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<|newrecord|> nctId: NCT06278246 id: 050/2021 briefTitle: Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2029-02 date: 2029-02 date: 2024-02-26 date: 2024-02-26 name: Centre for Addiction and Mental Health class: OTHER briefSummary: Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms. conditions: Schizophrenia conditions: Schizophreniform Disorders studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 58 type: ESTIMATED name: PET Scan measure: M4 receptor expression measure: Clinical Data Statistical Analysis measure: Statistical Analysis of Cognitive Data measure: Statistical Analysis of Psychopathological Personality Traits in Health Control Group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Addiction and Mental Health city: Toronto state: Ontario zip: M5T1R8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06278233 id: 2023/85-70 briefTitle: Bihemispheric Transcranial Direct Current Stimulation* on Speech Fluency acronym: TDCS overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-09 date: 2024-02-26 date: 2024-02-26 name: Biruni University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this study, a double-blind, randomized controlled research design from experimental research methods will be applied. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: One researcher not involved in any aspect of the study will randomize participants to the sham and tDCS study arms using blocked randomization. To ensure blinding, one researcher will record the administration of the tDCS and assessments, while independent speech-language pathologists will monitor the assessment recordings and score the test items. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Transcranial direct current stimulation measure: Disfluent syllables measure: Stuttering Severity Instrument- Fourth Edition (SSI-IV) score measure: The Overall Assessment of the Speaker's Experience of Stuttering (OASES) score sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Biruni University status: RECRUITING city: Istanbul state: Zeytinburnu zip: 34015 country: Turkey name: Feyzanur Ocak, Slp role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06278220 id: Corneal HOA briefTitle: Scheimpflug Versus Placido-disc System in Evaluation of Corneal Higher-Order Aberrations overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07 date: 2027-02 date: 2024-02-26 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: Aim of work:
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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 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam ) measure: Agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (pentacam) measure: Changes in high order aberrations after LASIK. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Naglaa Moustafa city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06278207 id: 22731 briefTitle: 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 acronym: FINEROD overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-30 date: 2024-06-30 date: 2024-02-26 date: 2024-04-18 name: Bayer class: INDUSTRY briefSummary: 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.
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The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.
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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 conditions: Type 2 Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2500 type: ESTIMATED name: Finerenone (BAY 94-8862) measure: Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone. measure: Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone. measure: Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone. measure: Proportion of finerenone initiators with and without UACR measurements at baseline measure: Mean UACR in the subcohort with UACR measurements measure: Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone. measure: Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone. measure: Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone. measure: Number of participants who initiate finerenone at a 10 mg dose daily measure: Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark measure: 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 measure: Number of participants who initiate finerenone at a 20 mg dose daily measure: Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark measure: 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 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer status: RECRUITING city: Berlin zip: 13353 country: Germany lat: 52.52437 lon: 13.41053 facility: Many Locations status: COMPLETED city: Multiple Locations country: Japan hasResults: False
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<|newrecord|> nctId: NCT06278194 id: 22.11.2023.589 briefTitle: Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-07-15 date: 2024-11-15 date: 2024-02-26 date: 2024-02-26 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: 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.
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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.
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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 conditions: Gasserian Ganglion; Lesion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Gasserian Ganglion Radiofrequency Thermocoagulation measure: Masseter muscle thickness measure: Masseter muscle thickness measure: Masseter muscle thickness sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278181 id: 2023/08/1545 briefTitle: Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon overallStatus: RECRUITING date: 2023-09-21 date: 2024-12-30 date: 2025-01-30 date: 2024-02-26 date: 2024-03-01 name: Karolinska Institutet class: OTHER name: University of Dschang name: European Foundation for the Study of Diabetes briefSummary: 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 conditions: Diabetes Mellitus conditions: Metabolic Syndrome conditions: Endemic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: asymptomatic malaria measure: symptomatic malaria measure: schistosoma infection measure: strongyloides infection sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Limbe Regional Hospital status: RECRUITING city: Limbe country: Cameroon name: George Awungafac, MD role: CONTACT phone: +23779750125 email: [email protected] lat: 4.02356 lon: 9.20608 hasResults: False
