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Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC).
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Putting together these data will allow to correlate clinical and radiological response to QOL and NC. conditions: Glioblastoma Multiforme conditions: Relapse studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: IA Carboplatin + IA Caelyx name: IA Carboplatin + IA Etoposide Phosphate measure: Tumor Response on MRI using the RANO Criteria measure: Progression-free Survival measure: Median overall survival measure: Treatment-related toxicity measure: Per treatment quality of life assessment measure: Incidence of treatment related Neurocognitive decline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUS status: RECRUITING city: Sherbrooke state: Quebec zip: J1H 5N4 country: Canada name: David Fortin, MD role: CONTACT phone: 819-346-1110 phoneExt: 13895 email: [email protected] name: Marie-Andrée Roy, Nurse role: CONTACT phone: 819-346-1110 phoneExt: 13895 email: [email protected] lat: 45.40008 lon: -71.89908 hasResults: False
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<|newrecord|> nctId: NCT06356870 id: BUE briefTitle: Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone. acronym: BMAC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-10 date: 2024-04-10 name: Cairo University class: OTHER briefSummary: radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting conditions: Alveolar Cleft Grafting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: BMAC MIXED WITH ALLOGRAFT name: Cancellous bone from anterior iliac crest measure: bone density measure: Bone gain measure: Postoperative donor site morbidity sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06356857 id: H-23070312 briefTitle: Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging acronym: Heart-Wave overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-04-10 date: 2024-04-11 name: Peter Hovind class: OTHER briefSummary: This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI. conditions: Myocardial Blood Flow studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT measure: [O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bispebjerg Hospital city: Copenhagen state: RegionH zip: 2400 country: Denmark name: Laila Seidelin, MD role: CONTACT phone: +4520353008 email: [email protected] name: Martin Krakauer, MD, Phd. role: CONTACT email: [email protected] name: Laila Seidelin, MD role: SUB_INVESTIGATOR name: Martin Krakauer, MD, P.hd role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06356844 id: 27.02.2023-E.142568 briefTitle: The Effect of Resolvins on the Resolve of Inflammatory Low Back Pain overallStatus: RECRUITING date: 2024-02-27 date: 2024-04 date: 2024-12 date: 2024-04-10 date: 2024-04-10 name: Bezmialem Vakif University class: OTHER briefSummary: Brief Summary: Inflammatory back pain is a chronic condition localized in the axial spine and sacroiliac joints.1 It often accompanies mechanical issues like lumbar disc herniation. While non-surgical interventions such as medication, physiotherapy, and epidural steroid injections are typically the initial approach, surgical options may be considered if these prove ineffective.2 Resolvins, derived from omega-3 fatty acids, have shown promise in reducing inflammation and pain. They help to resolve inflammatory responses, promote tissue repair, and decrease disc size, potentially reducing the need for surgery.3,4 This clinical trial aims to evaluate the efficacy of adding oral resolvins to transforaminal epidural steroid injections for treating lumbar disc herniation (LDH) The control group (Group C: n=25) will receive epidural steroids, while the study group (Group R: n=25) will receive both oral omega-3 supplementation and epidural steroids on the same day. Additionally, the study group will continue taking oral omega-3 supplements for six months.
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The primary outcome measure will be changes in protruded/extruded disc size assessed via MRI, with secondary outcomes including pain levels measured by the Numeric Rating Scale (NRS) and serum cytokine levels (IL-6, IL-17, IL-1 beta, TNF-alpha) over the study period.
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Discussion: This trial anticipates that combining the anti-inflammatory properties of resolvins with epidural steroid injection will provide a beneficial treatment for patients suffering from inflammatory low back pain. conditions: Low Back Pain conditions: Inflammatory Response conditions: Lumbar Disc Herniation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Resolvin supplement measure: changes in protruded/extruded disc size measure: Pain intensity score measure: Cytokine markers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aylin Ceren Şanlı status: RECRUITING city: Istanbul country: Turkey name: Aylin C Sanli, Asist Dr role: CONTACT phone: +0905496522412 email: [email protected] lat: 41.01384 lon: 28.94966 facility: Aylin Ceren status: COMPLETED city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06356831 id: Endomecryo briefTitle: National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis acronym: Endomercyo overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-07-31 date: 2028-01-31 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team conditions: Endometriosis conditions: Cryotherapy Effect conditions: Surgical conditions: Radiology studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis measure: Characterize the epidemiology of parietal endometriosis nodules measure: Characterize the epidemiology of parietal endometriosis nodules measure: To assess the impact of hormone treatment on parietal endometriosis measure: Assess the demographic distribution of parietal endometriosis measure: Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis measure: Evaluate the aesthetic impact of the treatments measure: Assess the complication rate between the two groups measure: Assess the Severity of Complications according to Society (SIR) of Interventional Radiology or Cardiovascular and Interventional Radiological Society of Europe ( CIRSE) for Radiologists measure: Assess the Severity of Complications according to Clavien Dindo for the surgeon measure: Assess the recidivism rate at 3 years measure: Assess the quality of life between the two groups with PGIC-7 questionnaire measure: Assess the quality of life between the two groups with asses EHP-5 questionnaire measure: Assess the quality of life between the two groups with asses EVA questionnaire measure: Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment measure: Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Tivoli city: Bordeaux country: France name: Horace ROMAN role: CONTACT email: [email protected] lat: 44.84044 lon: -0.5805 facility: CHU bordeaux city: Bordeau country: France lat: 48.32158 lon: 3.20107 facility: CHU Clermont Ferrand city: Clermont-Ferrand country: France name: Benoit Chauveau role: CONTACT email: [email protected] name: Michel CANIS role: CONTACT email: [email protected] lat: 45.77966 lon: 3.08628 facility: CHI Creteil city: Créteil country: France name: Leo RAZAKAMANANTSOA role: CONTACT email: [email protected] name: Yann SALHI role: CONTACT email: [email protected] lat: 48.78333 lon: 2.46667 facility: CHU de Lyon city: Lyon country: France name: Ana GJORGJIEVSKA-DELOV role: CONTACT email: [email protected] name: Gautier CHENE role: CONTACT email: [email protected] lat: 45.74848 lon: 4.84669 facility: APHP Marseille city: Marseill country: France lat: 43.29551 lon: 5.38958 facility: CHU Montpellier city: Montpellier country: France name: Cécile VERHEYDEN role: CONTACT email: [email protected] name: Claire VINCENS role: CONTACT email: [email protected] lat: 43.61092 lon: 3.87723 facility: CHU Nime city: Nîmes zip: 30000 country: France lat: 43.83333 lon: 4.35 facility: AP-HP - Tenon city: Paris country: France name: Milan NAJDAW role: CONTACT email: [email protected] name: Yohann DABI role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: AP-HP Hôpital Européen Georges Pompidou city: Paris country: France name: Tom BOEKEN role: CONTACT email: [email protected] name: Henri AZAIS role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: APHP Cochin-Port Royal city: Paris country: France name: Maxime BARAT role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: CHU Strasbourg city: Strasbourg country: France name: Afshin GANGI role: CONTACT email: [email protected] name: Emilie FALLER role: CONTACT email: [email protected] lat: 48.58392 lon: 7.74553 facility: CHU Toulouse city: Toulouse country: France name: Marie FARUCH role: CONTACT email: [email protected] name: Elodie CHANTALAT role: CONTACT email: [email protected] lat: 43.60426 lon: 1.44367 facility: CH Valencienne city: Valenciennes country: France name: Thibault POCLET role: CONTACT email: [email protected] name: Vassili FAGUE role: CONTACT email: [email protected] lat: 50.35 lon: 3.53333 hasResults: False
