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<|newrecord|> nctId: NCT06380738 id: D0817R00074 id: D0817R00074 type: OTHER domain: AstraZeneca briefTitle: Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed) acronym: PROceed overallStatus: RECRUITING date: 2024-02-14 date: 2027-01-31 date: 2027-01-31 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in. conditions: Metastatic Castration-resistant Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED measure: Time to treatment discontinuation measure: Time to first subsequent therapy sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Aschaffenburg country: Germany lat: 49.97704 lon: 9.15214 facility: Research Site status: RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: RECRUITING city: Duisburg country: Germany lat: 51.43247 lon: 6.76516 facility: Research Site status: NOT_YET_RECRUITING city: Franckfurt country: Germany facility: Research Site status: RECRUITING city: Halle country: Germany lat: 51.48159 lon: 11.97948 facility: Research Site status: RECRUITING city: Herzogenaurach country: Germany lat: 49.56798 lon: 10.88565 facility: Research Site status: NOT_YET_RECRUITING city: Leipzig country: Germany lat: 51.33962 lon: 12.37129 facility: Research Site status: NOT_YET_RECRUITING city: Lueneburg country: Germany lat: 53.2509 lon: 10.41409 facility: Research Site status: RECRUITING city: Muhlheim country: Germany lat: 50.11667 lon: 8.83333 facility: Research Site status: RECRUITING city: Nurnberg country: Germany lat: 49.45421 lon: 11.07752 facility: Research Site status: RECRUITING city: Russelsheim country: Germany lat: 49.98955 lon: 8.42251 facility: Research Site status: RECRUITING city: Speyer country: Germany lat: 49.32083 lon: 8.43111 facility: Research Site status: RECRUITING city: Wetzlar country: Germany lat: 50.56109 lon: 8.50495 hasResults: False
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<|newrecord|> nctId: NCT06380725 id: jshim8zay6vd briefTitle: The Treatment of High Intensity Transcranial Current Stimulation for Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-12 date: 2024-04-24 date: 2024-04-24 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment. conditions: Alzheimer's Disease conditions: Mild Cognitive Impairment conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Investigators designed a randomized double-blinded placebo-controlled trial by randomly dividing subjects into two groups: one is the treatment group and the other is the placebo group. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Investigators designed a double-blinded trial in which neither the investigator nor the subjects know whether they will be received the treatment or a placebo. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Transcranial alternating current stimulation(real stimulation) name: Transcranial alternating current stimulation(sham stimulation) measure: Cognitive appraisal measure: Global Cognitive appraisal measure: Psychobehavioral assessment measure: Near-infrared spectroscopy measure: Event related potential measurement measure: Peripheral blood biomarkers measure: Magnetic Resonance Imaging measure: Incidence of side effects sex: ALL minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06380712 id: 6509 briefTitle: HYPERTESSA "HyperTessa User Experience Study (HTUX)" overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-09-30 date: 2024-10-31 date: 2024-04-24 date: 2024-04-24 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Background: Hypertension is the primary cause of cardiovascular diseases and premature death in the world. Hypertension management starts with the control of blood pressure, whatever it is the type and severity. The optimum control of blood pressure requires regular and frequent auto-monitoring of blood pressure values, adherence to medication plan, and modification of lifestyle behaviours, including diet, quit smoking, and physical activity. This study is a pilot project to assess acceptance ad usability of a digital health solution to be used by patients diagnosed with hypertension. Materials and methods: Prior to the development of the solution, a literature research was performed, then focus group meetings were conducted with senior experts in the digital field, physicians treating hypertension, and patients. A mobile app and web platform were created to help patients in monitoring and reporting data about health status and lifestyle. In order to execute the study, first the physicians in charge of the study will register in the webApp, creating a personal account. Then, patients who meet the inclusion criteria are proposed to participate to the study and, in case of agreement, will be asked to sign the informed consent (IC) statement and the privacy policy. After the phase of profile setting and onboarding, the patient will start to use the mobile App for hypertension management. Once the patient has used the App for the observation period, the physician will be allowed to analyze the data to understand the level of acceptance and regular usage from each patient. This physician will perform this analysis using a web-based portal which is part of the digital solution. Results: During the study, data about usage patterns will be collected. Specific data about usability and acceptance will be gathered through the use of User Experience Questionnaire (UEQ) and unstructured interviews and tests. After each patient has completed the observation period, all the data will be analysed using mainly descriptive statistics to obtain metrics related to usage patterns, usability and adherence. The study results from this pilot phase will be used to modify the digital solution, leveraging an incremental, iterative logic following a co-design and agile methodology. After incorporating the feedback from this pilot and further enriching the solution, next phases of the study are forseen in order to assess the care benefit of such technology in terms of improved treatment outcomes, due to better adherence, higher motivation in practicing healthy lifestyle, better information, and personalized support from HCP. conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: User Experience / User Acceptance Indicators for patients measure: User Experience / User Acceptance Indicators for Healthcare Professionals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli., IRCCS city: Rome country: Italy name: Andrea Flex, MD, PhD role: CONTACT phone: + 39 06 3015 4293 email: andrea.flex@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06380699 id: HJG-CZQH-QHRD106-I briefTitle: Study to Assess PK, Safety and Tolerability in Healthy Subjects overallStatus: COMPLETED date: 2023-03-16 date: 2023-11-16 date: 2023-12-25 date: 2024-04-24 date: 2024-04-26 name: Changzhou Qianhong Bio-pharma Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ACTUAL name: QHRD106 Injection name: Yurekline name: placebo measure: Safety as assessed by incidence, severity, and causality of adverse events measure: Plasma measurements of QHRD106 measure: Concentration of bradykinin in plasma sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nanjing Drum Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06380686 id: AIO-KHT-0322/ass briefTitle: Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome acronym: HEAT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2030-05 date: 2024-04-24 date: 2024-04-24 name: AIO-Studien-gGmbH class: OTHER name: Merck Sharp & Dohme LLC briefSummary: Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent/metastatic head and neck tumor patients. conditions: Squamous Cell Carcinoma of the Oral Cavity conditions: Squamous Cell Carcinoma of the Oropharynx conditions: Squamous Cell Carcinoma of the Hypopharynx conditions: Squamous Cell Carcinoma of the Larynx studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: data collection measure: Sociodemographic factors measure: Treatments measure: Response rates measure: Treatment decision measure: Progression-free survival measure: Time-to-treatment-failure measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Essen city: Essen zip: 45147 country: Germany name: Victor Grünwald, Prof. Dr. role: CONTACT phone: +49 201 723 85584 email: viktor.gruenwald@uk-essen.de lat: 51.45657 lon: 7.01228 hasResults: False
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<|newrecord|> nctId: NCT06380673 id: s68299 briefTitle: Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy acronym: TEHITI overallStatus: RECRUITING date: 2024-04-22 date: 2028-12-30 date: 2029-12-30 date: 2024-04-24 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only). conditions: Food Allergy conditions: Cow Milk Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: Implementation of cow's milk in decreasingly heated forms name: Implementation of heated cow's milk name: No intervention measure: Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction measure: Time to complete tolerance in all three arms measure: Quality of life in all three arms measure: Clinical reactions measure: Side effects measure: IL-10-producing cow's milk specific regulatory T and B cells measure: BATs to mimic the outcome of cow's milk provocation tests sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Imelda Hospital Bonheiden status: RECRUITING city: Bonheiden country: Belgium name: Katrien Coppens, MD role: CONTACT lat: 51.02261 lon: 4.54714 facility: AZ Sint-Jan status: RECRUITING city: Brugge country: Belgium name: Kate Sauer, MD role: CONTACT lat: 51.20892 lon: 3.22424 facility: AZ Maria Middelares status: RECRUITING city: Ghent country: Belgium name: Jasmine Leus, MD role: CONTACT lat: 51.05 lon: 3.71667 facility: Jessa Hospital status: RECRUITING city: Hasselt country: Belgium name: Sophie Verelst, MD role: CONTACT lat: 50.93106 lon: 5.33781 facility: UZ Leuven Gasthuisberg status: RECRUITING city: Leuven country: Belgium name: Dominique MA Bullens, Prof. Dr. role: CONTACT phone: +32016343801 email: dominique.bullens@kuleuven.be lat: 50.87959 lon: 4.70093 hasResults: False
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<|newrecord|> nctId: NCT06380660 id: ACE-106-001 briefTitle: Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-22 date: 2028-12-21 date: 2029-03-21 date: 2024-04-24 date: 2024-04-24 name: Acerand Therapeutics (Shanghai) Limited class: INDUSTRY briefSummary: The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors. conditions: Solid Tumor, Adult conditions: BRCA1 Mutation conditions: BRCA2 Mutation conditions: Ovarian Cancer conditions: Breast Cancer conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 298 type: ESTIMATED name: ACE-86225106 tablet measure: Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs) measure: The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol measure: Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) and Time to Response (TTR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change measure: Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Cancer Hospital status: RECRUITING city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 facility: Sun Yat-Sen University Cancer Center status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Hubei Cancer Hospital status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: NOT_YET_RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06380647 id: 0004 briefTitle: Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns acronym: childburn overallStatus: COMPLETED date: 2019-10-01 date: 2020-09-30 date: 2020-09-30 date: 2024-04-24 date: 2024-04-24 name: King Edward Medical University class: OTHER briefSummary: Introduction: Early detection is important in treating patients with Eczema Herpeticum (EH), which may arise in paediatric burn patients. As soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. Several studies have indicated that acyclovir is the best treatment for EH lesions in the majority of individuals.