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<|newrecord|> nctId: NCT06278168 id: CNR-IRIB-PRO-2024-002 briefTitle: Awareness Training in Children With Autism Spectrum Disorder. overallStatus: RECRUITING date: 2023-06-12 date: 2024-06-01 date: 2025-05-08 date: 2024-02-26 date: 2024-02-26 name: Istituto per la Ricerca e l'Innovazione Biomedica class: OTHER name: Messina, Italy briefSummary: 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 conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Awareness training with using Oculus. name: Awareness training without using Oculus measure: Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) measure: Multidimensional Anxiety Scale for Children-Second Edition (MASC 2) measure: Screen for Child Anxiety Related Disorders (SCARED) sex: ALL minimumAge: 8 Years maximumAge: 14 Years stdAges: CHILD facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) status: RECRUITING city: Messina zip: 98164 country: Italy name: Flavia Marino role: CONTACT phone: +393395798263 email: [email protected] name: Maria Valeria Maiorana role: CONTACT phone: +393285856656 email: [email protected] name: Flavia Marino role: PRINCIPAL_INVESTIGATOR name: Germana Doria role: SUB_INVESTIGATOR name: Chiara Failla role: SUB_INVESTIGATOR name: Noemi Vetrano role: SUB_INVESTIGATOR name: Ileana Scarcella role: SUB_INVESTIGATOR name: Roberta Minutoli role: SUB_INVESTIGATOR name: Paola Chilà role: SUB_INVESTIGATOR name: Giovanni Pioggia role: SUB_INVESTIGATOR name: Gennaro Tartarisco role: SUB_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False
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<|newrecord|> nctId: NCT06278155 id: CNR-IRIB-PRO-2024-001 briefTitle: Social Relations Training for Children With ASD overallStatus: RECRUITING date: 2023-04-17 date: 2025-01-15 date: 2025-04-28 date: 2024-02-26 date: 2024-02-26 name: Istituto per la Ricerca e l'Innovazione Biomedica class: OTHER name: Messina, Italy briefSummary: 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.
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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.
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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.
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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.
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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 conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Social relation training with social robot name: Traditional social relations training measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form) sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) status: RECRUITING city: Messina zip: 98164 country: Italy name: Flavia Marino role: CONTACT phone: +393395798263 email: [email protected] name: Giovanni Pioggia role: CONTACT phone: +393203390892 email: [email protected] name: Flavia Marino role: PRINCIPAL_INVESTIGATOR name: Germana Doria role: SUB_INVESTIGATOR name: Chiara Failla role: SUB_INVESTIGATOR name: Noemi Vetrano role: SUB_INVESTIGATOR name: Ileana Scarcella role: SUB_INVESTIGATOR name: Roberta Minutoli role: SUB_INVESTIGATOR name: Paola Chilà role: SUB_INVESTIGATOR name: Giovanni Pioggia role: SUB_INVESTIGATOR name: Alfio Puglisi role: SUB_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False
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<|newrecord|> nctId: NCT06278142 id: ERTELEME_1 briefTitle: Web-Based Cognitive Behavior Therapy for Procrastination overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-07 date: 2024-02-26 date: 2024-02-26 name: Anadolu University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: Internet Based Intervention - GUIDED name: Internet Based Intervention - WİTHOUT GUİDANCE measure: Tuckman Procrastination Behaviour Scale measure: Cognitive Distortions Questionnaire measure: Time Management Scale measure: Attitude Scale for Internet-Based Interventions measure: Depression Anxiety Stress Scale-21 (DASS-21) measure: Sociodemographic Information Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278129 id: 4146 briefTitle: Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease acronym: MRI_SSHL/MD overallStatus: RECRUITING date: 2018-06-19 date: 2021-04-23 date: 2025-12-31 date: 2024-02-26 date: 2024-02-26 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: 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 conditions: Meniere Disease conditions: Ménière's Vertigo conditions: Meniere's Disease Aggravated conditions: Inner Ear Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: Vestibular myogenic potentials measure: Evaluation of inner ear structures in MRI images sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Audiology and Neuroradiology - Milan (Italy) status: RECRUITING city: Milan zip: 20133 country: Italy name: Diego Zanetti, MD Prof role: CONTACT phone: 00390255033936 email: [email protected] name: Federica Di Berardino, MD Prof role: PRINCIPAL_INVESTIGATOR name: Giorgio Conte, MD Prof role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06278116 id: 2024-ALIGNERSCLEANSIGN briefTitle: Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing overallStatus: RECRUITING date: 2024-03-01 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-03-05 name: University of Pavia class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Aligners cleansing with water name: Aligners cleansing with dish soap Svelto name: Aligners cleansing with Polident Antibacterial Denture Cleaner name: Aligners cleansing with Invisalign Cleaning Crystals name: Aligners cleansing with Geldis measure: Change in adsorbance (A) value measure: Changes in patient's perception measure: Changes in Probing Pocket Depth (PPD) values measure: Changes in Gingival Index (GI) values measure: Changes in Bleeding on probing (BOP) measure: Change in Schiff Air Index - Dental sensitivity test measure: Change of the BEWE Index Basic Erosive Wear Examination measure: Change in plaque index (PI): sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia status: RECRUITING city: Pavia state: Lombardy zip: 27100 country: Italy name: Andrea Scribante, DDS, PhD role: CONTACT phone: +39 0382516223 email: [email protected] lat: 45.19205 lon: 9.15917 hasResults: False
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<|newrecord|> nctId: NCT06278103 id: 2023PI113 briefTitle: Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas (MethylRH-M) acronym: MethylRH-M overallStatus: ENROLLING_BY_INVITATION date: 2000-01-01 date: 2024-07-01 date: 2024-09-01 date: 2024-02-26 date: 2024-02-26 name: Central Hospital, Nancy, France class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 180 type: ESTIMATED measure: immunohistochemical expression of different hormonal receptors measure: methylation profile of the promoters of hormonal receptor genes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278090 id: AUDC briefTitle: Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution acronym: GALPOL overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-02 date: 2026-07 date: 2024-02-26 date: 2024-02-28 name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz class: OTHER briefSummary: 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:
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• Whether ursodeoxycholic acid could decrease the gallbladder polyp size and therefore spare unnecessary follow up or surgical interventions
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Participants will be managed according to the standard practice of the department they are attended:
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* 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.
