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Purpose: This study aims to evaluate the effect of antigravity treadmill training on pain, gait characteristics, and function in patients with knee osteoarthritis. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study included 40 patients with knee osteoarthritis who were randomly assigned to one of two groups: the antigravity treadmill group (n=20) or the control group (n=20). For 12 weeks, the antigravity treadmill group received training on the Alter G treadmill (75% weight-bearing, 30 minutes per session, three times per week) combined with traditional physical therapy. During the same period, the control group received only traditional physical therapy. The Visual Analogue Scale, Walkway System, and the Western Ontario and McMaster Universities Arthritis Index were used to assess pain, spatiotemporal gait parameters, and patient function, respectively. All outcome measures were obtained pretreatment, post-treatment primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients were randomly assigned to either the antigravity treadmill group (n = 20) or the control group (n = 20 ) using an online randomization website (www.randomization.com). The control group received a conventional physical therapy program. The therapists responsible for measuring and assessing the outcomes remained blinded to the group assignments. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: antigravity treadmill name: physical therapy exercise program measure: Assessment of patient pain measure: Evaluation of gait parameters (step length) measure: Evaluation of gait parameters (step time) measure: Evaluation of gait parameters (velocity) measure: Evaluation of patient function sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347679 id: WCHSIRB-CT-2024-160 briefTitle: Effects of Aromatherapy on Anxiety and Pain During Dental Treatments in Adults: a Randomized Controlled Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-04-04 date: 2024-04-04 name: Sichuan University class: OTHER briefSummary: Dental anxiety is a common problem in dental care. The aim of this protocol is to evaluate the effect of orange and tea essential oil for the control of anxiety and pain in adults during dental treatments. conditions: Dental Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Aroma diffuser with single-note sweet orange essential oil name: Aroma diffuser with single-note tea tree essential oil name: Aroma diffuser with water measure: Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS) measure: Pain scale - Visual Analog Scale (VAS) measure: Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S) measure: Vital sign 1 - systolic blood pressure (SBP) measure: Vital sign 2 - diastolic blood pressure (DBP) measure: Vital sign 3 - heart rate (HR） measure: Vital sign 4 - oxygen saturation (SpO2） sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06347666 id: 23082905 briefTitle: Coaching in Early Development Project overallStatus: RECRUITING date: 2024-01-12 date: 2025-02 date: 2025-07 date: 2024-04-04 date: 2024-04-04 name: Rush University Medical Center class: OTHER briefSummary: Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. We will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff. conditions: Developmental Delay studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One group will receive the caregiver coaching intervention. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Caregiver coaching measure: Parenting Sense of Competence Scale measure: Parenting Stress Scale measure: Mullen Scales of Early Learning measure: Maternal Behavior Responsivity Scale sex: ALL minimumAge: 12 Months maximumAge: 6 Years stdAges: CHILD facility: Rush University Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Lauren Little role: CONTACT phone: 312-942-1759 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
<|newrecord|> nctId: NCT06347653 id: 2023KT127 briefTitle: Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL) overallStatus: RECRUITING date: 2023-11-28 date: 2027-01-31 date: 2030-01-31 date: 2024-04-04 date: 2024-04-04 name: Peking University class: OTHER briefSummary: This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients. conditions: Nodal T-follicular Helper Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: linperlisib combined with CHOP regimen measure: progression-free survival measure: ORR measure: CR rate measure: Success rate of stem cell collection measure: overall survival (OS) measure: time to next anti-lymphoma treatment measure: adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bejing Cancer Hospital status: RECRUITING city: Beijing state: Beijing country: China name: PING WEI LIU, master role: CONTACT phone: 0086-13522796323 lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06347640 id: KingAbdullahUH2 briefTitle: Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin overallStatus: RECRUITING date: 2023-04-01 date: 2025-12-01 date: 2027-12-01 date: 2024-04-04 date: 2024-04-04 name: King Abdullah University Hospital class: OTHER name: Jordan University of Science and Technology briefSummary: Regenerative endodontic procedures are intended to replace damaged tooth structures, including dentine and root structures, in addition to cells of the pulp-dentine complex. This treatment modality have been tested on immature necrotic teeth because they are anticipated to have a greater chance of pulp tissue regeneration.
However, it has been recently suggested for treating fully formed mature necrotic permanent teeth with closed apices since the conventional root canal treatment yielded many drawbacks.
A number of studies have evaluated the regeneration outcomes of using blood clot as a scaffold. However, there are limited studies in the literature on using other scaffolds such as platelet-rich fibrin (PRF).
