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The primary goal of this prospective observational study is to understand why some patients with M. avium lung disease have persistent or recurrent M. avium in their sputum despite treatment. The aim is to understand whether it is usually due to treatment failure or new infection. conditions: Mycobacterium Avium conditions: Mycobacterium Infections, Nontuberculous conditions: Mycobacterium Infections conditions: Nontuberculous Mycobacterial Lung Disease conditions: Respiratory Tract Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Whole genome sequencing testing measure: Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy measure: Whether patients with Mav-PD have evidence of polyclonal infection as demonstrated by the presence of >1 strain of M. avium in the pre-treatment sputum or a sputum sample during treatment measure: Whether there is a source of infection from the home water environment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M5G country: Canada name: Matty Mehrabi, B.Sc. M. Ed role: CONTACT phone: 416-603-5726 email: matty.mehrabi@uhn.ca name: Theodore Marras, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06266429 id: STUDY00001304 briefTitle: Metabolomic Profiling of Racial Disparity overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-02-20 name: Olubukola Nafiu class: OTHER briefSummary: Tonsillectomy ± adenoidectomy (T\&A) is one of the most common surgical operations with over 500,000 pediatric T\&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain. conditions: Adenoid Hypertrophy conditions: Tonsillar Hypertrophy conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Blood collection measure: Mean fold-change of metabolomics markers by race using untargeted reverse-phase liquid-chromatographic mass spectrometry measure: Highest pain score measure: Last pain score sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06266416 id: 115207 briefTitle: IMARA for Black Male Caregivers and Girls Empowerment (IMAGE) acronym: IMAGE overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2027-05-31 date: 2028-05-31 date: 2024-02-20 date: 2024-04-24 name: University of Illinois at Chicago class: OTHER name: University of Michigan briefSummary: The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence. conditions: Sexually Transmitted Infections (Not HIV or Hepatitis) conditions: HIV Infections conditions: Sexual Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will evaluate the efficacy of IMAGE with 14-18-year-old Black girls (n=300) and male caregivers (n=300) in a 2-arm individually randomized controlled trial. The researchers will compare SRH outcomes (STI incidence, self-reported sexual behavior) at 6- and 12-months among girls randomized to IMAGE or a time-matched general health promotion control program (FUEL).
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The researchers will simultaneously evaluate implementation determinants (barriers, facilitators, constraints) and processes at Community Based Organizations working through the 3 steps of the implementation model (Prepare, Roll out, and Sustain). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: INVESTIGATOR count: 612 type: ESTIMATED name: IMARA for Black Male Caregivers and Girls Empowerment name: Time-matched control program measure: STI Incidence in Participants measure: Rate of STI History among Participants measure: Number of Participants Using Condoms measure: Number of Sexual Partners of Participants sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois Chicago city: Chicago state: Illinois zip: 60612 country: United States name: LIsa Sharp, PhD role: CONTACT phone: 312-966-1819 email: sharpl@uic.edu name: Sue Littau role: CONTACT phone: 312.996.3932 email: slittau@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06266403 id: STUDY00024154 briefTitle: Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-03 date: 2029-03 date: 2024-02-20 date: 2024-02-20 name: Penn State University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and age-matched speakers.
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The question is, What are the effects of communicative interaction on verbal communication in people with ALS?
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Participants will read words and sentences while they are in a solo setting and interactive setting. conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: PALS and age-matched adults will participate in one solo speech production task (clear speech) and three interactive tasks (structured communicative interaction, unstructured communicative interaction, and clear speech structured communicative interaction) in which they work with an unfamiliar, naive interlocutor. This study is designed to examine the differences in speech produced in the four tasks. Comparisons of speech produced by PALS and age-matched adults will clarify whether differences in speech observed across the four tasks are a function of the speech difficulties experiences by PALS.
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Plans for Assignment - This is a single group study in which all participants will engage in the same tasks. primaryPurpose: BASIC_SCIENCE masking: NONE count: 300 type: ESTIMATED name: Structured Communicative Interaction name: Clear Speech name: Unstructured communicative interaction name: Clear Speech Structured Communicative Interaction measure: Formant frequencies of speech sounds measure: Intelligibility of recorded speech measure: Syntactic properties measure: Pragmatic Properties measure: Duration of speech sounds sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266390 id: 855007 briefTitle: Engaging sgACC With TMS for Depression overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-01-30 date: 2026-04 date: 2024-02-20 date: 2024-04-18 name: University of Pennsylvania class: OTHER name: National Institutes of Health (NIH) briefSummary: The purpose of this study is to investigate the responses of the brain region known as the subgenual anterior cingulate cortex (sgACC) during transcranial magnetic stimulation (TMS) in individuals with depression. Specifically, investigators aim to determine whether the sgACC is engaged when TMS is delivered to specific targets and if the engagement of sgACC changes throughout a full TMS treatment intervention. To achieve this goal, the investigators will employ a combination of TMS and Magnetic Resonance Imaging (MRI) procedures.