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<|newrecord|> nctId: NCT06356818 id: E-74555795-050.04-941155 briefTitle: Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-10 date: 2024-04-10 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: In this study, the effects of different treatment methods for ankle instability patients are being compared aiming to find the optimal treatment. Via comparing virtual reality, motor imagery, and classic rehabilitation programs to clarify their effects on ankle static and dynamic balance, proprioception, range of motion, muscle strength, pain, function and patient satisfaction. conditions: Ankle Sprains studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: three groups with a conventional therapy control group. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Conventional physiotherapy program name: Virtual reality (VR) name: Motor imagery (MI) measure: Visual Analog Scale (VAS) measure: Pressure Pain Threshold (PPT) measure: Star Excursion Balance Test (SEBT) measure: Single Leg Balance Test (SLBT) measure: Joint position sense (JPS) measure: Range of Motion (ROM) measure: Muscle strength measure: Cumberland ankle instability questionnaire (CAIT) measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Istanbul University-Cerrahpasa (IUC) city: Istanbul country: Turkey name: Doaa HAKAM, PT role: CONTACT phone: +905345456224 email: [email protected] name: YILDIZ AKBABA, Assoc. Prof. role: CONTACT email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06356805 id: rTMS in Fibromyalgia briefTitle: rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia acronym: rTMS overallStatus: COMPLETED date: 2023-01-10 date: 2024-01-30 date: 2024-02-20 date: 2024-04-10 date: 2024-04-10 name: Assiut University class: OTHER name: Tanta University briefSummary: the aim of this work was to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. Fibromyalgia Impact Questionnaire (FIQ), Hamilton depression and Anxiety scale and different cognitive rating scales were evaluated pre-1 month post sessions and pre -post 3 months later. all eligible patients with fibromyalgia (FM) were randomized to have 20 sessions of active or sham rTMS over right DLPFC. The improvement changes in groups were compared in each rating scale. conditions: Treatment Resistant Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: repetitive transcranial magnetic stimulation measure: 1- Assessment of Fibromyalgia Impact Questionnaire (FIQ) measure: 1-Assessment of Hamilton depression (HDRS) and Hamilton Anxiety scales (HARS) (pre- post sessions and pre post three months) measure: Assessment of different cognitive rating scales (Montreal cognitive Assessment scale (MoCa), and Rey Auditory Verbal Learning Test [RAVLT], sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Eman Khedr city: Assiut zip: 11517 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06356792 id: Obstetrics outcome in Abortion briefTitle: Obstetrics , Prenatal Outcomes in Recurrent Miscarriage acronym: OBPORPL overallStatus: RECRUITING date: 2024-04-21 date: 2025-03-21 date: 2025-03-21 date: 2024-04-10 date: 2024-04-10 name: Assiut University class: OTHER briefSummary: The effect of recurrent miscarriage on the outcome of the current pregnancy and if there's a relation between it and adverse out come conditions: Recurrent Miscarriage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 102 type: ESTIMATED measure: If there's relation between recurrent abortion and having a medical disorder during current pregnancy sex: FEMALE minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University status: RECRUITING city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06356779 id: H-23066725 briefTitle: Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease acronym: OLIGO-DK overallStatus: RECRUITING date: 2024-04-15 date: 2030-12-31 date: 2035-12-31 date: 2024-04-10 date: 2024-04-16 name: Gitte Fredberg Persson MD PhD class: OTHER briefSummary: This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations.
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The primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities. conditions: Oligometastatic Disease conditions: Metastases conditions: Ablation Techniques conditions: Radiotherapy conditions: Stereotactic Radiation conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1200 type: ESTIMATED name: Local ablative therapy (LAT) measure: Time to failure of local ablative therapy (LAT) strategy measure: Progression-free survival measure: Time to widespread progression measure: Freedom from systemic treatment measure: Overall survival measure: Time to progression measure: Time to local progression measure: Local lesion control rate at 1- and 3-years post-local ablative therapy measure: Time to distant progression measure: Investigator reported grade 3-5 CTCAE (v.5.0) LAT related toxicity measure: Harms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University Hospital Rigshospitalet status: NOT_YET_RECRUITING city: Copenhagen state: Capital Region Of Denmark zip: 2100 country: Denmark name: Mette Pøhl, MD PhD role: CONTACT name: Mette Pøhl, MD PhD role: PRINCIPAL_INVESTIGATOR name: Maja Maraldo, MD PhD role: SUB_INVESTIGATOR name: Morten Suppli, MD PhD role: SUB_INVESTIGATOR name: Rene H Petersen, MD PhD role: SUB_INVESTIGATOR name: Hans-Christian Pommergaard, MD PhD role: SUB_INVESTIGATOR name: Søren Møller, MD PhD role: SUB_INVESTIGATOR name: Michael Achiam, MD PhD role: SUB_INVESTIGATOR name: Mikkel Rosendahl, MD PhD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Copenhagen University Hospital Herlev and Gentofte status: RECRUITING city: Herlev state: Capital Region Of Denmark zip: 2730 country: Denmark name: Michael RT Laursen, MD role: CONTACT phone: +453868 9202 email: [email protected] name: Mette Felter, MD PhD role: SUB_INVESTIGATOR name: Henriette Lindberg, MD PhD role: PRINCIPAL_INVESTIGATOR name: Eva Serup-Hansen, MD PhD role: SUB_INVESTIGATOR name: Sebastian Krog, MD role: SUB_INVESTIGATOR name: Jesper Palshof, MD PhD role: SUB_INVESTIGATOR name: Bodil Engelmann, MD PhD role: SUB_INVESTIGATOR name: Eva Ellebæk, MD PhD role: SUB_INVESTIGATOR name: Lisbet Hölmich, MD PhD role: SUB_INVESTIGATOR lat: 55.72366 lon: 12.43998 facility: Hillerød Hospital status: NOT_YET_RECRUITING city: Hillerød state: Capital Region Of Denmark zip: 3400 country: Denmark name: Maria Lendorf role: CONTACT name: Maria Lendorf, MD PD role: PRINCIPAL_INVESTIGATOR lat: 55.92791 lon: 12.30081 facility: Aarhus University Hospital status: NOT_YET_RECRUITING city: Aarhus state: Central Denmark Region zip: 8200 country: Denmark name: Mette Marie Fode, MD PhD role: CONTACT email: [email protected] name: Mette Marie Fode, MD PhD role: PRINCIPAL_INVESTIGATOR name: Azza Khalil, MD PhD role: SUB_INVESTIGATOR name: Thomas Decker Christensen, MD PhD role: SUB_INVESTIGATOR name: Ole Graumann, MD PhD role: SUB_INVESTIGATOR name: Jørgen Bjerggaard Jensen, MD PhD role: SUB_INVESTIGATOR lat: 56.15674 lon: 10.21076 facility: Gødstrup Hospital status: NOT_YET_RECRUITING city: Herning state: Central Denmark Region zip: 7400 country: Denmark name: Trine Øllegaard role: CONTACT name: Trine Øllegaard, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 56.13932 lon: 8.97378 facility: Danish Center for Particle Therapy status: NOT_YET_RECRUITING city: Aarhus state: Central Region Denmark zip: 8200 country: Denmark name: Britte Weber, MD PhD role: CONTACT name: Britta Weber, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 56.15674 lon: 10.21076 facility: Aalborg University Hospital status: NOT_YET_RECRUITING city: Aalborg state: Northern Region Of Denmark zip: 9000 country: Denmark name: Jimmy Søndergaard, MD PhD role: CONTACT name: Laurids Ø Poulsen, MD PhD role: CONTACT name: Jimmi Søndergaard, MD PhD role: PRINCIPAL_INVESTIGATOR name: Laurids Ø Poulsen, MD PhD role: SUB_INVESTIGATOR name: Hella Sand, MSc role: SUB_INVESTIGATOR lat: 57.048 lon: 9.9187 facility: Odense University Hospital status: NOT_YET_RECRUITING city: Odense state: Southern Denmark Region zip: 5000 country: Denmark name: Tine Schytte, MD PhD role: CONTACT name: Tine Schytte, MD PhD role: PRINCIPAL_INVESTIGATOR name: Jørgen Johansen, MD PhD role: SUB_INVESTIGATOR name: Christina Nyborg, MD PhD role: SUB_INVESTIGATOR lat: 55.39594 lon: 10.38831 facility: Sønderborg Hospital status: NOT_YET_RECRUITING city: Sønderborg state: Southern Denmark Region zip: 6400 country: Denmark lat: 54.90896 lon: 9.78924 facility: Vejle Hospital status: NOT_YET_RECRUITING city: Vejle state: Southern Denmark Region zip: 7100 country: Denmark name: Charlotte Kristiansen, MD role: CONTACT name: Charlotte Kristiansen, MD role: PRINCIPAL_INVESTIGATOR name: Lars Fokdal, MD PhD role: SUB_INVESTIGATOR name: Lise Bentzen, MD PhD role: SUB_INVESTIGATOR lat: 55.70927 lon: 9.5357 facility: Zealand University Hospital, Roskilde and Næstved status: NOT_YET_RECRUITING city: Roskilde state: Zealand Region zip: 4000 country: Denmark name: Julie Gehl, MD DMSc role: CONTACT name: Julie Gehl, MD DMSc role: PRINCIPAL_INVESTIGATOR lat: 55.64152 lon: 12.08035 hasResults: False
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<|newrecord|> nctId: NCT06356766 id: 30.01.2024/009 briefTitle: Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-10-08 date: 2025-04-08 date: 2024-04-10 date: 2024-04-16 name: Istanbul University class: OTHER briefSummary: The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.
