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<\|newrecord\|> nctId: NCT06343766 id: RECO6U/24-2022 briefTitle: Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS. overallStatus: COMPLETED date: 2022-11-06 date: 2023-11-05 date: 2023-11-05 date: 2024-04-03 date: 2024-04-03 name: Amina Fouad Farag class: OTHER briefSummary: A Cross-Sectional Study aims to shed light on potential genetic determinants influencing dental caries susceptibility within this demographic and significantly understanding of genetic factors associated with dental caries, particularly within the context of the Egyptian population, providing valuable insights into the genetic aspects of oral health. The research methodology involved a comprehensive examination of these polymorphic loci ENAM, AMBN, TUFT1 and KLK4 and their prevalence, employing rigorous statistical analyses to establish potential correlations between these genetic variants and susceptibility to dental caries. conditions: Dental Caries Secondary to Polymorphisms conditions: Polymorphisms in Enamel Encoding Genes studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 204 type: ACTUAL name: DNA collation and genotyping measure: Polymorphisms in genes associated with enamel formation and mineralization and dental caries susceptibility. sex: ALL minimumAge: 15 Years maximumAge: 22 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Dentistry, October 6 University city: Giza zip: 12511 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
<\|newrecord\|> nctId: NCT06343753 id: FMASU MD46/2024 briefTitle: Quality of Recovery After Laparoscopic Cholecystectomy Comparing Opioid Free Analgesia Versus Opioid Free Anesthesia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-10-01 date: 2024-04-03 date: 2024-04-03 name: Ain Shams University class: OTHER briefSummary: The aim of this study is to compare the quality of recovery from general anesthesia and surgery using the quality of recovery 15 item scale (QoR-15) for participant's receiving opioid-Sparing anesthesia with those receiving standard opioid-containing anesthesia in Patients undergoing a scheduled laparoscopic cholecystectomy. conditions: Quality of Recovery conditions: Pain, Postoperative conditions: Elective Laparoscopic Cholecystectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Opioid free analgesia name: Opioid based Anesthesia measure: Quality of recovery measure: Post operative pain measure: Postoperative Hypoxia measure: Postoperative nausea and vomiting measure: Postoperative bradycardia measure: Postoperative hypotension measure: Postoperative hypertension sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams University city: Cairo country: Egypt name: Ahmed El-ghanam role: CONTACT phone: 201116171706 lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06343740 id: PSY-2324-S-0136 briefTitle: First Evaluation of COMET-Y acronym: COMET-Y overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Accare class: OTHER briefSummary: The goal of this pilot study is to evaluate COMET-Y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. The main questions is: Does COMET-Y, parallel to care as usual (CAU), improve self-esteem?
Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Youth and therapists will be assessed to evaluate feasibility and acceptability of the COMET-Y training. conditions: Self Esteem conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This pilot study is a pre-post study. primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: COMET-Y measure: Self Esteem measure: Domain-specific Self Esteem measure: Mental Health Problems measure: Quality of life measure: Affect measure: Resilience measure: Ecological Momentary Assessments - Global self-esteem measure: Ecological Momentary Assesments - Goal Based Outcome (GBO) tool for young people measure: Ecological Momentary Assesments - Domain-specific self-esteem sex: ALL minimumAge: 11 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343727 id: HS25870 (H2023:026) briefTitle: A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-03 date: 2024-04-03 name: Seven Oaks Hospital Chronic Disease Innovation Centre class: NETWORK name: University of Manitoba name: Manitoba Egg Farmers briefSummary: The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:
* To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.
* To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.
* To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks. conditions: Kidney Failure conditions: Frailty conditions: Kidney Disease, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is an open-label randomized controlled parallel arm feasibility tria primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Egg white protein pudding name: : Ensure Plus measure: Eligibility to randomization ratio measure: Weekly recruitment rate measure: Adherence to Egg pudding measure: Serum albumin measure: Hand grip strength measure: Change in gait speed measure: Five rep chair stand time measure: Tandem balance time measure: Serum bicarbonate measure: Calcium measure: Urine albumin measure: chloride measure: phosphorus measure: Potassium measure: Sodium measure: HbA1c sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343714 id: FB1003-04-101 briefTitle: A Study of FB1003 in Healthy Subject overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2025-06-30 date: 2025-06-30 date: 2024-04-03 date: 2024-04-03 name: 4B Technologies Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: FB1003 name: Placebo measure: The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo. measure: FB1003 serum concentrations over time measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of FB1003 measure: Presence of anti-FB1003 antibodies over time sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343701 id: BAİBÜ-SAT4 briefTitle: Investigation of Motor Imaging Skills in Children With Spastic Cerebral Palsy overallStatus: RECRUITING date: 2023-07-18 date: 2024-05-05 date: 2024-06-25 date: 2024-04-03 date: 2024-04-03 name: Abant Izzet Baysal University class: OTHER briefSummary: The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are:
* There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP.
* There is a difference between the explicit motor imagery skills of children with bilateral and unilateral CP.
* There is a difference between the implicit motor imagery skills of children with cerebral palsy and typically developing children.
