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NCT07363720
The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.
NCT07484672
Patients with type II diabetes are at high risk of developing cardiovascular diseases due to increased blood sugar, inflammation, insulin resistance, and physical inactivity. The effectiveness of exercises in improving cardiopulmonary fitness have not been well documented and practiced in Pakistan. The objective of this study is to determine the comparative effects of Periodized circuit and strength training in improving cardiovascular fitness, pulmonary functions , quality of life and glycemic control in type II diabetes patients. The study will be a randomized clinical trial. Based on the inclusion and exclusion criteria participants will be divided into 2 groups, Group A and Group B. The study will be 6 weeks, 3 sessions per week (18 sessions). Group A will be asked to perform Periodized circuit training 45 min per session (20 min aerobic exercise with 10 min warm up and cool down) with moderate intensity, 10min break and 15 min of resistance exercise while Group B will follow Conventional strength training 45 min per session, 35 min of strength and endurance training with 10 min of warm up and cool down. The study outcomes measures will be pulmonary functions (FEV1. FVC, FEV1/FVC ratio) through digital spirometer quality of life through health-related quality of life (HRQOL) questionnaire , cardiopulmonary fitness ( heart rate, blood pressure, oxygen saturation through 6MWT) and Glycemic control through (BCM). The data will be assessed at baseline, daily after the interventions and end of the study. Data will be analyzed using IBM SPSS software version 23. Key words: CT (Circuit training), CF (Cardiovascular fitness), PF (Pulmonary function), CST (Conventional strength training), CVD (cardiovascular disease), T2D (Type 2 diabetes), BCM (Blood Glucose Monitor)
NCT03855449
The Decision-Making Education for Choices in Diabetes Every Day (DECIDE) program (copyrighted) was created by Dr. Felicia Hill-Briggs and is used by permission for the purpose of this pilot study. This problem-solving curriculum is used to help manage everyday problems when living with diabetes. The purpose of this project is to complete an in-depth review of the Decision-Making Education for Choices in Diabetes Every Day (DECIDE) curriculum, which is delivered in a group face-to-face setting. Using a task analysis process, the investigators will use the findings from the review to develop a web-site version that will be called eDECIDE for use with a community group in Kansas. Phase 3: will be a pilot clinical trial (2 Arm Study) which examines the use of the eDECIDE curriculum compared to the traditional DECIDE curriculum delivered to participants individually.
NCT06541847
The trial will be an open label, single arm, phase 2 study to assess the tolerability and efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with progressive and/or symptomatic PN. This study will also investigate the safety and efficacy of HLX-1502 in a small cohort of 12 to 15 year olds.
NCT07051005
The goal of this clinical trial is to examine the feasibility and acceptability of an online programme that is based on Compassionate Mind Training (CMT) over four-weeks. The programme intends to share information and strategies to reduce diabetes distress, self-criticism, and shame, and improve physical health in people who have Type 1 and Type 2 Diabetes Mellitus.
NCT00924196
Background: Neurofibromatosis Type 1 (NF1) is a genetic disorder in which patients are at increased risk of developing tumors (usually non-cancerous) of the central and peripheral nervous system. The disease affects essentially every organ system. The natural course of NFI over time is poorly understood. For most patients the only treatment option is surgery. A better understanding of NF1 may be helpful for the design of future treatment studies. Objectives: To evaluate people with NF1 over 10 years in order to better understand the natural history of the disease. To characterize the patient population and to examine how NFI affects patients quality of life and function. Eligibility: Children, adolescents, and adults with NF1. Design: Participants have a comprehensive baseline evaluation including genetic testing, tumor imaging, pain and quality-of-life assessments, and neuropsychological, motor and endocrine evaluations. Patients are monitored every 6 months to every 3 years, depending on their individual findings at the baseline study. Tests may include the following, as appropriate: * Medical history, physical examination and blood tests. * Whole body and face photography to monitor visible deformities. * Neuropsychological testing, quality-of-life evaluations, motor function tests, endocrinologic evaluations, heart and lung function tests, hearing tests, bone density scans and other bone evaluations. * MRI and PET scans to detect and assess plexiform neurofibromas (tumors that arise from nerves and can cause serious problems), paraspinal neurofibromas (tumors that arise from nerves around the spine and can cause problems by compressing the spinal cord), and malignant peripheral nerve sheath tumors (a type of cancer that arises from a peripheral nerve or involves the sheath covering the nerve). * Eye exams, MRI scans and PET scans to evaluate optic pathway gliomas (tumors arising from the vision nerves or the brain areas for vision) and the chemicals within the tumor and brain. * Eye exams and photographs to evaluate the development of Lisch nodules (non-cancerous tumors on the eye). * Photographs of dermal neurofibromas (tumors of the skin), cafe-au-lait spots (dark or pigmented areas on the skin that are often the first signs of NF1) and other skin problems. * Pain evaluations to monitor the different types of pain patients experience, causes of the pain, how often the pain occurs, effect of the pain on quality of life, and what pain medications and alternative treatments, such as acupuncture, are effective.
