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<|newrecord|> nctId: NCT06366516 id: FUOBGY2024-23 briefTitle: Role of Methylation Test Triage in HPV Positive Women acronym: MTTRIHPW overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2026-02 date: 2024-04-16 date: 2024-04-16 name: Obstetrics & Gynecology Hospital of Fudan University class: OTHER name: Peking Union Medical College Hospital name: Chengdu Women's and Children's Central Hospital name: Guangdong Women and Children Hospital name: Second Hospital of Jilin University name: First Affiliated Hospital of Xinjiang Medical University name: Third Affiliated Hospital of Zhengzhou University briefSummary: The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening. conditions: Precancerous Cervical Lesion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Women who aged 25 to 65 years are screened for cervical cancer and they are all positive of high-risk HPV. primaryPurpose: SCREENING masking: NONE count: 10000 type: ESTIMATED name: Methylation Test measure: The sensitivity and specificity of methylation test in detecting CIN2+. measure: KAPPA value of methylation test. sex: FEMALE minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Obstetrics and Gynecology Hospital of Fudan University city: Shanghai state: Shanghai zip: 200011 country: China name: Long Sui, Professor role: CONTACT phone: 0086-021-33189900 email: [email protected] name: Qing Cong, PHD role: CONTACT phone: 0086-021-33189900 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06366503 id: RS-2023-05 briefTitle: Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation overallStatus: COMPLETED date: 2023-10-03 date: 2023-12-29 date: 2023-12-29 date: 2024-04-16 date: 2024-04-16 name: Revision Skincare class: INDUSTRY briefSummary: This randomized, single-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. This is a cosmetic study with a FDA-regulated device. |
A total of 22 healthy female subjects completed the study. conditions: Photoaging conditions: Wrinkle conditions: Skin Laxity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Single-Center, Double-Blinded, Split-Face, Controlled primaryPurpose: OTHER masking: DOUBLE maskingDescription: Subjects were randomly assigned to use the active post-procedure cream on one side of the face and the comparator anhydrous formulation on the opposite side of the face. |
The products were packaged in the same container and labelled post-procedure cream. This was a double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety were blinded to group during the study. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 23 type: ACTUAL name: Fractional Ablative CO2 Laser name: Facial Cleanser name: Facial Moisturizer name: Sunscreen name: Basic Ointment measure: Investigator Tolerability measure: Incidence of Adverse Events measure: Subject Tolerability measure: Self-Assessment Questionnaire sex: FEMALE minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Dermatology Group city: Blue Ash state: Ohio zip: 45242 country: United States lat: 39.232 lon: -84.37827 hasResults: False |
<|newrecord|> nctId: NCT06366490 id: CIP2023-001 briefTitle: Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy in Recurrent Epithelial Ovarian Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2025-03-01 date: 2024-04-16 date: 2024-04-16 name: PhotonPharma, Inc. class: INDUSTRY briefSummary: Safety and Immunogenicity of InnocellTM Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study is a 2-part design. For each participant, Part 1 will involve tissue procurement and confirmation of the ability to manufacture the Innocell vaccine, followed by Part 2 which is the treatment phase, involving Innocell administration to patients. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label Phase I trial with no masking count: 8 type: ESTIMATED name: Innocell Autologous Cellular Immunotherapy measure: Saferty and Immunogenicity of Innocell in Ovarian Cancer Patients measure: Safety of Innocell in Ovarian Cancer Patients measure: Immunogenicity of Innocell in Ovarian Cancer Patients measure: Immunogemicity in Ovarian Cancer Patients measure: Immunogenicity of Innocell Vaccine in Ovarian Cancer Patients sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366477 id: B-ER-103-417 briefTitle: Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke overallStatus: COMPLETED date: 2017-01-01 date: 2019-06-15 date: 2019-11-15 date: 2024-04-16 date: 2024-04-16 name: National Cheng-Kung University Hospital class: OTHER briefSummary: There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores. conditions: Rehabilitation conditions: Stroke conditions: Hand Grasp studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ACTUAL name: Vibration stimulation combined with task-oriented training measure: Fugl-Meyer assessment - wrist and hand measure: Box and Blocks Test measure: Motor Activity Log measure: Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366464 id: HBS-101-CL-312 briefTitle: A Study of Pitolisant in Patients With Prader-Willi Syndrome overallStatus: RECRUITING date: 2024-04 date: 2026-07 date: 2027-07 date: 2024-04-16 date: 2024-04-16 name: Harmony Biosciences, LLC class: INDUSTRY briefSummary: This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. |
The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. |
Secondary objectives include assessing the impact of pitolisant on: |
* Irritable and disruptive behaviors |
* Hyperphagia |
* Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech conditions: Prader-Willi Syndrome studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 134 type: ESTIMATED name: Pitolisant tablet name: Placebo tablet measure: Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score measure: Change in severity of irritable and disruptive behaviors as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Irritability domain measure: Change in overall severity of EDS as measured by the Caregiver Global Impression of Severity for Excessive Daytime Sleepiness (CaGI-S for EDS) measure: Change in overall severity of EDS as measured by the Clinical Global Impression of Severity for Excessive Daytime Sleepiness (CGI-S for EDS) measure: Change in overall severity of irritable and disruptive behaviors as measured by the Caregiver Global Impression of Severity (CaGI-S) for Irritable and/or Disruptive Behaviors measure: Change in severity of hyperphagia as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), in conjunction with the Food Safe Zone Questionnaire (FSZQ) measure: Change in severity of EDS as measured by the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD [parent/caregiver version]) total score measure: Change in severity of other behavioral problems as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Hyperactivity/Noncompliance, Inappropriate Speech, Social Withdrawal, and Stereotypic Behavior Domains measure: Percentage of patients reporting TEAEs sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Santa Monica Clinical Trials status: RECRUITING city: Los Angeles state: California zip: 90025 country: United States name: Daniel Norman, MD role: CONTACT name: Pooja Patel role: CONTACT phone: (310) 586-0843 email: [email protected] lat: 34.05223 lon: -118.24368 facility: Atlanta Diabetes Associates status: RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States name: David G. Robertson, MD role: CONTACT name: Amanda Maxson role: CONTACT phone: (404) 844-7775 email: [email protected] lat: 33.749 lon: -84.38798 hasResults: False |