* There is a difference between the explicit motor imagery skills of children with cerebral palsy and typically developing children. conditions: Cerebral Palsy, Spastic studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Implicit motor imagery name: Explicit motor imagery measure: Explicit motor imagery -1 measure: Explicit motor imagery - 2 measure: Explicit motor imagery - 3 measure: Implicit motor imagery sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi status: RECRUITING city: Zonguldak state: Ereğli zip: 67300 country: Turkey name: Seda AYAZ TAŞ, Phd role: CONTACT phone: 05495458040 email: seda.ayaztas@ibu.edu.tr lat: 41.45139 lon: 31.79305 facility: Bolu Abant İzzet Baysal University status: RECRUITING city: Bolu state: Gölköy/ Bolu zip: 14030 country: Turkey name: Seda Ayaz Taş, Phd role: CONTACT phone: 05495458040 email: seda.ayaztas@ibu.edu.tr lat: 40.73583 lon: 31.60611 facility: Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi status: RECRUITING city: Düzce state: Merkez zip: 81100 country: Turkey name: Seda AYAZ TAŞ, Phd role: CONTACT phone: 05495458040 email: seda.ayaztas@ibu.edu.tr lat: 40.83889 lon: 31.16389 hasResults: False
<\|newrecord\|> nctId: NCT06343688 id: BAIBU-FTR-SAT-5 briefTitle: "Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-04-01 date: 2024-04-03 date: 2024-04-03 name: Abant Izzet Baysal University class: OTHER briefSummary: " Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p \< 0.05 with a 95% confidence interval." conditions: Diplegic Cerebral Palsy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 38 type: ESTIMATED name: "Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO" measure: Wii Balance Board measure: "The Gross Motor Function Measure-88 (D-E) (GMFM-88) measure: The Functional Reach Test measure: "The Pediatric Berg Balance Scale (PBBS) measure: "The Eating and Drinking Ability Classification System (EDACS) measure: "The Manual Abilities Classification System (MACS) measure: "The Gross Motor Function Classification System (GMFCS) measure: "The Communication Function Classification System (CFCS) sex: ALL minimumAge: 4 Years maximumAge: 15 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06343675 id: Dnr 2024-00620-01 briefTitle: Systematic Health-promoting Work Environment Management in Dentistry overallStatus: RECRUITING date: 2024-04-04 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-05 name: Linkoeping University class: OTHER_GOV briefSummary: Research shows that the workplace is an important arena where much can be done to promote a sustainable working life while maintaining health. However, there is a lack of knowledge that is specific to dental care with regard to managers' and employees' perceptions of the work environment, systematic work environment management and work adaptations, as well as what measures in the workplace are necessary to create a health-promoting and sustainable work environment. There is also a lack of knowledge regarding what support employees and managers need in the systematic work environment management and what individual workplace adaptations that can work within dental care organizations. conditions: Occupational Health studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: There is no intervention measure: Work Ability Single Item Scale (WAS) measure: Work Ability physical demands measure: Work Ability mental demands measure: Sick leave measure: Structured Multidisciplinary Work Evaluation Tool (SMET) measure: Satisfaction with work measure: Global Health measure: Perceived stress measure: Health problems related to work measure: Pain during last 7 days measure: Psychological safety measure: Work environment problems measure: Health related problems measure: Questions about workplace improvements, work adjustments, and support in the workplace measure: Work adjustment and discomfort measure: Support and meaning in work measure: Sustainable work life measure: Systematic work environment management and safety measure: Targeted questions to managers measure: Work environment responsibility and measures measure: Work environment management support and education measure: Background data measure: Semi-structured individual interview study with managers, sub-study 2 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Occupational and Environmental Medicine Centre status: RECRUITING city: Linköping zip: 581 85 country: Sweden name: Anneli Peolsson, Prof., PhD role: CONTACT phone: +46700850599 email: Anneli.Peolsson@regionostergotland.se name: Carlotte Wåhlin, Assoc. Prof, PhD role: CONTACT phone: +46101036267 email: Charlotte.Wahlin@regionostergotland.se lat: 58.41086 lon: 15.62157 hasResults: False
<\|newrecord\|> nctId: NCT06343662 id: Meraki_Acquired Brain Injury briefTitle: Group Music Therapy for Acquired Brain Injury acronym: Meraki_ABI overallStatus: RECRUITING date: 2024-03-01 date: 2024-07 date: 2025-07 date: 2024-04-02 date: 2024-04-15 name: University of Valencia class: OTHER briefSummary: The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI. conditions: Acquired Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: MERAKI_ABI measure: Change in Discomfort ( Baseline (3 Assessments), Pre- Post) measure: Barthel Index measure: Pfeiffer Short Form Mental State Questionnaire, SPMSQ measure: Charlson Comorbidity Index (CCI), sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Dr. Moliner status: RECRUITING city: Serra state: Valencia country: Spain name: Miguel Fombuena, PhD role: CONTACT email: fombuena_mig@gva.es name: Selene Valero-Moreno, PhD role: SUB_INVESTIGATOR name: Isabel Bellver Vercher role: SUB_INVESTIGATOR name: Ana Alegre Soler role: SUB_INVESTIGATOR name: José Jorge Botella Trellis, Dr. role: SUB_INVESTIGATOR name: Cristina Rocío Espejo Fernández, Dra. role: SUB_INVESTIGATOR name: María Carmen Badía Picazo, Dra. role: SUB_INVESTIGATOR lat: 39.68333 lon: -0.43333 hasResults: False
<\|newrecord\|> nctId: NCT06343649 id: CEUMA 187-2023-H briefTitle: Explicit Motor Imagery in Persistent Pelvic Pain overallStatus: COMPLETED date: 2023-11-01 date: 2023-11-30 date: 2023-11-30 date: 2024-04-02 date: 2024-04-23 name: University of Valencia class: OTHER briefSummary: The goal of this clinical trial is to compare the response of Explicit Motor Imagery interventions in patients suffering Persistent Pelvic Pain. The main question it aims to answer is:
• Does the modality of application of Explicit Motor Imagery, either through visual or auditory stimuli, influence the response in patients suffering Persistent Pelvic Pain?
Participants will receive an online Explicit Motor Imagery program either through visual inputs or auditory inputs. They will be instructed to follow the program en register their response.
Researchers will compare visual Explicit Motor Imagery and auditory Explicit Motor Imagery to see if different inputs generate different responses in patients suffering Persistent Pelvic Pain. conditions: Pelvic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 49 type: ACTUAL name: Visual name: Auditory measure: Numerical Rating Scale measure: Pain Vigilance and Awareness Questionnaire measure: Movement Imagery Questionnaire-Revised sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False
<\|newrecord\|> nctId: NCT06343636 id: VG3927-02.101 briefTitle: A Phase 1 Study of VG-3927 in Healthy Adults overallStatus: ENROLLING_BY_INVITATION date: 2023-09-27 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Vigil Neuroscience, Inc. class: INDUSTRY briefSummary: A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927 in Healthy Adults conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: VG-3927 name: Placebo measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Pharmacology of Miami city: Miami state: Florida zip: 33014 country: United States lat: 25.77427 lon: -80.19366 hasResults: False
<\|newrecord\|> nctId: NCT06343623 id: fac.med.2018.15 briefTitle: Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure overallStatus: COMPLETED date: 2018-10-12 date: 2022-10-16 date: 2022-10-16 date: 2024-04-02 date: 2024-04-02 name: Minia University class: OTHER briefSummary: Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall conditions: Velopharyngeal Insufficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ACTUAL name: myomucosal resection and direct closure name: superiorly based flap measure: Improvement in the speech outcome measure: obstructive sleep apnea sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Faculty of medicine city: Minya zip: 61511 country: Egypt lat: 28.10988 lon: 30.7503 hasResults: False
