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NCT ID: NCT04226859 Recruiting - Clinical trials for Kidney Transplant Failure

Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation

TRAJAKT
Start date: January 2000
Phase:
Study type: Observational

The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD). However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described. An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease. Therefore, this study aims: 1. To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models; 2. To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions; 3. To investigate the associations of the eGFR trajectories with the progression to ESRD and death. Based on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.

NCT ID: NCT04226521 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Extracorporeal Photopheresis and Early Cardiac Graft Vasculopathy

ECP-OCT
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Heart transplantation is a golden standard for the treatment of terminal heart failure. The major cause of death in late posttransplant period is cardiac allograft vasculopathy (CAV). This posttransplant complication develops slowly over several years, and when diagnosed either by conventional coronary angiography or due to graft failure, it is often too advanced and difficult to treat since it is diffuse coronary artery disease. Therefore, early prevention of CAV is a subject of major interest in the transplant cardiology. Since CAV is associated with immune factors, immunomodulatory therapeutic options, like extracorporeal photopheresis are lately being investigated. Unlike conventional coronary angiography, optical coherence tomography (OCT) is able to detect the development of CAV in the earliest phase, i.e. even in the first post-transplant year. In our study, we plan to investigate the prophylactic effect of extracorporeal photopheresis in the early development of cardiac graft vasculopathy detected by OCT.

NCT ID: NCT04207892 Recruiting - Long Bone Fractures Clinical Trials

Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children

Start date: April 5, 2022
Phase:
Study type: Observational [Patient Registry]

International registry to collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. Data will be collected during follow-up visits according to standard of care at 3 to 8 weeks, 3, 6, 12 and 24 months

NCT ID: NCT04200898 Recruiting - Myopia Clinical Trials

Clinical Investigation of the CHEETAH SYSTEM FOR THE CORRECTION OF MYOPIA WITH AND WITHOUT ASTIGMATISM

Start date: December 31, 2019
Phase: N/A
Study type: Interventional

This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes.

NCT ID: NCT04197284 Recruiting - Clinical trials for Osteoarthritis, Knee

Determination of the Effectiveness of Certain Physical Methods in the Treatment of Knee Osteoarthritis

BFBOA
Start date: August 28, 2020
Phase: N/A
Study type: Interventional

Osteoarthritis (OA) is a chronic joint disease that involves the entire joint, causing cartilage damage, bone remodeling, osteophyte formation and loss of normal joint function. Knee OA is one of the leading causes of disability in the world and thus represents a major public health problem. Knee OA treatment can be operative and non-operative. Non-operative treatment includes pharmacological treatment, changing life style and physical therapy. The goal of physical therapy in knee OA is to reduce pain and improve knee function through therapeutic exercise, especially by strengthening the quadriceps muscle. In addition to therapeutic exercise, muscle electrical stimulation is often used, and in the literature there is evidence of biofeedback therapy efficacy. Goal of the study is to investigate whether there is a difference in pain reduction, increase in quadriceps muscle strength, and improvement in knee function in patients who had only kinesitherapy, from those who underwent kinesitherapy and biofeedback, and in patients who received electrical stimulation of quadriceps muscle with kinesitherapy. 93 patients with knee OA according to ACR criteria and Kellgren and Lawrence radiological classification grades 1 and 2 will be included in study. Subjects will complete: Visually Analogous Pain Scale (VAS), Western Ontario Universities Osteoarthritis Index (WOMAC), 36 Item Short Form Health Survey (SF 36), International Classification of Functioning, Disability and Health (ICF) osteoarthritis core set, and quadriceps muscle strength will be measured by EMG biofeedback device.

NCT ID: NCT04191408 Recruiting - Surgery Clinical Trials

Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04172272 Recruiting - Chronic Pain Clinical Trials

The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures

TAP
Start date: September 24, 2019
Phase: N/A
Study type: Interventional

This study evaluates the influence of the transversus abdominis plane block on the intensity of postoperative pain and the concentration of proinflammatory and pain factors after hysterectomy by laparotomy. The patients will be randomized in three groups.In the first group, patients will receive intravenous, systemic, multimodal analgesia.In the second group there will be patients in who will be given the TAP block. The TAP block will be given postoperatively before waking. It will be given bilaterally in the before mentioned anatomic region (the so-called lateral TAP block). In the third group there will be patients who will be treated with TAP block in addition to systemic, mutimodal analgesia. The research will be based on completing a questionnaire (VAS scale and QoR questionnaire) and taking peripheral blood out. We expect that the concentration of proinflammatory and pain factors in patients treated with a TAP block will be lower and the quality of recovery will be better than that of patients receiving standard analgesic therapy (systemic multimodal analgesia).

NCT ID: NCT04164511 Recruiting - Postoperative Pain Clinical Trials

Does Ice Cream Help With Post-tonsillectomy Pain

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

Tonsillectomy is one of the most performed procedures in childhood, which carries with it certain postoperative problems, such as the pain of the operated area. Sickness greatly impairs the quality of life in the postoperative period and further reduces food and fluid intake in children, which in turn causes prolonged recovery after surgery. The impact of cooling oropharynx in the form of ice cream consumption as a form of cryotherapy could help reduce the pain, reduce the use of oral analgesic therapy and help in faster recovery after surgery. Research goal: The aim of the study is to determine whether the consumption of ice cream, as a form of cryotherapy, influences the rate of postoperative recovery after tonsillectomy and the consumption of oral analgesics in children. The study was designed as a prospective, randomized, parallel-group, unmasked, and longitudinal study enroling 100 children undergoing tonsillectomy in a tertiary referral center. Of those children, 60 will consume the same ice cream (a combination of vanilla and chocolate as universally acceptable flavors) twice daily, morning and evening, for two weeks after surgery. 40 children will not consume ice cream during the stated period. Parents will be given a questionnaire with a validated VAS Wong-Baker FACES scale (Visual - Analogue - Scale) used by the Zagreb Pediatric Disease Clinic to be completed at home based on communication with the child and containing information on a visual-analogue subjective pain experience in children every morning after eating ice cream and the amount of analgesics the children received during the first two weeks after surgery. There will also be a record of the days when children began to consume food and drink in the same range and quality as before surgery.

NCT ID: NCT04162405 Recruiting - Hearing Loss Clinical Trials

Tinnitus in Patients With and Without Sensorineural Hearing Loss

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

The aim of this study is to evaluate hearing characteristics in patients with and without tinnitus using DPOAE and specific tinnitus severity index (TSI) and tinnitus handicap inventory (THI) questionnaires in both groups. Purpose of the research: Demonstrate that the characteristics of tinnitus depend on the presence and magnitude of hearing loss. Research participants: 150 patients coming for further audiological treatment due to tinnitus. Data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.