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* According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.
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Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly. conditions: Gallbladder Polyp studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: Ursodeoxycholic Acid Only Product measure: Reducing gallbladder polyp size by 2mm or more measure: Modification of the expected follow up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278077 id: C2104 id: 2022-003565-38 type: EUDRACT_NUMBER briefTitle: Neurexan - a Clinical Trial in Short-Term Insomnia Patients overallStatus: RECRUITING date: 2023-09-04 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Biologische Heilmittel Heel GmbH class: INDUSTRY briefSummary: 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.
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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.
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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.
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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 conditions: Stress Reaction studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, active- and placebo-controlled confirmatory clinical trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All involved personnel at the investigational site, the Sponsor (except production unit) and the CRO (except independent biostatistician for performing the randomization) will be blinded during the trial. The Investigator keeps the sealed treatment code envelopes throughout the course of the trial for the individual patients and must not break the code without a valid reason (e.g., in case of emergency). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Neurexan name: Placebo measure: Change from baseline in Sleep Efficiency. measure: Change from baseline in sleep pattern characterized by Number of Awakenings. measure: Change from baseline in daytime performance assessed by Epworth Sleepiness Scale patient questionnaire. measure: Ecological Momentary Assessments - continuous daily stress assessment. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jena University Hospital, Department of Psychiatry & Psychotherapy status: RECRUITING city: Jena state: Thuringia zip: 07743 country: Germany name: Martin Walter, MD role: CONTACT phone: +49 (0)3641 9390101 email: [email protected] lat: 50.92878 lon: 11.5899 hasResults: False
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<|newrecord|> nctId: NCT06278064 id: BFHHZML20240006 briefTitle: Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis overallStatus: RECRUITING date: 2024-02-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-26 date: 2024-02-26 name: Beijing Friendship Hospital class: OTHER briefSummary: 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 conditions: Esophagus Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 562 type: ESTIMATED name: Gastric Cancer name: Esophagus Cancer measure: Plasma proteins in patients with gastric cancer measure: Plasma proteins in patients with esophagus cancer sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China name: Lianmei Zhao, Ph.D. role: CONTACT lat: 38.04139 lon: 114.47861 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing country: China name: Li Min, Ph.D. role: CONTACT name: Li Min, Ph.D role: PRINCIPAL_INVESTIGATOR name: Chenjie Xu, Ph.D role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Cancer Hospital Chinese Academy of Medical Sciences status: RECRUITING city: Beijing country: China name: Yibin Xie, Ph.D role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06278051 id: 21411 briefTitle: An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism overallStatus: RECRUITING date: 2024-02-19 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-04-18 name: Bayer class: INDUSTRY name: Janssen Pharmaceutical Companies (formerly Johnson & Johnson Pharmaceutical Research & Development L.L.C.) briefSummary: 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.
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Venous thromboembolism (VTE) is a condition in which people have problems due to the formation of blood clots in their veins.
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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.
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Warfarin is another blood thinner that is available for VTE. In this study warfarin is the reference drug.
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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.
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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.
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In addition, this study will help learn more about the following in children with VTE:
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* The occurrence of major bleeding during treatment with rivaroxaban and during treatment with warfarin
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* 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
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* 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
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* 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.
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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.
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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.