<\|newrecord\|> nctId: NCT06343610 id: VIST TO-UV 01-2024 briefTitle: The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose acronym: VIST-TO-UV overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-10 date: 2024-04-02 date: 2024-04-02 name: VIST - Faculty of Applied Sciences class: OTHER briefSummary: This is a double-blind, randomized, placebo-controlled interventional study of the effect of multiple-dose dietary intake on minimal erythema dose and other skin parameters. conditions: Minimal Erythema Dose studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Active product name: Placebo measure: Change of minimal erythema dose measure: Change of redness formation sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VIST - Faculty of Applied Sciences, Institute of Cosmetics status: RECRUITING city: Ljubljana zip: 1000 country: Slovenia name: Katja Zmitek, PhD role: CONTACT phone: 002831700 email: katja.zmitek@vist.si name: Katja Žmitek, PhD role: PRINCIPAL_INVESTIGATOR name: Tina Pogačnik, MSc role: SUB_INVESTIGATOR name: Petra Keršmanc, MSc role: SUB_INVESTIGATOR name: Sara Jereb, Msc role: SUB_INVESTIGATOR lat: 46.05108 lon: 14.50513 hasResults: False
<\|newrecord\|> nctId: NCT06343597 id: 037.HPB.2020.R briefTitle: Volume Outcome Relationships and Effects overallStatus: RECRUITING date: 2020-06-15 date: 2025-06-15 date: 2025-06-15 date: 2024-04-02 date: 2024-04-02 name: Methodist Health System class: OTHER briefSummary: This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities. conditions: Esophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED measure: Esophageal Cancer resection in patients in high volume (more than 5 esophagectomy performed per year) and low volume (less than 5 esophagectomy performed per year) hospital facilities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Richardson Medical Center status: RECRUITING city: Richardson state: Texas zip: 75082 country: United States name: Crystee Cooper, DHEd role: CONTACT phone: 214-947-1280 email: clinicalresearch@mhd.com name: Zaid Haddadin, MS role: CONTACT phone: 2149471280 email: clinicalresearch@mhd.com name: Dhiresh Jeyarajah, MD role: PRINCIPAL_INVESTIGATOR lat: 32.94818 lon: -96.72972 hasResults: False
<\|newrecord\|> nctId: NCT06343584 id: 023.NUR.2021.M briefTitle: Are Personal Smartphones Hurting Work-Life Balance for Nurse Managers? overallStatus: COMPLETED date: 2021-07-01 date: 2022-05-06 date: 2022-05-06 date: 2024-04-02 date: 2024-04-02 name: Methodist Health System class: OTHER briefSummary: For leadership positions with only a handful of staff under their direct chain of command, this may not be all-consuming and detrimental to work-life balance. But for NMs with upwards of 100 direct reports, this can make for a never-ending stream of contact points. This study will implement several communication and behavioral strategies to determine how using provided smartphone tools impact work-life balance and professional burnout. conditions: Burnout studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6 type: ACTUAL name: Study will conducted over a six-month period using a quasi-experimental Pre-test/Post-test design using Stamm's (2009) ProQOL Scale. measure: • Impact of smartphone tool utilization will be measured using a pre-study survey and post-study survey using the Professional Quality of Life (ProQOL) Scale (Stamm, 2009). measure: • Participants in Group 1 will self-report on the post-study survey (Appendix D1) the number of tools implemented during the study duration. measure: • Participants in Group 1 will self-report on the post-study survey (Appendix D1) the frequency of tool utilization during the study duration using a Likert scale. measure: • Participants in Group 2 will self-report on the post-study survey (Appendix D2) using the ProQOL Scale. measure: • Responses to the post-study survey from participants in Group 2 will be compared to participants in Group 1 to determine if utilizing a separate work smartphone during business hours has a greater improvement on work-life balance and burnout. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Mansfield Medical Center city: Mansfield state: Texas zip: 76063 country: United States lat: 32.56319 lon: -97.14168 hasResults: False
<\|newrecord\|> nctId: NCT06343571 id: MED-EL_CRD_2022_12 briefTitle: Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode acronym: LOTOS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-02 date: 2024-04-02 name: MED-EL Elektromedizinische Geräte GesmbH class: INDUSTRY briefSummary: This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array. conditions: Cochlear Implants studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED measure: Evaluate short and long term longitudinal clinical performance data from MED-EL CIs to assess their clinical effectiveness and safety. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343558 id: 24C302 briefTitle: Gait and Balance Impairment in Rare and Very Rare Neurological Diseases acronym: GALVANISE overallStatus: RECRUITING date: 2023-05-30 date: 2027-05-01 date: 2027-05-01 date: 2024-04-02 date: 2024-04-02 name: Istituto Auxologico Italiano class: OTHER name: IRCCS Istituto Neurologico Carlo Besta briefSummary: Rare and very rare neurological diseases primarily or exclusively affect the nervous system with a prevalence of \< 5 out of 10'000 and 100'000 people, respectively. Besides these, there are undiagnosed neurological diseases: neurological conditions without a diagnosis after completing a full diagnostic examination.
Rare, very rare, and undiagnosed neurological diseases are complicated and progressive and often cause variegated motor signs, impairments, and syndromes.
Balance and gait are frequently affected in these conditions, already at the clinical examination. These balance and gait impairments limit activities and cause an increased risk of falling. Falls can eventually result in injuries, even severe.
There are only a few studies about these diseases, likely because of their rarity. Hence, the clinical presentation and the course of rare and very rare diseases are poorly known or even unknown. Essential information for these conditions' diagnosis, prognosis, treatment and rehabilitation is missing.
MaNeNeND is an observational study underway at the Fondazione IRCCS Istituto Neurologico "Carlo Besta" (Milano) aimed at detailing the clinical and biological features of very rare and undiagnosed neurological diseases.
Research questions:
1. Do patients with rare (Ra), very rare (V) and undiagnosed (U) neurological diseases suffer a balance and gait impairment?
2. Is there a correlation between the clinical and instrumental severity of the balance and gait impairment in RaVU neurological diseases?
3. Are instrumental measures more sensitive in detecting balance and gait impairments in patients affected by a RaVU neurological disease than the clinical measures?
4. Do the balance and gait impairments in RaVU neurological diseases worsen in time?
The current project aims at diagnosing, quantifying and detailing the balance and gait impairment in rare, very rare and undiagnosed neurological diseases.
To this aim, questionnaires, clinical scales and instrumental tests will be administered to these patients to collect a wide range of balance and gait measures.
These measures will also integrate those collected with MaNeNeND to provide a more detailed description of patients with rare, very rare and diagnosed neurological diseases.
Participants will complete two questionnaires: the Dizziness Handicap Inventory - short form (DHI-sf, an ordinal score of self-perceived balance) and the Modified Fatigue Impact Scale (MFIS, an ordinal score of self-perceived fatigue).
Moreover, a clinician will administer the Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance), the 10 m walking test (for measuring the gait speed and other gait parameters) and the Timed Up and Go test (an instrumental measure of mobility and balance). Walking and the Timed Up and Go tests will be recorded with a trunk-worn inertial measurement unit.
Finally, participants will be asked to complete an instrumental upright stance and gait assessment, the first consisting of standing on posturographic plates and the second of walking on a treadmill equipped with force sensors. When walking on the treadmill, an optoelectronic system will also record the position in time of limbs and trunk.
The quantification of the severity of the balance and gait impairment of the patients suffering a rare, very rare or undiagnosed neurological disease will highlight these persons' therapeutic and rehabilitative needs.