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Study participation will include completing various questionnaires, clinical assessments, receiving a full transcranial magnetic stimulation (TMS) treatment intervention (every weekday for 4-6 weeks), and undergoing MRI scans, both with and without concurrent TMS. conditions: Depression conditions: Major Depressive Disorder conditions: Persistent Depressive Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will receive rTMS to one of two targets. Participants will be randomly assigned to receive the TMS treatment intervention in one of two target conditions: half to their positive sgACC correlation target, while the remaining half to their negative sgACC correlation target. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will not be informed on which target they have been assigned to. whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Transcranial Magnetic Stimulation (TMS) measure: sgACC Blood Oxygen Level Dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs TMS Off) measure: Change in sgACC evoked response Pre/Post TMS treatment with positive and negative sgACC correlated targets sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Almaris Figueroa-González role: CONTACT email: almaris.figuera-gonzalez@pennmedicine.upenn.edu name: Ethan Hammett role: CONTACT email: ethan.hammett@pennmedicine.upen.edu name: Desmond J Oathes, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06266377 id: 11122023 briefTitle: AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-06-01 date: 2025-11-30 date: 2024-02-20 date: 2024-02-20 name: University of Pavia class: OTHER name: Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA) briefSummary: The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Non-randomized multi-center intervention with a single arm. Study participants will receive new adapted canteen menus according to the nutritional and sensory needs of the target population. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 200 type: ESTIMATED name: Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder name: Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder measure: Food acceptance of canteen menus by individuals enrolled in the study measure: Reduction in food selectivity as a result of the targeted nutrition education course sex: ALL minimumAge: 5 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Milano Ristorazione S.p.A. city: Milano zip: 20139 country: Italy lat: 45.46427 lon: 9.18951 facility: Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci". city: Roma zip: 00178 country: Italy lat: 41.89193 lon: 12.51133 facility: Istituto Tecnico Agrario Statale "Giuseppe Garibaldi" city: Roma zip: 00178 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06266364 id: IRB-24-22 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-20 date: 2024-03-05 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06266351 id: LASIKIOP briefTitle: EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS overallStatus: NOT_YET_RECRUITING date: 2024-02-12 date: 2024-06-01 date: 2024-08-01 date: 2024-02-20 date: 2024-02-20 name: Intuor Technologies, Inc. class: INDUSTRY briefSummary: The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes. conditions: Glaucoma conditions: Ocular Hypertension conditions: Normal Tension Glaucoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: This is observational IOP measurement measure: IOP measurement difference between CATS and GAT in LASIK patients sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arizona Eye Consultants city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Eye Specialty Group city: Memphis state: Tennessee zip: 38120 country: United States name: Sean Dodson role: CONTACT phone: 520-327-3487 email: sjmccafferty66@hotmail.com lat: 35.14953 lon: -90.04898 hasResults: False
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<|newrecord|> nctId: NCT06266338 id: STU-2023-1118 briefTitle: Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix) overallStatus: RECRUITING date: 2024-03-11 date: 2025-10-31 date: 2026-10-31 date: 2024-02-20 date: 2024-03-13 name: University of Texas Southwestern Medical Center class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The main purpose of this study is to gather information about an investigational drug combination, Lenvatinib in combination with pembrolizumab, that may help to treat cervical cancers. In this study, we are looking to see whether the combination of lenvatinib and pembrolizumab has any effect on slowing tumor growth in cervical cancer tumors. conditions: Cervix Cancer conditions: Cervical Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Pembrolizumab name: Lenvatinib measure: Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1 measure: Progression Free Survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors v1.1 sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Annette Paulsen role: CONTACT phone: 214-648-7097 role: CONTACT email: annette.paulsen@utsouthwestern.edu lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06266325 id: 6138 briefTitle: Development and Validation of a Dementia Life Expectancy Tool overallStatus: COMPLETED date: 2010-04-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-03-04 name: University of Toronto class: OTHER name: Sunnybrook Research Institute name: Ottawa Hospital Research Institute name: ICES briefSummary: Individuals with dementia and their caregivers are faced with challenging decisions throughout the course of the disease. These decisions may be about medical care (e.g., continuation of routine cancer screening, pursuit of cardiopulmonary resuscitation, initiation of palliative care services), institutionalization (i.e., transition to a long-term care facility), or financial planning. These inherently difficult decisions are made more difficult by prognostic uncertainty. Indeed, life expectancy is challenging to predict in dementia. Consequently, prognosis is infrequently discussed by healthcare providers with individuals with dementia and their families, which compromises their ability to plan for the future. A lack of prognostic awareness makes it difficult for patients, their