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The aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.
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The face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.
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Patients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.
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SPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p \<0.05 considered significant in all assessments, and accepted as two-tailed. conditions: Zone 2 Flexor Tendon Injuries of the Hand studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Telerehabilitation name: Face-to-face rehabilitation measure: Range of Motion measure: DASH measure: Pain of the affected hand measure: Muscle Strength sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06356753 id: RC19_0203 briefTitle: EndoxOmics : Exposome, Endometriosis and Fertility acronym: EndoxOmics overallStatus: COMPLETED date: 2019-09-01 date: 2021-03-31 date: 2021-03-31 date: 2024-04-10 date: 2024-04-10 name: Nantes University Hospital class: OTHER briefSummary: For several years, the effects of environmental pollution on human health have been a growing concern for the scientific community and public authorities. Among the many known chemical contaminants, persistent organic pollutants (POPs) are of particular concern because of their properties as endocrine disrupters, bioaccumulation and biomagnification. The associations between environmental pollutants, endometriosis and infertility remains poorly understood. The objective of this exploratory non interventional monocentric study conducted in the University Hospital of Nantes, is to identify endogenous molecular profiles associated with endometriosis and related infertility. This project implements an exploratory approach combining exposure and metabolomics approaches based on high-resolution mass spectrometry to identify exposure and metabolomics profiles associated with infertility, and biomarkers for potential prognostic application. conditions: Endometriosis conditions: Infertility, Female studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 87 type: ACTUAL measure: Identify endogenous molecular profiles of patients with infertile endometriosis measure: Characterize the internal chemical exposure profiles and metabolomic profiles in the different groups. measure: Compare the distribution of contaminant concentration levels and metabolomic profiles according to the media measured. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Nantes University Hospital city: Nantes state: Loire-Atlantique zip: 44093 country: France lat: 47.21725 lon: -1.55336 hasResults: False
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<|newrecord|> nctId: NCT06356740 id: 69HCL22_0878 id: 2023-508611-22-00 type: CTIS briefTitle: Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus acronym: PENCIL overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-11-01 date: 2029-06-01 date: 2024-04-10 date: 2024-04-10 name: Hospices Civils de Lyon class: OTHER briefSummary: Systemic lupus (SL) is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens, particularly native double-stranded deoxyribonucleic acid (DNA), and excessive production of antiviral cytokines: type I interferons, particularly interferon alpha (IFN-α). IFN-α production results from the excessive detection of nucleic acids (DNA or Ribonucleic Acid (RNA)) by endosomal or intracytoplasmic receptors that are capable of inducing interferon production. The precise mechanisms of cytoplasmic sensor activation remain unknown; however, recent work in the field of interferonopathies suggests a role for human endogenous retroviruses (HERVs). HERVs are remnants of ancient infections caused by exogenous retroviruses integrated into the genome during evolution and represent 8% of the human genome.Several studies have suggested a role for HERVs in the development and maintenance of an excessive immune response in lupus patients and other autoimmune diseases by affecting the type I interferons (I IFN) signalling pathway.
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To date, none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus (SLE) have been shown to be effective in the background treatment of SL or in preventing relapse. Consequently, there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies.
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In this study, an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors (NRTIs), abacavir/lamivudine, is proposed to treat SLE. Thus, we propose a pilot Phase II, randomized, open-label study using NRTIs in patients with SL in remission or with low clinical activity, and evaluating a biological endpoint (IFN signature), which is a direct proxy for the drug's expected effect.
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The main objective is to compare the addition of Abacavir/Lamivudine (Add-on) to standard care for 6 months, on the value of the interferon (IFN) transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State (LLDAS). conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open-label randomized, controlled study with 2 parallel arms (Add-on treatment versus standard of care treatment) primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Blood sample name: Treatment :Abacavir 600 mg/lamivudine 300 mg name: Lupus Impact Tracker questionnaire measure: Absolute variation in interferon signature (IFN) measure: percentage of patients maintaining LLDAS criteria measure: number of relapses measure: anti-native double-stranded DNA quantification measure: anti-extractable nuclear antigens (anti-ENA) quantification measure: interferon-α production quantification measure: Number of successful patients measure: Cumulative dose of intravenous (IV) corticosteroids measure: Lupus Impact Tracker questionnaire score measure: number of missed treatment measure: number of adverse event (AE) measure: number of serious adverse event (SAE) measure: HERVs transcription quantification sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Groupe Hospitalier Pellegrin-CHU de Bordeaux city: Bordeaux zip: 33076 country: France name: Christophe RICHEZ, MD, PhD role: CONTACT phone: 05 56 79 56 79 phoneExt: +33 email: [email protected] name: Christophe RICHEZ, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: Hôpital Femme-Mère-Enfant (HCL) city: Bron zip: 69677 country: France name: Alexandre BELOT, MD, PhD role: CONTACT phone: 04 27 85 61 26 phoneExt: +33 email: [email protected] name: Alexandre BELOT, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: CHU de Clermont-Ferrand - Hôpital Gabriel Montpied city: Clermont-Ferrand zip: 63003 country: France name: Marc ANDRE, MD, PhD role: CONTACT phone: 0473751440 phoneExt: +33 email: [email protected] name: Marc ANDRE, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: CHU Nord de Grenoble - Albert Michallon city: Grenoble zip: 38043 country: France name: Laurence BOUILLET, MD, PhD role: CONTACT phone: 04 76 76 76 40 phoneExt: +33 email: [email protected] name: Laurence BOUILLET, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.16667 lon: 5.71667 facility: Hôpital Claude Huriez city: Lille zip: 59037 country: France name: Éric HACHULLA, MD, PhD role: CONTACT phone: 03 20 44 56 50 phoneExt: +33 email: [email protected] name: Éric HACHULLA, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Hôpital de la Croix-Rousse (HCL) city: Lyon zip: 69004 country: France name: Yvan JAMILLOUX, MD, PhD role: CONTACT phone: 0426732636 phoneExt: +33 email: [email protected] name: Yvan JAMILLOUX, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Hôpital Edouard Herriot (HCL) city: Lyon zip: 69437 country: France name: Thomas BARBA, MD role: CONTACT phone: 0472119583 phoneExt: +33 email: [email protected] name: Thomas BARBA, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Hôpital Necker-Enfants malades city: Paris zip: 75015 country: France name: Brigitte BADER-MEUNIER, MD role: CONTACT phone: 0144494332 phoneExt: +33 email: [email protected] name: Brigitte BADER-MEUNIER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié-Salpêtrière city: Paris zip: 75651 country: France name: Zahir AMOURA, MD, PhD role: CONTACT phone: 01 42 17 80 01 phoneExt: +33 email: [email protected] name: Zahir AMOURA, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Lyon Sud (HCL) city: Pierre-Bénite zip: 69310 country: France name: Mael Richard, MD role: CONTACT phone: 0478861352 phoneExt: +33 email: [email protected] name: Mael Richard, MD role: PRINCIPAL_INVESTIGATOR lat: 45.7009 lon: 4.82511 facility: CHU de Saint-Etienne - Hôpital Nord city: Saint-Priest-en-Jarez zip: 42270 country: France name: Martin KILLIAN, MD, PhD role: CONTACT phone: 04 77 82 91 79 phoneExt: +33 email: [email protected] name: Martin KILLIAN, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.47501 lon: 4.37614 hasResults: False
