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NCT ID: NCT05744219 Not yet recruiting - Surgery Clinical Trials

Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial

IRIS
Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss. Post-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion. Patients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study. By the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg Ferric Carboxymaltose or placebo. The primary endpoint is a composite of death, number of RBC transfusions, post-operative severe anemia (Hb <80 g/L) and FACT-An Quality of life (QoL) five weeks after surgery, assessed by win ratio. The trial will also examine effects on; a) levels of Hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (<400 ml), high (400-4000 ml) and very high (>4000 ml) per-operative blood loss. Recruitment will continue until 338 patients are randomized or 304 have completed the five week follow up The coordinating center of the trial is the Department of Surgery at Uppsala University Hospital. Participating sites are also Linköping University Hospital and Lund University Hospital, all in Sweden. Other sites may be added.

NCT ID: NCT05752058 Not yet recruiting - Clinical trials for Liver Transplantation

Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children

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

The goal of this observational study is to identify the risk factors for early acute lung injury (ALI) after liver transplantation in children .The main questions it aims to answer are what the risk factors are for early ALI in children and to evaluate the predictive value for the development of ALI.Participants will be divided into non-ALI group and ALI group according to whether they had ALI in a week after liver transplantation.Researchers will compare the difference between the two groups and use multivariate logistic regression analysis to screen the risk factors of ALI, and receiver operating characteristic(ROC) curve was used to evaluate the predictive efficacy of risk factors.

NCT ID: NCT05756101 Not yet recruiting - Clinical trials for After Cardiac Surgery

Application of New Restraint Instruments in Safety Management of Patients After Cardiac Surgery

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

Restraint devices refer to various devices that restrict the activities of the body or a certain part of the body for patients who self-injure or may harm others, so as to maintain the safety of patients and ensure the smooth progress of treatment and care. The essence of restraint devices is to limit patient movement in order to reduce the risk of unexpected adverse events. With the in-depth implementation of high-quality nursing services, nurses have also paid more and more attention to restraint nursing and developed a variety of restraint tools. Common restraints include bed rails, wrist or ankle restraint straps, restraint vests, shoulder or belt-style restraint straps, mittens, etc. According to the limitations of traditional restraints, Deng Wandi et al. innovatively produced double safety restraint belts, racket gloves and safety vests, and the research results showed that innovative new restraint devices can effectively reduce the psychological pressure of nurses and improve the complications caused by restraint. According to the characteristics of critically ill patients, Xu Yan et al. innovatively produced a three-piece set of safety protection restraint equipment on the basis of the original restraint equipment, which is composed of a safety restraint vest, restraint gloves and knee restraint belt, and the research results show that the new restraint device can effectively reduce the adverse events caused by restraint and improve the satisfaction of family members. In view of the above problems, our department has developed a new protective restraint device for the protective restraint of postoperative intubated patients, and summarizes the nursing experience to provide clinical reference and theoretical basis for standardizing postoperative patient constraints. The project is now a general scientific research project of Zhejiang Provincial Department of Education, the project name is "Application Research of New Restraint Devices in Postoperative Patient Safety Management in Cardiac Surgery", and the funding source is self-financing.According to the individual characteristics of ICU patients and the needs of patients, a new type of restraint device was innovatively made and the effectiveness and safety of the new restraint device were studied, which provided clinical reference and theoretical basis for standardizing postoperative patient restraint.

NCT ID: NCT05760066 Not yet recruiting - Atrophy, Muscular Clinical Trials

Effects of Resistance Training Preconditioning on Skeletal Muscle Recovery From a Period of Disuse in Young Adults

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

The goal of this clinical trial is to compare the effects of resistance training (RT) preconditioning vs no training on disuse-induced atrophy and post-disuse resistance training in young healthy individuals. The main questions it aims to answer are: - To determine if performing RT prior to a period of disuse enhances the regain of strength, skeletal muscle size, and skeletal muscle quality while performing RT after a period of disuse. - To determine if performing RT prior to a period of disuse dampens the maladaptive effects of disuse on muscle size, muscle quality, and strength. - To determine the anabolic and proteolytic mechanisms underpinning the observed outcomes. Participants will: 1. Perform either 6 weeks of resistance training or maintain an untrained lifestyle 2. Perform 2 weeks of limb immobilization induced disuse of a randomized leg 3. Perform 6 weeks of resistance training Researchers will compare the resistance training preconditioning condition vs the non-trained condition to see if resistance training prior to a period of disuse is beneficial during the disuse period and in the return to training period on skeletal muscle size, strength, and underpinning molecular markers.

