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## Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode - NCT ID: NCT06263933 - Study ID: 2023-A01804-41 - Status: RECRUITING - Start Date: 2023-11-13 - Completion Date: 2025-11-13 - Lead Sponsor: Centre hospitalier de Ville-Evrard, France ### Study Description Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end. ### Conditions - Psychotic Episode ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Insight Scale - Semi-directional interviews - routine care - session of mutual assistance with a mediator psychologist ### Outcomes Primary Outcomes - The level of the increasing of The INSIGHT scale Secondary Outcomes - The increase of Recovery Scale - The semi-structured interview ### Location - Facility: Etablissement Public de Santé de Ville-Evrard, Neuilly-sur-Marne, N/A, 93330, France @@
## Neurofrailty: A Study of Late-onset Epilepsy and Its Associations - NCT ID: NCT06263920 - Study ID: 288703 - Status: RECRUITING - Start Date: 2022-05-05 - Completion Date: 2027-01-12 - Lead Sponsor: Lancashire Teaching Hospitals NHS Foundation Trust ### Study Description We don't know a great deal about why some people develop seizures in adulthood, but some researchers think that it might tell us something about the brain. A small number of people with first seizure in adulthood go on to experience problems like stroke or dementia later in life. However, stroke and dementia are common diseases, so we don't know whether there is a real association between these conditions. When people develop their first seizure in adult life, this is sometimes called Late-Onset Epilepsy. Through the NeuroFrailty study, we will observe 'brain health' over the years following the onset of a seizure, and I hope that it might give us more information about people with these kinds of seizures.The NeuroFrailty study involves observing people from the time of diagnosis of first seizure. At this time, we will look at investigations such as blood tests, blood pressure, brain scans, alongside other diagnoses which might tell us whether there are differences compared to people without seizures. For some people, we will also look in greater depth at lifestyle including exercise, driving, family planning, and memory assessments.Over the following years, we will look at how things change: for example whether there are changes in memory, new diagnoses, medication changes and how lifestyle has changed. Because there is so little research in this area, it is very difficult to predict what might happen. For example, some people can experience worse memory because of medication side effects; on the other hand, good seizure control following a diagnosis can sometimes lead to improved memory. Over years, it may become clear that some diseases are more likely in people with late-onset epilepsy than in people without such a diagnosis. You will receive a yearly newsletter to keep you updated on everything we learn about late-onset epilepsy.Purpose and BackgroundMost of the time, we do not know why an adult develops epilepsy. Some researchers think there may be a connection between epilepsy which starts in adulthood, and increased risk of stroke or dementia in the future. However, there is very little research or evidence in this area, so we cannot say whether this is true.What does taking part involve?This study is an observational study, which means that the management of participants' seizure disorder will not be affected if they choose to take part in this study. The purpose of this study is to watch participants over the course of several years, to find out more about seizures which start in adulthood.Participants can choose the level of involvement that is right for them.1. LOW involvement. A researcher will check hospital and General Practice (GP records) once or twice per year, for the LIMITED AND SPECIFIC purpose of checking: medications, any new diagnoses, investigations associated with stroke risk (such as cholesterol, blood pressure, heart trace) and any brain scans that have been performed. I will not have access to more detailed information, such as conversations between a participant and their GP.2. HIGH involvement. This involves being contacted by telephone once per year for 15-30 minutes to ask questions assessing memory and enquiring about lifestyle, such as exercise, smoking and alcohol use.3. VERY HIGH involvement. These participants will be contacted for a longer telephone conversation 30-45 minutes once per year about their experience of how epilepsy has affected home life, work and medications.If someone decides in the future that they don't want to be involved, they can withdraw from the study. However, once the study is completely finished, the information will be completely anonymous, which means that I won't be able to find individual's information in order to delete it.Glossary Seizure disorder = any disorder which involved having experienced at least one seizure. First seizure and epilepsy both can be classed as a form of seizure disorder.Neurofrailty = A condition whereby a person is at risk of stroke or dementia. ### Conditions - Late Onset Epilepsy - Stroke - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population? - Quality of Life - how of chronic illness is mediated Secondary Outcomes - What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population? - Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated? ### Location - Facility: Lancashire Teaching Hospitals NHS, Preston, Lancashire, PR2 9HT, United Kingdom @@
## Stellate Ganglion Block for Prevention of Post Mastectomy Depression - NCT ID: NCT06263907 - Study ID: stellate ganglion block - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-30 - Lead Sponsor: Mansoura University ### Study Description Complications after mastectomy include chronic pain and depression. ### Conditions - Mastectomy - Pain, Acute - Pain, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Stellate gangalion block ### Outcomes Primary Outcomes - incidence of postmastectomy depression Secondary Outcomes - incidence of postmastectomy depression - the need for postoperative antidepressant - acute postoperative pain at the incision site (breast and the axilla) - chronic postmastectomy pain at the incision site - incidence of nausea and vomiting - Functional pain in the ipsilateral shoulder - Any complications related to stellate ganglion injection ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Alexander Technique on Labor Pain and Anxiety - NCT ID: NCT06263894 - Study ID: MarmaraU-Ebe-ZDY-01 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2024-07-02 - Lead Sponsor: Marmara University ### Study Description This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. In calculating the sample size, G\Power (3.1.9.6) program was used to calculate the sample size with an error of 0.05, effect level of 0.5, power of 95%, and the required sample size for 2 groups was calculated as 34 people for each group with a total of 68 people. ### Conditions - Labor Pain - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Experimental group ### Outcomes Primary Outcomes* - Decreasing labor pain - Decreasing anxiety Secondary Outcomes ### Location - Facility: Başakşehir Çam and Sakura City Hospital, Istanbul, N/A, N/A, Turkey @@
## Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia - NCT ID: NCT06263881 - Study ID: MMH-407-009 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2026-12-31 - Lead Sponsor: Materia Medica Holding ### Study Description Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial. ### Conditions - Community-acquired Pneumonia - Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Raphamin - Placebo ### Outcomes Primary Outcomes - Percentage of patients with clinical cure at the test of cure (TOC) visit Secondary Outcomes - Average duration of antibacterial therapy ### Location - Facility: Northern Medical Clinical Center named after N.A. Semashko Federal Medical and Biological Agency, Arkhangelsk, N/A, 163000, Russian Federation @@
## First Observatory of Precocious Puberty. - NCT ID: NCT06263868 - Study ID: 69HCL23_1090 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-03-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data. ### Conditions - Puberty, Precocious ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of recruited patients with at least 80% of the main data collected - Missing data rate - At least 75% of patients included Secondary Outcomes ### Location - Facility: Clinique du Val d'Ouest, Ecully, Auvergne-Rhône-Alpes, 69130, France @@
## Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients - NCT ID: NCT06263855 - Study ID: 24-000352 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-07-01 - Completion Date: 2025-04-01 - Lead Sponsor: Mayo Clinic ### Study Description This pilot study aims to assess the feasibility of carrying out a full-scale pragmatic, cluster-randomized controlled trial which will investigate whether discharge summary writing assisted by a large language model (LLM), called CURE (Checker for Unvalidated Response Errors), improves care delivery without adversely impacting patient outcomes. ### Conditions - Large Language Model ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - CURE ### Outcomes Primary Outcomes - Rate of patient accrual Secondary Outcomes ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## Elamrousy Novel Approach of Socket Shield Technique - NCT ID: NCT06263842 - Study ID: KFSIRB200-132 - Status: RECRUITING - Start Date: 2024-02-10 - Completion Date: 2025-02-20 - Lead Sponsor: Kafrelsheikh University ### Study Description The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. ### Conditions - Implant Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - modified Elamrousy approach for socket shield technique - conventional socket shield - combined socket shild with xenograft ### Outcomes Primary Outcomes - Stability Quotient of dental implant (SQDI) - pink esthetic score (PES) - Midfacial Mucosal Alterations Secondary Outcomes - facial marginal bone level (FMBL) ### Location - Facility: Walid Elamrousy, Kafr Ash Shaykh, N/A, 76130, Egypt @@
## HCV Tappt Adherence Study - NCT ID: NCT06263829 - Study ID: 2023-1580 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-07-01 - Lead Sponsor: University of Illinois at Chicago ### Study Description The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.* The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates.* The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm. ### Conditions - Hepatitis C ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Use of Tappt App ### Outcomes Primary Outcomes - Medication adherence Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial - NCT ID: NCT06263816 - Study ID: CARVECIR - Status: NOT_YET_RECRUITING - Start Date: 2024-11-15 - Completion Date: 2030-06-15 - Lead Sponsor: University Hospital, Tours ### Study Description Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial. ### Conditions - Asymptomatic Cirrhosis - Clinically Significant Portal Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental group: Patients will be treated with carvedilol. - Control group: Patients will receive a placebo. ### Outcomes Primary Outcomes - To evaluate the effect of low dose carvedilol (<=12.5 mg per day) versus placebo on the occurrence of decompensation of cirrhosis or liver-related death at 36 months Secondary Outcomes ### Location - Facility: CHU Amiens Picardie, Amiens, N/A, N/A, France @@
## The Effect of Listening to Music on Chronic Low Back Pain - NCT ID: NCT06263803 - Study ID: Karataymusic - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-04-15 - Lead Sponsor: KTO Karatay University ### Study Description The effects of passive music listening on pain, anxiety and quality of life in patients with chronic low back pain in addition to physical therapy will be examined. ### Conditions - Pain, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Music listening, classic physical therapy ### Outcomes Primary Outcomes - Beck anxiety inventory - Visual Analogue Scale - Short From-36 Secondary Outcomes ### Location - Facility: Mustafa Savaş Torlak, Karatay, Eyalet/Yerleşke, 42000, Turkey @@
## Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial - NCT ID: NCT06263790 - Study ID: NEOUNIPD1(2024) - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-03 - Lead Sponsor: University Hospital Padova ### Study Description The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. ### Conditions - Neonatal Disease - Intubation; Difficult or Failed ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Intubating laryngeal mask - Direct laryngoscopy ### Outcomes Primary Outcomes - Success at the first attempt Secondary Outcomes - Time of device positioning - Participant's opinion on difficulty of the procedure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Early Detection of Children With Developmental Disabilities in Assiut Governorate - NCT ID: NCT06263777 - Study ID: P.T.REC/012/004142 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2021-09-30 - Lead Sponsor: Beni-Suef University ### Study Description The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years). ### Conditions - Developmental Disability - Development Delay - Motor Delay - Down Syndrome - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Nurses training program on early detection of disability ### Outcomes Primary Outcomes - Questionnaire of Screening and referral knowledge - Questionnaire of Disability Perception - questionnaire about Monitoring Practices - Follow up Secondary Outcomes ### Location - Facility: Tayseer Saber Abdeldayem, Banī Suwayf, Beni-Suef, 62521, Egypt @@
