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Randomized Controlled Trial clinical trials

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NCT ID: NCT06330233 Not yet recruiting - Pain Clinical Trials

Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This study is designed to provide the treatment plan for moxibustion for diabetic peripheral neuropathy (DPN) and provide a reference for clinical moxibustion for DPN. The patients will be randomly assigned to three clinical centers each center 44, then they will be distributed equally into 4 groups, which include the conventional treatment group and the moxibustion different minutes (5 minutes, 10 minutes, 15 minutes) per point group. The conventional treatment group will receive mecobalamin tablets and alpha-lipoic acid tablets for four weeks in conjunction with the patient's daily treatment (basal drug treatment for patients with combined hypertension and hyperlipidaemia). The frequency of moxibustion treatment is twice a week for 4 weeks. The outcomes were evaluated in the baseline period (the day before grouping), the treatment period (end of the 8th treatment) and the follow-up period (2 weeks after the end of treatment). The results of this study are expected to confirm the optimal amount of moxibustion for the treatment of diabetic peripheral neuralgia and to observe the efficacy of moxibustion in the treatment of diabetic peripheral neuralgia. It provides a reference for the clinical therapeutic operation standardization of moxibustion.

NCT ID: NCT06219096 Recruiting - Clinical trials for Randomized Controlled Trial

Application of ICG@HSA Complexes in Fluorescence Image-Guided Laparoscopic Anatomical Liver Resection

Start date: December 10, 2023
Phase: N/A
Study type: Interventional

This study is a single-center, prospective, randomized controlled trial that aims to compare the efficacy and safety of a new indocyanine green (ICG) administration protocol with the current guideline-recommended protocol for near-infrared (NIR) fluorescence imaging in laparoscopic anatomical hepatic resection. Primary liver cancer is a common malignancy worldwide. Laparoscopic liver resection has become increasingly popular due to its minimally invasive nature. During open and laparoscopic liver resection surgery, ICG, a fluorescent dye, is widely used to visualize liver segments and define tumor margins. However, there is a lack of high-level evidence regarding the timing and dosage of ICG administration in current protocols. In our preliminary study, we discovered a new method of pre-mixing ICG with albumin, which creates a more stable conjugate that could enhance fluorescence imaging during NIR laparoscopic hepatectomy. This study will include 100 patients with primary liver malignancies who are scheduled for laparoscopic anatomical hepatic resection. The patients will be randomly assigned in a 1:1 ratio to either the new ICG-albumin protocol (experimental group) or the standard ICG alone protocol (control group). The primary outcome will be the efficacy of fluorescence imaging, which will be evaluated using a 5-point scoring system by three independent experts. Secondary outcomes will include operation time, blood loss, tumor margin status, complications, length of stay, long-term recurrence, and survival. The hypothesis of this study is that pre-binding ICG with albumin creates a more stabilized fluorescent complex, which could significantly improve the efficacy of fluorescence navigation and hepatectomy outcomes compared to standard ICG alone. This study aims to provide high-quality evidence on optimal protocols for ICG use in laparoscopic fluorescent image-guided liver surgery. The results of this study could help establish standardized guidelines to improve the application of this important navigation technique and enhance surgical precision and outcomes for liver cancer patients worldwide. The study protocol will be approved by the Ethics Review Board and publicly registered before enrollment starts. All participants will be required to provide informed consent. This study will be conducted in compliance with the Declaration of Helsinki and national regulations on human subject protection to ensure ethics, privacy, and safety.

NCT ID: NCT06163781 Not yet recruiting - Clinical trials for Artificial Intelligence

Appropriate Use of Blood Cultures in the Emergency Department Through Machine Learning

ABC
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to study whether the use of our blood culture prediction tool is non-inferior to current practice and if it can improve certain outcomes in all adult patients presenting to the emergency department with a clinical indication for a blood culture analysis (according to the treating physician). The primary endpoint is 30-day mortality. Key secondary outcomes are: - hospital admission rates - in-hospital mortality - hospital length-of-stay. In the intervention group, the physician will follow the advice of our blood culture prediction tool. In the comparison group all patients will undergo a blood culture analysis.

NCT ID: NCT06150313 Recruiting - Clinical trials for Randomized Controlled Trial

Efficacy of the Mediational Intervention for Sensitizing Caregivers for Teachers and Self-Administered Versions

MISC-SA/T
Start date: September 12, 2023
Phase: N/A
Study type: Interventional

OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of 2 new modalities of the Mediational Intervention for Sensitizing Caregivers (MISC) in caregivers from general population, specifically, in teachers at primary school children who are also parents. The main QUESTIONS it aims to answer are: - Are the new versions of MISC (MISC-T for Teachers, and MISC-SA or Self-Administered) efficient to a) improve the quality of caregivers-child interaction, and b) benefit children mental health, compared with a control group defined as Treatment as Usual (TAU)? - Is there any effect-transference to the school-setting despite the MISC is trained out of the school setting? re the new versions of the MISC efficient to benefit teachers' well-being at work in terms of lower burn-out, higher perceived self-efficacy or better classroom climate? PARTICIPANTS will randomly receive one of the 3 versions of MISC: MISC-T (administered by videoconference in teams of 6-10 teachers), MISC-SA (self-administered by the participants in weekly sessions with Genially), and MISC-R (self-administered by the participants but mainly based in readings and cognitive exercises instead of video-feedback, the core element of MISC-T and MISC-SA). COMPARISONS: Researchers will compare all 3 groups among them to see to what extent: - MISC-T shows efficacy compared with MISC-R (TAU; control group) - MISC-SA shows efficacy compared with MISC-R (TAU; control group) - MISC-T is more efficient than MISC-SA

NCT ID: NCT06091501 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

LIVING - Physical Activity in a Self-management Program Among Persons With Type 2 Diabetes

Start date: October 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06058611 Not yet recruiting - Clinical trials for Mild Cognitive Impairment

Effects of a Computerised Cognitive Stimulation Versus Stimulating Leisure Activities

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05939986 Not yet recruiting - Anxiety Clinical Trials

A Protocol for a Virtual Reality Exposure Therapy for Fear of Flying.

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

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.

NCT ID: NCT05929638 Active, not recruiting - Multiple Sclerosis Clinical Trials

Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05902156 Not yet recruiting - Type 2 Diabetes Clinical Trials

Electronic Patient Decision Support System for Patients With Type 2 Diabetes (DiaPaDeSS)

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

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.

NCT ID: NCT05705336 Completed - Clinical trials for Randomized Controlled Trial

Clinical Trial Analyzing the Efficacy of Oral Administration of Tranexamic Acid in Spine Surgery.

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

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.