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The main question it aims to assess is will patient response to IL-23 therapies improve when simultaneously treated with fluconazole. conditions: Crohn's Disease conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double-blinded study whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Fluconazole name: Placebo name: IL-23 Therapy measure: Proportion of subjects achieving clinical response measure: Proportion of subjects achieving clinical remission measure: Proportion of patients achieving endoscopic response or remission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine city: New York state: New York zip: 10065 country: United States name: Grace Xiang, BS role: CONTACT phone: 646-697-0985 email: grx4001@med.cornell.edu name: Randy Longman, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Dana Lukin, MD, PhD role: SUB_INVESTIGATOR name: Ellen Scherl, MD role: SUB_INVESTIGATOR name: Iliyan Iliev, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<|newrecord|> nctId: NCT06274541 id: CTRIAL-IE 18-01 briefTitle: Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer (HGSEC): The t-BRCA Study overallStatus: ACTIVE_NOT_RECRUITING date: 2019-03-22 date: 2025-11 date: 2025-11 date: 2024-02-23 date: 2024-02-23 name: Cancer Trials Ireland class: NETWORK briefSummary: A pilot study to evaluate the feasibility of a NGS-based tumour BRCA1/2 mutation testing pathway initiated in the oncology clinic for patients with HGSEC, either at primary diagnosis or first relapse, whereby only patients with a positive germline BRCA1/2 mutation test will be referred to clinical genetics. conditions: Serous Ovarian Tumor conditions: Endometrioid Carcinoma Ovary conditions: Fallopian Tube Cancer conditions: Primary Peritoneal Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Somatic and Germline BRCA1/2 Testing measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience. measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience. measure: The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials). measure: The impact on patient management by use of clinical genetics counselling sessions. measure: The economic impact of implementing an upfront tumour BRCA1/2 mutation testing pathway in the oncology clinic for HGSEC on the Irish healthcare system, using a health economic analysis (decision analysis model) measure: The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland measure: Patient and disease characteristics (age, stage, degree of surgical cytoreduction, platinum sensitivity) associated with BRCA1/2 mutated HGSEC compared to BRCA1/2 wild type disease. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials measure: Identification of clinical outcomes (response platinum free interval (PFI)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. measure: Identification of clinical outcomes (progression free survival (PFS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. measure: Identification of clinical outcomes (overall survival (OS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mater Misericordiae University Hospital / Mater Private Hospital city: Dublin state: Leinster country: Ireland lat: 53.33306 lon: -6.24889 facility: St James's Hospital city: Dublin state: Leinster country: Ireland lat: 53.33306 lon: -6.24889 facility: Bon Secours city: Cork state: Munster country: Ireland lat: 51.89797 lon: -8.47061 facility: Cork University Hospital city: Cork state: Munster country: Ireland lat: 51.89797 lon: -8.47061 facility: University Hospital Limerick city: Limerick state: Munster country: Ireland lat: 52.66472 lon: -8.62306 hasResults: False
<|newrecord|> nctId: NCT06274528 id: 202301150 briefTitle: DORA and LP in Alzheimer's Disease Biomarkers overallStatus: RECRUITING date: 2024-03-11 date: 2029-03-11 date: 2029-03-11 date: 2024-02-23 date: 2024-03-29 name: Washington University School of Medicine class: OTHER briefSummary: The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the fluid around the brain known as cerebrospinal fluid (CSF). Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Pharmacist whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 201 type: ESTIMATED name: Lemborexant 10 mg name: Lemborexant 20mg name: Placebo measure: Changes CSF pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo measure: Number of participants with treatment-related adverse events measure: Measure the blood concentration of lemborexant 10 mg and 20 mg and determine the dose-response relationship with CSF pT181/T181 measure: Measure changes on blood plasma amyloid-beta isoforms (Aβ38, Aβ40, Aβ42) measure: Measure changes of CSF amyloid beta isoforms (Aβ38, Aβ40, Aβ42) measure: Measure changes of blood plasma p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217). measure: Measure changes of cerebrospinal fluid p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217). measure: Measure changes of cerebrospinal TREM2 (exploratory) measure: Measure changes of cerebrospinal NPTX2 (exploratory) measure: Measure changes of cerebrospinal NfL (exploratory) measure: Measure changes of blood plasma NfL (exploratory) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Washington University in St. Louis, School of Medicine status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Cristina Toedebusch, BS role: CONTACT phone: 314-747-0646 email: toedebuschc@wustl.edu name: Chloe Meehan, BS, MA role: CONTACT phone: 314-273-0878 email: cmeehan@wustl.edu name: Brendan P. Lucey, M.D. role: PRINCIPAL_INVESTIGATOR name: J. Philip Miller, Ph.D. role: SUB_INVESTIGATOR name: Jason Hassenstab, Ph.D. role: SUB_INVESTIGATOR name: David Carr, M.D. role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False
<|newrecord|> nctId: NCT06274515 id: WO44977 briefTitle: A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies acronym: REMERGE overallStatus: RECRUITING date: 2024-04-02 date: 2027-01-28 date: 2027-01-28 date: 2024-02-23 date: 2024-04-08 name: Hoffmann-La Roche class: INDUSTRY briefSummary: This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 320 type: ESTIMATED name: Tumor Tissue and Blood Draw measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) measure: Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) measure: Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1) measure: Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie status: RECRUITING city: Essen zip: 45136 country: Germany lat: 51.45657 lon: 7.01228 facility: I.R.S.T Srl IRCCS; Oncologia Medica status: RECRUITING city: Meldola state: Emilia-Romagna zip: 47014 country: Italy lat: 44.12775 lon: 12.0626 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<|newrecord|> nctId: NCT06274502 id: deep learning briefTitle: Automated Detection and Diagnosis of Pathological DRGs in PHN Patients Using Deep Learning and Magnetic Resonance overallStatus: COMPLETED date: 2023-10-01 date: 2024-01-31 date: 2024-01-31 date: 2024-02-23 date: 2024-03-06 name: Huazhong University of Science and Technology class: OTHER briefSummary: Here, this study aimed to develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning. This study retrospectively analyzed the DRG images of all patients with postherpetic neuralgia who underwent magnetic resonance neuroimaging examinations in our radiology department from January 2021 to February 2022. After image post-processing, the You Only Look Once (YOLO) version 8 was selected as the target algorithm model. Model performance was evaluated using metrics such as precision, recall, Average Precision, mean average precision and F1 score. conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 41 type: ACTUAL name: YOLOv8 measure: Develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan country: China lat: 30.58333 lon: 114.26667 hasResults: False