## The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients - NCT ID: NCT06263764 - Study ID: 23-11-1954 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-07-31 - Lead Sponsor: Indonesia University ### Study Description The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life. ### Conditions - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Listening to Qur'an Recital ### Outcomes Primary Outcomes - Difference in Quality of Life Pre and Post Intervention Secondary Outcomes ### Location - Facility: Faculty of Medicine Universitas Indonesia -Cipto Mangunkusumo Hospital, Jakarta, Indonesia, Jakarta, N/A, 10430, Indonesia @@
## Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes Such as Reach, Implementation, Sustainability, and Cost - NCT ID: NCT06263751 - Study ID: 202401096 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-06 - Lead Sponsor: Washington University School of Medicine ### Study Description The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers "prescribe" fruits and vegetables (F\&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F\&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost. ### Conditions - Food Insecurity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Product prescription program- NutriConnect Credit - Product prescription program- NutriConnect Delivery ### Outcomes Primary Outcomes - change in F&V intake Secondary Outcomes - Household food insecurity ### Location - Facility: Barnes Jewish Hospital, Saint Louis, Missouri, 63110, United States @@
## Cold and Heat Investigation to Lower Levels of Depression - NCT ID: NCT06263738 - Study ID: 2024-248 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04-01 - Lead Sponsor: Vail Health Behavioral Health ### Study Description This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments. ### Conditions - Depression - Mood Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Whole Body Hyperthermia - Cold Water Plunge ### Outcomes Primary Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS) Secondary Outcomes - Warwick Edinburgh Mental Well-Being Scale (WEMWBS) - Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety - Sheehan Disability Scale (SDS) - Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF) ### Location - Facility: Vail Health Behavioral Health Innovation Center, Edwards, Colorado, 81632, United States @@
## Protein Restriction (PR) for Weight Loss - NCT ID: NCT06263725 - Study ID: ALyster - Status: COMPLETED - Start Date: 2021-10-01 - Completion Date: 2023-12-31 - Lead Sponsor: University of Copenhagen ### Study Description Prolonged dietary protein restriction has been shown to increase energy expenditure in mice simultaneously with an increase in plasma FGF21 levels. In overfeeding studies, a protein-restricted diet reduces weight gain in both mice and humans compared with normal and high-protein diets. Further, in energy balance studies, when lean men are provided with a protein-restricted diet for five weeks, an increase in energy intake was necessary to obtain their body weight. However, whether the effect of a protein-restricted diet is the same when consumed by overweight to obese men has divergent results in both mice and humans. ### Conditions - Diet, Healthy, Body Weight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Restricted dietary protein - Habitual diet ### Outcomes Primary Outcomes - Body weight Secondary Outcomes - FGF21 ### Location - Facility: University of Copenhagen, Copenhagen, N/A, 2100, Denmark @@
## Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2 - NCT ID: NCT06263712 - Study ID: 2021-02504 (Project 2) - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2026-12 - Lead Sponsor: University of Bern ### Study Description The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment.The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2.Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1. ### Conditions - Inhibitory Control - Self Efficacy - Suicide Ideation - Suicide, Attempted - Locus of Control - Process Factors - Movement Synchrony ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Attempted Suicide Short Intervention Program (ASSIP) - Standard of care plus resource interview group (STAR) ### Outcomes Primary Outcomes - Differences in Inhibitory Control - Differences in Inhibitory Control - Differences in Inhibitory Control Secondary Outcomes - Movement analyses - Selective Attention and Interference Control - General Sense of Self-Efficacy - Locus of control - Psychological Pain - Suicidal ideation and behavior - Suicidal ideation ### Location - Facility: University Hospital of Psychiatry and Psychotherapy, University of Bern, Bern, N/A, 3008, Switzerland @@
## Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease - NCT ID: NCT06263699 - Study ID: S68225 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2025-01-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer. ### Conditions - Dupuytren's Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ROM measurement of the MCP and PIP joints in digits 4 and 5 ### Outcomes Primary Outcomes - Active Extension Deficits (AED) Secondary Outcomes ### Location - Facility: Universitaire Ziekenhuizen KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults - NCT ID: NCT06263686 - Study ID: DAN056 - Status: COMPLETED - Start Date: 2016-06-01 - Completion Date: 2016-12-31 - Lead Sponsor: University of Valladolid ### Study Description In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed. ### Conditions - Immune System - Innate Inflammatory Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Pasteurised yoghurt - Fresh yoghurt - Sterilised yoghurt ### Outcomes Primary Outcomes - T-cells - IFN-gamma induction - IgG Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Anti-Diabetic Medications to Fight PD and LBD - NCT ID: NCT06263673 - Study ID: 23-008183 - Status: RECRUITING - Start Date: 2024-04-17 - Completion Date: 2024-06-30 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia. ### Conditions - Lewy Body Dementia - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sitagliptin - Dapagliflozin - Placebo ### Outcomes Primary Outcomes - Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Change in Mini Mental State Examination Secondary Outcomes - Glucose - Supine blood pressure - Standing blood pressure ### Location - Facility: Mayo Clinic Florida, Jacksonville, Florida, 32224, United States @@
## Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression - NCT ID: NCT06263660 - Study ID: 2022-007 - Status: RECRUITING - Start Date: 2024-01-09 - Completion Date: 2026-01 - Lead Sponsor: Laureate Institute for Brain Research, Inc. ### Study Description This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Keto-like supplement - Placebo ### Outcomes Primary Outcomes - BOLD response during Monetary Incentive Delay Task Secondary Outcomes - BOLD response during Adjective Task ### Location - Facility: Laureate Institute for Brain Research, Tulsa, Oklahoma, 74136, United States @@
## Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area - NCT ID: NCT06263647 - Study ID: HSC-MS-23-0904 - Status: NOT_YET_RECRUITING - Start Date: 2025-06-01 - Completion Date: 2028-05-01 - Lead Sponsor: The University of Texas Health Science Center, Houston ### Study Description The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists ### Conditions - Firearm Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Houston-HVIP treatment - Enhanced Case Management ### Outcomes Primary Outcomes - Repeat violent victimization as assessed by the number of participants who return to the hospital system for a violent injury - Repeat violent victimization as assessed by the number of participants who are exposed to repeat violence but not admitted to the hospital captured using the Computer-assisted self-interviewing (CASI) instrument Secondary Outcomes - Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5) - Change in aggression as assessed by the Buss-Perry Aggression Questionnaire (BPAQ) - Change in general health as assessed by the 12-item Short Form Health Survey (SF-12) ### Location - Facility: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States @@
## Hand Exercises in Psoriatic Arthritis - NCT ID: NCT06263634 - Study ID: 2022-206 - Status: RECRUITING - Start Date: 2023-04-05 - Completion Date: 2024-05-05 - Lead Sponsor: Akdeniz University ### Study Description This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study. ### Conditions - Psoriatic Arthritis - Hand Rheumatism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hand exercises ### Outcomes Primary Outcomes - Psoriatic Arthritis Disease Activity Score (DAPSA) - Hand grip strength measurement - Hand fine grip strength measurement: Secondary Outcomes - Nine-Hole Peg Test - Duruöz Hand Index - Michigan Hand Outcome Questionnaire (MHQ) - Hand Functional Index (HFI) - Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL) ### Location - Facility: Akdeniz University, Antalya, N/A, N/A, Turkey @@
## Changing Portion Size Descriptions in a Cafeteria - NCT ID: NCT06263621 - Study ID: 855090 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-11 - Completion Date: 2024-05-29 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences. ### Conditions - Food Selection - Obesity - Weight Gain - Food Preferences ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Intervention "Standard" ### Outcomes Primary Outcomes - Average kcal per entree sold Secondary Outcomes - Number of entrée units purchased - Total kcal per transaction - Weekly gross sales ### Location - Facility: Courtyard Cafe, Boston, Massachusetts, 02115, United States @@
## Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation - NCT ID: NCT06263608 - Study ID: BUN B3002023000204 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2028-02 - Lead Sponsor: University Hospital, Antwerp ### Study Description The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction and symptom burden questionnaires twice: right after the polysomnography examination and after the 3-month treatment. ### Conditions - Atrial Fibrillation - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - (Cardio)Respiratory polygraphy (NOX T3s) - Polysomnography - Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) - Fitbit smartwatch ### Outcomes Primary Outcomes - AF burden before and after CPAP treatment Secondary Outcomes - Obstructive sleep apnea severity agreement between polygraphy and polysomnography - False positive rate of polygraphy - Total sleep apnea burden - CPAP/BiPAP/ASV compliance - Sleep score - Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ) - Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ) - Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS) - Polygraphy negative patients ### Location - Facility: University Hospital of Antwerp, Edegem, N/A, N/A, Belgium @@
