View clinical trials related to Randomized Controlled Trial.
Filter by:The goal of this pragmatic clinical trial is to evaluate two municipality-based interventions, Lev Livet (one without physical activity and one with) against no intervention in people with type 2 diabetes. The main questions it aims to answer are: • What is the additive effect of HiiT on accelerometer-measured physical activity? • Which factors that facilitate or limit the implementation of Lev Livet? • What are the health-economic implications of the intervention? Participants will participate in a disease management program with and without physical activity added. Researchers will compare with no intervention to see if Lev Livet improves diabetes self-management.
The aim of the study is to evaluate, at the level of global cognition, cognitive neuroconstructs, memory, verbal fluency, ADLs, IADLs, symptoms of depression and anxiety, the effectiveness of a personalised and adapted computerised cognitive stimulation programme (GI1) implemented from Primary Care versus stimulating leisure activities (GI2), in older adults aged 50 years and over with mild cognitive impairment and subjective cognitive impairment living in the community.
This study aims to assess whether adding vibrotactile stimulation to visual and auditory stimulation increases the efficacy of VRET for FoF treatment. Eighty-four participants (18-65 years old) will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and vibrotactile; VRET-M), the VRET with bimodal feedback (visual and auditory; VRET-B), or the imagery exposure treatment (IET) without sensory feedback. FoF-related symptoms (primary outcomes) will be measured administering the Fear of Flying Questionnaire-II (QPV-II), the Fear of Flying Scale (FFS), and the Visual Analogic Scale (VAS-A) before and after eight sessions of treatment, and at six- and 12-month follow-ups. Anxiety and the sense of presence experienced during exposure sessions (secondary outcome measures: VAS-A and VAS-P) will also be assessed. It is expected that participants in the VRET-M group will report a further reduction of FoF-related symptomatology after the treatment and at follow-ups compared to participants in the VRET-B and IET groups. Likewise, participants in the VRET-M group are expected to show higher sense of presence levels during exposure sessions in comparison to participants in the VRET-B and IET groups. It is expected that the IET group will report the lowest level of sense of presence and the poorest outcome after treatment and at follow-ups.
The study was conducted with patients with Multiple Sclerosis (MS) who applied to the Neurology Outpatient Clinic of Atatürk University Research Hospital, met the inclusion criteria and agreed to participate in the study. At the time of the study, 96 patients were interviewed. 26 patients were excluded from the study because they did not meet the research criteria, and 70 multiple sclerosis patients constituted the research sample. 1 person from the control group and 1 person from the experimental group did not continue to work and 1 person developed a lavender allergy. The study was completed with 63 multiple sclerosis patients.
This study evaluates the effects of an electronic patient decision support system developed for the use of patients with type 2 diabetes (DiaPaDeSS) on self-management, patient activation, and metabolic parameters. To manage type 2 diabetes after discharge, patients must continue to perform interventions at home, such as blood glucose monitoring, blood pressure measurement, weight measurement, medication use, and foot care. To achieve this, patient's self-management and activation levels should be increased. This can also lead to positive improvements in the metabolic parameters. It would be beneficial to develop DiaPaDeSS that can increase the self-management and activation levels of patients with type 2 diabetes. The investigators will develop the DiaPaDeSS intervention protocol. Our content includes patient education information about type 2 diabetes, self-management practice tasks (daily, weekly, quarterly), a type 2 diabetes patient education program according to DiaPaDeSS algorithms, and measurement questionnaires. The content of the DiaPaDeSS will be evaluated by 10 experts in the fields of medicine, nursing, and informatics. A feasibility test with seven patients will be conducted to evaluate the usability of DiaPaDeSS. A single-blind, randomized controlled trial design will be used. Patients with type 2 diabetes will be pretested and randomized (intervention 36, control 36) to the DiaPaDeSS intervention and control groups. Both the DiaPaDeSS intervention and control groups will use the DiaPaDeSS for three months. While participants in the DiaPaDeSS intervention group can reach all contents of the DiaPaDeSS, others can reach only these fields: self-management practice tasks (daily, weekly, quarterly), and measurements questionnaires. The effectiveness of the DiaPaDeSS will be evaluated at baseline and at month 3.
Study design: Randomized control trial Purpose: Evaluate the efficacy of oral administration of tranexamic acid (TXA) in spine surgeries to achieve blood loss reduction. Methods. A total of 60 patients undergoing major surgery of the spine, were randomly assigned into 2 groups. Group 1 was assigned as the control group and the other one included oral administration of tranexamic acid 2 hours prior to surgery. Outcomes measures included intraoperative blood loss, postoperative blood loss, hematological parameters, blood transfusion needed, and surgical complications.
The aim of this study is to compare the effectiveness of interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block in anesthesia for shoulder arthroscopy.
The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .
Objectives: (1) To analyze the effectiveness of adding a group-based form of Acceptance and Commitment Therapy (ACT) to the treatment as usual (TAU) for preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain at baseline and after psychological treatment. (2) To examine the effectiveness of ACT on the improvement of pain interference, pain-related and behavioral variables in degenerative lumbar pathology preoperative patients after lumbar spine surgery in comparison with TAU. (3) To measure the proximal and distal effects of ACT in preoperative patients with degenerative lumbar pathology who had the surgery after ACT program completion in comparison with proximal and distal TAU surgery effects on pain related variables. Method: A 12-month randomized controlled trial (RCT) will be conducted at Hospital del Mar (Barcelona). Only those preoperative degenerative lumbar pathology patients with psychosocial risk factors for chronic post-surgical pain will be randomized to pre-surgical ACT group or to TAU. Evaluations will be completed before treatment (baseline), after ACT therapy (3 months), a first follow-up (6 months from baseline alias 3 months after surgery), second follow-up (9 months from baseline alias 6 months after surgery), and final follow-up (15 months from baseline alias 12 months from surgery). Participants: 80 adult preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain will be randomly assigned to two arms: ACT + TAU vs TAU. Primary outcome: Pain interference. Secondary outcomes: pain intensity, pain catastrophising, pain acceptance, pain disability, kinesiophobia, depression symptoms, anxiety symptoms, psychological flexibility, and quality of life. Main statistical analyses: Intention-to-Treat analyses that will include all participants who undergo random allocation, using multiple imputation to replace missing values. General linear mixed-effects models will be performed using Restricted Maximum Likelihood to estimate the parameters. Calculation of between-groups effect sizes using Cohen's d and of the number-needed-to-treat.
Efficacy and safety evaluation of tolvaptan in the treatment of patients with right heart failure caused by pulmonary arterial hypertension