caregivers, and their healthcare providers to make medical decisions that strike the appropriate balance between prolonging life and promoting the quality of it. A clinical prediction tool has the promise to provide personalized and accurate estimations of life expectancy in individuals with dementia. Therefore, similar to the existing clinical prediction tools on our Project Big Life platform (www.projectbiglife.ca), we seek to create and to test a statistical model to predict survival, and to implement the model as a user-friendly, web-based calculator. The calculator will use self-reported sociodemographic, clinical, cognitive, functional, and nutritional information that is entered by patients, their caregivers, and/or their healthcare providers to output an estimated life expectancy. This estimate could inform the shared decision-making process, thereby empowering decisions that are compatible with a patient's clinical reality and concordant with their life goals. conditions: Dementia conditions: Death studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 202217 type: ACTUAL name: There is no intervention. Exposures are predictor variables of mortality. measure: Mortality sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266312 id: Maastricht UMC+ briefTitle: Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer acronym: APRIORI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-02-20 date: 2024-02-20 name: Maastricht University Medical Center class: OTHER name: Nationaal Fonds tegen Kanker briefSummary: The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy. conditions: Breast Cancer conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A prospective, single-centre, longitudinal mixed-methods feasibility study will be performed to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer. primaryPurpose: PREVENTION masking: NONE count: 11 type: ESTIMATED name: A multimodal prehabilitation programme measure: Recruitment rate (%) measure: Characteristics of included participants measure: Attendance rate for MIET sessions (%) measure: Adherence rate, exercise relative dose intensity (ExRDI) MIET (%) measure: Reasons for not having executed a training session as intended measure: Attendance rate HIIT + strength sessions (%) measure: Adherence rate, ExRDI HIIT training (%) measure: Adherence rate, ErXDI strength training (%) measure: Attendance rate for dietary consultations (%) measure: Percentage of use of the digital food diary 'Mijn Eetmeter'(%) measure: Percentage of days on which nutritional requirements were achieved (%) measure: Reasons for not achieving the nutritional requirements as intended measure: Drop-out rate (%) measure: Time point of drop-out measure: Reasons for drop-out measure: Serious adverse events (SAE) measure: Study related adverse events measure: Acceptance - Experiences with the multimodal lifestyle intervention measure: Acceptance - Suitability of the multimodal lifestyle intervention and study procedures measure: Acceptance - Barriers and enablers regarding participation in the study measure: Fatigue measure: Cardiorespiratory fitness measure: Muscle strength measure: Nutritional status measure: Weight (kg) measure: Height (cm) measure: Body Mass Index (BMI) measure: Energy and protein intake (absolute kcal and gr and gr/kg body weight per day) measure: Energy requirements (kcal) measure: Protein requirements measure: Circumference of upper arm and waist (cm) measure: Chemotherapy Relative Dose Intensity (RDI) measure: Treatment-related Side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266299 id: 2269-001 briefTitle: A Study of KK2269 in Adult Participants With Solid Tumors overallStatus: RECRUITING date: 2024-01-25 date: 2027-12 date: 2027-12 date: 2024-02-20 date: 2024-04-26 name: Kyowa Kirin, Inc. class: INDUSTRY briefSummary: This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.
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In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.
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In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible. conditions: Advanced Solid Tumor conditions: Metastatic Solid Tumor conditions: Gastric Adenocarcinoma conditions: Gastroesophageal Junction Adenocarcinoma conditions: Esophageal Adenocarcinoma conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 71 type: ESTIMATED name: KK2269 name: Docetaxel measure: Number of Subjects Experiencing Dose-limiting Toxicity measure: Number of Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center Hospital East status: RECRUITING city: Kashiwa City state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 facility: National Cancer Center Hospital status: RECRUITING city: Chuo-ku state: Tokyo zip: 104-0045 country: Japan lat: 35.57779 lon: 139.71685 hasResults: False
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<|newrecord|> nctId: NCT06266286 id: 2022-A00233-40 briefTitle: EXOPULSE Mollii Suit & Cerebral Palsy acronym: EXOCEP overallStatus: RECRUITING date: 2023-09-13 date: 2025-06-30 date: 2025-10-30 date: 2024-02-20 date: 2024-02-20 name: Institut De La Colonne Vertebrale Et Des Neurosciences class: OTHER briefSummary: Spasticity is a frequent and debilitating symptom in patients with cerebral palsy. It can alter the patients' balance, mobility, as well as their quality of life (QoL). The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous electric nerve stimulation using EXOPULSE Mollii suit, might be of help in this context. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The investigators designes a randomized crossover, sham-controlled, double- blind trial to demonstrate the improvement of motor functions and cerebral palsy related symptoms following two weeks of daily sessions of "active" versus "sham" EXOPULSE Mollii suit. A two-week washout period should be enough to prevent a potential carry- over effect.
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Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit and will consist of six months of active stimulation (sessions performed on a daily basis with the same parameters used for the active session in phase 1) on cerebral palsy related symptoms.
