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NCT ID: NCT04185883 Recruiting - Clinical trials for Advanced Solid Tumors

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

NCT ID: NCT04182841 Recruiting - COPD Clinical Trials

RheOx Registry Study in Europe

Start date: January 9, 2020
Phase: N/A
Study type: Interventional

Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.

NCT ID: NCT04182776 Recruiting - Pelvic Fracture Clinical Trials

Fragility Fractures of the Pelvis (FFP)

Start date: March 1, 2022
Phase:
Study type: Observational [Patient Registry]

Prospective data will be collected in approximately 420 patients, above the age of 65, suffering from an FFP type fracture equal to or higher than type II, according to Rommens and Hofmann. Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s, radiological outcomes, and anticipated or procedure-related adverse events (i.e. complications).

NCT ID: NCT04180761 Recruiting - Gastric Neoplasms Clinical Trials

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

ProPeC
Start date: November 2019
Phase: Phase 2
Study type: Interventional

This study investigates the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer.

NCT ID: NCT04176562 Recruiting - Clinical trials for Musculoskeletal Diseases

Prospective SPINE Registry

SPINE
Start date: January 28, 2020
Phase:
Study type: Observational [Patient Registry]

This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.

NCT ID: NCT04176523 Recruiting - Propionic Acidemia Clinical Trials

Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approach

PROTECT
Start date: January 15, 2019
Phase:
Study type: Observational

This is a prospective mixed-design study focused on the long-term management of propionic aciduria (PA) and methylmalonic aciduria (MMA) with N-carbamylglutamate (NCG) maintenance therapy. Treatment characteristics, clinical outcomes, and healthcare utilization data of patients diagnosed PA or MMA treated >6 months therapy with NCG are collected at baseline, 12 months, 18 months, 36 months and 54 months. Qualitative interviews with adult patients and caregivers are conducted >6 months after study enrollment to gain a better understanding of the disease burden and the treatment burden of patients and their families.

NCT ID: NCT04175327 Recruiting - Clinical trials for Great Vessel Reconstruction

Prospective and Non-randomized Registry of CardioCel 3D

Start date: August 28, 2020
Phase:
Study type: Observational

Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care. The Registry will collect data with a minimum of 50 subjects per major indication (minimum total of 200) in 5-10 sites in Europe. The clinical investigation will maintain data for each patient from the date of implant through 2 years post-implantation.

NCT ID: NCT04174547 Recruiting - Clinical trials for Myelodysplastic Syndromes

An European Platform for Translational Research in Myelodysplastic Syndromes

Start date: September 30, 2019
Phase:
Study type: Observational

Rationale Myelodysplastic syndromes (MDS) are rare cancers with unmet medical needs. Study of MDS has been rapidly transformed by genome characterization. The investigators hypothesize that comprehensive analyses of large patient population will allow to correctly estimate the effect of each mutation on clinical outcomes, and that niche factors and immune dysfunctions may influence the development of MDS, clonal evolution and response to treatments Aims 1- Investigate gene mutations, niche factors and immune dysfunctions influencing the development of MDS, and define biomarkers for early identification of individuals at risk; 2- Develop prognostic models for MDS patients through integration of comprehensive genomic/clinical information; 3- Define biomarkers to better stratify the individual probability of response to specific treatments Methods EuroBloodNet, the European Reference Network in rare hematological diseases, will provide a basis for research activities. Study of genomic features of clonal dominance in elderly subjects enrolled in large population-based studies and description of the dynamics of clonal establishment and evolution; study of bone marrow microenvironment to identify immune dysfunctions influencing MDS development. Development of inclusive statistical models to accurately predict clinical outcome at individual level, based on large MDS populations with comprehensive genomic/clinical data. Finally, analysis of mutational screening and immune profiles from patients enrolled in prospective trials, to provide evidence on genetic/immunologic profiles associated with probability of response to specific compounds Expected results To characterize how clonal hematopoiesis relates to the induction of MDS clinical phenotype, and to test the utility of gene sequencing to detect subjects at risk of developing MDS. To define effective prognostic systems and biomarkers to stratify the individual probability of response to treatment

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04173091 Recruiting - Clinical trials for Functional Tricuspid Regurgitation

Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation

TRuE
Start date: January 1, 2013
Phase:
Study type: Observational [Patient Registry]

This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.