Comparing the balance and gait impairment of rare, very rare and undiagnosed diseases with those of multiple sclerosis, Parkinson's disease and peripheral neuropathy will highlight if the formers' balance and gait impairment has unique characteristics that could help ease the diagnosis of these uncommon conditions.
The longitudinal measurements on rare, very rare and undiagnosed diseases will be paramount to identifying prognostic factors.
In addition, the data collected in the current study will be crucial for future studies, for example, for estimating the sample size in clinical trials. conditions: Multiple Sclerosis conditions: Parkinson Disease conditions: Peripheral Neuropathy conditions: Rare Diseases conditions: Healthy conditions: Healthy Aging studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Questionnaires, clinical scales and instrumental tests measure: Balance (Mini-BESTest) measure: Balance (Timed Up and Go test) measure: Gait speed measure: Gait analysis - kinematic - stride length measure: Gait analysis - kinematic - duration measure: Gait analysis - kinematic - width of the base of support measure: Gait analysis - kinematic - dorsal ankle angle measure: Gait analysis - dynamic - reaction force measure: Gait analysis - dynamic - ankle power measure: Gait analysis - dynamic - energy measure: Posturography - static - centre of pressure position measure: Posturography - static - centre of mass position measure: Posturography - dynamic - centre of pressure position measure: Posturography - dynamic - centre of mass position sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano status: RECRUITING city: Milano state: Milan country: Italy name: Antonio Caronni, MD, PhD role: CONTACT phone: 02 619111 email: a.caronni@auxologico.it lat: 45.46427 lon: 9.18951 facility: IRCCS Istituto Neurologico Carlo Besta status: ACTIVE_NOT_RECRUITING city: Milano country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06343545 id: Rehab_PROADI briefTitle: Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure acronym: Rehab overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-07-30 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: Hospital Israelita Albert Einstein class: OTHER briefSummary: To evaluate, through a randomized clinical trial in groups/clusters (stepped wedge), the impact of specific bundles for disability prevention and early rehabilitation, focused on 3 domains (ICU, Ward and post-discharge), on health-related quality of life and other long- and short-term outcomes in critically ill patients affected by hypoxemic acute respiratory failure with suspected COVID-19. conditions: Acute Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Cluster crossover randomized trial primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Standard of Care name: Rehabilitation measure: Quality of life measure: Mortality measure: Days alive and free of hospital measure: Rehospitalization measure: Return to work measure: Anxiety and Depression measure: New disability measure: Disability measure: Clinical Status measure: Cognitive impairment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343532 id: NIDA-SXC-Ph1b-001 briefTitle: SXC-2023 Cocaine Interaction Study overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2024-12 date: 2024-04-02 date: 2024-04-02 name: National Institute on Drug Abuse (NIDA) class: NIH name: Promentis Pharmaceuticals, Inc. name: Altasciences Company Inc. name: Technical Resources International, Inc. briefSummary: The goal of this clinical trial is to determine whether there are any interactions between the study drug and cocaine. Researchers will compare a treatment group and a placebo group to see if they experience any effects when administered cocaine after taking the treatment/placebo. conditions: Cocaine Use Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: SXC-2023 name: SXC-2023 Placebo measure: Determine Safety and Tolerability of Oral SXC-2023 Co-administered with Intravenous Cocaine by Collecting Vital Signs and Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Altasciences Clinical Kansas, Inc. city: Overland Park state: Kansas zip: 66212 country: United States name: Debra J Kelsh, MD role: CONTACT phone: 913-696-1601 email: DKelsh@altasciences.com name: Debra J Kelsh, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 hasResults: False
<\|newrecord\|> nctId: NCT06343519 id: Shocked Patients Monitoring briefTitle: Echocardiographic and Laboratory Findings in Hemodynamic Monitoring of Shocked Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-03 date: 2026-05 date: 2024-04-02 date: 2024-04-02 name: Assiut University class: OTHER briefSummary: Shocked patients require prompt and accurate assessment of their hemodynamic status to guide appropriate management. Echocardiography is a valuable tool for assessing cardiac function, while laboratory parameters such as mixed venous oxygen saturation and arterial blood lactate provide insights into tissue perfusion and oxygen metabolism. This study aims to compare echocardiographic findings, including cardiac index, speckle tracking parameters, and tissue Doppler indices, with laboratory findings in the evaluation of hemodynamic monitoring in shocked patients. conditions: Shock studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Echocardiography measure: Change in Shock Status After Fluid Therapy Based on Echocardiographic Assessment of Fluid Responsiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343506 id: 2023-929-EXPEDITED briefTitle: Ankle Dorsiflexion Changes With Assisted Stretching Device overallStatus: RECRUITING date: 2023-10-30 date: 2024-06-01 date: 2024-12-31 date: 2024-04-02 date: 2024-04-04 name: Montana State University class: OTHER briefSummary: Ankle range of motion is an important degree of freedom for performing activities of daily living. Limited range of ankle motion has been related to Achilles tendonitis, lower limb injury, and abnormal gait leading to overuse injury. While stretching and massage can help increase range of motion the amount and frequency of manual manipulation needed to affect range of motion is not accessible to an individual in their home. A new device has been developed to allow deep stretching of the ankle and surrounding muscles to help increase ankle dorsiflexion. This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The goal of this study is to determine the effect of using this device during a course of treatment to improve ankle dorsiflexion in individuals with decreased ankle range of motion. conditions: Physical Therapy Modality studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 10 type: ESTIMATED name: Grassroots Ankle Flex measure: Ankle Range of Motion measure: Ankle Strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neuromuscular Biomechanics Laboratory status: RECRUITING city: Bozeman state: Montana zip: 59717 country: United States name: Corey Pew, PhD role: CONTACT phone: 406-994-6769 email: Corey.Pew@montana.edu lat: 45.67965 lon: -111.03856 hasResults: False
<\|newrecord\|> nctId: NCT06343493 id: JALTAF briefTitle: Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery overallStatus: COMPLETED date: 2023-06-16 date: 2023-12-15 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Rawalpindi Medical College class: OTHER briefSummary: Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure.
This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50°C during surgery. Group B was the control group where room temperature saline was used. Operative field was assessed using the Boezaart score, duration of surgery and bleeding in ml.