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Summary:
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* Phase 1: randomized sham controlled crossover study (active versus sham condition)
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* Phase 2: Open label study (active condition) primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: EXOPULSE MOLLII SUIT (active) name: EXOPULSE MOLLII SUIT (sham) measure: Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation measure: Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS measure: Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS) measure: Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG) measure: Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y) measure: Pain will be assessed using the Pain Scale Chart (PSC) measure: Evaluation of overall improvement using the Clinical Global Impression (CGI) sex: ALL minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Centre Hospitalier Intercommunal D'Aix Pertuis status: RECRUITING city: Aix-en-Provence country: France name: PASCAL GRANIER, MD role: PRINCIPAL_INVESTIGATOR name: HELENE RAUSCENT, MD role: SUB_INVESTIGATOR lat: 43.5283 lon: 5.44973 facility: Centre Medico Chirurgical de Readaptation Des Massues status: NOT_YET_RECRUITING city: Lyon country: France name: EMMANUELLE CHALEAT - VALAYER, MD role: PRINCIPAL_INVESTIGATOR name: Marie-Charlotte D'ANJOU, MD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Centre de Sante Rossetti status: RECRUITING city: Nice country: France name: GAUTIER DE CHELLE, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Centre de Readaptation Pediatrique D'Oleron status: RECRUITING city: Saint-Trojan-les-Bains country: France name: SOLENE VIOT, MD role: PRINCIPAL_INVESTIGATOR lat: 45.84134 lon: -1.20728 hasResults: False
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<|newrecord|> nctId: NCT06266273 id: SBA 23/442 briefTitle: Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-20 name: Hacettepe University class: OTHER briefSummary: "Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale" is crucial in determining the specific functional status of the shoulder joint, especially for overhead athletes experiencing shoulder pain, to identify which sporting activities restrict them the most and to fill the gap in the literature. Additionally, visually indicating activities through photographs will provide visual feedback, making it easier to assess functional status. Our study aims to develop a specific functional survey for the shoulder joint in overhead athletes, examine the validity and reliability of this scale, and contribute to the literature. conditions: Questionnaire conditions: Athletes conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 170 type: ESTIMATED name: No intervention measure: Investigating the Development, Validity, and Reliability of The Sports Activity Avoidance Photo Scale sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Elif Turgut status: RECRUITING city: Ankara zip: 06300 country: Turkey name: Elif Turgut, Assoc. Prof. role: CONTACT phone: +90 (544) 264 56 00 email: elif.turgut.pt@gmail.com name: Birgül DINGIRDAN, Master role: SUB_INVESTIGATOR name: Büşra PAKÖZ, Master role: SUB_INVESTIGATOR name: Kübra ÇAYLAN GÜRSES, Master role: SUB_INVESTIGATOR name: Pınar KUYULU HAKSAL, Master role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06266260 id: 5486 briefTitle: Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP) acronym: EVADIPP overallStatus: RECRUITING date: 2023-09-11 date: 2025-04-01 date: 2026-04-01 date: 2024-02-20 date: 2024-02-20 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement. conditions: Portal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: EUS PPG measurement measure: Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs) measure: Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs) measure: Markers of hemodynamic response measure: Markers of hemodynamic response measure: Markers of hemodynamic response sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Policlinico Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Francesco Santopaolo, MD role: CONTACT phone: +393492754288 email: francesco.santopaolo@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06266247 id: 06-2023/16 id: KMU-BAP type: OTHER domain: KMU briefTitle: How Sirtuin Levels Change During Behçet Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-06-30 date: 2024-10-30 date: 2024-02-20 date: 2024-02-20 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Our primary aim in our study is to evaluate the relationship between the activity, which will be evaluated by clinical and standard phase reactants, and the IL-6 and TNF-α levels, which will be measured in serum, in Behçet\'s patients. Our secondary aim was to evaluate Sirtuin-1 in Behcet\'s patients and compare it with the normal population. Our third aim is to find out whether there is a relationship between these values and organ involvement. conditions: Behçet Disease conditions: Inflammation conditions: Vasculitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 60 type: ESTIMATED name: Take blood samples measure: Our primary aim is to evaluate the relationship between the activity to be evaluated with clinical and standard acute phase reactants and the IL-6 and TNF-α levels to be measured in serum in Behçet's patients. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karamanoğlu Mehmetbey University city: Karaman country: Turkey lat: 37.18111 lon: 33.215 hasResults: False
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<|newrecord|> nctId: NCT06266234 id: APHP230600 id: 10723253 Bis type: OTHER domain: CESREES briefTitle: Characterization by Automated System on Infantile Spasmes acronym: REASSESS overallStatus: RECRUITING date: 2024-02-01 date: 2026-01 date: 2026-01 date: 2024-02-20 date: 2024-03-13 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: OSO-AI briefSummary: Infantile spasms are defined by the occurrence of epileptic episodes characterized by the appearance of very specific motor seizures, made up of rapid, repeated contractions in flexion or extension known as spasms. This syndrome is of high concern as it will lead to mental retardation if it is not early identified and treated. Most often, spasms are characterized by sudden contractions of the body in flexion. More rarely, spasms occur in extension: the neck and legs suddenly tense, and the arms move upwards or sideways. Spasms may be accompanied by eye revulsion. They are brief, lasting 0.5 to 2 seconds each. At the start of the attack, they may be isolated, but then may occur in series lasting up to several tens of minutes.
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Because of its nature and duration, infantile spasm is often difficult to identify and is often confused with benign motor manifestations in children, such as hiccups or muscular jerks. This difficulty often leads to delays in diagnosis. Indeed, patients are often seen at the stage when cognitive regression has set in.
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The gold standard for diagnosing infantile spasms is to capture them on video-EEG to confirm the ictal correlate of the seizure. Although multiple variations are known, the ictal correlation is often a diffuse slow wave of high amplitude with subsequent electrodecrement. Yet continuous video electroencephalogram is an expensive and time-consuming resource often unavailable in developing countries and in many parts of the developed world. Furthermore, in an appropriate clinical scenario, continuous video-EEG may be unnecessary. For example, a home video examination with typical spasms combined with a definitively epileptic ambulatory EEG may certainly be adequate for the diagnosis of infantile spasms
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As part of Mr. Diop's thesis, the study team have developed a system for analyzing videos acquired in 2 dimensions from a simple smartphone or webcam and highlighting the existence of spasms in a child. The principle is to use computer vision and computer learning model to identify the spasms from these videos. The first prototype of this system achieved a positive predictive value of 77%, which is very good considering the small sample used (\< 100) but quite insufficient to obtain a diagnostic prediction for medical use, for which we hope for sensitivity and specificity of around 95%.
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The aim is to achieve a sensitivity and specificity of over 95% so that we can offer this detection system to healthcare professionals and parents of children who do not have rapid access to diagnosis. The aim is to develop a system enabling broad screening at the population level so that identified children can be more rapidly directed towards the healthcare system and appropriate treatment for their disease.
