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NCT ID: NCT06405906 Recruiting - Dietary Habits Clinical Trials

A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease

RADIGAL
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

The goal of this trial is to assess the effect on the quality of life (QoL) of recommending a fat-free diet versus a balanced WHO diet in symptomatic patients with gallstones and in patients undergoing cholecystectomy for gallstone disease. The main question it aims to answer is: • Is balanced WHO diet as good as low-fat diet in terms of patient reported outcomes when gallstone disease is managed non-operatively (RADIGAL-1) or cholecystectomy is performed (RADIGAL-2)? A validated QoL questionnaire (Gastrointestinal Quality of Life Index - GIQLI) will be administered both at baseline and during follow-up. Analysis of covariance with ordinary least squares estimation will be applied to estimate between-group differences in GIQLI scores at 3 months (primary endpoint). Patient adherence and the disease-related symptoms occurrence or hospitalizations will also be appraised (secondary endpoint). Participants presenting with biliary colic or acute cholecystitis (RADIGAL-1) or undergoing cholecystectomy for gallstones (RADIGAL-2) will: - be randomly assigned to recommending either a fat-free or a balanced WHO diet . - be contacted via phone call to complete the GIQLI questionnaire and document overall adherence to the diets and secondary outcome events. This trial examines the impact of diet on adverse events in gallstone disease, representing the first randomized study to focus on this aspect.

NCT ID: NCT06404983 Recruiting - Breast Cancer Clinical Trials

Opioid-free Anaesthesia in Breast Cancer Surgery

Start date: December 28, 2022
Phase: N/A
Study type: Interventional

Background: Various analgesic modalities are adopted for perioperative analgesia in breast cancer surgeries. Opioid-free and opioid-sparing techniques are gaining popularity due to the lack of opioid-dependent undesirable effects, including respiratory depression, urinary retention, nausea and vomiting, constipation, itching, opioid-induced hyperalgesia, tolerance, addiction, and immune system disorders. The goal of this prospective randomized clinical trial is to investigate the impact of opioid-free anaesthesia (OFA) versus conventional general anaesthesia (CGA) on postoperative analgesic requirements after breast cancer surgery (lumpectomy/mastectomy, with or without axillary lymph node excision). Secondary objectives include comparative perioperative evaluation of cognitive function and postoperative adverse events during the first 48 hours atfter surgery. Comparative evaluation of intraoperative haemodynamics and hospital length of stay are also secondary objectives, as well as the incidence of neuropathic pain assessed by validated questionnaires at 3 and 6 months postoperatively. During the preoperative screening, body measurements, age, gender, ASA (American Society of Anesthesiologists) physical status classification, educational level (using a 6-level scale: elementary, middle school, high school, higher education, higher education, and postgraduate/doctoral degree), home medication, and comorbidities (using the Charlson Comorbidity Index) are recorded. Intraoperatively, the duration of anaesthesia, duration of surgery, associated intraoperative data (e.g., haemodynamic instability, adverse effects associated with protocol-administered pharmaceutical agents, etc.), and medications administered (type and quantity) are recorded. The investigators expect to recruit at least 100 participants per group.

NCT ID: NCT06399393 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06398912 Recruiting - Premature Birth Clinical Trials

Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundamental Frequency

FunFreqNICU
Start date: April 20, 2023
Phase: N/A
Study type: Interventional

This research project stands to the intersection of neonatology, neuroscience, and music based interventions (MBIs), exploring the impact of structured sound on the brain activity of premature newborns in Neonatal Intensive Care Units (NICU). It embarks on a pioneering investigation to decipher how variations in musical stimuli, particularly those that differ in human profiles (gender and kinship) and fundamental frequencies, affect the short-term electroencephalographic (EEG) footprint of these vulnerable infants. The project aims to uncover profound insights into the therapeutic potential of music within neonatal care, thereby advancing our understanding of neurodevelopmental interventions for premature infants.

NCT ID: NCT06393478 Recruiting - Clinical trials for Coronary Artery Disease

Southeastern Europe Microcirculation Registry

SATURATION
Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

SATURATION is a prospective multicenter registry of consecutive patients who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA) and to assess the regional practice of patient selection, cardiovascular outcomes and additional procedures (stress testing, angiography, etc.) done after comprehensive invasive coronary physiology evaluation.

NCT ID: NCT06392139 Recruiting - Clinical trials for Other Mental Conditions

Specialized Healthcare Service for BPD Patients: Athens Trial

BPDAS
Start date: January 7, 2022
Phase: N/A
Study type: Interventional

A quasi-experimental pragmatic trial was developed to evaluate a specific health-care service for the treatment of biporal personality disorder (BPD) patients.The effectiveness and economic evaluation (cost-effectiveness and cost-utility) of this specific health-care service as it is offered in every-day clinical practice will be assesed. The main hypothesis of the particular study is that the specific health-care service for the treatment of BPD patients has better efficacy and cost-effectiveness than the treatment as usual. Furthermore, two additional substudies will be performed. The first one is a qualitative study on the experiences of patients and therapists of the specific program as compared to common treatment. The second substudy aims to investigate the effectiveness and the possible psychodynamic functions of the initial outpatient reception clinic of the specific program. Patients will be followed for 2 years.

