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Showing 1-20 of 109 trials
NCT04666155
The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.
NCT07202481
The goal of this clinical trial is to evaluate the effect of dietary fibers in the treatment of functional constipation in women. It will also assess the potential side effects associated with fiber consumption. The main questions it aims to answer are: * In women with constipation who do not consume adequate dietary fiber, does supplementation help improve bowel function? * Among the fibers studied, is there any hierarchy of effect in the treatment of constipation (i.e., is one more effective than the other)? The researchers will compare the effects of the two dietary fibers against each other and against a control to evaluate their impact. Participants will: * Consume 20 g of fiber daily for 6 days, divided into two doses of 10 g each. * Attend a nuclear medicine visit at the end of each 6-day fiber period to perform scintigraphy. * Keep a daily record of bowel habits and dietary intake.
NCT07488351
The aim of this study is to evaluate the associations of self-compassion and self-efficacy levels with symptom severity, functional status, and quality of life in individuals with Parkinson's disease.
NCT07483229
This study aims to compare the effectiveness of two different acupuncture techniques for treating a specific type of chronic constipation, known in Traditional Chinese Medicine as "Yang deficiency type" chronic functional constipation. Chronic functional constipation is a common condition characterized by difficult or infrequent bowel movements. The "Yang deficiency" pattern is believed to be caused by a lack of functional energy (Qi) and warmth in the body, leading to sluggish bowel motility. This study will enroll 60 eligible participants who will be randomly assigned to one of two groups: Experimental Group: Participants will receive "warm needling" therapy. This involves inserting acupuncture needles at specific points (Tianshu and Guanyuan) and then burning a small moxa stick on the needle handle to generate heat. Control Group: Participants will receive electroacupuncture at the same acupoints. This involves attaching the needles to a device that delivers a mild electric current. Both groups will receive treatment every other day, three times a week, for a total of four weeks. We will assess their constipation symptoms, anxiety and depression levels, and quality of life using standardized questionnaires immediately after the 4-week treatment and again 6 months later. The goal is to see which method provides better relief, both in the short term and long term.
NCT07427914
The goal of this clinical trial is to find out whether the functional food Benemix® helps treat constipation in adults and whether it is safe to use. The main questions this study aims to answer are: Does Benemix® help improve bowel movement frequency and consistency in adults with constipation? What medical problems, if any, do participants experience while taking Benemix®? Adults with constipation will take Benemix® every day for 15 days. During the second week, participants will have either an in-person clinic visit or a telemedicine appointment for checkups and tests. Participants will also receive follow-up phone calls to record: * daily treatment adherence * signs and symptoms * the number of bowel movements each day.
NCT04919980
Study to evaluate the safety and performance of the INNOVALVE system
NCT07099755
The aim of this study was to determine the effect of DNS on women with post-partum LBP. Post-partum low back pain (PLBP) represents a prevalent and clinically significant condition that adversely impacts mobility, pelvic floor integrity, functional performance, and quality of life in women following childbirth. Epidemiological data suggest that approximately 50% of women who experience pregnancy-related low back pain continue to report symptoms up to 12 months post-partum, while nearly 20% may develop chronic or disabling pain lasting up to three years. Moreover, the onset of LBP within the first three months postpartum is a strong predictor for the development of persistent or recurrent symptoms, emphasizing the importance of early intervention (Fukano et al., 2021). Dynamic Neuromuscular Stabilization (DNS) provides a novel and integrative rehabilitation framework based on developmental kinesiology, emphasizing the restoration of optimal joint centration, intra-abdominal pressure regulation, and neuromuscular coordination across the entire core system. DNS targets not just local symptoms but the underlying movement dysfunctions that contribute to persistent post-partum pain. This approach stands in contrast to traditional rehabilitation techniques that often emphasize symptomatic relief over functional re-patterning (Ghavipanje et al., 2021). The significance of this study lies in its investigation of DNS as an evidence-based, functional intervention for women with PLBP. It highlights the role of active patient engagement, corrective movement strategies, and motor control retraining in promoting long-term recovery. By demonstrating the effectiveness of DNS, this research contributes to the evolving body of literature supporting core-centric, integrated neuromuscular rehabilitation for post-partum populations, with potential implications for improving clinical outcomes and enhancing women's physical autonomy after childbirth. Delimitations The present study was delimited to the following criteria to ensure homogeneity of the sample and clinical relevance to post-partum rehabilitation: 1. Participants: Sixty post-partum women diagnosed with mechanical low back pain of 3 to 6 months duration were included, reflecting a subacute pain profile relevant for neuromuscular retraining. 