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The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care. conditions: Frailty conditions: Dependence conditions: Integrated Care studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clinical control study primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Intervention group Case Manager (CM) name: Control Group measure: Dependency in Activities of Daily Living (ADL) measure: Self-rated health measure: Life satisfaction measure: Satisfaction with quality of care measure: Health economics sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368661 id: 23.79 Colo-MAR 1 briefTitle: Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1) overallStatus: RECRUITING date: 2023-09-01 date: 2024-10-01 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Fundación Vithas class: OTHER name: CEU San Pablo University briefSummary: This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention. conditions: Nutrition Related Neoplasm/Cancer studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED measure: Dietary habits registry from participants: the dietary intake measure: Biomarkers in colon mucosa, precancerous lesions and colorectal cancer measure: Gut microbiota profile sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ciro Cabezas Checchi status: RECRUITING city: Vigo state: Pontevedra zip: 36206 country: Spain name: Ciro Cabezas Checchi, MD role: CONTACT phone: +34 986 82 11 00 email: CabezasCC@vithas.es lat: 42.23282 lon: -8.72264 hasResults: False
<\|newrecord\|> nctId: NCT06368648 id: CP-1 briefTitle: CoMind Early Feasibility Study acronym: CoMind EFS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-04 date: 2024-04-16 date: 2024-04-16 name: CoMind Technologies Limited class: INDUSTRY name: Lindus Health briefSummary: The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.
Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.
Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP. conditions: Intracranial Pressure conditions: Intracranial Pressure Changes conditions: Traumatic Brain Injury conditions: Intracerebral Hemorrhage conditions: Encephalitis conditions: Encephalopathy conditions: Hydrocephalus conditions: Stroke conditions: Autoregulation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 581 type: ESTIMATED measure: A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP measure: Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP. measure: Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population. measure: Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg). measure: Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform. measure: Demonstration of an non-invasive ICP model that can predict trends in ICP measure: A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and ABP. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368635 id: 2022-GSP-QN-8 briefTitle: The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study acronym: CCMD overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-03-31 date: 2024-04-16 date: 2024-04-18 name: Weijing Wang class: OTHER_GOV name: Chinese Academy of Medical Sciences, Fuwai Hospital briefSummary: Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds.
Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown.
The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD). conditions: Microcirculation conditions: Coronary Artery Disease conditions: Cerebrovascular Circulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Coronary angiography measure: MACE measure: MACE measure: Cerebral microcirculation measure: Cerebral microcirculation sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Weijing Wang, PhD role: CONTACT phone: +8601088326200 email: wangweijing99@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06368622 id: CDM10001814 briefTitle: Evolve China PMCF Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-11 date: 2031-08 date: 2024-04-16 date: 2024-04-16 name: Stryker Neurovascular class: INDUSTRY name: Stryker (Beijing) Healthcare Products Co., Ltd briefSummary: A prospective, multi-center, single-arm, open-label, observational post-market real-world registry. The expected duration of the study is 8 years (including up to 5-years' follow-up).
Each subject will be followed in accordance with the standard of care (SOC) at each participating hospital. conditions: Intracranial Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Surpass Evolve Flow Diverter System measure: Neurological death or disabling stroke measure: 100% occlusion without significant parent artery stenosis measure: Procedure- and device-related serious adverse events measure: Key neurological events measure: Procedural success measure: Device success measure: Re-sheathing success sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital Capital Medical University city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06368609 id: 2024-09 briefTitle: Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection acronym: PROTOSS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-16 date: 2024-04-18 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: Single center, no profit experimental study on sera available in the Tropica Biobank. conditions: Strongyloides Stercoralis Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: IgG RDT name: IgG4 RDT measure: RDTs IgG results: positive or negative measure: RDTs IgG4 results: positive or negative measure: Agreement between readers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital city: Negrar state: Verona zip: 37024 country: Italy name: Dora Buonfrate role: CONTACT email: dora.buonfrate@sacrocuore.it name: Dora Buonfrate role: PRINCIPAL_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False
<\|newrecord\|> nctId: NCT06368596 id: 2024-04 briefTitle: ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis acronym: ENDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-04-16 date: 2024-04-16 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation.
A control group would however be recruited for secondary objective 1 and 2.
The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice. conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 845 type: ESTIMATED name: Fusobacterium detection measure: Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis measure: Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis measure: Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis . measure: Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria di Negrar city: Negrar state: Verona country: Italy name: Marcello Ceccaroni, Doctor role: CONTACT email: marcello.ceccaroni@sacrocuore.it role: CONTACT phone: 0456013111 name: Marcello Ceccaroni role: PRINCIPAL_INVESTIGATOR name: Dora Buonfrate role: SUB_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False
<\|newrecord\|> nctId: NCT06368583 id: 24-05 briefTitle: The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia acronym: PAS-EDU-NLA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-23 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: During the process of labour and delivery, patients may experience a wide range of events in a short time frame. This study focuses on exploring these experiences and aims to incorporate the improvements from these experiences so that in future, the expectations of patients delivering can be met as much as possible. Since every patient and encounter is unique, they might have a variety of experiences, be it during the labour epidural placement or during the delivery of the baby. Our study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience and to then use this information to enhance the quality of future anesthesia care during labour and delivery.
Patients who underwent labour and delivery and received labour epidural for pain management will be approached the day following the delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of the obstetricians, anesthesiologists, and nurses with the goals of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice, a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during labour and delivery. conditions: Well-Being, Psychological studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Interview measure: Patient questionnaire measure: Patient interview sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Sabine Nabecker, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: sabine.nabecker@sinaihealth.ca name: Ron George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR name: Sunti Barahi, MD role: SUB_INVESTIGATOR name: Ratesh Bassi, MD role: SUB_INVESTIGATOR name: Afsheen Nasir, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06368570 id: 24-04 briefTitle: The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery acronym: PAS-EDU-RCD overallStatus: RECRUITING date: 2024-04-25 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-26 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD.
