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NCT ID: NCT05028192 Enrolling by invitation - Rectal Cancer Clinical Trials

Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia

MEx
Start date: September 27, 2021
Phase:
Study type: Observational

This study aims to define the contribution of cancer and chemotherapy to muscle and systemic alterations that drive the onset of cachexia in rectal cancer patients and validate in human cancer cachexia (CC) the alterations in mitochondrial function and neuromuscular junction (NMJ) observed in the experimental models, thus providing the rationale for potential anti-cachexia strategies based on exercise and or exercise mimetics.

NCT ID: NCT05027984 Recruiting - Clinical trials for Coronary Artery Disease

Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS

INTERCLIMA
Start date: June 30, 2021
Phase: N/A
Study type: Interventional

The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve[FFR]/instantaneous Wave-Free Ratio[iFR]/resting full-cycle ratio[RFR]) treatment of intermediate (40-70% diameter stenosis at quantitative coronary angiography), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1400 patients with ACS will be randomized into the study at approximately 40 sites worldwide.

NCT ID: NCT05027802 Active, not recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva (FOP)

A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.

PIVOINE
Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP. The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202 and Study PVO-1A-204) and who, in the investigator's judgement, may benefit from palovarotene therapy.

NCT ID: NCT05027594 Recruiting - Multiple Myeloma Clinical Trials

Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma

Start date: September 9, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase I, first-in-human (FIH), open-label, non-randomized, multi-center study to explore the safety, tolerability, pharmacokinetics and preliminary antitumor activity of NMS-03597812 in adult patients with RRMM who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable.

NCT ID: NCT05027568 Completed - Healthy Clinical Trials

A Study to Assess an ATX Inhibitor (IOA-289) in Healthy Volunteers

Start date: July 5, 2021
Phase: Phase 1
Study type: Interventional

The purpose of Part 1 of this First-in-Human trial is to evaluate the safety and tolerability after single ascending oral doses of IOA-289 given to healthy male subjects, compared to placebo. After the oral dose administrations, the amount of IOA-289 present in serum will be determined for pharmacokinetic characterisation. Also the reduction of LPA in plasma will be determined as a pharmacodynamic biomarker. Part 2 is optional and its conduct will be dependent on the pharmacokinetic data generated in Part 1. Part 2 will be a randomized, crossover, open label, single oral dose administration of IOA-289 to healthy male subjects either in a fasted state, or after a high-fat meal.

NCT ID: NCT05027360 Completed - Acute Heart Failure Clinical Trials

Sodium NItroPrusside Treatment in Acute Heart Failure

SNIP-AHF
Start date: June 1, 2021
Phase:
Study type: Observational

The primary objective of this multicentric observational retrospective study is to assess the efficacy and safety of SNP as part of the treatment regimen of AHF patients and to identify predictors of efficacy. The primary efficacy endpoint is brain natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) reduction (at least 25% from baseline levels) 48 hours after initiation of SNP infusion. AHF presentation (de novo or ADHF), systolic blood pression at presentation, left ventricle ejection fraction and dimension, entity of mitral regurgitation and central venous pressure will be evaluated in order to identify predictors of efficacy of SNP (in terms of primary endpoint).

NCT ID: NCT05027074 Active, not recruiting - Clinical trials for Kidney Failure, Chronic

Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)

Start date: September 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG). Data from this study will be used to aid dose selection of MK-2060 in future studies. The primary hypothesis is that at least one of the MK-2060 doses is superior to placebo in increasing the time to first occurrence of AVG event.

NCT ID: NCT05026840 Completed - Clinical trials for GDM Screening During COVID Pandemic

GDM Screening During COVID Pandemic. IADPSG vs WHO '99 Criteria

Start date: March 1, 2020
Phase:
Study type: Observational

All pregnant women who performed an OGTT following Italian Guidelines and then delivered at our University Hospital from march 2020 to march 2021 were prospectively enrolled in this study. Primary outcome of the study was the number of women to whom was diagnosed GDM with only the fasting glucose value (≥ 92 mg/dl), following Italian Diabetes Societies recommendations for COVID 19 pandemic period. In the same time, we prospectively collected the data of women who became diabetic following the criteria of WHO 1999 (fast glucose value ≥ 120 mg/dl, 2 hours later ≥ 140 mg/dl) still in use in some large countries like India. From the clinical charts, we reported the distribution of risk factors for GDM (maternal age ≥ 35 years, family history for diabetes type 2, ethnia, BMI ≥ 25, previous GDM) and clinical outcomes such as hypertensive disorders, preterm birth, macrosomia, intrauterine growth restriction and Caesarean section in emergency. These data will be compared between the 2 groups consisting in those diagnosed with only IADPSG criteria versus those diagnosed with only WHO '99 criteria.

NCT ID: NCT05026346 Recruiting - Rotator Cuff Tears Clinical Trials

Construction of an AI System for the Automatic Supervision of Shoulder's Rehabilitation Exercises (Rehab-SPIA)

Rehab-SPIA
Start date: April 1, 2020
Phase:
Study type: Observational

The current historical phase and the growing need for rehabilitation in the world make tele-rehabilitation systems, and e-Health in general, fundamental tools for increasing patient engagement and compliance with care, crucial elements for the preservation of the NHS from a perspective expenditure review and resource optimization. In particular, the rehabilitation patient has on average an adherence to the Home Exercise Program (HEP) between 30-50%, to which is frequently added a reduced effectiveness of motor learning due to the lack of feedback on the accuracy of the gesture, as is the case. it happens in the hospital or outpatient setting under the supervision of a therapist. The new computational approaches for the analysis of data on human movement, aimed at the development of algorithms to automatically supervise the accuracy of the patient's gesture during home self-treatment exercise such as those based on Artificial Intelligence (AI) and Machine Learning (ML), especially those of the latest generation, called sub-symbolics (or connectionists) can help. Among the most promising approaches are. Given the importance of the Home Exercise Program in shoulder disease, it was decided to select a population of patients affected by the main pathologies affecting this joint. The main objective of the study is to create and validate a software tool for the automatic and expert analysis of the correct execution of the main rehabilitation exercises for the functional recovery of the shoulder following orthopedic pathologies.

NCT ID: NCT05025982 Recruiting - Clinical trials for Description of an Effective Surgical Strategy to Treat Cancer-related Lymphedema

Combination of Lymphatico-venular Anastomosis and Liposuction to Treat Cancer-related Lymphedema

Start date: August 1, 2018
Phase:
Study type: Observational

- cooperation of an International team with many years of experience in surgical management of lymphedema - description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology - the combination of LVA and liposuction guarantees long lasting results