<|newrecord|> nctId: NCT06366451 id: MST01-AZN-05 id: PBI-MST-01 type: OTHER domain: Presage Biosciences briefTitle: PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-03 date: 2024-04-16 date: 2024-04-16 name: Presage Biosciences class: INDUSTRY name: AstraZeneca briefSummary: This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, and sabestomig within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This is a cohort substudy of a Master Protocol (PBI-MST-01, NCT04541108) framework, under which comparisons will not be made between substudy cohorts. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Rilvegostomig name: Volrustomig name: Sabestomig name: Pembrolizumab measure: Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, or pembrolizumab measure: Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UC Davis city: Sacramento state: California zip: 95817 country: United States name: Clinical Research Supervisor role: CONTACT name: Arnaud Bewley, MD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: LSU Health Sciences Center - Shreveport city: Shreveport state: Louisiana zip: 71115 country: United States name: Research Coordinator role: CONTACT lat: 32.52515 lon: -93.75018 facility: Montefiore Medical Center city: Bronx state: New York zip: 10467 country: United States name: Research Coordinator role: CONTACT lat: 40.84985 lon: -73.86641 facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Research Coordinator role: CONTACT lat: 35.9132 lon: -79.05584 facility: Oregon Health & Science University (OHSU) city: Portland state: Oregon zip: 97239 country: United States name: Research Coordinator role: CONTACT lat: 45.52345 lon: -122.67621 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Research Coordinator role: CONTACT lat: 39.95233 lon: -75.16379 facility: Sarah Cannon Medical Center city: Charleston state: South Carolina zip: 29406 country: United States name: Research Coordinator role: CONTACT lat: 32.77657 lon: -79.93092 hasResults: False |
<|newrecord|> nctId: NCT06366438 id: ABC vs Parentweb briefTitle: A Trial of Two Universal Programs for Parents of Teenagers overallStatus: COMPLETED date: 2021-12-11 date: 2024-01-15 date: 2024-03-24 date: 2024-04-15 date: 2024-04-22 name: Karolinska Institutet class: OTHER briefSummary: Parent training programs in groups and over internet can help parents improve their interaction and communication with their children. There is however a lack knowledge of how programs work for parents of teenagers, as most studies have concerned younger children. Furthermore, most studies have been conducted on programs for selective populations with elevated risk. The aim of this study was to investigate the effectiveness of two universal preventive parenting programs for teenagers: The group-based program 'ABC-teen' and the online-based 'ParentWeb'. Both programs aim to strengthen the parent-adolescent relationship and reduce negative communication. The programs are developed in Sweden with content based on other established parenting programs (e.g., Comet, Incredible Years, the Triple P). The aim of the present study was to evaluate the effects of the the two programs, with adolescent mental health as primary outcome. Several secondary outcome measures concerning parenting and parent-adolescent relationship were also collected. Parents were randomized to ABC-teen, ParentWeb or a 6 months Wait-List control. Parent- and adolescent ratings were collected at baseline, after 4 and after 12 months. All data collection has now been completed and the next step is to process and analyze the data. conditions: Mental Health Issue conditions: Mental Disorder conditions: Adolescent Behavior conditions: Adolescent Development conditions: Parent-Child Relations conditions: Parenting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized to one of the three arms upon allocation. primaryPurpose: PREVENTION masking: NONE count: 1247 type: ACTUAL name: ABC-teen name: ParentWeb measure: The Strength and Difficulties Questionnaire (SDQ) measure: Patient Health Questionnaire (PHQ-9) measure: Parental stress scale (PSS) measure: General Anxiety Disorder Scale (GAD-7) measure: Conflict scale measure: Adult Child Relationship Scale (ACRS) measure: Adolescents' openness scale measure: Brief Family Relationship Scale measure: Positive and Negative Parenting Behaviors measure: Me as a Parent measure: Conflict Resolution Efficacy measure: School Adjustment Scale measure: Stockholmsenkaten measure: Satisfaction Questionnaire measure: Attendance and engagement measures measure: Demographics measure: Organizational and therapist factors sex: ALL minimumAge: 13 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Bromma stadsdel city: Bromma zip: 16867 country: Sweden lat: 59.34 lon: 17.94 facility: Danderyd kommun city: Danderyd zip: 18231 country: Sweden lat: 59.3987 lon: 18.02942 facility: Ovanåkers kommun city: Edsbyn zip: 82831 country: Sweden lat: 61.37692 lon: 15.81747 facility: Farsta stadsdel city: Farsta zip: 12347 country: Sweden lat: 59.24423 lon: 18.09088 facility: Värmdö kommun city: Gustavsberg zip: 13430 country: Sweden lat: 59.32684 lon: 18.38975 facility: Göteborgs kommun city: Göteborg zip: 41140 country: Sweden lat: 57.70716 lon: 11.96679 facility: Götene kommun city: Götene zip: 53380 country: Sweden lat: 58.52824 lon: 13.49458 facility: Hallsbergs kommun city: Hallsberg zip: 69480 country: Sweden lat: 59.06463 lon: 15.10993 facility: Haninge kommun city: Handen zip: 13640 country: Sweden lat: 59.16809 lon: 18.13796 facility: Huddinge kommun city: Huddinge zip: 14161 country: Sweden lat: 59.23705 lon: 17.98192 facility: Hägersten-Älvsjö stadsdel city: Hägersten zip: 12626 country: Sweden lat: 59.30586 lon: 17.98719 facility: Tellusborgsskolan city: Hägersten zip: 12649 country: Sweden lat: 59.30586 lon: 17.98719 facility: Aspuddens skola city: Hägersten zip: 12655 country: Sweden lat: 59.30586 lon: 17.98719 facility: Hässelby Vällingby stadsdel city: Hässelby zip: 16555 country: Sweden facility: Höörs kommun city: Höör zip: 24331 country: Sweden lat: 55.93444 lon: 13.5385 facility: Järfälla kommun city: Jakobsberg zip: 17757 country: Sweden lat: 59.42268 lon: 17.83508 