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To achieve this goal, we need access to a standardized reference database that currently exists in the various pediatric electrophysiology laboratories of the Assistance Publique - Hôpitaux de Paris and the Île-de-France region. we propose using the films stored in these laboratories to teach the computer to recognize spasms that have already been formally identified by electrophysiologists and by ictal concordance. conditions: Infantile Spasm studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 5000 type: ESTIMATED measure: Automated computer detection of the spasms > 95% measure: Automated computer detection of the non spasms > 95% sex: ALL maximumAge: 3 Years stdAges: CHILD facility: Department of paediatric neurological care and intensive care unity (PICU), Raymond Poincaré hospital - APHP status: RECRUITING city: Garches zip: 92380 country: France lat: 48.84226 lon: 2.18232 hasResults: False
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<|newrecord|> nctId: NCT06266221 id: APHP200073 id: 2022-000712-59 type: EUDRACT_NUMBER briefTitle: Severe Erythema Multiforme - CORTICO acronym: SEMCORTICO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-01 date: 2027-11-01 date: 2024-02-20 date: 2024-02-20 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Erythema multiforme (EM) is an acute and often recurrent mucocutaneous disease. EM is considered a hypersensitivity immune-mediated reaction. The two main known triggering factors are Herpes simplex virus (HSV) and Mycoplasma pneumoniae (MP) infections. Typical target skin lesions characterize EM, especially oral MMs. EM is in fact mainly linked to the oral MM involvement, including intense mucosal pain, impaired food intake, weight loss, hospitalization and potential risk of fibrotic sequelae (oral, ocular, genital, oesophageal, respiratory tract) and recurrences.
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The objectives of treatment for severe EM in the acute phase are to reduce the duration of lesions, prevent complications and mucosal sequelae. However, despite the lack of evidence and consensus some medical teams often use a short regimen of SCS hoping to obtain a quicker improvement of the condition. However, the use of SCS at the acute phase is not codified and remains debated according to the existent literature. Current studies are mostly retrospective and based on small cohorts or case reports. A randomized, controlled trial would be therefore essential to properly evaluate the benefit of SCS in this pathology and provide strong support to clinicians in their decision making in severe EM during the acute phase.
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This research will be a Phase III randomized, multicentric, double-blind, controlled trial with two parallel groups. The efficacy of prednisone, oral at 1 mg/kg/day for 3 days, tapered to 0.75 mg/kg/day for 3 days, 0.50 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days is compared to that of placebo, oral for 12 days or IV methylprednisolone if oral route is impossible because of the self-reported inability for the patient to swallow due to the impacts of the oral lesions, with dosage equivalence at 0.8 mg/kg/day for 3 days, tapered to 0.6 mg/kg/day for 3 days, 0.4 mg/kg/day for 3 days, 0.2 mg/kg/day for 3 days, then stopped, compared to that of placebo.
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A stratification according to the food intake classification (0,1,2 vs 3) will be performed.
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An interim analysis is planned after the inclusion of 50 patients. Results of the interim analysis will be presented to the DSMB. During the interim analysis, inclusions may continue. conditions: Erythema Multiforme studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Prednisone 20 Mg name: Oral Placebo name: Methylprednisolone 120 Mg name: IV Placebo measure: Time to success measure: Evaluation of Pain measure: Food intake measure: Rescue therapy intake measure: Time to clear or almost clear healing of all sites measure: Time to fever resolution measure: Length of hospital stay measure: Number of days of consumption of level III analgesics measure: Evaluation of pain measure: Chopped or solid food intake resumption measure: Rate of patients in the two groups with need for a rescue therapy measure: Rate of sequelae measure: Rate of adverse events during the treatment and follow-up measure: Evaluation of the quality of life sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266208 id: UCV/2021-2022/201 briefTitle: Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte overallStatus: RECRUITING date: 2024-03-20 date: 2024-04-15 date: 2024-07-15 date: 2024-02-20 date: 2024-04-23 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER briefSummary: This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.
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Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.
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The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.