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Objective: Compare efficacy of the prophylactic acyclovir and placebo in preventing eczema Herpeticum in paediatric burn patients conditions: Herpes Virus Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sample size of 64 patients (32 patients in each group) was estimated by using 5% level of significance, 90% power of test with expected percentage of patients given prophylactic acyclovir as 81.3% and patients given placebo as 42.9%. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: parents were blinded to group allocation whoMasked: PARTICIPANT count: 64 type: ACTUAL name: Intravenous Acyclovir measure: Number of participants with positive Tzanck smear sex: ALL minimumAge: 1 Month maximumAge: 13 Years stdAges: CHILD facility: department of pediatric surgery King Edward Medical University city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06380634 id: NYalcinbas briefTitle: The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy overallStatus: COMPLETED date: 2023-01-23 date: 2023-12-31 date: 2024-02-20 date: 2024-04-24 date: 2024-04-24 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy. conditions: Motivational Interview conditions: Cosmetic Product Causing Toxic Effect studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design. primaryPurpose: SCREENING masking: NONE maskingDescription: The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). The researcher included pregnant women who met the inclusion criteria in the outpatient clinics on certain days of the week, in accordance with the randomization process. count: 130 type: ACTUAL name: Experimental group- Motivational Interview measure: Evaluation Form for Use of Domestic Chemicals and Personal Care Products measure: Self Efficacy Competence Scale measure: Endocrine Disruptors Attitude Scale sex: FEMALE minimumAge: 20 Years maximumAge: 43 Years stdAges: ADULT facility: Istanbul University Cerrahpasa city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-05 uploadDate: 2024-04-17T16:09 filename: Prot_000.pdf size: 142041 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-05 uploadDate: 2024-04-17T16:13 filename: SAP_001.pdf size: 234444 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-30 uploadDate: 2024-04-17T16:05 filename: ICF_002.pdf size: 75804 hasResults: False
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<|newrecord|> nctId: NCT06380621 id: IRC/1386/018 briefTitle: Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia overallStatus: COMPLETED date: 2018-03-15 date: 2019-02-15 date: 2019-03-15 date: 2024-04-24 date: 2024-04-24 name: B.P. Koirala Institute of Health Sciences class: OTHER briefSummary: The goal of this clinical trial is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed by laparoscopic bilateral TEP repair in all cases with a contralateral occult hernia and to compare complications, recurrence rates, postoperative pain, and operative duration with prospectively performed unilateral repairs in young to middle-aged patients presenting with unilateral hernias in the surgery outpatient department.
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The main questions it aims to answer are:
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* To compare complications, recurrence rates, postoperative pain, and operative duration between both groups.
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* Incidence of occult contralateral hernia Patients attending the OPD for unilateral inguinal hernia were counseled about the trial and fully encouraged to understand the difference between two procedures for unilateral hernia: bilateral exploration and bilateral TEP repair, upon which if a contralateral occult inguinal hernia was observed, documented, and controls were taken from the patients who denied bilateral exploration and underwent unilateral TEP repair. The allotment of patients was done in two groups of 30 patients each.
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Researchers will compare Group A( bilateral TEP) with Group B (unilateral TEP) to see if complications, recurrence rates, postoperative pain, and operative duration occur in each group conditions: Inguinal Hernia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Totally Extra Peritoneal repair (TEP) repair measure: To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair. measure: To measure incidence of intra- and post-operative complication between patients of unilateral and bilateral TEP repair sex: ALL minimumAge: 16 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Bikash Kumar Sah city: Dharān Bāzār state: Koshi zip: 56700 country: Nepal lat: 26.81248 lon: 87.28355 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2018-03-15 uploadDate: 2024-04-21T09:41 filename: Prot_ICF_000.pdf size: 450800 hasResults: False
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<|newrecord|> nctId: NCT06380608 id: 0047-23-ASF briefTitle: Levels of Fear, Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia overallStatus: RECRUITING date: 2023-09-01 date: 2024-09-30 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: Zoya Haitov Ben Zikri class: OTHER_GOV briefSummary: Tooth extraction is one of the most common procedures in dentistry. Surgical extraction of damaged wisdom teeth involves bone resection and injury to the soft tissue. Dental care often evokes high levels of anxiety.In addition, stress causes poor regulation of endocrine, autocrine and paracrine systems during the three stages of wound healing of the soft oral tissues. Therefore, special considerations are necessary when performing dental surgery on highly stressed patients. One of the options used in the last decade is to perform this procedure under general anesthesia.
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A stress response stimulates the secretion of cortisol hormone. Cortisol levels were found to be significantly higher before dental surgery, while after the operation the hormone level dropped significantly.
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The aim of the study is to assess the level of anxiety/fear and monitor the wound healing process among patients who are about to undergo surgery to remove wisdom teeth or no more than 3 jaw implants under local anesthesia in the dental clinic compared to patients who are about to undergo the same surgery under general anesthesia. conditions: Wisdom Teeth Extraction or Jaw Implant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 46 type: ESTIMATED name: Local anesthesia name: General anesthesia measure: Fear and anxiety measure: Wound heeling sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shamir (Asaf Harofe) Medical center status: RECRUITING city: Be'er Ya'aqov zip: 60930 country: Israel name: sara Bar Yehuda, MD role: CONTACT phone: 972528981004 email: sarabar1@shamir.gov.il lat: 31.93864 lon: 34.83749 hasResults: False
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<|newrecord|> nctId: NCT06380595 id: 23 -1533 briefTitle: Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms acronym: CEVARII overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2025-03 date: 2026-03 date: 2024-04-24 date: 2024-04-24 name: CEVARII class: OTHER name: University of Iowa name: University of Colorado, Denver name: University of Trieste name: University of Copenhagen name: University of Colorado, Colorado Springs briefSummary: Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533. conditions: Inflammatory Abdominal Aortic Aneurysm conditions: Aneurysm, Infected conditions: Aneurysm, Mycotic conditions: Abdominal Aortic Aneurysm conditions: Thoracoabdominal Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 220 type: ESTIMATED name: Complex endovascular aortic repair (cEVAR) measure: Primary Graft Patency measure: Bowel Ischemia measure: Presence of aortic aneurysm endoleak after surgery measure: Aneurysm-related mortality (ARM) measure: Conversion to Open Surgical Repair (OSR) measure: Aortic rupture measure: Post-operative infection-related complication (IRC) measure: The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies. measure: Assessment of Adverse Events (AEs) described in the protocol. measure: All Cause Mortality measure: Continued Aortic sac growth. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Healthcare city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06380582 id: NL85595.068.23 briefTitle: Indoor Air Quality, Temperature and Cognitive Performance acronym: AEOLUS overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-12-21 date: 2024-12-21 date: 2024-04-24 date: 2024-04-24 name: Maastricht University Medical Center class: OTHER briefSummary: Study design: A cross-over single-blinded treatment design will be used. Participants will undergo 4 different conditions: (1) low air flow and 23°C, (2) low air flow and 35°C, (3) high air flow and 23°C, and (4) high air flow and 35°C. Participants will be blinded to the air quality level; however, it is not possible to blind them to the temperature condition, as they will be able to perceive it as different.
