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NCT ID: NCT05781256 Completed - Clinical trials for Arterial Hypertension

Novel BP Monitoring Methods to Study the Association Between Sleep BP Patterns and BP Values in Daily Life

CABER-NET
Start date: June 1, 2022
Phase:
Study type: Observational

Out-of-office blood pressure (BP) measurement by means of ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) is recommended for the diagnosis and management of hypertension in the latest guidelines. Ambulatory BP values are more strongly associated with target organ damage and cardiovascular (CVD) events than office values. In particular, nocturnal blood pressure level and reduction of BP during the night (dipping) have been recognised as predictors of cardiovascular complications. However, in current clinical practice, these parameters are derived from ABPM. HBPM represents an inexpensive alternative to ABPM, is preferred by patients and provides a more realistic assessment of BP during an individual's daily life. However, until recently, HBPM did not offer the possibility to measure nocturnal BP or dipping. The development and validation of new BP devices, such as the NightView (OMRON Healthcare, HEM9601T-E3) could overcome this limitation, offering the possibility of home night-time BP measurements with minimal sleep disturbance. On the other hand the use of wearable devices such as HeartGuide (OMRON Healthcare, HEM-6411T-MAE) could provide BP values in daily life conditions. Compared with conventional HBP, typically measured in resting conditions at home, values obtained with wearable devices might be closer to daytime ABP values. Combining nocturnal HBP, with daytime BP from wearable device could therefore allow the estimation of dipping status comparable with that provided by ABPM. In order to compare HBP-derived dipping estimate with the gold standard ABPM-derived value, it is aimed to enrol patients with hypertension, assess their blood pressure profile with ABPM and provide them with both NightView and HeartGuide devices for 7 days. Then diurnal and nocturnal BP and dipping derived from standard 24-hour ABPM will be compared and the combination of NightView/HeartGuide in order to understand whether the latter can offer a reliable assessment of 24h BP pattern. For a better phenotypization of nocturnal BP and dipping status the following determinants of nocturnal BP and dipping status will be also investigated: sleep quality, sleep duration, the presence of sleep disorders, salt consumption, catecholamine phenotype. This study will offer the unique opportunity to understand whether such new HBP devices can be offered in alternative to ABPM in the assessment of 24h BP profile in patients with hypertension.

NCT ID: NCT05780255 Completed - Quality of Life Clinical Trials

Quality of Life 1y and 2 y After VV-ECMO for COVID-19

Start date: April 20, 2021
Phase:
Study type: Observational

This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients.

NCT ID: NCT05779384 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

The COPD Attack Study

COPA
Start date: July 7, 2019
Phase:
Study type: Observational

The goal of this observational study is to evaluate the frequency and predictors of exacerbations in COPD patient population in Uganda. The main questions it aims to answer are:- 1. What is the proportion of frequent exacerbators (≥2/year) and what factors are associated with the frequent exacerbator phenotype? 2. What is the frequency of exacerbations and what factors are correlated with exacerbation frequency? Participants will be asked to offer demographic ,clinical and exposure questions. Questionnaires assessing disease burden, and quality of life will be administered. Clinical measurements, and complete blood count will be collected ta baseline and on sick visits. Spirometry will be measured at baseline and on the last visit. Samples will be collected for storage. Participants will be followed up for one year.

NCT ID: NCT05778422 Completed - Shoulder Pain Clinical Trials

Bupivacaine or Radiofrequency for Shoulder Pain

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain

NCT ID: NCT05778240 Completed - Clinical trials for Congenital Heart Disease in Children

Adherence to Palivizumab Prophylaxis

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to analyze implications of two alternative nudge-interventions to increase adherence to palivizumab prophylaxis in children with congenital heart disease. The main questions investigators aim to answer are: - Are well-established cognitive biases effective in increasing patient families' adherence to the palivizumab prophylaxis program? - What are the factors that affect families' adherence to the prophylaxis program and whether and how the effects of interventions depend on these factors? To study these questions investigators planned to utilize four well-established cognitive biases in designing two alternative nudge-interventions and investigators measured the effectiveness of each nudge-intervention against a control group. Patients were randomly allocated to one control and two treatment groups. In the control group, investigators informed participants about the prophylaxis program and provided a schedule. Patients in the first treatment group were additionally called two days before appointments (status quo bias), and were asked to plan the appointment day (implementation intention). Patients in the second treatment group received biweekly messages informing them about the benefits of the program as well as the current adherence rate (availability bias and social norm).

NCT ID: NCT05774769 Completed - Clinical trials for Degenerative Mitral Valve Disease

Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.

Start date: October 9, 2021
Phase:
Study type: Observational

Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.

NCT ID: NCT05772598 Completed - Prostate Cancer Clinical Trials

Validating the 'Sexual Minorities and Prostate Cancer Scale' to Gold Standard Questionnaires

SMACS
Start date: March 15, 2023
Phase:
Study type: Observational

A cohort study comparing the novel 'Sexual Minorities and Prostate Cancer Scale' (SMACS) to the gold standard questionnaires investigating erectile dysfunction (IIEF) and incontinence (ICIQLUTSqol and ICIQ-UI) following robotic assisted radical prostatectomy

NCT ID: NCT05770921 Completed - Clinical trials for Paroxysmal Supraventricular Tachycardia

Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia(PSVT)

Start date: October 11, 2022
Phase: N/A
Study type: Interventional

The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia.

NCT ID: NCT05770076 Completed - Obesity Clinical Trials

Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Type 2 Diabetes Patients (DELI_Diab Study)

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients. The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month.

NCT ID: NCT05769881 Completed - Postoperative Pain Clinical Trials

Effects of Subcostal TAP Block and Local Anesthetic Infiltration After Laparoscopic Cholecystectomy

Start date: July 25, 2023
Phase: N/A
Study type: Interventional

Laparoscopic cholecystectomy surgery is an intra-abdominal surgery that is frequently used in the treatment of gallbladder-related pathologies. Compared to open surgery, the cost, the risk of bleeding, the risk of surgical site infection are lower, the need for hospitalization is shorter, and the recovery is rapid. Adequate pain relief is very important after laparoscopic cholecystectomy. Inadequate analgesia in post-operative period has been associated with pain-related cognitive dysfunction, atelectasis, thromboembolic events, increased surgery-related stress response, prolonged hospital stay, and chronic pain in patients. Acetaminophen, non-steroidal anti-inflammatory drugs, opioid analgesics, intraperitoneal washing, local anesthesia infiltration and various regional anesthesia techniques can be used for appropriate analgesia. Studies have shown that subcostal transversus abdominis block has good analgesic efficacy in laparoscopic cholecystectomy surgeries. In the perioperative and postoperative period, afferent nerve signals in the surgical incision area stimulate the hypothalamus, causing the release of CRH, arginine vasopressin, and cortisol depending on the size of the surgical procedure. Providing patients with appropriate postoperative analgesia reduces the release of the stress hormones cortisol and prolactin. In this study, the investigators are aiming to compare the post-operative analgesic affects and stress hormone responses of subcostal transversus abdominis plane block and local anesthetic infiltration in patients undergoing laparoscopic surgery. The study is planned to be prospective, randomized and single-blind.