This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth. Fifty patients with necrotic mature teeth with periapical lesions will be invited to participate in this study. Teeth will be treated using calcium hydroxide as intracanal medicament then using PRF (n=25) and blood clot (n=25) as scaffold. All teeth will be sealed coronally using NeoMTA Plus™. Treated teeth will be assessed clinically and radiographically using 2D periapical radiographs. The reported clinical and radiographic outcomes will be compared using SPSS. conditions: Pulp Revascularization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: induced bleeding name: plasma rich fibrin measure: Complete healing measure: regain the pulp sensibility sex: ALL minimumAge: 12 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Jordan University of Science and Technology status: RECRUITING city: Irbid zip: POBOX 3030 country: Jordan name: Lama A Awawdeh role: CONTACT phone: 0795412954 email: [email protected] lat: 32.55556 lon: 35.85 hasResults: False
<|newrecord|> nctId: NCT06347627 id: UW23139 briefTitle: Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18 overallStatus: ENROLLING_BY_INVITATION date: 2023-12-22 date: 2024-12 date: 2024-12 date: 2024-04-04 date: 2024-04-04 name: The University of Hong Kong class: OTHER name: London School of Hygiene and Tropical Medicine name: Nagasaki University briefSummary: This study aims to comprehensively assess confidence in and acceptance of human papillomavirus (HPV) vaccines among Japanese parents and caregivers with daughters aged 12-18 and their decision-making process. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1600 type: ESTIMATED name: Group 1 (I x S x S x F) name: Group 2 (O x S x S x F) name: Group 3 (I x E x S x F) name: Group 4 (O x E x S x F) name: Group 5 (I x S x S x M) name: Group 6 (O x S x S x M) name: Group 7 (I x E x S x M) name: Group 8 (O x E x S x M) name: Group 9 (I x S x D x F) name: Group 10 (O x S x D x F) name: Group 11 (I x E x D x F) name: Group 12 (O x E x D x F) name: Group 13 (I x S x D x M) name: Group 14 (O x S x D x M) name: Group 15 (I x E x D x M) name: Group 16 (O x E x D x M) measure: Willingness to receive HPV vaccines for daughters measure: Confidence in HPV vaccine safety sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London School of Hygiene and Tropical Medicine city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<|newrecord|> nctId: NCT06347614 id: 2021-FXY-042 briefTitle: Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study acronym: Two-step RP overallStatus: ACTIVE_NOT_RECRUITING date: 2021-09-01 date: 2024-12-01 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Sun Yat-sen University class: OTHER briefSummary: The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising? conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: Two-step Radical Prostatectomy measure: Biochemical Recurrence-free Survival measure: Surgical time measure: Estimated blood loss measure: Hospital stay measure: Continence ContinenceContinence Continence Continence Continence Continence Continence Continence Continence measure: Lower urinary tract symptoms measure: Erectile function measure: Positive surgical margin rate measure: Complication sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China lat: 23.11667 lon: 113.25 hasResults: False
<|newrecord|> nctId: NCT06347601 id: 2024-03-011AC briefTitle: Survey on Sexual and Gender in the Healthcare in Taiwan overallStatus: RECRUITING date: 2024-03-13 date: 2025-02-01 date: 2025-02-20 date: 2024-04-04 date: 2024-04-29 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: This study addresses the pervasive issue of sexual harassment within Taiwanese society, particularly within the medical field, where comprehensive research is lacking. The research objective is to explore patterns of sexual harassment and gender discrimination experiences among physicians and medical students in Taiwan, while also investigating potential associations with professional burnout and mental health. Employing a convergent mixed-methods design, the study combines quantitative surveys and qualitative in-depth interviews. While lacking a control group and utilizing non-blinding methods without random assignment, the study aims to recruit 1000 participants aged 18 or older, considering both valid responses and potential dropouts. Additionally, interviews will be conducted with 30 individuals who have experienced sexual harassment or are interested in gender issues. The research methods will assess sexual harassment experiences, professional burnout, and depressive symptoms as primary outcomes or indicators. conditions: Sexual Harassment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: Without Intervention measure: Center for Epidemiologic Studies Depression Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: Jheng-Min Yu, M.D. role: CONTACT phone: 0933238592 email: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False
<|newrecord|> nctId: NCT06347588 id: OBI&ICI briefTitle: Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-12 date: 2024-04-04 date: 2024-04-05 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study. conditions: Occult Hepatitis B Infection in Cancer Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA measure: To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV measure: Evaluation of the incidence of reactivation in patients during immunotherapy measure: Evaluation of the association between HBV-specific T-cell response and HBV reactivation measure: Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor characteristics (histology and stage) and type and line of treatment (immunotherapy, combined treatment with chemotherapy + immunotherapy). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs San Matteo Pavia city: Pavia state: PV zip: 27100 country: Italy name: Alessandra Ferrari role: CONTACT phone: 0382.503689 email: [email protected] name: ANGIOLETTA LASAGNA role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False
<|newrecord|> nctId: NCT06347575 id: APHP230522 briefTitle: Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients acronym: CAVERSTIM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2025-11 date: 2024-04-04 date: 2024-04-04 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Comphya SA briefSummary: The main objective of the study is to assess the safety and tolerability of cavernous nerve electrical stimulation in patients with spinal cord injured (SCI) by assessing and measuring complications.
As the secondary objectives, despite the limited cohort size, this long-term study aims to obtain preliminary data on efficacy of cavernous nerve stimulation to improve erectile function for sexual intercourse, as well as to assess patient's satisfaction using:
* Objective assessment of the erectile response upon CaverSTIM activation with the RigiScan device.
* Subjective assessment of the erectile function with validated questionnaires:
1. A 6-item self-report instrument assessing male erectile function (Erectile Function domain of the International Index of Erectile Function, IIEF-EF);