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Study population: The population consists of healthy young and middle-aged adults of both sexes between 18 and 40 years.
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Intervention (if applicable): Each participant undergoes 4 conditions in randomized order. Two conditions consist of poor air quality defined as 3,000 ppm carbon dioxide and 23°C or 35°C temperature, respectively. conditions: Indoor Air Quality, Temperature and Cognitive Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 22 type: ESTIMATED name: Temperature and Airflow combination measure: Cognition measure: Cognition measure: Heart Rate (bpm) measure: Metabolic Rate (ml/kg/min) measure: Blood Pressure (mmHg) measure: Blood samples measure: Saliva samples measure: Breathing rate measure: Temperature (C) measure: Humidity % measure: Carbon dioxide (CO2) concentration (ppm) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06380569 id: E-1139-21 Community Setting briefTitle: A Strength-Based Intervention to Improve Job Interview Skills in Young Adults in a Community Setting overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-24 date: 2024-04-24 name: Kessler Foundation class: OTHER briefSummary: We are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. We are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Kessler Foundation Strength Identification and Expression (KF-STRIDE®) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: KF-STRIDE® measure: Mock Job Interview measure: Employment Status measure: Time-to-reach Employment measure: Strength Knowledge and Strengths Use Scale (SKUS) measure: Youth Interview- Self Efficacy and Anxiety measure: Job Search Behavior Scale measure: Work Readiness Scale measure: Global Assessment of Character Strengths (GACS) measure: Rosenberg Self-Esteem Scale (RSES) sex: ALL minimumAge: 14 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06380556 id: 25.05.2022/68 briefTitle: The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates overallStatus: COMPLETED date: 2022-11-10 date: 2023-01-30 date: 2023-07-13 date: 2024-04-24 date: 2024-04-24 name: Istanbul Medeniyet University class: OTHER briefSummary: This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants. conditions: Procedural Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the study, participants were assigned to groups by block randomization. Type of delivery (vaginal and cesarean section), gender (male and female) and birth weight (2500-3000 g, 3001-3500 g, 3501 and above) variables were used for block randomization. Blocks were repeated three times in each group and 36 participants were assigned to each. A randomization list with 2 X 2 X 3 X 3 blocks was developed using an online randomization tool. In the study, the group to which the first participant was assigned was determined by a sealed envelope method. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Using the block randomization technique, participants were divided into three groups. A web-based randomization list generation tool was used to assign participants to groups. Control and intervention groups were coded as A, B and C using the sealed envelope method. Randomization information was withheld from the researcher involved in data collection until data was collected. The researcher determines which group each baby is in. The researcher found out during the painful procedure. (investigator blinding).
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Within the scope of the research, parents knew which group the baby was in. However, due to the nature of the sample group, the babies were blind.
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To avoid statistical bias, study groups were coded as A, B and C; statistical blinding was performed (statistician blinding). whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 108 type: ACTUAL name: ShotBlocker name: Mechanical vibration measure: Procedural pain score- Neonatal Infant Pain Scale (NIPS) measure: Crying time measure: Procedure time sex: ALL minimumAge: 38 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: Istanbul Medeniyet University city: Istanbul state: Kadıköy zip: 34720 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06380543 id: BILINCE briefTitle: ERCP Biliary Cannulation Success Using ESGE Algorithm acronym: BILINCE overallStatus: RECRUITING date: 2019-12-12 date: 2024-10-31 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: IRCCS San Raffaele class: OTHER name: Societa Italiana di Endoscopia Digestiva briefSummary: Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm.
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The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis. conditions: Biliary Tract Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: Success of ERCP biliary cannulation rate measure: ERCP complication rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS OSpedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Alberto Mariani, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06380530 id: SIMULA briefTitle: Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities acronym: SIMULA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-05 date: 2024-04-24 date: 2024-04-24 name: Istituto Ortopedico Rizzoli class: OTHER name: Ospedale Pediatrico Bambino Gesù name: Istituto Giannina Gaslini name: Galeazzi Orthopedic Institute name: Istituto Nazionale Tumori Regina Elena name: Policlinico San Matteo name: Istituto Clinico Humanitas briefSummary: Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice.
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One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes.
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The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions.
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The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through "in-silico" medicine (ISM) principles.
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At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI.
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The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures. conditions: Musculoskeletal Deformity conditions: Musculoskeletal Abnormalities conditions: Musculoskeletal Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Deformity correction measure: Achieved skeletal corrections measure: Achieved skeletal corrections measure: Operating room times measure: Fluoroscopy times measure: Blood loss measure: Intra- and peri-operative complications measure: Suitability of PSIs measure: Suitability of GSIs measure: Suitability of bone graft measure: Clinical-functional outcome measure: Clinical-functional outcome measure: Cost analysis sex: ALL minimumAge: 2 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Istituto Ortopedico Rizzoli city: Bologna state: BO zip: 40136 country: Italy name: Grazia Chiara Menozzi role: CONTACT phone: 0516266 phoneExt: 484 email: graziachiara.menozzi@ior.it lat: 44.49381 lon: 11.33875 facility: Istituto Clinico Humanitas city: Rozzano state: MI country: Italy lat: 45.38193 lon: 9.1559 facility: Istituto Giannina Gaslini city: Genova country: Italy name: Giorgio Marrè Brunenghi, MD role: CONTACT email: giorgiomarre@gaslini.org lat: 44.40478 lon: 8.94438 facility: Galeazzi Orthopedic Institute city: Milano country: Italy name: Fabio Verdoni, MD role: CONTACT email: fabio.verdoni@grupposandonato.it lat: 45.46427 lon: 9.18951 facility: Policlinico San Matteo city: Pavia country: Italy name: Gianluigi Pasta, MD role: CONTACT lat: 45.19205 lon: 9.15917 facility: Istituto Nazionale Tumori Regina Elena city: Roma country: Italy name: Roberto Biagini, MD role: CONTACT email: roberto.biagini@ifo.it lat: 41.89193 lon: 12.51133 facility: Ospedale Pediatrico Bambino Gesù city: Roma country: Italy name: Pier Francesco Costici, MD role: CONTACT email: pierfrancesco.costici@opbg.net lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06380517 id: ATS23 id: 2UG1EY011751 type: NIH link: https://reporter.nih.gov/quickSearch/2UG1EY011751 briefTitle: Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age acronym: ATS23 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-01 date: 2027-05-01 date: 2024-04-24 date: 2024-04-24 name: Jaeb Center for Health Research class: OTHER name: National Eye Institute (NEI) name: Pediatric Eye Disease Investigator Group briefSummary: In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks. conditions: Amblyopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 238 type: ESTIMATED name: Luminopia name: Eye Patch measure: Change in amblyopic eye logMAR distance VA between randomization and 26 weeks sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-01 uploadDate: 2024-04-18T09:58 filename: Prot_000.pdf size: 715474 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-04-17 uploadDate: 2024-04-18T15:02 filename: SAP_001.pdf size: 4154847 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-17 uploadDate: 2024-04-18T09:59 filename: ICF_002.pdf size: 248300 hasResults: False
