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## Bihemispheric Transcranial Direct Current Stimulation* on Speech Fluency - NCT ID: NCT06278233 - Study ID: 2023/85-70 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2024-09 - Lead Sponsor: Biruni University ### Study Description It will be determined whether bihemispheric stimulation (anodal to the left IFG and cathodal to the right IFG) is used with fluency-facilitating conditions for 5 consecutive days in individuals with stuttering and whether there is a difference in terms of the effects seen in speech fluency compared to the sham condition. ### Conditions - Stuttering, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial direct current stimulation ### Outcomes Primary Outcomes - Disfluent syllables Secondary Outcomes - Stuttering Severity Instrument- Fourth Edition (SSI-IV) score - The Overall Assessment of the Speaker's Experience of Stuttering (OASES) score ### Location - Facility: Biruni University, Istanbul, Zeytinburnu, 34015, Turkey @@
## Scheimpflug Versus Placido-disc System in Evaluation of Corneal Higher-Order Aberrations - NCT ID: NCT06278220 - Study ID: Corneal HOA - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-02 - Lead Sponsor: Assiut University ### Study Description Aim of work:To assess the agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam ) regard measuring corneal higher order aberrations before and after LASIK. ### Conditions - Corneal Higher-order Aberrations ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam ) ### Outcomes Primary Outcomes - Agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (pentacam) Secondary Outcomes - Changes in high order aberrations after LASIK. ### Location - Facility: Naglaa Moustafa, Assiut, N/A, N/A, Egypt @@
## An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions - NCT ID: NCT06278207 - Study ID: 22731 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-06-30 - Lead Sponsor: Bayer ### Study Description This is an observational study, in which data from people in Japan with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.The data will come from a network of commercial electronic health records (EHRs) and national claims data in Japan. They cover the period from July 1st, 2021 until September 2023. Only already available data is collected and studied. There are no required visits or tests in this study. ### Conditions - Chronic Kidney Disease - Type 2 Diabetes Mellitus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Finerenone (BAY 94-8862) ### Outcomes Primary Outcomes - Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone. - Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone. - Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone. Secondary Outcomes - Proportion of finerenone initiators with and without UACR measurements at baseline - Mean UACR in the subcohort with UACR measurements - Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone. - Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone. - Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone. - Number of participants who initiate finerenone at a 10 mg dose daily - Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark - Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark - Number of participants who initiate finerenone at a 20 mg dose daily - Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark - Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark ### Location - Facility: Bayer, Berlin, N/A, 13353, Germany @@
## Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment - NCT ID: NCT06278194 - Study ID: 22.11.2023.589 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-11-15 - Lead Sponsor: Başakşehir Çam & Sakura City Hospital ### Study Description Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle. ### Conditions - Trigeminal Neuralgia - Gasserian Ganglion; Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Gasserian Ganglion Radiofrequency Thermocoagulation ### Outcomes Primary Outcomes - Masseter muscle thickness - Masseter muscle thickness - Masseter muscle thickness Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon - NCT ID: NCT06278181 - Study ID: 2023/08/1545 - Status: RECRUITING - Start Date: 2023-09-21 - Completion Date: 2025-01-30 - Lead Sponsor: Karolinska Institutet ### Study Description Non-communicable diseases (NCDs) such as diabetes are increasing in countries where malaria transmission is common. This study aims to investigate the relationship between NCDs and parasitic infections in Cameroon. The investigators will assess the risk of malaria, as well as other parasitic diseases, in a prospectively followed group of adults with diabetes, compared with those without diabetes. Malaria parasites and intestinal worms will be tested using blood and stool collected at four time points during a one-year follow-up. In addition, this project will investigate how natural protection against malaria is affected by diabetes and other risk factors for heart diseases. ### Conditions - Malaria - Diabetes Mellitus - Metabolic Syndrome - Endemic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - asymptomatic malaria Secondary Outcomes - symptomatic malaria ### Location - Facility: Limbe Regional Hospital, Limbe, N/A, N/A, Cameroon @@
## Awareness Training in Children With Autism Spectrum Disorder. - NCT ID: NCT06278168 - Study ID: CNR-IRIB-PRO-2024-002 - Status: RECRUITING - Start Date: 2023-06-12 - Completion Date: 2025-05-08 - Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica ### Study Description The proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an IQ between 85 and 115. Conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster self-awareness, cognitive understanding, and an inclusive environment. Subsequently, the protocol advances to 12 individual sessions focused on emotional well-being and self-awareness, integrating Oculus technology and chest sensors for heart rate monitoring. Initiating the intervention, individual family meetings are scheduled to outline intervention goals and phases. The initial group sessions focus on social bonding, cognitive understanding, and creating an accepting atmosphere among participants. Utilizing activities addressing neurodiversity awareness and technological tools like tablets, the sessions encourage discussions on individual differences and sensitivities. The subsequent individual sessions are structured to explore personal values, identify inner critical voices, and develop emotional awareness through exercises exploring emotions and physical sensations. Progressively, the intervention introduces mindfulness, guiding participants to acknowledge emotions as normal and encouraging alignment of daily actions with personal values. Following this, sessions center on building observational skills, recognizing past behaviors, and fostering strengths tied to values. Participants are encouraged to distinguish between their critical "consultant" and the value-driven "explorer," fostering personal growth and reflection. The protocol's later stages delve into identifying personal strengths linked to core values and exploring value-driven goals. Visual exercises, metaphors, and flexible self-views are emphasized, promoting adaptability and self-evolution. The protocol concludes by advocating a flexible self-view, embracing change, and connecting oneself to ever-evolving metaphors like "a cup with changing contents" or "the ever-changing sky." These sessions culminate with visual relaxation facilitated through Oculus technology while simultaneously monitoring participants' heart rates using chest sensors. This comprehensive approach integrates technological tools with emotional and cognitive exercises, providing a multifaceted framework to enhance self-awareness and promote acceptance within the context of neurodiversity. ### Conditions - Autism - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Awareness training with using Oculus. - Awareness training without using Oculus ### Outcomes Primary Outcomes - Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) - Multidimensional Anxiety Scale for Children-Second Edition (MASC 2) - Screen for Child Anxiety Related Disorders (SCARED) Secondary Outcomes ### Location - Facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), Messina, N/A, 98164, Italy @@
## Social Relations Training for Children With ASD - NCT ID: NCT06278155 - Study ID: CNR-IRIB-PRO-2024-001 - Status: RECRUITING - Start Date: 2023-04-17 - Completion Date: 2025-04-28 - Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica ### Study Description The following protocol was developed with the intention of significantly improving social skills by focusing on increasing relationship skills among children with ASD. Divided into two distinct parts, "Basic Social Relationships" and "Intermediate Social Relationships," the protocol has 4 stages for the former and 5 stages for the latter. Each phase is preparatory to the next, and in addition, a teaching procedure is implemented that adopts three prompt levels (partial, moderate and total), gradually aiming to reduce the assistance provided to encourage independent response. This gradual approach is designed to stimulate greater independence in social interactions.The training lasts between 6 and 12 months, with one or two weekly group meetings lasting forty-five minutes each. Before the start and at the end of the protocol, participants are assessed using the Vineland scale to evaluate their adaptive behaviors.The primary goal is to enable children with autism to develop meaningful social skills, providing them with concrete tools to interact more effectively and independently with their peers, thus improving their quality of life and social involvement. The protocol involves two distinct groups, experimental and control group.The experimental group involves the use of a social robot that acts as a mediator in the interactions among participants. The role of the social robot is to facilitate, reinforce and support the participants' responses during the activities. The therapist coordinates with the social robot, helping to guide, reinforce and support participants' interactions.In the control group, the therapist takes on the role of mediating interactions, helping and facilitating participants' responses. There is no involvement of a social robot; therefore,the therapist self acts directly to guide, reinforce and support the participants' social interactions. ### Conditions - Autism - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Social relation training with social robot - Traditional social relations training ### Outcomes Primary Outcomes - Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form) Secondary Outcomes ### Location - Facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), Messina, N/A, 98164, Italy @@
## Web-Based Cognitive Behavior Therapy for Procrastination - NCT ID: NCT06278142 - Study ID: ERTELEME_1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-07 - Lead Sponsor: Anadolu University ### Study Description The main purpose of this study is to present the development process and project flow of an internet-based self-help intervention programme to reduce the level of procrastination among university students. ### Conditions - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Internet Based Intervention - GUIDED - Internet Based Intervention - WİTHOUT GUİDANCE ### Outcomes Primary Outcomes - Tuckman Procrastination Behaviour Scale - Cognitive Distortions Questionnaire - Time Management Scale - Attitude Scale for Internet-Based Interventions Secondary Outcomes - Depression Anxiety Stress Scale-21 (DASS-21) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease - NCT ID: NCT06278129 - Study ID: 4146 - Status: RECRUITING - Start Date: 2018-06-19 - Completion Date: 2025-12-31 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates. ### Conditions - Sudden Sensorineural Hearing Loss - Meniere Disease - Ménière's Vertigo - Meniere's Disease Aggravated - Inner Ear Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vestibular myogenic potentials ### Outcomes Primary Outcomes - Evaluation of inner ear structures in MRI images Secondary Outcomes ### Location - Facility: Audiology and Neuroradiology - Milan (Italy), Milan, N/A, 20133, Italy @@
## Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing - NCT ID: NCT06278116 - Study ID: 2024-ALIGNERSCLEANSIGN - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06 - Lead Sponsor: University of Pavia ### Study Description The aim of the study is to evaluate the most efficient product for the cleaning of Invisalign® clear aligners (Align Technology Inc., San Jose, CA, USA) through objective and subjective assessments after the use of 5 different products. For each aligner, one product is used for 2 weeks until all of them are used, therefore 5 different aligners are required for the study. A periodontal evaluation is conducted to assess variations during the time frame of the study. ### Conditions - Dental Malocclusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Aligners cleansing with water - Aligners cleansing with dish soap Svelto - Aligners cleansing with Polident Antibacterial Denture Cleaner - Aligners cleansing with Invisalign Cleaning Crystals - Aligners cleansing with Geldis ### Outcomes Primary Outcomes - Change in adsorbance (A) value - Changes in patient's perception Secondary Outcomes - Changes in Probing Pocket Depth (PPD) values - Changes in Gingival Index (GI) values - Changes in Bleeding on probing (BOP) - Change in Schiff Air Index - Dental sensitivity test - Change of the BEWE Index Basic Erosive Wear Examination - Change in plaque index (PI): ### Location - Facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy @@
## Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas (MethylRH-M) - NCT ID: NCT06278103 - Study ID: 2023PI113 - Status: ENROLLING_BY_INVITATION - Start Date: 2000-01-01 - Completion Date: 2024-09-01 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description This research aims to explore the relationship between hormonal receptor expression and the clinical and histopathological characteristics of meningiomas. The underlying hypothesis is that hormonal receptor expression, as well as the methylation profile of their gene promoters, are associated with specific aspects of meningiomas and patients' clinical outcomes. The main objective is to study the correlation between the immunohistochemical expression of hormonal receptors and clinicopathological data. The secondary objectif is to study the correlation between the methylation profile of hormonal receptor gene promoters and their immunohistochemical expression. ### Conditions - Meningioma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - immunohistochemical expression of different hormonal receptors Secondary Outcomes - methylation profile of the promoters of hormonal receptor genes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution - NCT ID: NCT06278090 - Study ID: AUDC - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-07 - Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz ### Study Description The goal of this observational study is to learn about the impact of ursodeoxycholic acid treatment on the gallbladder polyp evolution in patients with gallbladder polyps that undergo follow up. The main question it aims to answer is:• Whether ursodeoxycholic acid could decrease the gallbladder polyp size and therefore spare unnecessary follow up or surgical interventionsParticipants will be managed according to the standard practice of the department they are attended:* According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed Ursodeoxycholic Acid, at 10-15 mg/kg/day for at least 6 months.* According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly. ### Conditions - Gallbladder Polyp ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ursodeoxycholic Acid Only Product ### Outcomes Primary Outcomes - Reducing gallbladder polyp size by 2mm or more Secondary Outcomes - Modification of the expected follow up ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neurexan - a Clinical Trial in Short-Term Insomnia Patients - NCT ID: NCT06278077 - Study ID: C2104 - Status: RECRUITING - Start Date: 2023-09-04 - Completion Date: 2024-12-31 - Lead Sponsor: Biologische Heilmittel Heel GmbH ### Study Description This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing.Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires.The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms.Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia. ### Conditions - Insomnia - Stress Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neurexan - Placebo ### Outcomes Primary Outcomes - Change from baseline in Sleep Efficiency. Secondary Outcomes - Change from baseline in sleep pattern characterized by Number of Awakenings. - Change from baseline in daytime performance assessed by Epworth Sleepiness Scale patient questionnaire. - Ecological Momentary Assessments - continuous daily stress assessment. ### Location - Facility: Jena University Hospital, Department of Psychiatry & Psychotherapy, Jena, Thuringia, 07743, Germany @@
## Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis - NCT ID: NCT06278064 - Study ID: BFHHZML20240006 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-06-30 - Lead Sponsor: Beijing Friendship Hospital ### Study Description This study constitutes a case-control investigation employing a retrospective approach. Plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. Advanced Data-Independent Acquisition (DIA) proteomics and single-vesicle membrane protein detection techniques were employed to quantify protein content within exosomes. Specific protein biomarkers indicative of early-stage upper gastrointestinal tumors were identified. External validation of these protein markers was conducted using Parallel Reaction Monitoring (PRM) technology on an independent validation cohort. The objective is to establish protein marker predictions for early diagnosis of upper gastrointestinal tumors and prognostication of therapeutic efficacy. ### Conditions - Gastric Cancer - Esophagus Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gastric Cancer - Esophagus Cancer ### Outcomes Primary Outcomes - Plasma proteins in patients with gastric cancer - Plasma proteins in patients with esophagus cancer Secondary Outcomes ### Location - Facility: The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, N/A, China @@
## An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism - NCT ID: NCT06278051 - Study ID: 21411 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-12-31 - Lead Sponsor: Bayer ### Study Description This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors.Venous thromboembolism (VTE) is a condition in which people have problems due to the formation of blood clots in their veins.The study drug rivaroxaban is an approved treatment for VTE in children and adults in Japan. It is a blood thinner that prevents the blood from clotting by blocking a protein responsible for blood clotting.Warfarin is another blood thinner that is available for VTE. In this study warfarin is the reference drug.A previous study was carried out to learn about how well rivaroxaban works and how safe it is in children with VTE. However, to better understand the safety of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world.The main purpose of this study is to learn more about the occurrence of major bleeding in children taking rivaroxaban. Major bleeding can be bleeding within the skull, bleeding inside the eye, bleeding from an organ in the digestive system, or bleeding which requires being given blood from a donor.In addition, this study will help learn more about the following in children with VTE:* The occurrence of major bleeding during treatment with rivaroxaban and during treatment with warfarin* The occurrence of bleeding of importance in children being treated with rivaroxaban and in children being treated with warfarin. Bleeding of importance in children can be: bleeding from the lung, blood in the kidney, heavy menstrual bleeding* The occurrence of major bleeding and bleeding of importance in children who are taking drugs called anti platelet agents and NSAIDs to prevent blood clots at the same time as rivaroxaban, who are taking a drug that blocks the action of a protein called 'CYP3A4' at the same time as rivaroxaban, who have reduced kidney function, who have taken rivaroxaban for a long time, or who have taken other drugs by mouth to prevent blood clots before starting rivaroxaban* The occurrence of repeated VTE on treatment with rivaroxaban and on treatment with warfarin The children with VTE in this study are already receiving rivaroxaban or warfarin treatment as part of their regular care from their doctors.The data will come from an electronic health records database created by a company called Medical Data Vision. The data will be collected between January 2021 and June 2024.Researchers will look at the health information from children less than 18 years of age with VTE in Japan who are prescribed treatment with rivaroxaban or warfarin during the study period.In this study, only available data from routine care are collected. No visits or tests are required as part of this study ### Conditions - Venous Thromboembolism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Rivaroxaban granules for oral suspension - Warfarin ### Outcomes Primary Outcomes - Incidence of major bleeding in participants treated with rivaroxaban - Clinical characteristics and demographics of participants with pediatric VTE treated with rivaroxaban Secondary Outcomes - Incidence of major bleeding in participants treated with warfarin - Incidence of bleeding important in pediatrics in participants treated with rivaroxaban and treated with warfarin as reference - Incidence of major bleeding and bleeding important in pediatrics in participants treated with rivaroxaban and in special target patient groups ### Location - Facility: Many facilities, Multiple Locations, N/A, N/A, Japan @@
## Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder - NCT ID: NCT06278038 - Study ID: NO.0057 in 2024 Ethical Review - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-12-31 - Lead Sponsor: First Affiliated Hospital of Zhejiang University ### Study Description The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use. ### Conditions - Major Depression Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Toludesvenlafaxine hydrochloride sustained-release tablets - Venlafaxine hydrochloride sustained-release tablets ### Outcomes Primary Outcomes - Snaith-Hamilton Pleasure Scale (SHAPS) Total Score Secondary Outcomes - Snaith-Hamilton Pleasure Scale (SHAPS) Total Score - Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate - Dimensional Anhedonia Rating Scale (DARS) Score - Montgomery-Asberg Depression Rating Scale (MADRS) Score - 17-item Hamilton Depression Rating Scale (HAM-D17) Score - Sheehan Disability Scale (SDS) Score - Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dysphagia and Deep Cervical Flexor Muscles - NCT ID: NCT06278025 - Study ID: GO 19/833 - Status: COMPLETED - Start Date: 2019-09-01 - Completion Date: 2024-02-01 - Lead Sponsor: Atılım University ### Study Description Cervical posture is vital for normal swallowing function. Changes in cervical posture during swallowing alter the bolus flow and swallowing kinematics through changes in gravity and oropharyngeal space. The hyoid bone does not articulate with any bone, so it requires adequate tension of the hyolaryngeal complex and proper cervical postural alignment to maintain its stabilization and position. Changes in cervical posture and stabilization can cause changes in hyoid bone position and kinematics through muscles and ligaments which may lead to decrease in hyoid elevation, loss of optimal strength of the suprahyoid and infrahyoid muscles due to disrupted length-tension relationship, and an increased risk of aspiration due to insufficient laryngeal elevation. Further, deterioration in cervical posture and decreased stabilization resulting from cervical muscle weakness or/both endurance could affect the control and strength of masticatory muscles, tongue muscles and suprahyoid - infrahyoid muscles, which are involved in swallowing function. Whereby DCF weakness gives rise to inadequate cervical stabilization, change in hyoid bone stabilization, alterations in suprahyoid and infrahyoid muscle function, and decreased laryngeal elevation may adversely affect the normal function of the swallowing related muscles. Thus, decreased cervical stabilization, which is often seen in neurological diseases, may be related to neurogenic dysphagia. Given the known changes in cervical stabilization as a consequence of neurologic injury, the additional impact on swallowing or a potentially already neurologically-disordered swallow is considered. Thus, loss of cervical stabilization may be one of the factors affecting dysphagia in patients with neurological diseases providing more information on all potential factors contributing to swallow impairment, potentially leading to more targeted and effective swallowing interventions. However, there is no study investigating the role of the DCF muscles in dysphagia. Therefore, the aim of the present study was to comparison of deep cervical flexor muscle strength and endurance in patients with and without neurogenic dysphagia. ### Conditions - Dysphagia - Neurological Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - assessment ### Outcomes Primary Outcomes - dcf muscle strenght - dcf endurance Secondary Outcomes ### Location - Facility: Atilim University, Ankara, Incek, 06830, Turkey @@
## Development of Atılım Kinesiophobia Scale - NCT ID: NCT06278012 - Study ID: E-59394181-604.01.02-32288 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-03-30 - Lead Sponsor: Atılım University ### Study Description Background:Kinesiophobia or fear of movement, is defined as an excessive and irrational fear of physical movement to avoid painful injury, harm or re-injury. The existing scales measuring kinesiophobia are thought to have some limitations (the difficulty of patients to understand and answer the questions, the presence of questions that are not suitable for the patient's condition). These questionnaires may not have specific questions enough to assess fear of movement in different patient populations.Aim: The aim of this study is to develop and validate the Turkish Atılım Kinesiophobia Scale.Material/method:In the first stage of the study, research on kinesiophobia was reviewed and a total of 38 questions were created for the scale. The questions were submitted to the opinion of 11 experts working in the physiotherapy and rehabilitation field. Then A total of 100 patients with acute and chronic musculoskeletal pain completed the Turkish Atılım Kinesiophobia Scale and Tampa Scale of Kinesiophobia. ### Conditions - Kinesiophobia - Acute Pain - Chronic Pain - Fear of Movement ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The pilot study of the scale will be conducted with a total of 40 patients, 10 participants for each patient group. - item analyses and exploratory factor analysis (EFA) analysis will be performed with a sample size of 5 times the number of questions in the item pool with acute and chronic pain patients. Secondary Outcomes ### Location - Facility: Atılım University, Ankara, N/A, N/A, Turkey @@
## C.Difficile Observational Study - NCT ID: NCT06277999 - Study ID: D8820C00001 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-10-11 - Lead Sponsor: AstraZeneca ### Study Description D8820C00001 is an exploratory, non-interventional, unblinded, observational study evaluating the acceptability, feasibility and performance of methods to collect, transport and test biospecimens in participants ≥ 18 years of age with an active CDI. Participants will also be monitored for recurring episodes of diarrhea and will need to complete validated PROs and study evaluation questionnaires ### Conditions - Clostridium Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of participants that completed key study activities according to protocol Secondary Outcomes - Time intervals across stool sample collection logistics - Participant Experience and site staff evaluation questionnaires - Gather information to assess logistics, resourcing and performance of different toxin detection assays (eg. EIA, PCR, CCNA) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Early Diagnosis of Gastric Cancer Cachexia - NCT ID: NCT06277986 - Study ID: KY20212018-F-2 - Status: RECRUITING - Start Date: 2021-06-01 - Completion Date: 2024-09-01 - Lead Sponsor: Xijing Hospital ### Study Description Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia. ### Conditions - Cachexia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - cachexia ### Outcomes Primary Outcomes - BMI Secondary Outcomes ### Location - Facility: Fourth Military Medical University, Xi'an, Shaanxi, N/A, China @@
## Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience - NCT ID: NCT06277973 - Study ID: 0007551-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Tel Aviv University ### Study Description The study aims to assess the feasibility of an online intervention platform based on the Immediate Stabilization Procedure (ISP®). This intervention targets early trauma reactions, aiming to reduce the risk of future PTSD. ### Conditions - Post-traumatic Stress Disorder - Acute Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Eye Movement Desensitization and Reprocessing (EMDR) ### Outcomes Primary Outcomes - PCL-5 (Posttraumatic Stress Disorder Checklist) - GAD-7 (General Anxiety Disorder-7) - SSASI (The Short Scale Anxiety Sensitivity Index) - BSI 18 (Brief Symptom Inventory) - DES-II (Dissociative Experiences Scale) - DERS (Difficulties in Emotion Regulation Scale) - NSESSS (The National Stressful Events Survey Acute Stress Disorder Short Scale) - SASRQ (Stanford Acute Stress Reaction Questionnaire) - Exposure to traumatic event during the current war - PDEQ (Peritraumatic Dissociative Experiences Questionnaire) - TIS (Tonic Immobility Scale) - PDI (The Peritraumatic Distress Inventory) - Questionnaires to test user experience of the system - Questionnaire for examining the experience of the intervention - Qualitative interview - Questionnaire regarding receiving emotional treatment Secondary Outcomes ### Location - Facility: Tel Aviv University, Tel Aviv, N/A, N/A, Israel @@