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<|newrecord|> nctId: NCT06356727 id: 121CET-MICROREV-DCM briefTitle: Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling acronym: MICROREV overallStatus: RECRUITING date: 2024-01-03 date: 2026-01-31 date: 2030-01-31 date: 2024-04-10 date: 2024-04-10 name: Azienda Ospedaliera Universitaria Integrata Verona class: OTHER name: Abbott Medical Devices briefSummary: Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \<40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance. conditions: Heart Failure conditions: Left Ventricular Dysfunction conditions: Idiopathic Dilated Cardiomyopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multicenter single-arm experimental study. The study aims to perform a functional study of the coronary microcirculation with pressure guides, in patients with new diagnoses of dilated cardiomyopathy and clinical indication for coronary angiography. Following this, a multiparametric imaging study with transthoracic echo cardiography will be performed. 12 months after the optimization of medical therapy, the patient will receive a clinical, laboratory and instrumental re-evaluation of transthoracic cardiac color Doppler. The primary endpoint is the recovery of left ventricular function on cardiac imaging. Follow up will continue up to 5 years from enrollment through telephone contacts, outpatient visits and review of clinical data. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 190 type: ESTIMATED name: Thermodilution based assessment of coronary microcirculation measure: Rate of Left ventricular reverse remodeling (LVRR) measure: Adverse clinical events measure: Rate of LVRR at cardiac magnetic resonance measure: Changes in functional capacity at cardiopulmonary exercise test measure: Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling. measure: Left ventricle adverse cardiac remodeling at cardiovascular magnetic resonance. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria di Ferrara status: NOT_YET_RECRUITING city: Ferrara country: Italy name: Gianluca Campo role: CONTACT name: Elisabetta Tonet role: CONTACT lat: 44.83804 lon: 11.62057 facility: Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino status: NOT_YET_RECRUITING city: Genova country: Italy name: Italo Porto role: CONTACT lat: 44.40478 lon: 8.94438 facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele status: NOT_YET_RECRUITING city: Milan country: Italy name: Matteo Montorfano role: CONTACT name: Marco Ancona role: CONTACT lat: 45.46427 lon: 9.18951 facility: Ospedale Galeazzi di Sant'Ambrogio IRCCS status: NOT_YET_RECRUITING city: Milan country: Italy name: Giovanni Monizzi role: CONTACT lat: 45.46427 lon: 9.18951 facility: University of Naples Federico II status: NOT_YET_RECRUITING city: Naples country: Italy name: Giovanni Esposito role: CONTACT name: Luigi Di Serafino role: CONTACT lat: 40.85216 lon: 14.26811 facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: NOT_YET_RECRUITING city: Roma country: Italy name: Cristina Aurigemma role: CONTACT name: Francesco Burzotta role: CONTACT name: Antonio M Leone role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Sant'Andrea status: NOT_YET_RECRUITING city: Rome country: Italy name: Emanuele Barbato role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino status: NOT_YET_RECRUITING city: Torino country: Italy name: Fabrizio D'Ascenzo role: CONTACT lat: 45.07049 lon: 7.68682 facility: Azienda Ospedaliera Universitaria di Verona status: RECRUITING city: Verona zip: 37126 country: Italy name: Flavio Ribichini role: CONTACT phone: 0039 0458122320 email: [email protected] lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06356714 id: 13914704179 briefTitle: Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Status overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-08-01 date: 2024-04-10 date: 2024-04-10 name: Sun Jing class: OTHER briefSummary: Evaluate the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SD(Stable Disease) status in the real world. conditions: Colorectal Cancer conditions: Colorectal Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens measure: Progression-free survival(PFS) measure: Overall survival (OS) measure: Objective remission rate (ORR) measure: Disease Control Rate (DCR) measure: Incidence and extent of major security incidents measure: Quality of Life Score (QoL) for tumor patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356701 id: dongyandl briefTitle: Tumor Nutritional Therapy in the First-line Treatment of Stage IV NSCLC overallStatus: RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: The First Affiliated Hospital of Dalian Medical University class: OTHER briefSummary: A Single-center, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Tumor Nutritional Therapy Combined With Immune Checkpoint Inhibitors and Chemotherapy in the First-line Treatment of Stage IV NSCLC Without Driver Gene Mutations conditions: Long-Term Effects Secondary to Cancer Therapy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules) measure: PFS measure: Assessment of global disorders in patients with cancer measure: ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: DongYan status: RECRUITING city: Dalian City state: Liaoning zip: 116000 country: China name: DongYan Dong role: CONTACT phone: 18098876750 email: [email protected] hasResults: False
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<|newrecord|> nctId: NCT06356688 id: 13914704178 briefTitle: A Clinical Study on the Efficacy and Safety of Paclitaxel Polymer Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-06-20 date: 2024-04-10 date: 2024-04-10 name: Sun Jing class: OTHER briefSummary: The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (cadonilimab) in combination with platinum-containing chemotherapy (paclitaxel polymer micelles combined with cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with cadonilimab combined with chemotherapy. conditions: Locally Advanced Esophageal Squamous Cell Carcinoma conditions: Neoadjuvant Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: paclitaxel polymer micelles and cisplatin combined with Camrelizumab primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: paclitaxel polymer micelles and cisplatin combined with Cadonilimab measure: Pathological complete response (pCR) rates measure: Objective Rate of Effectiveness (ORR) measure: R0 Removal Rate measure: 2-year overall survival rate measure: 2-year disease free survival rate measure: major pathological response (MPR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356675 id: A single-arm pilot briefTitle: A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-07-01 date: 2028-07-01 date: 2024-04-10 date: 2024-04-10 name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine class: OTHER briefSummary: Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes. conditions: Advanced NSCLC studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Tislelizumab name: Anlotinib measure: objective response rate measure: progression free survival time measure: over survival time measure: disease control rate measure: safety including any grade adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356662 id: KY-2023-198 briefTitle: Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease overallStatus: RECRUITING date: 2024-01-23 date: 2024-08-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-10 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of Parkinson's disease. The changes of motor symptoms and the occurrence of adverse reactions in early Parkinson's disease patients who took tenofovir disoproxil fumarate and did not take Tenofovir disoproxil fumarate at different time points were compared. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Tenofovir Disoproxil Fumarate measure: UPDRS III（Unified Parkinson's Disease Rating Scale part 3） measure: Non-Motor Symptom Scale（NMSS） measure: creatinine(μmoI/L) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guohua Zhao status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Zhao Guohua, Doctor role: CONTACT phone: +86 13777812308 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06356649 id: ESOGU2 briefTitle: Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes During Extubation overallStatus: COMPLETED date: 2023-03-15 date: 2024-01-15 date: 2024-01-20 date: 2024-04-10 date: 2024-04-10 name: Eskisehir Osmangazi University class: OTHER briefSummary: Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. When the recovery-extubation phase is reached, intermittent bag-mask ventilation is usually used and the patient is allowed to breathe spontaneously and is extubated when an adequate respiratory level is reached. It has been shown in previous studies that the use of intermittent mask ventilation causes postoperative atelectasis. Different methods have been used to prevent postoperative atelectasis. In our study, we aimed to observe the effect of terminating general anesthesia at the end of the operation and using PEEP and pressure-supported ventilation during the extubation phase on early complications. conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 199 type: ACTUAL name: extubation measure: Complications developing during recovery-extubation measure: hemodynamic changes measure: hemodynamic data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskisehir Osmangazi University Medical Faculty city: Eskisehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False
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<|newrecord|> nctId: NCT06356636 id: P1216/2022 briefTitle: Impact of the Financial Inclusion Improves Sanitation and Health acronym: FINISH overallStatus: RECRUITING date: 2022-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: Amref Health Africa class: OTHER briefSummary: The goal of this interventional study is to evaluate the impacts of Financial Inclusion improvement sanitation and Health (FINISH) interventions in Kenya's Homa Bay County and Uganda's Kamwenge District among children under five. The main questions it aims to answer are:
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1. What is the estimated impact of the FINISH model on health outcomes (diarrhoea occurrence and hygienic behaviour) as well as social (school attendance and sanitation) in the intervention groups?