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<|newrecord|> nctId: NCT06380504 id: RSWITCH-Ethiopia briefTitle: Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia acronym: R-SWITCH overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2026-06-30 date: 2027-06-30 date: 2024-04-24 date: 2024-04-24 name: International Food Policy Research Institute class: OTHER name: Ethiopian Public Health Association name: UNICEF briefSummary: The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness. conditions: Acute Malnutrition, Severe conditions: Malnutrition, Child conditions: Wasting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomized controlled trial. Unit/cluster of assignment is health post catchment area. Parallel Assignment: baseline-endline design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Evaluator teams will be blinded from intervention allocation count: 1080 type: ESTIMATED name: R-SWITCH integrated intervention package measure: Period prevalence of SAM OTP treatment coverage in children 6-59 months of age measure: Point prevalence of SAM OTP treatment coverage in children 6-59 months of age measure: Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age measure: Screening coverage of SAM measure: Screening coverage of severe underweight measure: Platform specific screening coverage of SAM measure: Growth Monitoring Promotion (GMP) consultation attendance measure: AFD group meeting attendance measure: AFD home visit coverage measure: Prevalence of SAM measure: Prevalence of wasting measure: Prevalence of stunting measure: Prevalence of underweight and severe underweight measure: Mean height-for-age Z-score (HAZ) measure: Mean weight-for-height Z-score (WHZ) measure: Mean weight-for-age Z-score (WAZ) measure: Mean mid-upper arm circumference (MUAC) measure: Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting measure: Vaccination coverage measure: Introduction of (semi) solid and soft complementary foods measure: Minimum dietary diversity in infants and young children (6-23 mo) measure: Nr of food groups consumed by infants and young children (6-59 mo) measure: Minimum meal frequency in infants and young children measure: Minimum acceptable diet in infants and young children measure: Continuous breastfeeding 12-23 months measure: Egg and/or flesh food consumption measure: Sweet beverage consumption measure: Zero vegetable or fruit consumption consumption measure: Minimum milk feeding frequency for non-breastfed children measure: Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP) measure: SAM OTP adherence measure: Weight gain rate during SAM OTP measure: SAM OTP outcomes (drop-out, death, transfer, non-response rates) measure: SAM OTP duration sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06380491 id: REF.2338 id: UNAM-PAPIIT 32-IN216919 type: OTHER domain: Universidad Nacional Autonoma de Mexico (UNAM) briefTitle: Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA) acronym: MEBP-OSA overallStatus: RECRUITING date: 2023-06-22 date: 2024-11-22 date: 2025-01-22 date: 2024-04-24 date: 2024-04-25 name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran class: OTHER name: Universidad Nacional Autonoma de Mexico name: Emory University briefSummary: The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.
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The main question it aims to answer is:
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Does melatonin maintain sleep during night and recover the dipping blood pressure pattern? conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with a non-dipper pattern in blood pressure will randomly enter one of two options: 1) usual medical treatment; 2) treatment with melatonin plus usual care. primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Melatonin 3 MG Oral Tablet measure: Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) status: RECRUITING city: Mexico City country: Mexico lat: 19.42847 lon: -99.12766 hasResults: False
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<|newrecord|> nctId: NCT06380478 id: CPRO-000012 briefTitle: Safety and Efficacy of the Bi-Aspheric Monofocal IOL overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-05 date: 2024-12-25 date: 2024-04-24 date: 2024-04-24 name: ICARES Medicus, Inc. class: INDUSTRY name: AST Products, Inc. briefSummary: This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination. conditions: Cataract studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: aspicio Monofocal IOL measure: CDVA measure: Defocus curve measure: UDVA measure: UIVA measure: CIVA measure: IOL glistening measure: PCO measure: Satisfaction questionnaire measure: AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University Hospital status: RECRUITING city: Taoyuan state: Guishan District zip: 333 country: Taiwan name: Lisa Chen role: CONTACT email: lisa.phchen@gmail.com name: Yih-Shiou Hwang, MD role: PRINCIPAL_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06380465 id: 23-11-1838 briefTitle: The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-30 date: 2025-04-30 date: 2024-04-24 date: 2024-04-24 name: Indonesia University class: OTHER name: Fakultas Kedokteran Universitas Indonesia name: Universitas Padjadjaran name: Institut Pertanian Bogor name: School of Science and technology, Kwansei Gakuin University briefSummary: Cerebral small vessel disease (CSVD) is a major cause of disability, cognitive impairment, and functional loss in the elderly. CSVD occurs due to damage to arterioles, capillaries, and venules in the brain parenchyma, and can cause clinical and neuroimaging symptoms. CSVD also accounts for up to 25% of all ischemic stroke cases, and making it the second leading cause of death in the world after ischemic heart disease.
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Purple sweet potatoes, scientifically known as Ipomoea batatas (L.) Lam., contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant, anti-inflammatory, and potentially phytoestrogenic activity. These anthocyanins have been linked to a reduced risk of obesity, diabetes, and high cholesterol. They also show potential in improving endothelial function, thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases. Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways, gene expression, and protein function at the molecular level. In addition to their ability to enhance vascular flow, anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body. These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo.
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The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler, Nitric Oxide, L-Arginine and Adiponectin levels in blood, Cognitive Test and Gait. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participant who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment followed by randomization into 2 groups/arms consisting of 2 treatments (1 group getting the water extract pf purple sweet potato) and 1 control group that got placebo. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: The water extract of "Biang" variety purple sweet potato measure: Breath Holding Index measure: Nitric Oxide measure: L-Arginine measure: Adiponectin measure: Cognitive measure: Gait sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-02 uploadDate: 2024-04-18T03:49 filename: ICF_000.pdf size: 332637 hasResults: False
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<|newrecord|> nctId: NCT06380452 id: SKABUP id: 2023-507925-41-00 type: OTHER domain: EU-Trial-Nr. (EMA) briefTitle: Therapy for Scabies With Two Differently Concentrated Permethrin Creams acronym: SKABUP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-07 date: 2028-12 date: 2024-04-23 date: 2024-04-23 name: Infectopharm Arzneimittel GmbH class: INDUSTRY name: Winicker Norimed GmbH briefSummary: The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.
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The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%. conditions: Scabies studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: 5% Permethrin Creme name: 10% Permethrin Creme measure: clinical efficacy (yes/no) measure: effectiveness at Visit 1 measure: frequency of therapy success measure: itching measure: patients with evidence of mites measure: patients with use of antiscabiosa not compliant with the protocol measure: patients with new scabies efflorescences measure: patients with "additional confirmed" treatment failure measure: AEs, SAEs, ADRs, SUAWs sex: ALL minimumAge: 2 Years maximumAge: 85 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06380439 id: 23-10-1763 briefTitle: The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain overallStatus: RECRUITING date: 2024-04-23 date: 2024-07 date: 2024-07 date: 2024-04-23 date: 2024-04-29 name: Indonesia University class: OTHER briefSummary: Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.