facility: Skarpnäck stadsdel city: Johanneshov zip: 12153 country: Sweden lat: 59.29999 lon: 18.07903 facility: Enskede Årsta Vantör stadsdel city: Johanneshov zip: 12162 country: Sweden lat: 59.29999 lon: 18.07903 facility: Karlsborgs kommun city: Karlsborg zip: 54630 country: Sweden lat: 58.53724 lon: 14.5047 facility: Upplands-Bro kommun city: Kungsängen zip: 19640 country: Sweden lat: 59.47857 lon: 17.74834 facility: Kungälvs kommun city: Kungälv zip: 44281 country: Sweden lat: 57.87096 lon: 11.98054 facility: Leksands kommun city: Leksand zip: 79331 country: Sweden lat: 60.7303 lon: 14.99994 facility: Lidingö kommun city: Lidingö zip: 18182 country: Sweden lat: 59.36667 lon: 18.13333 facility: Lidköpings kommun city: Lidköping zip: 53132 country: Sweden lat: 58.50517 lon: 13.15765 facility: Lilla Edets kommun city: Lilla Edet zip: 46330 country: Sweden lat: 58.13333 lon: 12.13333 facility: Lindesbergs kommun city: Lindesberg zip: 71135 country: Sweden lat: 59.59202 lon: 15.2304 facility: Linköpings kommun city: Linköping zip: 58232 country: Sweden lat: 58.41086 lon: 15.62157 facility: Lomma kommun city: Lomma zip: 23431 country: Sweden lat: 55.67244 lon: 13.06849 facility: Lunds kommun city: Lund zip: 22223 country: Sweden lat: 55.70584 lon: 13.19321 facility: Mariestads kommun city: Mariestad zip: 54230 country: Sweden lat: 58.70971 lon: 13.82367 facility: Sigtuna kommun city: Märsta zip: 19547 country: Sweden lat: 59.62157 lon: 17.85476 facility: Nacka kommun city: Nacka zip: 13157 country: Sweden lat: 59.31053 lon: 18.16372 facility: Norrköpings kommun city: Norrköping zip: 60224 country: Sweden lat: 58.59419 lon: 16.1826 facility: Norrtälje kommun city: Norrtälje zip: 76128 country: Sweden lat: 59.75799 lon: 18.70496 facility: Nynäshamns kommun city: Nynäshamn zip: 14931 country: Sweden lat: 58.90337 lon: 17.94793 facility: Skellefteå kommun city: Skellefteå zip: 93131 country: Sweden lat: 64.75067 lon: 20.95279 facility: Skärholmen stadsdel city: Skärholmen zip: 12748 country: Sweden lat: 59.27549 lon: 17.90196 facility: Skövde kommun city: Skövde zip: 54183 country: Sweden lat: 58.39118 lon: 13.84506 facility: Sollentuna kommun city: Sollentuna zip: 19147 country: Sweden lat: 59.42804 lon: 17.95093 facility: Stenungsunds kommun city: Stenungsund zip: 44431 country: Sweden lat: 58.07046 lon: 11.8181 facility: Kungsholmen stadsdel city: Stockholm zip: 11218 country: Sweden lat: 59.33258 lon: 18.0649 facility: Norra Real city: Stockholm zip: 11355 country: Sweden lat: 59.33258 lon: 18.0649 facility: Norrmalm stadsdel city: Stockholm zip: 11526 country: Sweden lat: 59.33258 lon: 18.0649 facility: Östermalm stadsdel city: Stockholm zip: 11526 country: Sweden lat: 59.33258 lon: 18.0649 facility: Södermalm stadsdel city: Stockholm zip: 12030 country: Sweden lat: 59.33258 lon: 18.0649 facility: MFJ Hammarby Sjöstad city: Stockholm zip: 12068 country: Sweden lat: 59.33258 lon: 18.0649 facility: Sundbybergs stad city: Sundbyberg zip: 17458 country: Sweden lat: 59.36128 lon: 17.97114 facility: Sundsvalls kommun city: Sundsvall zip: 85232 country: Sweden lat: 62.39129 lon: 17.3063 facility: Sävsjö kommun city: Sävsjö zip: 57631 country: Sweden lat: 57.40327 lon: 14.66244 facility: Tidaholms kommun city: Tidaholm zip: 52231 country: Sweden lat: 58.18035 lon: 13.95824 facility: Trelleborgs kommun city: Trelleborg zip: 23142 country: Sweden lat: 55.37514 lon: 13.15691 facility: Botkyrka kommun city: Tumba zip: 147 41 country: Sweden lat: 59.19858 lon: 17.83317 facility: Täby kommun city: Täby zip: 18339 country: Sweden lat: 59.4439 lon: 18.06872 facility: Töreboda kommun city: Töreboda zip: 54530 country: Sweden lat: 58.70739 lon: 14.12597 facility: Vallentuna kommun city: Vallentuna zip: 18686 country: Sweden lat: 59.53436 lon: 18.07758 facility: Gotlands kommun city: Visby zip: 12142 country: Sweden lat: 57.64089 lon: 18.29602 facility: Vällingbyskolan city: Vällingby zip: 16264 country: Sweden lat: 59.36441 lon: 17.87407 facility: Växjö kommun city: Växjö zip: 35230 country: Sweden lat: 56.87767 lon: 14.80906 hasResults: False |
<|newrecord|> nctId: NCT06366425 id: RECHMPL23_0272 briefTitle: Screening for Chronic Liver Diseases in General Population acronym: HEPGEN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-01 date: 2025-03 date: 2024-04-15 date: 2024-04-17 name: University Hospital, Montpellier class: OTHER name: On-call medical home (MMG) Clermont-Hérault briefSummary: Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care. conditions: Fibrosis, Liver studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 260 type: ESTIMATED name: Blood sample then fibroscan measure: Evaluation of the liver fibrosis screening acceptability (FIB-4) measure: Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan) measure: Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>2.67 measure: Prevalence of excessive consumption of alcohol measure: Prevalence of a history or drug use measure: The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders) measure: prevalence of viral hepatitis measure: Description of socio-demographic characteristics of participants sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Montpellier city: Montpellier zip: 34295 country: France name: Magdalena MESZAROS, MD role: CONTACT phone: : 04 67 33 02 57 email: [email protected] name: Magdalena MESZAROS role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False |
<|newrecord|> nctId: NCT06366412 id: serum Tau-217 in elderly briefTitle: Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein. overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2026-03 date: 2024-04-15 date: 2024-04-15 name: Minia University Hospital class: OTHER briefSummary: To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 94 type: ESTIMATED name: Dexmedetomidine Hydrochloride name: normal saline measure: the effect of dexmedetomidine on serum Tau-217 protein value. measure: to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group. measure: Heart Rate changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours measure: Mean Arterial Blood Pressure changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Arwa Essam status: RECRUITING city: Minya zip: 61111 country: Egypt name: Arwa essam Essam, assistant lecturer role: CONTACT phone: +201017565658 email: [email protected] lat: 28.10988 lon: 30.7503 hasResults: False |
