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2. AD/HD traits positively predicts perceived criticism or rejection sensitivity
3. Perceived criticism or rejective sensitivity negatively predicts psychological well-being
4. Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being
5. Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
6. Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
7. Children with AD/HD from self-compassion intervention group yield greater improvement in self-compassion, emotional regulation and psychological well-being, than waitlist-control group. conditions: ADHD conditions: Self-Compassion conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention Group: In Phase 1, children participants receive a 6-session self-compassion intervention training, plus parents of the participants receive a 3-session parent group. once to twice a week, 90 minutes per session.
Wait-list Control: receives the same intervention in Phase 2 primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Self-Compassion Intervention measure: Self-Compassion Scale for Children (SCS-C) measure: Self-Compassion Scale for Children (SCS-C) measure: Self-Compassion Scale for Children (SCS-C) measure: Behavioural ratings on children's executive functions measure: Behavioural ratings on children's executive functions measure: Behavioural ratings on children's executive functions measure: Student's Life Satisfaction Scale (SLSS) measure: Student's Life Satisfaction Scale (SLSS) measure: Student's Life Satisfaction Scale (SLSS) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Perceived Criticism Scale (PCS) measure: The Perceived Criticism Scale (PCS) measure: The Perceived Criticism Scale (PCS) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Growth Mindset Scale measure: Growth Mindset Scale measure: Growth Mindset Scale sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: The University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Kwan Lok TANG role: CONTACT phone: +852-66532947 email: tangkl1020@gmail.com lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06352788 id: 202007224 briefTitle: From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices acronym: AFOSVA overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-08-31 date: 2028-09-01 date: 2024-04-08 date: 2024-04-08 name: Jason Wilken class: OTHER name: Mayo Clinic name: Vanderbilt University Medical Center name: Navy Medical Center San Diego name: Minneapolis Veterans Affairs Medical Center name: Johns Hopkins University briefSummary: This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury. conditions: Foot Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be cast and fit with either a carbon fiber custom dynamic orthosis (CDO) with a modular or mono design. After being fit with the CDO they will complete testing with the CDO in three different configurations (A, B, C) in a randomized order and without the CDO. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Study participants, investigators, and outcome assessors will be blinded to the condition being tested and will only be introduced to each condition as A, B, or C. Only study coordinators, who will verify adherence with the study protocol (CDO configuration), will not be blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Modular Carbon Fiber Custom Dynamic Orthosis (CDO) name: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) measure: PROMIS Physical Function measure: PROMIS Pain Interference measure: OPUS Satisfaction with Device and Services measure: Modified Socket Comfort Score - Comfort measure: Modified Socket Comfort Score - Smoothness measure: Numerical Pain Rating Scale measure: Preference - Ranked measure: Preference - CDO Configuration measure: Four Square Step Test (seconds) measure: Sit to Stand 5 Times (seconds) measure: Center of Pressure Velocity Magnitude (m/s) measure: Center of Pressure Velocity Timing (%stance) measure: Ankle Zero Moment Crossing (%stance) measure: Peak Ankle Dorsiflexion (degree) measure: Peak Ankle Plantarflexion Moment (Nm/kg) measure: Peak Ankle Push-Off Power (W/kg) measure: PROMIS Satisfaction with Participation in Social Activities measure: PROMIS Satisfaction with Participation in Discretionary Social Activities measure: PROMIS Depression measure: 10 Meter Shuttle Run (seconds) measure: Self Selected Walking Velocity (m/s) measure: Ankle Range of Motion (degrees) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352775 id: IRB00107112 briefTitle: Calcium Carbonate on Labor Induction overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-30 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: Aurora Health Care class: OTHER briefSummary: The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes. conditions: Pregnancy conditions: Uterine Contraction studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The quasi-experimental design will include a prospective treatment group and retrospective historical control group. The prospective treatment group will identify 50 patients who will be voluntarily consented and receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin. This group will be compared against a retrospective historical control group of 200 randomly selected patients (1:4 ratio) who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Calcium Carbonate measure: Duration of induction time measure: Rate of labor dystocia measure: Rate of cesarean deliveries measure: Total amount of oxytocin after cervical ripening measure: Gastrointestinal side effects measure: Blood loss measure: Rate of postpartum hemorrhage (>/= 500mL) measure: Neonatal composite adverse outcomes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aurora Sinai Medical Center city: Milwaukee state: Wisconsin zip: 53233 country: United States name: Marie Forgie, DO role: CONTACT phone: 414-219-5800 email: marie.forgie@aah.org name: Emily Malloy, PhD, CNM role: CONTACT phone: 414-219-6649 email: emily.malloy@aah.org lat: 43.0389 lon: -87.90647 hasResults: False
<\|newrecord\|> nctId: NCT06352762 id: Izmir Dokuz Eylul University briefTitle: The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy overallStatus: COMPLETED date: 2017-02-15 date: 2017-08-15 date: 2017-12-15 date: 2024-04-08 date: 2024-04-08 name: Izmir Bakircay University class: OTHER briefSummary: Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).
Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level. conditions: Spastic Hemiplegic Cerebral Palsy conditions: Upper Extremity Paresis conditions: Robotic Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted as a randomized controlled study.The first of the cases that met the study criteria was included in the study group, and the second in the control group. Randomization continued in this way. primaryPurpose: TREATMENT masking: NONE count: 36 type: ACTUAL name: Conventional physiotherapy name: Robotic Rehabilitation measure: Muscle Tone measure: Upper Extremity Motor Function measure: Manual Ability measure: Functional Independence sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nuriye Büyüktaş city: Bursa state: Nilüfer zip: 16130 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False
<\|newrecord\|> nctId: NCT06352749 id: BasqueCU2024 briefTitle: Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH) acronym: ExerMOT-NH overallStatus: RECRUITING date: 2024-03-18 date: 2025-11-30 date: 2025-11-30 date: 2024-04-08 date: 2024-04-08 name: University of the Basque Country (UPV/EHU) class: OTHER name: Fundación Miranda name: Residencia Albiz Santiago Llanos name: Aspaldiko name: Residencia Nuestra Señora de Begoña, Santurtzi briefSummary: The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10_2022_405_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active. conditions: Physical Function conditions: Cognitive Decline conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Each group will be assigned to control, online intervention or face-to-face intervention primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The investigators in charge of doing the statistical analysis and assessing the outcome measures will be blinded to group allocation. Due to the characteristics of the study, blinding the participants and the care provider (i.e., the professional conducting the exercise sessions) to the group allocation is not possible. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Advice to increase physical activity and reduce sedentary behavior name: Online Physical Exercise name: Face-to-Face Exercise measure: Trail Making Test (TMT) measure: Spanish Version of the Yesavage Depression Scale measure: 30-seconds Chair Sit to Stand test measure: MoCA (Montreal Cognitive Assessment) measure: Wechsler Adult Intelligence Scale III (WAIS-III) measure: EuroQol-5 dimensions (EQ-5D-5L) measure: The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008) measure: Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008) measure: Satisfaction with Life Scale measure: Short Physical Performance Battery (SPPB) measure: The Biceps Curl Test measure: The 2-minute Walk Test (2-MWT) measure: The 8 Feet Up-and-Go test measure: Handgrip strength test measure: Serum Brain Derived Neurotrophic Factor (BDNF) measure: Serum Klotho measure: Serum Glucose measure: Serum Urea measure: Serum Creatinine measure: Serum Uric Acid measure: Serum Cholesterol measure: Serum Triglycerides measure: Serum HDL-Cholesterol measure: Serum LDL-Cholesterol measure: Serum Glutamate Pyruvate Transaminase measure: Serum Glutamate Oxaloacetate Transaminase measure: Serum gamma glutamyl transferase measure: Serum Alkaline Phosphatase measure: Serum Creatin Kinase measure: Serum Lactate Dehydrogenase measure: Serum Bilirubin measure: Serum Sodium measure: Serum Potassium measure: Serum Chloride measure: Serum C Reactive Protein measure: Serum Albumin measure: Serum Total Protein measure: Serum Calcium measure: Serum Phosphorus measure: Serum D Vitamin measure: Erythrocyte count measure: Hemoglobin measure: Hematocrit measure: Mean Corpuscular Volume (MCV) measure: Mean Corpuscular Hemoglobin (MCH) measure: Mean Corpuscular Hemoglobin Concentration (MCHC) measure: Red Cell Distribution Width (RDW) measure: Leucocyte Count measure: Neutrophil Count and Percentage measure: Lymphocyte Count and Percentage measure: Monocyte Count and Percentage measure: Eosinophil Count and Percentage measure: Basophil Count and Percentage measure: Platelet Count measure: Platelet Mean Volumen measure: Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry measure: Fried's frailty phenotype score measure: Frail-NH frailty scale measure: The Pittsburgh Sleep Quality Index measure: Attendance rate measure: Dose modification measure: Adverse Events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Residencia Aspaldiko status: RECRUITING city: Portugalete state: Bizkaia zip: 48920 country: Spain name: Alvaro Mosquera role: CONTACT phone: 34-946250000 email: amosquera@aspaldiko.org lat: 43.32099 lon: -3.02064 facility: Residencia Nuestra Señora de Begoña status: NOT_YET_RECRUITING city: Santurtzi state: Bizkaia zip: 48980 country: Spain name: Janire R Ochoa role: CONTACT phone: 944836875 email: psicologa@residencia-santurtzi.com lat: 43.32842 lon: -3.03248 facility: Residencia Albiz Santiago LLanos status: NOT_YET_RECRUITING city: Sestao state: Bizkaia zip: 48910 country: Spain name: Olatz Larrinaga role: CONTACT phone: 946572220 email: direccion@residenciaalbiz.eus lat: 43.30975 lon: -3.00716 facility: Fundación Miranda status: NOT_YET_RECRUITING city: Barakaldo state: Vizcaya zip: 48902 country: Spain name: Celia Gómez role: CONTACT phone: 944382675 email: innovación@fundaciónmiranda.org lat: 43.29639 lon: -2.98813 hasResults: False
<\|newrecord\|> nctId: NCT06352736 id: LUTS2023 briefTitle: Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community overallStatus: RECRUITING date: 2023-06-01 date: 2025-10-01 date: 2025-12-31 date: 2024-04-08 date: 2024-04-15 name: Chinese PLA General Hospital class: OTHER briefSummary: This study, set up as a cross-sectional survey, seeks to delve into the disease burden and the demographic specifics of lower urinary tract symptoms (LUTS) among the male community in China. The investigators's main aim is to map out the overall and age-specific prevalence rates of LUTS within the Chinese male population. These insights are critical for understanding the public health dimensions of this condition. Moreover, the investigators plan to investigate several secondary aspects: the correlation of LUTS prevalence with factors like urbanization levels (rural vs. urban), geographical distribution, and lifestyle choices. Another significant focus will involve examining the treatment landscape for LUTS, looking at the portion of sufferers receiving treatment, the diversity in treatment durations, and the types of treatments employed (medication vs. surgery). This comprehensive analysis is intended to shed light on the prevailing management strategies for LUTS in China. The study is scheduled to unfold over 36 months and will comprise three pivotal phases: initial preparations, recruitment of subjects and collection of data, followed by the analysis of data and compilation of reports. The investigators will employ a range of methods such as questionnaires, physical exams, laboratory tests, imaging, and other medical evaluations to amass extensive data. This will allow the investigators to evaluate the prevalence of LUTS across various age groups among men and address the current gaps in epidemiological understanding. conditions: Lower Urinary Tract Symptoms studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 12567 type: ESTIMATED measure: International Prostate Symptom Score(IPSS) measure: Overactive Bladder Syndrome Score(OABSS) measure: International Consultation on Incontinence Questionnaire - Short Form(ICIQ-SF) measure: Quality of Life Score（QOL） measure: Prostatic volume measure: Maximum urinary flow rate measure: Residual urine measure: free prostatic specific antigen(fPSA) measure: total prostatic specific antigen(tPSA) measure: fPSA/ tPSA sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General Hospital status: RECRUITING city: Beijing zip: 100853 country: China name: Qing Yuan, Doctor's degree role: CONTACT phone: 18910980422 email: qyuanmd@outlook.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06352723 id: 2024P000856 briefTitle: Cenobamate in the Intensive Care Unit acronym: CENOBITE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-04-08 date: 2024-04-08 name: Brigham and Women's Hospital class: OTHER briefSummary: The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.
Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome. conditions: Epilepsy conditions: Neurologic Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm pilot study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Cenobamate measure: Target level measure: Maintenance level measure: Seizure cessation measure: Seizure burden change sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06352710 id: 2022-01510 briefTitle: Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project overallStatus: RECRUITING date: 2023-06-12 date: 2025-06-12 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: Cantonal Hospital of St. Gallen class: OTHER briefSummary: Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality.
The increasing use of smartphones offers unprecedented opportunities for data collection. We developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity).
By acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, we aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. We will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. We hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making. conditions: Disc Disease conditions: Instabilities Lumbar conditions: Brain Tumor conditions: Aneurysm studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: OP-Tracker App measure: Subjective Well-Being (SWI) measure: EQ-5D-5L measure: Rate of adverse events measure: Severity of adverse events measure: Correlation between TDN/CDG and SWI/QoL measure: Correlation between baseline factors and TDN grade measure: Difference between rate of adverse events and TDN distribution between different surgery groups sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kantonsspital St.Gallen status: RECRUITING city: St.Gallen zip: 9007 country: Switzerland name: Linda Bättig, MD role: CONTACT phone: +41 71 494 11 99 email: linda.baettig@kssg.ch lat: 47.42391 lon: 9.37477 hasResults: False
<\|newrecord\|> nctId: NCT06352697 id: DELI_MASLD briefTitle: Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study) overallStatus: COMPLETED date: 2023-02-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-08 date: 2024-04-09 name: Bogomolets National Medical University class: OTHER name: Taras Shevchenko National University of Kyiv name: Danylo Halytsky Lviv National Medical University name: Kyiv City Clinical Endocrinology Center name: Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine name: MirImmunoFarm name: Stellar Biotics briefSummary: The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces, serum lipid profile, transaminases activity and chronic systemic inflammatory markers in MASLD patients.