2. A log-diary five item questionnaire completed after each sexual attempt (Sexual Encounter Profile, SEP);
3. A self-reporting measure that scores erection hardness on a 4-point scale (Erection Hardness Score, EHS);
4. The Global Assessment Question (GAQ).
In addition, the study aims to refine the method of implantation (step-by-step delineation of all technical approaches for device implantation, including duration of surgical procedure, blood loss, methods to access the periprostatic region, tissue dissection, device placement and fixation) prior to planning for larger scale clinical investigation. conditions: Spinal Cord Injuries conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Implantation of the caverStim device measure: Safety evaluation measure: Pain assessement measure: Complications related to implantation surgery measure: Evaluation of IIEF-EF measure: Evaluation of EHS measure: Evaluation of SEP measure: Evaluation of GAQ sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of neurology-urology-andrology, Raymond Poincaré hospital - APHP city: Garches zip: 92380 country: France lat: 48.84226 lon: 2.18232 facility: Department of Urology, La pitié Salpêtrière Hospital - APHP city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 hasResults: False
<|newrecord|> nctId: NCT06347562 id: 934 briefTitle: Optical Genome Mapping for the Diagnosis of Neurodevelopmental Disorders overallStatus: RECRUITING date: 2022-06-15 date: 2025-06-14 date: 2025-06-14 date: 2024-04-04 date: 2024-04-04 name: IRCCS Eugenio Medea class: OTHER briefSummary: to evaluate the ability of the Optical genome Mapping (OGM) approach to detect simple and complex constitutional chromosomal aberrations of clinical relevance, which had previously been identified with standard diagnostic approaches (karyotyping, FISH, CNV-microarray) in the context of neurodevelopmental disorders (NDDs) with/wo congenital anomalies (CA) conditions: Neurodevelopmental Disorder (Diagnosis) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 58 type: ESTIMATED name: Optical Genome Mapping measure: Diagnostic concordance rate sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Scientific Institute E. Medea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Clara Bonaglia, PhD role: CONTACT phone: 031877913 phoneExt: +39 email: [email protected] lat: 45.80075 lon: 9.29 hasResults: False
<|newrecord|> nctId: NCT06347549 id: HE-SF2024/09 briefTitle: The Impact of Diaphragmatic Breathing Instructions and Inspiratory Pressures on Diaphragm Contraction in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2026-04-15 date: 2024-04-04 date: 2024-04-04 name: Hong Kong Metropolitan University class: OTHER briefSummary: This is a cross-sectional obsessional study.
This study aims (1) to investigate the relationship between sternocleidomastoid muscle recruitment and diaphragm thickness fraction during increasing inspiratory resistance in healthy adults; (2) to compare diaphragmatic and sternocleidomastoid muscle recruitment patterns with and without a standard diaphragmatic breathing instruction with increasing inspiratory resistance in healthy adults.
Participants will be asked to breathe through a pressure threshold inspiratory loading device under different inspiratory resistances with and without a standard diaphragmatic breathing instruction. sternocleidomastoid muscle activity will be measured with surface electromyography, and diaphragm thickness will be assessed with ultrasonography. conditions: Diaphragm studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 36 type: ESTIMATED name: Various intensities of inspiratory muscle training measure: Diaphragmatic thickening fraction measure: Muscle activation of the sternocleidomastoid muscle measure: Perceived Exertion Borg scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-25 uploadDate: 2024-03-28T00:38 filename: Prot_SAP_000.pdf size: 185477 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-25 uploadDate: 2024-03-28T00:39 filename: ICF_001.pdf size: 204027 hasResults: False
<|newrecord|> nctId: NCT06347536 id: IRAS331831 id: NIHR156698 type: OTHER_GRANT domain: NIHR HTA briefTitle: Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease acronym: RAPID overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12-31 date: 2027-12-31 date: 2024-04-04 date: 2024-04-19 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER name: King's College London name: University College, London name: Imperial College London name: University of Cambridge name: University of Southampton name: University of Nottingham name: University of Leicester name: Frimley Health NHS Foundation Trust name: Newcastle University name: University of Bristol name: Asthma and Lung UK briefSummary: Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality.
Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed.
A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum. conditions: COPD conditions: COPD Exacerbation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1400 type: ESTIMATED name: Supported rescue pack measure: Time to first all-cause readmission within 90 days of discharge measure: Time to and frequency of COPD-related readmissions at 30 and 90 days measure: Days alive and out of hospital at day 90 measure: Time to and frequency of all COPD exacerbations at days 30 and 90 measure: Cumulative systemic oral corticosteroids use over 90 days measure: Cumulative systemic antibiotic use over 90 days measure: Health care contacts at baseline, days 90 and 180, and 1 year measure: All cause readmission at 30 days measure: All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months measure: EQ-5D-5L Health questionnaire (quality of life) at days 90 and 180, and 1 year measure: Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at days 90 and 180 and 1 year measure: Qualitative interviews to examine and describe usual care measure: Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm measure: Serious adverse events measure: Antimicrobial resistance measure: Quality of life COPD assessment Test (CAT) score at days 90, 180 and 1 year sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Birminham NHS Foundation Trust city: Birmingham country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Blackpool Teaching Hospitals city: Blackpool country: United Kingdom lat: 53.81667 lon: -3.05 facility: Bradford Teaching Hospitals NHS Foundation Trust city: Bradford country: United Kingdom lat: 53.79391 lon: -1.75206 facility: University Hospitals Sussex NHS Foundation Trust city: Brighton country: United Kingdom lat: 50.82838 lon: -0.13947 facility: North Bristol University Trust city: Bristol country: United Kingdom lat: 51.45523 lon: -2.59665 facility: County Durham and Darlington NHS Foundation Trust city: Durham country: United Kingdom lat: 54.77676 lon: -1.57566 facility: East Suffolk and North Essex Foundation Trust city: Ipswich country: United Kingdom lat: 52.05917 lon: 1.15545 facility: University Hospitals of Morecambe Bay NHS Foundation Trust city: Lancaster country: United Kingdom lat: 54.04649 lon: -2.79988 facility: University Hospitals of Leicester NHS Trust city: Leicester country: United Kingdom lat: 52.6386 lon: -1.13169 facility: Cardiff and Vale University Health Board city: Llandough country: United Kingdom lat: 51.44556 lon: -3.44722 facility: Guy's and St Thomas' NHS Foundation Trust city: London country: United Kingdom name: Mona Bafadhel, Professor role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Royal Free London NHS Foundation Trust city: London country: United Kingdom name: John Hurst, Professor role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Maidstone and Tunbridge Wells NHS Trust city: Maidstone country: United Kingdom lat: 51.26667 lon: 0.51667 facility: South Tees NHS Foundation Trust city: Middlesbrough country: United Kingdom lat: 54.57623 lon: -1.23483 facility: Milton Keynes University Hospital NHS Foundation Trust city: Milton Keynes country: United Kingdom lat: 52.04172 lon: -0.75583 facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust city: Newcastle Upon Tyne country: United Kingdom lat: 54.97328 lon: -1.61396 facility: Northumbria Healthcare NHS Foundation Trust city: North Shields country: United Kingdom lat: 55.01646 lon: -1.44925 facility: Nottingham University Hospitals Trust city: Nottingham country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Oxford University Hospitals NHS Foundation Trust city: Oxford country: United Kingdom lat: 51.75222 lon: -1.25596 facility: Salisbury NHS Foundation Trust city: Salisbury country: United Kingdom lat: 51.06931 lon: -1.79569 facility: University Hospital Southampton NHS Foundation Trust city: Shirley country: United Kingdom lat: 52.41074 lon: -1.81952 facility: Frimley Health NHS Foundation Trust city: Slough country: United Kingdom lat: 51.50949 lon: -0.59541 facility: South Tyneside and Sunderland NHS Trust city: South Shields country: United Kingdom lat: 54.99859 lon: -1.4323 facility: Stockport NHS Foundation Trust city: Stockport country: United Kingdom lat: 53.40979 lon: -2.15761 facility: North Tees and Hartlepool NHS Foundation Trust city: Stockton-on-Tees country: United Kingdom lat: 54.56848 lon: -1.3187 facility: Sherwood Forest Hospitals NHS Foundation Trust city: Sutton In Ashfield country: United Kingdom lat: 53.12542 lon: -1.26135 facility: Somerset Foundation Trust city: Taunton country: United Kingdom lat: 51.01494 lon: -3.10293 facility: Somerset Foundation Trust city: Yeovil country: United Kingdom lat: 50.94159 lon: -2.63211 hasResults: False
<|newrecord|> nctId: NCT06347523 id: FirstShantou briefTitle: VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction overallStatus: RECRUITING date: 2024-04-02 date: 2024-10-01 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: First Affiliated Hospital of Shantou University Medical College class: OTHER briefSummary: Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group. conditions: Anterior Cruciate Ligament (ACL) Reconstruction conditions: Preoperative Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: The VR-based preoperative rehabilitation program; name: standard nursing care, measure: knee joint range of motion measure: Lysholm knee function score measure: SAS self-rating anxiety scale scale measure: SDS self-rating depression scale scale measure: Visual Analog Scale pain score measure: Barthel Index for basic activities of daily living measure: time to first ambulation post-surgery measure: postoperative complications measure: nursing satisfaction sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: "The First Affiliated Hospital of Shantou University Medical College status: RECRUITING city: Shantou state: Guangdong zip: 515000 country: China name: Zeshan Chen role: CONTACT phone: +8613592896271 lat: 23.36814 lon: 116.71479 hasResults: False
<|newrecord|> nctId: NCT06347510 id: E-25403353-050.99-174660 briefTitle: The Level of sST2 in Pediatric Heart Failure overallStatus: COMPLETED date: 2021-08-16 date: 2024-02-16 date: 2024-02-16 date: 2024-04-04 date: 2024-04-04 name: Eskisehir Osmangazi University class: OTHER briefSummary: Introduction: Suppression of tumorigenicity 2 (ST2) is a receptor member belongs to the Interleukin-1 (IL-1) family. The ligand and soluble versions are its two isoforms. The interleukin-33-ST2 ligand complexs development provides protection against heart fibrosis and hypertrophy. Investigations on heart failure in adults has demonstrated that it does not change by age, body mass index (BMI), creatinine, hemoglobin, and albumin levels, in contrast to NT pro brain natriuretric peptit. In adult heart failure patients, it has been demonstrated to be an independent predictor of mortality and cardiovascular events. The most recent guideline recommends using it as class 2b in the diagnosis of adult heart failure. Studies on ST2 in children are rare. The purpose of this study is to assess the prognostic value of ST2 for cardiovascular events in young individuals suffering from heart failure.