<|newrecord|> nctId: NCT06366399 id: 00156659 briefTitle: The Acute T-Rex (Timing of Resistance Exercise) Study overallStatus: RECRUITING date: 2023-11-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: University of Utah class: OTHER briefSummary: The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur \~1.5 hours after habitual wake, and PM exercise will occur \~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus. conditions: Diabetes Mellitus, Type 2 conditions: Insulin Resistance conditions: Glucose Intolerance conditions: Sleep Disturbance conditions: Overweight or Obesity conditions: Insulin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Resistance Exercise Timing measure: Insulin sensitivity measure: Sleep Duration measure: Sleep Staging measure: Sleep Quality measure: Sleep Efficiency measure: Muscular Strength measure: Perceived Hunger measure: Perceived Fullness measure: Perceived Prospective Food Consumption measure: Glucose Area Under Curve measure: Insulin Area Under Curve sex: ALL minimumAge: 50 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah HPER E Buildling status: RECRUITING city: Salt Lake City state: Utah zip: 84112 country: United States name: Jason V Thomas, MS role: CONTACT email: [email protected] name: Tanya M Halliday, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False |
<|newrecord|> nctId: NCT06366386 id: 5K43TW011963-03 type: NIH link: https://reporter.nih.gov/quickSearch/5K43TW011963-03 briefTitle: Integrating Hypertension Management in DSD for HIV acronym: HTN-DSD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-30 date: 2026-05-30 date: 2024-04-15 date: 2024-04-18 name: Infectious Diseases Research Collaboration, Uganda class: OTHER briefSummary: The goal of this implementation science study is to design evidence based and stakeholder informed implementation strategies to integrate the management of hypertension (HTN) into existing community anti-retro-viral treatment (ART) delivery models of HIV care in Uganda and evaluate their effectiveness and implementation outcomes. The main questions it aims to answer are: |
1. What are the perspectives of patients (hypertensive PLHIV) on integrating hypertension care in community ART delivery models of HIV care? |
2. What are the perspectives of health care providers', district leaders', and policymakers' perspectives on integrating hypertension care in community ART delivery models of HIV care? |
3. What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda? |
4. What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda? |
5. What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda? |
6. What is the cumulative incidence, types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN? Investigators will use qualitative research methods to explore key stakeholders' perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda; design implementation strategies that integrate the management of hypertension into existing community ART delivery models; determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models; evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models; determine the cumulative incidence, types and severity of medication-related adverse events and their predictors; and assess the patients and provider costs, health related quality of life, cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda. conditions: Hypertension conditions: HIV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1100 type: ESTIMATED name: Screening and treatment of hypertension among PLHIV in DSD models for HIV measure: Number of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure) measure: % of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure) measure: Mean blood pressure (both systolic and diastolic blood pressure) measure: Number and % of hypertensive PLHIV with suppressed Viral load measure: Number and % of patients retained in care measure: Number and % of PLHIV screened for HTN at least once in six months measure: Implementation costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Infectious Diseases Research Collaborations (IDRCUganda) city: Kampala state: Central zip: +256 country: Uganda name: Martin Muddu, MMED role: CONTACT phone: +256774004308 email: [email protected] lat: 0.31628 lon: 32.58219 hasResults: False |
<|newrecord|> nctId: NCT06366373 id: 531118232022 briefTitle: An Evaluation on a Mental Health Art Exhibition's Impact on Reducing Stigma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-02 date: 2024-04-15 date: 2024-04-15 name: Hunan University class: OTHER name: Central South University briefSummary: Mental health art exhibitions, as an intervention strategy integrating artistic expression and social contact, have the potential to positively impact the elimination of stigma and discrimination associated with mental health problems. This study will utilize a real-world quasi-randomized controlled trial design and a 6-month follow-up questionnaire survey to evaluate the intervention's impact on stigma/discrimination and related outcomes, such as mental health literacy. The evaluation will encompass four categories of people: those with lived experience of mental disorders, family members and friends of those with lived experience, health professionals, and the general public. Additionally, the cost-effectiveness of the art exhibition intervention will be analyzed. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The interventional study model for this clinical trial is a quasi-randomized controlled trial design. The intervention is the exhibition, organized by "Qixi Charity," will publicly display offline artworks reflecting the diverse dimensions of mental health and ill-health. In contrast, the control group in this study will receive either printed or online educational materials, serving as a more traditional educational intervention. The study will include a baseline survey before the interventions (T0), a follow-up survey in the first month after the interventions (T1), and a follow-up survey in the sixth month after the interventions (T2) in both the experimental group (those who attend the offline exhibition) and the control group (those who are unable to attend the exhibition but will be provided with printed/online education materials). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 1200 type: ESTIMATED name: A mental health art exhibition name: printed or online education materials measure: Stigma/discrimination regarding mental disorders measure: mental health literacy measure: intervention costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366360 id: Piano-Neglect briefTitle: Immersive Virtual Reality Treatment for Unilateral Spatial Neglect overallStatus: RECRUITING date: 2024-03-11 date: 2026-09 date: 2027-09 date: 2024-04-15 date: 2024-04-16 name: Hopitaux de Saint-Maurice class: OTHER briefSummary: Unilateral Spatial Neglect (USN) is a relatively common neuropsychological syndrome following stroke. It is characterized by difficulties in detecting, orienting and identifying events located in the hemispace contralateral to a brain lesion, unrelated to a primary motor or sensory disorder. Numerous methods have been developed for the rehabilitation of this syndrome. However, limitations in terms of efficacy are highlighted. These limitations may be linked to the fact that these methods are restricted to certain sensory modalities, thus failing to take into account the heterogeneity of the syndrome. Moreover, some patients' adherence to rehabilitation programs can also be complicated by motivational difficulties. Immersive Virtual Reality could help overcome these limitations. Indeed, it enables the introduction of new sensory modalities, notably auditory, to support a better apprehension of space. |