The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month. conditions: Metabolic Dysfunction Associated Steatotic Liver Disease conditions: Steatotic Liver Disease conditions: Hepatic Steatosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization was done by the study statistician based on a computer-generated list. The groups were homogeneous according to age, sex and diagnostic criteria. The assignment of groups was blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Probiotic lysate (postbiotic and metabiotc) name: Placebo measure: changes in fatty liver index (FLI) measure: hepatic steatosis index (HSI) measure: TyG index measure: Concentration of AST measure: Concentration of ALT measure: Concentration of Gamma-glutamyl Transferase (GGT) measure: Concentration of Total Cholesterol (TC) measure: Concentration of Tryglicerides (TG) measure: Concentration of LDL-Cholesterol (LDL-C) measure: Concentration of VLDL-Cholesterol (VLDL-C) measure: Concentration of HDL-Cholesterol (HDL-C) measure: Concentration of high sensitivity CRP (hs-CRP) measure: Concentration of IL-6 measure: waist circumferences (WC) measure: body mass index (BMI) measure: visceral fat content sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bogomolets National Medical University city: Kyiv zip: 01601 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Kyiv City Clinical Endocrinology Center city: Kyiv zip: 01601 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Taras Shevchenko National University of Kyiv city: Kyiv zip: 01601 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine city: Kyiv zip: 02000 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Danylo Halytsky Lviv National Medical University city: Lviv zip: 79010 country: Ukraine lat: 49.83826 lon: 24.02324 hasResults: False
<\|newrecord\|> nctId: NCT06352684 id: DP0001-SEV-CAB-II id: RS-2023-00227526 type: OTHER_GRANT domain: Korea Ministry of Science and ICT briefTitle: Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-24 date: 2025-01-14 date: 2025-01-14 date: 2024-04-08 date: 2024-04-08 name: BeamWorks Inc. class: INDUSTRY name: Severance Hospital briefSummary: The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ACTUAL name: CadAI-B for Breast measure: Area Under the LROC Curve measure: Lesion detection sensitivity and specificity sex: FEMALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University Severance Hospital city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06352671 id: 023-286 briefTitle: Prospective Long-Term Outcomes of a Standardized Ross Procedure acronym: ROSS overallStatus: RECRUITING date: 2023-10-12 date: 2025-12-01 date: 2026-01-01 date: 2024-04-08 date: 2024-04-08 name: Baylor Research Institute class: OTHER briefSummary: This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction. conditions: Ross Procedure (Pulmonary Autograft Replacement) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED measure: Survival of the patient at 1-, 5- and 10-year intervals measure: Rate of re-hospitalization measure: Rate of peri operative morbidity measure: Rate of re-operation measure: Rate of re-intervention measure: NYHA status measure: Anticoagulant usage measure: Bleeding events measure: Post operative infection sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor Scott and White Heart Hospital status: RECRUITING city: Plano state: Texas zip: 75093 country: United States name: Rincy Rajan role: CONTACT phone: 469-814-4981 email: Rincy.Rajan@BSWHealth.org name: Sarah Hale role: CONTACT phone: 4698144845 email: sarah.hale@bswhealth.org name: William Brinkman, MD role: PRINCIPAL_INVESTIGATOR lat: 33.01984 lon: -96.69889 hasResults: False
<\|newrecord\|> nctId: NCT06352658 id: #1/2024 briefTitle: Efficacy of Mandibular Advancement Device for Mild-Moderate Apnea overallStatus: COMPLETED date: 2023-02-01 date: 2024-01-01 date: 2024-01-10 date: 2024-04-08 date: 2024-04-08 name: Nourhan M.Aly class: OTHER briefSummary: This was a prospective randomized controlled clinical trial that aimed to compare the efficacy of conventional and CAD CAM mandibular advancement device. conditions: Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 26 type: ACTUAL name: Conventional mandibular advancement device name: CAD CAM mandibular advancement device measure: Apnea hypopnea index measure: Epwoth sleeplness scale (ESS) measure: Oxygen saturation measure: Snoring index sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University, Egypt city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
<\|newrecord\|> nctId: NCT06352645 id: STUDY00004879 briefTitle: Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-04-08 date: 2024-04-09 name: Tufts University class: OTHER name: Guangdong Bixdo Health Technology Co., Ltd. briefSummary: The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal. conditions: Plaque Induced Gingivitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled clinical trial primaryPurpose: TREATMENT masking: NONE count: 165 type: ESTIMATED name: Bixdo Ultra Compact Water Flosser name: Manual toothbrush measure: Inflammation Reduction measure: Bacterial plaque removal sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University School of Dental Medicine city: Boston state: Massachusetts zip: 02111 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06352632 id: ACT-GLOBAL_Master briefTitle: A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke acronym: ACT-GLOBAL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2034-04 date: 2024-04-08 date: 2024-04-23 name: The George Institute class: OTHER name: University of Calgary name: Berry Consultants briefSummary: Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke. ACT-GLOBAL is a multi-factorial, multi-arm, multi-stage, randomised, global adaptive platform trial for stroke, aiming to identify the treatment/s associated with the highest chance of improving outcome in stroke patients. In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options. conditions: Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Adaptive Platform Trial evaluating multiple interventions in multiple domains primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20000 type: ESTIMATED name: Standard-dose intravenous tenecteplase name: Low-dose intravenous tenecteplase name: No intravenous tenecteplase name: Conservative Blood Pressure Control name: Moderate Blood Pressure Control name: Intensive Blood Pressure Control name: Placebo name: NoNO-42 measure: modified Rankin scale (mRS) scores measure: Excellent functional neurological outcome measure: Independent functional neurological outcome measure: Health Related Quality of Life measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352619 id: ACT-GLOBAL_AIS_03 briefTitle: Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial acronym: ENCHANTED3/MT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-08 date: 2024-04-23 name: The George Institute class: OTHER name: University of Calgary name: Changhai Hospital briefSummary: Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic stroke (AIS) patients. Although two trials indicate harm from very intensive target-based treatment (SBP \<130 mmHg), the others neutral effects in the SBP range 140-160 mmHg. The ENCHANTED3/MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy. ENCHANTED3/MT will randomize (1:1:1) up to 2,000 patients with SBP ≥150 mmHg post-EVT to conservative (no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP \[≥180mmHg\]), moderate (SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP \[150-160mmHg\]), or intensive (SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher) BP management. conditions: Ischemic Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 2000 type: ESTIMATED name: Conservative SBP Control name: Moderate SBP Control name: Intensive SBP Control measure: modified Rankin scale measure: Excellent functional neurological outcome measure: Independent functional neurological outcome measure: Health Related Quality of Life measure: Mortality measure: Ordinal shift of 7 levels of modified Rankin scale measure: National Institute of Health Stroke Scale (NIHSS) score measure: Any intracranial haemorrhage (ICH) measure: Symptomatic intracerebral haemorrhage (sICH) measure: Serious Adverse Event (SAE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352606 id: 36264PR558/2/24 briefTitle: Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy overallStatus: RECRUITING date: 2024-04-06 date: 2024-09-01 date: 2024-09-01 date: 2024-04-08 date: 2024-04-09 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy. conditions: Spinal Anesthesia conditions: General Anesthesia conditions: Neonates conditions: Inguinal Herniorrhaphy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 74 type: ESTIMATED name: Spinal anesthesia name: General anesthesia measure: Heart rate measure: Heart rate measure: Mean arterial blood pressure measure: Incidence of bradycardia measure: Incidence of hypotension measure: Incidence of postoperative apnea measure: The duration of surgery measure: Need for postoperative O2 supplementation measure: Hospital stays sex: ALL minimumAge: 1 Day maximumAge: 1 Month stdAges: CHILD facility: Tanta University Hospitals status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Ahmed E Abo ElKheir, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06352593 id: 36264PR557/2/24 briefTitle: Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage overallStatus: RECRUITING date: 2024-04-06 date: 2024-09-01 date: 2024-09-01 date: 2024-04-08 date: 2024-04-09 name: Tanta University class: OTHER briefSummary: The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage. conditions: Dexmedetomidine conditions: Infusion conditions: Endovascular conditions: Aneurysmal Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Intraoperative Dexmedetomidine name: Placebo measure: Incidence of vasospasm measure: Incidence of morbidity and mortality (M/M) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University Hospitals status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Ahmed E Abo ElKheir, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06352580 id: COVID-19 Pediatric briefTitle: Covid-19 Pandemic and Pediatric Dentistry overallStatus: COMPLETED date: 2022-03-01 date: 2022-06-30 date: 2022-06-30 date: 2024-04-08 date: 2024-04-08 name: Abant Izzet Baysal University class: OTHER briefSummary: Coronavirus (SARS-CoV-2), which emerged in Wuhan, China in 2019 and causes severe respiratory infection, poses a potential risk for dentists and patients during dental treatments. It is a common situation during the pandemic period for parents of children needing dental treatment to want to postpone their children's treatment due to Covid-19. This study aimed to evaluate parents' concerns about their children's dentist appointments and ongoing dental treatments in the presence of the quarantine imposed due to Covid-19 and the Covid-19 vaccines that have started to be administered worldwide. In the study, an informative survey consisting of 26 questions was applied to determine how parents feel about the COVID-19 pandemic, how concerned they are about their children's oral health and dental treatment plan, and the changes caused by COVID-19 vaccination practices. The questions were created by 3 different experienced dentists and analysed by 2 different experienced dentists. Questions 7 and 26 were repeated at the beginning and end of the survey to give the same question and answer meaning. Thus, the reliability of the survey was tested. conditions: COVID-19 Pandemic studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: CROSS_SECTIONAL count: 438 type: ACTUAL name: Survey measure: Approach to dental treatments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Deniz Sıla Özdemir Çelik city: Merkez state: Bolu zip: 14030 country: Turkey hasResults: False
<\|newrecord\|> nctId: NCT06352567 id: BakircayU1394/1414 briefTitle: Symptoms Associated With Chemotherapy-Induced Peripheral Neuropathy overallStatus: RECRUITING date: 2024-01-18 date: 2024-06-22 date: 2024-08 date: 2024-04-08 date: 2024-04-09 name: Izmir Bakircay University class: OTHER briefSummary: Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.). conditions: Chemotherapy-induced Peripheral Neuropathy conditions: Breast Cancer conditions: Breast Cancer Female studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 112 type: ESTIMATED name: European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire measure: Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology status: RECRUITING city: İzmir state: Çiğli zip: 35620 country: Turkey name: Murat Akyol, MD role: CONTACT phone: +902324930000 email: dr-muratakyol@hotmail.com name: Alper Tuğral, PT, MSc role: CONTACT phone: +905074421420 email: alper.tugral@bakircay.edu.tr lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06352554 id: 2023/ETH02474:STING id: 224842/Z/21/Z type: OTHER_GRANT domain: Wellcome Trust id: 75A50122C00028 type: OTHER_GRANT domain: HHS/BARDA OTA briefTitle: Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections acronym: STING overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-12-30 date: 2025-01-30 date: 2024-04-08 date: 2024-04-09 name: SpeeDx Pty Ltd class: INDUSTRY name: Biomedical Advanced Research and Development Authority name: Wellcome Trust name: German Federal Ministry of Education and Research name: Australian Research Council Research Hub to Combat Antimicrobial Resistance briefSummary: This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples.
The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains.
Furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens. conditions: Diagnosis conditions: Gonorrhea conditions: Resistance Bacterial studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: To determine the feasibility of performing antibiotic susceptibility testing (AST) for Neisseria gonorrhoeae directly from patient samples using InSignia workflow and assay against commonly used & clinically relevant antibiotics. measure: To study the performance of the InSignia assay in determining antibiotic susceptibility of NG against commonly used & clinically relevant agents in clinical samples with comparison to gold standard methods. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352541 id: SOPH232-1122/I briefTitle: Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo. acronym: PRO-232 overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-06-30 date: 2025-06-30 date: 2024-04-08 date: 2024-04-11 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, parallel groups, double blind, one center. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double blind. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: PRO-232 name: Placebo measure: Incidence Unexpected Related Adverse Reactions measure: Changes in intraocular pressure (IOP) measure: Incidence of Stinging measure: Incidence of Expected Related Adverse Events measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Incidence of ocular symptoms (foreign body sensation and tearing) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352528 id: CA127-1070 briefTitle: A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2025-07-24 date: 2025-07-24 date: 2024-04-08 date: 2024-04-08 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function. conditions: Hepatic Impairment conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Repotrectinib measure: Maximum observed plasma concentration (Cmax) measure: Time of maximum observed plasma concentration (Tmax) measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) measure: Number of participants with Adverse Events (AEs) measure: Number of participants with Severe Adverse Events (SAEs) measure: Number of participants with physical examination abnormalities measure: Number of participants with vital sign abnormalities measure: Number of participants with electrocardiogram (ECG) abnormalities measure: Number of participants with clinical safety laboratory test abnormalities sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Local Institution - 0003 city: Miami Lakes state: Florida zip: 33014 country: United States name: Site 0003 role: CONTACT lat: 25.90871 lon: -80.30866 facility: Local Institution - 0001 city: Orlando state: Florida zip: 32809 country: United States name: Site 0001 role: CONTACT lat: 28.53834 lon: -81.37924 facility: Local Institution - 0002 city: San Antonio state: Texas zip: 78215 country: United States name: Site 0002 role: CONTACT lat: 29.42412 lon: -98.49363 hasResults: False
<\|newrecord\|> nctId: NCT06352515 id: T cells in Ulcerative colitis briefTitle: T Lymphocyte Subsets in Ulcerative Colitis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-06-01 date: 2024-04-08 date: 2024-04-29 name: Assiut University class: OTHER briefSummary: 1. Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.
2. Correlation of T-cell subsets to therapeutic response/ disease activity.
3. Assess the value of circulating IgG anti-Integrin αvβ6 in UC. conditions: Ulcerative Colitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED name: Flow cytometry measure: Study the distribution of T-cell subsets among ulcerative colitis patients. measure: Correlation of T-cell subtypes to therapeutic response sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352502 id: 202112-28 briefTitle: An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis overallStatus: RECRUITING date: 2022-01-28 date: 2024-09-30 date: 2024-09-30 date: 2024-04-08 date: 2024-04-08 name: Tang-Du Hospital class: OTHER briefSummary: EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis. conditions: EGF-R Positive Non-Small Cell Lung Cancer conditions: CNS Metastases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Furmonertinib measure: Intracranial Objective response rate measure: Intracranial Disease Control Rate measure: Intracranial progression-free survival measure: Progression-free survival measure: Overall Survival measure: Safety/Adverse event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tangdu Hopspital status: RECRUITING city: Xi'an state: Shanxi zip: 710038 country: China name: Haichuan Su, PhD role: CONTACT phone: 18629190366 email: such@fmmu.edu.cn name: Jie Min, PhD role: CONTACT phone: 13709202616 email: minjie1504@163.com name: Haichuan Su, PhD role: PRINCIPAL_INVESTIGATOR name: Jie Min, PhD role: SUB_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False
<\|newrecord\|> nctId: NCT06352489 id: Posterior component separation briefTitle: Evaluation of Posterior Component Separation Technique in the Management of Complex Ventral Hernia. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: * Assess short term outcome of posterior component separation technique(PCS) including the regain of the physiological function of the abdominal wall.
