Hamilton,, Canada
Adipose Tissue Gene Expression and Metabolomics Links to the Gut Microbiome-brain Axis
Phase
N/ASpan
157 weeksSponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaGirona
Recruiting
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
Phase IIIb, multicentre, single arm, Spain study assessing effectiveness/safety of capivasertib+fulvestrant in locally advanced (inoperable) or metastatic HR+/HER2- BC with the PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor. Capivasertib will be administered as 400mg BD, 4 days on 3 days off in combination with fulvestrant at the approved dose of monthly 500mg (2 × 5mL IV), with an additional loading dose in Cycle 1.
Phase
3Span
156 weeksSponsor
AstraZenecaGirona
Recruiting
Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
Phase
2Span
169 weeksSponsor
EMD Serono Research & Development Institute, Inc.Girona
Recruiting
Benefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis
Bronchiectasis is a prevalent chronic infectious disease with impaired mucociliary clearance. The persistence of high bacterial loads in the bronchi is associated with airway and systemic inflammation. Management is based on treatment of bronchial infection and on removal of secretions by airway clearance techniques (ACTs) although no therapy has been approved due to low quality of evidence. Inhalation of hypertonic saline (HS) could be useful in facilitate mucus removal especially if it is administer prior an effective ACT.Our hypothesis is that the long-term combination of HS and the ELTGOL technique will facilitate secretion removal in bronchiectasis and this will be associated with changes in mucus composition and better control of the disease. Study design: A 12-month parallel-group, multicentre, double-blind randomised-controlled trial. Patients will be randomly assigned to receiving HS, isotonic saline (IS) or no inhalation before practicing ELTGOL technique. The main objective is to evaluate the effect of the combination of once-daily inhaled HS and twice daily ELTGOL technique in mucus clearance in bronchiectasis. Secondary aims: to determine its effect on mucus properties, the impact of cough,exacerbations, quality of life, microbiology and pulmonary function; to evaluate adverse effects and adherence. Study population: adult patients with non-cystic fibrosis bronchiectasis in stable state with chronic mucopurulent or purulent sputum.
Phase
3Span
187 weeksSponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaGirona
Recruiting
Selection of Surgical Technique in Rectal Cancer
Phase
N/ASpan
105 weeksSponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaGirona
Recruiting
Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.
Phase
N/ASpan
161 weeksSponsor
Fundación GECPGirona
Recruiting
A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
The study consists of 2 sequential parts. 1. Safety Run-in - this part will compare dose levels of AZD0486 in combination with rituximab in order to establish the RP3D. 2. Phase III - The Phase III part will assess the superiority of AZD0486 at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms 1. Arm A: treatment with AZD0486 plus rituximab Schedule A 2. Arm B: treatment with AZD0486 plus rituximab Schedule B 3. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance and B-R
Phase
3Span
381 weeksSponsor
AstraZenecaGirona
Recruiting
Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.
Phase
N/ASpan
50 weeksSponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaGirona
Recruiting
Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX for the Prevention of COVID-19 in Adolescents From 12 Years to Less Than 18 Years of Age.
Phase
2Span
82 weeksSponsor
Hipra Scientific, S.L.UGirona
Recruiting
Healthy Volunteers
Plan to Evaluate Early Endothelialization of a Polymer Free Sirolimus-eluting Coronary Stent System (VIVO ISARTM) Compared With Everolimus-eluting Durable Polymer Stent (XIENCE SkypointTM) in Patients Undergoing Percutaneous Coronary Intervention.
To evaluate the stent endothelialization (> 20 microns) of VIVO ISARTM versus XIENCE SkypointTM stents at 1-month (very early strut covered) at follow-up by Optical Coherence Tomography (OCT) implanted IN THE SAME PATIENT during routine clinical practice.
Phase
N/ASpan
98 weeksSponsor
Fundación EPICGirona
Recruiting