The main objective of this study is to determine the efficacy of an immersive virtual reality rehabilitation protocol based on musical practice in patients suffering from USN. This study also aims to explore the benefits of this rehabilitation protocol on patients' daily lives, as well as to explore the influence of patients' mood and motivation on the benefits of the immersive virtual reality rehabilitation protocol. |
To achieve these goals, patients will benefit from immersive virtual reality rehabilitation based on music practice. This rehabilitation will be compared to conventional USN rehabilitation. To this end, patients will be divided into two groups: classical rehabilitation only or classical rehabilitation and immersive virtual reality in parallel. Each patient will be randomly assigned to one of the two groups for a period of 2 weeks. Pre- and post-rehabilitation assessments will be provided. conditions: Stroke conditions: Unilateral Spatial Neglect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each patient was assigned to a group that received 2 rehabilitations for 4 weeks, 1) both Immersive virtual reality therapy and a conventional rehabilitation first, and then conventional rehabilitation alone, or 2) A conventional rehabilitation alone and then both Immersive virtual reality therapy, and conventional rehabilitation. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Immersive Virtual Reality Intervention name: Conventional rehabilitation measure: Bells Test measure: Mesulam cancellation Task measure: Bisection Test measure: Copying Test measure: Scene description Task measure: Ecological scale of daily life activities measure: Piano bisection Task measure: Identifying the keys at the ends of the piano measure: Virtual reality Bells Test measure: Auditory Stimuli Localization Task in virtual reality measure: Ecological virtual reality bisection task measure: Virtual reality Baking Tray test measure: Mood assessment measure: Situational motivation questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpitaux de Saint-Maurice status: RECRUITING city: Saint-Maurice zip: 94410 country: France name: Secretary role: CONTACT phone: 01 43 96 68 22 phoneExt: +33 email: [email protected] lat: 48.82182 lon: 2.42716 hasResults: False |
<|newrecord|> nctId: NCT06366347 id: 23-695 briefTitle: ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-09-01 date: 2029-03-01 date: 2024-04-15 date: 2024-04-23 name: Dana-Farber Cancer Institute class: OTHER name: Eli Lilly and Company briefSummary: A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab. |
The names of the study drugs involved in this study are: |
* Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor) |
* Letrozole (a type of aromatase inhibitor) |
* Pembrolizumab (a type of monoclonal antibody) conditions: Endometrial Cancer conditions: Recurrent Endometrial Cancer conditions: TP53 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: Abemaciclib name: Letrozole name: Pembrolizumab measure: Median Progression Free Survival (PFS) measure: Grade 3-5 Adverse Events (AE) Rate measure: Median Overall Survival (OS) measure: Objective Response Rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center city: Boston state: Massachusetts zip: 02215 country: United States name: Meghan Shea, MD role: CONTACT phone: 617-667-3723 email: [email protected] name: Meghan Shea, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Panagiotis Konstantinopoulos, MD, PhD role: CONTACT phone: 617-632-2334 email: [email protected] name: Panagiotis Konstantinopoulos, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Panagiotis Konstantinopoulos, MD, PhD role: CONTACT phone: 617-632-2334 email: [email protected] name: Panagiotis Konstantinopoulos, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute at Foxborough city: Foxboro state: Massachusetts zip: 02035 country: United States name: Natalie Sinclair, MD role: CONTACT phone: 508-543-1700 email: [email protected] name: Natalie Sinclair, MD role: PRINCIPAL_INVESTIGATOR lat: 42.06538 lon: -71.24783 facility: Dana-Farber Cancer Institute at Milford city: Milford state: Massachusetts zip: 01757 country: United States name: Alexandra Bailey, MD role: CONTACT phone: 508-488-3700 email: [email protected] name: Alexandra Bailey, MD role: PRINCIPAL_INVESTIGATOR lat: 42.13982 lon: -71.51617 facility: Dana-Farber Cancer Institute at South Shore Hospital city: Weymouth state: Massachusetts zip: 02190 country: United States name: Meredith Faggen, MD role: CONTACT phone: 781-624-4800 email: [email protected] name: Meredith Faggen, MD role: PRINCIPAL_INVESTIGATOR lat: 42.22093 lon: -70.93977 hasResults: False |
<|newrecord|> nctId: NCT06366334 id: 23/02E briefTitle: Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation acronym: KSI overallStatus: RECRUITING date: 2024-01-15 date: 2024-08-30 date: 2024-09-30 date: 2024-04-15 date: 2024-04-15 name: Children's Hospital of Eastern Ontario class: OTHER briefSummary: Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available. |
Ketamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents. |
If intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond. conditions: Suicidal Ideation conditions: Suicidal Ideas studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Ketamine Hydrochloride name: Normal saline measure: Proportion of eligible participants who complete the study protocol measure: Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5) measure: Baseline distribution of responses to the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) measure: Baseline distribution of responses to the suicide item (#9) from the Beck Depression Index (BDI9). measure: Baseline pragmatic assessment of the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5), the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), and the suicide item (#9) from the Beck Depression Index (BDI9). measure: Assessment of blinding measure: Treatment efficacy measured by the Beck Scale for Suicidal Ideation (SSI5) measure: Treatment efficacy measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) measure: Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9) measure: Treatment durability measured by the Beck Scale for Suicidal Ideation (SSI5) measure: Treatment durability measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) measure: Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9) measure: Admission to Hospital measure: Length of Stay in Hospital measure: ED revisits measure: Safety Outcome 1: Clinically significant tachycardia measure: Safety Outcome 2: Clinically significant hypertension measure: Safety Outcome 3: Vomiting measure: Safety Outcome 4: Dissociation measure: Safety Outcome 5: Death sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Children's Hospital Of Eastern Ontario status: RECRUITING city: Ottawa state: Ontario zip: K1H 8L1 country: Canada name: Maala Bhatt, MD, MSc. role: CONTACT phone: 6137377600 phoneExt: 4178 email: [email protected] name: Tyrus Crawford role: CONTACT phone: 6137377600 phoneExt: 4178 email: [email protected] lat: 45.41117 lon: -75.69812 hasResults: False |