* Detect most common post operative complications related to AWR techniques in a 6 months duration after operation. conditions: Ventral Hernia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Posterior component separation technique. measure: Hernia recurrence measure: post operative short term complications sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352476 id: 10881-669 briefTitle: The Effect of Sleep Hygiene Given to Epilepsy Patients on Seizure Frequency and Sleep Quality overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-08 date: 2024-04-08 name: Marmara University class: OTHER briefSummary: Epilepsy is a disease that can be seen in everyone, including neurological, chronic, elderly and children. An estimated 50 million people in the world have epilepsy, patients have a history of two or more seizures, the exact cause is unknown, it negatively affects home, work and school life, and it directs individuals from their independent roles to semi-dependent and fully dependent roles (Smith \& Wagner \& Jonathan, 2015). "Neuronal networks hypersynchronization" develops epileptic seizures, can cause insomnia, and sleep quality may decrease with drug treatment (Sünter and Ağan, 2019). NREM sleep causes seizures through the "ictal and interactive effect" of sleep (Alp and Altındağ, 2014). Insomnia increases seizure discharges, neurological and systemic complications may develop, and serious morbidity and mortality may occur (Özer, 2005). Epilepsy patients frequently experience daytime sleepiness and nighttime insomnia (Gümüşyayla and Vural, 2017). Complementary medical approaches are also recommended along with drug treatment. Sleep hygiene training is recommended for sleep health in epilepsy as in chronic diseases. With good sleep health, symptoms can be eliminated and sequelae can be prevented by reducing epileptic discharges (Gammino at all., 2016). Quality sleep is essential for physiological and psychological health, and sleep disorders can be corrected with sleep hygiene training (Günaş, 2018). Randomized studies including sleep hygiene training are needed to prevent seizure recurrences, prevent or treat comorbid psychological diseases, and improve life activities of epilepsy patients (Lee at all., 2015). One-third of people's lives are spent in sleep, regular and adequate sleep protects physiological and psychological health, sleep hygiene training contributes to the recovery of sleep disorders and accompanying psychological comorbid diseases, sleep hygiene training is cost-free and easy to implement, where daily activities and behaviors are regulated, appropriate environmental conditions are provided. By regulating the circadian rhythm, melatonin is released during sleep at night and sleep disorders are prevented by preventing excessive cortisol release (http://www.psikiyatri.net/uyku-hijyeni / Access date: 28 May 2022; Alp and Altındağ, 2014; Güneş, 2018). . No research has been found on sleep hygiene training to relieve sleep deprivation, which is common in epilepsy patients. With good sleep hygiene, sleep and quality of life can be improved and epileptic seizures can be prevented or reduced.
Purpose of the research; To determine the effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality. Non-drug clinical research is an experimentally planned research with a pre-test post-test control group trial model. conditions: Epilepsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research is an experimental study with a pre-test and post-test control group trial model. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The participant will not know whether he or she is in the experimental or control group. whoMasked: PARTICIPANT count: 160 type: ESTIMATED name: Sleep Hygiene Training measure: Pittsburgh Sleep Quality Index measure: Pittsburgh Sleep Quality Index measure: epileptic seizure diary sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06352463 id: 406.XS.03.068 briefTitle: Intervention Social Anxiety: Combining Parent-child Treatment acronym: ISA overallStatus: RECRUITING date: 2024-04-15 date: 2025-07-01 date: 2025-07-01 date: 2024-04-08 date: 2024-04-08 name: Leiden University class: OTHER name: Leids Universitair Behandel en Expertise Centrum (LUBEC) name: GGZ Delfland name: Netherlands Organisation for Scientific Research briefSummary: The aim of this pilot project is to investigate a treatment program for children with social anxiety, in which children and their parents, parallel to each other, follow separate evidence-based interventions. The added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously. conditions: Social Anxiety Disorder of Childhood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 9 type: ESTIMATED name: Denken + Doen = Durven name: Supportive Parenting for Anxious Childhood Emotions measure: Change in severity of social anxiety in children measure: Change in anxiety-related symptoms and family accommodation sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: GGZ Delfland status: NOT_YET_RECRUITING city: Delft state: South-Holland zip: 2600GA country: Netherlands name: Anika Bexkens role: CONTACT email: a.bexkens@fsw.leidenuniv.nl lat: 52.00667 lon: 4.35556 facility: Leiden University status: RECRUITING city: Leiden state: South-Holland zip: 2333AK country: Netherlands lat: 52.15833 lon: 4.49306 facility: LUBEC status: RECRUITING city: Leiden state: South-Holland zip: 2333ZB country: Netherlands name: Anika Bexkens role: CONTACT email: a.bexkens@fsw.leidenuniv.nl lat: 52.15833 lon: 4.49306 hasResults: False
<\|newrecord\|> nctId: NCT06352450 id: DPT/Batch-Fall19/558 briefTitle: Comparison of Active Isolated Stretching Versus Myofascial Release of Knee Joint in Office Workers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-05-20 date: 2024-06-28 date: 2024-04-08 date: 2024-04-08 name: Superior University class: OTHER briefSummary: "Office workers often spend long hours sitting, which can lead to stiffness and reduced mobility. By studying these two techniques AIS and MFR, we can determine which one is more effective in helping office workers to improve their flexibility and range of motion in the knee joint because their sedentary work environment often leads to musculoskeletal issues, including limited knee joint mobility.
AIS involves stretching specific muscles while actively engaging opposing muscles to enhance the effectiveness of the stretch. It aims to increase the extensibility of muscles and improve joint mobility. On the other hand, MFR focuses on releasing tension and adhesions in the fascia, the connective tissue surrounding muscles and joints, to restore mobility and reduce pain.
Understanding the benefits and effectiveness of these techniques will contribute to evidence-based practices in occupational health and help office workers maintain optimal joint health" conditions: Stiffness; Spine conditions: Mobility Limitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Active isolated stretching (AIS) name: Myofascial release (MFR) measure: Numaric Pain Scale sex: ALL minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Al-Zahra Medical complex Johar town, Laser spine center Model town, Laser spine center Johar town. city: Lahore country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06352437 id: 1507-0001 id: 2023-508767-79-00 type: REGISTRY domain: CTIS id: U1111-1302-5933 type: REGISTRY domain: WHO International Clinical Trials Registry Platform (ICTRP) briefTitle: A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-07-14 date: 2025-07-14 date: 2024-04-08 date: 2024-04-08 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy.
The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood.
Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time.
Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 6 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 124 type: ESTIMATED name: BI 3034701 name: Placebo matching BI 3034701 measure: Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator measure: Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) following a single dose of BI 3034701 measure: Part A: Maximum measured concentration of the analyte in plasma (Cmax) following a single dose of BI 3034701 measure: Part B: Area under the concentration-time curve in plasma over the time interval from 0 to 168 hours (AUC0-168) following multiple doses of BI 3034701 measure: Part B: Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352424 id: 1458-0006 id: 2023-506233-30-01 type: REGISTRY domain: CTIS (EU) id: U1111-1293-4672 type: REGISTRY domain: WHO Registry briefTitle: A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-09 date: 2024-12-09 date: 2024-04-08 date: 2024-04-08 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: BI 456906 name: BI 1820237 name: Placebo for BI 1820237 name: Placebo for BI 456906 measure: Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352411 id: 1404-0009 id: 2023-508557-13-00 type: REGISTRY domain: CTIS id: U1111-1298-3135 type: REGISTRY domain: WHO registry briefTitle: A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2024-11-26 date: 2024-11-26 date: 2024-04-08 date: 2024-04-08 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.
The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood.
Study participants receive a single dose of BI 456906 as an injection under the skin. Participants are divided into 4 groups based on how well their kidneys work: 1 group without kidney problems, and 3 groups with mild, moderate, and severe kidney problems. Each participant without kidney problems is matched with participants from the other groups based on factors such as age, gender, race, and body mass index (BMI) to ensure accurate comparisons.