Patients who have undergone a routine CD will be approached the day following their delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study, which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of obstetricians, anesthesiologists and nurses with the goal of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during elective CD. conditions: Well-Being, Psychological studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Interview measure: Patient questionnaire measure: Patient interview sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Sabine Nabecker, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: sabine.nabecker@sinaihealth.ca name: Ron George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR name: Fernanda Septimio Lanza Oliveira, MD role: SUB_INVESTIGATOR name: Lada Kordich, MD role: SUB_INVESTIGATOR name: Afsheen Nasir, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06368557 id: 22/59602 briefTitle: Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders overallStatus: RECRUITING date: 2023-10-10 date: 2025-03 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: Region of Southern Denmark class: OTHER name: University of Aarhus briefSummary: The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to the
Diagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:
1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.
2. What effect different degrees of therapist support have on the treatment.
Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.
Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment. conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The RCT is designed as a superiority RCT with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally upon completing session 8 in the program, participants will be randomized to receive or not receive a booster session 12 weeks after finishing the intervention with an allocation ratio of 1:1. The design of the randomized trial is thus factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). Data will be collected with parent and adolescent questionnaires at five time points: pre-treatment, post-treatment and at follow-ups after 3, 6 and 12 months. primaryPurpose: TREATMENT masking: NONE maskingDescription: As the study concerns itself with psychotherapy and examines the difference in therapist support, it is practically impossible to blind participants and clinicians, and thus they are not blinded. The research team is involved in the day-to-day operation of the project, including the screening for suicidality, why blinding of the research team is also practically impossible with the current setup. However the analyzes of the trial results will be pseudo-anonymized, so that only the ID number appears on the data sheet in order to get as close to blinding as possible in relation to the research design. count: 168 type: ESTIMATED name: CoolMinds: Internet-based cognitive behavioral therapy (iCBT) measure: The Youth Online Diagnostic Assessment - Child and Parent Versions measure: Spence Children's Anxiety Scale- Child and Parent Versions measure: Child Anxiety Life Interference Scale- Child and Parent Version measure: The Mood and Feelings Questionnaire- Child and Parent Version measure: Working Alliance Inventory - Short Form measure: Working Alliance Inventory for Online Interventions measure: Children´s Anxiety Scale measure: The Short Mood and Feelings questionnaire measure: EuroQol-5 Dimension Youth measure: Client Satisfaction Questionnaire-8 measure: Systems Usability Scale measure: Negative Effects Questionnaire measure: Sociodemographic measures measure: Engagement measure: Cost-effectiveness measure: Cost-effectiveness measure: The Anxiety Disorders Interview Schedule for Children sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Centre for Digital Psychiatry status: RECRUITING city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark name: Helene Skaarnes, MSc (psych)) role: CONTACT phone: +4529649702 email: helene.skaarnes@rsyd.dk name: Kim Mathiasen, Ph.d. role: CONTACT phone: +4561677747 email: kmathiasen@health.sdu.dk lat: 55.39594 lon: 10.38831 hasResults: False
<\|newrecord\|> nctId: NCT06368544 id: M2023816 briefTitle: Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction overallStatus: RECRUITING date: 2024-01-07 date: 2030-02-07 date: 2030-02-07 date: 2024-04-16 date: 2024-04-16 name: Peking University Third Hospital class: OTHER briefSummary: A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation. conditions: Anterior Cruciate Ligament Injuries conditions: Cartilage Degeneration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: lower-body positive-pressure measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Biochemical characteristics of knee cartilage measure: Biochemical characteristics of knee cartilage sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing country: China name: ren shuang role: CONTACT phone: xixishuang123@126.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06368531 id: 2314270 briefTitle: Long-term Monitoring of Sleep With Ear-EEG in Patients With Chronic Pain overallStatus: RECRUITING date: 2024-04-04 date: 2025-02-15 date: 2025-08-15 date: 2024-04-16 date: 2024-04-16 name: Odense University Hospital class: OTHER name: University of Aarhus name: T&W Engineering A/S briefSummary: Insomnia is reported by more than 50% of patients with chronic pain. In this study, the investigators aim to advance the understanding of physiological sleep in individuals with chronic pain. To do this the investigators will monitor at-home sleep with an ear-EEG over 20 nights in patients with chronic pain and collect self-reported measures of sleep and pain. The collected data will be used to explore and characterize intra-individual variations in sleep metrics (e.g. total sleep time, time in each sleep stage (N1, N2, N3, REM), sleep latency, REM stage latency, wake after sleep onset, sleep efficiency, number of arousals and arousal index) over 20 nights. conditions: Chronic Pain conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED measure: sleep period time (SPT) from Ear EEG measure: Qualitative sleep parameters obtained from sleep diary. measure: Pain intensity rating measure: Time from sleep onset until final awakening (TST) from Ear EEG measure: Sleep efficiency (SE) from Ear EEG measure: Sleep onset latency (SOL) from Ear EEG measure: Wake after sleep onset (WASO) from Ear EEG measure: REM sleep latency from Ear EEG measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG measure: Number of awakenings within TST from Ear EEG measure: Arousal index which is number of arousals per hour from Ear EEG measure: Ease-of-use and Comfort with ear EEG measure: Adverse device effects measure: Polysomnography measure: Sleep quality measure: Insomnia measure: The Graded Chronic Pain Scale Revised measure: Age measure: Sex measure: Ethnicity measure: Height measure: Weight measure: Level of education measure: Obstructive sleep apnea sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense status: RECRUITING city: Odense zip: 5000 country: Denmark name: Henrik B Vaegter, PhD role: CONTACT phone: 004565413869 lat: 55.39594 lon: 10.38831 hasResults: False
