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NCT ID: NCT05296746 Recruiting - Clinical trials for Breast Cancer Stage II

Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

RIBOLARIS
Start date: May 3, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole. This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting.

NCT ID: NCT05295264 Recruiting - Clinical trials for Mental Health Wellness

Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After Coronavirus (COVID-19)

GESTACTIVE
Start date: March 17, 2022
Phase: N/A
Study type: Interventional

The complex process of pregnancy and childbirth can determine the future health of mother and child. It is the only vital process that involves the modification of practically all of a woman's body systems in order to sustain fetal life. In this sense, it is essential to ensure adequate functioning of all maternal physiological, mental and emotional mechanisms that facilitate fetal growth and development. Complications in any of these health domains and functions may contribute to pathologies and complications that have a detrimental impact on maternal and newborn health. Pregnancy could be a vulnerable period for women, especially regarding mental and emotional illnesses, which are more likely to manifest during this time compared to other periods of their life. In this sense, a high prevalence of prenatal stress, anxiety and depression exists, which are associated with downstream newborn complications as well. Depressive symptoms such as sadness, decreased interest in everyday activities, reduced energy and concentration are generated by the aforementioned gestational lability, these symptoms would appear (mostly) at the beginning of the pregnancy. Feelings of being overwhelmed, uneasiness, threat or imminent danger, uncertainty, difficulty in making decisions, obsessive thoughts could be caused by prenatal anxiety. According to scientific literature, the consequences of mental and emotional disturbances during pregnancy go beyond the gestational period and affect mother, fetus, newborn, and even child development, including complications such as preterm delivery, prolonged and more instrumental labor, low birth weight, pre-term birth, infant's physical and cognitive developmental delay, and the poor mother-infant relationship.

NCT ID: NCT05294796 Recruiting - Infections Clinical Trials

Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material

DURATIOM
Start date: August 9, 2022
Phase: Phase 3
Study type: Interventional

Infections associated with osteosynthesis material are among the most feared and challenging complications of trauma surgery and can lead to total function loss or limb amputation when complete recovery is to be expected without infection. This is a clinical trial with the purpose of evaluate the optimal duration of antibiotic therapy in Infections Associated With Osteosynthesis Material Implanted when implant is retained.

NCT ID: NCT05294770 Recruiting - Obesity Clinical Trials

Dietary Intervention in Obesity-related Glomerulopathy

ORG-VLCD-2022
Start date: July 18, 2022
Phase: N/A
Study type: Interventional

Obesity-related glomerulopathy (ORG) is a silent comorbidity associated with obesity whose incidence is increasing in parallel to the obesity epidemic. ORG is associated with serious health consequences including chronic kidney disease, end-stage renal disease, and increased mortality. Unfortunately, ORG has an absence of targeted therapy (except for the use of drugs blocking the renin-angiotensin system), and therefore the prognosis of this disease may be seriously compromised. Some previous studies have shown that weight loss could be effective to decrease albuminuria and reduce the declining in kidney function in subject with obesity. In line with this, in this study the investigators will evaluate the efficacy of two different dietary strategies for ORG, given the current lack of therapies for this condition. Thus, the investigators will conduct an open-label randomized controlled trial comparing a hypocaloric Mediterranean diet with a very-low calorie diet (VLCD), evaluating the efficacy on albuminuria reduction and changes in renal function. Also, the investigators will assess changes on body composition, blood pressure, markers of renal damage and inflammation, gut microbiota, and on renal ultrasound elastography.

NCT ID: NCT05294757 Recruiting - Sarcopenia Clinical Trials

Development of Continuous Assessment of Frailty and Muscle Quality in Older Subjects: ECOFRAIL Protocol

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

We are conducting a study in different centers in Spain in elderly people, in order to assess the effectiveness of a physical exercise intervention program in people in a situation of frailty. Frailty in an elderly person is a situation in which, although there are no major differences in their usual abilities, the person presents a certain decrease in their capacities. This slight decrease is usually accompanied by a progressive deterioration.

NCT ID: NCT05294614 Recruiting - Depression Clinical Trials

Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care

Start date: March 30, 2022
Phase: N/A
Study type: Interventional

Implementation of a psychological online intervention for low to moderate depression in primary care settings.

NCT ID: NCT05292950 Recruiting - Asthma Clinical Trials

Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease

Start date: June 27, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ARO-MUC5AC in normal healthy volunteers (NHVs), patients with moderate-to-severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In part 1 NHVs will receive a single dose of ARO-MUC5AC or placebo. In part 2 of the study, NHVs, adult patients with asthma, and adult patients with COPD will receive 3 doses of ARO-MUC5AC or placebo.

NCT ID: NCT05292846 Recruiting - Clinical trials for Coronary Artery Disease

Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures

DOAC-NOSTOP
Start date: January 20, 2022
Phase: Phase 4
Study type: Interventional

Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (PCI). The decision whether to continue the DOAC throughout periprocedural period or interrupt DOAC before planned procedure represents a substantial challenge in daily clinical practice. The objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.

NCT ID: NCT05292118 Recruiting - Clinical trials for Ischemic Heart Disease

Navitian PMCF Study ( rEPIC04C )

rEPIC04C
Start date: September 26, 2022
Phase:
Study type: Observational

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Navitian to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Navitian.

NCT ID: NCT05292092 Recruiting - Clinical trials for Ischemic Heart Disease

Essential Pro PMCF Study ( rEPIC04E )

rEPIC04E
Start date: September 26, 2022
Phase:
Study type: Observational

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.