Participants are in the study for about 2 months. They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The participants also answer questions about their well-being. The doctors regularly check participants' health and take note of any unwanted effects. conditions: Healthy conditions: Renal Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: BI 456906 measure: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) measure: Maximum measured concentration of BI 456906 in plasma (Cmax) measure: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352398 id: BBTuysuz briefTitle: Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients overallStatus: COMPLETED date: 2023-12-20 date: 2024-02-01 date: 2024-04-01 date: 2024-04-08 date: 2024-04-08 name: Burcu Bozdogan Tuysuz class: OTHER briefSummary: The 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. were administered 30 min before the end of the operation. Post operatively the patient was followed up with controlled analgesia. Demographic data, ASA scores, body mass indexes, peri-operative haemodynamic values, remifentanil consumption and duration of surgery were recorded. Post-operative first 24 hours NRS scores, morphine consumption, number of nausea and vomiting episodes were recorded. conditions: Video-Assisted Thoracoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 52 type: ACTUAL name: erector spina plan block name: Serratus posterior superior intercostal plan block (SPSIPB) name: 0.25% bupivacaine measure: morphine consumption first 24 hours measure: NRS pain score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medenıyet Unıversıty city: Istanbul state: Kadıkoy zip: 34734 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06352385 id: SH9H-2024-TK16-1.0 briefTitle: Epidemiological Investigation of Malocclusion in China overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-08 date: 2024-04-08 name: Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: Malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. Notably, the last comprehensive national prevalence data on malocclusion in China, which encompassed a significant sample size, dates back over two decades. Given the evolving nature of these epidemiological metrics, such as prevalence rates, it is imperative to update our understanding. Consequently, there is an urgent need for China to undertake a unified, standardized epidemiological survey of malocclusion with a substantial sample size to ensure accurate and timely data collection. conditions: Epidemiological Investigation conditions: Malocclusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 19847 type: ESTIMATED measure: The Prevalence rate of malocclusion measure: Dental Aesthetic Index of each age group measure: Index of Orthodontic Treatment Need of each age group measure: dietary habit measure: oral hygiene habits measure: Bad oral habit sex: ALL minimumAge: 4 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352372 id: tPBM Study briefTitle: Safety and Efficacy of tPBM for Epileptiform Activity in Autism acronym: tPBM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-06 date: 2024-04-08 date: 2024-04-08 name: Richard Frye class: OTHER briefSummary: For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions. conditions: Autism Spectrum Disorder conditions: EEG With Periodic Abnormalities conditions: Epilepsy conditions: Neurodevelopmental Disorders conditions: Neurological Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective, open label study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after treatment with, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) measure: Childhood Autism Rating Scores (CARS) measure: EEG Delta Power measure: Seizure frequency and severity measure: Social Responsiveness Scale (SRS) measure: Clinical Global Impression Scale (CGI) measure: NIH Toolbox sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: Rossignol Medical Center city: Phoenix state: Arizona zip: 85050 country: United States name: Richard E Frye, M.D., PhD role: CONTACT phone: 321-259-7111 email: drfrye@rossignolmedicalcenter.com name: Richard E Frye, M.D., PhD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 hasResults: False
<\|newrecord\|> nctId: NCT06352359 id: ONC-841-002 briefTitle: Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2025-06-30 date: 2027-06-30 date: 2024-04-08 date: 2024-04-10 name: OncoC4, Inc. class: INDUSTRY briefSummary: This is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: ONC-841 measure: Dose Limiting Toxicity (DLT) measure: Maximum Toxicity Dose (MTD) measure: Cmax of ONC-841 measure: The serum half-life of ONC-841 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California at Davis Cancer Center city: Sacramento state: California zip: 95817 country: United States name: Tianhong Li, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: Norton Cancer Center city: Louisville state: Kentucky zip: 40202 country: United States name: John Hamm, MD role: PRINCIPAL_INVESTIGATOR lat: 38.25424 lon: -85.75941 facility: Tranquil Clinical Research city: Houston state: Texas zip: 77598 country: United States name: John Knecht, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06352346 id: Plan Game_ABI&Psychiatry briefTitle: A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-04-08 date: 2024-04-08 name: ProPersona class: OTHER briefSummary: The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function (EF) deficits. EF deficits are often seen in patients with psychiatric disorders i.e. depression or anxiety. In order to minimize everyday disorganization, effective EF interventions are required. Interventions using compensatory strategies have the potential to enable patients to minimize disabilities, minimize participation problems and to function more independently in daily life. A well-known evidence-based intervention that uses compensatory strategies is Goal Management Training (GMT), a training that has been found to alleviate depressive symptoms in a depressed population. GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving. To adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks. Therefore, GMT is comprehensive, time-consuming and thus labour-intensive. Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care. Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e. strengthening of executive problems) rather than practicing compensatory strategies, with little or no transfer to improvements in daily life functioning. This study therefore aims to assess the potential of a newly developed Brain Game, based on compensatory strategies, as an add-on to GMT to develop a shortened and partly self-paced GMT intervention. The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI that also suffer from depression or anxiety, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task. Also we assess whether psychological symptoms alleviate following the GMT intervention and at 6-weeks follow-up. The study will be a multiple-baseline across individuals single-case experimental design (SCED). The study population consists of brain-injured patients, between 18 and 75 years old that receive in-patient mental neuropsychiatric healthcare. Participants eligible for the study must have EF deficits due to (nonprogressive) Acquired Brain Injury (ABI), minumum time post-onset of 3 months and depressive or anxiety symptoms. EF deficits will be assessed by extensive neuropsychological examination. Participants will be recruited from an inpatient clinic. In the course of one and a half year four participants will be recruited. conditions: Acquired Brain Injury conditions: Depressive Symptoms conditions: Anxiety conditions: Executive Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A randomized Single-case Experimental Design (SCED) with a follow-up period of 6 weeks. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure.
Phase A acts as a control and is therefore compared with phase B. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The target behavior (i.e. performance on an untrained shopping task) will be measured repeatedly, on a minimum of six occasions in each phase where possible, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria. Repeated measures of target behavior will be assessed via the OxMET-NL task and is scored automatically: no assessor input is required to either save or score the main outcome data. The secondary outcome measure(s) are scored by an outcome assessor who is blind to the order in which the secondary outcome measure(s) were taken. whoMasked: OUTCOMES_ASSESSOR count: 4 type: ESTIMATED name: Compensatory brain game supporting Goal Management Training intervention measure: Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B measure: Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up measure: Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS) measure: Change in performance on two trained IADL task (treatment goals) measure: Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL) measure: Change in strategy use during the performance of trained and untrained IADL tasks measure: Change in subjective experience of strategy use in daily life measure: Change in subjectively experienced psychological symptoms such as depressive, anxiety and stress symptoms. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ProPersona city: Wolfheze state: Gelderland zip: 6874 BE Wolfheze country: Netherlands name: Bea Tiemens, PhD role: CONTACT email: b.tiemens@propersona.nl name: Floor Poerschke, MSc role: SUB_INVESTIGATOR name: Emily Vink, MSc role: SUB_INVESTIGATOR lat: 52.00333 lon: 5.79028 hasResults: False
<\|newrecord\|> nctId: NCT06352333 id: Parasagittal Vs Cornerpocket briefTitle: Parasagittal Vs Cornerpocket Approaches overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-11-01 date: 2025-01-01 date: 2024-04-08 date: 2024-04-08 name: Sohag University class: OTHER briefSummary: Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.
Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.
Each approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .
A supraclavicular block can provide effective surgical anesthesia of the forearm and hand.
The most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of "looking" across the first rib, with the apex of the lung visualized close to thePlexus .
A new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach conditions: Supraclavicular Brachial Plexus Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Inclusion criteria:
* 18to60 yearsold
* ASA grade I to II
* Elective upper limb surgery primaryPurpose: SCREENING masking: NONE count: 80 type: ESTIMATED name: supraclavicular ultrasound guided brachial plexus block measure: Needle visibility in both approaches measure: Duration of sensory and motor block measure: Success rate measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Sohag university Hospital city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06352320 id: XJTU1AF2023LSK-533 briefTitle: Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH） overallStatus: NOT_YET_RECRUITING date: 2024-12-31 date: 2030-08-31 date: 2032-08-31 date: 2024-04-08 date: 2024-04-08 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment. conditions: Cardiomyopathies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED name: Diagnosis of HCM name: Diagnosis of DCM name: Diagnosis of ARVC name: Diagnosis of NDLVC name: Diagnosis of RCM name: Diagnosis of LVNC measure: Change in the incidence of mortality rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Xi'an Jiantong University city: Xi'an state: Shaanxi zip: 710061 country: China lat: 34.25833 lon: 108.92861 hasResults: False
<\|newrecord\|> nctId: NCT06352307 id: XJTU1AF2023LSK-532 briefTitle: Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy acronym: STARTER overallStatus: NOT_YET_RECRUITING date: 2024-12-31 date: 2030-08-31 date: 2032-08-31 date: 2024-04-08 date: 2024-04-08 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM. conditions: Arrhythmogenic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1500 type: ESTIMATED name: Diagnosis of ACM measure: Change in the incidence of mortality rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Xi'an Jiantong University city: Xi'an state: Shaanxi zip: 710061 country: China name: Guoliang Li role: CONTACT phone: 008613759982523 email: liguoliang_med@163.com name: Yang Yan role: CONTACT phone: +86.29.85323869 email: yangyan3@xjtu.edu.cn lat: 34.25833 lon: 108.92861 hasResults: False
<\|newrecord\|> nctId: NCT06352294 id: MSDALAKCI briefTitle: The Effects of Myofascial Relaxation Technique Applied Together With Core Stabilization Trainings on Balance, Pain, Joint Range of Motion and Functionality in Individuals With Chronic Neck Pain overallStatus: RECRUITING date: 2024-03-29 date: 2024-07 date: 2024-07 date: 2024-04-08 date: 2024-04-08 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Chronic neck pain is a musculoskeletal disorder that affects people frequently in life. Nov.