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Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients. conditions: Exostosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Exostectomy name: Cut fingernail measure: Nail-phalange distance measure: Nail Curvature Index measure: Thickness of the nail plate measure: Dorsal Osteophyte Height sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Enieto podologos status: RECRUITING city: Logroño state: La Rioja zip: 26003 country: Spain name: Eduardo Nieto-Garcia, Dr role: CONTACT phone: 941 25 55 66 email: clinica@enietopodologos.com name: eduardo Nieto-Garcia, Dr role: CONTACT phone: 941 25 55 66 email: eduardo.nieto@ucv.es name: Eduardo Nieto-Garcia, Dr role: SUB_INVESTIGATOR lat: 42.46667 lon: -2.45 facility: Centro podológico Valencia status: RECRUITING city: Valencia state: València zip: 46001 country: Spain name: Martín Redón role: CONTACT phone: 96 352 63 41 email: info@podologomartinredon.com name: Emma Guillem-escámez role: CONTACT phone: 96 352 63 41 email: em_chec@mail.ucv.es name: emma Guillem-Escamez role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Clinicas UCV status: RECRUITING city: Valencia state: València zip: 46001 country: Spain name: Pablo Vera-Ivars, Dr. role: CONTACT phone: 963 92 06 24 email: clinicas.ucv@ucv.es name: Cristina Mico-Salcedo role: CONTACT phone: 963 92 06 24 email: clinicas.ucv@ucv.es name: Javier Ferrer-Torregrosa, Dr role: PRINCIPAL_INVESTIGATOR name: Juan Vicente-Mampel, Dr. role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Clinica Pasito a pasito status: RECRUITING city: Valencia zip: 46008 country: Spain name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 963855535 email: clinicaspasitoapasito@gmail.com name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 644733882 email: javier.ferrer@ucv.es name: JAVIER Ferrer- TORREGROSA, Dr role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06266195 id: 5452 briefTitle: Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared acronym: PROVEIR_1 overallStatus: RECRUITING date: 2023-03-15 date: 2023-12-31 date: 2025-02-28 date: 2024-02-20 date: 2024-02-20 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma. conditions: Vesicle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: sierological test measure: primary endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FPGemelliIRCCS status: RECRUITING city: Roma state: Lazio zip: 00168 country: Italy name: Fabrizio Pizzolante, MD PhD role: CONTACT phone: +390630151 email: fabrizio.pizzolante@policlinicogemelli.it name: Gabriele Ciasca, Professor role: CONTACT phone: +390630151 email: gabriele.ciasca@unicatt.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06266182 id: 2020/39/B/HS6/01927 briefTitle: The Effect of an Online ACT Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-04 date: 2024-02-20 date: 2024-02-22 name: University of Social Sciences and Humanities, Warsaw class: OTHER name: National Science Centre, Poland briefSummary: This trial aimed to test internet-based Acceptance and Commitment Therapy (ACT) intervention to induce a meaning-making process in cancer patients following hematopoietic cell transplantation (HCT). ACT includes identifying personal values and engaging in activities consistent with these values, developing acceptance, as well as focusing on the present moment or performing activities with greater awareness. In total, 192 patients following the first (autologous or allogeneic) HCT will be randomly assigned in equal numbers to either the ACT intervention or an education session. Participants in both conditions will take part in 14-day training (about 5-10 minutes a day). The outcomes will be measured at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. Moreover, 6-9 additional participants will be randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at each post-intervention measure. The researchers hypothesized that ACT intervention would foster a meaning-making process and thus reduce distress induced by the discrepancy between global and situational meaning as compared to education. conditions: Hematopoietic Cell Transplantation Recipient conditions: Acceptance and Commitment Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is enhanced by a single-case experimental design (SCED), in which all study participants will receive the same intervention (i.e., intervention study model: single group). In SCED, there is no masking. The estimated total number of participants to be enrolled in SCED is 6-9. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 192 type: ESTIMATED name: Acceptance and Commitment Therapy name: Education measure: Distress (Global Meaning Violation Scale; GMVS) measure: Illness perception (Brief-Illness Perception Questionnaire; B-IPQ) measure: Global meaning (Meaning in Life Questionnaire; MLQ) measure: Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9) measure: Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items) measure: Deliberate meaning-making (Core Beliefs Inventory; CBI) measure: Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale) measure: Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF ) measure: Meanings made (Meaning of Loss Codebook; MLC) measure: Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4) measure: Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items) measure: Loneliness (the Community Life Survey) measure: Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3) measure: Daily subjective health (Daily Subjective Health Scale) measure: Daily affect (Daily Positive and Negative Affect Scale) measure: Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form) measure: Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form) measure: Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maria Skłodowska-Curie National Research Institute of Oncology Gliwice Branch, Department of Bone Marrow Transplantation and Oncohematology city: Gliwice zip: 44-102 country: Poland name: Małgorzata Sobczyk-Kruszelnicka, MD role: CONTACT phone: 011 48 322788520 email: malgorzata.sobczyk-kruszelnicka@gliwice.nio.gov.pl name: Małgorzata Sobczyk-Kruszelnicka, MD role: SUB_INVESTIGATOR lat: 50.29761 lon: 18.67658 hasResults: False
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<|newrecord|> nctId: NCT06266169 id: fpc-2023-ivf-01 briefTitle: Application of Spectral Methods to Assess Gametes, Embryos, and Human Reproductive Capabilities overallStatus: RECRUITING date: 2023-09-20 date: 2024-02-28 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Family Planning Center of Women's Welfare Clinic #44 of Pushkin District class: OTHER_GOV briefSummary: Relevance of the research topic: At present, in the world, a kind of "plateau" in the efficiency of assisted reproductive technologies has been achieved, which ensures a birth rate of 30% per embryo transfer. At the same time, a relatively high (15-20%) and stable rate of miscarriages is preserved. Until now, no effective methods for assessing the potential of gametes and embryos, as well as human reproductive capabilities, have been offered. In these conditions, to increase the rate of births after IVF, clinicians have to increase the number of transferred embryos at a time, however, this leads to a sharp increase in complications of IVF, such as multiple pregnancy. In addition, until today, the clinical effectiveness of assessing the potential of endometrium using gene expression determination methods has not been shown. Therefore, to ensure the effectiveness and safety of infertility treatment, it is necessary to develop methods for predicting the potential of gametes and embryos, as well as human reproductive capabilities. For this purpose, the investigators assume to use Raman spectroscopy of the environment obtained from the objects of research, as well as fluorescent spectroscopy of endometrium. The objects of the research are gametes (spermatozoa) and embryos, used culture medium, endometrium. The subject of the study is the set of factors, that exists in the objects of research and their ability to determine the outcomes of infertility treatment. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: For the retrospective (observational) stage of the study:
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Embryos: 424 samples of the culture medium used from individually cultured blastocysts that were fresh and frozen before transferring a single embryo from the institution's internal biobank. Each sample is attributed based on the presence or absence of progressing pregnancy after transfer at 12-14 weeks.