## Septal Ablation for Obstructive HCM - NCT ID: NCT06277960 - Study ID: CNS2301 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-11-30 - Lead Sponsor: SuZhou Sinus Medical Technologies Co.,Ltd ### Study Description Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited.Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches.The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy. ### Conditions - Hypertrophic Obstructive Cardiomyopathy (HOCM) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - percutaneous intramyocardial septal radiofrequency ablation system ### Outcomes Primary Outcomes - 30-day major adverse clinical events (MACE) Secondary Outcomes - Technical success rate - Short Form 36 (SF-36) health survey questionnaire - Improvement of left ventricular outflow tract gradient (LVOTG) - Improvement of NYHA functional classification - 6-min walk distance ### Location - Facility: Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, 310016, China @@
## Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward - NCT ID: NCT06277947 - Study ID: SYSKY-2024-096-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-05 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion. ### Conditions - Epithelial Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC) ### Outcomes Primary Outcomes - The incidence of adverse events of grade 3-5 Secondary Outcomes - Time to progress (TTP) - The Time to the First Subsequent Therapy，TTFST - Quality of life, QLQ-C30 ### Location - Facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, N/A, N/A, China @@
## A Study of RGT001-075 in Adult Patients With Obesity - NCT ID: NCT06277934 - Study ID: RGT001-075-203 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2024-07 - Lead Sponsor: Regor Pharmaceuticals Inc. ### Study Description This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RGT001-075 - Placebo ### Outcomes Primary Outcomes - Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings Secondary Outcomes - Percent change in body weight - Change in body weight in kilogram - Percentage of participants who achieve ≥5% and ≥10% body weight reduction - Change in Body mass index (BMI) in kg/m^2 - Change in waist circumference in centimetre - RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last) - RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf) - RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax) - RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax) - RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2) ### Location - Facility: Velocity Clinical Research, Los Angeles, California, 90057, United States @@
## Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery - NCT ID: NCT06277921 - Study ID: 110-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-12-31 - Lead Sponsor: P. Herzen Moscow Oncology Research Institute ### Study Description Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure.However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation. ### Conditions - Esophageal Cancer - Oesophageal Cancer - Siewert Type I Adenocarcinoma of Esophagogastric Junction - Siewert Type III Adenocarcinoma of Esophagogastric Junction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Elective Surgery for gastric cancer ### Outcomes Primary Outcomes - the type of complications and the incidence of it Secondary Outcomes ### Location - Facility: A.S. Loginov Moscow Clinical Scientific Center, Moscow, N/A, N/A, Russian Federation @@
## Postoperative Morbidity and Mortality After Gastric Cancer Surgery - NCT ID: NCT06277908 - Study ID: 110-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-12-31 - Lead Sponsor: P. Herzen Moscow Oncology Research Institute ### Study Description Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation. ### Conditions - Gastric Cancer - Siewert Type III Adenocarcinoma of Esophagogastric Junction - Stomach Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Elective Surgery for gastric cancer ### Outcomes Primary Outcomes - the type of complications and the incidence of it Secondary Outcomes ### Location - Facility: A.S. Loginov Moscow Clinical Scientific Center, Moscow, N/A, N/A, Russian Federation @@
## VOCs in Patients With Acute Cardiogenic Chest Pain - NCT ID: NCT06277895 - Study ID: KYLL-202401-047 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2024-12-31 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description The goal of this observation study is to compare VOCs in cardiogenic chest pain population/health conditions, to answer：Establishment and promotion of the application system of emergency rapid detection of expiratory Volatile Organic Compounds (VOCs) in patients with acute cardiogenic chest pain1. VOCs levels were measured at baseline in healthy people, and markers of VOCs that could be used to identify acute cardiogenic chest pain were sought.2. The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure. ### Conditions - Acute Coronary Syndrome - Acute Aortic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - VOCs ### Outcomes Primary Outcomes - Baseline VOCs (aldehydes) levels in healthy population Secondary Outcomes - MACE in patients with cardiogenic chest pain ### Location - Facility: Qilu hospital, Jinan, Shandong, 250012, China @@
## Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis - NCT ID: NCT06277882 - Study ID: Si 067/2024 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2025-05-31 - Lead Sponsor: Mahidol University ### Study Description The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general populationHAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.The main questions it aims to answer are:* Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.* Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis. ### Conditions - Cirrhosis - Hep A - Vaccination ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - HAVRIX ### Outcomes Primary Outcomes - Post-vaccination serological response rate Secondary Outcomes - Post-vaccination serological response - Post-vaccination serological response - Anti-hepatitis A Virus (HAV) antibody at month 1 - Anti-hepatitis A Virus (HAV) antibody at month 7 - Anti-hepatitis A Virus (HAV) antibody at 1 year ### Location - Facility: Faculty of Medicine, Siriraj Hospital, Bangkok Noi, Bangkok, 10700, Thailand @@
## Effectiveness Trial of Thermal Jacket - NCT ID: NCT06277869 - Study ID: PR-22146 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh ### Study Description Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.Maintaining continuous Kangaroo Mother Care (KMC) for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or low birthweight (LBW) neonates warm during transportation.The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings.Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh.Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh. ### Conditions - Preterm Neonate - Low Birthweight Neonate ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Thermal Jacket - Kangaroo Mother Care ### Outcomes Primary Outcomes - Body temperature of preterm or low birthweight neonates maintain the euthermic range. Secondary Outcomes ### Location - Facility: Lakshmipur District Hospital, Lakshmipur, Chattogram, 3700, Bangladesh @@
## Peer Interaction of Primiparas Sharing a Room With Multiparas With Successful Breastfeeding Experience - NCT ID: NCT06277856 - Study ID: Aysun Eksioglu - Status: RECRUITING - Start Date: 2023-09-15 - Completion Date: 2024-09-15 - Lead Sponsor: Ege University ### Study Description The World Health Organization (WHO) states that peer support breastfeeding education programs are effective interventions for improving breastfeeding outcomes. In this context, the WHO's Global Strategy for Infant and Young Child Feeding recommends the implementation of "lay health worker peer counselors" and "mother-to-mother support groups" to promote and support breastfeeding. The tenth step of the Baby-Friendly Hospital Initiative also emphasizes the importance of mother-to-mother support as a successful intervention for breastfeeding. However, in our country, there have been limited studies and efforts to provide peer education and support for breastfeeding. Although various valuable studies using different educational techniques have been conducted to improve breastfeeding rates, the integration of these programs into routine clinical practice remains insufficient. This study aims to implement a peer interactive education program in postpartum rooms to bring experienced and inexperienced mothers together, as part of the hospital routine. The project will focus on the development and implementation of a peer interactive education program and will investigate its impact on the breastfeeding self-efficacy of primiparous mothers. The research follows a two-group pre-test and post-test design, is non-blind, and uses randomized controlled methodology. Initially, the hospital rooms will be rearranged to accommodate the implementation of the peer support breastfeeding education module. Researcher midwives will provide a brief training to experienced peer educator mothers who have previously breastfed.Afterwards, the peer education program will be conducted when the experienced mother and primiparous mother are together in the room. The study emphasizes improving early postpartum breastfeeding success and aims to make peer interaction a routine part of hospital practice. The feasibility of implementing peer education in hospitals will be evaluated, considering its simplicity and practicality. The impact of peer interactions on the mother's breastfeeding self-efficacy and attitudes towards breastfeeding will be assessed.Overall, this research aims to improve breastfeeding rates by implementing peer support programs in hospital settings and evaluating the outcomes of peer interactions in terms of the mother's breastfeeding self-efficacy and attitudes towards breastfeeding. ### Conditions - Mothers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Peer interaction/control ### Outcomes Primary Outcomes - breastfeeding self-efficacy - exclusive breastfeeding rate Secondary Outcomes ### Location - Facility: Ege University, Izmir, N/A, 35100, Turkey @@
## Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates. - NCT ID: NCT06277843 - Study ID: PR-21131 - Status: COMPLETED - Start Date: 2022-06-13 - Completion Date: 2022-09-30 - Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh ### Study Description Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation.The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates.Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours. ### Conditions - Preterm - Low Birthweight - Hypothermia Neonatal ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Thermal Jacket ### Outcomes Primary Outcomes - Body temperature of preterm or low birthweight neonates and duration of time in euthermic range. Secondary Outcomes ### Location - Facility: Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, N/A, 1000, Bangladesh @@
## Physical Activity Monitoring in Myasthenia Gravis - NCT ID: NCT06277830 - Study ID: 2023P002788 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2024-06 - Lead Sponsor: Massachusetts General Hospital ### Study Description The goal of this observational study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG).The main question\[s\] it aims to answer are:* To measure the correlation of sensor-based measures of motor function with existing outcome measures including the MG-ADL, MGQOL15r, QMG, MGComposite, and Neuro-QOL Fatigue scales.* To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures.Participants will wear a pendant sensor for 7 days and then participate in tablet-based and in-person myasthenia-specific physical examinations. This will be performed in concert with routine care in the Massachusetts General Hospital MG clinic. ### Conditions - Myasthenia Gravis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Wearable sensor ### Outcomes Primary Outcomes - Primary outcome Secondary Outcomes - Exploratory outcome ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## The Effect of Chest Physiotherapy Methods Applied Before Aspiration on Respiratory Characteristics - NCT ID: NCT06277817 - Study ID: 2021/1916 - Status: COMPLETED - Start Date: 2021-05-19 - Completion Date: 2022-10-24 - Lead Sponsor: Inonu University ### Study Description Physiotherapy is one of the most frequently used supportive treatments in intensive care units due to its positive effects on critically ill patients. Chest physiotherapy (GF), which constitutes the most effective part of the physiotherapy programs applied to intensive care patients under mechanical ventilation (MV) support, consists of a series of techniques aimed at clearing airway secretions, facilitating appropriate lung ventilation by increasing lung volume and respiratory muscle strength, and improving the respiratory system and gas exchange. . Of these techniques, manually applied percussion vibration and expiratory rib cage compression (EGCC) are some of the most commonly applied GF techniques in patients on MV support. This study was conducted to evaluate the effect of chest physiotherapy techniques applied before aspiration on vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support. ### Conditions - Patient Involvement ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - expiratory rib cage compression - percussion vibration ### Outcomes Primary Outcomes - The effect of percussion vibration on the amount of secretion - Effect of expiratory rib cage compression on the amount of secretion - Effect of percussion vibration on blood gas parameters - Effect of expiratory rib cage compression on blood gas parameters - Perküsyon vibrasyonun yaşam bulgularına etkisi - Effect of expiratory rib cage compression on vital signs Secondary Outcomes ### Location - Facility: Tunceli State Hospital, Tunceli, N/A, 62000, Turkey @@
## A Phase I Study of LTC004 Combin With FC in Patients With Advanced/Metastatic Malignancies Tumor - NCT ID: NCT06277804 - Study ID: LTC004-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-07-01 - Lead Sponsor: Letolab ### Study Description This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced/Metastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). The objective of this study was to evaluate combination safety, tolerability, pharmacokinetic,pharmacodynamics characteristics, and initial efficacy in advanced malignant tumors. ### Conditions - Adult Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - LTC004 in Combination With Cyclophosphamide and Fludarabine ### Outcomes Primary Outcomes - Safety, tolerability and antitumor efficacy of Combination. Secondary Outcomes - PK Characteristics and immunogenicity of Combination ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma - NCT ID: NCT06277791 - Study ID: HStomatologyWuhan1 - Status: RECRUITING - Start Date: 2023-08-19 - Completion Date: 2025-07-31 - Lead Sponsor: Hospital of Stomatology, Wuhan University ### Study Description The goal of this \[type of study:clinical trial\] is to \[learn about\] in \[Clinical IVB stage oral squamous cell carcinoma patients\]. The main question it aims to answer are:• \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] Participants will \[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\'s condition, with a total follow-up of two years.