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Randomized Controlled Trial clinical trials

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NCT ID: NCT06412133 Not yet recruiting - Breast Cancer Clinical Trials

Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients

Start date: September 17, 2024
Phase: N/A
Study type: Interventional

This study examines the impact of phototherapy intervention on anxiety, stress, and body image among breast cancer patients. Participants engaged in a five-week, one-on-one session series, utilizing a pre-post-test design with parallel groups. Quantitative data were collected using the Depression Anxiety Stress Scales (DASS-21) and the Body Image Scale. In addition to quantitative measures, in-depth individual interviews were conducted to gather qualitative data. The combined data were then analysed to assess the effectiveness of the intervention.

NCT ID: NCT06385457 Not yet recruiting - Mental Health Issue Clinical Trials

The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking

Start date: April 29, 2024
Phase: N/A
Study type: Interventional

In this study the investigators will evaluate the effectiveness of Mindhelper.dk, which is the most comprehensive online youth mental health promotion service in Denmark. A minimum of 9,426 young people aged 15 to 25 will be recruited through social media and invited to participate in the study. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group. The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire. Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization. The investigators expect a small, positive effect on participants well-being and psychological functioning in intervention groups as compared to the control group.

NCT ID: NCT06358118 Not yet recruiting - Aging Clinical Trials

Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments. The main questions it aims to answer are: 1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity? 2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders. Participants will: 1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months;Follow-up for 6 months; 2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months; 3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events; 4. Urine and serum samples were collected before and after treatment;

NCT ID: NCT06330233 Not yet recruiting - Pain Clinical Trials

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

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

The purpose of this study is to provide moxibustion treatment for diabetic peripheral neuropathy (DPN) and to provide a reference for clinical treatment of DPN moxibustion. The first part: patients will be randomly assigned to 3 clinical centers, 18 in each center, and then equally divided into 2 groups, including routine treatment group and 15-minute moxibustion group. Patients in the routine treatment group were given mecobalamin tablets and epastat at the same time of daily treatment for 4 weeks (hypertension and hyperlipidemia combined with basic drug treatment). The frequency of moxibustion was 15 minutes per acupoint twice a week for four weeks. The results were evaluated during the baseline period (the day before the grouping), the treatment period (the end of the 8th treatment), and the follow-up period (2 weeks after the end of treatment). The results of this part are expected to confirm the therapeutic effect of moxibustion on diabetic peripheral neuropathy. The second part was divided into the moxibustion 15-minute group and the moxibustion 30-minute group, 75 cases in each group, and 50 cases needed to be assigned to each center. Except for the different durations of moxibustion, the moxibustion treatment methods and acupoints are the same. The results of this part are expected to confirm the optimal amount of moxibustion in the treatment of diabetic peripheral neuralgia and provide a reference for the standardization of clinical treatment of moxibustion.

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: 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: 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: NCT04944004 Not yet recruiting - Stroke Clinical Trials

Effectiveness of Computer-based Cognitive Training for Executive Functions After Stroke

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Objective: To determine the efficacy of computer-based cognitive training(CBCT) in patients with stroke in the community settings. Study Design: Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training in community settings. Treatment groups will attend individualized CBCT programme using CogniPlus® while control group will continue attend conventional treatment as usual (TAU). Assessment on the means difference in assessing functions will be done after the study. Samples: 100 patients with stroke will be recruited from the community, using a sampling frame of selected diagnosis and homogeneity. Expected Findings: Find out the training effects of selected CBCT on EF and daily functioning in patients with stroke

NCT ID: NCT03234231 Not yet recruiting - Clinical trials for Intellectual Disability

Supervised Brushing Programme for Intellectual Disabled Students

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Intellectual disabled persons faced more dental problems. According to a medical review paper of international and local studies, this group has poorer dental hygiene, more severe gum disease and more untreated caries. In 2010, a report from the guardians in Hong Kong mentioned that most adults with intellectual disability cannot clean their teeth, the have dental problems and it is very difficult for intellectually disabled students to co-operate during the dental treatment. In order to alleviate their dental problems, supervised toothbrushing programme and an oral health education talk are proposed. The investigators investigate the effectiveness of the supervised toothbrushing programme and an oral health education talk. The target group of the study is mild to moderate grade intellectual disabled students of special schools in Hong Kong. A clustered randomised controlled trial design is adopted.