<|newrecord|> nctId: NCT06274489 id: GSN000500 briefTitle: A Study to Evaluate Setanaxib in Patients With Alport Syndrome overallStatus: RECRUITING date: 2023-11-27 date: 2025-01-27 date: 2025-01-27 date: 2024-02-23 date: 2024-04-05 name: Calliditas Therapeutics AB class: INDUSTRY briefSummary: The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study.
Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function.
The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period. conditions: Alport Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 18 type: ESTIMATED name: Setanaxib name: Placebo measure: Percentage of patients with Serious Adverse Events (SAEs) measure: Percentage of patients with treatment-emergent Adverse Events of Special Interest (AESIs) measure: The ratio of urine protein to creatinine ratio (UPCR) analysed in 24-hour urine sample measure: Percentage of patients with a 25% reduction in UPCR analysed in 24-hour urine sample measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the area under the concentration-time curve over 24 hours at steady state (AUC0-24-ss) measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the minimum plasma concentration at steady state (Cmin-ss) measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the maximum plasma concentration at steady state (Cmax-ss) measure: Percentage of patients with clinically significant changes in heart rate measure: Percentage of patients with clinically significant changes blood pressure measure: Percentage of patients with clinically significant changes in 12-lead electrocardiogram (ECG) measure: Percentage of patients with clinically significant changes in physical examination measure: Percentage of patients with clinically significant changes in hematology, serum chemistry, urinalysis, and thyroid function measure: Percentage of patients with clinically significant changes in hearing audiometric testing (bone- and air-conduction) sex: ALL minimumAge: 12 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Fakultni Nemocnice Hradec Kralove status: RECRUITING city: Hradec Králové country: Czechia name: Roman Safranek role: CONTACT lat: 50.20923 lon: 15.83277 facility: Fakultni Nemocnice Olomouc status: RECRUITING city: Olomouc country: Czechia name: Karel Krejci role: CONTACT lat: 49.59552 lon: 17.25175 facility: Institut Klinicke a Experimentalni Mediciny status: RECRUITING city: Praha country: Czechia name: Ondrej Viklicky role: CONTACT lat: 50.08804 lon: 14.42076 facility: Vseobecna Fakultni Nemocnice v Praze status: RECRUITING city: Praha country: Czechia name: Vladimir Tesar role: CONTACT lat: 50.08804 lon: 14.42076 facility: Hospital Clinic Barcelona status: RECRUITING city: Barcelona state: L'eixample zip: 08036 country: Spain name: Marc Xipell Font role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitario 12 de Octubre status: RECRUITING city: Madrid state: Usera zip: 28041 country: Spain name: Enrique Morales role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Vall d'Hebron status: RECRUITING city: Barcelona country: Spain name: Irene Agraz Pamplona role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Reina Sofia status: RECRUITING city: Córdoba zip: 14004 country: Spain name: Cristina Rabasco role: CONTACT lat: 37.89155 lon: -4.77275 facility: Hospital Universitario Virgen de las Nieves status: RECRUITING city: Granada zip: 18014 country: Spain name: Rafael Jose Esteban de la Rosa role: CONTACT lat: 37.18817 lon: -3.60667 facility: Royal Free London NHS Foundation Trust status: RECRUITING city: London zip: NW3 2QG country: United Kingdom name: Daniel Gale role: CONTACT lat: 51.50853 lon: -0.12574 facility: Great Ormond Street Hospital for Children status: NOT_YET_RECRUITING city: London zip: WC1N 3JH country: United Kingdom name: Zainab Arslan role: CONTACT lat: 51.50853 lon: -0.12574 facility: Royal Manchester Children's Hospital status: RECRUITING city: Manchester zip: M13 9WL country: United Kingdom name: Rachel Lennon role: CONTACT lat: 53.48095 lon: -2.23743 facility: Nottingham City Hospital status: RECRUITING city: Nottingham country: United Kingdom name: Matthew Hall role: CONTACT lat: 52.9536 lon: -1.15047 hasResults: False
<|newrecord|> nctId: NCT06274476 id: 2020/9/9 briefTitle: Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement acronym: implant overallStatus: COMPLETED date: 2018-09-09 date: 2019-12-09 date: 2020-01-01 date: 2024-02-23 date: 2024-02-23 name: Cairo University class: OTHER briefSummary: evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically. conditions: Atrophic Maxillary Ridge and Mandibular Ridge studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: maxillary and mandibular atrophic ridge primaryPurpose: OTHER masking: DOUBLE maskingDescription: double whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 21 type: ACTUAL name: implant placement measure: implant success sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamed yahia Sharaf city: Zagazig state: Sharkia zip: 44715 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
<|newrecord|> nctId: NCT06274463 id: 2023-11-035 briefTitle: A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-02-21 date: 2024-12-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Bundang CHA Hospital class: OTHER briefSummary: To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease. conditions: Brain Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Exercise therapy including a trunk stabilization exercise program measure: Trunk Impairment Scale measure: Berg Balance Scale measure: Joint angle measure: Joint moment measure: Joint power sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06274450 id: C2202112 briefTitle: A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks overallStatus: COMPLETED date: 2022-07-06 date: 2022-09-02 date: 2022-09-02 date: 2024-02-23 date: 2024-02-23 name: Botanee Group Co., Ltd. class: INDUSTRY briefSummary: The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.