\]. ### Conditions - Clinical IVb Stage Oral Squamous Cell Carcinomas Patients ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab ### Outcomes Primary Outcomes - Effective mitigation rate（EMR） Secondary Outcomes - DFS - R0 resection rate - ORR - mOS ### Location - Facility: School of Stomatology Wuhan University, Hubei, Wuhan, 430079, China @@
## Effect of Combined Music and Taekwondo Training for Children With Autism Spectrum Disorder - NCT ID: NCT06277778 - Study ID: HSEARS20211117003-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The goal of this randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder. Participants will be asked to do combined music and taekwondo training or taekwondo training alone to evaluate if the combined training is better than the taekwondo training alone on mental and physical performance for children with autism spectrum disorder. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Taekwondo training with music therapy - Taekwondo training alone ### Outcomes Primary Outcomes - Engagement in the Training Sessions - Gross Motor Skills Secondary Outcomes - Physical Activity Level - Enjoyment State - Rate of Perceived Exertion - Taekwondo skills performance - Conners' Continuous Performance Test II - Comprehensive Trail-Making Test (CTMT) - Social Responsiveness Scale, second edition (SRS-2) - Childhood Autism Spectrum Test - Strength and Difficulties Questionnaires (SDQ) - Clinical Global Improvement (CGI) score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis - NCT ID: NCT06277765 - Study ID: CM310-101212 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2025-05-30 - Lead Sponsor: Keymed Biosciences Co.Ltd ### Study Description This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis. ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CM310 - placebo ### Outcomes Primary Outcomes - Proportion of subjects achieving EASI-75 at week 18 Secondary Outcomes ### Location - Facility: Peking University People's hospital, Beijing, N/A, N/A, China @@
## A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor) - NCT ID: NCT06277752 - Study ID: CIBI128A101 - Status: COMPLETED - Start Date: 2024-03-05 - Completion Date: 2024-03-16 - Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd. ### Study Description A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects. ### Conditions - Gout Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - dose-5 group - dose-1 group - dose-2 group - dose-4 group - dose-3 group ### Outcomes Primary Outcomes - PK parameter: Cmax - PK parameter: AUC - PK parameter: Tmax - PK parameter: T1/2 Secondary Outcomes - Safety parameter: AE - PD parameter: serum UA (uric acid） - Tolerability parameter: SAE ### Location - Facility: The First Affiliated, Zhengzhou, Henan, 450000, China @@
## Brain Effect Mechanism of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI - NCT ID: NCT06277739 - Study ID: 20220117020315695 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-06-01 - Completion Date: 2026-09-01 - Lead Sponsor: Zhou Xingchen ### Study Description The clinical symptoms of Lumbar Disc Herniation (LDH) can be effectively ameliorated through Spinal Manipulative Therapy (SMT), which is closely linked to the brain's pain-regulating mechanisms. Magnetic Resonance Imaging (MRI) offers an objective and visual means to study how the brain orchestrates the characteristics of analgesic effects. From the perspective of multimodal MRI, the investigators applied functional MRI (fMRI) and Magnetic Resonance Spectrum (MRS) techniques to comprehensively evaluate the characteristics of the effects of SMT on the brain region of LDH from the aspects of brain structure, brain function and brain metabolism. This multimodal MRI technique provides a biological basis for the clinical application of SMT in LDH. ### Conditions - Lumbar Disc Herniation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Spinal Manipulative Therapy - Sham Laser Treatment ### Outcomes Primary Outcomes - visual analogue scale (VAS) - Japanese Orthopaedic Association Scores (JOA) - Amplitude of Low-Frequency Fluctuation (ALFF) - Regional Homogeneity (ReHo) - Functional Connectivity (FC) - Magnetic Resonance Spectrum （MRS） Secondary Outcomes ### Location - Facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310053, China @@
## The Effect of Two Non-pharmacological Methods on Pain and Anxiety Experienced During Intrauterine Device Application. - NCT ID: NCT06277726 - Study ID: IU-SBE-CGI-01 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2024-04 - Lead Sponsor: Inonu University ### Study Description The purpose of this study is to determine the effect of emotional freedom technique and music, which are effective in relieving pain and anxiety, on the pain and anxiety that occur during intrauterine device application. ### Conditions - Intrauterine Devices ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Emotional freedom technique group - Music group - Control group ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) - State Anxiety Inventory Secondary Outcomes ### Location - Facility: Şırnak State Hospital, Şırnak, N/A, 73000, Turkey @@
## Preventing Exercise Resistance With Sedentary Interruptions - NCT ID: NCT06277713 - Study ID: CME2023/069 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-07-01 - Lead Sponsor: Hasselt University ### Study Description The goal of this randomised cross-over trial is to learn about the interaction between sedentary behaviour throughout the day and the metabolic effect of an exercise bout on that same day in office workers with an increased risk for chronic disease.The main question this study aims to answer is if the lipid-lowering effects of an exercise bout can be more pronounced by implementing alternations between a seated and a standing working position throughout the day.Participants will be asked to:* Complete three intervention periods for a duration of 2 days at their workplace,* Attend a supervised training session (60min) at the research facility at the end of each intervention period,* Attend three assessment days at the research facility where postprandial metabolism will be evaluated after a standardised meal test. ### Conditions - Sedentary Behavior - Lipid Metabolism Disorder - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Standing interruptions - Exercise bout - Sedentary ### Outcomes Primary Outcomes - Total and incremental area under the curve of postprandial response in lipid metabolism Secondary Outcomes - Total and incremental area under the curve of glucose and insulin postprandial responses - Resting metabolic rate ### Location - Facility: Hasselt University, Diepenbeek, Limburg, 3590, Belgium @@
## Effects Of Dynamic Stabilizatıon Exercises And HVLA Manipulatıon in Low Back Paın - NCT ID: NCT06277700 - Study ID: CMT001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-01 - Lead Sponsor: SEFA HAKTAN HATIK ### Study Description Our aim is to contribute to the literature by comparatively examining the effects of DNS exercises and chiropractic HVLA manipulation on pain, pain-related functional impairment (disability), physical competence level, dynamic fitness level of core muscles and postural deviations in patients with chronic nonspecific low back pain. ### Conditions - Low Back Pain - Neuromuscular Subluxation of Joint ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Chiropractic Manipulation (HVLA - high velocity low amplitude) - Dynamic Neuromuscular Stabilization ### Outcomes Primary Outcomes - Visual Analog Scale - Physical Adequacy Level - Disability Level - Dynamic Stabilization and Adaptibility - Posture Secondary Outcomes ### Location - Facility: Sefa Haktan Haktik, Sinop, N/A, N/A, Turkey @@
## Exploratory Study on the Application of Virtual Augmented Reality Combined With Finder in Preoperative Anterolateral Thigh Flap Perforator Positioning - NCT ID: NCT06277687 - Study ID: SYSKY-2024-023-02 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-01-01 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description Oral and maxillofacial region is an important anatomical part of human body, responsible for chewing, swallowing, language, expression, breathing and other physiological functions. The tissue defects in this area not only seriously affect the physiological function, but also lead to facial deformity and aesthetic damage, affecting the quality of life of patients. The anterolateral thigh flap has become one of the main methods for defect repair due to its large tissue volume and high survival rate, and one of the key steps to ensure a high survival rate is the location of the perforator. How to find the perforator more accurately by improving the detection scheme or locating the perforator according to the anatomical structure, and guide the preparation and cutting of the flap, is the main direction of current research. This study intends to conduct a exploratory study on perforator localization of flap , and explore its effectiveness and accuracy through sensitivity and specificity.In this study, a total of 24 patients with maxillofacial defects caused by tumors, trauma and other reasons requiring anterolateral femoral flap repair were included, and the perforator branch of femoral anterolateral flap was positioned preoperatively by Virtual augmented reality combined with perforator positioning device and color Doppler ultrasound. After the anterolateral thigh flap was prepared, the incision was closed in the donor area of the leg, and the flap was transplanted free to the maxillofacial defect area for repair. The sensitivity, specificity, positive predictive value, negative predictive value, distance difference and odds ratio of the two methods were calculated respectively, and the differences of each evaluation index between the two groups were compared, mainly to evaluate the sensitivity and specificity between the two groups. ### Conditions - Blood Vessel Perforation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Virtual Augmented Reality Combined With Finder ### Outcomes Primary Outcomes - Sensitivity - Specificity Secondary Outcomes - positive predictive value - negative predictive value - Youden Index ### Location - Facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guanzhou, Guangdong, 510000, China @@
## Efficacy of Cadonilimab in Non-squamous Non-small Cell Lung Cancer Patients Resistant to EGFR-TKI - NCT ID: NCT06277674 - Study ID: ZF2023-252 - Status: RECRUITING - Start Date: 2023-11-02 - Completion Date: 2025-06 - Lead Sponsor: Guangzhou University of Traditional Chinese Medicine ### Study Description This study was designed to evaluate the efficacy and safety of cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) in combination with pemetrexed and anlotinib for treatment of elderly patients with T790M-negative advanced non-squamous non-small cell lung cancer following resistance to EGFR-TKI. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cadonilimab plus Pemetrexed and Anlotinib ### Outcomes Primary Outcomes - ORR(Objective response rate) Secondary Outcomes - Progression-free survival (PFS) - (Disease control rate assessed by investigators) DCR (CR+PR+SD) - Overall survival (OS) ### Location - Facility: Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, 510120, China @@
## The Mom and Infant Outcomes (MOMI) Study - NCT ID: NCT06277661 - Study ID: 2023H0305 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-30 - Lead Sponsor: Ohio State University ### Study Description The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites. ### Conditions - Postpartum Depression - Postpartum Anxiety - Cardiometabolic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MOMI PODS - Enhanced Usual Care (EUC) ### Outcomes Primary Outcomes - Change in Life's Essential 8 (LE8) Composite Score - Change in Life's Essential 8 (LE8) Composite Score - Change in Life's Essential 8 (LE8) Composite Score - Change in Patient Health Questionnaire-9 (PHQ-9) Score - Change in Patient Health Questionnaire-9 (PHQ-9) Score - Change in Patient Health Questionnaire-9 (PHQ-9) Score - Change in Generalized Anxiety Disorder-7 (GAD-7) Score - Change in Generalized Anxiety Disorder-7 (GAD-7) Score - Change in Generalized Anxiety Disorder-7 (GAD-7) Score Secondary Outcomes ### Location - Facility: The Ohio State University, Columbus, Ohio, 43210, United States @@
## the Pericapsular Nerve Group (PENG) and Suprainguinal Fascia Iliaca Blocks (SIFIB) in Elderly Patients - NCT ID: NCT06277648 - Study ID: 18-2021 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2024-04-15 - Lead Sponsor: Haseki Training and Research Hospital ### Study Description This clinical trial aims to compare the effect of the pericapsular nerve group (PENG) and suprainguinal fascia iliaca blocks (SIFIB) on pain management in elderly patients with subtrochanteric femur fractures.The participants will be patients determined to have proximal femoral nailing. According to randomisation, each participant will receive either PENG or SIFIB postoperatively after spinal anaesthesia. The investigator will measure postoperative pain scores, total amount of analgesic consumption and motor ability postoperatively. ### Conditions - Collum Femoris Fracture - Pericapsular Nerve Group Block - Suprainguinal Fascia Iliaca Block ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - PENG block - SIFIB ### Outcomes Primary Outcomes - pain scores Secondary Outcomes - rescue analgesia ### Location - Facility: Haseki Training and Research Hospital, Istanbul, Sultangazi, N/A, Turkey @@
## Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases - NCT ID: NCT06277635 - Study ID: TAPAC001 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-04 - Lead Sponsor: Phramongkutklao College of Medicine and Hospital ### Study Description To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis ### Conditions - Rheumatoid Arthritis - Psoriatic Arthritis - Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Silymarin - Placebo ### Outcomes Primary Outcomes - AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L) Secondary Outcomes - AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN - AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L) - AST or ALT > 5X ULN or >3X ULN ( normal AST and ALT 0-50 U/L) with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice - Discontinuation rate of methotrexate - Adverse events - Change of DAS-28 ESR or CRP Score - Change of BASDAI Score - Change of ASDAS ESR or CRP Score - Change of BSA for psoriasis ### Location - Facility: Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand, 10400, Bangkok, 10400, Thailand @@