<|newrecord|> nctId: NCT06366321 id: 23-067 briefTitle: Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture overallStatus: COMPLETED date: 2024-01-01 date: 2024-01-23 date: 2024-02-01 date: 2024-04-15 date: 2024-04-16 name: British University In Egypt class: OTHER briefSummary: This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues. conditions: Dental Diseases conditions: Dental Trauma conditions: Bone Remodeling Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ACTUAL name: relining technique name: CAD/CAM milling technique measure: patient satisfaction using questionnaire measure: denture retention measure: denture adaptation to oral tissues sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: British University in Egypt city: El Shorouk state: Cairo zip: 4914085 country: Egypt lat: 30.13806 lon: 31.61556 hasResults: False |
<|newrecord|> nctId: NCT06366308 id: ProBiox briefTitle: Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-01 date: 2024-06-01 date: 2024-04-15 date: 2024-04-16 name: West China Hospital class: OTHER briefSummary: Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field. |
Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations. conditions: Prostate Cancer conditions: Pathology studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED name: Transperineal Prostate Biopsy measure: Positive rate of prostate biopsy sex: MALE minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366295 id: WUM.Perio.05 briefTitle: Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial overallStatus: RECRUITING date: 2023-06-01 date: 2024-04 date: 2024-11 date: 2024-04-15 date: 2024-04-17 name: Medical University of Warsaw class: OTHER briefSummary: The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 26 type: ESTIMATED name: subgingival mechanotherapy with perioscopy name: classical subgingival mechanotherapy measure: Probing pocket depth (PPD) measure: Clinical attachment level (CAL) measure: Bleeding on probing (BoP) measure: Plaque index (PI) measure: Width of keratinized tissue (KTW) measure: Gingival thickness (GT) measure: Subgingival plaque pathogens (Aa, Pg, Td) levels measure: Gingival crevicular fluid levels of cytokines sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw status: RECRUITING city: Warsaw state: Mazowieckie zip: 02-097 country: Poland name: Bartlomiej Gorski, DDS, PhD role: CONTACT phone: +48 22 502 20 99 email: [email protected] lat: 52.22977 lon: 21.01178 hasResults: False |
<|newrecord|> nctId: NCT06366282 id: IRB00110030 briefTitle: Pediatric and Caregiver Traumatic Stress Intervention (PACTS) acronym: PACTS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-03 date: 2025-03 date: 2024-04-15 date: 2024-04-26 name: Wake Forest University Health Sciences class: OTHER name: Childress Institute for Pediatric Trauma briefSummary: The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression. conditions: Traumatic Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 24 type: ESTIMATED name: Caregiver Counseling for Childhood Traumatic Injury name: Standard of Care for Childhood Traumatic Injury measure: Change in Kessler 6 Scores measure: Change in Patient Health Questionnaire - 9 (PHQ-9) Scores measure: Change in Child and Adolescent Trauma Screen (CATS) Scores sex: ALL minimumAge: 1 Year maximumAge: 6 Years stdAges: CHILD facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Elizabeth White, MA, LCMHCS role: CONTACT phone: 336-716-2801 email: [email protected] name: Elizabeth Shilling, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False |
<|newrecord|> nctId: NCT06366269 id: STUDY20240374 briefTitle: Acupuncture First for IC/BPS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-15 date: 2024-04-17 name: David Sheyn class: OTHER briefSummary: The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is: |
Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture. |
Participants will |
* complete surveys about their bladder pain symptoms |
* make behavioral changes that have been shown to improve bladder pain symptoms |
* attend six (6) weekly acupuncture sessions |
* attend six (6) weekly physical therapy sessions after finishing acupuncture conditions: Bladder Pain Syndrome conditions: Interstitial Cystitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Acupuncture name: Behavioral management name: Physical therapy measure: O'Leary-Sant Interstitial Cystitis Index (OLSICI) measure: Patient Global Impression of Improvement (PGI-I) measure: Short Form (SF-36) measure: Genitourinary Pain Index (GUPI) measure: Number of additional treatments used during study period measure: Number of unscheduled interactions sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366256 id: 1R01DC017301-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DC017301-01 briefTitle: Simplified Ultrasound Feedback for Speech Remediation acronym: SUFSR overallStatus: RECRUITING date: 2023-10-24 date: 2024-12 date: 2025-08 date: 2024-04-15 date: 2024-04-15 name: University of Cincinnati class: OTHER briefSummary: Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. The goal of the study is to test whether ultrasound biofeedback delivered without showing children a display of their tongue movements will be effective as a treatment for residual speech sound disorders in children. We focus on children who have trouble producing the sound "r" as in "rabbit". The first aim is to develop a fast reliable system to track movements of different parts of the tongue using ultrasound and to identify which combinations of movements will produce a good "r" and which do not. The second aim is to develop a motivational game in which children receive feedback on the success of their tongue movements by what happens to an animated character on a screen. This developed version of ultrasound feedback therapy will be compared to the traditional version of ultrasound feedback therapy to determine how the two approaches can best be utilized in the clinic. conditions: Speech Sound Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Traditional ultrasound biofeedback name: Simplified ultrasound biofeedback measure: Change in percent accurate words in probe list at beginning and midpoint of study measure: Change in percent accurate words in probe list at beginning and end of study sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: University of Cincinnati status: RECRUITING city: Cincinnati state: Ohio zip: 45220 country: United States name: Suzanne E Boyce, PhD role: CONTACT phone: 513-558-8509 email: [email protected] name: Sarah M Dugan, PhD role: CONTACT email: [email protected] lat: 39.12713 lon: -84.51435 hasResults: False |