This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink. conditions: Skin Laxity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ACTUAL name: skin care product name: Drinks with active ingredients Rosa Roxburghii and Pomegranate measure: Changes in the skin hydration measure: Changes in the skin glossiness measure: Changes in the skin firmness measure: Changes in the skin elasticity measure: Changes in the individual type angle measure: Changes in the melanin content measure: Changes in the proportion of crow's feet area measure: Changes in the proportion of fine lines under the eye measure: Changes in the CIE RGB of skin tone measure: Changes in the grade of Pigmentation measure: Skin condition Assessment after 4-week application measure: Skin condition Assessment after 8-week application measure: Changes in the satisfaction with the quality of life sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai China-norm Quality Technical Service Co ，Ltd city: Shanghai state: Shanghai zip: 200072 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06274437 id: BND-35-001 briefTitle: A Study of BND-35 in Participants With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2027-11 date: 2024-02-23 date: 2024-02-23 name: Biond Biologics class: INDUSTRY briefSummary: This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab. conditions: Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 280 type: ESTIMATED name: BND-35 name: Nivolumab name: Cetuximab measure: Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) measure: Part 1: Proportion of patients who discontinued study treatment due to TEAEs measure: Part 1: Incidence of TEAEs dose limiting toxicities (DLT) measure: Part 2: Objective Response Rate (ORR) per RECIST v1.1 measure: Part 2: Incidence of TEAEs and SAEs measure: Part 1: Objective Response Rate (ORR) per RECIST v1.1 measure: Part 1: Maximum observed plasma concentration (Cmax) measure: Part 1: Serum concentration at the end of the dosing interval (Ctrough) measure: Part 1: Time of maximum observed serum concentration (Tmax) measure: Part 1: Terminal elimination half-life (T1/2) measure: Part 1: Area under the plasma concentration-time curve (AUC) measure: Part 1: Incidence of anti-drug antibodies (ADA) measure: Part 2: Progression Free Survival (PFS) measure: Part 2: PFS rate measure: Part 2: Duration of Response measure: Part 2: Maximum observed plasma concentration (Cmax) measure: Part 2: Serum concentration at the end of the dosing interval (Ctrough) measure: Part 2: Time of maximum observed serum concentration (Tmax) measure: Part 2: Terminal elimination half-life (T1/2) measure: Part 2: Area under the plasma concentration-time curve (AUC) measure: Part 2: Incidence of anti-drug antibodies (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambam Health Care Campus city: Haifa zip: 3109601 country: Israel name: Ruth Perets role: CONTACT role: CONTACT phone: +97247776234 email: ru_perets@rambam.health.gov.il lat: 32.81841 lon: 34.9885 facility: Hadassah University Medical Center city: Jerusalem zip: 91120 country: Israel name: Jonathan Cohen role: CONTACT role: CONTACT phone: +97226776781 email: cohenjon@hadassah.org.il lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center city: Petah Tikva zip: 49100 country: Israel name: Solomon Shtemer role: CONTACT role: CONTACT phone: +97239378110 email: shtemers@clalit.org.il lat: 32.08707 lon: 34.88747 facility: Sheba Medical Center city: Ramat Gan zip: 52621 country: Israel name: Gal Strauss role: CONTACT phone: +97235304498 email: gal.strauss@sheba.health.gov.il lat: 32.08227 lon: 34.81065 facility: Tel Aviv Sourasky Medical Center city: Tel Aviv zip: 6423906 country: Israel name: Ravit Geva role: CONTACT phone: +97236973193 email: ravitg@tlvmc.gov.il lat: 32.08088 lon: 34.78057 hasResults: False
<|newrecord|> nctId: NCT06274424 id: HUS/211/2016 and HUS/2699/2018 briefTitle: Hair Cortisol and Symptoms in Children With Psychopathology During CBT overallStatus: COMPLETED date: 2016-07-01 date: 2019-10-01 date: 2019-10-01 date: 2024-02-23 date: 2024-02-29 name: Helsinki University Central Hospital class: OTHER briefSummary: This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study. conditions: Child Behavior Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: The Friends Program measure: Hair Cortisol Concentration measure: Parent- and teacher rated internalizing and externalizing symptoms measure: Child-rated internalizing symptoms measure: Parent-rated sleep disturbance symptoms sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06274411 id: KS2024014 briefTitle: Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention acronym: ESCORT overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-03-01 date: 2024-02-23 date: 2024-02-23 name: Beijing Anzhen Hospital class: OTHER briefSummary: The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :
• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI conditions: ECMO conditions: High-risk PCI studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Standby cannulated ECMO name: Prophylactic ECMO measure: Composite rate of 8 major adverse events measure: Platelet drop measure: Duration of ECMO support measure: Length of hospital stay measure: Hemoglobin drop measure: Serum interleukin-6 concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Liangshan Wang, MD role: CONTACT phone: 86-13811363372 email: wangliangshanbam@sina.com lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06274398 id: RITE Study briefTitle: Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study acronym: RITE PrEP overallStatus: RECRUITING date: 2024-01-16 date: 2024-10-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Eastern Virginia Medical School class: OTHER name: CONRAD name: Emory University name: Centers for Disease Control and Prevention briefSummary: This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days. conditions: Safety Issues studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Placebo-controlled, Double-blind primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: TAF/EVG rectal insert name: Matching placebo rectal insert measure: Frequency and intensity of Adverse Events measure: Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood measure: PK (Cmax) in rectal secretions measure: PK (Cmax) in rectal mucosal tissue measure: PK (Cmax) in cervicovaginal secretions measure: PK (Cmax) in cerviocovaginal mucosal tissues measure: Cytokine Profiles measure: Microbiome Profiles sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Emory Clinic status: RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Cassie Grimsley Ackerley, MD, MSc role: CONTACT email: cassie.marie.grimsley.ackerley@emory.edu lat: 33.749 lon: -84.38798 hasResults: False
<|newrecord|> nctId: NCT06274385 id: 2311010178 briefTitle: The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery. acronym: BET_RSE overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-06 date: 2024-02-23 date: 2024-02-23 name: Drexel University class: OTHER briefSummary: Betalains have well-known antioxidant and anti-inflammatory properties. Recent investigations examining the effects of a betalain-rich concentrate (BRC) on exercise and recovery performance show promise of BRC as an ergogenic aid. To date, no study has examined the effects of a single dose of a BRC on supramaximal performance and recovery. Therefore, the purpose of this study is to examine the effects of an acute dose of BRC on repeated-sprint cycling performance and recovery. conditions: Nutraceuticals studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Betalain-rich concentrate (AltRed) name: Placebo measure: Repeated Sprint Performance measure: Neuromuscular Fatigue sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Drexel University - Health Sciences Building status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19102 country: United States name: Arun Ramakrishnan, PhD role: CONTACT phone: 215-553-7018 email: ar88@drexel.edu lat: 39.95233 lon: -75.16379 hasResults: False
<|newrecord|> nctId: NCT06274372 id: FCV,V-2202 briefTitle: The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-07 date: 2024-08-06 date: 2024-08-06 date: 2024-02-23 date: 2024-03-06 name: Derince Training and Research Hospital class: OTHER briefSummary: It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations. conditions: Laparoscopic Surgeries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: flow controlled ventilation name: volume controlled ventilation measure: effects of flow controlled ventilation on heamodynamic parameters measure: effectcs of flow controlled ventiletion on respiratory parameters measure: effects of flow controlled ventilation on heamodynamic parameters measure: effects of flow controlled ventilation on heamodynamic parameters measure: effectcs of flow controlled ventiletion on respiratory parameters measure: respiratory related complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli Derince Training and Research Hospital city: Derince state: Kocaeli zip: 41900 country: Turkey hasResults: False
<|newrecord|> nctId: NCT06274359 id: 21-3985 briefTitle: Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2027-08-31 date: 2024-02-23 date: 2024-02-23 name: Denver Health and Hospital Authority class: OTHER briefSummary: While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases. conditions: Influenza studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Caregivers will be assigned randomly to receive a series of digital stories by text message or to receive usual care. primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Digital storytelling measure: Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary) measure: Intervention Feasibility measure: Intervention Acceptability measure: Intervention Appropriateness sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Denver Health Eastside Clinic city: Denver state: Colorado zip: 80205 country: United States lat: 39.73915 lon: -104.9847 facility: Denver Health Park Hill Clinic city: Denver state: Colorado zip: 80207 country: United States lat: 39.73915 lon: -104.9847 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-26 uploadDate: 2024-01-30T11:52 filename: ICF_000.pdf size: 298169 hasResults: False
<|newrecord|> nctId: NCT06274346 id: ahmedU briefTitle: Effect of Retro Walking Versus Isometric Multi-angular Exercises on Pain and Functional Performance in Knee Osteoarthritis in Geriatric Population overallStatus: COMPLETED date: 2023-06-01 date: 2023-11-10 date: 2023-11-30 date: 2024-02-23 date: 2024-02-23 name: Delta University for Science and Technology class: OTHER briefSummary: Osteoarthritis is a leading musculoskeletal cause of disability in elderly persons all over the world and a major cause of physical limitations and reduced quality of life (1). Its onset is around 40 years of age and it is estimated that over 80% of people over 55 have evidence of radiographic changes in the knee due to osteoarthritis. It has been estimated that the incidence has increased by the increase in life expectancy and it has been identified as a frequent cause for health services demand in patients over 65(2).
