Clinical Trials Logo

Filter by:
NCT ID: NCT04788888 Recruiting - Clinical trials for Symptomatic Severe Aortic Stenosis

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

VANTAGE
Start date: June 13, 2021
Phase: N/A
Study type: Interventional

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

NCT ID: NCT04788667 Recruiting - Chronic Migraine Clinical Trials

Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial

Start date: April 19, 2021
Phase: N/A
Study type: Interventional

Chronic migraine (CM) is a common and frequent disorder, which has a major impact on the quality of life of migraine sufferers, interfering with physical function, productivity at work, personal life and leisure, lifestyle and psychological well-being. The use of a prophylactic drug treatment is recommended if headache is present more than 8 days per month. In addition, several studies have shown benefits of non-pharmacological interventions such as self-management strategies, manual therapy and exercise. However, no studies have been found that analyse the beneficial effect of a combination of a preventive drug treatment and a health education programme. Thus, this project would offer a service of health education through a telerehabilitation programme for patients with chronic migraine under prophylactic drug treatment. The aim of this study is to compare the combination of a prophylactic drug therapy and a health education programme in the preventive treatment of patients with chronic migraine.based on the hypothesis that a health education program for chronic migraine patients could decrease the number of migraine days.

NCT ID: NCT04788615 Recruiting - Multiple Sclerosis Clinical Trials

Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

STHENOS
Start date: July 23, 2021
Phase: Phase 3
Study type: Interventional

This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients

NCT ID: NCT04787783 Recruiting - Mobile Applications Clinical Trials

Evaluation of the Utility of Preanestes@s, a Web Based Application for Preoperative Assessment

Preanestes@s
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal preoperative assessments when the participants are evaluated through a web based application (Preanestes@s) versus the traditional outpatient interview.

NCT ID: NCT04786574 Recruiting - Clinical trials for Autosomal Recessive Polycystic Kidney Disease (ARPKD)

A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of tolvaptan on the need for renal replacement therapy in pediatric subjects with autosomal recessive polycystic kidney disease (ARPKD)

NCT ID: NCT04785859 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Multiparametric Bronchopulmonary Prediction

PARADYS
Start date: December 1, 2020
Phase:
Study type: Observational

INTRODUCTION: Current Neonatology has failed to reduce the incidence of moderate-severe bronchopulmonary dysplasia (BPD). Although multiple models for predicting the risk of dysplasia in preterm infants have been studied, none have been implemented in clinical practice. OBJECTIVE: To calculate a mathematical model to predict moderate-severe bronchopulmonary dysplasia in newborns before 30 weeks of gestation based on pre and postnatal clinical variables, lung ultrasound images and detection of biomarkers in nasopharyngeal aspirate. METHODOLOGY: Multicenter case-control study, in which 10 Spanish neonatal intensive care units (NICU) will participate. All participants will undergo a lung ultrasound in the first 24 hours, on the third day of life, at one week and two weeks of life, a nasopharyngeal aspirate at one week of life, and cardiac ultrasound at one week and two weeks of life. It is expected to include 240 patients in 29 months of study among all participating units: 200 for the calculation of the model, and 40 more for its subsequent validation. These will be divided between those with a diagnosis of moderate-severe BPD and those without, and the values of each of the variables described in the methodology section will be compared between the two groups. Those with a significant difference will be entered into a logistic regression model to calculate those that best predict the final diagnosis. With the results of the calculated model, a mobile application will be created with a risk of moderate-severe BPD calculator in this population, for its worldwide distribution.

NCT ID: NCT04783844 Recruiting - Pancreas Neoplasm Clinical Trials

Usefulness of 3D Digital Reconstruction in the Imaging Diagnosis of Pancreatic Tumors

Start date: October 1, 2019
Phase:
Study type: Observational

Reconstruction using 3D virtual models has brought about a revolution in diagnostic imaging and its use is increasingly widespread. The objective of this work is to determine the precision of the 3D model when establishing the characteristics of tumors and their relationship with other anatomical structures.

NCT ID: NCT04783831 Recruiting - Pancreatic Cancer Clinical Trials

Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy

Start date: November 1, 2018
Phase:
Study type: Observational

Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications. Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum. The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).

NCT ID: NCT04783805 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Start date: March 3, 2021
Phase:
Study type: Observational

Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (<30 years), but evidence is insufficient on whether it is also advisable for older women. This study will be conducted to analyze spontaneous HSIL regression rates in women of reproductive age and establish whether conservative HSIL management could be safely recommended to women of childbearing potential, irrespective of age. This is a single-center prospective observational study that will include consecutive women of reproductive age, referred to a tertiary hospital due to HSIL between March 2021 and December 2025, who prefer conservative management rather than immediate cervical conization. All patients will be followed-up regularly with colposcopy, cytology, human papillomavirus (HPV) testing and biopsies. In case their lesions progress or HSIL persists after 24 months of follow-up, conization will be indicated. Rates of spontaneous regression or resolution, as well as progression rates, will be assessed. Furthermore, the association between potential predictive factors and HSIL resolution will be analyzed.

NCT ID: NCT04781543 Recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.