<|newrecord|> nctId: NCT06366243 id: CVL-231-HV-1012 briefTitle: A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-06-24 date: 2024-06-24 date: 2024-04-15 date: 2024-04-15 name: Cerevel Therapeutics, LLC class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the potential of gastric pH-dependent drug-drug interaction effect of esomeprazole, a proton pump inhibitor (PPI), on the pharmacokinetics (PK) of emraclidine in healthy adult participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Emraclidine name: Esomeprazole measure: Maximum Observed Plasma Concentration (Cmax) of Emraclidine measure: Time to Maximum (Peak) Plasma Concentration (Tmax) of Emraclidine measure: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Emraclidine measure: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Emraclidine measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values measure: Number of Participants With Clinically Significant Changes in Vital Sign Parameters measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments measure: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results measure: Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06366230 id: 24-41450 briefTitle: Adding Urea to the Final Dialysis Fluid overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-06-30 date: 2028-06-30 date: 2024-04-15 date: 2024-04-15 name: University of California, San Francisco class: OTHER briefSummary: At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis. conditions: Dysequilibrium Syndrome conditions: ESRD conditions: Hyperkalemia conditions: Metabolic Acidosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Urea in the dialysate measure: Disequilibrium measure: Serum potassium concentration measure: Serum CO2 concentration measure: Serum BUN concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zuckerberg San Francisco General Hospital city: San Francisco state: California zip: 94110 country: United States name: Ramin Sam, MD role: CONTACT phone: 628-206-6605 email: [email protected] lat: 37.77493 lon: -122.41942 hasResults: False |
<|newrecord|> nctId: NCT06366217 id: 20-32530A briefTitle: Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-19 name: University of California, San Francisco class: OTHER briefSummary: To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops. conditions: Dilation conditions: Pupil Reaction Absent studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 100 type: ESTIMATED name: MydCombi Device name: MydCombi Drug measure: Percent change in Spherical equivalent measure: Percent Change in maximum pupil diameter measure: Percent Change in pupil constriction percentage measure: Percent Change in Intraocular Pressure sex: ALL minimumAge: 2 Years stdAges: CHILD 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 hasResults: False |
<|newrecord|> nctId: NCT06366204 id: H23-03119 briefTitle: Lysine Requirements During Lactation overallStatus: RECRUITING date: 2024-01-01 date: 2025-03-31 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: University of British Columbia class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The study aims to establish lysine requirements using the indicator amino acid oxidation (IAAO) method in women exclusively breastfeeding a single infant aged 3-4 months, and how maternal lysine needs change once infant transition to complimentary feeding at a later age of 9-10 months. Each 8-hour study day will have an assigned test lysine intake ranging from deficient to excess. The diets will be provided in a complete protein shake format, meeting all nutrient requirements except for the test lysine intake. Breath samples evaluate the indicator's oxidation to determine protein synthesis in response to lysine intake. Urine and one blood sample will be collected to assess metabolite concentrations. conditions: Lactation conditions: Breastfeeding, Exclusive conditions: Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single day interventions; Repeated measures design. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Dietary Lysine Intakes measure: Carbon 13 Oxidation sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: BC Children's Hospital Research Institute status: RECRUITING city: Vancouver state: British Columbia zip: V5Z 4H4 country: Canada name: Taylor Bailey, BSc role: CONTACT phone: 705-698-7648 email: [email protected] name: Rajavel Elango, PhD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 hasResults: False |
<|newrecord|> nctId: NCT06366191 id: 2023/CHU/08 briefTitle: Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study acronym: A2P overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2025-04 date: 2025-07 date: 2024-04-15 date: 2024-04-15 name: Centre Hospitalier Universitaire de la Réunion class: OTHER briefSummary: A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system. conditions: Psychological Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: prevention algorithm name: Standard care measure: study acceptability rate measure: Adherence of patient to the watch measure: Adherence of patient to the health watch measure: Patient satisfaction (quantitatif) measure: Patient satisfaction (qualitatif) measure: Strong points of the health watch measure: Evolution of the patient journey in experimental arm measure: Occurrence of post-traumatic stress disorder measure: Complications associated with post-traumatic stress disorder measure: Complications associated with post-traumatic stress disorder measure: Complications associated with post-traumatic stress disorder measure: Complications associated with post-traumatic stress disorder sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366178 id: 2024/864 briefTitle: EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses acronym: EPBONF overallStatus: NOT_YET_RECRUITING date: 2024-12-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-15 date: 2024-04-15 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities. The damage is primarily aesthetic, but intracranial hypertension may also be observed. |
The treatment of craniostenosis involves surgery, to restore harmonious growth between the skull bones and the brain, and proper development of the latter. |
There are various surgical techniques for correction, based on remodeling of the upper forehead and the orbito-naso-frontal band (BONF). However, BONF reshaping is difficult to tailor to each individual child. In most cases, the surgeon performs the reshaping "freehand", without a template. The result is therefore subject to the surgeon's experience and judgment. |