The common clinical manifestations of knee OA include pain, stiffness, joint enlargement, crepitus, muscle weakness, deformity, impaired proprioception, reduced joint motion, and disability(3).
Patients with knee Osteoarthritis seems to develop their own gait pattern and try to unload the affected structures during gait. More over patients with less severe knee osteoarthritis develop a gait pattern that differs from patients with severe osteoarthritis and control group of patients (4).
Isometric exercises are types of strength training in which the joint angle and muscle length do not change during contraction, and therefore this approach can be advantageous in the early stages of knee rehabilitation in cases where the range of motion is restricted due to pain (13). No physical work is performed during isometric exercise. Intensity and duration combination reflects the energy consumption of an isometric contraction (14). In addition, muscle strength increases in isometric exercise are specific to the angle applied. It was also concluded that isometric exercise performed at different angles should be especially considered as an alternative strength training since it induces the most noticeable and fastest increase in muscle moment (15). A study was conducted to investigate the effects of isometric quadriceps exercise on muscle strength, pain, and function in knee osteoarthritis, it was concluded that isometric quadriceps exercise program showed beneficial effects on quadriceps muscle strength, pain, and functional disability in patients with osteoarthritis of the knee (16).
Another study was conducted to assess the effectiveness of Isometric exercise and counseling on level of pain among patients with Knee osteoarthritis, the authors concluded that Isometric exercise and counseling program has significantly reduced pain, stiffness and improved physical function and the authors recommended that Isometric exercise and counselling should be adopted as a routine care in the hospitals treating patients with knee osteoarthritis (17) Thus, we hypothesized that a less intensive walking program such as retro walking program could provide an additional benefit more than those experienced by forward walking program in the previous studies. Therefore, the primary aim of the present study was to compare the effect of retro walking versus isometric multiangular exercises group on knee pain and function in geriatric people.
Materials and Methods
This randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from June 2023 to November 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients.
Subjects:
Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. In each case, the diagnosis of knee OA was based on the criteria specified by the American College of Rheumatology.
We recorded the height, weight, and medical history, and lower extremity dominance, level of education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4) conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were randomly assigned into two groups through computer software. We put sixty patients on the software program and the program assigned them randomly. s exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given. Second group was treated by retrowalking exercises in addition to physical therapy interventions including short wave diathermy and strengthening exercise such as static quadriceps exercise, dynamic quadriceps exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given., which were given 3 times/week for 4 consecutive weeks. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4). whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Multiangular Isometric exercise measure: Pain intensity measure: Functional assessment: sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Delta University For Science and Technology city: Gamasa state: Almansourah zip: 38733 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False
<|newrecord|> nctId: NCT06274333 id: RC.18.1.2024 briefTitle: Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort overallStatus: RECRUITING date: 2024-02-28 date: 2024-05-30 date: 2024-05-30 date: 2024-02-23 date: 2024-03-15 name: Al-Azhar University class: OTHER name: Benha University briefSummary: The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia. conditions: Percutaneous Nephrolithotripsy (PCNL) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dexmedetomidine 0.5 mic/kg name: Tramadol 1mg/kg name: Paracetamol 10mg/kg measure: The incidence of catheter-related bladder discomfort (CRBD) measure: Postoperative pain measure: Meperidine requirement measure: Patient satisfaction measure: Surgeon satisfaction sex: MALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Neveen Kohaf status: RECRUITING city: Cairo zip: 11865 country: Egypt name: Neveen Kohaf, Ph.D role: CONTACT phone: +201069482380 email: nevenabdo@azhar.edu.eg name: Hany Bauiomy, M.D role: PRINCIPAL_INVESTIGATOR name: Ahmed M. Abosakaya, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06274320 id: LRP22002 LIPIKAR UREA 30% briefTitle: Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-02-23 date: 2024-02-28 name: Cosmetique Active International class: INDUSTRY briefSummary: This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment. conditions: Actinic Keratoses studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Group A: holistic approach name: Group B: Tolak® Standard of use measure: Change in lesion response rate measure: Percentage change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CentroDerm GmbH city: Wuppertal country: Germany lat: 51.27027 lon: 7.16755 hasResults: False
<|newrecord|> nctId: NCT06274307 id: IRB-21-10-4045 briefTitle: Efficacy of Transversus Abdominis Plane Block overallStatus: RECRUITING date: 2023-06-22 date: 2024-07-01 date: 2024-09-01 date: 2024-02-23 date: 2024-02-23 name: Justin Hruska class: OTHER briefSummary: This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method. conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The treatment group (Group 1) will have a transversus abdominis plane (TAP) block performed with an insufflated abdomen in the operating room. The control group (Group 2) will receive the traditionally performed standard of care TAP block performed in the post-anesthesia care unit primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Transversus abdominis plane block measure: Time to perform TAP Block measure: TAP block attempts measure: Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery measure: Postoperative Opioid Consumption measure: Ease of performing TAP Block-anatomical plane visualization measure: Ease of performing TAP Block-performance efficacy measure: Patient satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Detroit Medical Center Detroit Receiving Hospital status: RECRUITING city: Detroit state: Michigan zip: 48201 country: United States name: George M McKelvey, PhD role: CONTACT phone: 313-598-6036 email: gmckelve@dmc.org name: Justin Hruska, M.D. role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 facility: Detroit Medical Center, Harper University Hospital status: RECRUITING city: Detroit state: Michigan zip: 48201 country: United States name: George M McKelvey, PhD role: CONTACT phone: 313-598-6036 email: gmckelve@dmc.org name: Justin Hruska, MD role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 hasResults: False
<|newrecord|> nctId: NCT06274294 id: 2023/12 briefTitle: Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC acronym: PASSPORT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-01 date: 2024-02-23 date: 2024-02-23 name: CMC Ambroise Paré class: OTHER name: Paris IBD Center name: Celltrion HealthCare France briefSummary: The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.