<\|newrecord\|> nctId: NCT06368518 id: ID01/2024/MZHCM-Reg/NV briefTitle: Austrian HCM Registry overallStatus: RECRUITING date: 2024-03-08 date: 2034-03 date: 2034-03 date: 2024-04-16 date: 2024-04-16 name: Medical University of Graz class: OTHER briefSummary: The Austrian Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across Austria including academic and non-academic centers. Patients will undergo a structured examination process including assessment for symptoms of HCM, past medical history, concomitant medication, family history and the presence of HCM-specific red flags. Furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. All data are entered into an electronic case report form (eCRF) (Phoenix Clinical Trial Management System). In order to perform multicenter analyses, data can be extracted from the eCRF after approval by the steering committee. conditions: Hypertrophic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: All cause mortality measure: Cardiovascular events sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz state: Styria zip: 8036 country: Austria name: Nicolas Verheyen, MD, PHD role: CONTACT phone: 004331638530173 email: nicolas.verheyen@medunigraz.at name: Viktoria Santner, MD role: CONTACT email: viktoria.santner@medunigraz.at name: Nicolas Verheyen, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False
<\|newrecord\|> nctId: NCT06368505 id: R.24.02.2506.R1 briefTitle: Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome overallStatus: RECRUITING date: 2024-01-16 date: 2024-06-16 date: 2024-07-16 date: 2024-04-16 date: 2024-04-16 name: Osama Ahmed Elshafei class: OTHER briefSummary: The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:
* Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome
* Asses safety profile of both methods
Participants will:
* Randomized to one of the two arms
* Visit the clinic 1 and 3 months after intervention
* Assessed for efficacy and safety of the intervention conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: ultrasound guided PRP injection name: ultrasound guided hydrodissection measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) measure: The visual analog scale (VAS) measure: The cross-sectional area (CSA) of the Median nerve sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University status: RECRUITING city: Mansoura zip: 35511 country: Egypt name: osama elshafei, MD PHD role: CONTACT email: osama_elshafei@mans.edu.eg name: Dena El-Ghzzawy role: CONTACT email: Profdr_os@yahoo.com name: Dena El-Ghzzawy, MD role: SUB_INVESTIGATOR name: OSAMA ELSHAFEI, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06368492 id: P137 id: 2021-002909-10 type: EUDRACT_NUMBER id: NL78008.068.21 type: OTHER domain: METC azM/Maastricht University briefTitle: The Impact of Psilocybin on Pain in Fibromyalgia Patients acronym: PsiloFM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-16 date: 2024-04-16 name: Maastricht University class: OTHER name: Leiden University Medical Center briefSummary: Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.
Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.
Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.
Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: double-blind, randomized, within-subjects, placebo-controlled design. primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinding will be handled by one of the study pharmacies and order and allocation of the treatment to each participant will be completely randomized. This setup ensures that neither the participant nor the experimenter running the test day will be aware of the contents of the capsule. count: 35 type: ESTIMATED name: Psilocybin name: Hypnosis script measure: Ischemic Pain perception measure: Pressure-evoked Pain perception measure: Self-reported pain measure: Subjective effects: psychedelic phenomenology measure: Subjective effects: mood measure: Subjective effects: intensity of effects measure: Subjective effects: Ego dissolution measure: Subjective effects: Dissociation measure: Psychiatric symptoms measure: Cognitive performance measure: Vigilance measure: Empathy measure: Creativity measure: Creativity measure: Autobiographical memory measure: Autobiographical memory measure: Treatment expectancy measure: Treatment expectancy measure: Fibromyalgia-related pain measure: Personality measure: Absorption measure: Interpersonal Reactivity measure: Depression sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University city: Maastricht state: Limburg zip: 6226AK country: Netherlands name: Mauro Cavarra, MSc role: CONTACT phone: +313494438261 email: m.cavarra@maastrichtuniversity.nl lat: 50.84833 lon: 5.68889 facility: Leiden University Medical Center city: Leiden state: South Holland zip: 2333 country: Netherlands name: Monique van Velzen, PhD role: CONTACT email: M.van_Velzen@lumc.nl lat: 52.15833 lon: 4.49306 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-08 uploadDate: 2023-10-30T07:36 filename: Prot_SAP_000.pdf size: 673739 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-10 uploadDate: 2023-10-30T07:38 filename: ICF_001.pdf size: 451492 hasResults: False
<\|newrecord\|> nctId: NCT06368479 id: CLS-016B briefTitle: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-01 date: 2024-07-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care. conditions: Hepatitis B conditions: Hepatitis B Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 4400 type: ESTIMATED name: iStatis HBsAg Test measure: iStatis Performance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Epicentre Health Research status: RECRUITING city: Hillcrest state: Kwazulu Natal zip: 3650 country: South Africa name: Cherie Cawood role: CONTACT phone: +27828202955 email: cheriec@epicentre.org.za hasResults: False
<\|newrecord\|> nctId: NCT06368466 id: CLS-016A briefTitle: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-08-30 date: 2024-09-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY name: St Vincent's Hospital Melbourne briefSummary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions. conditions: Hepatitis B conditions: Hepatitis B Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 350 type: ESTIMATED name: iStatis HBsAg Test measure: Performance measure: Sensitivity and Specificity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Vincent's Hospital, Melbourne city: Melbourne state: Fitzroy Victoria zip: 3065 country: Australia name: Alex Thompson role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False
<\|newrecord\|> nctId: NCT06368453 id: CLS-003 briefTitle: A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing.