KEY WORDS:
* Chronic rhinosinusitis (CRS)
* Endoscopic sinus surgery
* Boezaart score conditions: Rhinosinusitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Normal saline heated up to 50 °C measure: Boezaart Score measure: Bleeding in ml measure: Duration of Surgery sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Benazir Bhutto Hospital city: Rawalpindi state: Punjab zip: 46000 country: Pakistan lat: 33.6007 lon: 73.0679 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-16 uploadDate: 2024-03-29T12:12 filename: Prot_SAP_000.pdf size: 142077 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-06-16 uploadDate: 2024-03-24T04:58 filename: ICF_001.pdf size: 48384 hasResults: False
<\|newrecord\|> nctId: NCT06343480 id: SMVOT2024CT briefTitle: Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term overallStatus: COMPLETED date: 2020-09-01 date: 2021-08-31 date: 2021-11-30 date: 2024-04-02 date: 2024-04-02 name: Federal Teaching Hospital Abakaliki class: OTHER_GOV briefSummary: Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes. conditions: Labor Onset and Length Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 120 type: ACTUAL name: Labour Induction measure: Mean induction delivery interval sex: FEMALE minimumAge: 15 Years maximumAge: 44 Years stdAges: CHILD stdAges: ADULT facility: Alex Ekwueme Federal University Teaching Hospital city: Abakaliki state: Ebonyi zip: 480001 country: Nigeria lat: 6.32485 lon: 8.11368 facility: Federal Teaching Hospital, Abakaliki city: Abakaliki state: Ebonyi zip: 480001 country: Nigeria lat: 6.32485 lon: 8.11368 hasResults: False
<\|newrecord\|> nctId: NCT06343467 id: A17-376 briefTitle: Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost? overallStatus: COMPLETED date: 2022-11-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-02 date: 2024-04-02 name: HealthPartners Institute class: OTHER briefSummary: Across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (ORIF) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. At the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. From a quality perspective each patient will be monitored both short and long term for complication and reoperation. This will be done through chart review. conditions: Distal Radius Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Surgeons alternated between using generic implants and conventional implants in their distal radius fracture patients over the course of six months. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients underwent the standard surgical consent, however the specific plate vendor that was used, was not specified by the physician. whoMasked: PARTICIPANT count: 101 type: ACTUAL name: Generic Volar Locking Plate name: Conventional Volar Locking Plate measure: 90-day reoperation rate measure: 90-day readmission rate measure: 90-day mortality rate measure: Implant Cost measure: Tourniquet Time measure: Estimated Blood Loss sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Regions Hospital city: Saint Paul state: Minnesota zip: 55101 country: United States lat: 44.94441 lon: -93.09327 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-08-16 uploadDate: 2024-03-14T00:31 filename: Prot_SAP_000.pdf size: 218626 hasResults: False
<\|newrecord\|> nctId: NCT06343454 id: 2023/04-03(KA-22111) briefTitle: The Effect of Different Head Positions on Occlusal Contacts During Digital Interocclusal Bite Registration overallStatus: COMPLETED date: 2023-10-25 date: 2024-01-27 date: 2024-03-03 date: 2024-04-02 date: 2024-04-02 name: Hacettepe University class: OTHER briefSummary: The goal of this clinical trial is to learn about different head position's effect on occlusal contacts during digital interocclusal record. The main question aims to answer is:
• Are different head positions in physiological limits can be affected the occlusal contact during interocclusal record? Participants will be asked to stand in three different physiological head positions (neutral, forward and backward) which are common in daily routine. In these positions, after maxillary and mandibular arch scans three different interocclusal records will be taken. Also for assessment of these records in digital occlusal analysis module (oJMA, zebras), three different oJMA record will be taken.
Researchers will compare neutral, forward and backward head positions to see if there are any difference in number, density and location of occlusal contacts. conditions: Occlusion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 36 type: ACTUAL name: Digital Interocclusal Record In Different Head Positions measure: Number of Occlusal Contacts measure: Density of Occlusal Contacts measure: Location of Occlusal Contacts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-04-17 uploadDate: 2024-03-29T04:39 filename: Prot_SAP_000.pdf size: 212403 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-17 uploadDate: 2024-03-29T04:39 filename: ICF_001.pdf size: 97067 hasResults: False
<\|newrecord\|> nctId: NCT06343441 id: SH9H-2024-T29-2 briefTitle: Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis conditions: Edentulous Jaw studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: intraoral scan name: open tray impression measure: Grade of framework passive fit sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343428 id: IEO 1519 briefTitle: Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients acronym: TAPIOCA overallStatus: RECRUITING date: 2021-07-19 date: 2024-07-19 date: 2026-07-19 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs.
The new classification made it possible to separate NETs G3 from high-grade, poorly-differentiated, NENs that are called neuroendocrine carcinomas (NECs).
However, in clinical practice, we observed that several clinical, pathological and radiological differences are arising among NET G3 patients, suggesting that a multiparametric definition of NET G3 is needed. conditions: Neuroendocrine Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Immunohistochemical characteristics analysis measure: Review of the functional imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Francesca Spada, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06343415 id: H-23052844 briefTitle: Robot-assisted Training After Traumatic Brain Injury and Disorders of Consciousness overallStatus: RECRUITING date: 2024-04-16 date: 2025-04-30 date: 2025-07-31 date: 2024-04-02 date: 2024-04-17 name: Christina Kruuse class: OTHER briefSummary: The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after traumatic brain injury and disorders of consciousness. The main questions it aims to answer are:
* Is the protocol feasible concerning inclusion in the study?
* Is the protocol feasible concerning protocol completion? Participants will randomly be assigned to either five days of robot-assisted gait training (GAIT), two days of pause, then five days of robot-assisted step training (STEP) or vice versa.
The investigators will explore and compare safety events, physiological measures and physical activity levels, behavioural measures, and functional disability outcomes. Further, the investigators report intervention and technical parameters in detail. conditions: Traumatic Brain Injury conditions: Disorders of Consciousness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: AB - BA primaryPurpose: OTHER masking: SINGLE maskingDescription: Assessors are blinded to allocation for the following exploratory clinical outcome scales: "Disability Rating Scale" and "Coma Recovery Scale-Revised".
