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NCT ID: NCT03936790 Enrolling by invitation - Cesarean Section Clinical Trials

Dose-response Study of Spinally Administered Ropivacaine for Caesarean Section in Tall Parturients

Start date: June 2, 2019
Phase: N/A
Study type: Interventional

The main goal is to determine the optimum dose of ropivacaine, a local anaesthetic, that provides regional anaesthesia with no or minimum adverse effects (i.e. hypotension) when given spinally in healthy full term tall parturients scheduled to undergo caesarean section under combined spinal / epidural anaesthesia (CSEA). The participants' height threshold is based on a local anthropometric research, which included over 2000 people. According to the above research the investigators calculated the female height distribution and decided to include in the study those distributed in the upper quartile (75th to 99th percentile). The female height distribution of the upper quartile ranges from 167 to 184 cm. Secondary objectives are adverse effects related to the anaesthetic technique (hypotension, discomfort, nausea, vomiting and pruritus), the speed of installation and the duration of the regional block (both sensory and motor), blood gas analysis of the newborn umbilical blood as well as newborn Apgar score and lastly the mothers' degree of satisfaction. This is a prospective non randomized double-blinded trial in which a specific algorithm for the local anaesthetic dose will be adopted (up-down sequential allocation). A written informed consent will be required by all participants. The perioperative management of all participants will follow standard clinical protocols. The dose of ropivacaine for each parturient is determined by the response of the previous participant to a higher or lower dose according to the sequential distribution algorithm (up-down sequential allocation). Specifically, the dose of ropivacaine for each parturient (except for the first) will fluctuate by 0.375 mg depending on the success (decrease by 0.375 mg) or failure (increase by 0.375 mg) of the spinal anaesthesia of the previous parturient enrolled in the study. The local anaesthetic dose of the first participant will be determined by a short pilot study.

NCT ID: NCT03745924 Enrolling by invitation - Haemophilia B Clinical Trials

A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN

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

This study will collect information on side effects and how well Refixia/REBINYN works during long-term treatment (prophylaxis) in males with haemophilia B. While taking part in this study, participants will receive the same treatment as given to them by their study doctor. All visits at the clinic are done in the same way as the participants are used to. During visits at the clinic, participants might be asked for some relevant tests if considered useful by their study doctor. During the visits, the participants study doctor might ask if the participants had any side effects since their last study visit. The participants will be asked to note down the number of bleeds and the treatment of their bleeds as well as their regular prophylaxis. During the visits to the clinic, the participants will be asked to answer some questionnaires about their quality of life and their ability to be physically active. The participant's participation in the study will last for 4-9 years, depending on when they join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.

NCT ID: NCT03683186 Enrolling by invitation - Hypertension Clinical Trials

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Start date: September 23, 2019
Phase: Phase 3
Study type: Interventional

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

NCT ID: NCT03568318 Enrolling by invitation - Atopic Dermatitis Clinical Trials

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

AD Up
Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03352648 Enrolling by invitation - Heart Failure Clinical Trials

CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry (DERIVATE)

DERIVATE
Start date: January 2007
Phase:
Study type: Observational

The DERIVATE study was conceived to integrate the information resulted from clinical data, transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging to provide a more reliable risk stratification in patients affected by heart failure (HF) and worthy of prophylactic implanted cardioverter defibrillator (ICD) therapy. The main purposes of this multicenter registry are to: 1) determine CMR findings, and specifically late gadolinium enhancement (LGE) features, T1 mapping, and extracellular volume (ECV) that predict sudden cardiac death (SCD) and ventricular arrhythmia; 2) provide a comprehensive clinical and imaging score that effectively improves the selection of patients who deserve a prophylactic ICD therapy; 3) evaluate the contribution of machine learning to predict major adverse cardiac events (MACE) as compared to standard clinical scores.