## A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral Intertrochanteric Fracture - NCT ID: NCT06277622 - Study ID: PekingUTH ZFCY PFUN - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Peking University Third Hospital ### Study Description This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of PFUN in the Chinese population, and verify the safety and efficacy of PFUN for patients with femoral intertrochanteric fracture. ### Conditions - Femoral Intertrochanteric Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PFUN - PFNA ### Outcomes Primary Outcomes - Internal fixation failure rate Secondary Outcomes - Number of Participants with Bone nonunion - Harris hip score - operation time - The times of intraoperative fluoroscopy - Number of Participants with Postoperative adverse events ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## A Trial Investigating Lu AF28996 in Healthy Adult Participants - NCT ID: NCT06277609 - Study ID: 20508A - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-05-18 - Lead Sponsor: H. Lundbeck A/S ### Study Description The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Lu AF28996 - Acetylsalicylic Acid - Mefenamic Acid - Amoxicillin/clavulanic acid ### Outcomes Primary Outcomes - Maximum Observed Concentration (Cmax) of Lu AF28996 - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996 Secondary Outcomes - Nominal Time Corresponding to the Occurrence of Cmax ### Location - Facility: Covance Dallas CRU, Dallas, Texas, 75247, United States @@
## The Effects of Progressive Clinical Pilates Exercises Applied as 2 Different Ways in Fibromyalgia - NCT ID: NCT06277596 - Study ID: ETK00-2023-0101 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-08-30 - Lead Sponsor: Eastern Mediterranean University ### Study Description The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50. ### Conditions - Fibromyalgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - Visual Analog Scale ( VAS ) Secondary Outcomes - Sociodemographic information (age) - Sociodemographic information (height) - Sociodemographic information (weight) - Trunk Muscle Endurance (McGill Endurance Test and Plank Test) - Chair Sit to stand test - 6 minute walk test - Fatigue Severity Scale - Pittsburgh Sleep Quality Index - Revised Fibromyalgia Impact Questionnaire - Fear-Avoidance Beliefs Questionnaire - Pain Self-Efficacy Questionnaire - Body Awareness Questionnaire - Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ) - Short form-36 (SF-36) - Treatment Satisfaction Evaluation ### Location - Facility: Eastern Mediterranean University, Famagusta, N/A, 99628, Cyprus @@
## Urban Care Farming on Living Well and Productive Engagement of Older Adults - NCT ID: NCT06277583 - Study ID: NUS-IRB-2023-191 - Status: RECRUITING - Start Date: 2023-11-28 - Completion Date: 2025-12-31 - Lead Sponsor: National University of Singapore ### Study Description The goal of the randomized controlled trials is to learn about the effects of urban farming interventions on older adults' physical, mental, and social well-being of older adults aged 50 and above. The main questions the study aims to answer are Q1. Would participants who have undergone the urban care farming intervention have lower stress levels compared to those who did not undergo the intervention? Q2. Would the quality of life and biopsychosocial factors of older adults who participate in the urban farming interventions be better before the intervention and compared to those who did not participate? Q3. Would running intervention programs as such demonstrate cost-effectiveness? Participants will be enrolled in 24 weekly lessons providing hands-on urban farming techniques, including physical activity, planting, and social interactions. Researchers will compare older participants with similar demographic profile to determine if the biological, psychological, and social factors are better for the intervention group. ### Conditions - Stress, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Urban care farming ### Outcomes Primary Outcomes - WHO Quality of Life Scale (WHOQOL-BREF) Secondary Outcomes - Immuno-biomarkers: IL-1RA, IL-6, IL-8 (CXCL8), IL-10, IL-13, IL-17A (CTLA-8), MIP-3 beta (CCL19), SDF-1 alpha, MMP-3, MMP-9, MCP-1 (CCL2), and TNF alpha - Brief sense of community scale (BSCS) - Fried phenotype of frailty - Lubben social network scale (LSNS-6) - Functional near-infrared spectroscopy - EQ5D - Geriatric anxiety scale (GAS-10) - MOCA - Brief resilience scale - De jong Gierveld loneliness scale - Fitbit - Body weight and height - Fasting plasma glucose, HbA1c - Serum Creatinine - Attitude towards eating healthy food - Waist and hip circumference - Blood pressure - Lipid panel - Eating fruits and vegetables behavior ### Location - Facility: NUS, Singapore, N/A, 117549, Singapore @@
## Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation in Patients With Knee Osteoarthritis. - NCT ID: NCT06277570 - Study ID: 2023-487 - Status: RECRUITING - Start Date: 2023-10-31 - Completion Date: 2025-06-30 - Lead Sponsor: Gulhane School of Medicine ### Study Description The aim of the study is to investigate the effects of superimposed neuromuscular electrical stimulation with active contraction on physical function, muscle and joint structure, functionality, and quality of life in patients with knee osteoarthritis. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - conventional physiotherapy - NMES - Superimposed NMES ### Outcomes Primary Outcomes - Muscle strength Secondary Outcomes - Joint position sense - Muscle structure and knee joint cartilage thickness - Joint range of motion - Short Form-36 - Western Ontario and McMaster Universities Osteoarthritis Index Scale - Visual Analog Scale (VAS) - Balance assessment - Functional capacity ### Location - Facility: Faculty of Physiotherapy and Rehabilitation, University of Health Sciences, Ankara, Etlik, 06018, Turkey @@
## Evaluation of the Effects of Virtual Reality Learning Environment on Nursing Student Non-technical Skills Development - NCT ID: NCT06277557 - Study ID: HSEARS20211229002 - Status: COMPLETED - Start Date: 2022-01-10 - Completion Date: 2023-08-31 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The goal of this waitlist control study is to evaluate the benefits of virtual reality teaching pedagogy to developing non-technical skills in nursing students.The main question\[s\] it aims to answer are:1. What is the relationship between VR training programs and students' situation awareness skills development?2. What is the relationship between VR training programs and students' communication skills development?3. What is the relationship between VR training programs and students' satisfaction/self-confidence in learning?4. What is the relationship between the sense of presence and satisfaction/ self-confidence in learning?5. How does the student's learning experience after VR training programs?Participants will attend the Virtual Reality training program. Researchers will compare the use of high-fidelity simulation to see if the non-technical skills were developed. ### Conditions - Educational Problems ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Virtual Reality ### Outcomes Primary Outcomes - Situation awareness and communication skills - Student's self-confidence in learning - Participants' sense of presence in this virtual clinical environment Secondary Outcomes ### Location - Facility: Timothy LAI, Kowloon, N/A, N/A, Hong Kong @@
## Analysis of Prognosis and Risk Factors of LAL Reconstruction Procedure for Patients With AF of the LAL: a Prospective Cohort Study - NCT ID: NCT06277544 - Study ID: M2024087 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-27 - Completion Date: 2026-06-30 - Lead Sponsor: Peking University Third Hospital ### Study Description To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome. ### Conditions - Avulsion Fracture of Lateral Ankle Ligament ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lateral ankle ligament repair or reconstruction ### Outcomes Primary Outcomes - Karlsson score Secondary Outcomes - Visual Analogue Scale (VAS) - American Orthopaedic Foot and Ankle Society (AOFAS) - Tegner Scale ### Location - Facility: Peking University Third Hospital, Beijing, N/A, N/A, China @@
## Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE) - NCT ID: NCT06277531 - Study ID: IRB00006761-M2024086 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-03-01 - Lead Sponsor: Peking University Third Hospital ### Study Description Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy. ### Conditions - Biliary Stricture - Bile Duct Cancer - Pancreas Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Patient is diagnosed with malignant disease from biliary system Secondary Outcomes ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 1000191, China @@
## System for Postoperative Admission to ICU for Patients With Digestive System Malignancy - NCT ID: NCT06277518 - Study ID: Liqin Deng - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-20 - Completion Date: 2026-06-20 - Lead Sponsor: General Hospital of Ningxia Medical University ### Study Description Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries. The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common complications of postoperative ICU admission were infections, especially respiratory infections and surgical site infections. A growing body of evidence supports that ICU stays are expensive, always occupy major hospital resources, and are associated with the worst outcomes. To date, there is insufficient evidence to determine which patients with digestive system tumors benefit the most from being admitted to the ICU after surgery. Therefore, this study intends to adopt retrospective study to determine the risk factors of postoperative ICU transfer for patients with digestive system malignant tumor, and build a risk prediction model for postoperative ICU admission, so as to guide the decision of postoperative ICU transfer for patients with digestive system malignant tumor. ### Conditions - Intensive Care Unit Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surgery for malignant tumors of the digestive system ### Outcomes Primary Outcomes - admitted to ICU after surgery Secondary Outcomes ### Location - Facility: General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China @@
## Efficacy and Safety Evaluation of Prebiotics Combined With Quadruple Probiotics in Improving Functional Constipation. - NCT ID: NCT06277505 - Study ID: 2023(164) - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-20 - Completion Date: 2024-06-20 - Lead Sponsor: The First Affiliated Hospital of Xiamen University ### Study Description The purpose of this study is to analyze the intestinal microecology of patients with functional constipation before and after treatment through intestinal microecological intervention, mainly using the combination of probiotics and prebiotics. We will record the patient's stool diary, including bowel movements, stool quality, bowel time, defecation difficulty, emptying sensation, manual operation and medication. At the same time, we will use the Bristol Fecal Traits Scale (BSFS) and the Constipation Patient Self-Rating Scale (PAC-SYM) and Constipation Patient Quality of Life Scale (PAC-QOL) scores completed weekly. In addition, we will monitor indicators of inflammation (IL-1β, IL-6, TNF-alpha) and intestinal barrier function (LPS), neurotransmitter (serotonin, acetylcholine)) to assess constipation improvement in patients with functional constipation. ### Conditions - Effect of Prebiotics and Probiotics on Functional Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Take prebiotics and probiotics - lifestyle guidance ### Outcomes Primary Outcomes - Change in the number of fully autonomous bowel movements per week at the end of treatment Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Xiamen Univisity, Xiamen, Fujian, 350000, China @@
## A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects - NCT ID: NCT06277492 - Study ID: GN-001 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-11-08 - Lead Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş. ### Study Description The goal of this randomized, double-blind, placebo-controlled, single-center study is to evaluate the safety, tolerability, pharmacokinetics of single and multiple oral doses of SUL-238 in healthy subjects (aged ≥40 years). ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Single ascending doses SUL-238 - Single dose Placebo - Single dose SUL-238 - Multiple ascending doses SUL-238 - Multiple doses Placebo ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria - Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges - Incidence of Treatment-Emergent Adverse Events as Measured by ECG - Incidence of Treatment-Emergent Adverse Events as Measured by physical examination and vital signs - Incidence of Treatment-Emergent Adverse Events as Measured by central nervous system (CNS) and autonomic nervous system (ANS) examination. Secondary Outcomes - PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after a single ascending dose (Part 1 and Part 2). - PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after multiple ascending doses (Part 3). - PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after single ascending dose (Part 1 and Part 2). - PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after multiple ascending doses (Part 3). - Renal clearance and percentage of drug excreted in urine after single and multiple ascending doses of SUL-238. - Percentage of drug excreted in feces after multiple ascending doses of SUL-238. - The cerebrospinal fluid (CSF) levels of SUL-238 ### Location - Facility: Erciyes University IKUM Center, Kayseri, N/A, 38030, Turkey @@
## Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study - NCT ID: NCT06277479 - Study ID: Rigshospitalet. Hematology - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03 - Completion Date: 2024-09 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life. ### Conditions - Hematological Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100) Secondary Outcomes - Health literacy Questionnaire (HLQ) - Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale ### Location - Facility: Mette Schaufuss Engedal, Copenhagen, N/A, 2100, Denmark @@
## Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls - NCT ID: NCT06277466 - Study ID: XYFY2023-KL478-01 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2028-01-31 - Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University ### Study Description In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes. ### Conditions - Type 2 Diabetes Mellitus - Gene Polymorphisms - Genetic Mutations - Susceptibility, Genetic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs - Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs ### Outcomes Primary Outcomes - Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients - Detection of T2DM susceptibility gene expression in controls - Correlation between T2DM susceptibility gene expression and clinicopathological features Secondary Outcomes - Baseline BMI of newly diagnosed with T2DM patients with different genotypes - Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes - Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes - Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes - Baseline TC of newly diagnosed with T2DM patients with different genotypes - Baseline TG of newly diagnosed with T2DM patients with different genotypes - Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes - Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes - Baseline BMI of controls with different genotypes - Baseline WHR of controls with different genotypes - Baseline FPG of controls with different genotypes - Baseline HbA1c of controls with different genotypes - Baseline TC of controls with different genotypes - Baseline TG of controls with different genotypes - Baseline HDL-C of controls with different genotypes - Baseline LDL-C of controls with different genotypes ### Location - Facility: China, Jiangsu, Department of Endocrinology, Xuzhou, N/A, 221006, China @@
## Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy - NCT ID: NCT06277453 - Study ID: 2024KY010 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-09-30 - Lead Sponsor: Fujian Medical University ### Study Description To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy. ### Conditions - Locally Advanced Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - surgery ### Outcomes Primary Outcomes - 3-year overall survival Secondary Outcomes ### Location - Facility: Department of Gastric Surgery， Fujian Medical University Union Hospital, Fuzhou, Fujian, N/A, China @@
## Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays - NCT ID: NCT06277440 - Study ID: NSTC 112-2314-B-341-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-30 - Lead Sponsor: Taipei Medical University ### Study Description To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated. ### Conditions - Attention Deficit Hyperactivity Disorders - Developmental Delays ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - cognitive training - active control ### Outcomes Primary Outcomes - Changes of executive function Secondary Outcomes - changes of symptoms of attention deficit hyperactivity disorder - changes of attention - Changes of sensory integration - changes of intelligence - changes of functional performance - Changes of family impact - Changes of quality of life - Changes in performance activity in kindergarten ### Location - Facility: Shin Kong Wu Ho-Su Memorial Hospital, Taipei, N/A, 111-01, Taiwan @@
## Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells - NCT ID: NCT06277427 - Study ID: [2023]S208 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2027-01-31 - Lead Sponsor: Lingli Dong ### Study Description Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis. ### Conditions - Lupus Nephritis - ANCA Associated Vasculitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PRG-1801 （CAR-T against BCMA） ### Outcomes Primary Outcomes - AE Incidence of PRG-1801 Single Infusion - Types and incidence of dose-limiting toxicity(DLT) after PRG-1801 cells infusion in subjects with refractory ANCA-associated vasculitis and refractory LN. Secondary Outcomes - Therapeutic effects-For refractory ANCA-associated vasculitis(The proportion of subjects who maintained remission after cell infusion) - Therapeutic effects-For refractory ANCA-associated vasculitis(Changes in VDI (Vasculitis Damage Index) scores from baseline after cell infusion) - Therapeutic effects-For refractory ANCA-associated vasculitis (Changes in glomerular filtration rate compared to baseline after cell infusion in subjects with renal involvement.) - Therapeutic effects-For refractory LN (Changes in SLEDAI-2000 score from baseline after cell infusion) - Therapeutic effects-For refractory LN (Changes in FACIT fatigue score from baseline after cell infusion ) - Therapeutic effects-For refractory LN (Changes in PGA score (0-10) from baseline after cell infusion) - Therapeutic effects-For refractory LN (Changes in eGFR(mL/min/1.73 m2) relative to baseline after cell infusion) - Therapeutic effects-For refractory LN (Changes in UPCR (g/24h）relative to baseline after cell infusion） - Therapeutic effects-For refractory LN (The proportion of subjects who achieved overall response rate after cell infusion.） - Therapeutic effects-For refractory LN（The proportion of subjects who achieved complete renal response after cell infusion.） - PK feature evaluation (PK parameters related to CAR copy number） - Serum sBCMA level - Serum ANCA titer level (AAV) - Serum dsDNA level (LN) - Serum ANA titer level (LN) - Serum complement C3 levels - Serum complement C4 levels - Serum immunoglobulin quantification - Levels of CRP levels - Levels of ferritin levels - Levels of cytokine levels - Changes of peripheral blood lymphocyte subsets - Expression levels of BCMA on peripheral blood B cell subsets surface - The level of anti drug antibody (ADA) ### Location - Facility: Tongji Hospital, Wuhan, Hubei, 430030, China @@
## a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication - NCT ID: NCT06277414 - Study ID: 2024ll0204001 - Status: RECRUITING - Start Date: 2018-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: The First Affiliated Hospital of University of South China ### Study Description To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP ### Conditions - Endoscopic Retrograde Cholangiopancreatography ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - collection of laboratory test results, imaging results and symptoms ### Outcomes Primary Outcomes - Number of Participants with Pancreatitis Secondary Outcomes - Number of Acute PEC(post-ERCP-cholecystitis ) - Number of Participants with Cholangitis - Number of Participants with Perforation - Number of Participants with bile duct stents ### Location - Facility: The First Affiliated Hospital of University of South China, Hengyang, Hunan, N/A, China @@
## Exercise in Patients With Hypermobile Joints and Knee Pain - NCT ID: NCT06277401 - Study ID: RCT_hypermobile_knee - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-06-01 - Lead Sponsor: University of Southern Denmark ### Study Description Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain. ### Conditions - Hypermobility, Joint - Hypermobility Syndrome - Knee Discomfort ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neuromuscular training for the knee - High-load strength training for the knee ### Outcomes Primary Outcomes - Visual Analogue Scale Nominated Activity Secondary Outcomes - Knee injury and Osteoarthritis Outcome Score (KOOS) - Adverse events - Dynamic knee strength - Knee reposition sense - Single-Leg-Hop for Distance ### Location - Facility: Physiotherapy Clinics Region of Southern Denmark, Odense, Fyn, 5000, Denmark @@
## Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment. - NCT ID: NCT06277388 - Study ID: GASTO-10108 - Status: RECRUITING - Start Date: 2021-06-05 - Completion Date: 2024-07-01 - Lead Sponsor: Sun Yat-sen University ### Study Description This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent combined concurrent chemoradiotherapy (CCRT) and immunotherapy. Additionally, It sought to analyze the predictive significance of cardiac parameters to both treatment toxicity and survival prognosis. ### Conditions - Non-small Cell Lung Cancer - Cardiac Toxicity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Impedance cardiography ### Outcomes Primary Outcomes - Stroke volume（SV） Secondary Outcomes ### Location - Facility: Hui Liu, Guangzhou, Guangdong, 510060, China @@
## The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia - NCT ID: NCT06277375 - Study ID: 813/793 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-09-14 - Completion Date: 2024-03-15 - Lead Sponsor: TC Erciyes University ### Study Description Fibromyalgia syndrome (FM) is defined as a non-inflammatory chronic pain syndrome with widespread pain in the musculoskeletal system, tender points (PINs) on physical examination and no specific laboratory findings. T Sampling was calculated using Power power (G Power 3.1.9.4) analysis. The effect size of the study was calculated based on the mean pain scores and standard deviations of the control and experimental groups taken from the study conducted by Field, et al. (2002). Accordingly, when 25 patients were included in each group, it was determined that the power was 85% at 5% Type I error level. The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. data will be collected with patient information form, fatigue severity scale and vas. ### Conditions - Massage Intervention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Massage ### Outcomes Primary Outcomes - VAS - Fatigue Secondary Outcomes ### Location - Facility: Dilek Efe Arslan, Kayseri, Melikgazi, 38280, Turkey @@
## Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia - NCT ID: NCT06277362 - Study ID: CLTI012023 - Status: RECRUITING - Start Date: 2020-01-31 - Completion Date: 2027-06 - Lead Sponsor: EndoCore Lab s.r.l. ### Study Description The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI. ### Conditions - Peripheral Arterial Disease - Critical Limb-Threatening Ischemia - Diabetic Foot ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Safety Composite Secondary Outcomes - Procedural Success - Primary Patency - Secondary Patency - A-V fistula flow rate - Minor amputation rates - Major amputation rates - Re-Treatment rate - Wound Size - TpcO2 - WIFi class - Freedom from all cause death - Freedom from procedure-related death - Rutherford class ### Location - Facility: Ospedale Pederzoli, Peschiera Del Garda, Veneto, 37019, Italy @@
## Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery - NCT ID: NCT06277349 - Study ID: MAUV1005 - Status: COMPLETED - Start Date: 2009-03-04 - Completion Date: 2011-01-04 - Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust ### Study Description The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery. ### Conditions - Cornea - Astigmatism - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Toric multifocal IOL - Non-toric multifocal IOL ### Outcomes Primary Outcomes - Composite scoring of unaided distance and near vision (monocularly) - Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Intravenous [Pyr1]Apelin-13 on Healthy Volunteers With Artificially Induced SIAD - NCT ID: NCT06277336 - Study ID: 2023-01716; kt23ChristCrain3 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description Hyponatremia is a common electrolyte imbalance which often results from hormonal disregulation. The study aims to investigate whether the apelin hormone, which plays a role in regulating salt and water balance in the body, can be used to treat hyponatremia.The study will involve healthy volunteers who will be given a medication that causes their bodies to retain water, thus inducing a temporary hyponatremia state. The researchers will measure the volunteers' blood and urine electrolyte levels to see how these are influenced by apelin administration. As comparison, the same measurements will be done in volunteers dosed with placebo instead of apelin.The researchers believe that apelin may be able to help to correct hyponatremia by increasing urine output. If the study focused in the healthy volunteers population is successful, the investigators will assess the effect of apelin administration in patients with chronic hyponatremia.The study's hypothesis is that intravenous apelin will increase urinary excretion and sodium levels in healthy participants with artificially induced hyponatremia. ### Conditions - SIAD - Syndrome of Inappropriate Antidiuresis - Hyponatremia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Placebo - Apelin Low Dose - Apelin High Dose - Selected Apelin Dose ### Outcomes Primary Outcomes - Total urinary excretion (ml) Secondary Outcomes - Hourly and total urinary excretion (ml) - Change in electrolyte free water clearance (ml/min) - Change in free water clearance (ml/min) - Change in plasma osmolality (mOsm/kg) - Change in plasma sodium (mmol/l) - Change in body weight (kg) ### Location - Facility: University Hospital Basel, Basel, N/A, 4031, Switzerland @@
## UCLA Health Patient Cardiology Care Gaps - NCT ID: NCT06277323 - Study ID: Cardio - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-30 - Completion Date: 2025-07-30 - Lead Sponsor: University of California, Los Angeles ### Study Description This is a prospective randomized clinical trial evaluating how two behaviorally-informed interventions (i.e., monthly report card and storyboard interventions) impact physician behavior, with the goal of closing care gaps in preventive care and disease management.In particular, the monthly report card intervention seeks to elevate physicians' intentions to close their patients' care gaps, while the storyboard intervention seeks to prompt action by making patients' care gaps salient. The trial investigates the separate and joint impacts of the proposed behaviorally-informed interventions on encouraging physicians to close their patients' care gaps. ### Conditions - Health Maintenance - Cardiology ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Monthly report card intervention - Storyboard intervention ### Outcomes Primary Outcomes - Care gap closure (patients seen) Secondary Outcomes - Care gap closure (all patients in panel) - Number of care gaps closed (patients seen) - Number of care gaps closed (all patients in panel) - HCC/RAF care gap closure (all patients in panel) ### Location - Facility: UCLA Health Department of Medicine, Quality Office, Los Angeles, California, 90095, United States @@
## Implementation of the 3 Wishes Project in Safety-Net Hospitals - NCT ID: NCT06277310 - Study ID: 3WP in SNH - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-19 - Completion Date: 2028-08 - Lead Sponsor: University of California, Los Angeles ### Study Description Dignified and compassionate end-of-life (EOL) care is a cornerstone of high-quality, patient-centered care, but in safety-net hospitals EOL care is often overlooked, considered too late, or not at all. By eliciting and implementing final wishes for dying patients, the 3 Wishes Project (3WP) has demonstrated, in tertiary academic centers, that acts of compassion can improve the EOL experience and help families cope with loss. The investigators propose to implement the 3WP in safety-net hospitals where there are less resources and more diverse, disadvantaged patient