Data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results. whoMasked: OUTCOMES_ASSESSOR count: 17 type: ESTIMATED name: GAIT-assisted training name: STEP-assisted training measure: Inclusion Rate measure: Completion Ratio of protocols measure: Exploratory Safety Outcomes measure: Disability Rating Scale (DRS) measure: Coma Recovery Scale-Revised (CRS-R) and level of consciousness measure: Early Functional Abilities (EFA) measure: Functional Independence Measure (FIM) measure: Physical activity intensity measure: Mean arterial pressure (MAP) measure: Heart Rate Variability (HRV) measure: Behavioural Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of brain and spinal cord injury status: RECRUITING city: Glostrup state: Greater Copenhagen zip: 2600 country: Denmark name: Christina Kruuse, Professor role: CONTACT email: christina.kruuse@regionh.dk name: Vibeke Wagner, MSc role: PRINCIPAL_INVESTIGATOR lat: 55.6666 lon: 12.40377 hasResults: False
<\|newrecord\|> nctId: NCT06343402 id: TBBO8520-101 id: ONKORAS-101 type: OTHER domain: TheRas briefTitle: Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-04 date: 2027-08 date: 2028-02 date: 2024-04-02 date: 2024-04-22 name: TheRas, Inc class: INDUSTRY briefSummary: A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer conditions: Non-small Cell Lung Cancer conditions: Metastatic Non-Small Cell Lung Cancer conditions: NSCLC conditions: KRAS G12C conditions: Metastatic Lung Cancer conditions: Advanced Lung Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1a: sequential/parallel, Phase 1b: parallel primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: BBO-8520 name: Pembrolizumab measure: Adverse Events measure: Dose-limiting toxicities (DLTs) measure: To evaluate preliminary antitumor activity of BBO-8520 measure: To evaluate preliminary antitumor activity of BBO-8520 measure: Overall Survival (OS) measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: SCRI Oncology Partners status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: NEXT Oncology status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 facility: Peter MacCallum Cancer Centre status: RECRUITING city: Melbourne state: Victoria zip: 3051 country: Australia lat: -37.814 lon: 144.96332 hasResults: False
<\|newrecord\|> nctId: NCT06343389 id: Soh-Med-24-03-14MS briefTitle: Acute Kidney Injury in Patients With Liver Cirrhosis overallStatus: RECRUITING date: 2024-04 date: 2024-10 date: 2025-04 date: 2024-04-02 date: 2024-04-02 name: Sohag University class: OTHER briefSummary: In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital. conditions: Acute Kidney Injury in Patients With Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: serum creatinine measure: Incidence of acute kidney injury in cirrhotic patients in Sohag University Hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06343376 id: I-3641523 id: NCI-2024-01818 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3641523 type: OTHER domain: Roswell Park Cancer Institute briefTitle: Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2029-04-15 date: 2024-04-02 date: 2024-04-02 name: Roswell Park Cancer Institute class: OTHER briefSummary: This phase I trial tests the safety, side effects, and best dose of genetically engineered cells called EGFRt/19-28z/IL-12 CAR T cells, and to see how they work in treating patients with hematologic malignancies that makes a protein called CD19 (CD19-positive) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Chimeric Antigen Receptor (CAR) T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. To improve the effectiveness of the modified T cells and to help the immune system fight cancer cells better, the modified T cells given in this study will include a gene that makes the T cells produce a cytokine (a molecule involved in signaling within the immune system) called interleukin-12 (IL-12). The researchers think that IL-12 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving EGFRt/19-28z/IL-12 CAR T cells may be safe and tolerable in treating patients with relapsed or refractory CD19+ hematologic malignancies. conditions: Recurrent Chronic Lymphocytic Leukemia conditions: Recurrent Diffuse Large B-Cell Lymphoma conditions: Recurrent Follicular Lymphoma conditions: Recurrent High Grade B-Cell Lymphoma conditions: Recurrent Mantle Cell Lymphoma conditions: Recurrent Transformed Chronic Lymphocytic Leukemia conditions: Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma conditions: Refractory Chronic Lymphocytic Leukemia conditions: Refractory Diffuse Large B-Cell Lymphoma conditions: Refractory Follicular Lymphoma conditions: Refractory High Grade B-Cell Lymphoma conditions: Refractory Mantle Cell Lymphoma conditions: Refractory Transformed Chronic Lymphocytic Leukemia conditions: Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Computed Tomography name: Cyclophosphamide name: Echocardiography name: EGFRt/19-28z/IL-12 CAR T-lymphocytes name: Fludarabine Phosphate name: Leukapheresis name: Multigated Acquisition Scan name: Positron Emission Tomography measure: Incidence of adverse events measure: Maximal tolerated dose (MTD) of EGFRt/19-28z/IL-12 chimeric antigen receptor T-cells measure: Incidence of complete remission (CR)/complete remission with incomplete count recovery (CRi) measure: Incidence of CR/CRi + partial response (PR) (ORR) measure: Event free survival measure: Overall survival measure: Progression-free survival measure: Modified T-cell persistence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Francisco J. Hernandez-ILizaliturri role: CONTACT phone: 716-845-1642 email: Francisco.Hernandez@RoswellPark.org name: Francisco J. Hernandez-ILizaliturri role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False
<\|newrecord\|> nctId: NCT06343363 id: 318352 briefTitle: Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety acronym: EARLY-Edge overallStatus: RECRUITING date: 2023-05-01 date: 2025-05 date: 2025-12 date: 2024-04-02 date: 2024-04-02 name: Oxford University Hospitals NHS Trust class: OTHER name: Edwards Lifesciences briefSummary: Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.
Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.
This prospective, observational cohort study will examine the safety and feasibility of this practice. conditions: Mitral Regurgitation conditions: Tricuspid Regurgitation conditions: Mitral Repair conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Early discharge protocol measure: Proportion of patients discharged 'early' after edge -to-edge repair measure: All - cause rehospitalisation after completion of procedure measure: All cause death after completion of procedure measure: Hospital length of stay measure: Proportion of patients requiring intensive care unit care measure: Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days measure: Symptomatic improvement measure: Heart failure hospitalisation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: John Radcliffe Hospital status: RECRUITING city: Oxford state: Oxfordshire zip: OX3 9DU country: United Kingdom name: Sam Dawkins, MBBS MRCP BSc DPhil role: CONTACT email: Sam.Dawkins@ouh.nhs.uk lat: 51.75222 lon: -1.25596 hasResults: False
<\|newrecord\|> nctId: NCT06343350 id: OPTDR01P briefTitle: OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Optain Health class: INDUSTRY briefSummary: In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates.
A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR. conditions: Diabetic Retinopathy conditions: Diabetes studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED name: OPTDR01 software application measure: Enrollment rate of eligible participants at clinical site sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Precision Research Institute city: San Diego state: California zip: 92114 country: United States name: Marie Inocentes role: CONTACT phone: 619-501-0371 phoneExt: 310 email: marie@prisandiego.com lat: 32.71533 lon: -117.15726 hasResults: False
<\|newrecord\|> nctId: NCT06343337 id: MSKUDİSCLİNİCALTRİALS_FYİLMAZ. briefTitle: The Effects of Pregnancy on Oral Health overallStatus: COMPLETED date: 2022-05-20 date: 2023-04-01 date: 2023-04-01 date: 2024-04-02 date: 2024-04-02 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: The aim of this study was to evaluate the effects of pregnancy on salivary pH, flow rate, caries experience and periodontal status.
The main questions it aims to answer are:
* Does pregnancy affect caries experience and periodontal status?
* Does pregnancy affect salivary pH and flow rate?
* Is there a difference between pregnant and non-pregnant woman with respect to caries experience, periodontal status, salivary pH and flow rate?