NCT ID: NCT03254537 Enrolling by invitation - Health Status Clinical Trials

Effect of Mediterranean Diets Based on Organic and Conventional Foods

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Results from a small number of human cohort studies are also available and indicate that there are positive associations between organic food consumption and reduced risk/incidence of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight. Results from animal dietary intervention studies suggest that (i) switching to organic food consumption results in significant changes in hormonal balances and an increase in immune system responsiveness and (ii) differences in pesticide residue, cadmium, protein and antioxidant concentrations between organic and conventional foods are major drivers for hormonal balances and immune system parameters in animals. However, there is virtually no published data from (i) long-term cohort studies focusing on chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative conditions) and (ii) controlled human dietary intervention studies comparing effects of organic and conventional diets. It is therefore currently not possible to assess whether and estimate to what extent organic food consumption may affect human health.

NCT ID: NCT02766205 Enrolling by invitation - Clinical trials for Embolic Stroke of Undetermined Source

Prediction of AF in ESUS

AF-ESUS
Start date: June 2016
Phase:
Study type: Observational [Patient Registry]

The aim of the proposed study is to identify predictors of covert atrial fibrillation (AF) in Embolic Stroke of Undetermined Source (ESUS) patients and develop a prognostic score for the identification of covert AF in this population.

NCT ID: NCT02742493 Enrolling by invitation - Gingival Recession Clinical Trials

RCT for the Effectiveness of 3 Orthodontic Retention Schemes on Post-treatment Stability and Gingival Recession

OrthRe10tion
Start date: April 2016
Phase: N/A
Study type: Interventional

The present study aims to assess the effectiveness of three different retention schemes used to maintain tooth position after orthodontic treatment with fixed orthodontic appliances (stability) and to evaluate possible association between retention scheme and gingival recessions on the lingual surfaces of the lower anterior teeth seen for up to 5 years post-treatment. Moreover the possible association between primary relapse tendency and long term occlusal stability will be evaluated.

NCT ID: NCT02699736 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV

EuroSIDA
Start date: January 1994
Phase:
Study type: Observational [Patient Registry]

The EuroSIDA study is a prospective observational cohort study of 23,000+ patients followed in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest pan-European cohort study and few studies of a comparable design are available on a global scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into the study through 11 cohorts since 1994. The main objective of the study remains the same as in 1994: to prospectively study, clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across Europe in order to determine their long-term virological, immunological and clinical outcomes. Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as the dramatic changes in morbidity and mortality when combination anti-retroviral therapy (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected patients, it is important for EuroSIDA to remain in the forefront of investigating the treatment benefits and adverse effects. All study documents, study status, newsletters, scientific publications and presentations are available online and are updated continuously at project website. In general terms, the objective of the EuroSIDA study is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort of consecutive HIV infected patients from across Europe in order to (1) assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a surveillance system to describe temporal changes and regional differences in the clinical course of HIV and HIV-related co-infections and co-morbidities in Europe.

NCT ID: NCT01827228 Enrolling by invitation - HIV Clinical Trials

Transmission Reduction Intervention Project

TRIP
Start date: April 2013
Phase: N/A
Study type: Interventional

Half or more of HIV transmission events may occur within the period of high infectivity (and often high risk behavior) that can last 11 months or more after a person is initially infected. Unfortunately, neither test-and-treat intervention methods nor Acute HIV Infection projects have found effective ways to intervene against transmission during this risky "recent infection" period. The investigators seek to develop effective intervention techniques against HIV transmission during the recent infection period using a combination of injection-, sexual- and social-network-based contact tracing methods; community alerts in the networks and venues of recent infectees; and the logic of going "up" and "down" infection chains. The investigators first Aim is to develop and evaluate ways to locate "seeds," defined as drug users and other people who have recently been infected. The investigators second Aim targets members of seeds' networks and people who attend their venues. The investigators will test them for acute and for recent infection, and alert them to the probability that their networks contain highly-infectious members so they should reduce their risk and transmission behaviors for the next several months to minimize their chances of getting infected. This may also reduce transmission by untested people with recent infection. Community, network and venue education about the need and value of supporting those with recent infection should reduce stigma. The investigators third Aim is to reduce HIV transmission and to develop new ways to evaluate "prevention for positives" generally as well as The investigators own success in reducing transmission. The investigators will do this using a combination of follow-up interviews and testing, including of viral loads; phylogenetic techniques; and discrete event simulation modeling to assess The investigators effectiveness.