The study aims to:
To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test. conditions: Human Immunodeficiency Virus I Infection conditions: Human Immunodeficiency Virus II Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: SINGLE whoMasked: CARE_PROVIDER count: 1700 type: ESTIMATED name: INSTI® HIV Self-Test measure: Clinical sensitivity and specificity of the INSTI® HIV Self-Test measure: The INSTI® HIV Self-Test usability and result interpretation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368440 id: D7860C00003 briefTitle: A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-10-04 date: 2024-10-04 date: 2024-04-16 date: 2024-04-16 name: AstraZeneca class: INDUSTRY briefSummary: The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: AZD6793 name: AZD6793 name: Placebo measure: Part 1 (SAD): Number of Participants with Adverse Events measure: Part 2 (MAD): Number of Participants with Adverse Events measure: Part 1 (SAD) : Maximum Observed Plasma Drug Concentration measure: Part 1 (SAD): Time to Reach Peak Concentration (tmax) measure: Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz) measure: Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12]) measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) measure: Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) measure: Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) measure: Part 1 (SAD): Dose Normalized AUClast measure: Part 1 (SAD): Dose Normalized AUCinf measure: Part 1 (SAD): Dose Normalized Cmax measure: Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax) measure: Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough) measure: Part 2 (MAD): Temporal Change Parameter (TCP) measure: Part 2 (MAD): Time to Reach Peak Concentration (tmax) measure: Part 2 (MAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz) measure: Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) measure: Part 2 (MAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) measure: Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) measure: Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau) measure: Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) measure: Part 2 (MAD): Dose Normalized AUClast measure: Part 2 (MAD): Dose Normalized AUCtau measure: Part 2 (MAD): Dose Normalized Cmax measure: Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC) measure: Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax) measure: Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2]) measure: Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf) measure: Part 2 (MAD): Renal Clearance (CLR) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Research Site city: Glendale state: California zip: 91206 country: United States lat: 34.14251 lon: -118.25508 hasResults: False
<\|newrecord\|> nctId: NCT06368427 id: D5980R00100 briefTitle: Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD acronym: COnCORD overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-09-30 date: 2025-09-30 date: 2024-04-16 date: 2024-04-16 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis. conditions: Chronic Obstructive Pulmonary Disease (COPD) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 250 type: ESTIMATED name: budesonide / glycopyrronium / formoterol measure: Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score measure: Change from baseline to 6 months in the CAT score measure: Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment measure: Percent responders of the CAT [MID=2] after 12 weeks of treatment measure: Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation measure: Drivers for initiation or switch to BGF MDI via physician questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368414 id: KCMLWP-2021-04 briefTitle: A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia acronym: AsterA overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-08-31 date: 2028-08-31 date: 2024-04-16 date: 2024-04-16 name: Korean Society of Hematology class: NETWORK briefSummary: To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI conditions: Chronic Myeloid Leukemia, Chronic Phase studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 69 type: ESTIMATED name: Asciminib measure: MR3.0 or less by 1 year sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-21 uploadDate: 2024-04-11T22:40 filename: Prot_000.pdf size: 903002 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-21 uploadDate: 2024-04-11T22:40 filename: Prot_001.pdf size: 903226 hasResults: False
<\|newrecord\|> nctId: NCT06368401 id: TP_01428 briefTitle: A First in Human Study for the Versa Device for Tricuspid Regurgitation overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Versa Vascular, Inc class: INDUSTRY briefSummary: This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates. conditions: Tricuspid Regurgitation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Versa Implant measure: Acute Procedural Success measure: Incidence of major adverse events (MAE) measure: Tricuspid Regurgitation Severity Change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Auckland City Hospital city: Auckland country: New Zealand name: Mark Webster, MD role: CONTACT lat: -36.84853 lon: 174.76349 hasResults: False
<\|newrecord\|> nctId: NCT06368388 id: S64854 briefTitle: Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force acronym: PHAGEFORCE overallStatus: RECRUITING date: 2021-06-01 date: 2024-12-01 date: 2025-06-01 date: 2024-04-16 date: 2024-04-16 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: KU Leuven briefSummary: PHAGEFORCE is a prospective, observational registry study. The University Hospitals Leuven has approved the application of phage therapy as standard-of-care only in patients for whom no curative treatment alternatives (antibiotic and/or surgical) are available ('last-resort cases'). A multidisciplinary phage task force, referred to as the Coordination group for Bacteriophage therapy Leuven (CBL) was set up. The CBL screens patients with difficult-to-treat infections, evaluates who could benefit from phage therapy and sets up the treatment protocol. With this study, the CBL aims to gain insight in the safety and efficacy of phage therapy by integrating and optimizing phage therapy in five distinct medical disciplines (with distinct routes of administration), facilitating long-term follow-up of patients. Furthermore, this study will gain insight in the biodistribution and exact mechanisms of action of phage therapy and thus be able to provide standardized guidelines for each patient population and route of administration. conditions: Musculoskeletal Infection conditions: Chronic Rhinosinusitis (Diagnosis) conditions: Sepsis conditions: Pulmonary Infection conditions: Hidradenitis Suppurativa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Prospective data collection name: Prospective data collection measure: Disease free period measure: Bacterial eradication measure: PROMIS global health (patient-reported outcome measurement information system) measure: PROMIS (patient-reported outcome measurement information system) physical function measure: PROMIS (patient-reported outcome measurement information system) pain interference measure: Sino-nasal outcome test (SNOT)-22 measure: Visual Analogue Scale (VAS) score measure: Cystic fibrosis questionnaire (CF-Q-R) measure: Dermatology Life Quality Index (DLQI) measure: Hidradenitis Suppurativa Quality of Life (HiSQoL) measure: Rate of exacerbations measure: Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR) measure: Lund-Mackay CT score measure: Lund Kennedy endoscopy score measure: Modified Davos score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Jolien Onsea, PhD role: CONTACT phone: 003216342041 email: jolien.onsea@uzleuven.be name: Willem-Jan Metsemakers, MD, PhD role: CONTACT phone: 003216344277 email: willem-jan.metsemakers@uzleuven.be name: Willem-Jan Metsemakers, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False