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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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Rivaroxaban granules for oral suspension name: Warfarin measure: Incidence of major bleeding in participants treated with rivaroxaban measure: Clinical characteristics and demographics of participants with pediatric VTE treated with rivaroxaban measure: Incidence of major bleeding in participants treated with warfarin measure: Incidence of bleeding important in pediatrics in participants treated with rivaroxaban and treated with warfarin as reference measure: Incidence of major bleeding and bleeding important in pediatrics in participants treated with rivaroxaban and in special target patient groups sex: ALL minimumAge: 0 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Many facilities status: RECRUITING city: Multiple Locations country: Japan facility: Bayer status: RECRUITING city: Osaka zip: 530-0001 country: Japan lat: 34.69374 lon: 135.50218 hasResults: False
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<|newrecord|> nctId: NCT06278038 id: NO.0057 in 2024 Ethical Review briefTitle: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-29 name: First Affiliated Hospital of Zhejiang University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Toludesvenlafaxine hydrochloride sustained-release tablets name: Venlafaxine hydrochloride sustained-release tablets measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score measure: Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate measure: Dimensional Anhedonia Rating Scale (DARS) Score measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score measure: Sheehan Disability Scale (SDS) Score measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score measure: Treatment Emergent Symptom Scale (TESS) Score measure: Arizona Sexual Experience Scale (ASEX) Score measure: Count of red blood cell in blood measure: Count of white blood cell in blood measure: Count of platelet in blood measure: Concentration of hemoglobin in blood measure: Concentration of alanine aminotransferase in blood measure: Concentration of aspartate aminotransferase in blood measure: Concentration of gamma-glutamyltransferase in blood measure: Concentration of blood glucose in blood measure: Concentration of serum creatinine in blood measure: Concentration of urea in blood measure: Concentration of total cholesterol in blood measure: Concentration of high density lipoprotein in blood measure: Concentration of low density lipoprotein in blood measure: Concentration of triglyceride in blood measure: Concentration of protein in urine measure: Concentration of sugar in urine measure: Count of white blood cell in urine measure: Count of red blood cell in urine measure: ECG QT Interval measure: Changes in weight measure: Changes in pulse measure: Changes in both systolic and diastolic blood pressure measure: Changes in respiration rate measure: Changes in armpit temperature sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278025 id: GO 19/833 briefTitle: Dysphagia and Deep Cervical Flexor Muscles overallStatus: COMPLETED date: 2019-09-01 date: 2024-02-01 date: 2024-02-01 date: 2024-02-26 date: 2024-03-18 name: Atılım University class: OTHER briefSummary: 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 conditions: Neurological Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL name: assessment measure: dcf muscle strenght measure: dcf endurance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atilim University city: Ankara state: Incek zip: 06830 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06278012 id: E-59394181-604.01.02-32288 briefTitle: Development of Atılım Kinesiophobia Scale overallStatus: RECRUITING date: 2024-01-01 date: 2024-03-30 date: 2024-03-30 date: 2024-02-26 date: 2024-04-01 name: Atılım University class: OTHER briefSummary: Background:
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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.
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Aim: The aim of this study is to develop and validate the Turkish Atılım Kinesiophobia Scale.
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Material/method:
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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 conditions: Acute Pain conditions: Chronic Pain conditions: Fear of Movement studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED measure: The pilot study of the scale will be conducted with a total of 40 patients, 10 participants for each patient group. measure: 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. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atılım University status: RECRUITING city: Ankara country: Turkey name: Naime Uluğ, PhD. role: CONTACT phone: +905365434409 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06277999 id: D8820C00001 briefTitle: C.Difficile Observational Study overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2024-10-11 date: 2024-10-11 date: 2024-02-26 date: 2024-02-26 name: AstraZeneca class: INDUSTRY briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Number of participants that completed key study activities according to protocol measure: Time intervals across stool sample collection logistics measure: Participant Experience and site staff evaluation questionnaires measure: Gather information to assess logistics, resourcing and performance of different toxin detection assays (eg. EIA, PCR, CCNA) sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06277986 id: KY20212018-F-2 briefTitle: Early Diagnosis of Gastric Cancer Cachexia overallStatus: RECRUITING date: 2021-06-01 date: 2024-09-01 date: 2024-09-01 date: 2024-02-26 date: 2024-02-26 name: Xijing Hospital class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: cachexia measure: BMI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fourth Military Medical University status: RECRUITING city: Xi'an state: Shaanxi country: China name: Jipeng Li role: CONTACT phone: +86-029-84771533 lat: 34.25833 lon: 108.92861 hasResults: False