NCT00001987
The study will allow researchers to obtain blood, plasma, DNA, and RNA for genetic studies of insulin. There will be a focus on the causes of insulin resistance and diabetes mellitus. Insulin is a hormone found in the body that controls the level of sugar in the blood. Insulin resistance refers to conditions like diabetes when insulin does not work properly. In this study researchers would like to compare patients with diabetes and other forms of insulin resistance to normal individuals. The study will investigate how insulin attaches to cells. Researchers will take 4 to 6 ounces (100-150 ml) of blood from adult patients and may request up to 12 ounces (one unit) of blood if necessary. Skin samples may be taken for a biopsy if further genetic testing is necessary. In addition some patients may be asked not to eat for up to 72 hours prior to testing....
NCT06066528
This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.
NCT05348733
This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: * Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants * Reasons for starting finerenone * Reasons for stopping finerenone early * How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) * Dosing of finerenone * Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: * Stopping finerenone treatment too early * Dialysis (a medical procedure to filter the blood of extra water and waste) * Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.
NCT07480161
The goal of this prospective randomized controlled clinical study is to evaluate the effectiveness and safety of intracavernosal injections of umbilical cord-derived mesenchymal stem cells (MSCs) and umbilical cord-derived MSC-derived exosomes in men aged 25 to 75 years with diabetic erectile dysfunction (ED) who have not responded adequately to conventional medical treatments such as phosphodiesterase type-5 (PDE-5) inhibitors. Diabetes mellitus is a major risk factor for erectile dysfunction and is associated with endothelial dysfunction, impaired smooth muscle relaxation, neuropathy, and increased fibrosis within penile tissue. Although many patients respond to standard pharmacological treatments, diabetic patients often demonstrate reduced responsiveness to these therapies. Regenerative medicine approaches, including stem cell therapy and stem cell-derived exosomes, have emerged as potential therapeutic strategies due to their regenerative, angiogenic, neuroprotective, and anti-fibrotic effects. The main questions this study aims to answer are: * Whether intracavernosal administration of mesenchymal stem cells or MSC-derived exosomes improves erectile function, as measured by changes in the International Index of Erectile Function-5 (IIEF-5) and Erectile Hardness Score (EHS). * Whether penile hemodynamics improve following treatment, as assessed by penile Doppler ultrasonography parameters including peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI). Participants will be randomly assigned to one of three groups: * Intracavernosal placebo injection * Intracavernosal injection of umbilical cord-derived mesenchymal stem cells (5×10⁶ cells) * Intracavernosal injection of umbilical cord-derived mesenchymal stem cell-derived exosomes (75 μg) All interventions will be administered as a single intracavernosal injection under controlled clinical conditions. Participants will undergo baseline evaluation including medical history, physical examination, erectile function assessment using the IIEF-5 questionnaire, and penile Doppler ultrasonography. Follow-up evaluations will be conducted at 1, 3, 6, and 12 months after treatment to assess changes in erectile function, penile vascular parameters, and treatment-related adverse events. The study will also monitor potential side effects such as pain, bruising, hematoma, edema, or other complications related to the intracavernosal injection procedure. Participants will be recruited from patients presenting to the urology outpatient clinic with diabetic erectile dysfunction. Eligible participants must have a diagnosis of erectile dysfunction for at least six months, a history of diabetes mellitus for at least five years, and insufficient response to standard medical therapy. Patients with penile anatomical deformities, active infections, malignancy, unstable cardiovascular disease, autoimmune disease, or other contraindications to intracavernosal treatment will be excluded.
NCT07336030
This study is conducted to assess baduanjin exercise for its ability to reduce cortisol levels in type 2 diabetic patients which in turn contributes to lowering blood glucose levels. the potential improvement in blood sugar levels can positively affect patients' quality of life and improving activities of daily living by reducing complications and dependance on medications , so baduanjin exercise supports the concept of health sustainability and enhancing long term wellbeing.
NCT04786262
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
NCT04335656
This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.