Method: The study included pediatric patients (0-18 years old) with congenital heart disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. Height, weight, gender, saturation, heart failure classification (Ross or New York heart Assosiation), medications taken, the electrocardiogram, echocardiography, Pro BNP, and sST2 values of the patients, as well as any hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery during follow-up Data on arrhythmia and death were gathered during a 1-year follow-up. The SPSS software application was used to carry out the statistical analysis. conditions: Congenital Heart Disease conditions: Congestive Heart Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 59 type: ACTUAL name: Suppression of tumorigenicity 2 (ST2) measure: Soluble suppression of tumorigenicity levels with or without major cardiovascular event measure: Pro BNP levels measure: Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery) sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Eskisehir Osmangazi University city: Eskisehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False
<|newrecord|> nctId: NCT06347497 id: 000001230988 briefTitle: Zonisamide Versus Topiramate in Migraine overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-02 date: 2025-05-01 date: 2024-04-04 date: 2024-04-24 name: Kafrelsheikh University class: OTHER briefSummary: Investigators aim to compare the effect of zonisamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency conditions: Migraine studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or topiramate and acetaminophen from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included zonisamide and acetaminophen, and Drug B included topiramate and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Zonisamide 50 MG name: Topiramate 50 MG measure: The change in migraine days per 28 days measure: The total number of migraine days after three months of treatment measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency. measure: HIT-6 score absolute reduction in each group after three months of treatment measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months. sex: ALL minimumAge: 10 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: [email protected] lat: 31.11174 lon: 30.93991 hasResults: False
<|newrecord|> nctId: NCT06347484 id: IRB00411716 briefTitle: Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT) acronym: CONNECT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-10 date: 2024-04-04 date: 2024-04-04 name: Johns Hopkins University class: OTHER name: Morgan State University name: American Heart Association briefSummary: The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning community that provides tailored education on cardiovascular (CV) health and research participation; connects community members to CV-related research; and disseminates CV-related study findings. The overreaching goal of CONNECT is to improve participation of underrepresented communities in CV research, including as women, Black adults, and Latino adults, through increasing participants' clinical trial awareness, trust in biomedical research, and willingness to participate in clinical trials. CONNECT will use digital and community-engaged approaches to identify and recruit 1000 adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on CV health and research participation via text message. Participants will also have the opportunity to be matched to ongoing CV research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The investigators hypothesize that CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials and that the proportion of Black and Latin adults and women enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment. conditions: Cardiovascular Diseases conditions: Hypertension conditions: Diabetes Type 2 conditions: Stroke conditions: Recruitment conditions: Overweight and Obesity conditions: Hyperlipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: Formal Toned Educational Messages name: Understanding Toned Educational Messages name: Casual Toned Educational Messages measure: Participant accrual measure: Participant accrual in partnering cardiovascular research studies measure: Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT) measure: Clinical trials awareness and knowledge will be assessed using items adapted from the Health Information National Trends Survey (HINTS) measure: Willingness to participate in research will be measured by asking participants one related question sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347471 id: SBS-2023-477 briefTitle: The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy acronym: SPARTAN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-04 date: 2024-04-04 date: 2024-04-04 name: Infectious Diseases Research Collaboration, Uganda class: OTHER name: London School of Hygiene and Tropical Medicine name: Radboud University Medical Center briefSummary: A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and are treated with conventional artemisinin-combination therapies (ACT) as part of standard clinical care. From this population, we will select P. falciparum gametocyte carriers.
Before, during and after ACT treatment, the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy, molecular methods, parasite culture and mosquito feeding assays. Parasite clearance will be determined in the first days (d0-3) after treatment.
The study population will consist of passively recruited patients with uncomplicated P. falciparum malaria who are microscopy positive for gametocytes. Participants will be treated with conventional therapies for uncomplicated malaria without randomization: artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA-PPQ). All doses are supervised. Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment.
Gametocyte carriage and gametocyte commitment/production will be determined for resistant and wild type infections before, during and after treatment. In addition, venous blood will be collected at three timepoints to assess transmission to mosquitoes before (d0), during (d2) and after treatment (d7). The total duration of participation will be 7 days, the primary endpoint will be the reduction in mosquito infection rates at d2 (artemether-lumefantrine) or d7 (dihydroartemisinin-piperaquine) compared to pre-treatment. conditions: Falciparum; Malaria studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Artemether-lumefantrine name: Dihydroartemisinin-Piperaquine measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline. measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline measure: Mean oocyst intensity (in all/all infected mosquitoes) measure: Male and female gametocyte sex ratio (proportion male) measure: Gametocyte circulation time measure: Gametocyte area under the curve measure: Asexual parasite prevalence measure: Asexual parasite density measure: Total parasite prevalence measure: Total parasite density measure: The density of ΔPfK13 vs wild type genotypes measure: The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Ambrosoli Memorial Hospital city: Kalongo state: Agago District country: Uganda name: Maurice Akao, MBChB role: CONTACT facility: Patongo Health Facility IV city: Patongo state: Agago District country: Uganda name: MD role: CONTACT lat: 2.74472 lon: 33.32417 hasResults: False
<|newrecord|> nctId: NCT06347458 id: BG-CA-23-001 briefTitle: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-08 date: 2024-04-04 date: 2024-04-04 name: Guangzhou Bio-gene Technology Co., Ltd class: INDUSTRY briefSummary: This is a single-arm, single-dose dose-escalation and dose-expansion study. conditions: Leukemia conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: BG1805 measure: 1.Dose Limited Toxicity Rate measure: 2.Incidence of Treatment-Emergent Adverse Events measure: 3.Concentration of CAR-T cells after Infusion (PK) measure: 4.overall response rate, ORR measure: 5.Concentration of Cytokine after Infusion (PD) sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06347445 id: GSM012024 briefTitle: Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study) acronym: TEMD-2 overallStatus: COMPLETED date: 2022-10-01 date: 2023-01-30 date: 2023-01-30 date: 2024-04-04 date: 2024-04-04 name: Gulhane School of Medicine class: OTHER briefSummary: This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey. conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 5707 type: ACTUAL name: There is no intervention. measure: Glycemia control status of Turkish adult patients with diabetes mellitus measure: Blood pressure control status of Turkish adult patients with diabetes mellitus measure: Lipid control status of Turkish adult patients with diabetes mellitus. measure: Weight control status of Turkish adult patients with diabetes mellitus. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gulhane School of Medicine Department of Endocrinology and Metabolism city: Ankara zip: 06010 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06347432 id: 24-119-H briefTitle: Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-03 date: 2027-03 date: 2024-04-04 date: 2024-04-04 name: Grand Valley State University class: OTHER briefSummary: For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Power wheelchair skills training using the IndieTrainer system measure: Change in understanding how to use a power wheelchair measure: Change in power wheelchair skill performance measure: Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance measure: Change in children's perceptions of changes in their performance of power wheelchair skill performance sex: ALL minimumAge: 5 Years maximumAge: 17 Years stdAges: CHILD facility: Grand Valley State University city: Grand Rapids state: Michigan zip: 49503 country: United States lat: 42.96336 lon: -85.66809 hasResults: False
<|newrecord|> nctId: NCT06347419 id: Iayas8 briefTitle: Body Awareness and Spinal Stability in Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-06-30 date: 2024-07-30 date: 2024-04-04 date: 2024-04-04 name: Gazi University class: OTHER briefSummary: Thirty volunteer patients diagnosed with scoliosis by a specialist physician at Gazi University Hospital Orthopedics and Traumatology Department and subsequently referred to Gazi University Physiotherapy and Rehabilitation Department for exercise training will be included in the study. The lumbar Pressure Measurement Test with Stabilizer and Rotation Stability Tests will be utilized to evaluate the spinal stability of the patients. Body awareness will be assessed using the Body Awareness Survey, comprising 18 questions. All assessments will be conducted at the Orthopedic Rehabilitation Clinic within the relevant department.