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<|newrecord|> nctId: NCT06277973 id: 0007551-2 briefTitle: Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-05 date: 2024-02-26 date: 2024-03-27 name: Tel Aviv University class: OTHER briefSummary: 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 conditions: Acute Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly allocated to one of the following groups: the experiment group and the waiting list group. Each group will receive the intervention but in the waiting list group this will occur a week later:
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Experiment group:
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Day 1 - questionnaires (T1) Day 4 - intervention Day 7 - questionnaires (T2) Day 97 - follow up questionnaires (T3)
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Waiting list group:
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Day 1 - questionnaires (T0) Day 7 - questionnaires (T1) Day 11- intervention Day 14- questionnaires (T2) Day 104- follow up questionnaires (T3) The parallel element of this model lies in the first week of the study: the experiment group goes through 2 measurements with the intervention in the middle of the week, whereas the waiting list group goes through 2 measurements without the intervention. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants will be informed that the intervention will occur between 2 days and 14 days and that they will fill 3-4 surveys. They will not be aware that there are two groups. whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Eye Movement Desensitization and Reprocessing (EMDR) measure: PCL-5 (Posttraumatic Stress Disorder Checklist) measure: GAD-7 (General Anxiety Disorder-7) measure: SSASI (The Short Scale Anxiety Sensitivity Index) measure: BSI 18 (Brief Symptom Inventory) measure: DES-II (Dissociative Experiences Scale) measure: DERS (Difficulties in Emotion Regulation Scale) measure: NSESSS (The National Stressful Events Survey Acute Stress Disorder Short Scale) measure: SASRQ (Stanford Acute Stress Reaction Questionnaire) measure: Exposure to traumatic event during the current war measure: PDEQ (Peritraumatic Dissociative Experiences Questionnaire) measure: TIS (Tonic Immobility Scale) measure: PDI (The Peritraumatic Distress Inventory) measure: Questionnaires to test user experience of the system measure: Questionnaire for examining the experience of the intervention measure: Qualitative interview measure: Questionnaire regarding receiving emotional treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tel Aviv University city: Tel Aviv country: Israel lat: 32.08088 lon: 34.78057 hasResults: False
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<|newrecord|> nctId: NCT06277960 id: CNS2301 briefTitle: Septal Ablation for Obstructive HCM overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-06-30 date: 2024-11-30 date: 2024-02-26 date: 2024-02-26 name: SuZhou Sinus Medical Technologies Co.,Ltd class: INDUSTRY briefSummary: 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.
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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.
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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) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: percutaneous intramyocardial septal radiofrequency ablation system measure: 30-day major adverse clinical events (MACE) measure: Technical success rate measure: Short Form 36 (SF-36) health survey questionnaire measure: Improvement of left ventricular outflow tract gradient (LVOTG) measure: Improvement of NYHA functional classification measure: 6-min walk distance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Run Run Shaw Hospital city: Hangzhou state: Zhejiang zip: 310016 country: China name: Yaxun Sun, MD role: CONTACT phone: +86 15057173170 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06277947 id: SYSKY-2024-096-01 briefTitle: Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward acronym: GARD-HIPEC overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2025-05 date: 2024-02-26 date: 2024-02-26 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER name: Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients would receive C-HIPEC in the general ward after interval debulking surgery in 24 hours. primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC) measure: The incidence of adverse events of grade 3-5 measure: Time to progress (TTP) measure: The Time to the First Subsequent Therapy，TTFST measure: Quality of life, QLQ-C30 sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University city: Guangzhou country: China lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06277934 id: RGT001-075-203 briefTitle: A Study of RGT001-075 in Adult Patients With Obesity overallStatus: RECRUITING date: 2024-03-08 date: 2024-06 date: 2024-07 date: 2024-02-26 date: 2024-04-04 name: Regor Pharmaceuticals Inc. class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: RGT001-075 name: Placebo measure: 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 measure: Percent change in body weight measure: Change in body weight in kilogram measure: Percentage of participants who achieve ≥5% and ≥10% body weight reduction measure: Change in Body mass index (BMI) in kg/m^2 measure: Change in waist circumference in centimetre measure: RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last) measure: RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf) measure: RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax) measure: RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax) measure: RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research status: RECRUITING city: Los Angeles state: California zip: 90057 country: United States name: David Guzman, MD role: CONTACT lat: 34.05223 lon: -118.24368 facility: Velocity Clinical Research status: RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States name: Robert Buynak, MD