NCT ID: NCT06391840 Recruiting - Airway Ultrasound Clinical Trials

Airway Ultrasound as an Independent Predictor of Difficult Laryngoscopy in Patients Receiving General Anesthesia for Elective Surgery

Start date: May 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to determine the usefulness of pre-operative airway ultrasound in predicting difficult laryngoscopy in patients receiving general anesthesia for elective surgery. The main question it aims to answer is the independent prognostic value of pre-operative airway ultrasound.

NCT ID: NCT06376058 Recruiting - Cesarean Section Clinical Trials

Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section

annie-mariana
Start date: January 10, 2024
Phase: N/A
Study type: Interventional

This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections

NCT ID: NCT06367413 Recruiting - Clinical trials for Aseptic Muscle Injury

Effects of Protein and NAC Co-ingestion on Skeletal Muscle Recovery

PRoNAC
Start date: April 8, 2024
Phase: N/A
Study type: Interventional

Previous evidence suggests that though N-acetylcysteine (NAC) supplementation following eccentric exercise-induced muscle damage disrupts the skeletal muscle's repair and remodelling process at 8 days of recovery, it attenuates substantially the decline of skeletal muscle performance during the first 48 hours of recovery. The enhanced performance capacity during the first phase of recovery in response to NAC supplementation might be attributed to the altered redox status in skeletal muscle as a consequence of the NAC-mediated elevation of reduced glutathione (GSH) levels. The rise in GSH results in a redox-dependent attenuation of immune cell mobilisation and reduction of oxidative stress response, leading to a blunted rise of muscle damage and inflammatory markers during the first 2-3 days of recovery. However, following exercise-induced muscle damage, protein synthesis increases in skeletal muscle over the next 24-48 hours to support its repair process, and thus protein supplementation might accelerate the recovery process by enhancing the protein synthetic response. Therefore, the present study aims at investigating for first time the combined effect of NAC and whey protein supplementation on the short-term (during the first 72 hours) recovery process of skeletal muscle following damaging exercise (eccentric exercise) and compared it with the well-documented efficacy of NAC supplementation. The results of this study might be particularly useful for athletes, such as those in soccer and basketball, that participate in 3 games or intense training sessions during the same macrocycle with only 48-72 hours of recovery in-between.

NCT ID: NCT06363097 Recruiting - Hypertension Clinical Trials

Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease

Start date: September 4, 2023
Phase:
Study type: Observational

In chronic kidney disease (CKD), hypertension is characterized by the phenomenon of sodium-sensitivity, i.e., the disproportionate increase in blood pressure (BP) due to an increase in dietary sodium consumption to maintain homeostasis through urinary sodium excretion. Impaired renal circulation, blunt suppression of renin-angiotensin-aldosterone system, sympathetic nervous system overactivity, paradoxically reduced levels of atrial natriuretic peptide and hyperinsulinemia represent the main pathophysiologic mechanisms. Accumulated evidence has suggested that uromodulin plays a central role in the development of sodium-sensitive hypertension. Uromodulin is a kidney-specific glycoprotein which is exclusively produced by the epithelial cells lining the thick ascending limb and early distal convoluted tubule. It is currently recognized as a multifaceted player in kidney physiology and disease, with discrete roles for intracellular, urinary, interstitial and serum uromodulin. Among these, urinary uromodulin modulates renal sodium handling through regulating tubular transporters that reabsorb sodium and are targeted by diuretics, i.e., the loop diuretic-sensitive Na+-K+-2Cl- cotransporter type 2 (NKCC2) and the thiazide-sensitive Na+/Cl- cotransporter (NCC). Given these roles, the contribution of uromodulin to sodium-sensitive hypertension has been proposed. In preclinical models, uromodulin deficiency causes decreased BP that is resistant to dietary salt, while uromodulin overexpression causes hypertension due to increased tubular sodium reabsorption that is responsive to furosemide. Genetic human studies have identified robust associations of specific UMOD gene variants with sodium sensitivity and incident hypertension risk, while comprehensive Mendelian randomization studies have affirmed these associations by highlighting the causal relationship between UMOD variants, urinary uromodulin levels and hypertension. Furthermore, clinical studies in both healthy individuals and hypertensive patients have indicated a link between sodium sensitivity and uromodulin, directly affecting mean BP levels and BP response to salt intake. With regards to CKD population, solid data on the link of uromodulin with sodium sensitivity are currently missing from the literature. There is only a pediatric study in the setting of CKD (stages 2-3), which failed to show an association between urinary uromodulin levels indexed to urinary creatinine (UMOD/uCr) and either 24-hour or office BP; however, this study has several limitations, and its results should be interpreted with caution. To best of our knowledge, there is no study up to date investigating the effect of dietary sodium intake on 24-hour ambulatory blood pressure depending on urinary uromodulin levels in adult CKD patients.