2. Age Range: Participants were between 18 and 34 years of age, corresponding to typical reproductive and early post-partum demographic profiles. 3. Body Mass Index (BMI): Only individuals with a BMI between 25 kg/m² and 35 kg/m² were included to account for mild to moderate overweight status, a known factor in post-partum back dysfunction. 4. Medication Exclusion: Participants did not receive any analgesics, anti-inflammatories, or therapeutic interventions throughout the study period to eliminate confounding effects. 5. Medical Exclusion: Women with a history of severe trauma, skeletal injuries, fractures, neurologic or chronic inflammatory disorders, primary or metastatic neoplasms, osteoporosis, or chronic neuromuscular conditions contributing to LBP were excluded. 6. Consent and Stability: Only medically stable women who provided written informed consent were included, in line with ethical standards for human subject research. Limitations Despite careful design and standardized intervention protocols, the current study was subject to several limitations inherent in clinical research involving post-partum populations: 1. Emotional and Psychological Factors: The emotional state of post-partum women - including symptoms of fatigue, anxiety, or depressive mood - may have influenced motivation, engagement, and consistency during therapeutic sessions. These psychosocial elements are known to modulate both pain perception and motor performance (Morin et al., 2018). 2. Participant Cooperation and Compliance: Variability in the degree of cooperation and adherence to prescribed home exercises may have introduced inconsistencies in treatment effects. Factors such as childcare responsibilities and sleep disturbances can influence session attendance and follow-through (Boissonnault \& Blanpied, 2018). 3. Individual Response to Therapy: There may have been biological and neuromuscular differences in how participants responded to the DNS approach. Genetic variability, post-partum recovery rate, and prior physical activity levels are all variables that can modulate treatment outcomes (Kolar et al., 2014). 4. Motor Learning and Skill Acquisition: DNS-based exercises require a level of motor learning and sensory awareness, which varies among individuals. Differences in performance ability and learning curve may have affected the precision and efficiency with which patients executed the exercises (Kolar et al., 2012). 5. Socioeconomic and Cultural Differences: Economic status, educational background, and cultural norms influenced participants' access to resources, health beliefs, and commitment to therapeutic regimens. (smith et al.2023)
NCT07368166
Population-based and clinical studies indicate that a substantial proportion of children and adolescents are exposed to one or more potentially traumatic events (PTEs) Approximately 16 % of those affected by childhood trauma go on to develop post-traumatic stress disorder (PTSD), with an even higher proportion experiencing subclinical levels of post-traumatic stress symptoms (PTSS). In Switzerland, over half of adolescents report exposure to at least one PTE, with 4.2 % meeting diagnostic criteria for PTSD. PTSD frequently impacts young people's social and educational functioning, often impairing their ability to engage in everyday life activities that are important or meaningful to them. Although the psychological consequences of PTSD are well documented, there is limited empirical understanding of how PTSS specifically affects day-to-day functioning in young people. A key reason for this gap is the absence of a validated instrument specifically designed to assess PTSD-related functional impairment in children and adolescents. To address this need, the PTSD-iMPairment in Adolescent \& Children's Capacity for Thriving (PTSD-iMPACT) measure was developed. This tool aims to systematically assess the extent of PTSD-related functional impairment in children and adolescents across key life domains, such as family, friends, school, apprenticeship, hobbies or media use. The overall aim of this study is to evaluate the psychometric properties of the PTSD-iMPACT questionnaire in a clinical and in a non-clinical sample and to provide an internationally applicable standard instrument for the assessment of PTSD-related functional impairment in trauma-exposed children and adolescents. In the long term, the aim is to ensure that the care and support provided to children and adolescents who experience difficulties in their daily lives due to post-traumatic stress symptoms are sustainably monitored and improved.
NCT07014696
This clinical trial aims to compare the effects of kinesio taping and PNF on hemiplegic hand functions. In addition, the effects of these applications on body structure, activity, and participation will be examined. The main questions it aims to answer are: Do kinesio taping and PNF applications have different effects on hemiplegic hand function? Are kinesio taping and PNF applications effective in body structure, activity, and participation? The researchers will compare the advantages of kinesio taping and PNF applications over each other. Participants: Kinesio taping and/or PNF applications will be applied 3 days a week for 8 weeks. Tests will be performed on the first and last day of the study to evaluate hand functions.