## Semaglutide and Preoperative Residual Gastric Volumes - NCT ID: NCT06263595 - Study ID: REB23-1754 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of Calgary ### Study Description Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide. ### Conditions - Pulmonary Aspiration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - gastric antral sonography ### Outcomes Primary Outcomes - Number of participants presenting with a full stomach Secondary Outcomes - Number of occurrences requiring change in anesthetic management plan - Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume - Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration ### Location - Facility: South Health Campus, Calgary, Alberta, T3M 1M4, Canada @@
## Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya - NCT ID: NCT06263582 - Study ID: IGHID12333 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-02 - Lead Sponsor: UNC Lineberger Comprehensive Cancer Center ### Study Description This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants. ### Conditions - Cervix Cancer - Cervix Intraepithelial Neoplasia Grade 3 - Cervix; Intraepithelial Neoplasia, Grade I - Cervix; Intraepithelial Neoplasia, Grade II ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Artesunate pessary - blood draws for pharmacokinetics of the study drug ### Outcomes Primary Outcomes - To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin Secondary Outcomes - To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS) - To determine the maximum concentration of Artesunate (AS) - To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax) - To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days - To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA - To determine the half-life (t1/2) of Artesunate (AS) - To determine the half-life (t1/2) of dihydroartemisinin (DHA) - To determine the apparent clearance (CL/F) of Artesunate (AS) - To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA) - To determine the volume of distribution (V/F) of Artesunate (AS) - To determine the volume of distribution (V/F) of dihydroartemisinin (DHA) - Type, frequency, severity, and duration of adverse events ### Location - Facility: Lumumba Sub-County Hospital, Kisumu, N/A, N/A, Kenya @@
## Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study - NCT ID: NCT06263569 - Study ID: SDB 2023-002 - Status: COMPLETED - Start Date: 2023-05-24 - Completion Date: 2023-05-24 - Lead Sponsor: JointResearch ### Study Description The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial. ### Conditions - Hip Osteoarthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Total hip arthroplasty ### Outcomes Primary Outcomes - Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline Secondary Outcomes - Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline ### Location - Facility: OLVG, Amsterdam, Noord Holland, 1090 HM, Netherlands @@
## Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms - NCT ID: NCT06263556 - Study ID: 2023/389 - Status: RECRUITING - Start Date: 2024-01-17 - Completion Date: 2024-12-05 - Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Study Description Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS. ### Conditions - Multiple Sclerosis - Lower Urinary Tract Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pelvic floor exercises - Transcutaneous posterior tibial nerve stimulation - Sham stimulation ### Outcomes Primary Outcomes - Incontinence Quality of Life (I-QOL) Secondary Outcomes - Post-void residue (PVR) - Bladder diary - International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) ### Location - Facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Istanbul, N/A, N/A, Turkey @@
## Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC - NCT ID: NCT06263543 - Study ID: 2023-MAH-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-10 - Lead Sponsor: Reshma L. Mahtani, D.O. ### Study Description The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd. ### Conditions - Breast Cancer - Metastatic Breast Cancer - Advanced Breast Cancer - Hormone-receptor-positive Breast Cancer - Human Epidermal Growth Factor 2 Low Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sacituzumab govitecan ### Outcomes Primary Outcomes - Overall response rate (ORR) Secondary Outcomes - Clinical benefit rate (CBR) - Progression-free survival (PFS) - Overall survival (OS) - Duration of response (DOR) - Global Quality of Life - Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) - Laboratory and Vital Sign Abnormalities - Growth Factor Support ### Location - Facility: UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, 90404, United States @@
## Prognostic Significance of ctDNA in HL - NCT ID: NCT06263530 - Study ID: NU22-03-00182 - Status: RECRUITING - Start Date: 2022-01-02 - Completion Date: 2027-12-31 - Lead Sponsor: Interni hematologicka klinika FNKV ### Study Description Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy. ### Conditions - Prognostic Cancer Model ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identification of tumor specific mutation profiles at dg. of HL based on ctDNA - Quantitative analysis of ctDNA level during the first-line chemotherapy - Identification of tumor specific mutation profiles at relapse of classical HL Secondary Outcomes - In vitro functional characterization of identified DNA variants and/or mutations ### Location - Facility: University Hospital Hradec Kralove, Hradec Kralove, N/A, 50005, Czechia @@
## Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients - NCT ID: NCT06263517 - Study ID: SPA-S-899-01-21 - Status: RECRUITING - Start Date: 2023-10-12 - Completion Date: 2025-10 - Lead Sponsor: SPA Società Prodotti Antibiotici S.p.A. ### Study Description The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.The main questions it aims to answer are:* in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate* in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III* in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA ### Conditions - Osteoarthritis of Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Clodronate - Clodronate - Clodronate - Placebo ### Outcomes Primary Outcomes - Efficacy: VAS Reduction Secondary Outcomes - VAS mean changes - VAS mean changes observed 120 minutes after IA - Lequesne Algofunctional Index mean changes - WOMAC mean changes - Range of motion mean changes - Paracetamol consumption ### Location - Facility: IRCCS Istituti Clinici Maugeri, Castel Goffredo, Mantova, 46042, Italy @@
## The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies. - NCT ID: NCT06263504 - Study ID: DM001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-10-15 - Lead Sponsor: NMSI DENTMASTER ### Study Description In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.The endpoints will be :Primary endpoint:• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.Secondary endpoints:* Change in pain intensity measured by visual analog scale (VAS).* Improvement of functional indicators of the temporomandibular joint, including range of motion.* Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months. ### Conditions - Malocclusion - Musculoskeletal Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - at correcting malocclusions or restoring the integrity of the dentition - comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system. ### Outcomes Primary Outcomes - Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition. Secondary Outcomes - Change in pain intensity measured by visual analog scale (VAS). - Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion. - Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale ### Location - Facility: Nmsi Dentmaster, Novosibirsk, Novosibirsk Region, 630090, Russian Federation @@
## Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients - NCT ID: NCT06263491 - Study ID: 2023-0413 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2027-03-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL. ### Conditions - Mantle Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Rituximab - Pirtobrutinib ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease - NCT ID: NCT06263478 - Study ID: INCA34176-358 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2025-12-31 - Lead Sponsor: Incyte Biosciences Japan GK ### Study Description This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD). ### Conditions - Chronic Graft-versus-host-disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - INCA034176 ### Outcomes Primary Outcomes - Overall Response Rate in the First 6 Cycles Secondary Outcomes - Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score - Overall Response Rate - Duration of Response - Organ-specific Response Rate - Percent reduction in average daily dose (or equivalent) of corticosteroids - Proportion of participants who discontinue corticosteroid use - Number of participants with Treatment-emergent Adverse Events (TEAEs) - Change from baseline in Karnofsky/Lansky performance status - Axatilimab pharmacokinetic (PK) in Plasma - Number of Participants with Anti-Drug Antibody (ADA) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis - NCT ID: NCT06263465 - Study ID: CALM - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-12-31 - Lead Sponsor: Zhujiang Hospital ### Study Description The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis. ### Conditions - Bacterial Vaginosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Lactobacillus cispatus - placebo ### Outcomes Primary Outcomes - BV recurrence rate Secondary Outcomes - vaginal secretions 16s rRNA gene sequencing - BV recurrence rate ### Location - Facility: Zhuhai People'S Hospital, Zhuhai, Guangdong, 519050, China @@
## Beta-Blocker Influences on Inflammatory and Neural Responses to Stress - NCT ID: NCT06263452 - Study ID: 23-2768 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease. ### Conditions - Cardiovascular Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Propranolol - Placebo ### Outcomes Primary Outcomes - Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress - Change in levels of inflammatory gene expression in response to social stress Secondary Outcomes ### Location - Facility: Social Neuroscience and Health Laboratory, Chapel Hill, North Carolina, 27514, United States @@
## Surveillance of HFMD in Pediatric Outpatients - NCT ID: NCT06263439 - Study ID: RNI 2023 MIRAND - Status: RECRUITING - Start Date: 2023-06-20 - Completion Date: 2028-06-20 - Lead Sponsor: University Hospital, Clermont-Ferrand ### Study Description The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV. ### Conditions - Hand, Foot and Mouth Disease - Herpangina - Enterovirus Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Throat/buccal swab sample ### Outcomes Primary Outcomes - Prevalence of different types of Enteroviruses Secondary Outcomes - Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses ### Location - Facility: CHU de Clermont-Ferrand, Clermont-Ferrand, N/A, 63000, France @@
## Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney) - NCT ID: NCT06263426 - Study ID: IRB00387066 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-09 - Lead Sponsor: Johns Hopkins University ### Study Description This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV. ### Conditions - Hiv ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HIV D+/R+ - HIV D-/R+ ### Outcomes Primary Outcomes - Cumulative incidence of death and allograft rejection. Secondary Outcomes - Participant survival - Graft survival - Type and severity of graft rejection - Time to first rejection - Rate of rejection events over time - Graft function over time measured by eGFR trajectory - Incidence of HIV viremia post-transplant - Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant - Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant - Incidence of surgical and vascular transplant complications post-transplant - Incidence and causes of chronic kidney disease post-transplant - Incidence of post-transplant malignancies - Incidence of de novo donor specific antibody (DSA) ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions - NCT ID: NCT06263413 - Study ID: 24.12.2266-GHM - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-09-30 - Lead Sponsor: AI Labs Group S.L ### Study Description Artificial intelligence (AI) based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field. Amid the COVID-19 pandemic, limited access to in-person healthcare services drove shifts in medical care, hastening the adoption of telemedicine. In this context, AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance. In dermatology, pigmented lesions, acne, and alopecia are three recurring pathology groups with high demand in dermatological centers. Both triage, clinical evaluation, and patient follow-up require in-person resources and specialist dedication. Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload.Advancements in image recognition and interpretation, as well as in artificial intelligence, have spurred innovations in diagnosing various pathologies, including skin conditions. Computer-Aided Diagnosis (CAD) systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician.In this study, the Legit.Health tool, developed by AI LABS GROUP S.L., which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions, will be evaluated. The purpose of this tool is to automatically prioritize patients with greater urgency, assign the type of consultation (dermatological or aesthetic), enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff, and provide a visual record (photograph) of the condition for later review by external experts.Thus, the main objective of this study is to validate that Legit.Health, based on Artificial Intelligence, improves efficiency in clinical flow and patient care processes, thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination.The secondary objectives focus on measuring the diagnostic performance of Legit.Health:Demonstrate that Legit.Health enhances healthcare professionals\' ability to detect malignant or suspicious pigmented lesions.Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia.Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with acne.Additionally, the study aims to assess the utility of this tool:Automate the triage/initial assessment process in patients presenting with pigmented lesions.Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation (esthetic or dermatological).Evaluate Legit.Health\'s usability by the patient. Demonstrate that Legit.Health increases specialist satisfaction. Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation, whether in aesthetic or dermatological settings.Methodology Study Design Type This is an observational study, both prospective with a longitudinal character and retrospective case series.Study Period This study estimates a recruitment period of 3 months. The total study duration is estimated at 6 months, including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing, data analysis, and preparation of the final study report.The total study duration for each participant with pigmented lesions will be 1-3 months. The duration for patients with acne and alopecia will be 1 day.Study Population Adult patients (≥ 18 years) with skin pathologies treated at the Dermatology Unit of IDEI. ### Conditions - Acne - Acne Vulgaris - Alopecia, Androgenetic - Pigmented Lesions - Pigmented Skin Lesion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Concordance between the physician's diagnosis and that of the tool. - Agreement of detected malignancy between the dermatologist and Legit.Health tool Secondary Outcomes - Acne severity - Severity of alopecia ### Location - Facility: IDEI Hospital, Madrid, N/A, 28009, Spain @@
## Recovery Levels of Depression Patients and Caregiver Psychoeducation - NCT ID: NCT06263400 - Study ID: randomized trial - Status: RECRUITING - Start Date: 2022-09-01 - Completion Date: 2024-12-30 - Lead Sponsor: Aydin Adnan Menderes University ### Study Description To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels. ### Conditions - Psychoeducation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - psychoeducation and follow-up study ### Outcomes Primary Outcomes - to patients before training - pre-training caregivers Secondary Outcomes - after training - after training ### Location - Facility: AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing, Aydın, Aydın/Turkey, 09000, Turkey @@
## Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine - NCT ID: NCT06263387 - Study ID: FILObsLAM_VENAZA - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2025-03-30 - Lead Sponsor: French Innovative Leukemia Organisation ### Study Description Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition. ### Conditions - AML, Adult ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort - characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort - characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort Secondary Outcomes - characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life - describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient. ### Location - Facility: Amiens CHU, Amiens, N/A, N/A, France @@
## Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery - NCT ID: NCT06263374 - Study ID: 69HCL21_0355 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-03-31 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \[watching a non-emotional content film or filling out a crossword or Sudoku grid\] to maxillofacial physiotherapy. ### Conditions - Maxillofacial Abnormalities ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Motor imagery of the jaw - Control task (Sudoku or Crossword puzzle) ### Outcomes Primary Outcomes - Maximal mouth opening measured in millimeters using a caliper Secondary Outcomes - Active maximum mouth opening in millimeter using a vernier caliper - Active jaw range of motion (ROM) other than maximal opening - Maxillofacial pain - Body weight mass (kilograms) - Orthodontic associated treatment - Compliance with physiotherapy and intervention - Orofacial function - Maxillofacial quality of life - Level of achievement of the goals set by the patient before surgery - Motor imagery capability ### Location - Facility: Cabinet Bataille, Lyon, N/A, 69003, France @@
## Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma. - NCT ID: NCT06263361 - Study ID: NCH02-2021 - Status: RECRUITING - Start Date: 2021-10-01 - Completion Date: 2026-12-31 - Lead Sponsor: IRCCS San Raffaele ### Study Description Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings. ### Conditions - Cerebral Lymphoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MRI imaging - Cerebral biopsy ### Outcomes Primary Outcomes - MRI imaging - MRI imaging - MRI imaging - MRI imaging - Define immunopathological features Secondary Outcomes - Accuracy of fluoresceine guided stereotactic biopsy ### Location - Facility: IRCCS San Raffaele Scientific Institute, Milan, N/A, 20132, Italy @@
## A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes - NCT ID: NCT06263348 - Study ID: HMM0601 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2026-04-30 - Lead Sponsor: Hua Medicine Limited ### Study Description The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin. ### Conditions - Type2diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dorzagliatin tablets ### Outcomes Primary Outcomes - Incidences of ADRs and SAEs Secondary Outcomes - Blood glucose indicators - Response rate ### Location - Facility: China-Japan Friendship Hospital, Beijing, Beijing, 100029, China @@
## MBI for Psychological Distress, SI and NSSI Among Young Adults - NCT ID: NCT06263335 - Study ID: Fatima Jinnah Women University - Status: COMPLETED - Start Date: 2022-02-28 - Completion Date: 2022-05-28 - Lead Sponsor: Fatima Jinnah Women University ### Study Description Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups. ### Conditions - Psychological Distress - Suicidal Ideation - Non-Suicidal Self Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mindfulness Based Stress Reduction Intervention ### Outcomes Primary Outcomes - Psychological Distress - Suicidal Ideation - Non-Suicidal Self-Injury (NSSI) Secondary Outcomes ### Location - Facility: Fatima Jinnah Women University, Rawalpindi, Punjab, 46000, Pakistan @@
## The ROAMM-EHR Study - NCT ID: NCT06263322 - Study ID: IRB202200419 - Status: RECRUITING - Start Date: 2023-11-16 - Completion Date: 2026-10-17 - Lead Sponsor: University of Florida ### Study Description In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes. ### Conditions - Peripheral Arterial Disease - Chronic Limb-Threatening Ischemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Actionable remotely generated health data - Non-Actionable remotely generated health data ### Outcomes Primary Outcomes - 6-min walk distance Secondary Outcomes - self-reported quality of life ### Location - Facility: Institute of Aging, Gainesville, Florida, 32611, United States @@
## Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis - NCT ID: NCT06263309 - Study ID: Femoralneckfracture - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-09-01 - Lead Sponsor: Istanbul University ### Study Description OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.METHODS:Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment. ### Conditions - Femoral Neck Fractures - Femoral Neck Shortening ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Femoral neck shortening measurement ### Outcomes Primary Outcomes - Harris Hip score Secondary Outcomes ### Location - Facility: University, İstanbul, N/A, 34093, Turkey @@
## Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare - NCT ID: NCT06263296 - Study ID: UW 24-055 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-09-30 - Lead Sponsor: Queen Mary Hospital, Hong Kong ### Study Description Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general populationThere is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:1. Higher level of health-related quality of life,2. Higher level of self-efficacy3. Higher level of score in Burn Rehabilitation Knowledge4. Lower pain level, as measured by Numeric Pain Rating Scale; and5. Lower level of itchinessThe desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required. ### Conditions - Burns - Self Efficacy - Burn Second Degree - Burns Third Degree - Quality of Life - Adherence, Treatment - Burn Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Self Management Education ### Outcomes Primary Outcomes - Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12 - Change from Baseline in the Generic Quality of life at Week 4 & Week 12 - Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire Secondary Outcomes - Change from Baseline in the Self efficacy at Week 4 & Week 12 - Change from Baseline in the Itchiness of life at Week 4 & Week 12 - Change from Baseline in the Pain level at Week 4 & Week 12 ### Location - Facility: LIU Siu Kwong, Hong Kong, N/A, N/A, China @@
## Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer - NCT ID: NCT06263283 - Study ID: PROICM 2023-04 KYO - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle ### Study Description Every year in France, nearly 3,000 women develop a cervical cancer. The average age of women diagnosed is 51. Uterovaginal brachytherapy is one of the reference treatments.To allow this treatment, an applicator is first placed under general anaesthesia in the vaginal zone. Then, the pulsed Dose Rate (PDR) or high dose rate (HDR) uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room. Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed.Prolonged immobilization, the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety. According to a study, 40% of patients have post-traumatic stress at 3 months of treatment. A Danish team highlights the significant decrease in physical capacity during and after treatment.Thus, as a recent literature review concludes, there is a real need to develop Non-Pharmacological-Interventions (NPI) to limit the aftereffects. It also seems important to provide support for self-management of symptoms.Among NPI of interest, Yoga is a mind-body practice that can decrease perceived stress. A systematic review confirms that yoga can reduce stress during cancer treatment. This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises. Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits. Finally, a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention. A lot of work has been done with promising results without the result of a consensus applicable to all care situations.Moreover, educational requirements are high in women treated to gynecological cancer.Meeting these needs helps to improve quality of life, pain management and drug use.Integrating Patient Educational Project (PEP) therefore seems relevant as an additional tool in patient empowerment. In addition, the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy.The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy. ### Conditions - Cervical Cancer - Brachytherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - session of Kine-Yoga ### Outcomes Primary Outcomes - Evaluation of the Kine-Yoga-PEP intervention to standard care during the uterovaginal brachytherapy on perceived stress at 15 days of treatment initiation in patients treated for cervical cancer. Secondary Outcomes - assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention - Evaluation of the immediate effect of the Kine-Yoga-PEP intervention in the experimental group on perceived stress, pain (overall and due to immobility) and the evolution of these parameters during brachytherapy. - Evaluation of the evolution of fatigue during uterovaginal brachytherapy - assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy - Description of the use of anxiolytics by group (experimental vs control) - Description of the experiences of patients treated for cervical cancer during uterovaginal brachytherapy receiving a Kine-Yoga-PEP intervention (approximately 20 patients in the experimental group ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee - NCT ID: NCT06263270 - Study ID: 12-2023-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: Cytonics Corporation ### Study Description The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment. ### Conditions - Osteoarthritis, Knee - Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CYT-108, a recombinant protease inhibitor - Phosphate Buffered Saline (PBS) ### Outcomes Primary Outcomes - Adverse Events - Blood Pressure - Heart Rate - Respiratory Rate - Body Temperature - Titer of Human Anti-Drug Antibody Secondary Outcomes - Change in WOMAC Scores (Pain, Stiffness, and Difficulty Performing Daily Activities) - Time of Onset ### Location - Facility: Emeritus Research, Camberwell, Victoria, 3124, Australia @@
## The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients - NCT ID: NCT06263257 - Study ID: 2023-631 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-04 - Lead Sponsor: Busra Nur Temur ### Study Description The aim of this study is to evaluate the impact of mandala art therapy on the anxiety and comfort levels of living kidney transplant recipients. While kidney transplantation improves the recipients' quality of life, it may also expose them to psychological, physical, and social challenges post-transplant. This situation can increase recipients' levels of anxiety, making them cope with psychiatric issues and affecting their comfort levels. Feeling psychologically and physiologically comfortable is a crucial component of a successful recovery process for recipients.Mandala art therapy is known as an effective method that supports the mental health, physical functioning, and social and emotional well-being of individuals with health issues. Mandalas can contribute to comfort by promoting inner peace, focusing attention, and encouraging creative expression. This study aims to investigate the impact of mandala art therapy on anxiety and comfort levels in kidney transplant recipients. To achieve this goal, a mixed-methods study using a randomized controlled and nested experimental design is planned.The results of this study will provide valuable insights to healthcare providers by elucidating the impact of mandala art therapy on comfort and anxiety levels in living kidney transplant recipients. This information may guide healthcare professionals in enhancing kidney transplant recipients' psychological and emotional well-being, reducing stress, and promoting higher levels of comfort through mandala art therapy.H0a: There is no effect of Mandala Art Therapy on the perceived anxiety level in living kidney transplant recipients.H0b: There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients. ### Conditions - Anxiety - Transplant;Failure,Kidney - Transplant Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mandala Art Therapy ### Outcomes Primary Outcomes - Reduction in anxiety levels - Increasing comfort level Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Specifying the Anti-inflammatory Effects of Ziltivekimab - NCT ID: NCT06263244 - Study ID: NL83403.018.22 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics. ### Conditions - Atherosclerosis - Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ziltivekimab - Placebo ### Outcomes Primary Outcomes - TBRmax coronary arteries - monocyte activation marker protein expression Secondary Outcomes - delta PCAT - Correlation delta TBRmax and CCTA derived plaque characteristics - delta SUVmax bone marrow - delta TBRmax ascending aorta - changes monocyte phenotype - changes in hsCRP - changes plasma cytokine and chemokine levels (pg/mL) - changes plasma cytokine and chemokine levels (ng/mL) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) - NCT ID: NCT06263231 - Study ID: IT-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-12 - Lead Sponsor: Intensity Therapeutics, Inc. ### Study Description To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen. ### Conditions - Sarcoma,Soft Tissue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - INT230-6 - Eribulin - Trabectedin - Pazopanib ### Outcomes Primary Outcomes - Overall Survival (OS) Secondary Outcomes - Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma - Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil - NCT ID: NCT06263218 - Study ID: CCR-2023-200344 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-10-01 - Completion Date: 2024-12-29 - Lead Sponsor: Hospital do Rim e Hipertensão ### Study Description This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable. ### Conditions - CMV Infection - CMV Viremia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of infection, CMV disease, and tissue invasive disease. Secondary Outcomes - Incidence recurrent CMV infection/disease - Incidence of refractory CMV infection/disease ### Location - Facility: Hospital do Rim, São Paulo, N/A, 04038-002, Brazil @@
## Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques - NCT ID: NCT06263205 - Study ID: Dressing - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-24 - Lead Sponsor: Fudan University ### Study Description The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are:1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques?2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs.This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses. ### Conditions - Gastrointestinal Tumors - Surgical Wound Infection - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Non-Dressing of Surgical Wound - Regular Dressing Change of Surgical Wound ### Outcomes Primary Outcomes - Rate of Postoperative Wound Healing Complications Secondary Outcomes - Patient Pain Levels - Medical Costs Associated with Wound Care ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 2000000, China @@
## Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles - NCT ID: NCT06263192 - Study ID: AMH-IUI - Status: COMPLETED - Start Date: 2020-10-01 - Completion Date: 2023-05-01 - Lead Sponsor: Jose Antonio Moreno ### Study Description The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels \> and \< 1.1 ng/mL. ### Conditions - Infertility, Female - Anti-Mullerian Hormone Deficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intrauterine insemination ### Outcomes Primary Outcomes - Cummulative pregnancy rate Secondary Outcomes ### Location - Facility: Fertty International, Barcelona, N/A, 08010, Spain @@
## Feasibility of Aerobic Exercise for Recovery From Work-related Concussion - NCT ID: NCT06263179 - Study ID: STUDY00007706 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-30 - Lead Sponsor: State University of New York at Buffalo ### Study Description There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion. ### Conditions - Concussion, Brain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Target Heartrate Aerobic Exercise ### Outcomes Primary Outcomes - Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed. Secondary Outcomes - Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale - Change in Patient Health Questionnaire-9 (PHQ-9) - Change in Generalized Anxiety Disorder-7 (GAD-7) - Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5) - Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) - Work Climate Questionnaire - 6-Item Version - Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) - Time to return to work measured in days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: A Randomized Controlled Study - NCT ID: NCT06263166 - Study ID: 5535 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Ondokuz Mayıs University ### Study Description Women who will undergo vaginal examinations randomly assigned to intervention (n = 44) and control (n = 44) groups at a public hospital in Turkey will participate in the study. Stress ball application before vaginal examination will be explained to women in the intervention group. These women will be asked to tighten and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed. Data regarding pain and anxiety outcomes will be collected before and after the examination.The main questions it aims to answer are:* question 1: What is the effect of stress ball application on women's anxiety level during vaginal examination?* question 2: What is the effect of stress ball application on women's pain level during vaginal examination? ### Conditions - Anxiety State - Pain - Exanimation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Stress ball intervention ### Outcomes Primary Outcomes - Anxiety change - Pain level Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy - NCT ID: NCT06263153 - Study ID: OSU-23329 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Yuanquan Yang ### Study Description This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy. ### Conditions - Bladder Urothelial Carcinoma - Muscle Invasive Bladder Carcinoma - Stage II Bladder Cancer AJCC v8 - Stage IIIA Bladder Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Computed Tomography - Durvalumab - Futibatinib - Magnetic Resonance Imaging - Radical Cystectomy ### Outcomes Primary Outcomes - Complete pathologic response rate Secondary Outcomes - Incidence of adverse events (AEs) - Pathologic down-staging rate to non-muscle invasive disease - Overall survival - Progression free survival - Frequency and severity of adverse events, including delay in cystectomy ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study - NCT ID: NCT06263140 - Study ID: Chula-ARC 001/21 - Status: COMPLETED - Start Date: 2021-05-30 - Completion Date: 2022-02-01 - Lead Sponsor: Chulalongkorn University ### Study Description Serum vitamin D levels in drug-induced non-immediate reactions ### Conditions - Stevens-Johnson Syndrome - Drug Reaction With Eosinophilia and Systemic Symptom - Maculopapular Exanthem - Vitamin D Deficiency - Drug-Induced Rash ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Serum vitamin D levels Secondary Outcomes ### Location - Facility: Faculty of Medicine, Chulalongkorn University, Bangkok, N/A, 10330, Thailand @@
## Sensory Motor Interventions on Preterm Infants - NCT ID: NCT06263127 - Study ID: CMUH112-REC2-104 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-01-10 - Lead Sponsor: China Medical University Hospital ### Study Description Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants. ### Conditions - Preterm Infants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - oral stimulation - infants massage ### Outcomes Primary Outcomes - Oral intake - Transition time of oral feeding Secondary Outcomes - weight gain - Hospital stay - Neonatal Neurobehavioral Examination-Chinese Version(NNE-C) - Infant/Toddler Sensory Profile-Chinese Version(ITSP-C) - Premature Bottle Feeding Questionnaire(PBFQ) ### Location - Facility: China Medical University Hospital, Taichung, N/A, 404, Taiwan @@
## Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients - NCT ID: NCT06263114 - Study ID: 00002826 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-01-01 - Lead Sponsor: Children's Mercy Hospital Kansas City ### Study Description Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected. ### Conditions - Liver Transplant; Complications - Liver Failure, Acute ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - TruGraf® Liver gene expression panel (GEP) ### Outcomes Primary Outcomes - Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy. Secondary Outcomes - Comparison of the GEP to non-rejection injury found on biopsy - Utility of the GEP for monitoring liver injury ### Location - Facility: Children's Mercy Hospitals and Clinics, Kansas City, Missouri, 64108, United States @@
## Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery - NCT ID: NCT06263101 - Study ID: ChaoyangHospital - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-10-01 - Lead Sponsor: Chaoyang Hospital of China Medical University ### Study Description Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. The incidence of this issue varies among medical institutions, impacting patient nutrition, prolonging hospital stays, and increasing healthcare costs.The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD. Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery, emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function.This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery. The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery (ERAS). ### Conditions - Postoperative Gastrointestinal Dysfunction (POGD) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biochemical testing of abdominal drainage fluid - Cytological examination of abdominal drainage fluid - Peripheral blood cytology tests ### Outcomes Primary Outcomes - Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1 Secondary Outcomes - Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3 - Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 1 - Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 3 - Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1. - Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3. ### Location - Facility: Chaoyang Central Hospital of China Medical University, Chaoyang, Liaoning, N/A, China @@
## EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer. - NCT ID: NCT06263088 - Study ID: CASE15223 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-06-30 - Lead Sponsor: Case Comprehensive Cancer Center ### Study Description This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).This study has 3 components as follows-1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis. ### Conditions - Gastrointestinal Cancer - Colon Cancer - Rectal Cancer - Anal Cancer - Esophageal Cancer - Stomach Cancer - Appendix Cancer - Pancreas Cancer - Liver Cancer - Neuroendocrine Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - EQUITY GI ### Outcomes Primary Outcomes - Biomarker testing rate of Black participants diagnosed with GI cancer Secondary Outcomes - Clinical trial enrollment rate among black participants diagnosed with GI cancer - Change in Health literacy test among black participants diagnosed with GI cancer - Change in Health literacy score among black participants diagnosed with GI cancer ### Location - Facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106, United States @@
## Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM) - NCT ID: NCT06263075 - Study ID: 717/2023/Oss/AOUBo - Status: RECRUITING - Start Date: 2023-12-13 - Completion Date: 2026-06 - Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna ### Study Description Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements. ### Conditions - Craniosynostoses - Hypovolemia - Hemorrhage - Hemodynamic Instability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intraoperative monitoring ### Outcomes Primary Outcomes - Hemodynamic events occurring during surgery Secondary Outcomes - Evaluation of changes in volemic status - Evaluation of changes in volemic status - Evaluation of changes in systemic vascular resistance - Evaluation of changes in cardiac function - Evaluation of changes in cardiac function ### Location - Facility: IRCCS AOU of Bologna Policlinico Sant'Orsola, Bologna, BO, 40138, Italy @@
## Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study - NCT ID: NCT06263062 - Study ID: women undergoing colposcopy - Status: RECRUITING - Start Date: 2021-01-07 - Completion Date: 2024-06-15 - Lead Sponsor: Alanya Alaaddin Keykubat University ### Study Description Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy. ### Conditions - Cancer Fear - Cervical Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Awareness-Based Coping with Fear of Cancer Programme ### Outcomes Primary Outcomes - The Cancer Worry Scale Secondary Outcomes - Philadelphia Mindfulness Scale ### Location - Facility: Alanya Alaaddin Keykubat University, Alanya, N/A, 7400, Turkey @@
## Is Ejaculation Preservation TURis the Natural Evolution of the "Gold Standard". - NCT ID: NCT06263049 - Study ID: ejaculation post TURP - Status: COMPLETED - Start Date: 2023-05-01 - Completion Date: 2024-02-01 - Lead Sponsor: Ain Shams University ### Study Description evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence ### Conditions - Benign Prostatic Hyperplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - transurethral resection of prostate ### Outcomes Primary Outcomes - post operative antegrade ejaculation Secondary Outcomes - post operative urine continence ### Location - Facility: Ain shams university, Cairo, N/A, N/A, Egypt @@
## Morphometric Examination of the Larynx - NCT ID: NCT06263036 - Study ID: Bilgen S - Status: COMPLETED - Start Date: 2013-01-10 - Completion Date: 2013-06-10 - Lead Sponsor: Acibadem University ### Study Description Objective: To measure laryngeal dimensions in a sample of Turkish cadavers including males and females of various ages and heights.Patients and Methods: Morphological measurement was performed on 102 laryngeal specimens. Laryngeal cartilages were collected from human cadavers. All dimensions of the cartilages were measured using a thread and vernier calipers. Age, sex, and height were recorded. Results for men and women were compared. ### Conditions - Laryngeal Dimensions in Males and Females ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Men - Women ### Outcomes Primary Outcomes - To measure laryngeal dimensions in cadavers Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation - NCT ID: NCT06263023 - Study ID: 34L-CP-02-009 - Status: RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-09 - Lead Sponsor: 34 Lives, PBC ### Study Description This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals. ### Conditions - Organ Preservation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sub-Normothermic Machine Preservation and Assessment ### Outcomes Primary Outcomes - Transplant Allocation Success Secondary Outcomes - 7-Day Delayed Graft Function (DGF) - Graft Survival - Patient Survival - Serum Creatinine (sCr) - eGFR - Long term data collection- Graft Survival - Long term data collection- Patient Survival - Long term data collection- Serum Creatinine - Long term data collection- eGFR ### Location - Facility: Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, Florida, 33136, United States @@
## Allopregnanolone as a Regenerative Treatment for Parkinson's Disease - NCT ID: NCT06263010 - Study ID: CIBS-2023-01 - Status: RECRUITING - Start Date: 2024-01-12 - Completion Date: 2024-12 - Lead Sponsor: Roberta Brinton ### Study Description The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are:1. Is a large-scale clinical trial testing how well it works in patients with PD feasible?2. Is allopregnanolone safe and well-tolerated in patients with PD.3. Can we see any signals of changes in imaging and clinical scales?Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Allopregnanolone ### Outcomes Primary Outcomes - Study completion Secondary Outcomes - Adverse Events - Infusion Reactions - Pharmacokinetics: Peak Plasma Concentration (Cmax) - Pharmacokinetics: Time of peak concentration (tmax) - Pharmacokinetics: Half-life (t1/2) - Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) ### Location - Facility: The University of Arizona Clinical & Translational Science Research Center, Tucson, Arizona, 85721, United States @@
## Effectiveness of Pilates and Taping in Office Workers With Neck Pain - NCT ID: NCT06262997 - Study ID: TU-FTR-AMUTLU-2 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-02-15 - Lead Sponsor: Tarsus University ### Study Description The aim of this study is to investigate the effectiveness of pilates and kinesiotape applications in office workers with neck pain. In this direction, neck pain and disability, pain threshold, muscle strength, range of motion, core endurance, postural awareness and quality of life will be evaluated. ### Conditions - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pilates - Pilates and Kinesiotape ### Outcomes Primary Outcomes - Neck Disability Index Secondary Outcomes - Pain PressureThreshold - Muscle Strength - Range of Motion - Prone Bridge Test - Sits Up Test: - Postural Habits and Awareness Scale - Short Form 36 ### Location - Facility: Tarsus University, Mersin, N/A, N/A, Turkey @@
## Therapeutic Play Before Nasopharyngeal Swabbing in Children - NCT ID: NCT06262984 - Study ID: 2023/21-754 - Status: COMPLETED - Start Date: 2024-02-19 - Completion Date: 2024-03-13 - Lead Sponsor: Maltepe University ### Study Description The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure. ### Conditions - Behavior, Coping ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Therapeutic Play ### Outcomes Primary Outcomes - Children's emotional manifestation Secondary Outcomes ### Location - Facility: Maltepe University, Istanbul, N/A, N/A, Turkey @@
## Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital - NCT ID: NCT06262971 - Study ID: PCI-LM-Registry-2018 - Status: COMPLETED - Start Date: 2018-06-01 - Completion Date: 2023-12-31 - Lead Sponsor: Medipol University ### Study Description This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI). The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease. ### Conditions - Coronary Artery Disease - Left Main Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Percutaneous coronary intervention ### Outcomes Primary Outcomes - Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI Secondary Outcomes - Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR) - Procedure-Related Complications Within 30 Days of PCI - Health-Related Quality of Life (HRQoL) Scores One Year After PCI - Rate of stent thrombosis ### Location - Facility: Istanbul Medipol University, Istanbul, N/A, N/A, Turkey @@
## Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent - NCT ID: NCT06262958 - Study ID: KUH5703459 - Status: RECRUITING - Start Date: 2017-08-07 - Completion Date: 2030-06-01 - Lead Sponsor: Kuopio University Hospital ### Study Description ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it ### Conditions - Alcoholism - Substance Abuse - Alcohol Dependence - Alcohol-Related Disorders - Substance Use Disorders - Adolescent Behavior - Adolescent Problem Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ASSIST - Treatment as usual ### Outcomes Primary Outcomes - Decreased consumption of alcohol, tobacco or substances Secondary Outcomes - BDI scores - GAD scores ### Location - Facility: Kuopio University Hospital, Kuopio, N/A, 70110, Finland @@
## Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery. - NCT ID: NCT06262945 - Study ID: YDU/2024/120-1808 - Status: COMPLETED - Start Date: 2024-01-02 - Completion Date: 2024-02-07 - Lead Sponsor: Beste Erismen ### Study Description The aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 4 randomly separated groups. In group 1, PRF was applied to the tooth socket. In group 2, PRF was applied to the tooth socket combined with Low Laser Treatment extraorally to the extraction area for three days within surgery day In group 3, Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day. In group 4 (control group), tradional osteomy was made. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation. All of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days. ### Conditions - Impacted Third Molar Tooth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnoses - traditional osteotomies - platelet rich fibrin - Antibiotics, Penicillin - low laser therapy, bicure laser - Analgesic ### Outcomes Primary Outcomes - Visual analogue scale (VAS) - Visual analogue scale (VAS) - Visual analogue scale (VAS) - Visual analogue scale (VAS) - Trismus - Trismus - Trismus - Trismus - Swelling - Swelling - Swelling - Swelling Secondary Outcomes - the number of analgesic tablets - the number of analgesic tablets - the number of analgesic tablets - the number of analgesic tablets ### Location - Facility: Near East University, Nicosia, Lefkosa, 99138, Cyprus @@
## Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response - NCT ID: NCT06262932 - Study ID: RADS regimen - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: Police General Hospital, Thailand ### Study Description The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen* Repeated dosing regimen* Standard dosing regimen ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Amiodarone ### Outcomes Primary Outcomes - Heart rate Secondary Outcomes - Normal sinus rhythm at 24 hours - Heart rate - Major adverse cardiovascular events - Phlebitis - Changed in heart rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Special Drug Use-results Surveillance of Tafinlar/Mekinist - NCT ID: NCT06262919 - Study ID: CDRB436I1401 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2031-12-31 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture. ### Conditions - BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tafinlar/Mekinist ### Outcomes Primary Outcomes - [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation - [Adult patients] overall response rate (ORR) Secondary Outcomes - [Pediatric patients] Incidence proportion of ORR - [Pediatric and adult patients] Incidence proportion of PFS - [Pediatric patients] Number of patients with changes in height and body weight and sexual maturation ### Location - Facility: Novartis Investigative Site, Kobe, Hyogo, 650-0011, Japan @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06262906 - Study ID: BA-VCAP-01 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy - NCT ID: NCT06262893 - Study ID: Shoulder nerve blocks - Status: NOT_YET_RECRUITING - Start Date: 2024-02-25 - Completion Date: 2026-01 - Lead Sponsor: Assiut University ### Study Description In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment. ### Conditions - Shoulder Arthroscopy Blocks - Dexamethasone ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Shoulder arthroscopy blocks ### Outcomes Primary Outcomes - Postoperative analgesia by visual analog scale (VAS). Secondary Outcomes - Diaphragmatic excursion ### Location - Facility: Assiut University, Assiut, N/A, N/A, Egypt @@
## Dietary Supplementation on Gastrointestinal Barrier Function - NCT ID: NCT06262880 - Study ID: BIO-2305 - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2025-02-06 - Lead Sponsor: Brightseed ### Study Description The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo. ### Conditions - Intestinal Permeability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - plant derived phenolics - Microcrystaline cellulose (MCC) ### Outcomes Primary Outcomes - 0-2 h urine 13C Mannitol excretion Secondary Outcomes - 2 to 8 h urine 13C Mannitol - 0 to 2 h urine LMR - 2 to 8 h urine LMR - Blood Biomarkers - Blood Biomarkers - Blood Biomarkers - Fecal Biomarkers - Fecal Biomarkers - Inflammatory Biomarkers (Blood) - Inflammatory Biomarkers (Blood) - Inflammatory Biomarkers (Blood) - Inflammatory Biomarkers (Blood) - 7-day recall of gastrointestinal symptoms - 7-day recall of gastrointestinal symptoms - Stool frequency - Stool consistency - Body Weight ### Location - Facility: Biofortis, Addison, Illinois, 60101, United States @@
## Early Allergen System Experience - NCT ID: NCT06262867 - Study ID: ReadySetFood - Status: NOT_YET_RECRUITING - Start Date: 2024-03-07 - Completion Date: 2026-09-01 - Lead Sponsor: Prollergy dba Ready Set Food ### Study Description Multiple clinical trials have demonstrated that early allergen introduction, feeding babies common food allergens before six months, decreases children's risk of developing a food allergy. Despite successful food allergy introduction trials showing that food allergies can be prevented, early introduction in the required amount can be challenging for parents. In some studies, less than 20% of parents introduce peanuts before their child is six months old, and few feed them regularly after introduction. Ready. Set. Food! is a direct-to-consumer product that offers a convenient supplement with a daily dose regimen that can be added to breastmilk, formula, or food to make early allergen introduction easy. The formulation includes cow's milk, egg, and peanut, representing the majority of childhood food allergies, and the protein levels are based on doses found to be effective in clinical trials. Over 200,000 infants have used Ready. Set. Food!.This study investigates the effectiveness of introducing common allergens to infants with the goal of preventing food allergies. The study will enroll 1,100 infants stratified by their risk of developing a food allergy who are assigned to either receive Ready. Set. Food! supplements or follow standard allergen introduction practices recommended by their pediatrician.The goal of this study is to assess how Ready. Set. Food! allergen introduction supplements improve the experience of parents introducing allergens, decrease healthcare costs related to food allergies, and decrease food allergy prevalence. ### Conditions - Food Allergy in Infants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ready. Set. Food! Stage 1 Mix ins ### Outcomes Primary Outcomes - The proportion of caregivers who are adherent with the evidence-based guidance for cow's milk, egg, and peanut during the 6 - month period Secondary Outcomes - Frequency of caregiver-reported allergy or food introduction-related adverse events (AEs) after introduction of cow's milk, egg, and peanut - Frequency of caregiver-reported serious adverse events (SAEs) after introduction of cow's milk, egg, and peanut - Frequency of caregiver-reported special interest adverse events (FPIES and anaphylaxis) after introduction to cow's milk, egg, and peanut by 12 months of age ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study - NCT ID: NCT06262854 - Study ID: AOU Careggi Firenze - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-05-31 - Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi ### Study Description This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures. ### Conditions - Diabete Mellitus - Foot Ulcer - Osteomyelitis - Foot - Surgical Procedure, Unspecified ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Calcium-sulphate granules with tobramicina+vancomicina ### Outcomes Primary Outcomes - The composite primary endpoint of this study will be the incidence osteomyelitis recurrence or new osteomyelitis in adjacent sites or tissue infection at the site of osteomyelitis. Secondary Outcomes - Proportion of healed patients - Proportion of osteomyelitis recurrence - Proportion of post-surgical tissue infection - Proportion of wound recurrence - Proportion of patients undergoing major amputation - Proportion of patients undergoing new surgical intervention - Ulcer time-to-healing - Osteomyelitis time-to-recurrence - Any serious adverse events - Any non serious adverse events - Proportion of post-surgical dehiscence - Direct medical costs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments - NCT ID: NCT06262841 - Study ID: Murat Kaan Erdem - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2023-04-01 - Lead Sponsor: Ankara University ### Study Description The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life. ### Conditions - Impacted Third Molar Tooth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Piezosurgery - Conventional burs ### Outcomes Primary Outcomes - Change in Oral Health-related Quality of Life Secondary Outcomes - Change in pain - Change in Mouth opening - Operation time - Change in facial swelling ### Location - Facility: Ankara University Faculty of Dentistry, Ankara, Çankaya, 06510, Turkey @@
## HEARTWISE - P-CARDIAC for Chinese: Population-based Study - NCT ID: NCT06262828 - Study ID: UW 24-064 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-04-30 - Lead Sponsor: The University of Hong Kong ### Study Description Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC. ### Conditions - Cardiovascular Diseases - CVD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The relationship between P-CARDIAC risk score and heart disease related symptoms - P-CARDIAC risk thresholds determination Secondary Outcomes ### Location - Facility: School of Nursing, The University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@
## The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction - NCT ID: NCT06262815 - Study ID: 2023-06806-01 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Daniel Wilhelms ### Study Description Small bowel obstruction (SBO) occurs when the normal movements of the small bowel is obstructed, most commonly due to adhesion related to previous abdominal surgery. This may cause strangulation of the small bowel with reduced blood flow which is a surgical emergency requiring prompt treatment in the operating room. If there are no signs of strangulation or ischemia of the bowel at the time of diagnosis, international guidelines recommend initial treatment with intravenous fluids and nasogastric tube placement. However, there is emerging debate regarding non-selective treatment with nasogastric tube placement in patients with SBO. This management started around 1930 as a means to reduce pain in patients with SBO, in conjunction with other additions to management, like intravenous fluids. However the effect and utility of routine nasogastric tube placement have not been prospectively evaluated. There are a total of three retrospective observational studies in the past decade with a total of 759 patients where 292 (36%) were managed without a nasogastric tube. There was no difference in the rates of conservative treatment failure (requiring surgery), complications (vomiting, pneumonia) or mortality between patients receiving a nasogastric tube and those who didn't. However, the retrospective design of these studies limits their validity. Furthermore, nasogastric tube placement has been shown to be one of the more painful interventions patients may experience in-hospital. This calls into question the patient benefit of routine nasogastric tube placement in patients with SBO and further studies are needed to discern the utility of this intervention.Definitive treatment for SBO is surgical adhesiolysis but there is debate regarding the timing of surgery, particularly in older adults. A large proportion of patients may be managed conservatively with oral contrast and repeated radiological evaluation and the obstruction will resolve in many patients within 24 to 48 hours. This timeframe is dependent on factors related to the disease itself as well as patient related factors like previous surgery and comorbidities. Older patients are at high risk for complications but current available data is insufficient to inform practice in this population. Frailty, a state of increased vulnerability and susceptibility to adverse events, has been shown to be an independent prognosticator in older adults in the Emergency Department(ED) and suggested as a potential measure to risk stratify older adults with SBO. However to the authors knowledge there is no available data on frailty in older adults with SBO and only one prospective observational trial looking at older adults with SBO. Despite SBO being one of the most common surgical emergencies in older adults.To investigate the potential benefit of nasogastric tube placement in patients with SBO and the ability of frailty to prognosticate outcomes in older adults better evidence is needed. ### Conditions - Small Bowel Obstruction - Frailty - Nasogastric Tube ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nasogastric tube placement - Clinical Frailty Scale ### Outcomes Primary Outcomes - Pain at Emergency Department discharge Secondary Outcomes - Nausea at Emergency Department discharge - Hospital Length of Stay - Mortality - Admission for Small bowel obstruction - Emergency Surgery - Emergency Department Length of Stay ### Location - Facility: Sahlgrenska Universitetssjukhuset, Göteborg, N/A, N/A, Sweden @@
## Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression - NCT ID: NCT06262802 - Study ID: 123123 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Radwa Hydar Ragab ### Study Description Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions ### Conditions - Odontogenic Cysts ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Active decompression ### Outcomes Primary Outcomes - Volume change Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## RAT-HEMATO : Return to Work After Malignant Hemopathy - NCT ID: NCT06262789 - Study ID: 49RC23_0011 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-04-01 - Lead Sponsor: University Hospital, Angers ### Study Description Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their "pre-cancer life" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality. ### Conditions - Leukemia - Lymphoma - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - "Return-to-work after cancer" consultation ### Outcomes Primary Outcomes - Return-to-work rate at 1 year (percentage) Secondary Outcomes - Cumulative incidence of return-to-work at 1 year - Change or not of the professional situation in the 2 arms - Factors influencing return to work - Quality of life (SF-12 score) evolution - Anxiety and depression (HAD scale) evolution - Return-to-work self-efficacy (RTW-SE-11 scale) evolution - Self-assessment of the benefit of the "return-to-work after cancer" consultation ### Location - Facility: Angers University hospital, Angers, N/A, N/A, France @@
## Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients - NCT ID: NCT06262776 - Study ID: SIRZOSTER1.01 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-11 - Lead Sponsor: Central Adelaide Local Health Network Incorporated ### Study Description The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination. ### Conditions - Immunosuppression - Vaccine Response Impaired ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Recombinant zoster vaccine adjuvanted (SHINGRIX) ### Outcomes Primary Outcomes - Functional T cell memory Secondary Outcomes - Frequency of virus specific T cells - Magnitude of antibody response - Concentration of post-vaccination circulating cytokines - Frequency of polyfunctional T cells - Magnitude of vaccine-induced cross-protective antiviral responses - Frequency of virus-specific T stem cell memory compared to baseline ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## High-intensity Laser Therapy for Sacroiliac Joint Pain - NCT ID: NCT06262763 - Study ID: HILT for SIJP - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-03 - Completion Date: 2024-03-28 - Lead Sponsor: Kafrelsheikh University ### Study Description Effect of high intensity laser on sacroiliac joint pain ### Conditions - Sacroiliac Joint Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Laser Therapy - Traditional exercises - Placebo laser ### Outcomes Primary Outcomes - Pain intensity Secondary Outcomes - Pressure pain threshold ### Location - Facility: Kafr Al-Sheikh University, Kafr Ash Shaykh, N/A, N/A, Egypt @@
## Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study - NCT ID: NCT06262750 - Study ID: 00375/23 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-11-01 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients ### Conditions - Splanchnic Vein Thrombosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidenze of bleedings events - Incidence of venous and arterial thromboembolic events - Rate of progress /stable /regressive - incidence of liver related events Secondary Outcomes ### Location - Facility: UOC Servizio e DH Ematologia, Rome, N/A, 00168, Italy @@
## Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol - NCT ID: NCT06262737 - Study ID: RBHP 2023 CHIAMBARETTA - Status: RECRUITING - Start Date: 2023-09-30 - Completion Date: 2025-10-01 - Lead Sponsor: University Hospital, Clermont-Ferrand ### Study Description The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF. ### Conditions - Macular Degeneration - Diabetic Macular Edema - Retinal Vein Occlusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - OSDI Secondary Outcomes - OSDI - HM - AM - NIBUT 1 - NIBUT 2 - Interferometry ### Location - Facility: CHU de Clermont-Ferrand, Clermont-Ferrand, N/A, 63000, France @@
## Breast Reshaping Following Massive Weight Loss - NCT ID: NCT06262724 - Study ID: Perforator Flaps - Status: COMPLETED - Start Date: 2021-08-01 - Completion Date: 2024-01-01 - Lead Sponsor: Ain Shams University ### Study Description Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss ### Conditions - Breast Ptosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Breast auto-augmentation ### Outcomes Primary Outcomes - Measurement of breast volume by sono-mammography Secondary Outcomes - Sternal notch to nipple distance - Nipple to inframammary fold distance - Measure of nipple-to-nipple distance ### Location - Facility: Faculty of Medicine, Ain Shams University, Cairo, Abbasia, 11591, Egypt @@
## Effects of Vitamin C on Skeletal Muscle - NCT ID: NCT06262711 - Study ID: 321917 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-03 - Lead Sponsor: University of East Anglia ### Study Description As part of the ageing process muscles become weaker. One of the reasons for this is that mitochondria, the 'engines' that provide energy to fuel muscles, age and work less efficiently. Mitochondria are found in almost all cells in the human body. Mitochondria take in nutrients that are provided from food and break these down to create energy-rich compounds to fuel many different processes in the body. Muscles are loaded with mitochondria because they require a lot of energy. Mitochondria naturally produce small compounds called oxidants that can damage muscle cells and can cause inflammation. The cells in the body have a natural defence system to protect against oxidants, but when mitochondria age and become less efficient, the amount of oxidants that they produce can increase. These oxidants can damage muscles and the mitochondria themselves. Antioxidants, such as vitamin C, may help protect muscles from the damage caused by oxidants, and may help mitochondria work more efficiently. In this study, the investigators will explore whether vitamin C can help mitochondria work more efficiently, which may improve muscle strength, and help older people to remain mobile and independent for longer. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Vitamin C - Placebo ### Outcomes Primary Outcomes - Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups. Secondary Outcomes - Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups. - Difference in knee extension strength between vitamin C and placebo groups. - Difference in hand grip strength between vitamin C and placebo groups. - Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups. - Difference in plasma vitamin C between vitamin C and placebo groups. - Difference in serum hs-CRP between vitamin C and placebo groups. - Difference in serum IL-6 between vitamin C and placebo groups. - Difference in serum TNF-α between vitamin C and placebo groups. - Difference in plasma P1NP between vitamin C and placebo groups. - Difference in plasma CTX between vitamin C and placebo groups. ### Location - Facility: University of East Anglia, Norwich, Norfolk, NR4 7TJ, United Kingdom @@
## The Effect of HBM-Based Education on Nursing Students - NCT ID: NCT06262698 - Study ID: 81825902.903/148 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2025-06-30 - Lead Sponsor: Kafkas University ### Study Description The purpose of the study is to investigate the effect of HBM-based education on CAM knowledge, attitudes, and health beliefs related to medication use among nursing students through a randomized controlled trial.Research hypotheses:Hypothesis 01: There is no effect of HBM-based education on CAM knowledge level among nursing students.Hypothesis 1: There is an effect of HBM-based education on CAM knowledge level among nursing students.Hypothesis 02: There is no effect of HBM-based education on CAM attitude level among nursing students.Hypothesis 2: There is an effect of HBM-based education on CAM attitude level among nursing students.Hypothesis 03: There is no effect of HBM-based education on health beliefs related to medication use among nursing students.Hypothesis 3: There is an effect of HBM-based education on health beliefs related to medication use among nursing students. ### Conditions - Nursing - Evidence-Based Nursing ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Experiment group - Pre-post test ### Outcomes Primary Outcomes - The TCM Attitude Scale (CACMAS) The GETAT Attitude Scale (CACMAS): The scale, developed by McFadden et al. (2010), consists of 27 items rated on a 7-point Likert scale. Its Turkish validity and reliability were established by Köse et al. (2018). - The Medication Health Belief Scale Secondary Outcomes ### Location - Facility: Kafkas University Faculty of Health Sciences, Kars, N/A, 36500, Turkey @@
## Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins - NCT ID: NCT06262685 - Study ID: 2023-509418-12-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-03-04 - Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz ### Study Description This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol ### Conditions - Cardiovascular Diseases - Dyslipidemias - Statin Adverse Reaction - Pharmacogenic Myopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines - Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines - Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines - Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines - Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines - Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines - Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines - Standard of Care (SoC) dosing of atorvastatin - Standard of Care (SoC) dosing of simvastatin - Standard of Care (SoC) dosing of pitavastatin - Standard of Care (SoC) dosing of rosuvastatin - Standard of Care (SoC) dosing of prasavastatin - Standard of Care (SoC) dosing of lovastatin - Standard of Care (SoC) dosing of fluvastatin ### Outcomes Primary Outcomes - Incidence of clinically relevant statin-associated musculoskeletal events Secondary Outcomes - Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate - Baseline change in statin therapy prescription - Cost of a statin preemptive pharmacogenetic prescription scheme ### Location - Facility: Hospital La Paz, Madrid, Comunidad De Madrid, 28046, Spain @@
## Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process - NCT ID: NCT06262672 - Study ID: PR0319R01 - Status: COMPLETED - Start Date: 2021-05-20 - Completion Date: 2021-11-20 - Lead Sponsor: Kırklareli University ### Study Description The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail. ### Conditions - Health Behavior - Sleep - Body Weight ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Evaluation form ### Outcomes Primary Outcomes - Health Promotion Life-Style Profile (HPLP-II) - Pittsburgh Sleep Quality Index (PSQI) - Anthropometric Measurements Secondary Outcomes ### Location - Facility: Kirklareli University, Kirklareli, Kayalı, 39000, Turkey @@
## The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula - NCT ID: NCT06262659 - Study ID: 2023-142 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2024-09-10 - Lead Sponsor: Kudret Atakan Tekin ### Study Description Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives. ### Conditions - Arteriovenous Fistula ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Doppler Ultrasonography Assessment ### Outcomes Primary Outcomes - intraoperative Arteriovenous Fistula Flow Measurement Secondary Outcomes ### Location - Facility: Kudret Atakan Tekin, Merkez, Çorum, N/A, Turkey @@
## Video-conferencing FACT for Young Children With Special Needs - NCT ID: NCT06262646 - Study ID: NTEC-2023-677 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-01-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population. ### Conditions - Autism Spectrum Disorder - Attention Deficit Hyperactivity Disorder - Specific Learning Disorder - Communication Disorders - Motor Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Focused Acceptance and Commitment Therapy - Control Group ### Outcomes Primary Outcomes - Parenting stress Secondary Outcomes - Parental depressive symptoms - Parental anxiety symptoms - Parental Psychological Flexibility - ACT Core Process Utilization ### Location - Facility: The Chinese University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@