Postural control is based on the process of correctly identifying and selectively focusing the incoming afferent input of the Central Nervous System (CNS).
The main treatment options for people with neck pain include soft tissue and joint mobilizations, stabilization exercises for the neck, trunk and shoulder muscles, cervical Deckings, relaxation training, strengthening exercises and body awareness and posture training Nov.
In this study, it was aimed to investigate the effects of myofascial relaxation on balance, pain, joint range of motion and functionality in individuals with chronic neck pain by dividing them into two groups in the form of core stabilization and core stabilization and myofascial relaxation.
The study included 45 people between the ages of 18 and 65 Dec. In two groups, the core stabilization group will be 22 people, and the core stabilization and myofascial relaxation group will be 23 people. The study period is planned as 6 weeks and 3 sessions per week. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: Core stability training name: Core stability training and myofascial relase measure: Pain severity measure: Pressure pain threshold (PPT) measure: Balance measure: Range of motion measure: Neck Disability İndex measure: DASH sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kırşehir Ahi Evran Üniversitesi status: RECRUITING city: Merkez state: Kırşehir country: Turkey name: Muhammed Samed Dalakçı role: CONTACT phone: 905445325572 email: samed.dalakci@gmail.com hasResults: False
<\|newrecord\|> nctId: NCT06352281 id: KM-007 briefTitle: Efficacy and Safety of CAR-T Cells Therepy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP) overallStatus: RECRUITING date: 2024-02-01 date: 2026-01-01 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China class: OTHER briefSummary: It is a single-center, single-arm, open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP). conditions: ITP - Immune Thrombocytopenia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: CAR-T cells measure: Portion of patients with response (R) measure: Portion of patients with complete response (CR) measure: Portion of patients with relapse measure: Time (in days) from treatment start to response (R) measure: Time (in days) from treatment to complete response (CR) measure: Duration (in days) of response (R) measure: Incidence of adverse events(AE) after infusion sex: ALL minimumAge: 8 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China status: RECRUITING city: Kunming state: Yunnan zip: 650000 country: China name: Wang Sanbin, Doctor role: CONTACT phone: 13187424131 phoneExt: +86 email: sanbin1011@163.com lat: 25.03889 lon: 102.71833 hasResults: False
<\|newrecord\|> nctId: NCT06352268 id: IEC-368/17.07.2023 briefTitle: Lesioning Procedures for Movement Disorders overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12-31 date: 2028-12-31 date: 2024-04-08 date: 2024-04-08 name: All India Institute of Medical Sciences, New Delhi class: OTHER briefSummary: Dystonia is a rare syndrome with varying etiologies. Similarly, tremor conditions refractory to medical management and disabling that they need surgical interventions are rare in our setting. So far there are no randomized controlled trials of pallidotomy for management of dystonia. There is scant literature on the long term efficacy and safety of Pallidotomy, thalamotomy and other such lesioning procedures in the management of movement disorders. The current literature is significantly plagued by publication bias as case reports with successful outcomes are likely to be selectively published in journals or conference abstracts. Lesioning procedures though seem to be effective are often considered to be risky, especially bilateral pallidotomy is not preferred by several centres. However, our center routinely performs simultaneous bilateral pallidotomy. To generate long term data on the efficacy and safety of lesioning procedures in rare diseases like dystonias especially the effect of functional neurosurgery on varying etiologies of the disease, robust registries are required which collect data on all consecutive patients who undergo the procedure. conditions: Dystonia conditions: Parkinson Disease conditions: Essential Tremor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Pallidal, subthalamic or thalamic lesioning measure: Long term functional outcomes measure: Long term functional outcomes measure: Predictors of outcomes measure: Demography measure: Clinical features measure: Laboratory findings measure: Imaging features measure: Treatment trends measure: Clinical features measure: Treatment trends sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: All India Institute of Medical Sciences, New Delhi city: New Delhi state: Delhi zip: 110029 country: India name: Arunmozhimaran Elavarasi, MD DM role: CONTACT phone: +919013844274 email: arun_ela@yahoo.com lat: 28.63576 lon: 77.22445 hasResults: False
<\|newrecord\|> nctId: NCT06352255 id: AR1937 briefTitle: Pain and Anxiety During Local Block overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2025-07 date: 2024-04-08 date: 2024-04-08 name: University of Seville class: OTHER briefSummary: INTRODUCTION: Currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. However, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. Most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry.
OBJECTIVES: It is intended to determine the pain after an anesthetic block in H of Frost in the first finger with different application methods, such as syringe and carpule. As secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients.
METHODOLOGY: Experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria.
Result: after the completion of the study CONCLUSIONS: After the completion of the study conditions: Anesthesia, Local conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Digital block measure: Grade of Pain postinyection measure: Anxiety before the intervention sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352242 id: RECHMPL24-0076 UF 9572 briefTitle: Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma? acronym: CARTROG overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2026-04-08 date: 2026-04-08 date: 2024-04-08 date: 2024-04-08 name: University Hospital, Montpellier class: OTHER briefSummary: CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic "signature" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL. conditions: Diffuse Large B Cell Lymphoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 85 type: ESTIMATED name: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients name: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers measure: Identification of a phenotypic "signature" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma. measure: Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of grade II or more immunological adverse events measure: Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of serious hematological side effects. measure: Determination of the trogocytosis level of normal lymphocytes and NK cells in healthy subjects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352229 id: 514-0335/23-2000 briefTitle: The Playful Learning in Infancy Program acronym: PLIP overallStatus: RECRUITING date: 2023-06-01 date: 2026-11-30 date: 2026-11-30 date: 2024-04-08 date: 2024-04-08 name: University of Copenhagen class: OTHER name: LEGO Foundation briefSummary: In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.
The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.
Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program. conditions: Parent-Child Relations conditions: Infant Development studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Evaluation is based on a parallel group study, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 2327 type: ESTIMATED name: Playful Learning in Infancy Program name: Postnatal care as usual measure: Parental Playful interactions measure: Parental Stress measure: Infant Socio-emotional Development measure: Infant Level of Play measure: Parental Mind-Mindedness measure: Parental Attachment Style measure: Parental Mental Well-Being measure: Infant Screen Time measure: Questions developed for the study regarding Parental Involvement measure: Questions developed for the study regarding Parental Knowledge of Play measure: Parental Experience of the PLIP measure: Health Visitors' Experience of the PLIP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen status: RECRUITING city: Copenhagen zip: 1353 country: Denmark name: Mette S. Væver, PhD role: CONTACT phone: +45 35324906 email: mette.vaever@psy.ku.dk name: Maja Nyström-Hansen, PhD role: CONTACT phone: +4535336499 email: mnh@psy.ku.dk lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06352216 id: Elo-Ger-2023-1642 briefTitle: Prevalence of Synovitis in Patients With Haemophilia A acronym: SynoPrev overallStatus: RECRUITING date: 2024-04-15 date: 2027-02 date: 2027-03 date: 2024-04-08 date: 2024-04-16 name: University Hospital, Bonn class: OTHER name: Swedish Orphan Biovitrum briefSummary: The aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia A. conditions: Haemophilia A conditions: Synovitis conditions: Hemophilia Arthropathy conditions: Sonography studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US); Haemophilia joint health score (HJHS) measure: Haemophilia early arthropathy detection with ultrasound (HEAD-US) measure: The Hemophilia Joint Health Score version 2.1 (HJHS) measure: PROMIS-29 Questionaire measure: Haemophilia Activities List (HAL) measure: Baseline Characteristics sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bonn status: RECRUITING city: Bonn state: NRW zip: 53113 country: Germany name: Andreas C. Strauss, PD Dr. med. role: CONTACT phone: 004922828714176 email: andreas.strauss@ukbonn.de name: Andreas C. Strauss, PD Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 50.73438 lon: 7.09549 hasResults: False
<\|newrecord\|> nctId: NCT06352203 id: AUT/23.02 briefTitle: Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-11 date: 2024-04-08 date: 2024-04-08 name: ProbiSearch SL class: INDUSTRY briefSummary: Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.
An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.
The duration of the study will be of 6 months approximately, including 6 months of product intake.
Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. conditions: Neurodevelopmental Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Probiotic name: Placebo measure: Number of children with intestinal dysbiosis after 6 months of treatment. sex: ALL minimumAge: 3 Years maximumAge: 7 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06352190 id: SY-5007-I-04 briefTitle: A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-08 date: 2024-04-08 name: Shouyao Holdings (Beijing) Co. LTD class: OTHER briefSummary: This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: [14C] SY-5007 measure: Total radioactivity in plasma PK: Cmax measure: Total radioactivity in plasma PK: Tmax measure: Total radioactivity in plasma PK: AUC0-t measure: Total radioactivity in plasma PK: t½ measure: Total radioactivity in plasma PK: CL/F measure: Whole blood to plasma total radioactivity ratio measure: Cumulative total radioactivity in urine and faeces measure: Metabolic profiling in plasma, urinary and fecal excretion measure: Cmax of SY-5007 and its metabolites measure: Tmax of SY-5007 and its metabolites measure: AUC0-t of SY-5007 and its metabolites measure: t½ of SY-5007 and its metabolites measure: CL/F of SY-5007 and its metabolites measure: Incidence of adverse events sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing zip: 100050 country: China name: Ruihua Dong, MD role: CONTACT phone: 86-010-63139033 email: ruihua_dong_rw@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06352177 id: protocol-1 briefTitle: Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD acronym: ENLIGHTEN overallStatus: NOT_YET_RECRUITING date: 2025-04-01 date: 2029-12-31 date: 2030-08-01 date: 2024-04-08 date: 2024-04-08 name: Milton S. Hershey Medical Center class: OTHER briefSummary: The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH. People who have MASH, the progressive subtype of MASLD, have the highest risk for liver disease progression and poor outcomes, including cirrhosis and hepatocellular carcinoma, and greater overall mortality. Thus, these participants are expected to experience the greatest benefit from treatment.
This is a randomized, controlled trial comparing DTx lifestyle intervention in participants with non-cirrhotic MASH to standard clinical care. The study includes a screening period (up to 2 wks.) followed by randomization, 48-wk treatment period and 12-wk follow-up period (total duration up to 62 wks.). conditions: NASH conditions: NASH - Nonalcoholic Steatohepatitis conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 50/50 randomization primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Noom Weight Application measure: Clinically significant liver fat loss measure: Sustained clinically significant body weight loss measure: Sustained clinically significant body weight loss measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06352164 id: ZYS2024-03 briefTitle: Efficacy Classification Prediction of the Effects of Acupuncture on Abdominal Pain in Patients With Crohn's Disease overallStatus: COMPLETED date: 2015-03-01 date: 2023-12-31 date: 2024-03-31 date: 2024-04-08 date: 2024-04-09 name: Shanghai Institute of Acupuncture, Moxibustion and Meridian class: OTHER briefSummary: Machine learning algorithms are applied to discover gut flora markers that predict the clinical efficacy of acupuncture, so as to screen the appropriate population for acupuncture and optimise the allocation of healthcare resources. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 55 type: ACTUAL name: Acupuncture treatment measure: Characterisation of gut microflora strains predictive of acupuncture efficacy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian city: Shanghai zip: 200000 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06352151 id: 2022-041 briefTitle: Effects of Orofacial Therapy and Therapeutic Yoga in Children With Down Syndrome overallStatus: RECRUITING date: 2023-10-01 date: 2024-09-28 date: 2024-12-30 date: 2024-04-08 date: 2024-04-09 name: Hasan Kalyoncu University class: OTHER briefSummary: The study aims to compare the effects of orofacial therapy and therapeutic yoga on swallowing, sleep habits, and quality of life in children with Down syndrome. conditions: Down Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Routine Physiotherapy Group name: Orofacial Treatment Group name: Therapeutic Yoga Group measure: The Pediatric Functional Independence Measure measure: Pediatric Eating Assessment Tool-10 measure: Children's Sleep Habits Questionnaire measure: The Health-Related Quality of Life Scale-KIDSCREEN-27 sex: ALL minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Hasan Kalyoncu University status: RECRUITING city: Gaziantep zip: 27410 country: Turkey name: Aysenur Tuncer, PhD role: CONTACT phone: +903422118080 name: Yasemin Kotevoglu, MSc role: CONTACT lat: 37.05944 lon: 37.3825 hasResults: False
<\|newrecord\|> nctId: NCT06352138 id: ENCASE briefTitle: Comparative Study of Two Recombinant Human Erythropoietin Products on Chronic Kidney Disease Patients acronym: ENCASE overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-03 date: 2027-03 date: 2024-04-08 date: 2024-04-08 name: Megalabs class: INDUSTRY name: Azidus Laboratories briefSummary: Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for subcutaneous use, compared to Eprex® (Janssen-Cilag Farmacêutica Ltda.), in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis conditions: Anemia of Chronic Kidney Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicentre, double-blind, randomised, parallel, equivalence trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 280 type: ESTIMATED name: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. name: Active comparator: European Union licenced epoetin alfa measure: Mean Absolute Change in Hemoglobin Levels measure: Change in Mean Hb Level measure: immunogenicity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Megalabs city: Colonia Nicolich state: Canelones zip: 15000 country: Uruguay name: Victoria Rodriguez, MD role: CONTACT phone: 26836300 phoneExt: 3110 email: vrodriguez@megalabs.global lat: -34.81516 lon: -56.02435 hasResults: False
<\|newrecord\|> nctId: NCT06352125 id: TP-CLN-100503 briefTitle: An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge overallStatus: COMPLETED date: 2021-12-09 date: 2023-01-31 date: 2023-01-31 date: 2024-04-08 date: 2024-04-08 name: Haemonetics Corporation class: INDUSTRY name: ClinStatDevice name: Boston Healthcare Technologies Consultants, LLC briefSummary: This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators. conditions: Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 338 type: ACTUAL name: TEG 6s Citrated K, KH, RTH, FFH Cartridge name: Clauss Fibrinogen measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California - San Francisco city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: University of Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Ochsner Clinic city: New Orleans state: Louisiana zip: 70121 country: United States lat: 29.95465 lon: -90.07507 facility: Lifebridge Health (Sinai Hospital) city: Baltimore state: Maryland zip: 21215 country: United States lat: 39.29038 lon: -76.61219 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: University of Texas Health Science Center - San Antonio city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False

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