The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The full sample size comprises 130 patients, with 65 patients allocated to each arm. The arms are defined as follows:
* Experimental Arm: Patients receive CT-P13 SC at weeks 0, 1, 2, 3, 4, and 6, followed by subcutaneous administration every two weeks until week 24.
* Control Arm: Patients receive CT-P13 IV at weeks 0 and 2, followed by subcutaneous administration every two weeks until week 24. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 130 type: ESTIMATED name: CT-P13 measure: Ratio SC/IV measure: Ctrough at week 24 (non-inferiority) measure: AUC at week 24 measure: Clinical response at week 6 and week 24 measure: IBD disability index at week 6 measure: Fecal calprotectin at week 24 measure: Clinical remission at week 6 and week 24 measure: Presence of antibodies to infliximab at Week 6 and Week 24 measure: Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24) measure: Adverse events, including injection site reactions and hypersensitivity reactions measure: TSQM collected at Week 6 and Week 24 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06274281 id: TOMs_FMD briefTitle: Digital Telerehabilitation in Functional Motor Disorders overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2026-02-01 date: 2024-02-23 date: 2024-02-23 name: Universita di Verona class: OTHER briefSummary: Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, including abnormal gait/balance disorders. Patients experience high degrees of disability and distress, equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in their management. However, the current systems of rehabilitation delivery face two main challenges. Patients are not receiving the amount and kind of evidence-based rehabilitation they need due to the lack of rehabilitation professionals and experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. Digital medicine is a new field that means "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized." It can upgrade rehabilitation practice, addressing the existing critical components towards marked efficiency and productivity. Digital telerehabilitation will increase the accessibility to personalized rehabilitation by expert professionals placing tools to monitor the patient's health by themselves.
The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition.
This feasibility study provides preliminary data on the integration of a real-time gait and activity analysis by wearable devices in the real world with a digital platform to improve the diagnosis, monitoring, and rehabilitation of patients with FMDs. conditions: Functional Movement Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an experimental single-blind randomized-controlled trial (RCT) with 2-parallel arms comparing the effects between the experimental group (EG) and control group (CG). After screening, a simple randomization list will be generated by a physician using an automated randomization system (alloca-tion ratio 1:1) to assign eligible patients to either the EG or the CG. Group allocation will be kept concealed. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor will be blinded to the type of intervention performed by the patient. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Digital Telerehabilitation name: Usual care measure: number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation measure: Budget issues related to TOMs measure: Time spent to train patients measure: Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score measure: Multidimensional Fatigue Inventory Scale (MFI-20) score measure: Change in the Brief Pain Inventory (BPI) score measure: Change in the Beck Depression Inventory (BDI-II) score measure: Change in the Beck Anxiety Inventory (BAI) score measure: Change in the 12-item Short-Form Health Survey (SF-12) score measure: The EuroQol-5D (EQ-5D) measure: iMTA Productivity Cost Questionnaire measure: Change in the Clinical Global Impression (CGI) score measure: Gait outcome: Gait speed measure: Gait outcome: Stride length measure: Gait outcome: Cadence measure: Balance outcome: CoP trajectory measure: Balance outcomes: Sway area sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona city: Verona zip: 37131 country: Italy lat: 45.4299 lon: 10.98444 facility: USD Parkinson's Disease and Movement Disorders Unit city: Verona zip: 37134 country: Italy lat: 45.4299 lon: 10.98444 hasResults: False
<|newrecord|> nctId: NCT06274268 id: CHMS23006 briefTitle: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments acronym: SARC-ONCO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-05-01 date: 2028-05-01 date: 2024-02-23 date: 2024-02-23 name: Centre Hospitalier Metropole Savoie class: OTHER name: Université Savoie Mont Blanc briefSummary: The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers.
The main question it aims to answer is :
Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment?
The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests. conditions: Sarcopenia conditions: Oncology conditions: Physical Inactivity conditions: Toxicity Due to Chemotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective cohort study primaryPurpose: DIAGNOSTIC masking: NONE count: 700 type: ESTIMATED name: Sarcopenia diagnostic test measure: Event-free survival according to sarcopenic statut measure: Event-free survival according to the link between: 1/ the dose/lean mass ratio and 2/ body composition and the occurrence of adverse events linked to treatment. measure: Progression free-survival measure: Overall survival measure: Objective response rate at 6 and 12 months measure: Number of patients classified as sarcopenic by BIA method and CT method. measure: Exploratory: Event-free survival during PACLITAXEL protocol measure: Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2). measure: Exploratory: RCB-based objective response rate at 6 and 12 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06274255 id: BalikesirU briefTitle: Serum Magnesium Level and Pediatric Migraine acronym: Migraine overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-10 date: 2024-05-15 date: 2024-02-23 date: 2024-02-23 name: Mersin University class: OTHER briefSummary: Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels.