The results obtained from this study will elucidate the relationship between body awareness and spinal stability in individuals with scoliosis. conditions: Scoliosis Idiopathic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Physiotherapy evaluation measure: Spinal stability measure: Rotary Stability measure: Body Awareness sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University Hospital city: Ankara zip: 06500 country: Turkey name: İnci H Ayas role: CONTACT phone: 0 312 216 26 21 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06347406 id: FSKesihatan briefTitle: Effects of Combined Physiotherapy Management and Education overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-04 date: 2024-04-04 name: Fakulti Sains Kesihatan class: OTHER briefSummary: This observational study aims to determine the effects of combined physiotherapy programs and education in patellofemoral pain syndrome. The main questions it aims to answer are:
* Are there any effects of combined physiotherapy program among individuals with PFPS on:
i) Pain ii) Muscle functions (strength, muscle bulk, flexibility) iii) Knee muscle functional performance (anteromedial lunge, step-down, bilateral squat, and balance and reach) iv) Kinesiophobia v) Quality of life Participants will be
* Measure for the anthropometrics data including body weight, height, and BMI.
* Answer the Numerical Pain Rating scale
* Abswe Malay version of KOOS-PF and TAMPA scale.
* Once they finished with the questionnaire, the participants will be stationed into station 1 (HDD), station 2 (Realtime Ultrasound) and station 3 (Dartfish Motion Analysis) Treatment they will receive
* Blood flow restrictions cuff with physiotherapy exercises
* Patient education Researcher will compare Blood flow exercises combined with physiotherapy exercises and education (Group A) with Physiotherapy exercises (Group B) to see if there is an effect on i) Pain ii) Muscle Functions (strength, muscle bulk, flexibility iii) Functional performance (anteromedial lunge, step-down, bilateral squat, balance, and reach) iv) Kinesiophobia v) Quality of life conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 128 type: ESTIMATED name: Blood flow restriction combined with physiotherapy and education measure: Numerical Pain Rating measure: The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) measure: Tampa Scale measure: Hand held dynamometer (HDD) measure: Knee Muscle performance Test with Dartfish software measure: Real time ultrasounds sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Fakulti Sains Kesihatan status: RECRUITING city: Shah Alam state: Selangor Darul Ehsan zip: 42300 country: Malaysia name: Zarina Zahari role: CONTACT phone: 0132094170 email: [email protected] name: Nurul Atiqah Mohamed Mosbi role: CONTACT phone: 603-3258 4300 email: [email protected] lat: 3.08507 lon: 101.53281 hasResults: False
<|newrecord|> nctId: NCT06347393 id: 6425 briefTitle: Transgender and Gender Diverse Individuals Screening for Breast Cancer acronym: GENESIS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-31 date: 2026-03-31 date: 2024-04-04 date: 2024-04-24 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER name: Istituto Europeo di Oncologia name: Luigi Sacco University Hospital name: Fatebenefratelli Hospital name: Ospedale Policlinico San Martino name: Università degli studi di Messina, Messina name: IRCCS Azienda Ospedaliero-Universitaria di Bologna name: Arcispedale Santa Maria Nuova-IRCCS name: Federico II University name: Azienda Ospedaliero-Universitaria Careggi briefSummary: The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 1600 type: ESTIMATED name: Mammography and Breast Ultrasound measure: Incidence of Breast Cancer measure: The adherence rate to the screening sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347380 id: CIP011 briefTitle: Usability Study of the FemPulse System overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-30 date: 2024-08-30 date: 2024-04-04 date: 2024-04-04 name: FemPulse Corporation class: INDUSTRY briefSummary: The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable. conditions: Overactive Bladder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: FemPulse System measure: Patient Satisfaction sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347367 id: EU-FTR-GK-01 briefTitle: Short-term Effect of Exercise and Self-manual Approaches to Bloating - Distention overallStatus: RECRUITING date: 2023-01-01 date: 2024-04-17 date: 2024-04-19 date: 2024-04-04 date: 2024-04-04 name: Ege University class: OTHER briefSummary: Abdominal bloating and distension (ABD) are the most commonly gastrointestinal symptoms reported by patients with various functional gut disorders such as functional dyspepsia, irritable bowel syndrome and it is frequently associated with constipation. The pathophysiology of ABD is complex, often multifactorial and poorly understood. The reseach was hypothesised that short-term self-manual approaches and exercise for core muscles would have a positive effect on the symptoms of ABD. conditions: Gastrointestinal System Disease conditions: Functional Bloating conditions: Distension; Bowel conditions: Gastrointestinal Motility Disorder conditions: Pelvic Floor Dyssynergia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) and Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple (Participant, Investigator and Outcomes Assessor) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) name: Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles) measure: Abdominal bloating and distention (ABD) Perception of sensations measure: Superficial Electromyography (EMG) measure: Gastrointestinal Symptom Rating Scale (GSRS) measure: High-resolution anorectal manometry (HRAM) measure: Balloon Expulsion Test (BET) measure: Colon Transit Time (CTT) measure: Ultrasonography (USG) measure: Digital dynamometer sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University Faculty of Medicine, Department of Gastroenterology status: RECRUITING city: İzmir state: Bornova zip: 35100 country: Turkey name: Gülruh KARABAĞLI role: CONTACT phone: +90 5326612245 email: [email protected] lat: 38.41273 lon: 27.13838 hasResults: False