* Is there a difference among first, second and third trimester with respect to caries experience, periodontal status, salivary pH and flow rate? conditions: Pregnancy Related conditions: Dental Caries conditions: Periodontal Diseases conditions: Saliva Altered studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: The individual who evaluates the salivary pH and flow rate. whoMasked: OUTCOMES_ASSESSOR count: 198 type: ACTUAL name: Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman measure: The effects of pregnancy on caries experience measure: The effects of pregnancy on periodontal status. measure: The effects of pregnancy on salivary pH. measure: The effects of pregnancy on salivary flow rate. sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fatma Yilmaz city: Mentese state: Mugla zip: 48000 country: Turkey hasResults: False
<\|newrecord\|> nctId: NCT06343324 id: 2023/012 briefTitle: Effect of Web-Based Adaptation and Insomnia Severity in Individuals Using Noninvasive Ventilators at Home overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-02-01 date: 2024-04-01 date: 2024-04-02 date: 2024-04-03 name: KTO Karatay University class: OTHER briefSummary: Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this device. This study will produce evidence for this effect and contribute to the awareness of healthcare professionals working in this field. The WEB-based training module to be developed aims to increase compliance with NIV in patients using NIV at home for a long time and to manage symptoms such as insomnia that may develop due to NIV. conditions: Noninvasive Ventilation conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Web-based education measure: Patient Identifiable Characteristics Form measure: S³-NIV Questionnaire measure: insomnia severity index measure: Expected behavioral changes in the individual survey sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University Konya Beyhekim Training and Research Hospital city: Konya state: Selçuklu zip: 42060 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<\|newrecord\|> nctId: NCT06343311 id: EBUS22CD19AR100 briefTitle: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) acronym: Starlight-1 overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-12-31 date: 2027-12-31 date: 2024-04-02 date: 2024-04-18 name: Estrella Biopharma, Inc. class: INDUSTRY name: Eureka Therapeutics Inc. briefSummary: This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase. conditions: B-Cell Non-Hodgkin's Lymphoma (NHL) conditions: Lymphoma, Non-Hodgkins conditions: Lymphomas Non-Hodgkin's B-Cell conditions: Non-Hodgkin Lymphoma conditions: Non-Hodgkin's Lymphoma conditions: Large B-Cell Lymphoma conditions: Lymphoma, Non-Hodgkin's, Adult conditions: Lymphoma conditions: Refractory Non-Hodgkin Lymphoma conditions: Relapsed Non-Hodgkin Lymphoma conditions: Lymphoma, Non-Hodgkin conditions: HIV Associated Lymphoma conditions: CNS Lymphoma conditions: High-grade B-cell Lymphoma conditions: Refractory B-Cell Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: EB103 measure: To assess the Dose Limiting Toxicities of EB103. measure: Incidence rates of Treatment-Emergent Adverse Events of EB103. measure: Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103. measure: To determine the Recommended Phase II Dose (RP2D) of EB103. measure: To assess the Overall Response Rate of EB103 in our study subject population. measure: To assess the Disease Control Rate of EB103 in our study subject population. measure: To assess the Duration of Response of EB103 in our study subject population. measure: To assess the Progression-Free Survival rate of EB103 in our study subject population. measure: To assess the Event-Free Survival rate of EB103 in our study subject population. measure: To assess the Overall Survival rate of EB103 in our study subject population. measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax). measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax). measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343298 id: ES_MANP_2001 briefTitle: To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-01 date: 2025-08-01 date: 2024-04-02 date: 2024-04-10 name: E-Star BioTech, LLC class: INDUSTRY name: Mayo Clinic name: PPD briefSummary: This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action. conditions: Difficult to Control Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: MANP name: Placebo Matched control measure: Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42. measure: Incidence and severity of Adverse events through 4- weeks post end of treatment. measure: Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment. measure: Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment. measure: Change in Clinic sitting systolic blood pressure measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - Tmax measure: Anti-drug Antibody measure: Differential Outcomes in African-American Subject versus Non-African American Subjects measure: Metabolic biomarkers - Glucose measure: Metabolic biomarkers - Insulin measure: Metabolic biomarkers - HbA1C measure: Lipid biomarkers - HDL measure: Lipid biomarkers - LDL measure: Lipid biomarkers - TG sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343285 id: 20231215 briefTitle: Upper Limb Tremor Reduction in Essential Tremor Patients acronym: ULTRE overallStatus: RECRUITING date: 2024-01-01 date: 2024-05 date: 2024-06 date: 2024-04-02 date: 2024-04-03 name: Encora, Inc. class: INDUSTRY briefSummary: This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor. conditions: Essential Tremor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Three different arms in a randomized order primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization schedule maintained by non-Clinical personnel whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Encora Therapeutics Tremor Reduction Device measure: Tolerability measure: Safety measure: Bain & Findley Activity of Daily Living (BF-ADL) #2 measure: BF-ADL #4 measure: BF-ADL #17 measure: BF-ADL #21 measure: Patient Global Impression of Change (PGI-C) measure: Clinician Global Impression of Change (CGI-C) measure: Tremor power as measured by gyroscope measure: The Essential Tremor Rating Scale (TETRAS) #2.4 measure: TETRAS #2.6 measure: TETRAS #2.8 measure: Patient Global Impression of Severity (PGI-S) measure: Clinician Global Impression of Severity (CGI-S) measure: Tremor power as measured by accelerometer sex: ALL minimumAge: 22 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Encora Therapeutics status: RECRUITING city: Cambridge state: Massachusetts zip: 02139 country: United States name: Kristi Winterfeldt, MSHS role: CONTACT phone: 763-248-1210 email: kristi@encoratherapeutics.com name: Taylor Robertson role: CONTACT phone: 7814221105 email: taylor@encoratherapeutics.com name: Kristi Winterfeldt, MSHS role: PRINCIPAL_INVESTIGATOR name: Fatta Nahab, MD role: SUB_INVESTIGATOR lat: 42.3751 lon: -71.10561 hasResults: False
<\|newrecord\|> nctId: NCT06343272 id: LEGO briefTitle: Lymphocyte Enhancement in Gastroenteric Oncology overallStatus: RECRUITING date: 2022-03-22 date: 2024-12-22 date: 2025-02-28 date: 2024-04-02 date: 2024-04-03 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER name: University of Pavia briefSummary: LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens. conditions: Advanced Gastrointestinal Cancers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: EAA supplementation name: Isocaloric placebo measure: Exit from lymphopenia measure: The change in the % of lymphocytes over time measure: The proportion of patients with G3-G5 toxicity measure: The percentage of chemotherapy dose administered compared to that expected for the patients. measure: plasma aminoacids composition chang during treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Alessandra Ferrari role: CONTACT phone: 0382.503689 phoneExt: +39 email: alessandra.ferrari@smatteo.pv.it name: Salvatore Corallo role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06343259 id: 2534 briefTitle: The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-08-14 date: 2024-04-02 date: 2024-04-02 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: In this prospective, randomized, single-blind study, we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery. Cardiovascular events are a leading cause of mortality and morbidity following non-cardiac surgery, with myocardial