<\|newrecord\|> nctId: NCT06368375 id: PRPF31-3102022BO2 briefTitle: Clinical and Genetic Findings in Patients With PRPF31-associated Retinitis Pigmentosa overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-30 date: 2023-06-30 date: 2024-04-16 date: 2024-04-16 name: University Hospital Tuebingen class: OTHER briefSummary: Retrospective chart review study to elucidate the genotype and phenotype of patients with PRPF31-associated retinitis pigmentosa and asymptomatic carriers of the respective variant(s) conditions: Retinitis Pigmentosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 87 type: ACTUAL measure: Best Corrected Visual Acuity (BCVA) measure: Visual Field (VF) measure: Fundus Photography (FP) measure: Optos measure: Autofluorescence (AF) measure: Optical Coherence Tomography (OCT) measure: Full-Field Electroretinogram (ff-ERG) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen city: Tuebingen state: Baden-Wuerttemberg zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False
<\|newrecord\|> nctId: NCT06368362 id: CBM-I001 briefTitle: Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain overallStatus: COMPLETED date: 2020-11-17 date: 2021-05-01 date: 2021-05-01 date: 2024-04-16 date: 2024-04-16 name: University of Southampton class: OTHER name: Economic and Social Research Council, United Kingdom briefSummary: Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals. conditions: Chronic Pain conditions: Musculoskeletal Pain Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of participants (chronic musculoskeletal pain, healthy) were recruited, and within each group participants were randomised to one of two experimental conditions with a 1:1 allocation ratio with a parallel design. Participants with chronic musculoskeletal pain were randomised to benign CBM-I or no CBM-I, and healthy participants were randomised to benign CBM-I or pain-related CBM-I. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants are not informed of the conditioned they are randomised to in this psychological intervention. whoMasked: PARTICIPANT count: 84 type: ACTUAL name: Benign cognitive bias modification for interpretation name: Pain-related cognitive bias modification for interpretation measure: Emotional response to exercise induced pain measure: Emotional response to pain-related images measure: Fear of Pain measure: Anxiety measure: Depression measure: Emotional response to average clinical pain measure: Pain severity measure: Pain interference measure: Pain-related interpretation bias index sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southampton city: Southampton state: Hampshire zip: SO17 1BJ country: United Kingdom lat: 50.90395 lon: -1.40428 hasResults: False
<\|newrecord\|> nctId: NCT06368349 id: 202101771B0 briefTitle: Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma overallStatus: COMPLETED date: 2022-03-01 date: 2023-06-21 date: 2023-06-30 date: 2024-04-16 date: 2024-04-18 name: Chang Gung Memorial Hospital class: OTHER briefSummary: A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry. conditions: Lymphopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 190 type: ACTUAL measure: Persistent lymphopenia predict poor overall survival measure: T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient measure: Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery city: Kaohsiung zip: 833 country: Taiwan lat: 22.61626 lon: 120.31333 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-10-20 uploadDate: 2024-04-11T03:02 filename: Prot_SAP_000.pdf size: 422513 hasResults: False
<\|newrecord\|> nctId: NCT06368336 id: 994894 briefTitle: Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study. overallStatus: COMPLETED date: 2008-01-01 date: 2022-04-01 date: 2022-12-31 date: 2024-04-16 date: 2024-04-17 name: Uppsala University Hospital class: OTHER name: Sepsisfonden briefSummary: The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU). conditions: Sepsis conditions: Septic Shock conditions: Sepsis, Severe studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 210484 type: ACTUAL measure: Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis measure: Ability to work before and after ICU (intensive care unit) treatment for Sepsis measure: The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368323 id: H-01-24-9931 briefTitle: Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia overallStatus: RECRUITING date: 2024-04-22 date: 2025-12-31 date: 2025-12-31 date: 2024-04-16 date: 2024-04-22 name: University of Ottawa class: OTHER name: Toronto Metropolitan University name: Université de Montréal name: Université du Québec à Trois-Rivières name: University of South Florida briefSummary: The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care.
The main question it aims to answer is:
Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia?
Participants will have:
12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h) conditions: Aphasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel group randomized trial design with a secondary crossover extension primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes will be measured by blinded assessors where possible, using blinded video or audio recordings. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Choir singing name: Usual care measure: Communication Index measure: Level of confidence in communication measure: Aphasia severity index measure: Speech and language in functional communication measure: Apraxia of speech severity measure: Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) measure: Emotional wellbeing measure: Social participation measure: Generic measure of health measure: Appetence to music measure: Singing voice abilities measure: Voice - Pitch measure: Voice - Maximum Phonation Time measure: Voice - Dynamic range measure: Mood measure: Biosocial indexes measure: Expectations on a 100-scale measure: Satisfaction on a 100-scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33620 country: United States name: Jennifer Bugos, Ph.D. role: CONTACT email: bugosj@usf.edu lat: 27.94752 lon: -82.45843 facility: University of Ottawa status: RECRUITING city: Ottawa state: Ontario zip: K1N 6N5 country: Canada name: Anna Zumbansen, PhD role: CONTACT phone: 613-562-5800 phoneExt: 8393 email: azumbans@uottawa.ca name: Narges Bayat, Master role: CONTACT phone: 613-562-5800 phoneExt: 8393 email: nbaya063@uottawa.ca lat: 45.41117 lon: -75.69812 facility: Toronto Metropolitan University status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M5B 0C3 country: Canada name: Arla Good, Ph.D. role: CONTACT email: arla.good@torontomu.ca lat: 43.70011 lon: -79.4163 facility: Université de Montréal status: NOT_YET_RECRUITING city: Montréal state: Quebec zip: H3C 3J7 country: Canada name: Carole Anglade, Ph.D. role: CONTACT email: carole.anglade@umontreal.ca lat: 45.50884 lon: -73.58781 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-16 uploadDate: 2024-04-10T11:45 filename: ICF_000.pdf size: 129388 hasResults: False
<\|newrecord\|> nctId: NCT06368310 id: R124807 id: 23/WM/0166 type: OTHER domain: NHS Research Ethics Committee Reference briefTitle: FIH Clinical Investigation of Graphene Electrodes for Brain Mapping overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2025-01-31 date: 2025-01-31 date: 2024-04-16 date: 2024-04-16 name: University of Manchester class: OTHER name: Northern Care Alliance NHS Foundation Trust name: European Commission name: Inbrain Neuroelectronics briefSummary: The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are:
* To understand the safety of these new electrodes when used during brain tumor surgery (primary objective);
* To assess the quality of the brain signals recorded with the new electrodes, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives).
Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study. They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery. conditions: Brain Tumor conditions: Glioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 8 type: ESTIMATED name: INBRAIN Graphene Cortical Interface measure: To evaluate the preliminary safety of the investigational device for its intended use measure: Assess the ability of the device to record signals from the brain measure: Evaluate the ability of the device to provide functional stimulation of the brain measure: Assess stability of sensing and stimulating electrodes measure: Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery measure: Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory) measure: Assess the quality of the recorded baseline brain activity - sensing part B (exploratory) measure: Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory) measure: Evaluate decoding capability from data recorded during language task (exploratory) measure: Evaluate signal characteristics of tumour infiltrated brain regions (exploratory) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust city: Salford state: Greater Manchester zip: M6 8HD country: United Kingdom name: Hannah Howlett role: CONTACT email: RDResearch@nca.nhs.uk name: David J Coope, PhD FRCS role: PRINCIPAL_INVESTIGATOR lat: 53.48771 lon: -2.29042 hasResults: False
<\|newrecord\|> nctId: NCT06368297 id: BSERE22-APP007-FED briefTitle: The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-16 date: 2024-04-16 name: University of Macau class: OTHER briefSummary: This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses. conditions: Overweight and Obesity conditions: Cognitive Change conditions: Psychophysiologic Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ketone Monoester Supplementation name: Ketogenic diet measure: Brain Plasticity measure: Grey Matter Volume measure: Cortical Thickness measure: Blood-Oxygen-Level-Dependent (BOLD) Signal Changes measure: Blood Glucose measure: Blood Beta-Hydroxybutyrate measure: Blood Insulin measure: Leptin measure: Ghrelin measure: Brain-Derived Neurotrophic Factor measure: Reaction Time of Attention Network Test measure: Accuracy of Attention Network Test measure: Reaction Time of Stroop Task measure: Accuracy of Stroop Task measure: Reaction Time of N-back Task measure: Accuracy of N-back Task measure: Cerebral Hemoglobin Concentration measure: Height in Kilograms measure: Weight in Meters measure: Body Fat Percentage measure: Fat Mass measure: Muscle Mass measure: Body Water measure: Body Mass Index measure: Skinfold Thickness measure: Maximal Oxygen Uptake sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368284 id: IRB-MTP_2022_09_202201170 briefTitle: Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results acronym: TP-JET overallStatus: RECRUITING date: 2023-01-01 date: 2024-04-01 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: University Hospital, Montpellier class: OTHER briefSummary: French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023.
Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice. conditions: Perineum; Tear, Traumatic conditions: Anal Tear conditions: Anal Incontinence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident measure: Rate of fecal incontinence measure: Rate of permanent stoma measure: Rate of acontractile bladder measure: Rate of sexual dysfunction measure: Rate of impact on quality of life sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Montpellier status: RECRUITING city: Montpellier zip: 34295 country: France name: Thomas BARDOL, MD role: CONTACT phone: 04 67 33 90 69 email: t-bardol@chu-montpellier.fr lat: 43.61092 lon: 3.87723 hasResults: False
<\|newrecord\|> nctId: NCT06368271 id: Lipidomix briefTitle: Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile acronym: Lipidomix overallStatus: COMPLETED date: 2021-10-01 date: 2024-02-28 date: 2024-02-28 date: 2024-04-16 date: 2024-04-16 name: University of Copenhagen class: OTHER briefSummary: In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover. conditions: Healthy Nutrition conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days. primaryPurpose: BASIC_SCIENCE masking: NONE count: 4 type: ACTUAL name: Lipidomics measure: Meal test including medium-chain fatty acids measure: Resting metabolic rate sex: MALE minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: University of Copenhagen city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 facility: Department of Nutrition, Exercise and Sports city: Copenhagen country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06368258 id: Curr-RYR2023 briefTitle: Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-12-01 date: 2025-05-02 date: 2024-04-16 date: 2024-04-16 name: University of Bologna class: OTHER briefSummary: The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated. conditions: Hypercholesterolemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Red yeast rice name: Placebo measure: Treatment-dependent change in LDL-C measure: Treatment-dependent change in Total Cholesterol measure: Treatment-dependent change in Non-HDL-C measure: Treatment-dependent change in liver parameters measure: Treatment-dependent change in CPK plasma levels measure: Treatment-dependent change in plasma proteomic pattern sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico S.Orsola-Malpighi city: Bologna country: Italy lat: 44.49381 lon: 11.33875 hasResults: False
<\|newrecord\|> nctId: NCT06368245 id: SMART briefTitle: Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions overallStatus: NOT_YET_RECRUITING date: 2024-10-15 date: 2027-12-15 date: 2029-07-31 date: 2024-04-16 date: 2024-04-16 name: AO Foundation, AO Spine class: OTHER briefSummary: This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites. conditions: Spinal Fusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1244 type: ESTIMATED name: long-segment posterior TL instrumented fusion measure: Rod fracture (RF) measure: Time to rod fracture measure: Time to rod fracture measure: Configurations of supplementary rod constructs measure: Treatment for rod fracture measure: Recurrent RFs measure: Other mechanical failures measure: Surgical complications sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota Medical Center city: Minneapolis state: Minnesota zip: 55454 country: United States name: David Polly, MD role: CONTACT email: pollydw@umn.edu lat: 44.97997 lon: -93.26384 facility: University of Virginia city: Charlottesville state: Virginia zip: 22908 country: United States name: Justin S Smith, MD, PhD role: CONTACT phone: 434-243-6339 email: jss7f@virginia.edu name: Judith G Beenhakker role: CONTACT email: JGB3P@uvahealth.org lat: 38.02931 lon: -78.47668 hasResults: False
<\|newrecord\|> nctId: NCT06368232 id: 19.036.123.125 briefTitle: Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study overallStatus: COMPLETED date: 2022-02-15 date: 2023-04-15 date: 2023-04-15 date: 2024-04-16 date: 2024-04-16 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: This study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. Data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. Preoperative and postoperative biochemical parameters along with anthropometric measurements will assess. conditions: Bariatric Surgery Candidate conditions: Gastrostomy conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 76 type: ACTUAL name: püPatients undergoing bariatric surgery measure: Body Weight measure: BMI (Body Mass Index) measure: Lean Mass measure: Fat Mass measure: Fasting Blood Glucose measure: HbA1c measure: Iron levels measure: Vitamin D level measure: Lipid Profile (Triglycerides, LDL, HDL) sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT facility: Ankara Yıldırım Beyazıt University city: Ankara zip: 06760 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06368219 id: 0108161 briefTitle: Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Alexandria University class: OTHER briefSummary: This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:
* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
* Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.