populations, and hypothesize that there will be similar positive effects on the EOL experience for patients, families, and clinicians. ### Conditions - End of Life ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - 3 Wishes Project ### Outcomes Primary Outcomes - Families' assessment of the quality of end-of-life, particularly in emotional and spiritual support. Secondary Outcomes - Family anxiety and depression - Nurse Burnout - Family PTSD ### Location - Facility: LA General Hospital, Los Angeles, California, 90033, United States @@
## Prognotic Role of CMR in Takotsubo Syndrome - NCT ID: NCT06277297 - Study ID: NP/2022/4583 - Status: RECRUITING - Start Date: 2022-11-09 - Completion Date: 2032-11 - Lead Sponsor: University of Cagliari ### Study Description The primary objective of this observational registry is to develop a comprehensive clinical and imaging score (incorporating echocardiography and cardiac magnetic resonance data) that enhances risk stratification for patients with Takotsubo syndrome.The secondary objectives of this registry are as follows:Investigate the diagnostic value of cardiac magnetic resonance parameters in predicting in-hospital and long-term outcomes in patients with Takotsubo syndrome.Compare the proposed risk stratification score for patients with Takotsubo syndrome with previously existing scores.Investigate the contribution of machine learning models in predicting in-hospital and long-term outcomes compared to standard clinical scores.The design and rationale of this registry are available at 10.1097/RTI.0000000000000709 ### Conditions - Takotsubo Cardiomyopathy - Machine Learning - Magnetic Resonance Imaging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All-cause mortality Secondary Outcomes ### Location - Facility: University of Cagliari, Cagliari, N/A, 09100, Italy @@
## Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects - NCT ID: NCT06277284 - Study ID: MG-K10-I-002 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-23 - Completion Date: 2024-04 - Lead Sponsor: Shanghai Mabgeek Biotech.Co.Ltd ### Study Description Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults ### Conditions - Pharmacokinetics ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MG-K10 humanized monoclonal antibody injection (prefilled syringe) - MG-K10 humanized monoclonal antibody injection（Penicillin bottle） ### Outcomes Primary Outcomes - Pharmacokinetic: the maximum concentration (Cmax) - Pharmacokinetic: area under the curve of o~t - Pharmacokinetic: area under the curve of o~∞ Secondary Outcomes - Safety evaluation index ### Location - Facility: The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230061, China @@
## E-cigarettes as a Harm Reduction Strategy - NCT ID: NCT06277271 - Study ID: 1901611-9 - Status: RECRUITING - Start Date: 2023-06-20 - Completion Date: 2024-03-20 - Lead Sponsor: Prisma Health-Upstate ### Study Description E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics. ### Conditions - Smoking ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - E-cigarette ### Outcomes Primary Outcomes - Percentage of people who are eligible - Percentage of consented participants - Percentage of participants who report using the e-cigarette at least once a day - Percentage of participants with at least one puff of study e-cigarette - Percentage of daily diary completed Secondary Outcomes - Cigarette dependence measured via the Fagerstrom test for nicotine dependence - Cigarette demand measured via the cigarette purchase task - Combustible cigarette smoking - Switching to e-cigarettes - Smoking reduction ### Location - Facility: Prisma Health, Greenville, South Carolina, 29609, United States @@
## Patient Empowerment in the Management of Gestational Diabetes Mellitus - NCT ID: NCT06277258 - Study ID: BSMMU/2022/9656 - Status: RECRUITING - Start Date: 2023-01-31 - Completion Date: 2024-12 - Lead Sponsor: Public Health Foundation of Bangladesh ### Study Description This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person. ### Conditions - Diabetes Mellitus in Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Patient Empowerment model ### Outcomes Primary Outcomes - Number of Participants with adverse maternal pregnancy outcome - Number of Participants with adverse foetal outcome - Number of Participants with adequate glycaemic control Secondary Outcomes - Maternal satisfaction ### Location - Facility: Azimpur Maternity hospital ( MCHTI), Dhaka, N/A, 1205, Bangladesh @@
## A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis. - NCT ID: NCT06277245 - Study ID: LK001303 - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2025-11-30 - Lead Sponsor: Lynk Pharmaceuticals Co., Ltd ### Study Description This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy. ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LNK01001 - Placebo ### Outcomes Primary Outcomes - Eczema Area and Severity Index (EASI-75) at Week 16 - Investigator's Global Assessment (IGA) score of 0/1 at Week 16 Secondary Outcomes - Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16 - Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at all visits other than Week 16. - Change from Baseline in Eczema Area and Severity Index at all visits. - Eczema Area and Severity Index (EASI 75) at all visits other than Week 16 ### Location - Facility: Dermatological Hospital of Southern Medical University, Guangzhou, N/A, N/A, China @@
## Nutrition Care in Patients Living With Chronic Pain - NCT ID: NCT06277232 - Study ID: HMV-2023-00504 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-10-31 - Lead Sponsor: Linkoeping University ### Study Description The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain.The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes. ### Conditions - Nutrition Poor - Overweight and Obesity - Mobile Phone Use - Pain, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nutrition care - Dialogue and education (part of Interdisciplinary Pain Rehabilitation Program) - activity training (part of Interdisciplinary Pain Rehabilitation Program) - meetings (part of Interdisciplinary Pain Rehabilitation Program) - Cognitive behavioral therapy (part of Interdisciplinary Pain Rehabilitation Program) - Relaxation techniques (part of Interdisciplinary Pain Rehabilitation Program) - Physical exercise (part of Interdisciplinary Pain Rehabilitation Program) ### Outcomes Primary Outcomes - Pain intensity (numeric rating scale) - Pain interference (one aspect in Multidimensional Pain inventory) - Dietary habits (a lifestyle questionnaire) - Perceived Usability (System Usability Scale) - Perceived benefit (numeric rating scale) - Adherences/ compliances of nutritional care (numeric rating scale) Secondary Outcomes - Difficulty sleeping (Insomnia Severity Index) - Emotional distress (The Hospital Anxiety and Depression Scale, HAD) - Impact of chronic pain (Multidimensional Pain inventory) - Health- related quality of life 1 (EQ-5D) - Health- related quality of life 2 (RAND-36) - Pain coping (Chronic Pain Acceptance Questionnaire, CPAQ) - Fear of movement (Tampa scale for Kinesiophobia) - Physical activity and sedentary behavior (self-estimated time, questionnaire) - Body fatness (physiological parameter) - Body weight (physiological parameter) - Biomarkers explored from blood samples (physiological parameters such as proteins, lipids, metabolites and micro-RNA) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1) - NCT ID: NCT06277219 - Study ID: LAT010-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: Latticon Antibody Therapeutics, Inc ### Study Description This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, immunogenicity, PK, PD, and antitumor activity in patients with advanced solid tumors. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - LAT010 - LAT010 + ICI ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1) - Incidence of changes in clinical laboratory values (Phase 1) - Incidence of dose-limiting toxicities (DLTs) (Phase 1) - Objective response rate (ORR) per RECIST 1.1 (Phase 2) Secondary Outcomes - Maximum plasma concentration (Cmax) of LAT010 - Area under the plasma concentration-time curve (AUC) of LAT010 - Terminal phase half-life (t1/2) of LAT010 - Time to maximum concentration of LAT010 - Trough concentration of LAT010 - Volume of distribution of LAT010 - Clearance of LAT010 - ADA occurrence and titer in serum - Objective response rate (ORR) per RECIST 1.1 (Phase 1 ) - Duration of response (DOR) - Disease control rate (DCR) - Progression-free survival (PFS) - Overall survival (OS) - Incidence of AEs and SAEs ### Location - Facility: Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States @@
## A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma - NCT ID: NCT06277206 - Study ID: FAPIPDAC02 - Status: COMPLETED - Start Date: 2021-08-04 - Completion Date: 2024-02-10 - Lead Sponsor: Zhejiang University ### Study Description To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC ### Conditions - 18F-FAPI - Pancreas Adenocarcinoma - Systemic Treatment - Pathologic Response ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 18F-FAPI PET/CT ### Outcomes Primary Outcomes - Change of Maximum standardized uptake value - Change of Mean standardized uptake value Secondary Outcomes - Maximum standardized uptake value - Mean standardized uptake value - Metabolic Tumor Volume - Total Lesion FAP expression - Change of Metabolic Tumor Volume - Change of Total Lesion FAP expression ### Location - Facility: First Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, Zhejiang, 310003, China @@
## Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients - NCT ID: NCT06277193 - Study ID: KonyaBeyhekimTRH - Status: COMPLETED - Start Date: 2020-11-03 - Completion Date: 2023-09-28 - Lead Sponsor: Konya Beyhekim Training and Research Hospital ### Study Description This study (study type: cross-sectional) aims to investigate the relationship of sarcopenia level with balance, fear of falling and risk of falling in the elderly female population. In the first stage, 166 participants were divided into two groups: sarcopenia and non-sarcopenia. Afterwards, they were categorized according to sarcopenia level (probable sarcopenia group, sarcopenia group, severe sarcopenia group, group without sarcopenia) and comparisons were made between these subgroups. Then, they were evaluated with various scales and tests (in terms of balance, fear of falling and risk of falling). ### Conditions - Sarcopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia. - Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia. - Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia. - Evaluation of balance status, fear of falling and risk of falling in patients with severe sarcopenia. ### Outcomes Primary Outcomes - Sociodemographic data - Berg Balance Scale(BBS) - Falls Efficacy Scale (FES) - Balance and Gait Assessment Scale Secondary Outcomes - Biochemical data - Co-morbidities - Number of drugs - Basic activities of daily living (Katz) - Instrumental activities of living (Lawton-Brody; IADL) - Mini-nutritional evaluation (MNA-Short form) - Mini-mental state assessment (MMSE) - Yesavage Geriatric Depression Scale Short Form (GDS-SF) - FRAIL fragility index - Short physical performance battery (SPPB) - Timed up and go test (TUG) - The Tampa Scale for Kinesiophobia (TSK) ### Location - Facility: Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic, Selçuklu, Konya, N/A, Turkey @@
## 68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC - NCT ID: NCT06277180 - Study ID: TCR-FAPI for MTC Surgery - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2027-12-31 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level. ### Conditions - Medullary Thyroid Cancer - Prositron Emission Tomography - Fibroblast Activation Protein Inhibitor - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Surgery - Surgery ### Outcomes Primary Outcomes - 1-month post-surgery calcitonin level Secondary Outcomes - 2-year event free survival - Ratio of patient that change surgical plan - Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions ### Location - Facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, N/A, 100021, China @@
## A Phase I Study of Human Interferon Alfa 1b Inhalation Solution in Healthy Participants - NCT ID: NCT06277167 - Study ID: KXZY-GB05-101 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-07 - Completion Date: 2024-05-21 - Lead Sponsor: Kexing Biopharm Co., Ltd. ### Study Description A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Human interferon alfa 1b inhalation solution - Human interferon alfa 1b inhalation solution placebo - Human interferon alfa 1b inhalation solution - Human interferon alfa 1b inhalation solution placebo ### Outcomes Primary Outcomes - TEAEs - (ADRs) - (SAE) - TEAEs that lead to subject discontinuation from the study Secondary Outcomes - Cmax After a Single Dose of GB05 Drug Product - Tmax After a Single Dose of GB05 Drug Product - AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product - t1/2 After a Single Dose of GB05 Drug Product - Ke After a Single Dose of GB05 Drug Product - Vd After a Single Dose of GB05 Drug Product - MRT After a Single Dose of GB05 Drug Product - CL After a Single Dose of GB05 Drug Product - Cmax,ss After Multiple Doses of GB05 Drug Product - Cmin,ss After Multiple Doses of GB05 Drug Product - Css_av After Multiple Doses of GB05 Drug Product - DF After Multiple Doses of GB05 Drug Product - (Cmax,ss-Cmin,ss)/Cmin,ss After Multiple Doses of GB05 Drug Product - ADA - NAb ### Location - Facility: The Third Hospital of Changsha, Changsha, N/A, N/A, China @@
## MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma - NCT ID: NCT06277154 - Study ID: MASCT-I-2004 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2027-02 - Lead Sponsor: HRYZ Biotech Co. ### Study Description This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma. ### Conditions - Leiomyosarcoma - Liposarcoma - Synovial Sarcoma - Angiosarcoma - Undifferentiated Pleomorphic Sarcoma - Epithelioid Sarcoma - Malignant Peripheral Nerve Sheath Tumors - Fibrosarcoma - Pleomorphic Rhabdomyosarcoma - Endometrial Stromal Sarcoma - Desmoplastic Small Round Cell Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MASCT-I - Doxorubicin - Ifosfamide ### Outcomes Primary Outcomes - Progression-Free Survival (PFS) Secondary Outcomes - Overall Survival (OS) - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of response (DoR) - Adverse events and serious adverse events - Adverse events and serious adverse events related to MASCT-I - Rate and severity of clinically-significant abnormalities in laboratory testings ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, N/A, N/A, China @@
## The Vitality Mammography Messaging Study - NCT ID: NCT06277141 - Study ID: M230742 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-27 - Completion Date: 2024-03-31 - Lead Sponsor: Wits Health Consortium (Pty) Ltd ### Study Description The investigators will be conducting a randomized