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2. What are the perspectives, attitudes, and practices of various stakeholders (communities, governments, entrepreneurs, and financiers) regarding the FINISH model?
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3. What is the cost-effectiveness of the FINISH model, including the amount of leverage funds generated?
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The FINISH model postulates that countries will be supported to improve the enabling business environment for sanitation, markets to offer improved safely managed services and products at an affordable price, and formal and informal financial institutions will offer more funding to businesses and households for satiation and hygiene.
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Researchers will then compare intervention areas (Homa Bay in Kenya and Kamwenge in Uganda) with control areas (Siaya and Bushenyi in Kenya and Uganda, respectively) to see if the FINISH intervention leads to improved sanitation, health outcomes, and economic benefits. conditions: Health Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants are divided into two or more groups, with each group receiving a different intervention or a control condition. The outcomes of each group are compared at the end of the study to assess the effectiveness of the intervention. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE maskingDescription: to be updated whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1090 type: ESTIMATED name: Financial Inclusion Improves Sanitation and Health measure: Health outcome, measured as, Proportion of households with diarrhoea occurrence in children under five years, and social outcome measured as proportion of households whose children missed school due to diarrhoea occurrence sex: ALL minimumAge: 0 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Homa Bay county status: RECRUITING city: Homa Bay country: Kenya name: Martin Dr Muchangi, PhD role: CONTACT phone: 0721453712 email: [email protected] lat: -0.52731 lon: 34.45714 hasResults: False
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<|newrecord|> nctId: NCT06356623 id: SHDC2202020401 briefTitle: A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2024-08-05 date: 2024-08-06 date: 2024-04-10 date: 2024-04-10 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: PONV management has been recommended as a necessary part of enhanced recovery protocols during the perioperative period, and PONV risk assessment is, therefore, a necessary first step in determining the number of medications or strategies for prophylaxis and treatment by considering the number of modifiable and non-modifiable risk factors. However, the external validity of two commonly-used PONV prediction models for patients undergoing liver surgery is unsatisfied, and need to be updated for liver cancer populations to better inform personalized perioperative care regime and individualized decision-making in clinical practice. conditions: Nausea and Vomiting, Postoperative conditions: Liver Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 476 type: ESTIMATED name: 1 measure: Postoperative nausea and vomiting sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356610 id: ALCS-REG-23-08-HT briefTitle: Pharmacokinetic and Subjective Effects of Heated Tobacco Products overallStatus: RECRUITING date: 2024-02-06 date: 2024-09 date: 2025-06 date: 2024-04-10 date: 2024-04-10 name: Altria Client Services LLC class: INDUSTRY name: Celerion briefSummary: This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor varieties (Ploom® HTPs, Japan Tobacco Inc.) in adult menthol and non-menthol combustible cigarette smokers (males and females between the ages of 22 and 65). The study will include participants' UBCC (Usual Brand Combustible Cigarette) and a nicotine gum (Nicorette®) as high and low abuse liability reference products, respectively, to the HTP. Study participation is expected to last up to 34 days, including a 28-day screening period (that includes a 5-day at-home HTP product trial period), and a 6-day in-clinic confinement period (from Check-in \[Day -1\] through the end-of-study \[EOS\] visit on Day 6). conditions: Tobacco Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK and subjective effects of HTPs (2 menthol varieties, Products A and B; 2 tobacco flavor varieties, Products C and D). The study will include participants' UBCC (Product F) and a nicotine gum (Product E) as high and low abuse liability reference products. Sponsor will prepare the randomization schedule. On Day -1 participants will be randomized at 1:1:1:1:1:1 ratio into 1 of 6 sequences as listed below. At least 60 participants will be randomized to ensure approximately 48 completed participants, with approximately 24 menthol and 24 non-menthol cigarette smokers. Participants will be stratified by sex and cigarette type for each of the sequences. A 6x6 Latin Square with the following sequences will be used for the randomization: Sequence 1 = ABFCED Sequence 2 = BCADFE Sequence 3 = CDBEAF Sequence 4 = DECFBA Sequence 5 = EFDACB Sequence 6 = FAEBDC. primaryPurpose: OTHER masking: SINGLE maskingDescription: Study participants will know when they are using their UBCC (usual brand combustible cigarette) and the nicotine gum. However, participants will not be informed of which Ploom® HTS (heated tobacco stick) product they are using. Participants will not see the stick or device packaging. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Test Product A name: Test Product B name: Test Product C name: Test Product D name: Reference Product E name: Reference Product F measure: Plasma Nicotine Concentration Pharmacokinetic (PK) Measurement measure: Product Liking of Heated Tobacco Products (HTP) measure: Tobacco Nicotine Withdrawal Questionnaire measure: Direct Effects of Product Questionnaire measure: Use the Product Again Questionnaire measure: Modified Cigarette Evaluation Questionnaire (mCEQ) - Cigarette measure: Modified Cigarette Evaluation Questionnaire - HTP measure: Modified Cigarette Evaluation Questionnaire-NRT measure: Product Use for HTP-Units Dispensed measure: Product Use for UBCC-Units Dispensed measure: Product Use for Nicotine Gum-Units Dispensed measure: Product Use for HTP-Puff Count measure: Product Use for UBCC-Puff Count measure: Physiological Heart Rate (HR) Assessment-HTP measure: Physiological Heart Rate (HR) Assessment-UBCC measure: Physiological Heart Rate (HR) Assessment-Nicotine Gum sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States name: Mark Adams, MD role: CONTACT phone: 859-264-8999 email: [email protected] lat: 37.98869 lon: -84.47772 facility: QPS Bio-Kinetic status: RECRUITING city: Springfield state: Missouri zip: 65802 country: United States name: Donald W Burkindine, DO role: CONTACT phone: 417-893-6161 email: [email protected] lat: 37.21533 lon: -93.29824 facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Knoxville state: Tennessee zip: 37920 country: United States name: William Smith, MD role: CONTACT phone: 865-305-9100 email: [email protected] lat: 35.96064 lon: -83.92074 hasResults: False
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<|newrecord|> nctId: NCT06356597 id: KY2024-004-A briefTitle: Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-12 date: 2027-12-12 date: 2024-04-10 date: 2024-04-10 name: Jing-yuan Fang, MD, Ph. D class: OTHER briefSummary: The aim of this study is to evaluate the efficacy and safety of Tislelizumab with Fruquintinib, Metronidazole treatment in MSS/MSI-L advanced colorectal cancer patients with high abundance of Fusobacterium nucleatum in a single arm Phase II clinical. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Tislelizumab with Fruquintinib, Metronidazole measure: objective response rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai First People's Hospital status: RECRUITING city: Shanghai country: China name: Qi Li role: CONTACT lat: 31.22222 lon: 121.45806 facility: Shanghai Ninth People's Hospital status: NOT_YET_RECRUITING city: Shanghai country: China name: Yanjie Zhang role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06356584 id: SDZLEC2024-078-01 briefTitle: Sintilimab Combined With Fruquintinib/Regorafenib ± Radiotherapy for Third-line Treatment of Advanced Metastatic Colorectal Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-04-10 date: 2024-04-10 name: Shandong Cancer Hospital and Institute class: OTHER briefSummary: Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. Despite advancements in first- and second-line treatments, third-line therapies for advanced CRC remain limited, emphasizing the need for novel strategies. This prospective study evaluates the efficacy of combined therapy involving Sintilimab, Fruquintinib/Regorafenib, and radiotherapy in advanced CRC. The study cohort comprises patients with non-liver metastatic advanced CRC and those with liver metastases, each receiving tailored treatment protocols. The primary objectives are to assess progression-free survival (PFS), overall survival (OS), and treatment response rates. Subgroup analyses will focus on liver metastases to delineate their impact on treatment outcomes. The rationale for this study stems from the intricate interplay between immunotherapy, targeted therapy, and radiotherapy in CRC management. Previous data suggest a negative correlation between liver metastases and immunotherapy efficacy, necessitating a comprehensive approach integrating multiple treatment modalities. Radiotherapy, particularly stereotactic body radiation therapy (SBRT), has shown promise in controlling liver tumors and modulating the tumor microenvironment, potentially enhancing immunotherapy responses. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for advanced CRC by elucidating the efficacy and safety of this combined treatment approach. The findings may pave the way for personalized treatment strategies tailored to individual patient characteristics, ultimately improving clinical outcomes in this challenging disease setting. conditions: Colorectal Cancer conditions: Immunotherapy conditions: Radiotherapy conditions: Targeted Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 141 type: ESTIMATED name: Sintilimab measure: Progression-free survival (PFS) measure: Overall response rate (ORR) measure: Disease control rate (DCR) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinbo Yue status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Jin Bo Yue role: CONTACT phone: 0531-67626442 phoneExt: 0531-67626442 email: [email protected] lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06356571 id: LPS18183 id: U1111-1298-7348 type: OTHER domain: WHO ICTRP briefTitle: A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma acronym: SubQSA overallStatus: NOT_YET_RECRUITING date: 2024-06-11 date: 2027-01-08 date: 2027-07-15 date: 2024-04-10 date: 2024-04-17 name: Sanofi class: INDUSTRY briefSummary: The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy. conditions: Plasma Cell Myeloma Refractory studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Isatuximab SC-OBDS name: Montelukast name: Dexamethasone name: Acetaminophen name: Diphenhydramine name: Methylprednisolone name: Carfilzomib measure: Overall response rate (ORR) measure: Number of participants with infusion reactions (IRs) measure: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable) measure: Number of participants with injection site reactions (ISRs) measure: CR or better measure: VGPR or better measure: Duration of response (DOR) measure: Time to first response (TT1R) measure: Time to best response (TTBR) measure: Patient experience and Satisfaction Questionnaire v2 (PESQ v2) measure: Positivity titer of anti-drug antibodies (ADA) in a subset of 15 participants measure: Maximum observed concentration (Cmax) of isatuximab in a subset of 15 participants measure: Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of 15 participants sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356558 id: IRB-300010279 id: R01CA271303 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA271303 briefTitle: Adapting Enhanced Recovery Programs for Low Health Literacy Patients overallStatus: NOT_YET_RECRUITING date: 2026-05 date: 2027-08 date: 2028-05 date: 2024-04-10 date: 2024-04-10 name: University of Alabama at Birmingham class: OTHER name: National Cancer Institute (NCI) briefSummary: Low health literacy patients are a vulnerable population at high-risk for surgical disparities including longer hospital stays, more complications, and more readmissions. This study will adapt enhanced recovery programs (ERPs) to low health literacy patients with a multilevel, health literacy-based implementation strategy (called VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) to improve ERP fidelity and thereby outcomes. In the final aim of this project (Specific Aim 3), the VISACT intervention will be tested in a pilot trial. Findings from this study will lay the foundation for a multi-institutional stepped-wedge trial and establish key principles for adapting interventions to eliminate disparities. conditions: Surgery conditions: Health Knowledge, Attitudes, Practice conditions: Colorectal Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This pilot study will be a pre-post trial of the intervention (VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) at 2 sites. This design was selected because the intervention is an implementation strategy and it will not be possible to randomize patients to a non-intervention arm once the VISACT is delivered to a facility. All patients, providers, and organizational units will be subject to downstream effects of VISACT once implemented. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1050 type: ESTIMATED name: Educational intervention (VISACT) measure: Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers. measure: Efficacy - Length-of-stay of index surgical hospitalization measure: Adoption - Completion rate of the intervention (VISACT) by participants per month measure: Implementation - Fidelity rate of patients with components of the Enhanced Recovery Program measure: Maintenance - Long-term adoption rate of the intervention (VISACT) per year measure: Efficacy - Readmission rate measure: Efficacy - Complications rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356545 id: OMICS_CODE_01 briefTitle: Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-04-10 date: 2024-04-10 name: Children's Hospital of Fudan University class: OTHER briefSummary: This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model. conditions: Diarrhea Infantile studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Clinical phenotype of congenital diarrhea and enteropathy in China measure: Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features measure: Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning sex: ALL minimumAge: 1 Month maximumAge: 3 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06356532 id: 202312197544 briefTitle: the Intensive Care Unit Diary for Liver Transplant Recipients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: Chang Gung Memorial Hospital class: OTHER briefSummary: the purpose of this study is to assess the effectiveness of the intensive care unit diary for intensive care unit liver transplant recipients. conditions: Liver Transplant Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants in the control group received the routine care including communication and companionship provided by the nurses of the intensive care unit.
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The participants in the intervention group received the intensive care unit diary writing and reading. Participants are required to write at least one sentence daily. The primary writers will be the patients themselves, and in cases where patients are unable to write, their family members will write on their behalf. After completion, the diary will be handed over to the patients to review its contents for at least 10 minutes before bedtime, allowing them to write down their immediate reflections and thoughts on when they read. This process will continue until the 14th day post-operation. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Outcomes Assessor is blinded to the group assignments of the patients. She is tasked with collecting the measured outcomes from the patients. Data collection will be conducted by co-principal investigator of the research team. She will distribute the questionnaires at enrollment, and on the 7th and 14th days post-operation. Once notified by the researchers, data collector will distribute and collect the questionnaires. Upon completion, the questionnaires will be sealed in envelopes by the data collectors. whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: intensive care unit diary measure: change from baseline in depression on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in anxiety on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in stress on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in sense of coherence on the Sense of Coherence Scale at post operation day 7 and day 14 measure: change from baseline in emotional stress on the Brief Symptom Rating Scale at post operation day 7 and day 14 measure: change from baseline in delirium on the intensive care delirium screening checklist at post operation day 1 and day 14 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356519 id: YOUNGBC-29 briefTitle: Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-10 date: 2024-04-10 name: Fudan University class: OTHER briefSummary: The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Sacituzumab Govitecan measure: PFS measure: ORR measure: OS measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Biyun Wang role: CONTACT phone: 18017312387 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06356506 id: 2022-P2-338-01 briefTitle: A Study on Factors of Biochemical Response in Autoimmune Hepatitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2034-05-01 date: 2034-05-01 date: 2024-04-10 date: 2024-04-19 name: Beijing Friendship Hospital class: OTHER briefSummary: The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:
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Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up. conditions: Autoimmune Hepatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 630 type: ESTIMATED measure: Alanine aminotransferase (ALT) recovery measure: Aspartate transaminase (AST) recovery measure: Immunoglobulin G (IgG) recovery measure: Death measure: Liver transplantaiton measure: Progression to hepatocellular carcinoma (HCC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06356493 id: OBIIA CMNT briefTitle: Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD overallStatus: COMPLETED date: 2020-01-02 date: 2022-12-31 date: 2022-12-31 date: 2024-04-10 date: 2024-04-10 name: Tunis University class: OTHER briefSummary: The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.