NCT ID: NCT05760417 Not yet recruiting - Osteoporosis Clinical Trials

Awareness of Osteoporosis in Patients With Hyperthyroidism

Start date: August 1, 2023
Phase:
Study type: Observational [Patient Registry]

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Multiple sclerosis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hyperthyroidism.

NCT ID: NCT05762926 Not yet recruiting - Alzheimer Disease Clinical Trials

Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer's Disease

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

This is a randomized, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo, and the Institute of Physical Medicine and Rehabilitation (IMREA) at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo. Participants will be classified according to the stage of Alzheimer's disease, determined by a psychiatrist and neuropsychologists. A total of 50 volunteers will be randomized blindly. In addition to evaluating the clinical course and imaging examination, the use of scales that assess functional and cognitive disability will be used for the recruitment of volunteers. Volunteers will be randomized into two study groups, and will receive the intervention that will consist of ten sessions, held twice a week. The Storz Neurolithâ„¢ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.

NCT ID: NCT05768737 Not yet recruiting - Osteoporosis Clinical Trials

Awareness of Osteoporosis in Patients With Hepatitis B Infection

Start date: August 1, 2023
Phase:
Study type: Observational [Patient Registry]

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with hepatitis b virus infection are at increased risk for developing osteoporosis. Identifying whether patients with hepatitis b virus infection have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hepatitis b virus infection.

NCT ID: NCT05769413 Not yet recruiting - Osteoporosis Clinical Trials

Awareness of Osteoporosis in HIV Patients

Start date: August 1, 2023
Phase:
Study type: Observational [Patient Registry]

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with human immunodeficiency virus infection are at increased risk for developing osteoporosis. Identifying whether patients with human immunodeficiency virus infection have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with human immunodeficiency virus infection.

NCT ID: NCT05769907 Not yet recruiting - Obesity Clinical Trials

Protocol for a Feasibility of a Motivational Interviewing for Weight Loss in Adults

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

Abstract Introduction: This pilot study will determine the recruitment feasibility, retention, and adhesion for a motivational interviewing program for weight loss in adults according to the processes of change in weight loss. Methods and Analysis: The single-arm pilot study will be a feasibility study of the Motivation to Lose Weight version 1 (MLW v.1). The study includes presential and online sessions. Participants will be recruited through advertisements on social media and selected according to the inclusion criteria. Participants will receive 8 sessions of approximately 30-45 minutes of motivational interviewing (MI) according to the processes of change in weight loss, as measured by the S-Weight scale. The results will be evaluated at the beginning and the end of the program, which will last 8 weeks. The primary outcome of the study is feasibility. The intervention will be feasible if adherence to the proposed activities in the sessions is greater than 70%, we can recruit 10 patients within 8 weeks, the proportion of interested people and registered participants is greater than 30%, and more than 75% of participants attend the final study visit. The secondary outcome is weight loss, fat mass percentage, muscle mass, waist and hip measurements, and the scores of behavioral scales. Ethics and discussion: The feasibility of this project consists of proposing an individualized intervention based on MI strategy(s) for each participant, according to the stage of readiness, and thus, help to evolve in the process of losing weight. This intervention aims to increase the participant's confidence level to implement actions that lead to the progression of behavior and, consequently, the action and maintenance of the lost weight. This study was approved by the Research Ethics Committee (REC) of the Hospital de Clínicas de Porto Alegre (HCPA) under number 20220209 CAAE 59573622300005327.

NCT ID: NCT05775705 Not yet recruiting - Lymphoma Clinical Trials

L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH

Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

The efficacy and safety of L-DEP (PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated hemophagocytic lymphohistiocytosis.