<|newrecord|> nctId: NCT06347354 id: CRO-2024-15 briefTitle: Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Breast Cancer and Metastatic Lymph Nodes acronym: FLUO overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-08 date: 2025-08 date: 2024-04-04 date: 2024-04-04 name: Centro di Riferimento Oncologico - Aviano class: OTHER briefSummary: In the case of a pre-operative diagnosis of ductal carcinoma in situ (DCIS), sentinel lymph node biopsy is generally not indicated whereas it is considered standard clinical practice for patients with clinical stage I-II infiltrating breast cancer who have clinically negative axillary lymph nodes or clinically suspicious lymph nodes with negative needle aspiration findings. It is not uncommon that, in patients with ductal carcinoma in situ at preoperative diagnosis, there may be an upgrade on definitive histological examination due to the identification of foci of infiltration (about one-fifth of cases), requiring axillary lymph node biopsy in a second surgery. Prospective studies have shown that the sentinel lymph node identification rate after recent breast-conserving surgery is suboptimal. With regard to the false negative rate (FNR), several studies demonstrated that it could be associated with different techniques used for lymph node identification. Lymph node biopsy by Indocyanine green (ICG) is capable of identifying the sentinel lymph node, however, there are no data in literature on the permanence of ICG in the lymph node system. The knowledge of this data would allow the application of this method, already considered safe for the identification of the sentinel lymph node at the time of breast surgery, also in those situations in which the sentinel lymph node biopsy is postponed due to the upgrade of definitive histological diagnosis from carcinoma in situ to infiltrating/micro-infiltrating carcinoma.The main objective of this trial is to evaluate the permanence of fluorescence at the level of axillary lymph nodes 3 weeks after subcutaneous injection in patients who are candidates to radical axillary surgery. Marking the sentinel lymph node before breast surgery in cases of DCIS with risk factors could reduce the false negative rate, allowing to increase the accuracy of the procedure in identifying the lymph node potentially involved by metastatic infiltration. In addition, the identification of the sentinel lymph node in patients who are candidates to radical axillary surgery, could increase the sensitivity of the surgery in staging axillary disease and could make the lymph node exeresis more targeted, reducing the morbidity of the surgery resulting in a better outcome for the patient. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Indocyanine green measure: Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery measure: Identification of the total number of fluorescent lymph nodes measure: Differences in the qualitative assessment (intensity) of fluorescence between the removed lymph nodes: lymph nodes will be divided into group A "intense fluorescence" and group B "mild fluorescence" measure: Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes measure: Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS city: Aviano state: Pordenone zip: 33081 country: Italy name: Stefano Fracon, MD role: CONTACT phone: 0434659317 email: [email protected] name: Samuele Massarut, MD role: CONTACT email: [email protected] name: Stefano Fracon, MD role: PRINCIPAL_INVESTIGATOR lat: 46.07056 lon: 12.59472 hasResults: False
<|newrecord|> nctId: NCT06347341 id: 2019-A02014-53 briefTitle: GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity acronym: GLUTN overallStatus: TERMINATED date: 2021-10-27 date: 2023-03-24 date: 2023-03-24 date: 2024-04-04 date: 2024-04-04 name: University Hospital, Clermont-Ferrand class: OTHER name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement name: UCA (UFR de Médecine et UFR Pharmacie) briefSummary: For 25 years, non-celiac gluten sensitivity (NCGS) has been the subject of very prolific and confusing scientific literature. This clinical entity is defined by the appearance of digestive and extradigestive symptoms in the hours/days following the consumption of foods containing gluten, in the absence of celiac disease (CD) and wheat allergy (WA). The physiopathological mechanisms, neither allergic or autoimmune, remain poorly defined and no The main objective of the study was to demonstrate the role of gluten in triggering digestive symptoms and extradigestive products from the NCGS. The secondary objectives were to identify the pathophysiological mechanisms and diagnostic marker(s).usable diagnostic marker in the clinic has not yet been identified. conditions: The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective, crossover, randomized, double-blind clinical study comparing a gluten-containing diet to a gluten-free diet. primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: Clinical study comparing a gluten-containing diet to a gluten-free diet measure: The main objective of the study is to confirm the role of gluten in triggering the digestive and extradigestive symptoms of NCGS. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Estaing city: Clermont-Ferrand zip: 63100 country: France lat: 45.77966 lon: 3.08628 hasResults: False
<|newrecord|> nctId: NCT06347328 id: 23-AOI-01 briefTitle: The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain acronym: InCHO overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-01 date: 2027-03 date: 2024-04-04 date: 2024-04-05 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Lumbar facet joints have been implicated in chronic low back pain in over 45% of patients with isolated chronic common low back pain.