role: CONTACT lat: 41.47309 lon: -87.06114 facility: Velocity Clinical Research status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States name: Frederick Raiser, MD role: CONTACT lat: 41.25626 lon: -95.94043 facility: Velocity Clinical Research status: RECRUITING city: Vestal state: New York zip: 13850 country: United States name: Eric Lorraine, MD role: CONTACT lat: 42.08507 lon: -76.05381 facility: Velocity Clinical Research status: RECRUITING city: Durham state: North Carolina zip: 27701 country: United States name: William Cromwell, MD role: CONTACT lat: 35.99403 lon: -78.89862 facility: Velocity Clinical Research status: RECRUITING city: Cleveland state: Ohio zip: 44122 country: United States name: Margaret Rhee, MD role: CONTACT lat: 41.4995 lon: -81.69541 facility: Velocity Clinical Research status: RECRUITING city: Medford state: Oregon zip: 97504 country: United States name: Sarah Smiley, MD role: CONTACT lat: 42.32652 lon: -122.87559 facility: Velocity Clinical Research status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States name: David Fried, MD role: CONTACT lat: 41.66038 lon: -71.45589 facility: Velocity Clinical Research status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender, MD role: CONTACT lat: 32.78306 lon: -96.80667 facility: Velocity Clinical Research status: RECRUITING city: West Jordan state: Utah zip: 84088 country: United States name: Barbara Rizzardi, MD role: CONTACT lat: 40.60967 lon: -111.9391 hasResults: False
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<|newrecord|> nctId: NCT06277921 id: 110-2 briefTitle: Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery acronym: ESOSTAT overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-09-18 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: P. Herzen Moscow Oncology Research Institute class: OTHER_GOV name: National Medical Research Radiological Centre of the Ministry of Health of Russia briefSummary: 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.
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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 conditions: Oesophageal Cancer conditions: Siewert Type I Adenocarcinoma of Esophagogastric Junction conditions: Siewert Type III Adenocarcinoma of Esophagogastric Junction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Elective Surgery for gastric cancer measure: the type of complications and the incidence of it sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.S. Loginov Moscow Clinical Scientific Center city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: I.M. Sechenov First Moscow State Medical University city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: P.Herzen Moscow Oncological Research Institute city: Moscow country: Russian Federation name: Andrey Ryabov role: CONTACT name: Nuriddin Abdulkhakimov role: CONTACT lat: 55.75222 lon: 37.61556 facility: Petrovsky National Research Centre of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Vishnevsky National Medical Research Center of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Oncological Dispensary city: Nizhny Novgorod country: Russian Federation lat: 56.32867 lon: 44.00205 facility: A.Tsyb Medical Radiological Research Centre city: Obninsk country: Russian Federation lat: 55.09681 lon: 36.61006 facility: National Medical Research Centre for Oncology city: Rostov-on-Don country: Russian Federation lat: 47.23135 lon: 39.72328 facility: Petrov National Medical Research Center of Oncology city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 hasResults: False
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<|newrecord|> nctId: NCT06277908 id: 110-1 briefTitle: Postoperative Morbidity and Mortality After Gastric Cancer Surgery acronym: GASTROSTAT overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-09-18 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: P. Herzen Moscow Oncology Research Institute class: OTHER_GOV name: National Medical Research Radiological Centre of the Ministry of Health of Russia briefSummary: 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 conditions: Siewert Type III Adenocarcinoma of Esophagogastric Junction conditions: Stomach Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 700 type: ESTIMATED name: Elective Surgery for gastric cancer measure: the type of complications and the incidence of it sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.S. Loginov Moscow Clinical Scientific Center city: Moscow country: Russian Federation name: Roman Izrailov role: CONTACT name: Nikolay Semenov role: CONTACT lat: 55.75222 lon: 37.61556 facility: A.Tsyb Medical Radiological Research Centre city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: I.M. Sechenov First Moscow State Medical University city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: P.Herzen Moscow Oncological Research Institute city: Moscow country: Russian Federation name: Andrey Ryabov role: CONTACT name: Nuriddin Abdulkhakimov role: CONTACT lat: 55.75222 lon: 37.61556 facility: Petrovsky National Research Centre of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Vishnevsky National Medical Research Center of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Oncological Dispensary city: Nizhny Novgorod country: Russian Federation lat: 56.32867 lon: 44.00205 facility: National Medical Research Centre for Oncology city: Rostov-on-Don country: Russian Federation lat: 47.23135 lon: 39.72328 facility: Petrov National Medical Research Center of Oncology city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 hasResults: False
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<|newrecord|> nctId: NCT06277895 id: KYLL-202401-047 briefTitle: VOCs in Patients With Acute Cardiogenic Chest Pain overallStatus: RECRUITING date: 2024-01-26 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Qilu Hospital of Shandong University class: OTHER briefSummary: 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 pain
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1. 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.