injury after non-cardiac surgery (MINS) being a significant concern. MINS, characterized by asymptomatic elevation of troponin levels without accompanying ECG findings, is closely associated with postoperative mortality. With the increasing prevalence of comorbidities in the elderly population and the rising frequency of non-cardiac surgeries in this demographic, understanding the effects of different anesthesia types on postoperative myocardial injury is crucial. conditions: Myocardial Injury After Non-cardiac Surgery conditions: Hypotension During Surgery conditions: Anesthesia, General conditions: Anesthesia, Spinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: General Anesthesia name: Spinal Anesthesia measure: Myocardial Injury After Non-Cardiac Surgery (MINS) measure: The duration of intensive care unit (ICU) stay measure: The duration of hospital stay sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Sisli Hamidiye Etfal Training and Research Hospital city: Istanbul zip: 34396 country: Turkey name: Mustafa Bilgehan AYIK role: CONTACT phone: +905377247984 email: drbilgehanayik@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06343246 id: MustafaKemalU briefTitle: Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension overallStatus: RECRUITING date: 2023-05-01 date: 2024-03-30 date: 2024-03-30 date: 2024-04-02 date: 2024-04-02 name: Mustafa Kemal University class: OTHER briefSummary: This study was planned to investigate the effectiveness of combined exercise training, that is, functional inspiratory muscle training, with breathing exercises to be applied with a portable, easy-to-use respiratory muscle strengthening device, on exercise capacity and peripheral muscle strength. conditions: Hypertension,Essential studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective Randomized Controlled Study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Inspiratory muscle training with device measure: Change of the exercise capacity from baseline to 8 week measure: Change of the peripheral muscle strenght from baseline to 8 week measure: change of the upper extremity exercise capacity from baseline to 8 week measure: change of the postural balance from baseline to 8 week measure: change of the physical activity from baseline to 8 week measure: change of the quality of life from baseline to 8 week measure: change of the Fev1/Fvc sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hatay Mustafa Kemal University status: RECRUITING city: Hatay state: Antakya country: Turkey name: İrem hüzmeli role: CONTACT email: fztirem@gmail.com lat: 38.40227 lon: 27.10486 hasResults: False
<\|newrecord\|> nctId: NCT06343233 id: FATE briefTitle: FAiling HearT in the Elderly (FATE) Study acronym: FATE overallStatus: RECRUITING date: 2019-11-19 date: 2024-12 date: 2024-12 date: 2024-04-02 date: 2024-04-02 name: IRCCS Multimedica class: OTHER briefSummary: In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. The Cardiology Network, responding to the indications of the National Health Research Program, which includes research models oriented towards prevention studies with objectives and priority areas of intervention such as "acquiring scientific knowledge necessary for implementing both secondary and tertiary prevention programs for patients and primary prevention for contacts, where indicated, or for subjects exposed to specific risk factors", aims to identify strategies and/or prognostic and predictive factors of outcomes through the construction of thoroughly studied case series and systematic collection of biological materials, as well as the definition of research models based on clinical outcomes.
The Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure. conditions: Heart Failure conditions: Frailty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: usual care measure: Hospitalization or death at 12 months measure: Hospitalization or death at 6-12-18 months measure: hospitalizations and/or death from cardiovascular causes measure: association between events and patient characteristics sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT) status: RECRUITING city: Montescano state: Italy/Pavia zip: 27040 country: Italy name: Maria Teresa La Rovere, MD role: CONTACT phone: +39 0385 247290 email: mariateresa.larovere@icsmaugeri.it lat: 45.03196 lon: 9.28366 facility: IRCCS Centro Cardiologico Monzino status: RECRUITING city: Milan state: MIlano zip: 20138 country: Italy name: PierGiuseppe Agostoni, MD role: CONTACT phone: +39 02 58002772 email: piergiuseppe.agostoni@unimi.it lat: 45.46427 lon: 9.18951 facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: Milano zip: 20089 country: Italy name: Cristina Panico, MD role: CONTACT phone: +39 0282241 email: cristina.panico@humanitas.it lat: 45.38193 lon: 9.1559 facility: IRCCS MultiMedica status: RECRUITING city: Sesto San Giovanni state: Milano zip: 20099 country: Italy name: Gaia Cattadori, MD role: CONTACT phone: +39 02 8687 8889 email: gaia.cattadori@multimedica.it lat: 45.53329 lon: 9.22585 facility: Ospedale Policlinico San Martino IRCCS status: RECRUITING city: Genova zip: 16132 country: Italy name: Pietro Ameri, MD role: CONTACT phone: +39 0103538928 email: pietroameri@unige.it lat: 44.40478 lon: 8.94438 facility: IRCCS Auxologico status: RECRUITING city: Milano zip: 20149 country: Italy name: Gianluca Caldara, MD role: CONTACT phone: +39 02 61911 251 email: g.caldara@auxologico.it lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milan zip: 20100 country: Italy name: Marco Vicenzi, MD role: CONTACT phone: +39 02 503 20512 email: marco.vicenzi@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06343220 id: AWARE 2.0 briefTitle: Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research overallStatus: RECRUITING date: 2024-04-10 date: 2024-09 date: 2024-09 date: 2024-04-02 date: 2024-04-29 name: Huntington Study Group class: NETWORK name: Roche Products Limited briefSummary: The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. conditions: Huntington Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Examine awareness measure: Provide the HD research community with the insight. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntington Study Group status: RECRUITING city: Rochester state: New York zip: 14618 country: United States name: Elise Kayson, MS role: CONTACT phone: 800-487-7671 email: info@myhdstory.org lat: 43.15478 lon: -77.61556 hasResults: False
<\|newrecord\|> nctId: NCT06343207 id: 249637 briefTitle: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability overallStatus: COMPLETED date: 2022-11-22 date: 2023-02-02 date: 2023-02-02 date: 2024-04-02 date: 2024-04-02 name: Charles University, Czech Republic class: OTHER briefSummary: To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI). conditions: Ankle Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Controlled Trial primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: INVESTIGATOR count: 39 type: ACTUAL name: Percussive massage gun therapy measure: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability. sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of physical education and sport, Charles University city: Praha zip: 16252 country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False
<\|newrecord\|> nctId: NCT06343194 id: 6162 briefTitle: Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism acronym: EMG_BRUX overallStatus: RECRUITING date: 2023-02-09 date: 2024-05-31 date: 2024-12-22 date: 2024-04-02 date: 2024-04-11 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.
The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.
The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.
The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients. conditions: Sleep Bruxism conditions: Masseter Muscle Hypertrophy conditions: Grinding Teeth studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: bruxism patients and non-bruxism patients primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Bruxoff ® measure: Change in potentials recorded by Bruxoff ® in bruxism patients. measure: Change of signs and symptoms of bruxism sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: UOC Odontoiatria Generale e Ortodonzia, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy name: Massimo Cordaro, professor role: CONTACT phone: +39 0630154286 email: massimo.cordaro@unicatt.it lat: 41.89193 lon: 12.51133 hasResults: False

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