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Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture conditions: Pain, Postoperative conditions: Hip Osteoarthritis conditions: Hip Fractures conditions: Hip Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: wrist ankle acupuncture measure: Visual Analog Scale measure: recovery rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cipto Mangunkusumo Hospital status: RECRUITING city: Jakarta Pusat state: Jakarta zip: 10430 country: Indonesia name: Cipto Mangunkusumo Hospital role: CONTACT phone: 1 500 135 lat: -6.1818 lon: 106.8223 facility: Fatmawati Hospital status: RECRUITING city: Jakarta zip: 12430 country: Indonesia name: Fatmawati Hospital role: CONTACT phone: 0217501524 lat: -6.21462 lon: 106.84513 facility: Persahabatan Hospital status: RECRUITING city: Jakarta zip: 13230 country: Indonesia name: Persahabatan Hospital role: CONTACT phone: (021) 4891708 lat: -6.21462 lon: 106.84513 hasResults: False
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<|newrecord|> nctId: NCT06380426 id: APHP230441 id: IDRCB : 2023-A02003-42 type: OTHER domain: ANSM briefTitle: Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema) acronym: ObGeSema overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-04-30 date: 2027-11-30 date: 2024-04-23 date: 2024-04-23 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Rare genetic forms of obesity, so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways.
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More than 60 genes encoding for proteins located in the hypothalamic leptin/melanocortin pathway have been described in the French National Protocol for Diagnostic and Care (PNDS).
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The natural history of monogenic obesity is characterized by an early onset in childhood, with a major increase in weight in adolescence and young adulthood. The worsening of obesity exposes these patients to severe complications.
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Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers. Clinical management is complex and requires comprehensive, specialized and multidisciplinary management. But the usual lifestyle approaches have so far shown disappointing results, similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity, justifying new approaches.
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In this context, evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications.
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GLP-1 (glucagon-like peptide 1) based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications. This is the case for Semaglutide 2.4mg/week (WEGOVY®), developed by Novo Nordisk. However, there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity.
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The hypothesis in this study is that treatment with Semaglutide 2.4mg/week (WEGOVY®) could be as effective in monogenic obesities as in common obesity. conditions: Monogenic Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 175 type: ESTIMATED measure: Change in weight and Body Mass Index (BMI) measure: Change in weight and Body Mass Index (BMI) measure: Reduction of body weight equal to or above 5% measure: Change in Hunger score measure: Change in eating behaviour measured by Food Craving questionnaire measure: Change in eating behaviour measured by the Binge Eating Scale (BES) measure: Change in eating behaviour measured by the Dutch Eating Behaviour Questionnaire (DEBQ) measure: Change in eating behaviour measured by the Dykens questionnaire measure: Change in eating behaviour measured by the Child Eating Behaviour Questionnaire (CEBQ) measure: Change in the International physical activity questionnaire (IPAQ - short form) measure: Change in Digestive disorders (GIQLI ) measure: Change in sleep disorder (MCTQ score) measure: Change in score of quality of life scores (patient and parents) measure: Change in anxiety and depression score measure: Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre de référence Syndrome de Prader-Willi et autres obésités avec troubles du comportement alimentaire (PRADORT). Service de Nutrition, GH Pitié-Salpêtrière, APHP city: Paris zip: 75013 country: France name: Emilie GUILLON role: CONTACT email: emilie.guillon-ext@aphp.fr name: Sarra POCHON role: CONTACT phone: +33(1)42167574 email: sarra.pochon@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06380413 id: 78972024.7.0000.5313 briefTitle: Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-12-31 date: 2025-07-31 date: 2024-04-23 date: 2024-04-23 name: Federal University of Pelotas class: OTHER briefSummary: Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers.
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Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.
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Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty healthy and physically inactive subjects, 60 to 75 years of age, are recruited. Participants are randomly allocated on a 1:1 ratio to a 12-week intervention of Tai Chi Chuan plus walking program twice a week, or an active-control group of walking twice a week. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Tai Chi Chuan Plus Walking name: Walking measure: Maximal dynamic strength measure: Functional test - 30-s Chair-stand test measure: Dynamic muscular endurance measure: Isometric handgrip strength measure: Isometric back-leg-chest strength measure: Functional tests - arm curl measure: Functional tests - 8-ft Up-and-Go measure: Functional tests - Chair Sit-and-Reach measure: Functional tests - Back Scratch measure: Funcional tests - 6-min Walk measure: Static balance - 30-second single-leg stance test measure: Quadriceps muscle thickness measure: Quadriceps muscle quality measure: Objective cognitive function - Trail Making Test (TMT) measure: Objective cognitive function - Controlled Oral Word Association Test (COWAT) measure: Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref) measure: Sleep quality - Pittsburgh Sleep Quality Index measure: Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS) measure: Body mass measure: Height measure: Waist and hip circumferences measure: Monitoring the intensity of training sessions - Borg Category-Ratio 10 (CR-10) measure: Follow-up questionnaire measure: Adherence assessments measure: Health Questionnaire measure: Level of physical activity - International Physical Activity Questionnaire (IPAQ) - extended version measure: Cognitive screening - Mini-mental state examination (MMSE) sex: ALL minimumAge: 60 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Escola Superior de Educação Física e FIsioterapia city: Pelotas state: Rio Grande Do Sul zip: 96055630 country: Brazil name: Cristine L Alberton, PhD role: CONTACT lat: -31.77194 lon: -52.3425 hasResults: False
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<|newrecord|> nctId: NCT06380400 id: 0000-0001-5786-4385 briefTitle: The Effect of Foot Bath on Birth Pain and Birth Comfort overallStatus: RECRUITING date: 2024-02-01 date: 2024-07-30 date: 2024-07-30 date: 2024-04-23 date: 2024-04-23 name: Selcuk University class: OTHER briefSummary: Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women. conditions: Parturition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 196 type: ESTIMATED name: Foot bath measure: Visuell analog scale score of the pregnant woman measure: Birth comfort scale score of the pregnant woman sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Habibe Bay Ozcalik status: RECRUITING city: Konya zip: 42250 country: Turkey name: Habibe Bay Ozcalik role: CONTACT phone: 05424469343 email: habiberk@hotmail.com lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06380387 id: H-21046543 briefTitle: Whole Body Metabolism in Children Before and After Treatment of CNS Tumor overallStatus: RECRUITING date: 2023-03-23 date: 2025-12 date: 2026-12 date: 2024-04-23 date: 2024-04-23 name: Rigshospitalet, Denmark class: OTHER briefSummary: At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome.
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By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.