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The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders. conditions: Hemorrhage conditions: Placenta Accreta Spectrum conditions: Cesarean Section Complications studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 38 type: ACTUAL name: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries name: caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries measure: calculated blood loss measure: Transfusion peroperatively measure: Duration of surgery measure: Postoperative hospital stay measure: Postoperative transfer to the intensive care unit measure: Morbidity sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Haithem Aloui city: Manouba state: Nabeul zip: 2010 country: Tunisia lat: 36.80803 lon: 10.09721 facility: Haithem Aloui city: Tunis state: Nabeul zip: 2010 country: Tunisia lat: 36.81897 lon: 10.16579 hasResults: False
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<|newrecord|> nctId: NCT06356480 id: 266 briefTitle: 1% Acetic Acid vs Normal Saline Dressing inManagement of Diabetic Foot overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-04 date: 2024-04 date: 2024-04-10 date: 2024-04-10 name: Dr. Muhammad Naeem class: OTHER briefSummary: Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic diabetic wounds conditions: Granulation of Chronic Diabetic Wounds conditions: Diabetic Wounds studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 74 type: ACTUAL name: 1% Acetic acid dressing measure: Early epithelialization and granulation sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pak Emirates military hospital city: Rawalpindi state: Punjab country: Pakistan lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06356467 id: FARINET briefTitle: Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs acronym: FARINET overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-21 date: 2024-12-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-12 name: IRCCS San Raffaele class: OTHER briefSummary: Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated. conditions: Neuroendocrine Tumors conditions: GEP-NET studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 450 type: ESTIMATED measure: Global Progression Free Survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS OSpedale San Raffaele city: Milan zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06356454 id: KAPCON-CR briefTitle: Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-02 date: 2025-06-02 date: 2025-12-02 date: 2024-04-10 date: 2024-04-15 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Despite significant clinical benefits and recommendations of clinical practice guidelines to refer patients for exercise and physical activity counselling in the capacity of cardiac rehabilitation (CR), CR is largely underutilised and not implemented effectively. Studies have reported that the reasons for the low implementation of CR are multifactorial at the healthcare system, physician and patient levels. Therefore, the aim of this study was to investigate the knowledge, attitudes and practical applications of paediatric cardiologists regarding cardiac rehabilitation and specifically exercise and physical activity in children with congenital heart disease (CHD). conditions: Physician's Role studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease measure: The score of Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease sex: ALL minimumAge: 32 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356441 id: B2024-039-01 briefTitle: Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-10 date: 2024-04-10 name: Sun Yat-sen University class: OTHER briefSummary: The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation. conditions: Artificial Intelligence Supported Image Reviewing studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10400 type: ESTIMATED name: AI measure: sensitivity measure: specificity measure: positive predictive value measure: negative predictive value measure: total time of interpretation for all the MR images measure: the rate of discussion with a third radiologist measure: the detection rate of local recurrence in the AI-supported reading group measure: the sensitivity in the subgroups of different rT-stage measure: the incidence of cases whose recurrent risks and contours cannot be provided by the AI model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Fang-Yun Xie role: CONTACT phone: +8602087342926 email: [email protected] name: Pu-Yun OuYang role: CONTACT phone: +8602087342926 email: [email protected] name: Fang-Yun Xie role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06356428 id: KARYÖN-DR briefTitle: Psychometric Properties and Cross-cultural Adaptation of the Turkish Version of Physcian Attitudes Toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R) overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2025-05-13 date: 2025-08-13 date: 2024-04-10 date: 2024-04-15 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Research has reported that the reasons for low implementation of CR are multifactorial at the health system, physician and patient levels. It has also been found that patients are more likely to initiate CR if physicians strongly and positively promote the importance of CR participation. Unfortunately, there are insufficient and ineffective data on CR, referral to CR and both clinical and cost-effectiveness outcomes of CR in Turkey. In this context, it is important to examine more objectively from the perspective of physicians who play a key role in referring patients to CR. However, in our country, there is no relatively objective measurement tool to evaluate physicians' attitudes towards CR. Therefore, this study aims to adapt the original "Physician Attitudes towards Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)" into Turkish and to examine its psychometric properties. conditions: Physician's Role studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Physcian Attitudes toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R) measure: Physician Attitudes toward Cardiac Rehabilitation and Referral (PACRR)-Revised Scale Score sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356415 id: Dex Dex in infraclavicular briefTitle: Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-30 date: 2024-09-30 date: 2024-04-10 date: 2024-04-10 name: Suez Canal University class: OTHER briefSummary: Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects. conditions: Upper Extremity Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The sealed-envelope technique will be used. An assistant who is not involved in patient care will make and combine bupivacaine, whether it contains adjuvants or not. Thus, all patients, operators, and outcome assessors remain blinded to the nature of the perineural adjuvant whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Bupivacaine injection name: Bupivacaine+ Dexamethasone+ Dexmedetomidine measure: Onset of sensory block sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356402 id: 8510224SMCPD briefTitle: An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-12 date: 2024-04-10 date: 2024-04-10 name: Ziauddin University class: OTHER name: Universiti Sains Malaysia briefSummary: This pilot study evaluates the feasibility of conducting a larger Randomized Controlled Trial to compare three oral health education delivery methods to a control group. Except for the control group, mothers in the three intervention groups will receive the same oral health education based on the OHEM module but differ in the delivery methods, namely lecture, exhibition, and demonstration. All groups will receive a booklet and oral hygiene kits and be instructed to educate their children at home. Pre- and post-intervention assessments include the satisfaction of participants, the researchers' evaluation and cost of the trial, oral hygiene status, and the knowledge of the parents and children. conditions: Dental Plaque conditions: Gingivitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 540 type: ESTIMATED name: Oral Health Educational Module for Mothers (OHEM) lecture name: Oral Health Educational Module for Mothers (OHEM) exhibition name: Oral Health Educational Module for Mothers (OHEM) demonstration measure: Satisfaction of participants: measure: Recruitment and participation of participants in the study measure: Cost of the trial measure: Dental plaque scores measure: Gingival scores measure: Oral health KAP scores measure: Oral health behaviors measure: Oral health-related quality of life using Oral health impact profile-14 sex: ALL minimumAge: 12 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Primary Healthcare Center Gulshan-e-Sikandarabad Shireen Jinnah Colony city: Karachi country: Pakistan name: Sidra Mohiuddin, MDS role: PRINCIPAL_INVESTIGATOR lat: 24.8608 lon: 67.0104 hasResults: False
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<|newrecord|> nctId: NCT06356389 id: JX11502MA-Ib-II briefTitle: A Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of JX11502MA Capsule in Patients With Schizophrenia. overallStatus: COMPLETED date: 2022-03-02 date: 2022-12-27 date: 2023-01-28 date: 2024-04-10 date: 2024-04-10 name: Zhejiang Jingxin Pharmaceutical Co., Ltd. class: INDUSTRY name: Shanghai Mental Health Center briefSummary: A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double-Blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: JX11502MA name: Placebo measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 28 measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Day 28 measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Day 28 measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 measure: Tmax measure: Css_min measure: Css_max measure: Css_av measure: AUC0-t,ss measure: AUC0-∞,ss measure: AUCtau,ss measure: t1/2 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Shanghai Mental Health Center city: Shanghai state: Shanghai zip: 201109 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06356376 id: UAarhus_AGK_MNG_2 briefTitle: The Effects of Pain and Pain Relief on Peripheral Nerve Excitability overallStatus: RECRUITING date: 2023-12-20 date: 2024-04-30 date: 2024-04-30 date: 2024-04-10 date: 2024-04-10 name: University of Aarhus class: OTHER name: Lundbeck Foundation briefSummary: This study will assess changes in nerve excitability of C-fibers, and changes in sympathetic or parasympathetic tone, when the subject experiences pain and pain relief.