A surgical instrument (template) has been developed to guide the surgeon in the ideal reshaping of the BONF in patients with anterior craniostenosis (anterior plagiocephaly and trigonocephaly), according to each child's specific morphology. |
The aim of EPBONF research is to evaluate the benefits of using this template on the symmetry and angle of the BONF. conditions: Craniosynostoses studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: BONFIX system measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. sex: ALL minimumAge: 4 Months maximumAge: 24 Months stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06366165 id: ACU-Med3 briefTitle: Linking Special Care Dentistry Curriculum to Seemingly Irrelevant Comedy overallStatus: RECRUITING date: 2021-10-01 date: 2021-10-01 date: 2024-08-30 date: 2024-04-15 date: 2024-04-15 name: Cairo University class: OTHER briefSummary: As Special care dentistry curriculum is very complicated and has a lot of details. Upon teaching it, the investigator will include memes and videos of movies and cartoons and will test the degree of retention of the information after years of passing the subject's exam. conditions: Learning Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Testing the procedure of using a different mode of teaching medical content primaryPurpose: SCREENING masking: NONE count: 700 type: ESTIMATED name: seemingly irrelevant funny videos and memes in teaching measure: degree of retention of information sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ahram Candian University status: RECRUITING city: Giza country: Egypt name: Ayat Gamal-AbdelNaser role: CONTACT phone: 01001874257 email: [email protected] lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06366152 id: 43N2US2105 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-15 date: 2024-04-15 name: [Redacted] hasResults: False |
<|newrecord|> nctId: NCT06366139 id: Trigeminal RFT vs max/mand PRF briefTitle: Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia overallStatus: COMPLETED date: 2023-01-11 date: 2024-02-04 date: 2024-03-07 date: 2024-04-15 date: 2024-04-15 name: Diskapi Teaching and Research Hospital class: OTHER briefSummary: Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared. conditions: Trigeminal Neuralgia conditions: Headache Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ACTUAL name: Radiofrequency thermocoagulation of the trigeminal ganglion name: Maxillary/Mandibular nerve pulsed radiofrequency measure: Numerical rating scale (NRS) measure: The Medication Quantification Scale III (MQS III) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diskapi Training and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06366126 id: Child Abuse briefTitle: Long Term Impact of Child Abuse in University Students overallStatus: COMPLETED date: 2023-02-01 date: 2023-08-31 date: 2023-08-31 date: 2024-04-15 date: 2024-04-15 name: Delta University for Science and Technology class: OTHER briefSummary: Based on research and studies, a broad conceptualization of child abuse and neglect has progressively been constructed, defining it as all actions carried out by caregivers that significantly interfere in the child's optimum development and do not adhere to social standards. This conceptualization contemplates aspects such as neglecting physical-biological, cognitive, emotional, and social needs, and the different types of child maltreatment are also classified. |
This study aimed too evaluate the psychological and social long-term effects of different types of child abuse. conditions: Child Abuse studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 242 type: ACTUAL measure: tailored questionnaire sex: ALL minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: Amira Hussin Mohammed city: Gamasa zip: 35712 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False |
<|newrecord|> nctId: NCT06366113 id: 2023-A00363-42 briefTitle: Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD) acronym: CHRONOBIO overallStatus: RECRUITING date: 2024-01-02 date: 2024-01-02 date: 2024-07-01 date: 2024-04-15 date: 2024-04-17 name: Michaël RACODON class: OTHER briefSummary: Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies. |
The program should not be improved by introducing new subjects such as circadian rhythm. conditions: Respiratory Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Pulmonary rehabilitation measure: 6-minute walk test (6MWT) measure: Time limit test (Time-lim) measure: Sit to stand test (STT) measure: Single arm curl Test (SAC) measure: Single-leg stance test (SLT) measure: Hospital Anxiety and Depression Scale (HAD) measure: Pittsburgh Sleep Quality Index sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique la Mitterie status: RECRUITING city: Lille zip: 59130 country: France name: Michaël RACODON, PhD role: CONTACT phone: +33320223457 email: [email protected] lat: 50.63297 lon: 3.05858 hasResults: False |
<|newrecord|> nctId: NCT06366100 id: 2023I060 briefTitle: Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction overallStatus: RECRUITING date: 2024-02-01 date: 2025-06-30 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: Universidad de Zaragoza class: OTHER name: Ministerio de Sanidad, Servicios Sociales e Igualdad briefSummary: The aim of this study is to evaluate the dissemination and implementation process of two transdiagnostic psychological interventions (Dialectical Behavioral Therapy for Substance Use Disorders-DBT-SUD and Unified Protocol-UP) to treat alcohol addiction by mental health practitioners in the Spanish National Health System. The main questions this study aims to answer are: |
Are there differences before and after receiving DBT-SUD and UP training in the attitudes toward evidence-based psychological treatments (EBPTs), level of burnout and organizational climate and readiness to implement the interventions in mental health practitioners working with alcohol addiction? |
What is the degree of acceptability and intention to use the interventions in clinical practice with people with alcohol addiction of the practitioners after each training (DBT-SUD and UP)? |
In what degree the implementation outcomes (adoption, reach, appropriateness, feasibility, fidelity, sustainability) will be achieved by the practitioners implementing DBT-SUD and UP in clinical practice? |
What are the main barriers and facilitators that practitioners will encounter during the process of implementing DBT-SUD and UP in clinical practice? |
What variables will predict a successful implementation considering previous characteristics of the professionals and the organizational outcomes? |
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