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The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis. conditions: CNS Tumor, Childhood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Meal measure: Protein breakdown measure: Protein synthesis measure: Phenylalanine concentration measure: Phe oxidation to TYR measure: Whole-body protein synthesis measure: Whole-body protein degradation measure: Netto protein balance measure: Glucose Rate of appearance measure: Total glucose Rate of appearance measure: Total glucose Rate of disappearance measure: Endogenous glucose measure: Oral phenylalanine Rate of appearance measure: Phenylalanine oxidation measure: Rate of Appearance of Palmitate in Plasma measure: Rate of Disappearance of Palmitate measure: Concentration of ketones measure: Glucose measure: Quality of Skeletal Muscle measure: Protein synthesis rate measure: Pain score measure: Life quality score measure: Muscle biopsy measure: Incretins measure: Glucagon measure: Liver parameters ALT, AST, GGT measure: Bilirubin measure: International normalized ratio (INR) measure: LDH measure: Insulin measure: catecholamines measure: Blood pressure measure: Waist- and hip circumference measure: Lipids measure: Concentration of Plasma Amino Acids measure: Concentration of Plasma Glucose measure: Concentration of Plasma Palmitate measure: Concentration of Plasma Free Fatty Acids measure: Level of HbA1c sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet status: RECRUITING city: Copenhagen state: Copenhagen Ø zip: 2100 country: Denmark name: Mette Cathrine Ørngreen, MD, DMSc role: CONTACT phone: 35455935 email: mette.cathrine.oerngreen.01@regionh.dk name: Mette Cathrine Ørngreen, MD, DMSc role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06380374 id: 2024\01 briefTitle: Gamification in Disaster Nursing Education overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-07-01 date: 2024-07-22 date: 2024-04-23 date: 2024-04-23 name: Selcuk University class: OTHER briefSummary: This research will be conducted as a randomized controlled study with a parallel design to evaluate the effectiveness of the disaster nursing training program prepared with a gamification strategy based on multiple intelligence theory for final-year public health nursing students. Research hypothesis "H1a: The disaster nursing knowledge level of the students participating in the program, which is prepared with a Gamification Strategy Based on Multiple Intelligence Theory, differs from the control group. H1b: The perception of volunteering towards disaster nursing differs for the students included in the Program Prepared with Gamification Strategy Based on Multiple Intelligence Theory compared to the control group. H1c: The self-efficacy level of students involved in the Program Prepared with Gamification Strategy Based on Multiple Intelligences Theory regarding disaster nursing differs from the control group." conditions: Gamification conditions: Nursing Students conditions: Multiple Intelligence Theory conditions: Disaster Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 72 type: ESTIMATED name: Gamification in Disaster Nursing Education measure: Level of knowledge related to disaster nursing services measure: Volunteer intention to become a disaster nurse measure: Perception of self-efficacy related to disaster nursing sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Selcuk University Faculty of Nursing city: Konya state: Selcuklu zip: 42000 country: Turkey name: Sema Yilmaz Dean, MD role: CONTACT phone: +903322230763 email: hemsirelikfakultesi@selcuk.edu.tr lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06380361 id: SEN-ONCO-1 briefTitle: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology acronym: INSPECT overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-03-31 date: 2025-04-01 date: 2024-04-23 date: 2024-04-23 name: Sensome class: INDUSTRY briefSummary: The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial. primaryPurpose: OTHER masking: NONE maskingDescription: No masking count: 30 type: ESTIMATED name: BioSpy System measure: The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy. measure: The ability of BioSpy Sysem to differentiate the lesion from healthy tissue measure: The ability of BioSpy Sysem to differentiate various lesion types sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06380348 id: JMT101-012 briefTitle: JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2027-03-26 date: 2028-03-26 date: 2024-04-23 date: 2024-04-23 name: Shanghai JMT-Bio Inc. class: INDUSTRY briefSummary: This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.
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Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1). conditions: Local Advanced or Metastatic NSCLC studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 398 type: ESTIMATED name: JMT101 Injection name: Osimertinib tablet name: Cisplatin injection name: Pemetrexed injection measure: Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1 measure: Overall Survival (OS) measure: Overall Response Rate (ORR) by IRC per RECIST 1.1 measure: Duration of Response (DoR) by IRC per RECIST 1.1 measure: PFS by investigator per RECIST 1.1 measure: ORR by investigator per RECIST 1.1 measure: DoR by investigator per RECIST 1.1 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06380335 id: RTX001-01S briefTitle: Study in Patients With Decompensated Liver Cirrhosis acronym: OPAL overallStatus: RECRUITING date: 2023-10-10 date: 2024-12-31 date: 2026-11-03 date: 2024-04-23 date: 2024-04-23 name: Resolution Therapeutics Limited class: NETWORK briefSummary: OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient. conditions: Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 240 type: ESTIMATED measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Explore clinical and laboratory parameters. measure: Evaluate the effect of disease progression on biomarkers of inflammatory activity sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bristol Royal Infirmary status: RECRUITING city: Bristol zip: BS2 8HW country: United Kingdom lat: 51.45523 lon: -2.59665 facility: Royal Infirmary Edinburgh status: RECRUITING city: Edinburgh zip: EH16 4SA country: United Kingdom lat: 55.95206 lon: -3.19648 facility: Royal Liverpool Hospital status: RECRUITING city: Liverpool zip: L7 8XP country: United Kingdom lat: 53.41058 lon: -2.97794 facility: Royal Free Hospital status: RECRUITING city: London zip: NW3 2QG country: United Kingdom lat: 51.50853 lon: -0.12574 facility: King's College Hospital status: RECRUITING city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 facility: St George's Hospital status: RECRUITING city: London zip: SW17 0QT country: United Kingdom lat: 51.50853 lon: -0.12574 facility: St Mary's Hospital status: RECRUITING city: London zip: W2 1NY country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Nottingham University Hospital status: RECRUITING city: Nottingham zip: NG5 1PB country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Sunderland Royal Hospital status: RECRUITING city: Sunderland zip: SR4 7TP country: United Kingdom lat: 54.90465 lon: -1.38222 hasResults: False
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<|newrecord|> nctId: NCT06380322 id: PBRC 2023-034 briefTitle: Military Health and Nutrition Examination Study acronym: MHANES overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-23 date: 2024-04-23 name: Pennington Biomedical Research Center class: OTHER name: U.S. Army Medical Research and Development Command briefSummary: The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population. conditions: Hypertension conditions: Type 2 Diabetes conditions: Dyslipidemias conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Dietary intake measure: Dietary quality measure: Depression measure: Anxiety measure: Resilience measure: Posttraumatic stress disorder measure: Self-efficacy measure: Mood measure: Physical activity measure: Physical activity measure: Physical performance measure: Physical injuries measure: Sleep duration and quality measure: Sleep duration and quality measure: Eating behavior (Satiety) measure: Eating behavior (Fast Eating Rate) measure: Eating behavior (Slow Eating Rate) measure: Blood pressure measure: Anthropometric and body composition measures measure: Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation measure: Albumin, iodine, and other biomarkers of health measure: Gut microbiome composition measure: Prescription and over-the-counter medication and supplement use measure: Resting metabolic rate (RMR) measure: Heart rate variability (HRV) measure: Genomics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pennington Biomedical Research Center city: Baton Rouge state: Louisiana zip: 70808 country: United States name: Claire E Berryman, PhD, RD role: CONTACT email: claire.berryman@pbrc.edu lat: 30.45075 lon: -91.15455 hasResults: False
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<|newrecord|> nctId: NCT06380309 id: LY001-I001 briefTitle: A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE overallStatus: RECRUITING date: 2024-05-06 date: 2025-11-30 date: 2027-10-30 date: 2024-04-23 date: 2024-04-23 name: Peking University class: OTHER briefSummary: Subjects were inoperable Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focusing on MSS type colorectal cancer) who had failed standard systemic therapy.
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In the first stage, each subject was given three doses on day 1, day 3 and day 5, and was divided into 4 dose groups, including 1 subject in the first dose group and 3-6 subjects in each of the last three dose groups. The second stage was the dose extension stage, with 2 dose groups, at least 10 subjects were enrolled in the selected group, and the administration method was the same as that of the first stage. There were about 20-60 cases in the two stages. conditions: Advanced Malignant Solid Tumor of Digestive System studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: IDOV-SAFE measure: Occurrence of dose-limiting toxicity (DLT) measure: Incidence of adverse events (AE) measure: The level of (non-essential) viral DNA in tumor tissue measure: Tumor markers measure: Anti-vaccinia virus neutralizing antibody test(VV-Nab) measure: Levels of viral DNA in blood measure: Levels of viral DNA in saliva measure: T cell subsets measure: Cytokines measure: ORR measure: DCR measure: DOR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing country: China name: Lin Shen role: CONTACT phone: +86 10 8819 6561 email: doctorshenlin@sina.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06380296 id: 2024-10240 briefTitle: Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-03 date: 2024-04-23 date: 2024-04-23 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications. conditions: Pulp Disease, Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Primary molars pulpotomies with NeoMTA name: Primary molar pulpotomies with NeoPUTTY measure: Success rate of a primary molar pulpotomy measure: Radiographic success of a primary molar pulpotomy sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06380283 id: 2024-10221 briefTitle: The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety overallStatus: RECRUITING date: 2024-03-21 date: 2025-07 date: 2026-01 date: 2024-04-23 date: 2024-04-23 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.