Material-Method: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic between 01.09.2019 and 01.04.2023 and diagnosed with migraine were enrolled retrospectively. Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic in the same period as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin, hematocrit, platelet, glucose, calcium, magnesium, vitamin D, folate and ferritin levels) characteristics were recorded. conditions: Migraine, Magnesium, Pediatric studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Serum Magnesium Level and Pediatric Migraine measure: Serum Magnesium Level and Pediatric Migraine sex: ALL minimumAge: 72 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hilal Aydın city: Balıkesir state: Türkiye zip: 33343 country: Turkey name: Hilal Aydın, assoc. Dr. role: CONTACT phone: +902666121461 email: drhilalaydin@gmail.com name: Hilal Aydın, assoc. Dr. role: CONTACT phone: +905072607541 email: drhilalaydin@gmail.com lat: 39.64917 lon: 27.88611 facility: Aysen Orman city: Mersin state: Türkiye zip: 33343 country: Turkey lat: 36.79526 lon: 34.61792 facility: MersinU city: Mersin state: Türkiye zip: 33343 country: Turkey name: Aysen Orman role: CONTACT email: ormanaysen709@gmail.com name: Aysen Orman role: CONTACT phone: 3242410000 phoneExt: 2646 email: ormanaysen709@gmail.com lat: 36.79526 lon: 34.61792 facility: Aysen Orman city: Mersin state: Türkiye zip: 38000 country: Turkey name: Aysen Orman, assoc. Dr. role: CONTACT phone: +903242410000 phoneExt: +903242410000 email: ormanaysen709@gmail.com name: Aysen Orman, assoc. Dr. role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False
<|newrecord|> nctId: NCT06274242 id: MU-CIRB 2022/300.0711 briefTitle: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-10 date: 2023-07-22 date: 2024-04-19 date: 2024-02-23 date: 2024-02-23 name: Mahidol University class: OTHER briefSummary: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 98 type: ACTUAL name: Haruna name: Placebo Powder measure: Change in Stool Frequency measure: Change in Fecal Microbiota measure: Change in Stool consistency sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Mahidol University city: Nakhon Pathom zip: 73170 country: Thailand lat: 13.8196 lon: 100.04427 hasResults: False
<|newrecord|> nctId: NCT06274229 id: EA4/252/23 briefTitle: DivAirCity Social Health Survey acronym: DivAirCitySH overallStatus: RECRUITING date: 2024-02-20 date: 2024-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: Charite University, Berlin, Germany class: OTHER name: Universitat Politècnica de València name: Universitatea din Bucuresti name: University of Aarhus name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy name: European Commission briefSummary: To reduce stress among urban residents, the consortium members of the European Council Horizon 2020 research program DivAirCity install different stress reducing, noise reducing and air quality improving means in the five cities of the consortium. This study measures physiological and psychological stress and health factors before and after the implementation of the project (at intervention sites) and compares the change (improvement) to the change in comparable places where no means were installed (control site). conditions: Psychological Stress conditions: Psychological Well-Being conditions: Pollution; Exposure studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Air pollution and noise reducing installations measure: WHO-5 Well-being Scale measure: Kessler K6 psychological distress measure: ASKU questionnaire measure: Questionnaire for General Physiological Health measure: Questionnaire about feelings of safety and security at the site sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité -- Universitaetsmedizin Berlin status: RECRUITING city: Berlin zip: 14109 country: Germany name: Farid I Kandil, PhD role: CONTACT phone: +491605631744 email: farid-ihab.kandil@charite.de lat: 52.52437 lon: 13.41053 hasResults: False
<|newrecord|> nctId: NCT06274216 id: 4381021ABOS briefTitle: The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial overallStatus: COMPLETED date: 2021-09-01 date: 2022-03-30 date: 2022-04-01 date: 2024-02-23 date: 2024-02-23 name: Ziauddin University class: OTHER briefSummary: Dental implantation is a new technique for the single or more missing tooth replacement. Dental professionals might utilize the findings of this investigation to generate local data and learn more about how vitamin D affects bone metabolism and implant osseo-integration. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D conditions: Osseointegration Failure of Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research commences through a self-administered questionnaire such as age, gender, weight, height, BMI, smoking habits, sun exposure, and employment status.
Prior to implant surgery, each participant undergoes a blood test to assess their vitamin D levels.
Detailed records are maintained concerning the anatomical position (molar, pre-molar, canine, and incisor) and implant site (maxilla and mandible) for every participant.
Group Formation: The participant pool is stratified into two distinct groups - Group A and Group B. This categorization is essential for implementing and comparing different interventions within the study. Group A undergoes a specific intervention wherein they receive a daily oral dose of 5000 IU of vitamin D3 for a duration of 12 weeks. In contrast, Group B receives a placebo.
Following the intervention period, the implants are allowed to cure adequately primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Groups A and B were created out of all patients who had signed up. Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks , whereas patients in group B received a placebo. Patients were blinded to the study medication. The implants were then allowed to cure adequately and submerged for a further three months. Patients were summoned back three months later to un-cover the implant.