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The investigators will continuously measure blood pressure, heart rate, respiration rate, gastric motility, sympathetic skin response and C-fiber excitability while using thermal stimuli before and after an analgesic. conditions: Analgesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Heat Stimulation measure: C-fiber excitability measure: Action potential duration (ms) measure: Action potential amplitude (V) measure: Heart-rate variability (ms) measure: Blood pressure variability (mmHg) measure: Sympathetic Skin Response (V) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danish Pain Research Center status: RECRUITING city: Aarhus N zip: 8200 country: Denmark name: Alexander G Kristensen, MD,PhD role: CONTACT phone: +45 93 52 28 64 email: [email protected] lat: 56.15674 lon: 10.21076 hasResults: False
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<|newrecord|> nctId: NCT06356363 id: 2023_RIPH_005_OncoPREMs briefTitle: Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway (Onco-PREMs) acronym: OncoPREMs overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-11-01 date: 2025-11-01 date: 2024-04-10 date: 2024-04-10 name: Institut Jean-Godinot class: OTHER name: Université de Reims Champagne-Ardenne briefSummary: Healthcare systems are evolving, giving increasing prominence to the patient-centered model, accompanied by objective and perceived outcomes.
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PREMs (Patient Reported Experience Measures) are used to assess how patients feel about their experience of care. PREMs enable patients to take an active role in their own care, and enable healthcare establishments to identify areas for improvement that can be incorporated into their quality processes.
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In oncology, the collection of patient-perceived quality regarding their care pathway would enable better coordination of their care. While a few initiatives have emerged in the field of PREMs, the development of a reliable questionnaire assessing patient perception of their care pathway in oncology remains a challenge. conditions: Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Data collection measure: Psychometric validation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356350 id: IUC_jia_scoliosis_gait briefTitle: Exercise Programs on Gait in Children With Scoliosis Diagnosed JIA overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-01 date: 2024-04-10 date: 2024-04-19 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk (1). These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA (2, 3). All these situations can lead to scoliosis, which we often encounter in children with JIA. Current studies describing various 3-dimension (3D) exercise methods (SEAS, Schroth, Dobomed, BSPTS, Side-shift, Lyon, etc.) effective on scoliosis (4). However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children with scoliosis diagnosed JIA. conditions: Scoliosis Idiopathic conditions: Juvenile Idiopathic Arthritis conditions: Gait, Frontal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Conventional exercises name: 3D exercises measure: ATR measure: Cobb angle measure: Maximum Loading measure: Center of mass displacement measure: Walking speed sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Istanbul University-Cerrahpasa status: RECRUITING city: Istanbul country: Turkey name: Gökçe Leblebici role: CONTACT phone: 05397395718 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06356337 id: STUDY-22-01199 briefTitle: A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1 overallStatus: RECRUITING date: 2024-02-22 date: 2024-08-31 date: 2025-08-31 date: 2024-04-10 date: 2024-04-10 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: The purpose of this research study is to investigate the relationship between light and circadian rhythms. Twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested. conditions: Alzheimer's Disease conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Light goggles name: Orange glasses measure: Saliva samples for melatonin levels measure: Light exposure using the Speck measure: Sleep time using actigraphy sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Light and Health Research Center status: RECRUITING city: Menands state: New York zip: 12204 country: United States name: Barbara Plitnick role: CONTACT phone: 518-242-4603 email: [email protected] name: Mariana Figueiro role: PRINCIPAL_INVESTIGATOR lat: 42.69202 lon: -73.72456 hasResults: False
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<|newrecord|> nctId: NCT06356324 id: 2021-13347 briefTitle: The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery overallStatus: COMPLETED date: 2021-10-18 date: 2024-01-31 date: 2024-04-01 date: 2024-04-10 date: 2024-04-10 name: Montefiore Medical Center class: OTHER briefSummary: This study investigates whether television viewing or music listening can reduce pre-operative anxiety and improve surgical outcomes for patients undergoing cataract surgery. It aims to determine the effectiveness of these interventions compared to a control group and assess their impact on physiological markers of anxiety as well as the incidence of intra-operative hypertensive events.
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The key questions that are to be answered are:
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1. Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?
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2. Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients? conditions: Anxiety conditions: Intraoperative Hypertension conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants assigned to one of three groups: music listening, tv viewing, or control (waiting with ambient noise) primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 650 type: ACTUAL name: Music Intervention name: Television Intervention measure: Intraoperative hypertensive event measure: Change in VAS-A measurements for Anxiety measure: Change in Heart Rate measurements for Anxiety measure: Change in Blood pressure measurements for Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center city: New York state: New York zip: 10467 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06356311 id: 2870-015 id: 2023-505423-31 type: REGISTRY domain: EU CT id: U1111-1291-7109 type: OTHER domain: UTN id: MK-2870-015 type: OTHER domain: Merck Id briefTitle: A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2027-01-04 date: 2028-05-05 date: 2024-04-10 date: 2024-04-29 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS). conditions: Gastroesophageal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Sacituzumab tirumotecan name: Trifluridine-Tipiracil name: Irinotecan name: Paclitaxel name: Docetaxel measure: Overall Survival (OS) measure: Progression-free survival (PFS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Number of Participants Who Experience an Adverse Event (AE) measure: Number of Participants Who Discontinue Study Intervention Due to an AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06356298 id: MCHH_004 briefTitle: Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-10 date: 2024-04-24 name: Maternal and Child Health Hospital of Hubei Province class: OTHER briefSummary: The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.
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Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .
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The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA. conditions: Anesthesia Intubation Complication conditions: Airway conditions: Adenotonsillectomy conditions: Children studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: Airway Management: Flexible Reinforced Laryngeal Mask Airway name: Airway Management: Endotracheal Tube measure: Peak airway pressure measure: Petco2 measure: Ventilation leakage or not measure: Mean arterial pressure (MAP) measure: Heart rate (HR) measure: Recovery time measure: Extubation time measure: Dosage of anesthetic measure: Success of FLMA or ETT measure: Surgeon satisfaction measure: Adverse events sex: ALL minimumAge: 2 Years maximumAge: 10 Years stdAges: CHILD facility: Maternal and Child Health Hospital of Hubei Province city: Wuhan state: Hubei zip: 430000 country: China lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06356285 id: 6995049 briefTitle: Testing New Ways to Name Antimicrobial Resistance overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-06-01 date: 2024-06-01 date: 2024-04-10 date: 2024-04-10 name: Imperial College London class: OTHER name: The Behavioural Insights Team briefSummary: This study aims to investigate the public's views on antibiotics and the impact of different ways to name the potential consequences of antibiotics not working in the future. It is known that current ways to name this don't resonate well with the public, and the study team have worked with members of the public through focus groups and community workshops to develop new ways of describing this in a process of co-design. This study aims to test four different ways of presenting this potential crisis to the public, some of which are new communication strategies designed by the public themselves, to evaluate which are the most memorable and investigate the impact on behaviour change.
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Adults aged over 18, living in the United Kingdom, who have already signed up to a market panel research company will be eligible to participate in this study.
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