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Semen: 340 samples of sperm from the internal biobank of couples undergoing ICSI, each sample is attributed based on the success or failure of the embryological stage.
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Endometrium: 300 samples of luminescent and visible spectra of patients' endometrium undergoing embryo transfer, each sample is attributed based on the presence or absence of ongoing pregnancy after transfer.
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For the prospective (interventional) stage of the study:
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For each object of study, the size of the dataset for prospective testing can only be determined after passing the observational part of the study. primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 1064 type: ESTIMATED name: making artificial intelligence based decisions of gamete, embryo and endometrial potential measure: Embryonic model performance measure: Gamete model performance measure: Endometrial model performance measure: Embryonic model clinical efficiency measure: Endometrial model clinical efficiency sex: ALL minimumAge: 20 Years maximumAge: 44 Years stdAges: ADULT facility: Family planning center status: RECRUITING city: Saint Petersburg state: Pushkin zip: 196608 country: Russian Federation name: Alexey Gryaznov role: CONTACT phone: +7(812)414-57-09 email: libra19831010@mail.ru lat: 59.93863 lon: 30.31413 hasResults: False
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<|newrecord|> nctId: NCT06266156 id: BMU-HTUNC-01 briefTitle: Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients overallStatus: COMPLETED date: 2023-08-05 date: 2023-11-03 date: 2023-12-27 date: 2024-02-20 date: 2024-02-20 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: The goal of this observational study is to learn about in effect of consecutive dental visits on dental anxiety of paediatric patients.
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The main question\[s\]it aims to answer are:
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* Did the anxiety level of pediatric patients decrease in consecutive treatment sessions?
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* Were there changes in the physiological parameters related to stress level of pediatric patients in consecutive treatment sessions?
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Participants will fill out the questionnaire about dental anxiety in each dental treatment sessions before and after dental treatment.
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Researchers will compare paeditric patients have two caries on mandibular molars to see if changes dental anxiety levels and physiological parameters such as heart rates and oxygen saturations during dental treatments in consecutive dental treatment sessions. conditions: Dental Anxiety studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 240 type: ACTUAL name: Score of anxiety questionnaire name: Heart rate name: Oxygen saturation measure: Determination of sample size. measure: Inviting participants to the study. measure: Determination of dental anxiety score of participants before dental treatment in first dental session measure: Heart rate measuring in first dental session. measure: Oxygen saturation measuring in first dental session. measure: Determination of dental anxiety score of participants after dental treatment in first dental session measure: Determination of dental anxiety score of participants before dental treatment in second dental session measure: Heart rate measuring in second dental session. measure: Oxygen saturation measuring in second dental session. measure: Determination of dental anxiety score of participants after dental treatment in second dental session sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: Burdur Mehmet Akif Ersoy University Faculty of Dentistry city: Burdur state: Centrum zip: 15100 country: Turkey lat: 37.72028 lon: 30.29083 hasResults: False
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<|newrecord|> nctId: NCT06266143 id: Y101D03 briefTitle: A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-08 date: 2024-07-30 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Wuhan YZY Biopharma Co., Ltd. class: INDUSTRY briefSummary: The Phase Ib/II study is an open-label, single-arm, multicenter trial designed to assess the efficacy and safety of Y101D in combination with Gemcitabine and Albumin Paclitaxel as first-line systemic treatment for advanced pancreatic cancer patients. The Phase Ib portion of the study aims to evaluate the safety of escalating doses of Y101D in combination with the standard regimen of Gemcitabine and Albumin Paclitaxel and determine the recommended phase 2 dose (RP2D). The Phase II portion of the study aims to evaluate the effectiveness of this combination treatment in a small population of patients. conditions: Advanced Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 71 type: ACTUAL name: Y101D measure: Dose Limiting Toxicities (DLTs) measure: RP2D measure: Objective Response Rate (ORR) measure: Peak Serum Concentration (Cmax) measure: Trough Serum Concentration (Ctrough) measure: Area under the serum concentration versus time curve (AUC) during one treatment cycle (21 days) measure: The TGF-β concentration in serum measure: The CA19-9 concentration in serum measure: The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06266130 id: EM-11-050087 briefTitle: Digital Bonding vs. Direct Bonding Study overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2026-08 date: 2024-02-20 date: 2024-02-20 name: 3M class: INDUSTRY briefSummary: This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets. conditions: Orthodontic Brackets studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups, treatment group (digital bonding) and control group (direct bonding). Subjects will be enrolled and randomized into treatment or control group at each orthodontic practice. primaryPurpose: OTHER masking: NONE maskingDescription: Due to the nature of the devices, Investigator blinding is not feasible for the study. count: 178 type: ESTIMATED name: Treatment Group Digital Bonding Tray name: Control Group Direct Bonding measure: Prep-and-bonding time measure: Number of adjustment visits to complete treatment measure: Overall chair time sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266117 id: SBF-HMS-GES-03 briefTitle: Pain, Anxiety, and Comfort Levels in Coronary Angiography overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-03-30 date: 2024-07-30 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER briefSummary: The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit. conditions: Pain conditions: Anxiety conditions: Nursing Caries studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 216 type: ESTIMATED measure: Pain level measure: Anxiety measure: Comfort sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abant Izzet Baysal University Faculty of Health Science city: Bolu state: Merkez zip: 14100 country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False