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This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment. conditions: Children, Only conditions: Dental Anxiety conditions: Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 128 type: ESTIMATED name: Virtual reality headset measure: Children's pain perception during dental treatment measure: Children's fear during dental treatment measure: Children's acceptability of virtual reality intervention during dental care measure: Oral health care provider's acceptability of virtual reality during dental care sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre status: RECRUITING city: Montreal state: Quebec country: Canada name: Beatriz Ferraz dos Santos, DDS, MSc role: CONTACT phone: +1 (514) 412-4400 phoneExt: 23357 email: beatriz.ferrazdossantos@muhc.mcgill.ca lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06380270 id: LUMHS/B12/Temp/14.04.2024 briefTitle: Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-31 date: 2024-12-31 date: 2024-04-23 date: 2024-04-23 name: Liaquat University of Medical & Health Sciences class: OTHER briefSummary: Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene. conditions: Strep Throat studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Oral probiotic Streptococcus salivarius K12 sachet measure: Effect on oral health physical condition measure: Effect on other physical features measure: Effect on vital signs measure: Effect on vital signs measure: Effect on vital signs measure: Effect on vital signs measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood electrolytes balance measure: Effect on hematology measure: Incidence of inflammation measure: Incidence of gastrointestinal side effects measure: Incidence of Adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Liaquat University of Medical and Health Sciences city: Jāmshoro zip: 76090 country: Pakistan name: Dr. Amjad Khan, DPhil role: CONTACT phone: 03000506955 email: amjadkhan@lumhs.edu.pk lat: 25.43773 lon: 68.28522 hasResults: False
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<|newrecord|> nctId: NCT06380257 id: ANBA briefTitle: Anorexia Nervosa and Brain in Adolescence overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2030-08 date: 2030-12 date: 2024-04-23 date: 2024-04-23 name: Kuopio University Hospital class: OTHER briefSummary: Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Observational study methods measure: Neuroimaging measure: Neuroimaging measure: Psychiatric evaluation measure: Body composition measurement measure: Laboratory tests sex: ALL minimumAge: 16 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06380244 id: 1072.6120.136.2023 briefTitle: Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery overallStatus: RECRUITING date: 2024-03-10 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Jagiellonian University class: OTHER briefSummary: Due to the increasing number of reports of cancer progression in people undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially in cancer patients. The opioid-free protocol is also used in postoperative analgesia. It is estimated that up to 75% of surgical patients experience chronic postoperative pain, which has a particularly negative impact on the quality of life.
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The investigators would like to compare pain during the first 48 postoperative hours of patients undergoing abdominal surgery who would be anesthetized with opioids and without opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after operations). A secondary objective will be to measure total oxycodone consumption in the postoperative period in both groups. Other secondary objectives: assessment of postoperative nausea and vomiting (PONV). conditions: Analgesics, Opioid conditions: Anesthesia, Endotracheal conditions: Anesthesia, General studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: anesthesia without opioids measure: Pain level measure: Total long acting opioid consumption in oxycodone equivalents sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University status: RECRUITING city: Kraków state: Malopolskie zip: 31501 country: Poland name: Tomasz Skladzien, phd md role: CONTACT phone: 506602250 phoneExt: 48 email: t.skladzien@interia.pl lat: 50.06143 lon: 19.93658 hasResults: False
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<|newrecord|> nctId: NCT06380231 id: IRU-YAZILE-001 briefTitle: Skin-to-skin Contact Between Premature Infant and Mother overallStatus: COMPLETED date: 2019-11-01 date: 2019-12-01 date: 2020-12-01 date: 2024-04-23 date: 2024-04-23 name: Istanbul Rumeli University class: OTHER briefSummary: Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days. conditions: Kangaroo-mother Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ACTUAL name: kangaroo mother care (KMC) measure: power analysis measure: The effect of kangaroo mother care sex: ALL minimumAge: 24 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: TC Istanbul Rumeli University city: Istanbul state: Haliç zip: 34445 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06380218 id: 2023-A00249-36 briefTitle: Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE) acronym: SAFE overallStatus: RECRUITING date: 2023-07-11 date: 2025-03-01 date: 2025-08-01 date: 2024-04-23 date: 2024-04-23 name: Institut Pasteur de Lille class: OTHER briefSummary: The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Nutrional and physical activity program measure: Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program measure: Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Satisfaction of Primevere products sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NutrInvest - Institut Pasteur de Lille status: RECRUITING city: Lille state: Nord zip: 59019 country: France name: Coralie Berthier, PhD role: CONTACT phone: 0320877333 phoneExt: 0033 email: coralie.berthier@pasteur-lille.fr name: Bérengère Legendre role: CONTACT phone: 0320877346 phoneExt: 0033 email: berengere.legendre@pasteur-lille.fr name: Jean-Michel Lecerf, MD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 hasResults: False
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<|newrecord|> nctId: NCT06380205 id: INCB54707-111 briefTitle: A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females overallStatus: RECRUITING date: 2024-05-07 date: 2024-06-07 date: 2024-06-07 date: 2024-04-23 date: 2024-04-24 name: Incyte Corporation class: INDUSTRY briefSummary: The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Povorcitinib name: Levonorgestrel/Ethinyl estradiol measure: Levonorgestrel (LNG) concentration in plasma measure: Ethinyl estradiol (EE) concentration in plasma measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Additional LNG/EE PK parameters in plasma measure: Povorcitinib concentration in plasma sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Celerion Clinical Research Unit status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 hasResults: False
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<|newrecord|> nctId: NCT06380192 id: HJ22-DEE-RETRO briefTitle: Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data acronym: DEE-RETRO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-23 date: 2024-04-23 name: Imagine Institute class: OTHER briefSummary: Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.
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The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent. conditions: Developmental and Epileptic Encephalopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: Identification of early diagnostic of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies measure: Identification of predictive biomarkers of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies measure: Identification of patient subgroups presenting the identified biomarkers measure: Assessment of patients' quality of life measure: Assessment of age-related adaptive behavior measure: Assessment of behavioral disorders measure: Assessment of autism spectrum disorders sex: ALL maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06380179 id: USUHS.2023-126 briefTitle: Photomedicine Project 14: PBMT for Performance Enhancement in SOF acronym: SOF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-08 date: 2026-01 date: 2024-04-23 date: 2024-04-23 name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) class: UNKNOWN name: Uniformed Services University (USU) of the Health Sciences name: 1st Special Forces Group (Airborne), United States Army name: United States Army Special Operations Command name: The Geneva Foundation briefSummary: Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.
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The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.
