart failure patients, compared to 20 procedures with FCS on site. Data analysis revealed no significant differences in acute outcomes or electronic parameters at one year follow-up compared to on-site FCS. Finally, this study demonstrates the safety after testing at one year of follow-up.

NCT ID: NCT06403904 Recruiting - Breast Cancer Clinical Trials

Assessing Clinical Features and Outcome of Breast Cancer in PALB2 Mutation Carriers: the Palbreast Study

PALBREAST
Start date: October 2, 2023
Phase:
Study type: Observational

The Modena hereditary breast cancer group identified 3498 BRCA test candidates affected by breast cancer (BC). Among those, 392 were BRCA1/2 positive (11.2%). Since 2018, the site started to analyze eligible BC patients by multi gene panel (MGP) test. Fifty hundred sixty BRCA negative patients have been recalled, whereas other 934 were firstly analyzed by MGP. Totally, among 1494 BC patients analyzed by MGP test, 33 were PALB2 mutation carriers (2%). By involving the Italian Society of Genetic Oncology and 11 European Institutions, it is calculated to identify about 300 PALB2 mutation carriers. PALB2 is a breast cancer susceptibility gene that encodes the BRCA2- interacting protein. Mono-allelic mutations of PALB2 are associated with an increased risk for breast and ovarian cancer in women, prostate cancer in men, and pancreatic cancer in both gender. Women with no family history of breast cancer have a cumulative risk of 33%, compared to 58% in women with two or more family members with breast cancer. Several studies with populations ranging from to 54 to 362 individuals aimed to describe breast cancer phenotypic characteristics in PALB2 mutation carriers. Some of these studies suggested an association with triple-negative phenotype, older age at diagnosis (>30 years), tumor size > 2 cm, negative HER2 status, lymph nodes positive and bilaterality. Nevertheless, results among different studies are contradictory and no data on prognosis of these patients are reported. Furthermore, the clinical potential of PARP inhibition beyond currently approved indications to additional patients whose tumors have (epi)genetic changes affecting homologous recombination repair raises new interest in PALB2 mutations as molecular target. Primary objectives is to study the incidence and mortality rates of gPALB2 Breast Cancer.

NCT ID: NCT06403748 Not yet recruiting - Inflammation Clinical Trials

Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a food supplement is able to significantly influence plasma lipid levels. Furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.

NCT ID: NCT06403631 Recruiting - Multiple Sclerosis Clinical Trials

Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis

MindFlowMS
Start date: November 6, 2023
Phase:
Study type: Observational

The overall goal of this observational study is to learn about the psychological resources of mindfulness and flow experience available to persons newly diagnosed with multiple sclerosis (MS). The primary study aim will be to analyze the relation of flow and mindfulness with mental health among individuals who received an MS diagnosis within the last year. Secondary aims will be to analyze the daily activities preferentially associated with flow, and to evaluate possible changes in daily flow retrieval. Participants will answer questionnaires measuring flow, mindfulness, positive mental health, anxiety and depression at project start and 6 months later.

NCT ID: NCT06403618 Not yet recruiting - Clinical trials for Cervical Intraepithelial Neoplasia Grade 2

Evaluation of the PreCursor-M+® in CIN2

Start date: May 15, 2024
Phase:
Study type: Observational

The goal of this observational study is to to evaluate the accuracy and sensitivity of PreCursor-M+ on a post-aliquot of liquid-based cytology (LBC) cervical samples (biopsy) obtained by physicians in a group of women with histologically-proven diagnoses of CIN2. The PreCursor-M+® assay is a multiplex real-time methylation specific PCR test that identifies the level of promotor methylation of the host cell genes FAM19A4 and miR124-2, known biomarkers associated with cervical carcinoma and transforming CIN in cervical cells. To evaluate the clinical course of CIN2 at 2 years after the first diagnosis, with an interval evaluation at 6 months. After enrolment, women will be divided into two groups: "active surveillance" and "immediate treatment". In the first group, clinical outcomes to be assessed, in relation to the PreCursor-M+ result at baseline, will include regression to <CIN2, persistence of CIN2, and progression to CIN3+. In the second group, we will evaluate the histological diagnosis at cone specimen (downgrading or upgrading) and the 2-year cumulative incidence of CIN2+ recurrence based on the PreCursor-M+ result at baseline.