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<|newrecord|> nctId: NCT06266104 id: Protocol V1.4_04012024 briefTitle: Image Enhanced Endoscopy IBD overallStatus: RECRUITING date: 2024-04-03 date: 2025-12-31 date: 2026-03-01 date: 2024-02-20 date: 2024-04-12 name: Royal Perth Hospital class: OTHER briefSummary: Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future. conditions: Inflammatory Bowel Diseases conditions: Dysplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: INVESTIGATOR count: 270 type: ESTIMATED name: Image Enhanced Endoscopy Filters measure: Dysplasia Detection Rate measure: Withdrawal times measure: Characterisation of lesions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Perth Hosptial status: RECRUITING city: Perth state: Western Australia zip: 6000 country: Australia name: Sherman Picardo, MBBS role: CONTACT phone: 92242244 lat: -31.95224 lon: 115.8614 hasResults: False
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<|newrecord|> nctId: NCT06266091 id: M70102 briefTitle: Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-24 date: 2024-03-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Wuhan YZY Biopharma Co., Ltd. class: INDUSTRY briefSummary: A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy. conditions: Malignant Ascites studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: M701 name: paracentesis measure: Puncture-free survival, PuFS measure: objective response rate (ORR) of malignant ascites measure: Progression-free Survival, PFS measure: Overall survival, OS measure: Quality of Life, QoL measure: Safety profiles measure: Positive rate of ADA and Nab in serum measure: The EpCAM expression in ascites measure: Trough serum concentration (Ctrough) measure: Peak serum concentration (Cmax) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100141 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06266078 id: School of Nursing briefTitle: A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-12-15 date: 2024-02-20 date: 2024-02-20 name: University of Campinas, Brazil class: OTHER briefSummary: Background: Many factors influence Personal Protective Equipment (PPE) compliance for use in health care, specifically the PPE usability and related human factors. It is known that issues related to the usability of new technologies, including professional behavioral and attitudinal patterns, the technologies adoption within the workflow and teamwork strengths can be investigated by using Simulation-Based Research (SBR) before its implemented. This study aims to develop and validate a simulation protocol for the assessment of human factors and usability of innovative PPEs used in critical care units. The ultimate goals is to define a standard method for PPEs assessment and comparison worldwide. Method: methodological study with a quantitative approach to be carried out in two phases: a) development and validation by experts of a simulation protocol; b) piloting of the simulation protocol. For the protocol validation phase, 14 experts with experience in the themes of infection prevention and control or clinical simulation will be included. The experts will be invited via email and will assess the simulation protocol content using the criteria of pertinence, clarity and relevance. To ensure that the simulation protocol is feasible and reliable, a piloting phase will take place at the simulation center in São Paulo and 36 health professionals with work experience in critical care units will be included. The health professionals will perform specific tasks assigned to them, wearing pre-defined PPEs in each simulation round. Errors and difficulties during PPE assembly, donning and doffing; performance of individual and team activities, as well as communication problems and self-contamination risk, will be observed during the tasks. At the end of the simulation round, the participants will take part in a debriefing, where they will answer questionnaires about comfort, perception of safety, thermal sensations, usability and perceived workload related to the PPE used. Content validity index (CVI) and intraclass correlation coefficient (ICC) will be calculated. This study protocol was approved by the Research Ethics Committee of the School of Nursing, University of São Paulo. The informed consent form will be applied both to the experts and to the health care workers. conditions: Personal Protective Equipment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Firstly, a minimum of 14 experts will validate the content, using the Delphi technique of two tools (A) The innovative PPE assessment tool; and B) the simulation scenario script.
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After reaching consensus among the experts, the protocol will be piloted. Two identical sessions will be conducted using the cross-over method with all participants, so that the same participant performs the tasks using the innovative PPE and the comparative PPE, allowing the participants compare characteristics of both PPE. The PPE use sequence and the PPE type will be randomized to minimize biases. Between both sessions there will a 30-minute break for the participants.
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For the purpose of the development and piloting of this simulation protocol, the innovative PPE were selected according to compliance with the specifications required by the World Health Organization. It will enrolled 36 healthcare workers in piloting test. primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 9 type: ESTIMATED name: Innovative PPE name: Traditional PPE measure: Content Validity of the items included in the "Innovative PPE assessment tool" and in the "Simulation scenario script" measure: Errors during PPE assembly/preparation, donning and doffing measure: Communication impairments while using PPE measure: Self-contamination risk in the professional while using and doffing the PPE measure: Influence of PPE on individual performance measure: Influence of PPE on team performance and behavioral changes measure: Changes in mobility and comfort while using PPE measure: Thermal sensations measure: Perception regarding safety and satisfaction of the PPE user measure: Perceived workload measure: Usability measure: Complementary Content Analysis - qualitative data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266065 id: 8.1-23/260-2;02/013AG briefTitle: Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia overallStatus: RECRUITING date: 2024-02-27 date: 2026-06 date: 2026-06 date: 2024-02-20 date: 2024-03-06 name: Clinical Hospital Centre Zagreb class: OTHER briefSummary: The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
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