Low back pain is the most common form of spinal pain, more chronic and severe than cancer pain. The annual prevalence of chronic low back pain ranges from 15% to 45% (one-off prevalence, 30%; lifetime prevalence, 54-80%). Because of this extremely high incidence, doctors from a wide range of specialities perform interventional techniques in a variety of settings.
Facet joints have long been recognised as a source of back pain. In 1911, Goldthwait first recognised their role as a potential source of back pain. In 1933, Ghormley introduced the term "facet syndrome", defining lumbosacral pain with or without radicular pain. Badgley later suggested that facet joints could be a primary source of pain independently of spinal nerve compression. They demonstrated the role of posterior facet joints (PFJs) in a large number of patients with low back pain whose symptoms were not caused by a herniated disc. The underlying physiological concept of the PJF was introduced by Hirsch et al in 1963. They demonstrated that injecting a hypertonic saline solution into the region of the facet joints caused pain.
The management of chronic low back pain due to zygapophyseal involvement (lumbar facet joints) consists primarily of conservative treatment. This is based on analgesics, anti-inflammatory drugs, physiotherapy and weight loss, where appropriate. Other non-surgical options may be proposed, including glucocorticoid injections into the facet joints. Glucocorticoid injections, which act by reducing inflammation, are commonly used in routine care to treat spinal pain. This pain may be due to a variety of pathologies, including discogenic or facet-related, or mixed, ligamentous or muscular, linked to a regional or global disorder of spinal statics. They are commonly used as a standard treatment for chronic spinal pain.
Traditionally, in routine clinical practice, if there is significant paravertebral contracture and the clinical signs point to posterior joint involvement, a glucocorticoid injection is given in the doctor's surgery at the time of consultation, using anatomical landmarks to guide needle placement. However, few studies have demonstrated the efficacy of anatomical marking for infiltration of posterior joints, notably Cohen et al. Sui's systematic review of the use of this technique.
With the advent of new imaging modalities such as ultrasound, more and more practitioners are turning to image-guided injections. To date, only the fluoroscopy-guided technique is considered reliable for facet joint infiltration.
In order to improve the clinical efficacy of the various interventional therapeutic solutions, some authors have supported the use of ultrasound guidance. Several studies have been published comparing ultrasound-guided infiltration and infiltration using anatomical location in the shoulder region, the iliopsoas and in epicondilitis. While ultrasound guidance in areas such as the iliopsoas or the shoulder seems useful, it has not yet been proven that guidance is advantageous in spinal areas, such as the facet joints.
To our knowledge, no randomised, methodologically sound study has yet been carried out to compare the benefit of ultrasound-guided infiltration versus infiltration with anatomical location.
The aim of our study is to show that ultrasound-guided zygoapophyseal infiltration is superior to anatomically-guided infiltration in terms of pain assessment. conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: echo-guided infiltration name: non-echo-guided infiltration measure: Change of pain progression measure: measure function state by EIFEL questionnaire measure: measure function state by ODI questionnaire measure: pain evaluation by VAS scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de NICE city: Nice state: CHU De Nice zip: 06000 country: France name: STEPHANIE FERRERO, MD role: CONTACT phone: +33492035477 email: [email protected] name: CHRISTIAN ROUX, Pr role: CONTACT email: [email protected] name: STEPHANIE FERRERO, MD role: PRINCIPAL_INVESTIGATOR name: CHRISTIAN ROUX, Pr role: SUB_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Ch Cannes city: Cannes country: France name: JOHANNA AZYLAY, MD role: CONTACT email: [email protected] lat: 43.55135 lon: 7.01275 hasResults: False
<|newrecord|> nctId: NCT06347315 id: 2302.CLI briefTitle: Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI) overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-12-15 date: 2027-12-15 date: 2024-04-04 date: 2024-04-29 name: Société des Produits Nestlé (SPN) class: INDUSTRY briefSummary: Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI) conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel and pivotal primaryPurpose: OTHER masking: TRIPLE maskingDescription: Randomized whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 380 type: ESTIMATED name: BrainXpert name: Placebo measure: Preclinical Alzheimer's Cognitive Composite (PACC) score measure: Preclinical Alzheimer's Cognitive Composite (PACC) (components effects) measure: Montreal Cognitive Assessment (MoCA) score measure: Preclinical Alzheimer's Cognitive Composite (PACC) accelerated decline measure: Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory IIb Delayed Recall Score accelerated decline measure: Mini-Mental State Examination (MMSE) score accelerated decline measure: Emergent Adverse Events (Safety and tolerability) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347302 id: EID 2023 briefTitle: Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment acronym: LIPIDRET overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-04-04 date: 2024-04-04 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Retinal detachment is a condition with an estimated incidence of between 9.5 and 18.2 cases per 100,000 individuals.
It is an ophthalmological emergency that threatens visual acuity and requires surgery. However, despite satisfactory post-operative anatomical results, vitreoretinal proliferation and photoreceptor death can still have a negative impact on visual prognosis. These complications are still not fully understood.
A previous study carried out by the Eye, Nutrition and Cell Signalling team at the CSGA, comparing mouse models of retinal detachment with healthy control retinas, revealed an increase in pro-inflammatory cytokines and a change in retinal lipid abundance in detached retinas.
However, these results have yet to be confirmed in humans. Our main hypothesis is that the vitreous content of omega-3 PUFAs and proteins is altered during the onset of retinal detachment, since it reflects both intraocular inflammation and photoreceptor apoptosis.