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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 conditions: Acute Aortic Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1400 type: ESTIMATED name: VOCs measure: Baseline VOCs (aldehydes) levels in healthy population measure: MACE in patients with cardiogenic chest pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: yuan bian role: CONTACT phone: 18560084775 email: [email protected] lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06277882 id: Si 067/2024 briefTitle: Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis overallStatus: RECRUITING date: 2024-02-29 date: 2025-03-01 date: 2025-05-31 date: 2024-02-26 date: 2024-03-19 name: Mahidol University class: OTHER briefSummary: 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.
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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 population
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HAV 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.
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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.
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The main questions it aims to answer are:
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* 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.
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* 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 conditions: Hep A conditions: Vaccination studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: HAVRIX measure: Post-vaccination serological response rate measure: Post-vaccination serological response measure: Post-vaccination serological response measure: Anti-hepatitis A Virus (HAV) antibody at month 1 measure: Anti-hepatitis A Virus (HAV) antibody at month 7 measure: Anti-hepatitis A Virus (HAV) antibody at 1 year sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Siriraj Hospital status: RECRUITING city: Bangkok Noi state: Bangkok zip: 10700 country: Thailand name: Watcharasak Chotiyaputta, Asso Prof role: CONTACT phone: 6624197281 email: [email protected] lat: 13.76266 lon: 100.47798 hasResults: False
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<|newrecord|> nctId: NCT06277869 id: PR-22146 briefTitle: Effectiveness Trial of Thermal Jacket overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-22 date: 2024-12-31 date: 2024-02-26 date: 2024-03-07 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh name: Directorate General of Health Services (DGHS), Bangladesh name: Poeticgem International Ltd briefSummary: 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.
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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.
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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.
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Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh.
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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 conditions: Low Birthweight Neonate studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Stepped wedge cluster randomised trial primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Thermal Jacket name: Kangaroo Mother Care measure: Body temperature of preterm or low birthweight neonates maintain the euthermic range. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Lakshmipur District Hospital status: RECRUITING city: Lakshmipur state: Chattogram zip: 3700 country: Bangladesh name: Ahmed Kabir, MBBS role: CONTACT phone: 01842587456 email: [email protected] lat: 22.9443 lon: 90.83005 facility: Kushtia 250 Bedded General Hospital status: RECRUITING city: Kushtia state: Khulna zip: 7000 country: Bangladesh name: Md. Rafiqul Islam, MBBS role: CONTACT phone: 01829699289 email: [email protected] lat: 23.9028 lon: 89.11943 facility: Jamalpur 250 Beded General Hospital status: NOT_YET_RECRUITING city: Jamalpur state: Mymensingh zip: 2000 country: Bangladesh name: Muhammad Mahfuzur Rahman, MBBS role: CONTACT phone: 01716267689 email: [email protected] lat: 24.91965 lon: 89.94812 hasResults: False
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<|newrecord|> nctId: NCT06277856 id: Aysun Eksioglu id: Ayse Akyar type: OTHER domain: Ege University briefTitle: Peer Interaction of Primiparas Sharing a Room With Multiparas With Successful Breastfeeding Experience overallStatus: RECRUITING date: 2023-09-15 date: 2024-06-15 date: 2024-09-15 date: 2024-02-26 date: 2024-02-26 name: Ege University class: OTHER briefSummary: 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.
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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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: In order to eliminate selection bias in the study, "block randomisation" method, one of the fixed probability randomisation methods, will be used and women who meet the inclusion criteria will be distributed to the intervention and control groups. whoMasked: INVESTIGATOR count: 128 type: ESTIMATED name: Peer interaction/control measure: breastfeeding self-efficacy measure: exclusive breastfeeding rate sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Ege University status: RECRUITING city: Izmir zip: 35100 country: Turkey name: Ayşe Akyar, Midwife role: CONTACT phone: +905538507280 email: [email protected]; lat: 38.41273 lon: 27.13838 hasResults: False
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<|newrecord|> nctId: NCT06277843 id: PR-21131 briefTitle: Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates. overallStatus: COMPLETED date: 2022-06-13 date: 2022-09-01 date: 2022-09-30 date: 2024-02-26 date: 2024-02-26 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh name: Directorate General of Health Services (DGHS), Bangladesh name: Poeticgem International Ltd name: University of Dhaka briefSummary: 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.
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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.
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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.