NCT07337343
Severe constipation affects 10% of children, often leading to significant physical and emotional distress. While constipation is commonly associated with impaired bowel movements, it is fundamentally linked to abnormalities in colonic motility - the coordinated contractions that facilitate passage of stool through the colon and out of the body. Diagnosis of constipation is based upon the Rome IV criteria, which assess symptoms as reported or remembered over the previous 3 months. However, reporting symptoms experienced can be challenging for children and young people for many reasons, such as the overlap of sensations, including fullness, bloating, and discomfort, and an inability to recall or precisely distinguish and describe what they are feeling. This study intends to design, develop, and validate symptom pictograms for children aged 8-17 with colonic or lower gut symptoms.
NCT07010146
The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control. Participants will: Take estrogen for 1 year either (i) in its natural form as a patch twice a week (and progesterone by mouth for 12 days of each month), or (ii) in its natural form as a pill daily (and progesterone by mouth for 12 days of each month), or (iii) in a synthetic form as a birth control patch weekly for 3 weeks with 1 week off the patch. You will not be able to choose which form of estrogen you will receive as this will be assigned to you based on a pre-existing randomization sequence (like the flip of a coin) Take provided calcium and vitamin D supplements Attend 4 study visits over 12 months with two at the beginning and then every 6 months that include: History and Physical Exams Lab Work Imaging studies Questionnaires Dietary recalls
NCT07321431
This is a multicenter, prospective, randomized, double-blind, crossover study involving healthy individuals, aiming to evaluate the stability of oral protein bars + olive oil as a new method for determining gallbladder contraction function and its optimal diagnostic time window.
NCT04306939
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making. The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.
NCT04147884
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
NCT06700239
Purpose of this clinical study is to demonstrate the safety and efficacy of MIA-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR grade ≥3) despite optimal medical therapy, who have been determined by the site's local heart team to be at intermediate or greater estimated risk for mortality and morbidity with tricuspid valve surgery.
NCT07243158
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.
NCT06583408
The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.
NCT07104435
This aim of this study is to examine the therapeutic impacts of a group-based recreational program that delivers guided visual artmaking and dual-task exergaming, to older adults. Outcomes of interest include cognitive function (attention, task-switching, interference inhibition), physical function (balance, walking, lower-limb strength), and dual-task performance. Key implementation outcomes including intervention fidelity, feasibility, and acceptability will be explored to inform design of future community-based intervention programs.
NCT05663970
The goal of this randomized control trial is to test the efficacy of the Social ABCs 6 week, group-based model using a virtual delivery platform. The Social ABCs is a caregiver-mediated early intervention program, aiming to increase child skills in directed, intentional vocalizations, and shared smiling with a primary caregiver for toddlers identified as early signs or a confirmed diagnosis of autism spectrum disorder (ASD), or having related social communication challenges. A positive RCT was previously completed using the program's in-person individual, 12-week model, and a pilot study showing preliminary promise of the virtual group-based model has also been published. This adaptation to a virtual, group-based model maintains the core components of the intervention, but allows caregivers to meet and discuss the content as a group from their home environments and complete the program in a shorter timeframe. The main questions it aims to answer are: * Is the Social ABCs virtual group-based model an effective early intervention program for toddlers aged 12-42 months with probable or confirmed ASD, or experiencing social communication challenges, when compared to an active control condition? * Can primary caregivers of these toddlers achieve implementation fidelity in the Social ABCs intervention strategies using the 6-week virtual delivery model? Participants will be randomized into the treatment condition (A) where they will receive the Social ABCs virtual group-based intervention or, into a Control condition (B), where they meet virtually with other caregivers in the control groups over the course of 6 weeks, viewing and discussing 3 didactic presentations around general child development content (not autism- or Social ABCs-specific). Video and questionnaire data will be collected before (Time 0) and after (Time 1) the 6 week period. After an additional 6-8 weeks, the same data will be collected from both groups as a follow-up time point (Time 2). Researchers will compare the Treatment group and the Control group to measure change in the target behaviours for the child, the caregiver's use of strategies, as well as caregiver stress and self-efficacy, across time-points.
NCT06437119
The study attempts to conduct randomized controlled trials to understand whether daily exposure to environmental pollutants can cause harm to human health, explore whether the intake of composite polyphenols can alleviate potential health hazards caused by environmental pollutants, and provide scientific basis for the prevention and treatment of health hazards caused by environmental pollutant exposure.