controlled trial amongst members of a Wellness Program to test receipt of mammogram using the Whatsapp social media platform and testing various messages. ### Conditions - Breast Cancer Female ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Standard message - Radiology booking site link. - Radiology practice telephone numbers - Radiology site link and telephone numbers ### Outcomes Primary Outcomes - Comparison of mammography screening rates using WhatsApp Secondary Outcomes ### Location - Facility: University of Witwatersrand, Johannesburg, Gauteng, N/A, South Africa @@
## A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia. - NCT ID: NCT06277128 - Study ID: WS016-Ⅱ-01 - Status: RECRUITING - Start Date: 2023-09-11 - Completion Date: 2024-08-04 - Lead Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. ### Study Description The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase. ### Conditions - Hyperkalemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - WS016 3g - WS016 6g - WS016 12g - Matching Placebo ### Outcomes Primary Outcomes - Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase - Exponential rate of change in S-K levels during the maintenance treatment phase Secondary Outcomes - Mean change in S-K levels during the acute treatment phase - Proportion of participants recover from hyperkalemia - Time to normalization in S-K levels - Proportion of patients remaining normokalemic - Mean change in S-K levels during the maintenance treatment phase ### Location - Facility: Peking University People's Hospital, Beijing, Beijing, 100000, China @@
## Acute and Long-term Effects of CPAP in OSA - NCT ID: NCT06277115 - Study ID: BASEC Nr. 2020-02002 - Status: RECRUITING - Start Date: 2021-02-01 - Completion Date: 2024-12 - Lead Sponsor: University of Zurich ### Study Description Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence). ### Conditions - Obstructive Sleep Apnea of Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Continuous positive airway pressure (CPAP) ### Outcomes Primary Outcomes - Nocturnal systolic blood pressure - Epworth Sleepines Scale Score (ESS) Secondary Outcomes - 48h, 24h, diurnal and nocturnal systolic and diastolic blood pressure - Office systolic and diastolic blood pressure - 48h, 24h, diurnal, nocturnal and office heart rate - Heart rate variability in the time and frequency domain (CV, RMSSD, pRR50, LF, HF, LF/HF) - Blood pressure variability (BPV, systolic and diastolic) - Baroreflex sensitivity (BRS) - Arterial stiffness - Measures of nocturnal hypoventilation (median and maximal transcutaneous partial pressure of CO2 = tcpCO2) - Measures of nocturnal hypoxaemia (mean nocturnal oxygen saturation = ¢SpO2) - Measures of nocturnal hypoxaemia (time spent with SpO2 below 90% = t<90) - Measures of nocturnal hypoxaemia (hypoxic burden) - Measures of OSA severity (apnoea-hypopnoea-index) - Measures of OSA severity (oxygen-desaturation index) - Sleepiness (Stanford Sleepiness Scale (SSS)) - Fatigue (fatigue severity scale (FSS)) - Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ)) - Superoxide dismutase - Urinary catecholamines - Pulse rise index (>6 beats per minute) - Nocturnal oxymetry measures (¢SpO2, t<90, ODI-3%, ODI-4%) ### Location - Facility: University Hospital Zurich, Zurich, N/A, 8091, Switzerland @@
## Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture - NCT ID: NCT06277102 - Study ID: Music pain FHF - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2024-06-01 - Lead Sponsor: Hospital Authority, Hong Kong ### Study Description Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital. ### Conditions - Hip Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - music listening ### Outcomes Primary Outcomes - Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture Secondary Outcomes - Modified functional ambulatory classification (MFAC) in postoperative Day 3 among subjects with fragility hip fracture - New mobility score (NMS) in postoperative Day 3 among subjects with fragility hip fracture ### Location - Facility: Ward G9, Queen Elizabeth Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## Curve Correction of Early Onset Scoliosis by Mehta Serial Casts - NCT ID: NCT06277089 - Study ID: Correction of EOS by casts - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-09-01 - Lead Sponsor: Assiut University ### Study Description Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis ### Conditions - Scoliosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Casts ### Outcomes Primary Outcomes - Difference of the scoliotic cobb angle at last cast Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients. - NCT ID: NCT06277076 - Study ID: FMD1234 - Status: COMPLETED - Start Date: 2023-01-28 - Completion Date: 2023-08-15 - Lead Sponsor: Saint-Joseph University ### Study Description The dental implant placed freehand with a digital planing is vastly increasing. The accuracy between the planned and the placed implants still not well determined. Between a single implant and a full mouth rehabilitation, the precision is very wide. A precision scale must be settled according to each indication in order to offer the clinician a safety and a predictability for his procedures. ### Conditions - Dental Implant - Computer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Computer Implant guided Surgery ### Outcomes Primary Outcomes - Assess Accuracy of Implant Placement in Vertical Displacement (VD). - Assess Accuracy of Implant Placement in Horizontal Displacement (HD) - Assess Accuracy of Implant Placement in Error Depth (ED) - Assess Accuracy of Implant Placement in Error Angle (EA) Secondary Outcomes - Evaluate Precision of the Printed Guide - Study Complications and Adverse Events ### Location - Facility: Saint Joseph University of Beirut/Dental school, Beirut, N/A, 1107 2180, Lebanon @@
## nVNS for the Prevention and Treatment of Primary Headache - NCT ID: NCT06277063 - Study ID: NFEC-2024-057 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2026-12-30 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description This study is a single-center, randomized, double-blind controlled study. Patients will be randomly assigned to two groups by envelope drawing. The subjects will be divided into two groups: the acute intervention group and the preventive intervention group. In each group, the subjects will be randomly divided into the experimental group and the control group by means of envelope extraction.Children and adolescents (7-20 years old) with migraine who met the inclusion criteria will be enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention will be compared. The intervention method is as follows: ictal intervention, in which subjects will be evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode will be located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity will be adjusted for stimulation. Therefore, this study will verify the effect of nVNS on the acute attack and preventive treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters. ### Conditions - Primary Headache - Migraine in Adolescence - Migraine in Children - Cluster Headache - Tension Headache ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcutaneous auricular vagus nerve stimulation - Sham transcutaneous auricular vagus nerve stimulation ### Outcomes Primary Outcomes - Visual analogue scales(VAS)-actue period - Visual analogue scales(VAS)-prevention period Secondary Outcomes - Heart rate variability(HRV) - Electromyography(EMG) ### Location - Facility: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, N/A, China @@
## Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma - NCT ID: NCT06277050 - Study ID: NPC-ICMB - Status: NOT_YET_RECRUITING - Start Date: 2024-03-07 - Completion Date: 2030-02-20 - Lead Sponsor: Jiangxi Provincial Cancer Hospital ### Study Description N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure.The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy). ### Conditions - Nasopharyngeal Carcinoma - High-Risk Cancer - Maintenance Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Maintenance Therapy with Toripalimab and Capecitabine - Maintenance Therapy with Capecitabine ### Outcomes Primary Outcomes - Progression-free Survival Secondary Outcomes - Distant Metastasis-Free Survival - Overall Survival - Loco-Regional Recurrence-Free Survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729) - NCT ID: NCT06277037 - Study ID: AB-729-204 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-15 - Completion Date: 2029-10-30 - Lead Sponsor: Arbutus Biopharma Corporation ### Study Description This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study \[EOS\] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation). ### Conditions - Long Term Follow-up ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-interventional ### Outcomes Primary Outcomes - To evaluate the durability of effect of imdusiran on HBV parameters - To evaluate the durability of effect of imdusiran on HBV parameters - To evaluate the durability of effect of imdusiran on HBV parameters Secondary Outcomes ### Location - Facility: The Alfred Hospital, Melbourne, Victoria, 3004, Australia @@
## A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients - NCT ID: NCT06277024 - Study ID: FUGES-32 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2027-12-31 - Lead Sponsor: Fujian Medical University ### Study Description Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients ### Conditions - Overall Response Rate ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Combination of Cardonizumab with Lenvatinib and SOX regimen ### Outcomes Primary Outcomes - ORR Secondary Outcomes ### Location - Facility: Department of Gastric Surgery， Fujian Medical University Union Hospital, Fuzhou, Fujian, N/A, China @@
## Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research - NCT ID: NCT06277011 - Study ID: Meta10-19-004 - Status: RECRUITING - Start Date: 2023-02-10 - Completion Date: 2025-05-15 - Lead Sponsor: Anhui Provincial Hospital ### Study Description A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies ### Conditions - Acute Lymphoblastic Leukemia - Non-hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Metabolically Armed CD19 CAR-T cells ### Outcomes Primary Outcomes - MTD - Objective response rate (ORR) Secondary Outcomes - Concentration of CAR-T cells - Pharmacodynamics of CAR-T cells ### Location - Facility: Anhui Provincial Hospital, Hefei, Anhui, 518000, China @@
## A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis - NCT ID: NCT06276998 - Study ID: LK001304 - Status: RECRUITING - Start Date: 2023-12-12 - Completion Date: 2026-11-20 - Lead Sponsor: Lynk Pharmaceuticals Co., Ltd ### Study Description Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs).The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1. ### Conditions - Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LNK01001 - Placebo ### Outcomes Primary Outcomes - Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 Secondary Outcomes - Change from Baseline in Disease Activity Score 28 (DAS28) (CRP) at week 24 - Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at week 24 - Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at all visits. - Percentage of Participants with an American College of Rheumatology 70% (ACR70) Response at all visits. - Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at all visits. - Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at all visits - Percentage of Participants with an American College of Rheumatology 20% (ACR20) Response at all visits (except week 24). - Change from Baseline in the Severity of Morning Stiffness at all visits. ### Location - Facility: Peking Union Medical College Hospital, Beijing, N/A, N/A, China @@
## Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements During Clear Aligner Therapy - NCT ID: NCT06276985 - Study ID: 977/91 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-25 - Completion Date: 2024-07-25 - Lead Sponsor: Al-Azhar University ### Study Description The aim of this prospective clinical project will be to compare the effect of platelet rich fibrin versus low- intensity pulsed ultrasound on therate of different orthodontic tooth movements during clear aligner therapy. ### Conditions - Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - low intensity pulsed ultrasound and iPRF ### Outcomes Primary Outcomes - Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter Secondary Outcomes ### Location - Facility: AlAzhar university, Cairo, N/A, N/A, Egypt @@
## Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical in Scoliosis - NCT ID: NCT06276972 - Study ID: P.T.REC/012/005000 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-12 - Completion Date: 2024-03-15 - Lead Sponsor: Delta University for Science and Technology ### Study Description To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents ### Conditions - Scoliosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Cobb's angle - Coronal balance - length of the the tibia and femur - tibiofemoral angle - knee joint line convergence angle - lower limb mechanical axis; and mechanical axis deviation Secondary Outcomes ### Location - Facility: Delta university for science and technology, Gamasa, Dakahleya, 7731168, Egypt @@
## The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth - NCT ID: NCT06276959 - Study ID: WCHSIRB-D-2022-430 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-03-01 - Lead Sponsor: West China College of Stomatology ### Study Description As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies. ### Conditions - Dental Caries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - intraoral scanning - clinical oral examination - cone-beam computed tomography ### Outcomes Primary Outcomes - positive percent agreement - negative percent agreement - overall percent agreement Secondary Outcomes - Proximal caries positive site diagnosed by CBCT - Proximal caries positive site diagnosed by near-infrared imaging (NIRI) - Proximal caries positive site diagnosed by unaided visual examination (UVE) ### Location - Facility: West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, China @@
## Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia - NCT ID: NCT06276946 - Study ID: LCCC2244 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2029-01 - Lead Sponsor: UNC Lineberger Comprehensive Cancer Center ### Study Description Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering. ### Conditions - Oropharynx Cancer - Head and Neck Cancer - Xerostomia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - standard radiotherapy - experimental radiotherapy ### Outcomes Primary Outcomes - The difference in patient-reported xerostomia 6 months Secondary Outcomes - Saliva mass - Parotid duct dose constraint - The difference in patient-reported xerostomia 12 months - Xerostomia by NCI-CTCAE ### Location - Facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology, Chapel Hill, North Carolina, 27599, United States @@