the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events conditions: Procedural Sedation studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: ketamine- midazolam versus ketamine- propofol measure: Induction and recovery time for both combinations measure: incidence and severity of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368206 id: OBPM_Calfree2024 briefTitle: Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device at Fingertip (Aktiia G2C) Against Double Auscultation, and Comparison With Oscillometry and Aktiia Bracelet G2 overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-23 name: Aktiia SA class: INDUSTRY briefSummary: The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to evaluate the performances and safety of the Aktiia.product-G2C that doesn't require any calibrations, as compared against double auscultation for BP reference measurements, and finger pulse oximeter for pulse rate reference measurements, for a cohort of subjects characterized by a wide variety of phenotypes. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references. primaryPurpose: OTHER masking: NONE count: 85 type: ESTIMATED name: Investigational device Aktiia G2C name: Marketed device used as reference for blood pressure monitoring: double auscultation cuff name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2 name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff name: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter measure: Blood pressure mean value of differences measure: Blood pressure standard deviation of differences measure: Pulse rate root-mean-square error sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUV city: Lausanne zip: 1011 country: Switzerland lat: 46.516 lon: 6.63282 hasResults: False
<\|newrecord\|> nctId: NCT06368193 id: Neuralert 001 briefTitle: The Neuralert Stroke Monitor Pilot Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-16 date: 2024-04-16 name: Neuralert Technologies LLC class: INDUSTRY briefSummary: This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, clinical usability, and tolerability. conditions: Stroke conditions: Surgery studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Neuralert Monitor measure: Data Aggregation measure: Time to alarm reception measure: Time to alarm reponse measure: Stroke detection sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of the University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Stephanie Cummings role: CONTACT phone: 215-662-3363 email: stephanie.cummings@pennmedicine.upenn.edu name: Scott Kasner, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06368180 id: 439106274 briefTitle: The Efficacy of a RAGT & BWSTT on Children With CP overallStatus: COMPLETED date: 2020-08-30 date: 2021-02-21 date: 2021-03-08 date: 2024-04-16 date: 2024-04-16 name: King Saud University class: OTHER briefSummary: This study compared the effects of RAGT and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral CP conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Robotic-assisted gait training Body weight-supported treadmill training primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Robotic assisted gait training measure: Gait spatio-temporal parameters measure: Six-minute walk test (6MWT) sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: King Abdu Aziz Medical City city: Riyadh country: Saudi Arabia lat: 24.68773 lon: 46.72185 hasResults: False
<\|newrecord\|> nctId: NCT06368167 id: SHR2554-202 briefTitle: A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-16 date: 2024-04-16 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma conditions: Follicular Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 105 type: ESTIMATED name: SHR2554 measure: Objective response rate (ORR) assessed by independent review committee (IRC) measure: ORR assessed by investigator measure: Progression free survival measure: Time to Response measure: Duration of response measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Yuqin Song role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06368154 id: HCHLL-2019-08 briefTitle: Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Hunan Children's Hospital class: OTHER_GOV briefSummary: Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs. conditions: Exosomes conditions: Newborn conditions: Bone Diseases, Metabolic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: exosomes sex: ALL minimumAge: 0 Hours maximumAge: 72 Hours stdAges: CHILD facility: Hunan Children's Hospital status: RECRUITING city: Changsha state: Hunan zip: 410007 country: China name: yinzhi y liu, master role: CONTACT phone: 13467532228 email: liuyinzhi0837@163.com lat: 28.19874 lon: 112.97087 hasResults: False
<\|newrecord\|> nctId: NCT06368141 id: 2023294 briefTitle: Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer acronym: NeoCHIC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-02-28 date: 2026-04-30 date: 2024-04-16 date: 2024-04-16 name: Ruijin Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are:
* Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer?
* Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer?
Participants will receive:
* a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen.
* a sequential CAPEOX plus Serplulimab regimen.
* a standard complete mesocolic excision (CME) operation. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Serplulimab name: Capecitabine name: Oxaliplatin measure: pathologic complete response sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital city: Shanghai state: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06368128 id: HS-24_51 briefTitle: Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study acronym: CLIMB overallStatus: RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Northern Michigan University class: OTHER briefSummary: The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention). conditions: Lifestyle Factors conditions: Physical Inactivity conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial with participants allocated to either a control or intervention group; comparison between groups and within groups primaryPurpose: PREVENTION masking: NONE count: 12 type: ESTIMATED name: Indoor Rock Climbing Exercise Training Program measure: Fasting lipids measure: Fasting glucose measure: Hemoglobin a1c measure: Physical activity and sedentary behavior measure: Sedentary behavior bouts (30 min, 60 min, >60 min) measure: Cardiorespiratory fitness measure: Muscular fitness measure: Handgrip strength asymmetry measure: Lower-body dynamic balance measure: Health-related quality of life using CDC Health-Related Quality of Life Scale measure: Exercise self-efficacy measured via Self-efficacy for exercise scale measure: Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale measure: Perceived stress measure: Blood pressure measure: Body composition measure: Bone density sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Northern Michigan University status: RECRUITING city: Marquette state: Michigan zip: 49855 country: United States name: Lisa Eckert, PhD role: CONTACT phone: 906-227-1291 email: leckert@nmu.edu name: Megan C Nelson, PhD role: PRINCIPAL_INVESTIGATOR lat: 46.54354 lon: -87.39542 hasResults: False
<\|newrecord\|> nctId: NCT06368115 id: 00023453 id: 4R33AG069794 type: NIH link: https://reporter.nih.gov/quickSearch/4R33AG069794 briefTitle: A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2 acronym: DPRESCRIBE-AD2 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: University of Massachusetts, Worcester class: OTHER name: National Institute on Aging (NIA) name: Harvard Pilgrim Health Care name: Humana Healthcare Research, Inc. name: Carelon Research briefSummary: Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design will be a prospective, randomized, "open-label" educational intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention mailed one time; (2) a combined patient/caregiver and provider educational intervention mailed two times; and (3) usual care. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10000 type: ESTIMATED name: Educational Materials measure: Absence of Inappropriate Medication Prescription Dispensing measure: Dose Change measure: Polypharmacy measure: Rates of Health Care and Emergency Care Utilization measure: Mortality measure: Switching within Classes sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMass Chan Medical School city: Worcester state: Massachusetts zip: 01605 country: United States name: Cassie L Saphirak role: CONTACT phone: 508-856-3493 email: cassandra.saphirak@umassmed.edu lat: 42.26259 lon: -71.80229 hasResults: False
<\|newrecord\|> nctId: NCT06368102 id: R6-03 briefTitle: Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04 date: 2025-08 date: 2024-04-16 date: 2024-04-16 name: Uji Takeda Hospital class: OTHER briefSummary: The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 70 type: ESTIMATED name: Ampicillin measure: Occurrence of surgical site infection measure: Occurrence of alveolar osteitis sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368089 id: REC.66-474-30-2 id: MR-PSU:66-30-21-406 type: OTHER_GRANT domain: Faculty of Medicine, Prince of Songkla University briefTitle: Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-03 date: 2024-04-16 date: 2024-04-16 name: Prince of Songkla University class: OTHER briefSummary: Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to:
1. Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period.
2. Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program. conditions: Ventilator Dependent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomization primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Inspiratory muscle training (IMT) group name: Early mobilization (EM) group measure: Maximum inspiratory pressure (MIP) measure: Dynamic lung compliance (Cdyn) measure: Weaning time measure: Weaning outcome measure: Grip strength measure: chest wall expansion sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital city: Songkhla zip: 90110 country: Thailand lat: 7.19882 lon: 100.5951 hasResults: False
<\|newrecord\|> nctId: NCT06368076 id: H-23065096 briefTitle: High-intensity Interval Training in Patients With Spinal Muscular Atrophy overallStatus: RECRUITING date: 2024-01-09 date: 2024-08 date: 2025-01 date: 2024-04-16 date: 2024-04-16 name: Rigshospitalet, Denmark class: OTHER briefSummary: Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy. conditions: Spinal Muscular Atrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Exercise measure: Questionnaire on fatigue measure: Questionnaire on pain. measure: Questionnaire on constipation measure: Questionnaire on quality of life measure: Questionnaire on sleep quality measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: MRI scan liver size measure: MR-elastography measure: MRI scan liver steatosis measure: Ultrasound scan measure: MRI scan measure: MRI scan measure: Exercise test measure: Motorscore sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Sophia Frølich, stud.med role: CONTACT phone: + 45 3545 3561 email: sophia.vera.froelich.01@regionh.dk name: Noémie Receveur, stud.med role: CONTACT phone: +4535453561 email: noemie.anne-marie.receveur.03@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06368063 id: HE-202301 briefTitle: The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2028-03 date: 2024-04-16 date: 2024-04-25 name: Health Science Center of Xi'an Jiaotong University class: OTHER name: LinkDoc Technology (Beijing) Co. Ltd. name: Huazhong University of Science and Technology briefSummary: The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer conditions: Pancreatic Cancer Resectable studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 642 type: ESTIMATED name: Huaier granule name: chemotherapy drugs measure: Disease-free survival measure: Overall survival measure: Progression-free survival measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE) measure: The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06368050 id: IRB00067187.2 briefTitle: Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-11 date: 2024-11 date: 2024-04-16 date: 2024-04-16 name: Wake Forest University Health Sciences class: OTHER name: Childress Institute briefSummary: The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein. conditions: Head Injury conditions: Sport Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: practice structure intervention measure: Number of practice head impacts measure: Number of practice head acceleration events measure: Practice head impact rate measure: Practice head acceleration even rate measure: Median linear acceleration measure: Median rotational acceleration measure: Median rotational velocity measure: 95th percentile linear acceleration measure: 95th percentile rotational acceleration measure: 95th percentile rotational velocity measure: Feasibility of Intervention Measure (FIM) Values measure: Acceptability of Intervention Measure (AIM) Values measure: Number of practices the intervention was implemented as prescribed measure: Average minutes per practice of live time sex: ALL minimumAge: 11 Years maximumAge: 14 Years stdAges: CHILD facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Jill Urban, PhD, MPH role: CONTACT phone: 336-716-0947 email: jurban@wakehealth.edu name: Konstantia Strates role: CONTACT phone: 336-713-1263 email: kcstrate@wakehealth.edu name: Jill Urban, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False
<\|newrecord\|> nctId: NCT06368037 id: DragonFire-02 briefTitle: Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-06 date: 2026-06 date: 2024-04-16 date: 2024-04-16 name: Hangzhou Valgen Medtech Co., Ltd class: INDUSTRY briefSummary: This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively. conditions: Obstructive Hypertrophic Cardiomyopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: DragonFire Transcatheter Myocardial Radiofrequency Ablation System measure: The rate of freedom from major adverse events at 30 days postoperatively measure: The success rate of treatment at 6 months postoperatively sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Theater Command General Hospital of the Chinese People's Liberation Army city: Shenyang country: China lat: 41.79222 lon: 123.43278 hasResults: False
<\|newrecord\|> nctId: NCT06368024 id: CL-12-600 briefTitle: Establishment of Delphi-MD Safety Performance and Reliability overallStatus: COMPLETED date: 2023-11-28 date: 2023-11-28 date: 2023-11-28 date: 2024-04-16 date: 2024-04-26 name: QuantalX Neuroscience class: INDUSTRY briefSummary: A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements. conditions: Neurologic Disorder conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 263 type: ACTUAL name: This is a retrospective analysis study of data collected with a diagnostic medical device measure: Cortical Excitability measure: Specific Peak Amplitudes measure: GMFP sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: QuantalX Neuroscience Ltd. city: Kfar Saba state: Center zip: 4453001 country: Israel lat: 32.175 lon: 34.90694 hasResults: False
<\|newrecord\|> nctId: NCT06368011 id: MustafaKU-CINCINOGLU-001 briefTitle: The Impact of Acceptance and Commitment Therapy on Stigmatization overallStatus: ENROLLING_BY_INVITATION date: 2023-04-15 date: 2023-07-31 date: 2024-06-30 date: 2024-04-16 date: 2024-04-16 name: Mustafa Kemal University class: OTHER briefSummary: The goal of study is to determine the effect of acceptance and commitment therapy-based psychoeducation on the level of stigmatization applied to relatives of schizophrenia patients.
Type of study: This study was planned as a pretest-posttest quasi-experimental design with an observation and control group.
Participants: The population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Community Mental Health Center in a state hospital in Ankara.

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