The both groups were compared for the difference of osseo-integration at 3 months, as well as difference of osseo-integration were compared with respect to implant site (maxilla and mandible).
Additionally, change in vitamin D levels were also assessed pre-operatively and post-operatively at 3 months. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ACTUAL name: Vitamin D3 name: Vitamin E 400 measure: Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) measure: Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Afifa Razi city: Karachi state: Sindh zip: 74700 country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False
<|newrecord|> nctId: NCT06274203 id: 10584-2/5-2023 briefTitle: High Dose Vitamin D Supplementation in Children With Sickle Cell Disease overallStatus: COMPLETED date: 2023-05-03 date: 2024-01-30 date: 2024-02-10 date: 2024-02-23 date: 2024-02-23 name: Zagazig University class: OTHER_GOV briefSummary: Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL. conditions: Sickle Cell Disease conditions: Vitamin D Deficiency conditions: Health Related Quality of Life conditions: Hand Grip Strength conditions: Bone Mineral Density studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 75 type: ACTUAL name: Vitamin D3 measure: Serum 25(OH)D level measure: Bone mineral density (BMD) measure: Maximum handgrip strength (HGS) measure: Health related quality of life (HRQL) measure: Serum concentrations of C reactive protein (CRP) measure: Serum concentrations of Erythrocyte sedimentation rate (ESR) measure: Safety reporting of any adverse events measure: Safety measurements of serum Ca measure: childhood health assessment measure: Safety measurements of serum 25(OH)D levels sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Zagazig university city: Zagazig state: Sharkia zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
<|newrecord|> nctId: NCT06274190 id: S68746 briefTitle: Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary acronym: Treatable overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-10 date: 2026-03 date: 2024-02-23 date: 2024-04-08 name: KU Leuven class: OTHER name: Universitaire Ziekenhuizen KU Leuven briefSummary: Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms. conditions: Rectal Cancer conditions: LARS - Low Anterior Resection Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 118 type: ESTIMATED name: bowel e-diary measure: Selection of items for the newly developed bowel diary measure: Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants measure: The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer measure: The usability of the newly developed e-diary will be evaluated through conversations with patients who have undergone rectal surgery for rectal cancer, after these patients have used the e-diary for seven consecutive days measure: Construct validity of the newly developed bowel e-diary measure: Criterion validity of the newly developed bowel e-diary measure: Test-retest reliability of the newly developed bowel e-diary measure: Responsiveness of the newly developed bowel e-diary in patients after rectal surgery for rectal cancer. The newly validated e-diary is the primary outcome. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06274177 id: BTL-785_CTUS1400 briefTitle: Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-26 date: 2024-04-01 date: 2024-04-01 date: 2024-02-23 date: 2024-02-23 name: BTL Industries Ltd. class: INDUSTRY briefSummary: This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment. conditions: Fat Burn studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ACTUAL name: BTL-785-7 measure: Submental fat thickness reduction measure: Incidence of Treatment-related Adverse Events measure: Change on the Clinician Reported - Submental Fat Rating Scale score measure: Satisfaction Assessed by the Satisfaction Questionnaire measure: Change in the submental-cervical angle measure: Comfort Assessed by Therapy Comfort Questionnaire sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Precision Skin LLC city: Davie state: Florida zip: 33328 country: United States lat: 26.06287 lon: -80.2331 facility: Chicago Cosmetic and Dermatologic Research city: Chicago state: Illinois zip: 60654 country: United States lat: 41.85003 lon: -87.65005 facility: New Jersey Plastic Surgery (NJPS) city: Montclair state: New Jersey zip: 07042 country: United States lat: 40.82593 lon: -74.20903 facility: Gentile Facial Plastic and Aesthetic Laser Center city: Youngstown state: Ohio zip: 44512 country: United States lat: 41.09978 lon: -80.64952 hasResults: False
<|newrecord|> nctId: NCT06274164 id: H-54820 / RAI1 briefTitle: Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders overallStatus: RECRUITING date: 2024-03-13 date: 2027-03 date: 2027-03 date: 2024-02-23 date: 2024-04-01 name: Baylor College of Medicine class: OTHER name: Doris Duke Charitable Foundation briefSummary: Currently, there is no clinically available genetic-based treatment for RAI1 (Retinoic Acid-Induced 1) -related disorders other than symptomatic management and there are no established clinical or molecular biomarkers that could be used as measures for the efficacy of therapy in future treatment studies. Biomarkers are measures of what is happening inside the body, shown by the results of laboratory, imaging or other tests.
Biomarkers can help doctors and scientists diagnose diseases and health conditions, monitor responses to treatment and see how a person's disease or health condition changes over time.
The goal of this observational and laboratory study is to develop clinical, neurophysiology and molecular biomarkers in RAI1-related disorders. The main question\[s\] it aims to answer are:
* to characterize the disease features more precisely and analyze the differentiating and overlapping features of RAI1-related disorders (Smith-Magenis syndrome and Potocki-Lupski Syndrome)
* to identify clinical, neurophysiology, and laboratory biomarkers that differentiate RAI1-related disorders one from another.
Participants will have to complete:
* a clinical examination
* a blood draw
* a skin biopsy (optional)