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The specific aims of this study are to:
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1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
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2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
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3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population. conditions: Photobiomodulation Therapy conditions: Photomedicine conditions: Low-Level Laser Therapy conditions: Performance Enhancement conditions: Quadriceps conditions: Special Operations Readiness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Approach: Special Operators attending THOR3 coach led training will be invited to participate. After consenting and screening for inclusion/exclusion, participants will be randomized into two groups: 1) sham PBMT and 2) PBMT (applied to quadriceps up to 3 times per week, post coach-led training, taking approximately 5-20 minutes each time). Baseline measurements will include body fat percentage, height, weight and military/demographic information. Metrics for counter movement jump and self-reported delayed muscle onset soreness will be taken at baseline and weekly for three weeks. Isokinetic dynamometer measurements for the lower extremities, and self-reported exertion and fatigue will be taken at baseline and at the 3-week follow-up (post three-week intervention). Oura rings will be assigned at baseline and will continuously measure sleep, heart rate, Sp02, and activity. Activity and pain will also be self-reported throughout the duration of the study. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: In order to facilitate participant blinding to their randomized study group, all participants (regardless of their assigned study group) will be asked to wear blackout glasses and headphones during their treatment. whoMasked: PARTICIPANT count: 116 type: ESTIMATED name: THOR3 training + Photobiomodulation Therapy (PBMT) name: THOR3 training + sham PBMT measure: Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse measure: Countermovement Jump (CMJ) initial baseline: peak force production measure: Countermovement Jump (CMJ) initial baseline: rate of force production measure: Countermovement Jump (CMJ) initial baseline: unilateral performance comparison measure: Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 1 follow-up: peak force production measure: Countermovement Jump (CMJ) week 1 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison measure: Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 2 follow-up: peak force production measure: Countermovement Jump (CMJ) week 2 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison measure: Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 3 follow-up: peak force production measure: Countermovement Jump (CMJ) week 3 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison measure: Isometric Quadriceps Strength Testing initial baseline measure: Isometric Hamstrings Strength Testing initial baseline measure: Isokinetic Quadriceps Strength Testing initial baseline measure: Isokinetic Hamstrings Strength Testing initial baseline measure: Isometric Quadriceps Strength Testing 3-week follow-up measure: Isometric Hamstrings Strength Testing 3-week follow-up measure: Isokinetic Quadriceps Strength Testing 3-week follow-up measure: Isokinetic Hamstrings Strength Testing 3-week follow-up measure: Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline measure: Defense and Veteran's Pain Rating Scale (DVPRS) daily reports measure: Visual Analog Scale (VAS) initial baseline measure: Visual Analog Scale (VAS) week 1 follow-up measure: Visual Analog Scale (VAS) week 2 follow-up measure: Visual Analog Scale (VAS) week 3 follow-up measure: Borg Modified Rating of Perceived Exertion (RPE) initial baseline measure: Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up measure: Elloumi fatigue scale initial baseline measure: Elloumi fatigue scale 3-week follow-up measure: Quick Physical Activity Rating scale (QPAR) measure: Oura Ring Sleep Data: sleep metrics - sleep duration measure: Oura Ring Sleep Data: sleep metrics - time in bed measure: Oura Ring Sleep Data: sleep metrics - light sleep length measure: Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length measure: Oura Ring Sleep Data: sleep metrics - deep sleep length measure: Oura Ring Sleep Data: sleep metrics - sleep latency measure: Oura Ring Sleep Data: sleep metrics - sleep efficiency score measure: Oura Ring Sleep Data: sleep metrics - sleep quality score measure: Oura Ring Sleep Data: Readiness trends - body temperature changes measure: Oura Ring Sleep Data: Readiness trends - heart rate changes measure: Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV) measure: Oura Ring Sleep Data: Readiness trends - respiration rate measure: Oura Ring Sleep Data: Readiness trends - blood oxygen saturation measure: Oura Ring Sleep Data: Readiness trends - sleep regularity measure: Oura Ring Sleep Data: Readiness trends - readiness score measure: Body Measurements: Height (cm) measure: Body Measurements: Weight (kg/lbs) measure: Body Measurements: Body composition (% body fat) measure: Body Measurements: C1 - proximal thigh circumference (cm) measure: Body Measurements: C2 - distal thigh circumference (cm) measure: Body Measurements: L1 - length of thigh (cm) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-20 uploadDate: 2024-03-29T15:19 filename: Prot_SAP_000.pdf size: 435470 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-19 uploadDate: 2024-03-29T15:20 filename: ICF_001.pdf size: 165533 hasResults: False
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<|newrecord|> nctId: NCT06380166 id: A23-356 briefTitle: Hepatitis C Lab Testing Comparison Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-23 date: 2024-04-23 name: HealthPartners Institute class: OTHER briefSummary: Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories. conditions: Hepatitis C studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ESTIMATED name: Hepatitis C core antigen measure: Serum on the clot stability measure: Serum off the clot stability measure: Plasma on the gel stability measure: Plasma off the gel stability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06380153 id: HM005PS1S07 briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-23 date: 2024-04-23 name: Ganzhou Hemay Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment. conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Hemay005 measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t） measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) measure: Relevant pharmacokinetic parameters，half-life (T1/2) measure: Relevant pharmacokinetic parameters，clearance (CL/F) measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F) measure: Relevant pharmacokinetic parameters ，Renal clearance rate（CLr） sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06380140 id: cami3zgmxf3vqyc30ndmdqh6gfjid1 briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study overallStatus: RECRUITING date: 2023-05-03 date: 2024-03-03 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: University of Roma La Sapienza class: OTHER briefSummary: Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain.
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The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:
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* predict the severity of pain;
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* select most suitable pain relief therapy for the patient. conditions: Post Operative Pain conditions: Inguinal Hernia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 71 type: ESTIMATED name: Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Augusto Lauro status: RECRUITING city: Roma zip: 000186 country: Italy name: Augusto Lauro role: CONTACT phone: +39 388 8663 879 email: augusto.lauro@uniroma1.it lat: 41.89193 lon: 12.51133 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-03 uploadDate: 2024-04-18T14:17 filename: Prot_SAP_000.pdf size: 274127 hasResults: False
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<|newrecord|> nctId: NCT06380127 id: CEFADE012021 briefTitle: Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes overallStatus: COMPLETED date: 2021-10-01 date: 2023-09-30 date: 2023-12-15 date: 2024-04-23 date: 2024-04-24 name: Universidade do Porto class: OTHER briefSummary: The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention. conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The trial will follow a 28-week crossover design: 12 weeks for the first intervention period, a 4-week washout, and another 12 weeks for the second intervention period. Nursing homes (clusters) were randomized into sequences (AB or BA), where intervention A involve concurrent exercise training, and B is usual care.
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Data collection will occurre at four points: baseline, post-first intervention period, post-washout/pre-second intervention period and post-crossover. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: Exercise training measure: Change from Baseline on Short Physical Performance Battery (SPBB) measure: Change from Baseline on Handgrip test measure: Change from baseline on isokinetic knee strength measure: Change from Baseline on circulating levels of myostatin measure: Change from Baseline on circulating levels of Decorin sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Faculty of Sports, University of Porto city: Porto zip: 4000 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False
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<|newrecord|> nctId: NCT06380114 id: STUDY00009296 briefTitle: Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-04 date: 2027-11 date: 2024-04-23 date: 2024-04-25 name: University of Rochester class: OTHER name: National Institutes of Health (NIH) briefSummary: Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time.
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Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 11-17 year-olds. conditions: Hpv studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 16000 type: ESTIMATED name: Communication name: Standing Orders measure: HPV vaccination sex: ALL minimumAge: 11 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06380101 id: NEAAR-LARC briefTitle: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) acronym: NEAAR-LARC overallStatus: RECRUITING date: 2023-09-08 date: 2024-12 date: 2025-06 date: 2024-04-23 date: 2024-04-23 name: University of South Florida class: OTHER briefSummary: This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy. conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: NEAAR Medical Food measure: Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea measure: Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema measure: Absolute and relative change from baseline of circulating non-essential amino acids measure: Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food measure: molecular ctDNA response. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: RECRUITING city: Tampa state: Florida zip: 33606 country: United States name: Jennifer Burgess, MS role: CONTACT phone: 434-806-6445 email: jburgess@tgh.org name: Veronique Perry, MSHA role: CONTACT phone: 2549873658 email: vperry@tgh.org name: Richard Tuli, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False
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<|newrecord|> nctId: NCT06380088 id: VEM-DINOGMI-24 briefTitle: Improving Motor Skills: The Role of Music and Encouragement overallStatus: COMPLETED date: 2022-07-01 date: 2023-08-05 date: 2024-03-15 date: 2024-04-23 date: 2024-04-23 name: Universita degli Studi di Genova class: OTHER briefSummary: This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.
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Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 25 type: ACTUAL name: Isometric Task measure: Duration of the task measure: Biceps Brachii muscle fatigue measure: Triceps Brachii muscle fatigue measure: Biceps Brachii activity measure: Triceps Brachii activity sex: ALL minimumAge: 27 Years maximumAge: 40 Years stdAges: ADULT facility: Università degli Studi di Genova city: Genova zip: 16122 country: Italy lat: 44.40478 lon: 8.94438 hasResults: False
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