NCT06748963
This study compares aerobic exercise training performed before breakfast (i.e., in the fasted state) to similar training performed after breakfast in people with type 1 diabetes. Training will take place over 12 weeks.
NCT07472855
This study explores the effect of an individualized dietary intervention program based on COM-B theory on improving health outcomes in patients with T2DM, improvement in metabolic health indicators and an increased diabetes remission rate, as well as changes in dietary adherence, self-management ability, and self-efficacy.
NCT07465640
Background: Diabetic foot ulcer (DFU) is a frequent complication of chronic, uncontrolled diabetes mellitus (DM). Treatment with antibiotics, daily dressing, wound debridement, and wound off-loading is often prescribed. However, many DFU patients still progress into severe outcomes, including non-healing of wounds, infections, necrosis, and osteomyelitis. Prior research has shown that the application of pulsating electromagnetic field (PEMF) could accelerate wound healing, including in those afflicted with DFUs. Therefore, this study aimed to evaluate the efficacy of a locally developed CRAD ULCER X-01 device that uses the principles of PEMF in promoting DFU healing. Methods: A total of 32 patients with chronic, non-healing DFUs will be recruited from the Orthopaedic Clinic of Hospital Angkatan Tentera Tuanku Mizan and divided into control (C) (n=8) and treatment (T) (n=24) groups. All patients will receive a standard daily dressing. The PEMF will be supplemented for 1 hour/day, 2 hours/day, and 3 hours/day for T1, T2, and T3 subgroups, respectively (n=8 per group); whereas the C group will be controlled for placebo effect (device in-place but switched off). The therapy duration will be until the wound is closed or for a maximum period of three months. All patients will undergo wound assessment, wound edge tissue histology by haematoxylin and eosin (H\&E) staining, and immunohistology (for vascular endothelial growth factor \[VEGF\] and fibroblast growth factor 2 \[FGF-2\] expression), as well as serum superoxide dismutase (SOD) and C-reactive protein (CRP) at preand post-treatment, along with glycated haemoglobin (HbA1c) measurement only at post-treatment to control for confounder (i.e., glucose control for the past three months). This study hypothesizes that PEMF therapy by CRAD ULCER X-01 device will accelerate DFU healing and improve tissue integrity, with minimal systemic effects assessed via oxidative stress and inflammatory markers. Conclusion: The results from this study will validate PEMF's effectiveness in promoting DFU healing and establish the potential use of locally developed CRAD ULCER X-01 devices as supplementary therapy to standard DFU care.
NCT07463456
This cross-sectional observational study validates the concordance of a low-cost thermographic camera (HIKMICRO Mini2 V2, \~200 Euro) against a professional clinical standard (HIKMICRO M60) for diabetic foot assessment. Both cameras simultaneously capture plantar thermographic images from 130 participants with diabetes mellitus. Maximum contralateral thermal asymmetry (Delta T\_max) across 6 plantar regions of interest (ROIs) is the primary endpoint, analyzed by intraclass correlation coefficient (ICC) and Bland-Altman method.
NCT02494986
The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and are expected to continue experiencing clinical benefit from RPV treatment.
NCT07464223
This study evaluates changes in pancreatic fat and recovery of pancreatic function in obese patients undergoing laparoscopic sleeve gastrectomy (LSG), a weight-loss surgery. Obesity can cause fat to accumulate in the pancreas, which may impair insulin production and lead to type 2 diabetes. This study uses magnetic resonance imaging (MRI) to measure pancreatic fat before and after surgery to understand how weight loss affects pancreatic function. About 50 obese patients (BMI \> 32 kg/m²) aged 16-60 years who are scheduled for LSG will be enrolled. Participants will undergo MRI scans of the pancreas and blood tests before surgery and at 1, 3, and 6 months after surgery. The MRI uses a safe, non-invasive technique called Dixon imaging to measure fat content in different parts of the pancreas (head, body, and tail). Blood tests will measure fasting glucose, insulin, C-peptide, and HbA1c to assess pancreatic function. The study aims to determine whether reduction in pancreatic fat after weight-loss surgery is associated with improved insulin secretion and reduced insulin resistance. This information may help doctors better understand how bariatric surgery improves metabolic health and guide postoperative patient management. Participation involves no additional risk beyond routine clinical care. All MRI scans and blood tests are part of standard postoperative monitoring for bariatric surgery patients.
NCT07464119
This is a single-arm, open-label clinical trial designed to assess the safety and therapeutic efficacy of iPSC-derived islet cell infusion in patients with diabetes mellitus.