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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 conditions: Low Birthweight conditions: Hypothermia Neonatal studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm non-randomized trial primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: Thermal Jacket measure: Body temperature of preterm or low birthweight neonates and duration of time in euthermic range. sex: ALL minimumAge: 0 Hours maximumAge: 72 Hours stdAges: CHILD facility: Bangabandhu Sheikh Mujib Medical University (BSMMU) city: Dhaka zip: 1000 country: Bangladesh lat: 23.7104 lon: 90.40744 hasResults: False
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<|newrecord|> nctId: NCT06277830 id: 2023P002788 briefTitle: Physical Activity Monitoring in Myasthenia Gravis overallStatus: RECRUITING date: 2024-02-14 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-03-04 name: Massachusetts General Hospital class: OTHER name: BioSensics briefSummary: 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).
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The main question\[s\] it aims to answer are:
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* 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.
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* To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures.
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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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED name: Wearable sensor measure: Primary outcome measure: Exploratory outcome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Carina Stafstrom, BS role: CONTACT email: [email protected] role: CONTACT phone: 617-726-5175 lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06277817 id: 2021/1916 briefTitle: The Effect of Chest Physiotherapy Methods Applied Before Aspiration on Respiratory Characteristics overallStatus: COMPLETED date: 2021-05-19 date: 2021-06-25 date: 2022-10-24 date: 2024-02-26 date: 2024-02-26 name: Inonu University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The randomization of this study was performed by a statistical expert independent of the study, using the computer-assisted Random Allocation Rule method, which is one of the random assignment methods (http://biostatapps.inonu.edu.tr/RAY/).78 patients to be included in the study were divided into 3 groups and assigned an equal number of patients in each group according to the results of the random assignment method. In order to assign patients to research groups impartially, the research groups determined were written on papers and group assignments were made by drawing lots. Thus, the number of individuals in the groups and the probability of each patient included in the study being in either of the experimental or control groups were equalized. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 78 type: ACTUAL name: expiratory rib cage compression name: percussion vibration measure: The effect of percussion vibration on the amount of secretion measure: Effect of expiratory rib cage compression on the amount of secretion measure: Effect of percussion vibration on blood gas parameters measure: Effect of expiratory rib cage compression on blood gas parameters measure: Perküsyon vibrasyonun yaşam bulgularına etkisi measure: Effect of expiratory rib cage compression on vital signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tunceli State Hospital city: Tunceli zip: 62000 country: Turkey lat: 39.09921 lon: 39.54351 hasResults: False
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<|newrecord|> nctId: NCT06277804 id: LTC004-102 briefTitle: A Phase I Study of LTC004 Combin With FC in Patients With Advanced/Metastatic Malignancies Tumor overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-07-01 date: 2027-07-01 date: 2024-02-26 date: 2024-02-26 name: Letolab class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: LTC004 in Combination With Cyclophosphamide and Fludarabine measure: Safety, tolerability and antitumor efficacy of Combination. measure: PK Characteristics and immunogenicity of Combination sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06277791 id: HStomatologyWuhan1 briefTitle: The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma overallStatus: RECRUITING date: 2023-08-19 date: 2024-07-31 date: 2025-07-31 date: 2024-02-26 date: 2024-02-26 name: Hospital of Stomatology, Wuhan University class: OTHER briefSummary: 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:
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• \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Adebrelimab measure: Effective mitigation rate（EMR） measure: DFS measure: R0 resection rate measure: ORR measure: mOS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Stomatology Wuhan University status: RECRUITING city: Hubei state: Wuhan zip: 430079 country: China name: JJia Associate Professor role: CONTACT phone: +8613277924848 email: [email protected] name: zili Yu role: PRINCIPAL_INVESTIGATOR hasResults: False
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<|newrecord|> nctId: NCT06277778 id: HSEARS20211117003-03 briefTitle: Effect of Combined Music and Taekwondo Training for Children With Autism Spectrum Disorder overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-12-31 date: 2024-02-26 date: 2024-02-26 name: The Hong Kong Polytechnic University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Taekwondo training with music therapy name: Taekwondo training alone measure: Engagement in the Training Sessions measure: Gross Motor Skills measure: Physical Activity Level measure: Enjoyment State measure: Rate of Perceived Exertion measure: Taekwondo skills performance measure: Conners' Continuous Performance Test II measure: Comprehensive Trail-Making Test (CTMT) measure: Social Responsiveness Scale, second edition (SRS-2) measure: Childhood Autism Spectrum Test measure: Strength and Difficulties Questionnaires (SDQ) measure: Clinical Global Improvement (CGI) score sex: ALL minimumAge: 7 Years maximumAge: 9 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06277765 id: CM310-101212 briefTitle: Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2025-05-30 date: 2024-02-26 date: 2024-02-26 name: Keymed Biosciences Co.Ltd class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: CM310 name: placebo measure: Proportion of subjects achieving EASI-75 at week 18 sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Peking University People's hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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